fda consumer, november 1976 · sion of nu vita foods, inc., a health food store in portland,...

[ FDA] NOVEMBER 1976

ONSUMER

Countdown On Color Additives

A

Th i s Mon th

If variety is indeed the spice of life, FDA must rank as oneof the tangiest Federal agencies around. This month'sFDA Consumer, for instance, includes articles on FDAregulatory actions on drugs and on color additives, a reporton the Agency's efforts to keep adulterated food off themarket, and an explanation of when, why, and how products a re reca l l ed .

Two recent FDA actions on drugs illustrate different approaches to the same end: safe, effective, responsible useof prescription medicines. There has been a dramatic increase in the past decade in the use of drugs containingestrogens to treat the symptoms of menopause in women.These drugs can be effective in treating menopausal symptoms, but FDA believes there has been a tendency to usethem more x)ften and for longer periods than is desirable.FDA has taken two steps—one aimed at patients and theother at physicians—to put the use of estrogens in betterperspective. There's a report beginning on page 8.

Almost 18 million prescriptions for propoxyphene werefilled last year. The drug, more familiar under the tradename Darvon, is used to relieve pain. Propoxyphene doesrelieve pain, but there also is disturbing evidence of its potential for abuse. As a result, FDA has recommended thatpropoxyphene be placed under the restrictions of the Controlled Substances Act. For an explanation of what therestrictions would mean, and why they were recommended,turn to page 19.

Technology has a way of creating new problems as wellas solving old ones. Food is a case in point. Advancementsin food preservation and the development of many newfoods have made possible a much more varied diet. Butnew food substances and vastly improved techniques ofchemical analyses have added complex new dimensions tothe old problem of Preventing Food Adulteration, as thearticle on page 10 points out.

One aspect of food technology that has been the subjectof considerable public interest is the use of color additives.Some 80 color additives have had FDA's "provisional" approval for use in food, drugs, or cosmetics. The Agencynow has established a schedule for making a final decisiono n t h e u s e o f a l l o f t h e s e c o l o r s . Yo u c a n c h e c k t h e t i m et a b l e i n C o u n t d o w n o n C o l o r A d d i t i v e s .

Inside Front Cover Photo: An FDA engineer tests a television set to determine what conditions might cause it toemit radiation in excess of the amount permitted by Federalstandards. Vio lat ion of the radiat ion emission standardscould be grounds for a recall. The guidelines that governFDA's role in the recall of products that it regulates arethe subject of an article beginning on page 16.

F D A C o n s u m e r / N o v e m b e r 1 9 7 6 / 1

CoisrSUMERVOL. 10 NO. 9 / NOVEMBER 1976

Update

C o u n t d o w n o n C o l o r A d d i t i v e s

D a v i d M a t h e w s

Secretary, U.S. Department of Health,E d u c a t i o n , a n d W e l f a r e

Theodore Cooper, M.D.Assistant Secretary for Health

Alexander M. Schmidt, M.D.Commissioner of Food and Drugs

J o h n T. W a l d e nA s s i s t a n t C o m m i s s i o n e r f o r P u b l i c A f f a i r s

E l l i s R o t t m a n / E d i t o r

Harold C. Hopkins/Editor ial Director

J e s s e R . N i c h o l s / A r t D i r e c t o r

Frederick L. Townshend/Production Manager

Informing Patients About Estrogens

Preventing Food Adulteration

Clarifying Recall Policies

FDA CONSUMER, the official magazine of theFood and Drug Administration, is publishedmonthly, except for combined July-August andDecember-January issues. Subscriptionsmay be ordered from the Superintendent ofDocuments, Government Printing Office,Washington, D.C. 20402, at $8.55 a year($2.15 additional for foreign mailing).

A d d r e s s f o r e d i t o r i a l m a t t e r s : F D A

CONSUMER, HFI-20, Food and DrugAdministration, 5600 Fishers Lane, Rockville,M d . 2 0 8 5 7 .

Controls Urged on Top Rx Pain Drug

News Highlights

Regional Reports

S t a t e A c t i o n s

Seizures and Postal Service Cases

Text of articles published in FDA CONSUMERmay be republished without permission.C r e d i t t o F D A C O N S U M E R a s t h e s o u r c eis appreciated. Use of funds for printing thispublication approved by the Office ofManagement and Budget November 1, 1972.

FDA CONSUMER was previously known asF D A P A P E R S .Section 705 [375] of the Food, Drug, andC o s m e t i c A c t :

(a) The Secretary shall cause to be publishedfrom time to time reports summarizing alljudgments, decrees, and court orders whichhave been rendered under this Act, includingthe nature of charge and the disposition thereof.

(b) The Secretary may also cause to bedisseminated information regarding food, drugs,devices, or cosmetics in situations involving, inthe opinion of the Secretary, imminent dangerto health, or gross deception of the consumer.Nothing in this section shall be construed toprohibit the Secretary from collecting,reporting, and illustrating the results of theinvestigations of the Department.

Notices of JudgmentCover Design: Zeb Rogerson

2 / N o v e m b e r 1 9 7 6 / F D A C o n s u m e r

Update

FDA to Curb Use of F luorocarbons

Last year a Federal task force recommended thatFDA and other regulatory agencies be ready to moveon a ban of aerosol spray cans if the NationalAcademy*of Sciences confirmed suspicions thatfluorocarbon propellants were affecting theatmosphere. It had been theorized that fluorocarbonsreleased into the atmosphere from spray cans couldcause a reduction in the ozone layer which protectsthe earth from the harmful ultraviolet rays of thesun. The ozone depletion theory, and the steps takenby FDA so it would be ready to act if necessary,were the subject of an article entitled Aerosols,Ozone, and FDA, in the September 1975 FDAConsumer. Here's an update.

The Food and Drug Administration hasannounced its intention to take regulatory action toend the nonessential use of fluorocarbon propellantsin all food, drugs, and cosmetics. Commissioner ofFood and Drugs Alexander M. Schmidt, M.D., saidthe Agency's decision was based on a report by theNational Academy of Sciences confirming thatfluorocarbon propellants used in aerosol productsare damaging the ozone.

Schmidt said FDA would take the followinga c t i o n s :

• Propose an orderly phaseout of all nonessentialuses of fluorocarbon propellants in food, drug,and cosmetic products.

• Pending elimination of fluorocarbon propellants,require an interim warning label on all food, drug,and cosmetic containers using such propellants.

Although the exact language is yet to be workedout, the new labeling will indicate that the productcontains a fluorocarbon which damages thee n v i r o n m e n t .

FDA regulates approximately 80 percentof all products now packaged in aerosol containers.

Schmidt announced the Agency's intentions ina letter to Dr. Russell W. Peterson, chairman ofthe Council on Environmental Quality.

In its report on the effects of fluorocarbons onthe ozone layer, the National Academy of Sciences'(NAS) Committee on Impacts of StratosphericChange said that up to two years of additionalresearch may be needed to better determine the

degree of ozone depletion caused by the propellants.It recommended that final regulatory actions awaitthe resu l t o f that research.

Schmidt said, however, that "a narrowing ofthe probable range of ozone depletion caused bycontinued use of fluorocarbons won't change theultimate regulatory situation.

"G iven t he e f f ec t s on human hea l t h even a two

percent ozone depletion from 'unessential' usesof fluorocarbons is undesirable," he said.

"The known fact," added the Commissioner, "isthat fluorocarbon propellants primarily used todispense cosmetics are breaking down the ozonelayer. Without remedy, the result could be profoundadverse impact on our weather and on the incidenceof skin cancer in people. Its a simple case ofnegligible benefit measured against possible catastrophic risk, both for individual citizens and forsociety. Our course of action seems clear beyondd o u b t .

"My conclusion, [therefore,] is that FDA shouldset in motion the regulatory processes for whichit is responsible in order to begin the reduction ande v e n t u a l e n d t o t h e n o n e s s e n t i a l u s e s o f fl u o r ocarbons in food, drug, and cosmetic products."

Commissioner Schmidt emphasized that thephaseout program for prohibiting nonessential useof the suspect propellants in food, drugs, andcosmetics would be developed on the basis of reasonable regulation and minimum cost to consumers.

The phaseout will not involve product recalls.Schmidt also said that the Agency will work with

industry to assure that adding the interim warninglabels will be done in the easiest and least expensiveway. One possibility is printing the warning onspray can caps or using stick-on labels.

Details of the phaseout and labeling plans willb e d e s c r i b e d i n F e d e r a l R e g i s t e r a n n o u n c e m e n t s .The first announcement will describe the labelingprogram, and state the Agency's commitment tothe phaseout plan. A second document will explainthe phaseout in detail. The first document wasexpected to be ready by mid-November; the secondw i l l f o l l o w a f e w w e e k s l a t e r.

The NAS Committee report said that any regulat i o n o f fl u o r o c a r b o n s s h o u l d t a k e i n t o c o n s i d e r a t i o nthe importance of each use of fluorocarbons tohuman life, with some uses, including those for


medicinal purposes, meriting special consideration.A Federal Task Force on Inadvertent Modifica

tion of the Stratosphere (IMOS), created in 1974to study the fiuorocarbon-ozone problem, voted toaccept the NAS Committee report on the basis ofits scientific merit, but recommended that Federalagencies begin immediately to initiate rule-makingprocedures to regulate fiuorocarbon uses.

Foods, drugs, and cosmetics using aerosol spraypropellants are regulated by FDA. Pesticides arethe responsibility of the Environmental ProtectionAgency, while the mechanical aspects of spray cansare controlled by the Consumer Product SafetyC o m m i s s i o n .

Aerosol sprays account for about 74 percent ofall fluorocarbons released into the atmosphere.Air conditioners, refrigerators, and freezers areresponsible for 14 percent of all fiuorocarbonreleases, and foams account for about 12 percent.O f fl u o r o c a r b o n s r e l e a s e d f r o m a e r o s o l s a l m o s t 6 0

percent come from antiperspirants, deodorants, andhair sprays. Medical products are responsible forabout 2 percent of aerosol fiuorocarbons. Otherproducts that use fiuorocarbon propellants includefoods, insecticides, laundry products, room deodorants, paints, waxes, and cleaners.

Among its recommendations, the NAS committeecalled for legislation giving Government agenciesauthority to act against fluorocarbons; for labelingof all products containing fluorocarbons as a guideto consumers; and for more research, particularlyin the areas of climate and climatic change, and theeffects of ultraviolet radiation on plants and animals.

Because o f concern that the increase in u l t rav io le tradiat ion as a resul t o f ozone reduct ion wi l l lead tomore cases of skin cancer, the Committee alsorecommended development of programs to teachsusceptible people how to protect themselves fromthe harmful rays of the sun.

Mercury Lamp Safety Criteria ProposedA Ithough they may not know what they are, most

people have seen mercury vapor lamps. These lampsare commonly used for street lights and parkingareas, and are being increasingly used to lightgymnasiums, sports arenas, department stores, andother commercial and industrial facilities. They arehighly efficient and long lived, but as an article(Shedding Some Light on Light) in the September1976 FDA Consumer pointed out they can pose apotential health hazard. Here's an update.

The Food and Drug Administration has proposedsafety criteria to protect consumers from possibleexposure to ultraviolet light from damaged mercuryvapor lamps.

The action is designed to be an interim measure toprotect consumers from potential hazard fromdamaged lamps while a formal performancestandard is developed. Because of the need for FDAto follow specific administrative requirements inissuing the standard, the process could take as longas two years.

Mercury vapor lamps are recognizable becausethey produce a bluish-white light. FDA estimatesthat 25 million lamps are now in use in theU n i t e d S t a t e s .

The lamps pose a hazard when the outer globe isbroken. When this occurs, intense ultraviolet lightcan escape from the inner bulb. Exposure canproduce severe eye irritation and sunburn-likereddening of the skin around the face and shoulders.

The safety criteria FDA has proposed wouldeliminate the potential hazard by having the lampsgo off within two minutes after the outer globe isbroken. Lamps that do not meet the safety criteriawould be considered defective by FDA and orderedoff the market under the Radiation Control forHealth and Safety Act.

Alexander M. Schmidt, M.D., Commissioner ofFood and Drugs, said: "The problem posed bydamaged mercury vapor lamps concerns us becausemost people are not aware that the exposed corebulbs can emit potentially-harmful ultraviolet light.We are asking all manufacturers to act as quickly aspossible to meet the safety features we are proposing.In the meantime, we will proceed as rapidly as wecan to develop a mandatory standard."

FDA has twice alerted all State and local healthofficials to the potential problem, in December 1974and again in May 1976. A notice to physicians aboutthe problem was published in the Journal of theAmerican Medical Association, October 13,1 9 7 5 .

The proposed interim criteria was published inthe Federal Register, Friday, October 8, 1976.Comments will be accepted until December 7 andmay be submitted to the Hearing Clerk, Room 4-65,5600 Fishers Lane, Rockville, Maryland 20857.


C o u n t d o w nO n C o l o rA d d i t i v e s

FDA has banned the use of carbonblack and Red No. 4, two colors thathave been used in food, and withdrawnapproval of 10 cosmetic colors. Atimetable has been established forsubmission of test data to FDA on52 other color additives so the Agencycan make a final decision on whetherto permit their continued use. Theseactions are part of a major FDA effortto clear the decks of color additivesthat have received only provisionalapproval for use in food, drugs, andcosmet i cs .

by Flarold Hopkins

FDA has begun the countdown on aseries of actions that will producea fi n a l d e t e r m i n a t i o n o n t h e s t a t u s o fm o r e t h a n 8 0 c o l o r a d d i t i v e s t h a t f o rsome years have had the Agency's provisional approval for use in food,drugs, and cosmetics. When the actionsare completed all provisionally approved color additives will have received FDA's full blessing or havebeen ou t l awed .

The countdown began September 23w h e n F D A a n n o u n c e d t h a t :

• The color carbon black no longercould be used in food, drugs, or cosmet ics .

• T h e c o l o r F D & C R e d N o . 4 n o

longer could be used in maraschinocherries or ingested drugs.

• Provisional approval for 10 substances used only in cosmetics wouldbe withdrawn in 30 days because thepetitions requesting approval of theses u b s t a n c e s h a v e b e e n w i t h d r a w n .

• "Permanent" approval would begranted by the end of the year for 20colors on the provisional list which areused only in cosmetics or externallyapplied drugs and which are considered safe for these uses.

• Provisional approval will be continued for a specified time for 52 othercolors—only three of which are provisionally permitted for use in food—if industry conducts specific additionaltests or supplies other information considered necessary to establish safe conditions for their use. There are no significant questions about the safety ofany of these 52 colors, but additionali n f o r m a t i o n i s n e e d e d b e f o r e F D A c a ndecide whether they can be "permanently" approved under requirementsof the Food, Drug, and Cosmetic Act.

In publishing its package of regulations and proposals in the September2 3 F e d e r a l R e g i s t e r, F D A m o u n t e da large scale assault on the list of colorsthat were given provisional approvalu n d e r t e r m s o f t h e C o l o r A d d i t i v eAmendments of 1960. This legislationauthorized FDA to permit color addit i v e s i n u s e a t t h e t i m e t h e l a w w a se n a c t e d t o c o n t i n u e t o b e u s e d o n a

provisional basis pending settlement ofsafety questions.

A large number of colors have beencarried on the provisionally approvedlist since passage of the 1960 law without definite resolution of their safetystatus. Increasing public concern aboutchemical additives in food, drugs,and cosmetics and their relationship tot h e o c c u r r e n c e o f c a n c e r o r o t h e rhealth problems caused FDA to re-

In publishing its package of regulations and proposals, FDA mounted alarge-scale assault on the list ofcolors that were given provisionalapproval under terms of the ColorAdditive Amendment of 1960.

examine the status of all provisionallyapproved colors and to develop atimetable for making final determinations about their safety.

The law requires the sponsor of acolor additive to submit information toFDA on the additive's chemistry andtoxicity and on how it would be usedin food, drugs, or cosmetics. The lawpermits the use in food, drugs, or cosmetics only of color additives that havebeen evaluated and for which conditions of safe use have been prescribedin regulations. Under the color additive regulations FDA may permit theuse of a color in foods or drugs or cosmetics or any combination of the three.

Additives that have been given provisional approval under the 1960 lawmay continue to be used only whilestudies are being conducted and whiledata are being obtained and reviewedby FDA for "permanent" approval ofthe additive. In addition, a provisionally approved color additive may continue to be used only as long as FDAis satisfied that its use does not presenta risk to the public.

Increased public interest in coloradditives dates from reports a fewyears back of studies which raisedquestions about the safety of a colorcalled Red No. 2, then widely used infoods and drugs. Red No. 2 has beent a k e n o f f t h e m a r k e t a n d i t s c o n t i n u e duse prohibited by FDA because nos t u d i e s w e r e a v a i l a b l e t o r e s o l v e t h e

safety questions.In its September 23 order banning

carbon black, use of which dates backb e f o r e e n a c t m e n t o f t h e C o l o r A d d i

tives Amendments of 1960, FDA saidthat industry has been unable to assurethe Agency that carbon black containsno extractable polynuclear aromatichydrocarbons (PNA's) some of whicha r e k n o w n t o c a u s e c a n c e r . C a r b o nblack had been used in candies such asblack jelly beans and licorice, as an inkfor identifying drug tablets or capsules,and in cosmetics such as eye shadowa n d m a s c a r a .

FDA's ruling of September 23 onRed No. 4 ended provisional authorityfor its use for reddening maraschinocherries and for use in drugs taken internally. In the future. Red No. 4 maybe used only in drugs and cosmeticsthat are applied outside the body, forwhich it will have "permanent" listing.

Red. No. 4 was first permitted to beused in food in 1929 and in drugs andc o s m e t i c s i n 1 9 3 9 . I t w a s d e l e t e d f o ruse in foods and ingested drugs andcosmet ics in 1964 a f te r i t was found to

produce adverse effects in dogs insafety studies. The following year, atthe request of industry and on the basisof preliminary data, FDA permitted itsu s e i n m a r a s c h i n o c h e r r i e s a f t e r c o n

cluding this limited use would not beharmful to the public. FDA also permitted its use in ingested drugs takenf o r s h o r t t e r m s o f s i x w e e k s o r l e s safter determining that consumptionwas likely to be minimal.

After a subsequent study that stillfailed to establish the safety of RedNo. 4 and after those requesting thatit be "permanently" approved failed toa c t o n F D A ' s n o t i c e t h a t n e w s t u d i e swere needed, FDA decided to end pro-


The law permits the use in food,drugs, or cosmetics only of coloradditives that have been evaluatedand for which conditions of safe usehave been prescribed in regulations.

visional listing of Red No. 4 for thesetwo remaining ingested uses and permit its use only in externally applieddrugs and cosmetics.

The 10 substances deleted by FDAfrom the list of provisionally approvedcolors as of October 26 are aluminumstearate, bentonite, calcium silicate,calcium stearate, gold, kaolin, lithiumstearate, magnesium aluminum silicate,magnesium stearate, and zinc stearate.The Cosmetic, Toiletry, and FragranceAssociation (CTFA) originally hadpetitioned for "permanent" approval ofnine of these colors but requested withdrawal of its petitions when a surveydisclosed that none of its member firmsare using any of the substances ascolors, although they are used for othertechnical purposes. In deleting thesenine from provisional listing, FDA hasincluded a tenth, gold, for which nopetitions for "permanent" approvalhave been submi t t ed .

FDA concluded that the safety of20 colors for their petitioned uses hasbeen adequately demonstrated and expects to give them "permanent" listingby the end of this year. Of these 20colors, 10 are for externally applieddrugs and cosmetics and 10 for externally applied cosmetics. Seven of thelatter 10 are for use in the eye areaand two of these seven are also for usein cosmetics that may be ingested.

Of the 52 colors that will continueto be provisionally approved, FDA willrequire short term animal studies forsome and long term studies for others.Various dates between July 1, 1977,and December 31, 1980, have been

proposed as deadlines for deletingthese colors from the provisional listand either adding them to the "permanent" list or, if safety has not beenestablished, ending their use. FDA willrequire long term toxicity studies for31 of the colors. For these, the deadline proposed for deletion from provisional listing was December 31, 1980.FDA said that available studies of theseco lors show no adverse e f fec ts . But thestudies are deficient by today's standard's and therefore inadequate toserve as a basis for concluding that thecolors should be "permanently" approved.

Additives that have been given FDAapproval under the 1960 law often arereferred to as having been granted"permanent approval" or "permanentlisting" to distinguish them from additives that have provisional listing. Thelaw actually does not provide for"permanent" approval or listing. It permits "provisional listing" pending completion of required safety studies forcolors that were in use at the time thelaw was enacted, and "listing" for colors that have fully satisfied the testingrequirements.

FDA has pointed out that it is alsoengaged in a review of the data thatsupported approval of many food additives as well as color additives whichhave been approved for regular instead of provisional status, and may inthe future require additional data ont h e m .

Harold Hopkins is editorial director ofF D A C o n s u m e r


Concern about the extended use ofestrogens during and after the menopause has led FDA to propose abrochure that patients would receivewhen they have an estrogen prescription filled. The proposed brochure tellspatients in plain language the benefitsand risks of using estrogens so theyare better able to decide for themselveswhether they want to use these drugs.

Few drugs have generated morecontroversy and emotion thanestrogens. Estrogens are femalehormones. They are used in treatingthe symptoms of menopause, andin the treatment of certain diseases.In the past they were prescribed tohelp prevent miscarriage.

Much of the controversy surrounding the proper use of estrogens stemsfrom the fact that all drugs entailr isks as wel l as benefits. With most

drugs, the risk must be measuredagainst the benefits derived fromeffect ive t reatment of a d isease or

injury. But as Commissioner of Foodand Drugs Alexander M. Schmidthas pointed out, "Estrogens are different from many other drugs in thatthey are given to otherwise healthywomen undergoing the natural processof menopause. The FDA believes itessen t ia l tha t women be in fo rmed andthat they decide for themselves ifthe r isks are wor th the benefits . "

A n e s t i m a t e d 5 m i l l i o n w o m e n

annually take estrogens for menopausal symptoms. Many have continued taking the drug after menopauseunder the illusion that it will prolongtheir youth. At the same time, research scientists have been comingup with some disturbing information.A number of recent studies have produced ev idence t ha t women whotake estrogens for more than a yearhave an increased risk of developingcancer of the endometrium—the liningof the uterus—compared with women

who do not take estrogens. Otherstudies have shown that daughters ofwomen who were given one particularestrogen—diethylstilbestrol (DES)—to prevent miscarriage have an increased risk of developing a formof vaginal or cervical cancer that isotherwise extremely rare. There alsohave been reports suggesting that useof estrogens during pregnancy islinked with congenital birth defects.

To be sure that both physiciansand patients fully understand the risksas well as the benefits of estrogens,FDA has proposed two new requirements for labeling of these drugs. First,FDA has ordered immediate revisionof the labeling or prescribing information that physicians receive aboutestrogens. Manufacturers are to printand distribute the revised labelingby the end of November 1976.

In a second action, FDA proposeda new brochure to be given to patientsat the time they have estrogen prescriptions filled. The full text of theproposed patient brochure was published in the Federal Register,September 29. Public comments arebeing sought on the brochure andshould be submitted to the HearingClerk, Food and Drug Administration,Room 4-65, 5600 Fishers Fane,Rockville, Maryland 20857. Thedead l i ne f o r commen ts i s November28. In the meantime, manufacturersare being encouraged to distribute thebrochure even while public reactionis being sought.

Both the physician and proposedpatient labeling make the followingpoints:

• If estrogens are used for morethan a year to treat the symptoms ofmenopause, there is an increased riskof cancer of the uterus in the user.The risk of cancer appears to begreater the longer estrogens are usedand the higher the dose. Thus, itis important that if women take estro

gens they take them in the lowestpossible dose that will control symptoms and only as long as the drug isneeded. Physicians should reevaluatethe need for continuing estrogentreatment at least every six months.

• Women should be examined bytheir physicians no less than onceevery six months while takingestrogens.

• Pregnant women should neverbe given estrogens. Estrogens maydamage the offspring.

• In general, estrogens should notbe taken by women with breast oruterine cancer, undiagnosed abnormalvaginal bleeding or clotting in thelegs or lungs, or by women who havehad heart disease, angina (chestpains), or a stroke.

• Estrogens should not be used totreat simple nervousness duringmenopause, because they have notbeen shown to be effect ive for that

purpose. Neither have estrogens beenshown to keep the skin soft or tokeep women feeling young.

The physician labeling particularlyemphasizes, in a boxed warningrequired to appear in a bold facetype, that estrogens have been reported to increase the risk of cancerof the uterus and should not be usedduring pregnancy. The box warningsays that there is no evidence thatestrogens are effective in preventingthreatened or habitual miscarriage.

The physician labeling specifies thatestrogens given to women during orafter menopause should be used onlyto t rea t modera te to seve re vasomoto r

symptoms—commonly called "hotflashes" or "hot flushes." The physician labeling further recommends thatestrogens be given cyclically—threeweeks on the drug, followed by oneweek off—and that the drug shouldbe discontinued or reduced in dosageat 3 - to 6 -month in te rva ls to de te rminewhether i t is st i l l needed.

Earlier this year, FDA commun i c a t e d t h e i n f o r m a t i o n c o n t a i n e d i nthe new labeling to all physicians andother health professions via the DrugBulletin, an FDA publication thatgoes to 700,000 health professionals.

The new labeling applies to allprescription drugs containing estrogens except for birth control pills anddiethylstilbestrol when used as anemergency contraceptive after intercourse. Special patient brochure requirements already have been established for these drugs. The patientbrochure for birth control pills, nowbeing revised, has been in use since1970 when FDA began its programcalling for special patient brochuresfor selected prescription drugs.

In announcing the new labelingrequirements, FDA CommissionerSchmidt said: "Estrogens are valuabledrugs. They are needed when thesymptoms of the 'change of life'become severe. FDA's purpose isto keep these drugs on the market butto reduce ove ruse and m isuse . "


Preyenting IbodA d u l t e i a t i o fi

There's nothing new about foodadulteration; the ancient Romanscomplained of it. But there is moreto adulteration now than there wasthen because technology has createdmany new substances that are used onand in food and which may adulterateit. And methods of detection are farmore sophisticated and sensitive todaythan they were even a few decades ago.FDA's primary way of dealing withthis age-old problem is to emphasizepreventive measures so offending products don't reach the marketplace.

by Emil Corwin

The inspector poured a little ale on awooden bench and sat on the wetspot. If his leather breeches stuck tothe bench, it showed the ale was adulterated with sugar, and the adulteratorwas fined. Such was the test for thepresence of sugar, an illegal additive inale, in early England.

Today's chemists, with no discomfor t , can detect and measure someadulterants in a product if it containsa hundreth of a part per million.

Despite the fantastic leap in testingprocedures, adulteration remains a major problem. For many years after theFood and Drug Administration wasestablished, its principal activity wasto discover and in i t iate court act ionagainst adulterated or misbranded foodand drug products. This activity continues, but with an important shift inemphasis. Instead of taking action afterthe adulteration has happened, FDAis broadening its efforts to prevent itfrom happening in the first place.

Nevertheless, the adulteration prob

lem persists; 80 percent of FDA courtactions each year involve food adulteration. Why is this happening?

One reason is that the growth oftechnology has made possible an enormous array of dyes, preservatives,emulsifiers, and similar agents for usein food. This in turn has created anew set of problems which involvesestablishing criteria for determining thesafety of these additives in food. Usedin safe quantities, additives are usefuland necessary; otherwise their presencein food constitutes adulteration.

Another reason for the cont inuedoccurrence of adulteration is that theterm itself covers a lot of ground. Forexample, a food which itself may notbe contaminated, may be consideredadulterated if it is produced or packedor held in an unsanitary environment.

Not all adulteration of food involvessubstances that are added or that getinto food incidentally as a result of themanufacturing, processing, or packaging or because the food is stored orshipped under insanitary conditions.Adulteration also may be caused bycertain molds or toxicants that occurin such foods as corn, peanuts, rice,oats, and other staples, usually as aresult of improper storage conditions.Affatoxin, which has been shown tocause cancer in laboratory animals, isproduced by a mold that grows on peanuts, corn, and similar crops. Whereit can be shown analytically that affatoxin is present in these foods they areregarded as adulterated and subject toregulatory action.

Some idea of the diversity of violations that comes under the heading ofadulteration may be seen in any typi

cal listing of seizure or prosecutionactions taken by FDA. ^'Adulteration"was charged in each of the followinga c t i o n s :

• A v i tamin tab le t tha t con ta ineda n u n s a f e f o o d a d d i t i v e .

• F i s h t h a t c o n t a i n e d a n e x c e s samount of mercury.

• I c e c r e a m t h a t c o n t a i n e d c o u m a -

rin, a food additive, which was notused in conformity with regulations.

• A frozen food product found tohave an excess of '1ce glaze."

• Various food products containingdecomposed materials, or metal fragm e n t s , o r i n s e c t i n f e s t a t i o n .

• Candy and ice cream that contained the color additive Red No. 2 after an FDA ban on that substance became e f fec t i ve .

• Vegetables found to contain a pesticide in excess of tolerance levels.

To help industry fulfill its responsibility to grow, process, and marketfood that is safe and wholesome, FDAhas promulgated Good ManufacturingPractice (GMP) Regulations to provide guidelines for sanitation and product integrity.

Adulteration of food and drink is anage-old problem. The Roman author,Pliny the Elder, complained of dealersw h o a d u l t e r a t e d w i n e w i t h w a t e r i nthe proportion of 20 parts of water toone of wine, and added "smoke andnoxious herbs" for flavor and color.

The 16th century churchman MartinLuther was contemptuous of merchantswho placed pepper, ginger, saffron,and other spices in damp vaults to increase their weight. "There is not asingle article," he wrote, "out of whichthey cannot make a profit through false

1 0 / N o v e m b e r 1 9 7 6 J F D A C o n s u m e r

Tracking down adulterated food occupied much of FDA's time during theAgency's early years. In 1910, FDAdiscovered that reject eggs were beingcollected and processed for use inbakery products. The telltale smell ofthe bad eggs would "bake out." Eggcandlers (top)—people who gradedeggs for freshness and quality—wereone source of the rejects. The adulterated eggs were seized by FDA inspectors and U.S. marshals (center photowearing derby hats) and destroyed inan open diunp.

I ' D A C o n s u m e r / N o v e m b e r 1 9 7 6 / I I

Today's scanning electron microscopes can magnify 62,000 times,making it possible to "see" and photograph particles as small as eight-millionths of an inch. The micro-photography equipment first used byF D A t o d e t e c t a d u l t e r a t i o n c o u l d

magnify only about 200 times, but itproduced remarkably clear picturesand made a major contribution tofood and drug standards of purity.These photo-micrographs—made in1907 by B. J. Howard, developer ofthe equipment—show pepper adulterated with ground olive pits (left) andpepper adulterated with bran flour.The man shown adjusting one of theearly microphotography cameras isn o t H o w a r d .

o t

$

1 2 / N o v e i n l j e r 1 9 7 6 / F D A C o n s u m e r

Spinach pickers work in a producewarehouse i n 1910 . Unde r t he 1906

food and drug law the Government hadto find out that a food itself actuallywas contaminated before it could betaken off the market. It wasn't until the1938 law was passed that food becamelegally adulterated because it was produced under insanitary conditions.

measuring, counting or by producinga r t i fi c i a l c o l o r s . T h e r e i s n o e n d t otheir trickery."

I n t h e w o n d r o u s w o r l d o f 1 9 t h c e n

tury adulterants one finds such intriguing names as sloe, annatos, quassia, mangel-wurzel, catechu, litharge,coccLi lus indicLis for hard mul tum),hartshorn shavings, flash, and stuff.Some adu l te ran ts , l i ke coccu lus , ablack extract used by tanners anddyers, but also used in brewing beer,are as poisonous as they sound.

O t h e r a d u l t e r a n t s , l i k e r o a s t e d ,ground horse or ox liver, or mahoganysawdust, al l of which were used ascoffee extenders, cheated the consumerbut posed no great danger to health.Those who drank some other beveragesat times ran the greater health risk.

Exhaus ted t ea l eaves co l l ec ted f r om

inns, taverns, etc. , were somet imescolored with poisonous lead and copper compounds and sold as new tea.

White wine was at times spiked withdangerous lead preparations to clearmuddiness as well as to prevent itfrom turning vinegary.

Beer, which in some countries rankedsecond to bread as a necessity of life,has had a long history of adulteration. A century ago chemicals of varying degrees of toxicity were added tobeer to age it, color it, disguise thetaste of sour and insipid brews, andenhance its foamy qualities. The chemical picrotoxin in that period concealedt h e a d d i t i o n o f w a t e r — a c a s e o f o n eadulterant used to cover up another.

As scientific research progressed,some substances thought to be safe foru s e i n f o o d w e r e f o u n d t o b e h a z a r d

ous. In 1966, for example, an outbreak of heart attacks among heavybeer dr inkers in Quebec led to thediscovery that cobalt sulfate, a chemical additive used to improve foamstability, was a causative factor in 40illnesses, of which 18 ended fatally.F D A t h e r e a f t e r b a n n e d i t s u s e i n a l lfermented malt beverages. Again, inJuly 1976, the chemical trichloroethy-lene (TCE), used as a solvent in themanufacture of modified hop extractfor beer production (and as a decaffein-ating agent in coffee) was found tocause l i ve r cancer in m ice . As soon asan order can be drafted, FDA will propose a ban on the use of TCE in food.

The historical turning point in thefight against adulteration probably began with Frederick Accum's "Treatiseo n t h e A d u l t e r a t i o n o f F o o d a n d C u l

inary Poisons," published in Londoni n 1 8 2 0 . T h e T r e a t i s e b e c a m e a n i nstant best seller. Within three years itwent through four editions, was translated into several foreign languages,and a reprint edition published in Philadelphia was reviewed widely and favorably throughout this country.

One rev iewer w i t h a sense o f wh im

sy, after describing the practices ofadulterators revealed by Accum, wrote."It is so horribly pleasant to reflecthow we are in this way be-swindled,betrayed, be-drugged and be-devilled,that we are almost angry with Mr.Accum for the great service he hasdone the community by opening oureyes, at the risk of shutting our mouthsf o r e v e r . "

Accum, a chemist , descr ibed howbread, tea, coffee, beer, wine, salad oil.

cream, spices and other "articles ofs u b s i s t e n c e " w e r e d e b a s e d w i t h f r a u dulent and sometimes dangerous ingred i e n t s . H e w e n t f u r t h e r . H e l i s t e d t h en a m e s o f m e r c h a n t s c o n v i c t e d o f t r a f

ficking in illegal adulterants, cited thek inds o f adu l te ran ts used , and theamoun ts o f t he fines assessed fo r t he i roffense. For his pains in producingwhat is regarded as the first seriousw o r k o n a d u l t e r a t i o n , A c c u m w a sforced to ffee England. The threat oflawsuits by irate food dealers was toomuch for the young chemist to bear.

Accum obviously was ahead of histime. Today, FDA regularly publishesnames of firms involved in seizures,prosecutions, injunctions, product corrections, and recalls.

H o w d o e s o n e d e fi n e a d u l t e r a t i o n ?The question is probably more difficultto answer today than in 1906 when thefirst U.S. Federal pure food and druglaw was passed. With the availabilityof modern sensitive equipment to det e c t i n fi n i t e s i m a l t r a c e s o f c o n t a m inants, how should l imi ts be set , forexample, on poisonous or deleterioussubstances, such as mercury or kepone,that get into the environment and theninto food. Or, in manufacturing, howmuch foreign matter should be allowedin processed food products?

When more sensitive equipmentmakes it possible to find small traceso f c o n t a m i n a n t s t h a t a r e t h e m s e l v e sharmless—such as insect fragments—the problem for FDA is to determinethe legally unacceptable, or adulteration, level. On the other hand, when acontaminant poses a safety hazard—such as mercury in fish—a maximum

I ' D A C o n s u m e r / N o v e m b e r 1 9 7 6 / 1 3

Food can be adulterated by substances that get into itfrom the packaging material. Here, a chemist fromFDA's packaging laboratory conducts a test to determine if a substance from a food packaging material willmigrate into food.

The term adulteration covers a variety of violations offood regulations, and there are a variety of ways todetect it. Sometimes a simple visual examination isettough; in other instances laboratory analyses arerequired. FDA even has people trained to smell food—they are called organoleptic experts—to determine ifi t is adul terated.

1 4 / N o v e m b e r 1 9 7 6 / F D A C o n s u m e r

FDA has increased its inspections offood processing plants and warehousessubstantially in recent years. Foodbeing processed or stored in thesefacilities is sampled to check fora d u l t e r a t i o n .

a l l o w a b l e l e v e l i s e s t a b l i s h e d t h a t i sf a r b e l o w t h e a m o u n t k n o w n t o b eharmful in humans. For example, FDAcons ide rs fish adu l te ra ted i f i t con ta insmore than 0.5 parts of mercury per 1million parts of the edible portion offi s h . S t u d i e s h a v e i n d i c a t e d t h a t t h etoxic level is well above that figure.The 0.5 level provides a comfortablemargin of safety. For some substancesthere is no acceptable level. FDA regulations stipulate, for instance, that thepesticide dieldrin makes a food unacceptable for human consumption ifthere is any detectable amount in thef o o d .

It is unfortunately a fact that manylaws to protect the public have beenenacted only after repeated findingsand warnings that consumers were being exposed to hazardous products orafter a major catastrophe or tragedyoccurred. The original Federal Foodand Drugs Act of 1906 was such a law.It was enacted only after a long campaign and numerous exposes aboutAmericans being killed or injured byfoods inadequately processed and preserved with such dangerous additivesas fomialdehyde, sulphurous acid, andcopper sulfate. Drugs were alsodangerously adulterated with alcohol,opium, and substances made from coalt a r .

An eyelash dye that blinded a woma n i n t h e 1 9 3 0 ' s l e d t o i n c l u s i o n o f acosmetics section in the Federal Food,Drug, and Cosmetic Act of 1938. TheAct itself, which required that thesafety of new drugs be established byscientific studies before they are marketed, was enacted largely as a resultof the death of more than 100 people

f r o m a n e l i x i r o f s u l f a n i l i m i d e .T h e 1 9 3 8 l a w s t i l l i s t h e b e d r o c k o f

FDA's regulatory system. Over theyears, however, there has been an evolution in the way the law is enforced.There is now much greater stress onpreventive enforcement, on keepingproducts that violate the law fromreaching the marketplace, rather thantaking action after they have been soldand caused an injury or illness or resulted in a complaint from a consumer.Among developments that have reinforced preventive action:

• The requirement that processorsbear the burden of proving food andc o l o r a d d i t i v e s a r e s a f e b e f o r e s u c hadditives are used in food products.

• The requirement that canners oflow-acid foods file a description of theircanning processes with FDA. If a process is found inadequate to insure thatthe food is safe, the inadequacies mustbe corrected before FDA will permitthe food to be shipped in interstatec o m m e r c e .

• Approximately 1,100 employeesh a v e b e e n a d d e d t o F D A ' s s t a f f i n t h e

past four years to inspect food plantsand identify those operating under insanitary conditions. The number offood inspections has increased fromabout 8,000 in 1972 to over 14,000 in1 9 7 5 .

• New and improved analyticalm e t h o d s h a v e e n a b l e d F D A t o d e t e c t

up to 150 pesticide compounds whichmay be present at low levels in food.

• Better methodologies have beendeveloped for detection of toxic heavymetals, toxic animal drug residues, andh a r m f u l i n d u s t r i a l c h e m i c a l s .

• Food monitoring sampling pro

c e d u r e s h a v e b e e n b r o a d e n e d t o i nc l u d e w h a t i s k n o w n a s a t o t a l d i e t

survey. This entails the retail purchaseby FDA of a two weeks' supply offood based on the average diets ofc h i l d r e n a n d a d u l t s . T h e s e f o o d s a r ecooked or otherwise prepared as isnormally done for meals and then analyzed for industrial chemicals, pesticides, heavy metals, and other contaminants. There are strong indicationsthat such monitoring of food contaminants has already contributed to ther e d u c t i o n o f l e v e l s o f s u c h c o n t a m in a n t s .

• A food surveillance bill now beingconsidered in Congress would strengthen FDA's ability to protect consumersfrom adulterated food by extendingthe Agency's now limited authority toinspect food plants. FDA inspectors,for example, are not entitled to inspectrecords showing source of materials,quality controls, etc. The new bill, already passed by the Senate, is designedto remedy these weaknesses.

For more than 70 years FDA hasb e e n t h e N a t i o n ' s f r o n t l i n e o f d e f e n s e

against adulterated food. It still is today, and these defenses are busier nowthan ever. That does not mean, however, that food is more dangerous thanever, or that more mistakes are beingmade. On the contrary, it means thatas new and more sophisticated methodsof research and analysis are developedthey are being put to work in behalf oft h e A m e r i c a n c o n s u m e r .

Emi l Corwin is a pub l ic in format ionspecialist with FDA's Office of PublicAffairs.

I - D A C o n s u m e r / N o v e n t h e r 1 9 7 6 / 1 5

Clari^lngRecal l Pol icies

Recalls are among the most publicizedand least understood of FDA's activities. Now FDA has proposed regulations that—for the first time—spellout the specific responsibilities ofmanufacturers, distributors, and FDAin conducting a product recall.

by James Greene

CCT7DA Announces Reca l l o f Con-l a m i n a t e d C o s m e t i c s "

"Label Mixup Forces Recall of 29,-0 5 5 B o t t l e s o f P i l l s "

" F D A A n n o u n c e s R e c a l l o f H e a r t

Drug"" F D A O r d e r s P e a n u t B u t t e r R e c a l l "T h e s e a n d s i m i l a r h e a d l i n e s t h a t

crop up regularly in newspapers and onnews broadcasts emphasize the keyrole FDA plays in protecting consumers against defective products.Most of FDA's regulatory programsare designed to prevent defective foods,drugs, and medical devices from everreaching the marketplace by assuringthat they are manufactured and processed properly. But when dangerousproducts do get on the market FDA'simmediate concern is to get them offquickly and efficiently. Usually, thebest way to accomplish this is througha reca l l .

Because recalls involve productsth a t a r e d e fe c t i ve a n d so m e t i m e s d a n

gerous, they often are a newsworthyaspect.of FDA's activities. They alsoare one of the least understood aspects,not only by consumers but often by thenews media and occasionally even bythe regulated industry. The headlineabove reporting that FDA ordered apeanut butter recall is a good example.It appeared in a major daily newspaperbut it is wrong in indicating that FDAc a n " o r d e r " a r e c a l l . F D A h a s n o a u -

1 6 / N o v e m h e r 1 9 7 6 / F D A C o n s u m e r

thority under the Federal Food, Drug,and Cosmetic Act to order a recall, although it can request a firm to recalla product.

In an effort to make its policies andprocedures better understood, FDAhas proposed regulations which detail—for the first time—the specific responsibilities of manufacturers, distributors, and FDA in conducting a produ c t r e c a l l .

The proposed regulations were publ i s h e d i n t h e J u n e 3 0 F e d e r a l R e g i ster with 90 days allowed for comments by industry and the public. FDAnow is reviewing the comments received before issuing final regulations.

Most recalls of products regulated

and expense for all product recalls. Under the proposal, manufacturers anddistributors would be urged to developdetailed contingency plans for productrecalls which could be put into effectw h e n e v e r n e e d e d . I f a r e c a l l w e r e r e

quired, the manufacturer or distributorw o u l d b e a s k e d t o s u b m i t t o F D A

periodic status reports detailing theprogress of the recall and would beresponsible for follow-up checks on therecall's success in removing the produ c t f r o m t h e m a r k e t .

The proposal calls for establishmento f a H e a l t h H a z a r d E v a l u a t i o n C o mm i t t e e i n e a c h o f F D A ' s s i x b u r e a u s —

Foods, Drugs, Veterinary Medicine,Radiological Health, Biologies, and

Spoiled CookiesandGrapehuit Juice Are Recalledby FDA are carried out voluntarily bythe manufacturer or distributor of theproduct. In some instances, a companydiscovers that one of its products isdefective and recalls it entirely on itsown. In others, FDA informs a company of findings that one of its productsis defective and suggests or requests arecall. Usually, the company will comply; if it does not FDA can seek acourt order authorizing the FederalGovernment to seize the product.

A recall may not result in the product actually being removed from themarketplace if the violation in questioncan be corrected by the distributor orr e t a i l e r. C o r r e c t i o n s o f t h i s k i n d c o u l dinclude minor relabeling, repairing, ormodifying a product without its rem o v a l o r r e t u r n t o t h e m a n u f a c t u r e r .

The proposed regulations make cleartha t manu fac tu re r s and d i s t r i bu to r s a re

expected to assume the responsibility

Medical Devices and Diagnostic Produ c t s . T h e m a i n f u n c t i o n o f t h e s e F D Ac o m m i t t e e s w o u l d b e t o d e t e r m i n e t h ehealth hazard of products being recalled. Depending on the health hazardinvolved, the committees would placeproducts in one of three recall classifications that have been used by FDAfor a number of years:

• Class I recalls are for dangerousor defective products that predictablycould cause serious health problemso r d e a t h . F o o d f o u n d t o c o n t a i n b o t u -linal toxin, a label mixup on a life-saving drug, or a defective artificialheart valve are examples of productsthat could fall into this category.

• Class II recalls are for productsthat might cause a temporary healthproblem, or pose only a slight threatof a serious nature. Examples might bea drug that is under strength and whichis not used to treat life-threatening sit-

■ ■■

::'-' ,tirK§

An FDA microbiologist analyses afood sample for the presence ofbotiilinal toxin. The finding ofb o t i d i n a l t o x i n i n c a n n e d m u s h r o o m sin 1973 triggered one of the mostextensive recalls in FDA history.Before it was over FDA personnel hadmade almost 250,000 effectivenesschecks at a l l market leve ls to c learstocks of potentially contaminatedmushrooms and food containing themas ingredients.

A California firm voluntarily recalledits hand-operated resuscitators after anFDA examination of the medicaldev ice revea led i t was hard to

compress and if held incorrectly wouldnot push air into the lungs of anunconscious person. In addition to therecall, the State of California placedan embargo on approximately 3,000 ofthe devices that were .stored in awarehouse for distribution intoc o n s u m e r c h a n n e l s .

When a potential radiation hazardresulted in the 1975 recall of some400,000 television sets, FDA technicians were able to trace the problemto this circuit board, a variation ofwhich was used in all 45 models ofthe imported sets involved in ther e c a l l .

F D A C o n s u m e r / N o v e m b e r 1 9 7 6 / 1 7

P r o d u c t R e c a l l s F o r F i s c a l Ye a r 1 9 7 5

Class 1 C lass 2 Class 3 T o t a l

Bureau of Drugs 1 5 3 6 0 1 0 0 4 7 5Bureau of Medical Devices and Diagnostic Products 1 6 1 6 9 2 8 2 1 3Bureau o f Foods 1 0 6 2 9 2 1 6 4Bureau of Veterinary Medicine 0 1 5 2 1 3 6Bureau of Biologies 0 2 3 9 3 2Bureau of Radiological Health 0 2 8 0 2 8

41 6 5 7 2 5 0 9 4 8

uations, or an x-ray machine givingoff unnecessarily high but not acutelyh a z a r d o u s r a d i a t i o n . C l a s s I I r e c a l l salso include products that are adulterated, products which involve grossfraud or deception to the consumer, orproducts with labeling that is misleading to the point where it might posea danger of injury or damage to thec o n s u m e r . O v e r t w o - t h i r d s o f a l l r ecalls fall into Class II (see table).

• Class III recalls are for productsunlikely to cause any adverse healthreactions, but which are in violation ofFDA regulations. An example might bea bottle of aspirin that contains 90t a b l e t s i n s t e a d o f t h e I C Q s t a t e d o nthe labe l .

The class assigned to a recall doesnot dictate a specific course of actionthe Agency and the recalling firm areto follow. Recalls are classified only asa means of indicating to the public therelat ive ser iousness of the hazard asso-

CAMED PIMIENTOSRECALLED BY F.D.A.ciated with a specific recall.

The proposed regulations call onmanufacturers or distributors to notifyFDA promptly of a planned recall.Firms would be asked to provide FDAw i t h d e t a i l e d i n f o r m a t i o n o n t h e r e c a l l

including what is wrong with the product, any potential health hazards involved, the date and c i rcumstancesu n d e r w h i c h t h e d e f e c t o r h e a l t h h a zard was discovered, the amount of theproduct involved, when it was manufactured, where it was distributed, andt h e n a m e s o f t h e fi r m ' s o f fi c i a l s i nvolved in the recall plan.

The proposal also calls for the development of a "strategy" for eachr e c a l l t o d e t e r m i n e h o w e x t e n s i v e i t

F.D.A. Orders 6,500 CasesOf Red-Dyed Mints Recalledshould be, whether a public warning isneeded, and the extent to which thecompany must check the effectivenessof the recall. The strategy would bedetermined by such factors as the classof the recall, how much of the producthas been distributed and where, theease of identifying the product, andother pertinent considerations. Eachrecall strategy would be tailored to fitthe circumstances of the product inquestion.

The extent of a recall depends primarily on the degree of potential healthhazards involved. For example, if acanned food product purchased by aconsumer at a retail store is found byFDA to contain botulinal toxin, an eff o r t w o u l d b e m a d e t o r e t r i e v e a l l t h ecans in circulation, including those inthe hands of consumers. As part ofthis effort, FDA would issue a publicwarning via the news media to alert asmany consumers as possible to the pot e n t i a l h a z a r d .

On the other hand, if a food productcontains insect fragments that are notconsidered harmful to health, it mightbe recalled only from distributors orf r o m d i s t r i b u t o r s a n d r e t a i l s t o r e s . I nsuch a case there would be no publicwarning issued by FDA but the recallwould be listed on the Agency's Weekly Recall List. Begun in 1967, theWeekly Recall List is available fromF D A ' s O f fi c e o f P u b l i c A f f a i r s . I t l i s t sa l l r e c a l l s t h a t a r e i n i t i a t e d o r m o n itored by FDA.

The proposed regulations establishguidelines for the use of public warnings in recalls. Generally, they call forFDA to use this form of publicity whena product recall involves a serious

hea l t h haza rd t ha t cou ld be d im in i shed

through the issuance of press releasesor other public announcements.

FDA would not generally seek widespread publicity, however, on the recall of a hazardous product if it wered i s t r i b u t e d t o a l i m i t e d n u m b e r o fusers who could be quickly identifiedand contacted. An example might bethe recall of a specific type or modelof a heart pacemaker. FD.A wouldseek to identify the patients who havethe defective devices and notify thephysicians who implanted them. They,in turn, would notify their patients.F D A b e l i e v e s t h a t i n s u c h i n s t a n c e sissuance of widespread publicity wouldunnecessarily alarm thousands of people whose pacemakers are functioningperfectly and who have no cause forc o n c e r n .

The proposed regulations also dealwith FDA's role in checking the effect iveness o f a reca l l . When a reca l l has

PEPPERS RECALLEDAS BOTULISM HITS 7b e e n i n i t i a t e d F D A w o u l d m o n i t o r t h e

parties that received the product tocheck that the recalling company followed through on the recall plan. Aninspection by FDA personnel of firmsreceiving the product is the best way toassure that the recall is being carriedout properly. But for FDA personnelto routinely visit each place that mayhave received the product would beextremely costly. As a result, FDA nowIs testing the reliability of using mail-grams, telegrams, and the telephonea s a n e c o n o m i c a l a l t e r n a t i v e t o o n s i t e

inspections.

James Greene is a staff wr i ter withFDA's Office of Publ ic Affa i rs .


G m t r o l sUrgedO nTopRxPain Drug

FDA has recommended and the DrugEnforcement Administrat ion hasproposed placing restrictions onpropoxyphene, a widely prescribedpain-killing drug better known undert h e b r a n d n a m e D a r v o n .

by Annabel Hecht

ttTJain is a thing that is glad to beIT forgotten," wrote poet RobinsonJeffers. Americans have been trying toforget their pains with millions of prescriptions for pain-killing drugs everyyear. One of the most widely used ofthese drugs is propoxyphene, a chemica l re la t i ve o f methadone.

Propoxyphene is better known asDarvon, the brand name under whichit is most often sold. Approximately16.4 million new and refill prescriptions for Darvon were filled last year.Another 1.4 million prescriptions forpropoxyphene were written under various other brand names.

Although it is described as a mild,non-narcotic analgesic, and is conside r e d s a f e a n d e f f e c t i v e w h e n u s e dunder medical supervision, propoxyphene has proved to have a significantpotential for abuse. Overused, incor

rectly used, mixed with other drugs ora l c o h o l — i t c a n b e — a n d i n a s u b s t a nt i a l n u m b e r o f c a s e s h a s b e e n — f a t a l .

In light of evidence that propoxyphene is a drug of abuse, the DrugEnforcement Administration — actingo n t h e r e c o m m e n d a t i o n o f t h e F o o dand Drug Administration—has proposed that it be put under Schedule IVo f t h e C o n t r o l l e d S u b s t a n c e s A c t . T h i smeans that a prescription could be refi l l ed no more than five t imes i n a s i x -month period and would have to berenewed every six months by a physic i a n . P h a r m a c i s t s a l s o w o u l d b e r e

quired to keep records of all outstanding prescriptions and anyone convictedof illegally selling the drug would besubject to penalties.

In calling for controls on propoxyphene, FDA was following the recomm e n d a t i o n o f i t s C o n t r o l l e d S u b s t a n c e s

Advisory Committee, which earlierthis year completed a review of information on the drug's use and effects.What the Advisory Committee foundwas growing evidence of deaths fromoverdoses of propoxyphene. A DrugEnforcement Administration survey ofdrug crisis centers and hospital emergency rooms reported 1,300 deaths

from this cause in a three-year period.Other studies have revealed disturbingincreases of propoxyphene deaths yearby year. Many are suicides; almosthalf were so classified in one report.Often the individuals—many of whomare young people—have had historiesof psychological problems, despondency or depression. Some have previoushistories of drug abuse.

The painkiller, freely available frommilitary medical facilities, was reporte d t o b e t h e m o s t c o m m o n c a u s e o f

drug abuse death in the armed forcesin Europe during one three-month period. Still another report from Milwaukee, Wisconsin, indicated that propoxyphene is the most commonlyabused drug among young people inthat area.

Why deaths from use of propoxyphene are on the rise cannot be easilyexplained. It has been suggested thatthe decreasing use of short-acting barb i t u r a t e s — s u c h a s S e c o n a l o r n e m b u

tal—may be a contributing factor. Itis possible, too, that physicians andpatients do not fully realize how potent propoxyphene can be, particularlywhen it is combined with other drugsor with alcohol. To provide more in-

t ' D A C o n s u m e r / N o v e m b e r 1 9 7 6 / 1 9

formation on propoxyphene's potentialfor abuse, Eli Lilly and Co., the manufacturer of Darvon, has strengthenedthe prescribing advice (called physician labeling) about Darvon that issupplied to doctors. The physician'slabeling, which was revised in cooperation with FDA, now says that propoxyphene's potential for abuse is" s i m i l a r t o t h a t o f c o d e i n e . . . a n d

propoxyphene should be prescribedwith the same degree of caution appropriate to the use of codeine."

Questions about propoxyphene's poten t i a l f o r abuse we re r a i sed even before the drug was first marketed in1957. In 1956 and again in 1958 theWorld Health Organization and theCommittee on Drug Addiction andNarcotics of the National Academy ofSc iences/Nat iona l Research Counc i lr e c o m m e n d e d s o m e f o r m o f c o n t r o l .The Uni ted Sta tes d id not ac t on these

recommendations, but 32 nations didand propoxyphene was controlled inthose coun t r ies .

In 1962, after five years of marketing experience and widespread use,the NAS/NRC Commi t tee conc ludedthere was no need for control of propoxyphene since there were few actualc a s e s o f a b u s e . T h e Wo r l d H e a l t h O rganization, in turn, reversed its original evaluation of the drug in 1964.The issue arose again in 1966 whenFDA's Advisory Committee on Abuse

of Depressant and Stimulant Drugslooked into the advisability of recommending regulation. The Committeefound that propoxyphene was widelyu s e d b u t c o n c l u d e d t h a t i t " h a s u n

pleasant side effects and dependenceon it is extremely rare."

S i n c e t h a t t i m e a n u m b e r o f e v e n t sh a v e o c c u r r e d t h a t l e d F D A t o r e e v a luate its position:

• T h e C o n t r o l l e d S u b s t a n c e s A c t o f

1970 added flexibility to the control ofabusable drugs. The Act establishedfive levels or degrees of control basedon a drug's potential danger and otherf a c t o r s . P r e v i o u s l a w s t e n d e d t o r es t r i c t t he cho i ce t o t o ta l con t ro l o r noc o n t r o l .

• In 1969, propoxyphene manufacturers were exempted from requirements that they make periodic reportsto FDA on distribution of the drug.This made monitoring of the drug'sd i s t r i b u t i o n d i f fi c u l t a n d d e c r e a s e d t h echances of detecting trends that mightbe related to changing patterns ofabuse.

• Propoxyphene napsylate—a formof propoxyphene that does not diss o l v e i n w a t e r — w a s i n t r o d u c e d i n t h eUnited States in 1971. Some physicians have been using the new formi n s t e a d o f m e t h a d o n e f o r t r e a t m e n t o f

people addicted to opiate drugs, although the safety and effectiveness ofth is t reatment has not been estab

lished. The use of an abusable drug totreat known drug addicts is a causef o r c o n c e r n .

• In 1973, the Bureau of Narcoticsand Dangerous Drugs (now the DrugEn fo rcemen t Admin i s t ra t i on ) recommended to FDA that propoxyphene inits various forms be put under Schedu l e I V o f t h e C o n t r o l l e d S u b s t a n c e sAct. Eli Lilly and Co. opposed ther e c o m m e n d a t i o n .

F D A ' s C o n t r o l l e d S u b s t a n c e s A d

visory Committee discussed controls atits meetings in 1974, but decided notto recommend this action pending re-evaluation of existing data and thegathering of additional information.In April 1976, the Committee reviewed information acquired since 1974and determined that propoxypheneshould be placed under Schedule IVc o n t r o l s .

The DEA proposal to put propoxyphene under Schedule IV of the Controlled Substances Act was publishedin the September 29 Federal Register. Comments on the proposal willbe accepted by DEA until December1, 1976, and should be submitted tothe Administrator, Drug EnforcementAdministration, Department of Justice,Room 1130, 1405 Eye Street, N.W.,Washington, D.C. 20537.

Annabel Hecht is a staff writer withFDA's Office of Public Affairs.


News Highlights

Firm to Drop Medical Claims for Bread

ITT Continental Baking Co., Rye, New York, has informed FDA that it will change the labeling and promotionfor i t s F resh Hor izons Bread to e l im ina te a l l med ica l c la ims.

ITT Continental agreed to make the changes after ameeting with FDA's Bureau of Drugs.

FDA had sent a regulatory letter to the company sayingthat medical claims for the bread made it legally a "drug".FDA said it would initiate legal action if the company didnot discontinue making such claims.

ITT Continental told FDA that it would immediatelyorder new labels for its bread, and would put them intouse in four weeks. It also agreed to recall and destroy allcopies of a promotional leaflet available in food stores. Inaddition, the company agreed to change all advertising andpromotion directed at physicians which made medicalc l a i ms f o r t h e b re a d .

I T T C o n t i n e n t a l i n t r o d u c e d F r e s h H o r i z o n s B r e a d e a r l i e rthis year with a national promotion campaign. The labelon the product said the bread was high in fiber, and "thereis increasing scientific and medical opinion that fiber may. . . prevent several serious diseases."

S i m i l a r c l a i m s w e r e m a d e i n c o n s u m e r l e a fl e t s a v a i l a b l eat retail food stores, and FDA learned that the companyhad planned an advertising campaign in medical journalsand in mailings to physicians suggesting that the bread isuseful in preventing serious diseases.

FDA concluded that the medical c laims made for theproduct, in the absence of any scientific substantiation,m i s b r a n d e d i t .

FDA to Require Warning on Progestins

FDA has announced that it is taking steps to warnphysicians and women about the risks of using drugs containing female hormones called progestins during pregn a n c y .

When taken early in pregnancy, progestins may damagethe fetus, causing heart defects or deformed legs and arms.

The most common brand names of prescription drugscontaining a progestin are Delalutin, Duphaston, Norlutate,Norlutin, and Provera.

Progestins are used to treat women who have nomenstrual flow or who have abnormal bleeding from theu t e r u s .

FDA said it is preparing the necessary documents to:• Require manufacturers of progestins to print and dis

tribute a special patient brochure emphasizing that thedrugs should never be taken during early pregnancy.

• Order manufacturer^ of all progestin-containing drugsto include in their labeling for physicians a warning that thedrug may damage the fetus and that it should not be takenduring early pregnancy.

• Require the physician labeling to state there are nostudies showing that progestin is effective in preventingmiscarriage. The drug once was used widely for thisp u r p o s e .

• Require the physician labeling to say the drug shouldnever be used as a pregnancy test, as it once was.

• Distribute to 700,000 physicians, pharmacists, andother health professionals an FDA Drug Bulletin repeating and expanding upon an earlier warning against theuse of progestin during early pregnancy.

FDA announced on September 29, 1976, that it hadordered changes in labeling for another class of femalehormone, estrogen, to warn against use during pregnancy,also because of the ability of these drugs to damage theoffspring. FDA intends to require the same warning forbirth control pills, which combine an estrogen and aprogestin.

FDA previously had taken action to discourage use ofprogestins during pregnancy. Since 1973, FDA has notallowed drug makers to recommend in labeling or advertising that the drug be used during pregnancy. In theJanuary 1975, FDA Drug Bulletin, the Agency warnedthat neither progestin nor estrogen should be used duringp r e g n a n c y.

Study Set on Hyperkinesis, Food ColorsFDA has signed a $106,840 contract with the Kaiser

Foundation Research Institute, Oakland, California, tostudy whether artificial food and color additives may berelated to behavioral changes in children. The theory thatsuch a relationship exists has been advanced by Dr. Benjamin Feingold.

The study involves about 20 children aged 1-6 who havehad behavioral problems and who have been reported tohave improved when placed on diets free from food andcolor additives. In the study, these children will have various art ificial colors added to their diets to see whether


there is any behavioral change.The study is scheduled for completion in February 1978.The need for studies to test the Feingold theory was

recommended earlier this year by the Interagency Collaborative Group on Hyperkinesis, appointed by Dr. TheodoreCooper, Assistant Secretary for Health of the Departmento f Hea l th , Educa t i on , and We l fa re . The con t rac t w i thKaiser is in response to that recommendation. FDA is considering additional similar projects to evaluate the Feingoldtheory.

Cosmetic Firms Plan Safety Reviev^^ Panel

The Cosmetic, Toiletry and Fragrance Association(CTFA), a trade association representing 200 cosmeticmanufacturers, has advised FDA that it will establish anexpert review panel to help assure the safety of cosmeticingredients.

Under the CTFA program, an independent panel ofdermatology and toxicology experts will determine whetheran ingredient is safe, not safe, or needs additional information to demonstrate its safety. CTFA will ask FDA toappoint a liaison to the panel. A consumer liaison and anindustry liaison also will be appointed to the panel. FDAis reviewing the CTFA program to see if it satisfies criteriafor FDA participation.

In commenting on the CTFA's intent to conduct a safetyreview program, FDA made the following observations:

• Establishment of an industry-sponsored ingredientreview program will not alter FDA's need for new legalauthority to obtain data on cosmetic injuries and safetyof products.

• The CTFA review program could aid manufacturersin determining what additional studies are needed, but itshould not excuse any manufacturer from substantiatingthe safety of a product before marketing.

• FDA will not give official status to CTFA reviewprogram reports, except where they disclose a basis forbanning a substance or taking other regulatory action.

• FDA expects that evaluations and other informationdeveloped by the panel will be made available to thepublic. (In announcing the program, CTFA said it wouldprovide for public availability of information.)

Court Backs FDA Handling of Chloroform Ban

The U.S. District Court for the District of Columbia hasruled in FDA's favor in a suit brought by the Health Research Group challenging FDA's actions in banning chloroform as an ingredient in human drugs and cosmetics.

In removing chloroform from the market, FDA first announced its intention to ban the product because tests indicated that it caused cancer in animals and asked forpublic comments on this proposal. After reviewing the public comments, FDA then issued a final order making theban effective July 29, 1976. After that date, it became illegal to introduce into interstate commerce human drugs orcosmetics having chloroform as an ingredient. No recall ofexisting products was required, as FDA concluded that theexperiments on animals did not prove that chloroform induces cancer in humans. The Health Research Group hadsaid in its suit that the ban should have taken effect immedi

ately and that existing products should have been recalled.In his decision in FDA's favor. Judge Lewis Smith said

that the administrative procedures followed by FDA in firstproposing the ban and then issuing a final order were in fullaccord with the requirements of the law.

The judge also reflected a sensitivity to FDA's role andresponsibilities. "Various practical considerations can becited in support of the FDA's approach here," he wrote."There are about 2,000 human drug products and twobrands of toothpastes (i.e. cosmetics) on the market whichcontain chloroform as an ingredient. Approximately 837firms engage in manufacturing, labeling and distributingactivities relating to chloroform. The FDA has a limitedn u m b e r o f r e s o u r c e s a s w e l l a s s u b s t a n t i a l a n d v a r i e d r e

sponsibilities under the Act. . . . The agency could thusreasonably determine that a precipitous ban on chloroformwas both impracticable and unenforceable and that theprompt, orderly replacement of chloroform products represented a more responsible approach."

FDA Denies Request to Remarket Cyclamate

The Food and Drug Administration has formally denieda petition by Abbott Laboratories of North Chicago, Illinois, to remarket the artificial sweetener cyclamate. Theformal notice appeared in the Federal Register, October4, 1976.

FDA had announced May 11, 1976, that it had advisedAbbott to withdraw the petition and that failure to withdraw i t would resu l t in a formal denia l .

FDA denied the petition because of unresolved questionsabout the safety of cyclamate.

Abbott has indicated that it will request a hearing on thedenial before FDA's Administrative Law Judge. The banon marketing of cyclamate would remain in effect while ahearing is held.

Guide l ines Stud ied on Radioact ive Food

FDA is developing guidelines for emergency-responseplanning in the event a radiological incident causes radioa c t i v e c o n t a m i n a t i o n o f h u m a n f o o d a n d a n i m a l f e e d s .

The guidelines will be of a general nature, adaptable toa wide range of conditions, and take into account such factors as the health significance of the contamination, agricultural practices in the area, and distribution and usepatterns of potentially contaminated food and animal feeds.A principal factor will be the determination of the levelsof radioactive contamination that will call for protectiveaction. Responsibility for such emergency planning wasassigned to FDA through the Department of Health, Education, and Welfare by the Federal Preparedness Agencyi n D e c e m b e r 1 9 7 5 .

FDA is especially concerned with a number of issuessuch as the feasibility of alternative actions; balancing therisks of radioactive contamination against monetary costsor other adverse effects of implementing protective actions;the suitability of using contaminated human food or animalfeed in food-producing animals; the level of contaminationat which normal use of food and feed should be resumed;the effectiveness and potential adverse effects of variousprotective actions; and the monetary costs of such actions.


Rules Tell How to Get Hearing Information

FDA has published in the Federal Register rules explaining how the public can obtain information about formal hearings that are conducted by the Agency.

Such hearings—held before FDA's Administrative LawJudge—are known as "evidentiary" because parties to thecase present their position and the evidence which supportsit. On the basis of the evidence, the Administrative LawJudge prepares a ruling which is then reviewed by the Commissioner of Food and Drugs who makes the final decision.

In recent months, FDA has conducted hearings on dietary foods, withdrawal of approval for use of methadone,and the denial of approval of a New Drug Application.Hearings are expected on FDA's proposed withdrawal ofapproval for use of several drugs in humans and animals,including diethylstilbestrol (DBS), which is used as agrowth promotant in beef cattle.

Public interest and consumer groups have increasinglysought an active role in these hearings, and a petition hasbeen received—which the Agency is considering—proposing that FDA pay attorney fees and other expenses for suchparticipation. At present, any interested person may requestto appear and make a presentation, but the Agency doesnot assist directly or indirectly in that appearance, and doesnot offer legal advice.

The procedures, which were published in the August 5,1976 Federal Register, designate FDA's Office of Compliance as the source of general information about formalhearings, and the Administrative Law Judge as the officialto whom requests for pleadings, filing dates, and othermatters concerning the conduct of a particular hearingshou ld be addressed .

FDA Seeks to Halt Sale of Arthritis Drug

FDA has announced that it is acting to remove from themarket Naprosyn, a prescription drug used to relievearthritis pain. The action is the result of an Agency investigation that revealed that one safety study submitted bythe manufac turer conta ined miss ta tements and omi t tede s s e n t i a l i n f o r m a t i o n .

Naprosyn (generic name naproxyn) is manufactured bySyntex Laboratories, Palo Alto, California. The study inquestion was conducted under Syntex sponsorship by Industrial Bio-Test Laboratories, Northbrook, 111.

The questionable study, conducted on rats, was intendedto show the long-term safety of Naprosyn. FDA's investigation showed, among other deficiencies, that test laboratory recordkeeping was inadequate, that the existence oftumors in some test animals was not reported, and thatmany test animals examined after death had already enteredadvanced states of decomposition, rendering the examinat ions un re l i ab le .

With the validity of the two-year study challenged, FDAhas i nsu ffic ien t ev idence de r i ved f rom an ima l s tud iesdemonstrating the long-term safety of the drug for humans.FDA therefore is seeking its removal from the market.

A notice of the FDA's intention to revoke approval ofNaprosyn was publ ished in the Federa l Regis terOctober 15, 1976. Syntex had 30 days to request a hearing,as provided by law. To justify a hearing, Syntex would

have to show there are disputable issues of material facts.Because of the possibility that Naprosyn soon may not

be available, it would be wise for patients to discuss withtheir physicians alternative drugs to relieve arthritis pain.Three non-aspirin prescription drugs similar to Naprosynare presently marketed with FDA approval.

Naprosyn has been approved for marketing since March11, 1976.

The application submitted by Syntex for this approvalstated that the Industrial Bio-Test rat study contained asufficient number of test animals to permit adequate evaluation. FDA examination of the original laboratory records,however, reveals that no complete set of records was maintained for any single animal among the 160 that began thestudy. No systematic records of daily examination of animals, as required in such tests, were available during theFDA investigation.

Syntex represented that a specific set of animal tissueshad been examined by microscope but FDA found onlysome of the specified tissue samples to have been collectedor prepared for examination.

Tumors were found in animals but not reported to FDA.T h e s a m e w a s t r u e w i t h l e s i o n s o t h e r t h a n t u m o r s .

FDA also found that the Syntex application omitted thefact that a majority of animals examined post-mortem hadalready entered a state of advanced decomposition, rendering even external observations unreliable.

In addition, many of the 47 animals described in one logas having been destroyed without examination were reported in another log as having been examined and theresults reported to FDA.

Finally, the problem of animal decomposition was foundby FDA to be so extensive that this fact alone, had it beenreported to FDA, would have rendered the entire studyunacceptable.

Syntex was made aware of all findings by FDA onAugust 5, 1976. The company submitted its re-analysis ofthe study to the FDA at a meeting between FDA andSyntex on August 20, 1976. In the judgment of FDA, thisSyntex report did not provide the information neededand legal proceedings for withdrawal of the drug weretherefore instituted as required by law.

Warning Issued on Psoriasis Drug

The Food and Drug Administration has warned patientswho are taking Triazure tablets, a prescription drug forextremely severe cases of psoriasis, to discontinue takingthe drug immediately and to contact their physicians.

The drug may cause life-threatening or fatal blood clotsin the veins and arteries of these patients.

At FDA's request, the drug's manufacturer, Parke, Davis& Co., Detroit, is removing the drug from the market.

Parke-Davis also has recalled all existing stocks of thedrug. The company has alerted all physicians who mayprescribe drugs for psoriasis, all pharmacists, and otherhealth professionals who may have the drug of the recall,and that patients should be notified.

Parke-Davis estimates that 500 to 1,000 patients havetaken Triazure since it was first marketed August 18, 1975.

Triazure tablets (azaribine) are white and are markedprominently with "P-D 931."


Regional Reports

"Regional Reports" consists of important information on inspections, product seizures, court proceedings, andother regulatory and administrativeactions initiated by FDA's regional anddistrict field offices across the countryto provide protection to consumersunder Federal laws. "State Actions,"the section immediately following"Regional Reports," consists of similarinformation about the consumer protection activities of State and localg o v e r n m e n t s .

R E G I O N I INew Jersey, New York, Puerto Rico,Virgin Islands

Diapulse Corp. of America, LakeSuccess, New York, and its president,Jesse Ross, and vice president-treasurer, Joseph I. Ross, have been foundguilty on five counts of violating theprovisions of a permanent injunctionwhich called for inspection of the firmand its records by FDA's New YorkDistrict. Judge John Dooling, of theU.S. D is t r i c t Cour t fo r the Eas te rnDistrict of New York, found the firmand the two officials guilty of repeatedly preventing the inspection of thefirm and fined them a total of $6,250.The defendants are appealing the ruling. The firm manufactures a devicecalled a Diapulse, which is describedin company literature as a deep-tissue,pulsed-frequency device that is effective for more than 100 diseases andrelated conditions. FDA action relatingto the Diapulse dates back to 1965when one of the devices was seizedbecause i t was misbranded.

J o i n t a c t i o n b e t w e e n F D A ' s B u f f a l oD is t r i c t and the New York S ta te De

partment of Agriculture and Marketshas resulted in 210,000 pounds ofpotatoes, valued at $11,000, beingdiver ted fo r use in fe r t i l i ze r. Twotrailerloads of potatoes, part of a five-truck shipment from McMarth Produce Co., Norfolk, Virginia, wererefused by a food firm in Windsor,

Ontario, because of advanced decomposition. When the two shipmentsre-entered the United States at Buffalo,FDA inspectors discovered the rottenpotatoes and learned from one of thetruck drivers that the remaining threetrailers were located in a railyard inSloan, New York, a Buffalo suburb.F D A c o n t a c t e d t h e N e w Yo r k S t a t e

Department of Agriculture and Markets which embargoed the five-truckshipment and arranged for the disposalof the potatoes as an ingredient forf e r t i l i z e r.

Two hundred pairs of rubber healthsandals valued at $485 were detainedby the Buffalo District because theirlabeling contained false and misleadingclaims and lacked adequate directionsfor use. The labeling claimed thesandals were helpful in the treatmentof flat, cold, weak or burning feet, andother ailments. The sandals, manufactured by Pioneer Alum and Plasticsin Flong Kong, were released formarketing after they were relabeled toremove a l l hea l th c la ims.

The Fede ra l Gove rnmen t se i zed 210kits of pizza ingredients at Lenora'sPizza in Buffalo after a routine inspec

tion by FDA's Buffalo District. Investigators discovered the labeling on thepizza kits violated the Fair Packagingand Labeling Act by not carrying thename of the manufacturer and usingtype in its statement of contents of asmaller size than legally required.Af ter the fi rm fa i led to recover theseized goods to correct the labelingviolations, the U.S. District Court inBuffalo ordered that the pizza kits,which were valued at over $500, bedonated to Our Lady of VictoryHomes of Charity in Lackawanna,New York, for the use of the patientsand res idents .

Cooperation between FDA's Newark District and the New Jersey Department of Health resulted in thetracing and subsequent destruction ofover 1,000 pounds of swordfish whichcon ta ined excess ive amoun ts o f mer

cury. The fish was shipped from theStock Island Lobster Co., Key West,Florida, to the Fulton Fish Market inNew York, where investigators fromF D A ' s N e w Yo r k D i s t r i c t c o l l e c t e d

samples to check for mercury contamination. Before the analysis was complete, however, the swordfish wasshipped to a restaurant in Atlantic


City, New Jersey. At FDA's request,the New Jersey Department of Healthplaced an embargo on the fish to prevent its being used for food until theanalysis could be completed. Results ofFDA's analysis showed the mercurylevel to be 1.6 parts per million, morethan three t imes the a l lowable level

permitted by FDA. The New JerseyDepartment of Health obtained a condemnation order and the embargoedfish was destroyed.

Las t summer ano ther lo t o f sword-

fish, valued at $2,000, was destroyedby FDA's New York District becauseof high levels of mercury. Both actionswere the resul ts o f cont inued surve i llance by FDA's Orlando District ofswordfish caught along the coast of thewestern Florida panhandle and suspected of containing high levels ofmercury. FDA investigators in Floridatraced shipments of the fish to marketsin t he No r theas t and a le r t ed FDAoffices in the areas to the potentialc o n t a m i n a t i o n .

Each summer thousands of peoplehead for the seashore, and this year sodid two investigators from FDA'sNewark District to perform routine inspections of candy manufacturersalong the boardwalks in Atlantic City,Cape May, and other New Jersey shoreresorts. The investigators discoveredfour candy companies using Red No. 2food coloring in their salt water taffy.Red No. 2 is a color addit ive that wasbanned by FDA early this year. UnderFDA supervision, the firms voluntarilydestroyed 372 pounds of the taffy containing the color.

R E G I O N I I IDelaware, Maryland, Pennsylvania,Virginia, West Virginia

Joint action between FDA's Cincinnati and Philadelphia Districts resultedin Federal Government seizure of 246boxes of phentermine hydrochloridecapsules in possession of S. A. Vitanza,a doctor of osteopathy in Erie, Pennsylvania. The drug was manufacturedby M. M. Mast & Co., South Euclid,Ohio, under the brand name of Ona-Mast 30 for use in weight reducingdiets. The seizure was based on a routine inspection of the Ohio firm whereFDA investigators discovered the drugdid not have an approved New DrugApplication from FDA and was notproduced in compliance with FDA's

Good Manufacturing Practice Regulations. The labeling of the drug wasalso in v io lat ion for fa i lure to bear theestablished name, the quantity of active ingredients, adequate directionsfor use, and the name and place ofbusiness of the manufacturer, packer,o r d i s t r i b u t o r .

A U.S. marshal seized nearly600,000 dosage units (tablets, capsules, liquids) of 12 drugs at LannettManufacturing Co., Inc., Philadelphia,because of mislabeling violations. Theseizure resulted from an inspection ofthe firm by investigators from FDA'sPhiladelphia District who discoveredthe drugs did not have approved NewDrug Applications from FDA, andthe labels did not indicate directionsfor use. Among the drugs seized were136,000 Chlorulan tablets for use inthe treatment of edema (retention ofbody fluids) and 9,600 Procainamidecapsules for use in the treatment ofc e r t a i n h e a r t c o n d i t i o n s . T h e w h o l esale value of the drugs was placed atabout $20,000.

General Cocoa Co., Inc., and Inter-natio Corp., import brokers of NewYork City, reconditioned by fumigation over two million pounds of insect-infested cocoa beans. The shipment,offered for import from Ghana, hadbeen detained at the port of Norfolkby FDA's Balrimore District. Thecocoa beans, valued at over $1.5 million, were destined for New York whenBaltimore District inspectors, awareof a two-year-old FDA-initiated alerton contaminated cocoa beans, discovered that they were contaminated.

R E G I O N I VAlabama, Florida, Georgia, Kentucky,Mississippi, North Carolina, SouthCarolina, Tennessee.

Inspectors from FDA's Atlanta Dis

trict found damage to food establishments along the North Carolina coastfrom Hurricane Belle, which hit partsof the east coast last summer. Loss ofelectrical power at a processing plantin Wanchese, North Carolina, resultedin inadequate refrigeration of crabson hand. Approximately 200 poundsof crabs were voluntarily destroyedunder FDA supervision. Such inspection surveys are routinely performedby FDA following natural disasters.

Bass and Swaggerty Wholesale FoodDistributors, Holly Hill, Florida, wasfined $2,500 by Judge John A. Reed,Jr., in the U.S. District Court for theMiddle District of Florida after a juryfound the firm guilty of allowing foodto become adulterated. The prosecutionresulted from two inspections by FDA'sOr lando D is t r i c t wh i ch revea led a con

tinuing problem of rodent and insectadulteration of food products at thewarehouse, as well as poor sanitaryprocedures.

Approximately 6,000 22-milliliterbottles of Eyecool, nonprescriptioneye drops, were recalled by MilroyLaboratories, Milton Roy Corp., Tele-vast, Florida, because of bacteriacontamination. Samples of the eyedrops collected during inspection at thefirm by FDA's Orlando District wereanalyzed at FDA's Atlanta Laboratoryand found to contain harmful bacteria.The firm reports it has not receivedany complaints of injury associatedwith use of the eye drops.

R E G I O N VIllinois, Indiana, Michigan, Minnesota,Ohio, Wisconsin

Wilton Enterprises, Inc., Chicago, afood color distributor, voluntarily destroyed $3,000 worth of Red No. 2, acolor additive that was banned by FDAearlier this year, after inspectors fromFDA's Chicago District discoveredduring a routine inspection that thefirm was still distributing the additive.

Consumer complaints to FDA'sKansas City District about explodingcans of apple juice led to the destruction of 343 cases of Vintage Foodsbrand apple juice in a warehouse near-Cincinnati. The Kansas City Districthad notified FDA's Detroit District,which then inspected the processor.Vintage Foods, Inc., Bailey, Michigan,


where investigators discovered thecompany was using inadequate processing practices in violation of FDA'sGood Manufacturing Practice Regulations. The Cincinnati District, in response to the Detroit District's requestto other FDA districts for samples ofthe product, found 343 cases in a localwarehouse. Laboratory analysis confirmed the presence of yeast, mold,bacteria, and carbon dioxide gas in theapple juice. The U.S. District Court forSouthwestern Ohio ordered the applejuice destroyed under the supervisiono f F D A a n d a U . S . m a r s h a l .

R E G I O N V I I IColorado, Montana, North Dakota,South Dakota, Utah, Wyoming

A total of 18,000 pounds of cheddarcheese, manufactured at the ShawneeMission Industries, Horton, Kansas,was recalled by three Denver wholesalers after tests performed by FDA'sDenver D is t r i c t and the Center fo r D isease Control in Atlanta, as well as theColorado State and Pueblo City-County Health Departments, foundSalmonella bacteria in samples of thecheese. The comprehensive testing wasdone after hospitals in Denver andPueblo experienced a sudden increasein cases of salmonella poisoning, whichthe State health department describedas an epidemic. Over 300 cases weretreated by the hospitals during the lastdays of July. A joint FDA-State investigation revealed that most of the victims had eaten at local Mexican-stylerestaurants within four days beforebecoming sick. Further investigationrevealed that each person had eaten ameal containing cheddar cheese, andthat this was the only food eaten incommon by those who became sick.Investigators traced the cheese to theHorton, Kansas firm, which haltedfurther distribution of the product.

An investigator from FDA's SaltLake City Resident Post witnessed thevoluntary destruction in Ogden, Utah,of approximately 26,000 8-ounce bottles of Max Factor Wild StrawberryBubble Bath because of possible bact e r i a l c o n t a m i n a t i o n . T h e M a x F a c t o rhome office in Hollywood, California,recalled the bubble bath after its personnel discovered the possible contamination during a routine qualitycontrol check at Coseway Co., Inc.,the manufacturer of the product in

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Gardena, California. Another 28,000bottles were later destroyed by the firmat the same incinerator in Ogden. Totalvalue of the products recalledamounted to over $27,000.

R E G I O N I XArizona, California, Guam, Hawaii,N e v a d a

The Real Aloe Co., Simi Valley,California, voluntarily recalled anddestroyed over 14,000 pieces of literature wh ich were d is t r ibu ted w i th a

company product called Aloe VeraGel. The gel is made from the aloeplant, which is a type of lily whoseleaves produce a juice used as a purgat ive and ton ic . The l i te ra tu re c la imedthe product was effective for treatmentof hemorrhoids, tired feet, diabetes,acne, colitis, constipation, and numerous o ther a ffl ic t ions . When the d is t r ibutor was told by an inspector fromFDA's San F ranc i sco D is t r i c t t ha t such

unproven claims were in violation ofFederal law, the firm initiated the recal l f rom over 700 heal th food storeswhich handled the product. The inspector had collected a sample of the gelalong with the literature from the firmafter having been notified of the product by FDA's Portland, Oregon, Resident Post.

A lot of nearly 400,000 pounds ofgreen coffee beans, offered for importfrom Colombia, was detained byFDA's San Francisco District during arou t i ne dock examina t i on a f te r i nves t i

gators discovered asbestos fibers hadpenetrated the burlap bags in which thecoffee beans were packaged. Investiga

tors traced the fibers to the ship's holdwhere asbestos had been carr ied on a

previous voyage.

R E G I O N XAlaska, Idaho, Washington

T h e F e d e r a l G o v e r n m e n t s e i z e d 1 3 0

pounds of apricot kernels in the possession of Nu Vita Foods, Inc., a healthfood store in Portland, Oregon, following a consumer complaint to FDA's

Sea t t l e D is t r i c t . The consumer had

purchased a two-pound bag of kernelsat a health food store in Pasco, Washington, and became seriously ill afterconsuming approximately 15 of thekernels. Her physician diagnosed theillness as cyanide poisoning. Investigation by FDA's Yakima (Wash.)Res ident Post showed the kerne ls hadbeen shipped from Nu Vita Foods, Inc.,and a laboratory analysis of a sampleco l l ec ted f rom the fi rm revea led the

presence of hydrocyanic acid (hydrogencyanide) in sufficient quantity to causethe product to be injurious to health.

A U.S. marshal se ized three Sola-rama Board microthermal panels inthe possession of Scientific MassageTherapy, Lebanon, Oregon, followingan inspection by FDA's Portland Resident Post. FDA investigators obtainedphotographs of the devices along withliterature which suggested the panelswere e ffec t ive for the t reatment o fnumerous health problems includingemphysema, cataracts, chronic constipation, and neurosis. The Governmentcharged the devices were misbrandedbecause the labeling failed to give adequate directions for effective use ofthe product against these health hazards. The devices originally were shipped by World of Solarama, Greenville,South Carolina, to Solarama Northwest, Tualatin, Oregon, which in turnshipped them to the Lebanon, Oregon,fi r m .

A U.S. marshal seized over 18,000tablets of hydrogenated ergot alkaloidsand 83,000 chlorothiazide tablets inthe possession of Mutual WholesaleDrug Co., Portland, Oregon. The Government charged that the products,which were manufactured and shippedby Bolar Pharmaceutical Co., Inc.,Copiague, New York, are new drugswithout an approved New Drug Applic a t i o n .

2 6 / N o v e m t j e r 1 9 7 6 / F D A C o n s u m e r

State Actions

Cancer Information training program resulted in the tem- which it will stop manufacturing andporary closing down of three Sullivan distributing a product it advertised as a

Roswell Park Memorial Institute, County restaurants and the discovery natural miracle food. The firm adver-the New York State Health Depart- of multiple violations in a fourth that tised the product, called Miracillin, inment's cancer research and treatment could lead to fines totalling more than full-page ads in major newspaperscenter in Buffalo, has developed an $72,000. As part of training and certi- across the country. The advertisementinnovative service that provides infor- fication, a New York State Health claimed the product might aid users inmation to physicians, health profes- Department inspector and a senior losing weight, preventing heart attacks,sionals, and the public about cancer- food service specialist from FDA's cancer, and numerous other diseases,causing elements in the environment. New York Region inspected the same As a result of the ads, inspectors fromThe Environmental Clearinghouse dis- randomly selected restaurants. Results the California State Health Depart-seminates information on hundreds of of the inspections were compared as a ment. Food and Drug Section, embar-substances that have been shown to means of checking the State employee's goed the firm's entire supply of Mira-cause cancer in humans or animals. inspection technique. During the in- cillin, which reportedly consisted of 90

j Readers can contact the Clearinghouse spection it became apparent that at one percent bran flakes and 10 percent beeby writing to the Office of Cancer restaurant, the Steak Pub, there were pollen.Communication, Room 242, Roswell gross sanitation violations. In addition to stopping the manu-Park Memorial Institute, 666 Elm The inspectors informed the local facture of the product, and paying theStreet, Buffalo, New York 14203, or office of tlie State Health Department fine, the president of the firm, Barryby calling (716) 845-4400. whose own senior sanitarian inspected Marantz, also agreed in Superior

the premises and found 145 violations. Court to refund money to purchasersDamaged Sugar Destroyed which five were termed major. The of the product. The refunds are ex-local health department ordered the pected to total about $75,000.

I T h e c o m b i n e d e f f o r t s o f t h e N e w p l a c e c l o s e d .York State Department of Agriculture When State officials posted the do- Bakery Corrections Orderedand Markets and FDA's New York sure notice, the owner, in the presenceDistrict resulted in the seizure and of health officers, an assistant State The owners of the New Palace Bak-voluntary destruction of 460 hundred- attorney general, and a uniformed po- ery, Hamtramck, Michigan, have beenpound bags of water-damaged sugar liceman, tore down the placard and placed on two years' probation byimported from Brazil. The State re- refused to close. That action resulted Municipal Judge Walter A. Paruk,ported to the New York District that it in the owner appearing before State after pleading no contest to a numberhad seized 98 bags at a warehousfe in Supreme Court Judge Robert C. Wil- of sanitation violations that wereBrooklyn because the ink on the label hams where he agreed to hire a sanita- charged as a result of inspections bypenetrated through the burlap into the tion consultant. A follow-up inspection the Michigan Department of Agricul-sugar. When FDA learned that the ordered by the judge revealed that the ture. The owners, Eugene Smielewskidamage had been caused by water major violations had been corrected and Blaze and Savka Vesilinovski,entering the hold of a ship en route but that 69 minor violations remained. originally pleaded not guilty to thefrom Brazil, investigators were as- The owner faces the possibility of charges, but changed their pleas whensigned to check the remainder of the health department fines totaling Judge Paruk threatened to close thelot at the warehouse for similar water $72,500 and the filing of criminal bakery if they did not take immediatedamage. Of the original shipment of charges for tearing down the closure steps to end the insanitary conditions.60,000 bags, another 362 were found notice and refusing to close. The other A management sanitation program waswater damaged and were voluntarily three area restaurants reopened after prepared by the building owner anddestroyed in the presence of an FDA having eliminated insanitary conditions after three reinspections by the Michi-investigator. found by the State health inspectors. gan Department of Agriculture the

judge accepted the defendants' pleas ofRealistic Training 'Miracle Food' Sales Halted no contest, placed them on two years'

probation, and suspended all fines andWhat started as routine training in Meredith Laboratories, Calabasas, costs. The probation terms requiresanitary inspection of food establish- California, paid a $30,000 fine and fulfillment of the sanitation programments for a New York State health entered into a stipulated judgment in within a specified schedule, and noofficial under an FDA-administered Los Angeles Superior Court under further violation of State laws.

F D A C o n s u m e r N o v e m b e r 1 9 7 6 / 2 7

Seizures and Postal Service Cases

SEIZURE ACTIONS charging violation of the Federal Food, Drug, and Cosmetic Act are published when they are reported byt h e F D A D i s t r i c t O f fi c e .

A total of 35 actions to remove from the consumer market products charged to be violative was reported in September. These included23 seizures of foods: 1 involved charges concerning poisonous and deleterious substances, 20 involved charges concerning contamination,and 2 involved charges concerning economic and labeling violations. Other seizures included 1 of color additive, 8 of drugs (including 3of veterinary/medicated feed), 2 of medical devices, and 1 of cosmetic.

P R O D U C T , P L A C E & D A T E S E I Z E D M A N U F A C T U R E R ( M ) , P A C K E R ( P ) , C H A R G E SSHIPPER (S), DEALER (D)

F O O D / P o i s o n o u s a n d D e l e t e r i o u s S u b s t a n c e s

Swordfish fillet, frozen/TreasureIsland, Fla. 8/2/76

Garcia Bros. Seafood/Miami, Fla. (S);Better Bait Supply, Inc./Miami, Fla.(P)

Contain the added poisonous and deleterious subs t a n c e m e r c u r y .

Contamination, Spoilage, Insanitary Handling

Apricots, dried/Minneapolis, Minn.4 / 2 / 7 6Minneapolis, Minn. 4/19/76

Beans, red kidney; pinto beans/Oak-field. Wis. 5/24/76

Coffee beans/New Orleans, La.5 / 4 / 7 6Dallas, Tex. 5/24/76

Cookies & tea biscuits/St. Louis, Mo.6 / 1 7 / 7 6

Fennel seeds/Utica, N.Y. 8/3/76

Mung beans/Cleveland, Ohio 8/16/76

Paprika/Oxnard, Calif. 8/4/76

Peanuts, unshelled/St. Louis, Mo.7 / 1 5 / 7 6

Pecans, shelled/San Antonio, Tex.6 / 2 8 / 7 6

Pickles, acrid-sweet/San Francisco,C a l i f . 5 / 1 9 / 7 6

Pizza sauce/Buffalo, N.Y. 3/23/76

Popcorn/Paintsville, Ky. 4/13/76

Rice, sugar, various warehouse stocks/Detroi t , Mich. 8/3/76

Salmon, frozen/Wilmington, Calif .5 / 1 4 / 7 6canned/San Juan, P.R. 4/26/76

Sugar, dextrose/St. Louis, Mo. 2/3/76

nonfat dry milk, chocolate-flavoredpowder/New Haven, Mo. 4/1/76

Vanilla wafers, strawberry-flavoredwafers, pretzel sticks/MulberryGrove, 111. 6/22/76

J . F . B r a u n & S o n s , I n c . / L a k e S u ccess, N.Y. (S)

M a m m o t h S p r i n g C a n n i n g C o r p . /Oakfield, Wis. (D)

Strachan Shipping Co./New Orleans,La. (D)

Imported from Mexico.

Midwest Commodi t ies, Inc. /MulberryGrove, 111. (S)

G e n e r a l S p i c e C o . , I n c . / M a l d e n ,Mass. (M,S)

Sam Wah Yick Kee Co. /C leve land,Ohio (D)

G e n t r y I n t e r n a t i o n a l , I n c . / O x n a r d ,Calif. (D)

Rethemeyer Coffee Co./St. Louis, Mo.(D)

S.N.A. Nut Co./Mansfield, La. (M,S)

Imported from Thailand.

Imported from Portugal.

W i l l i a m s W h o l e s a l e G r o c e r y C o . /Paintsville, Ky. (D)

The Miesel Co./Detroit, Mich. (D)

As to r i a F i sh Fac to r /As to r i a , O reg .(S)

Frosty F ish Co. / Wi lmington, Cal i f .(S,P)

International Distributing Corp./St.Louis, Mo. (D)

P e p s i C o l a B o t t l i n g C o . , o f N e wHaven, Inc./New Haven, Mo. (D)

Midwest Commodit ies, Inc./MulberryGrove, 111. (D)

D i r t a n d i n s e c t c o n t a m i n a t e d .

Held under insanitary conditions.

Held under insani tary condi t ions; b i rd contamin a t e d .

He ld unde r i nsan i t a r y cond i t i ons i n r a i l ca r i nT e x a s .

Held under insani tary condi t ions; some cookiesr o d e n t c o n t a m i n a t e d .

Unfit for food due to dirt & stones; dirt and stonessubs t i tu ted fo r fenne l seeds .

Held under insanitary condit ions; insect contamin a t e d .

Held under insanitary conditions; rodent contamin a t e d .

Held under insanitary conditions.

C o n t a i n E . c o l i .

Decomposed, conta ined in swol len and leak ingc a n s .

Unfit for food, contained in swollen, leaking, andrusty cans; lacked common or usual name ofeach ingredient.


He ld unde r i nsan i t a r y cond i t i ons ; some foodsr o d e n t c o n t a m i n a t e d .

Decomposed.


Held under insanitary conditions; rodent contamin a t e d ( w a f e r s ) .


PRODUCT, PLACE & DATE SEIZED M A N U FA C T U R E R ( M ) , PA C K E R ( P ) ,SHIPPER (S), DEALER (D)

C H A R G E S

Economic and Labeling Violations

Candy rolls, pecan-log/Memphis,Te n n . 5 / 1 3 / 7 6

Pepperoncini/Boston, Mass. 7/6/76

Stuckey's, Inc./Eastman, Ga. (M,S)

Glor ia Packing Corp. /Boston, Mass.( D , P )

Artificial pecan pieces substituted in part for pecanpieces.

Short weight.

C O L O R A D D I T I V E

Flavorol's No. 39405/Tampa, Fla.7 / 1 4 / 7 6

Flavorol Labs, Inc./Indianapolis, Ind.(S)

Contains nonconforming color additive Red No. 2.

D R U G S / H u m a n U s e

Chlorothiazide tablets/Cincinnati,O h i o 8 / 2 / 7 6

Newington, Conn. 8/9/76Ronkokoma, N.Y. 7 /22/76

San Francisco, Calif. 8/5/76

Trihydrogine sublingual tablets/NorthHol lywood, Cal i f . 7/26/76

B o l a r P h a r m a c e u t i c a l C o . , I n c . /Copiague, N.Y. (M,S)

B o l a r P h a r m a c e u t i c a l C o . , I n c . /Copiague, N.Y. (M)

B o l a r P h a r m a c e u t i c a l C o . , I n c . /Copiague, N.Y. (M,S)

No approved New Drug Application.

Lacked adequate directions for use and was notexempted, since no approved New Drug Applic a t i o n .

No approved New Drug Application.

New drug without effective New Drug Application.

Fyewash/Omaha, Nebr. 6/9/76

Naquasone boluses, and dexamycin,dexamethasone, stilbestrol, oxytocininjectables/Binghamton, N.Y.6 / 2 3 / 7 6

Probios plus boluses/Gainesville, Ga.8 / 1 9 / 7 6

Veterinary/Medicated Feed

ABS Corp./Omaha, Nebr. (D)

Wesley R. Smith, t/a IndependentBuyers Association/Binghamton,N . Y. ( D )

NuLabs, Inc./Portland, Oreg. (M,S)

Quality falls below that which it purports and isrepresented to possess; false and misleadinglabeling statements, since not sterile as repres e n t e d .

Lacked adequate directions for use, and was notexempted since the articles were not held Torsale only to, or on order of, a veterinarian.

New animal drug for which no approved NewAnimal Drug Application was effective.

Bio-lectron panels for humans andpanels for horses/Hollywood, Fla.4 / 2 9 / 7 6

Therapuncteur and punctoscopedevices/Oklahoma City, Okla.8 / 5 / 7 6

M E D I C A L D E V I C E S

Solarama of Kentucky, Inc./Louis-ville, Ky. (M,S)

Med-F-Prise/Orlando, Fla. (M,S)

False and misleading claims for and adequatedirections for arthritis, bursitis, sinusitis, thrush,bowed tendons, wobbles, leg trouble and stiffness and soreness (horses); false and misleadingclaims for and inadequate directions for arthritis, bursitis, backaches, nervous tension, speedhealing, and other such claims (human).

Lacked adequate directions for use; false and misleading claims for auriculotherapy, for acupunc tu re , and fo r t rea tment o f a number o fspecified body areas.

Eye shadow/Houston, Tex. 6/10/76

C O S M E T I C

Jeneal Studios, Inc./Houston, Tex.(P,D)

Label lacked name and address of packer-distributors, and lacked a quantity of contentss t a t e m e n t .

FDA Consumer / November 1976 / 29

U.S. POSTAL SERVICE actions taken in medical cases as authorized in the Mail Fraud Statute (18 U.S.C. 1341) and/or theFalse Representation Statute (39 U.S.C. 3005) as reported by the Chief Postal Inspector.

Complaints Filed by Law Department Under 39 U.S.C. 3005 (False Representation)

July 1, 1976: Anode-Cathode, P.O. Box 284, Lawndale, California.Advertising and sale through the mail of an electrical device,representing the ability to control arthritis.

July 12, 1976: National Health Products, 1924 Genesee St., Utica,New York. Advert ising and sale through the mail of apricotkernels, representing the ability of a cancer treatment.

Ju ly 12, 1976: Advisors, Box 773, San Bernard ino, Cal i forn ia.Advertising and sale through the mail of various leather andrubber devices, representing the abi l i ty to rel ieve and curea r t h r i t i s .

Ju ly 14, 1976: Fran-Mar Enterpr ises, P.O. Box 130, Rockvale,Colorado. Advertising and sale through the mail of a pamphleten t i t l ed "The Franmar, " rep resen t ing the ab i l i t y to causeweight loss.

July 15, 1976: Natural Research, 842 Bland Street, Bluefield, WestVirginia. Advertising and sale through the mail of a bookleten t i t led "The Secre t o f a Shap l ie r You, " con ta in ing in fo rmat ion represent ing the abi l i ty to increase the s ize of thebreast without exercises, gimmicks, or creams.

July 23, 1976: Doctor 's Laborator ies, Box 398-D, Punta Gorda,F l o r i d a . A d v e r t i s i n g a n d s a l e t h r o u g h t h e m a i l o f t h e"Rotasage Scalp Massager," a circular rubber device representing the ability to increase hair growth.

July 27, 1976: Sophistication Plus, 1 Wolfs Lane, New Rochelle,New York. Advertising and sale through the mail of a pamphletcontaining information representing the ability to increase thebustline quickly, easily, and safely, bringing healthy new bloodcirculation to the breast and surrounding muscles.

J u l y 2 9 , 1 9 7 6 : N u t r i e n t L a b o r a t o r i e s , I n c . , P. O . B o x 8 0 3 0 8 ,Chamblee, Georgia. Advertising and sale through the mail ofthe product "Skin Vitamin Capsules," representing the abilityto fight cellulite and premature wrinkles.

August 4, 1976: Magic Mold, Inc., 210 Hanse Avenue, Freeport,New York. Advertising and sale through the mail of a mineral

and v i tamin capsule, represent ing the abi l i ty to make hai rgrow, shine, and look radiant.

August 6, 1976: Covina Health Foods, 130 Shopper's Lane, Covina,California. Advertising and sale through the mail of the product"Wate-Aid Tablets," representing the ability to cause fat loss.

August 11, 1976: Swedish Diet, 739 Park Avenue, Freehold, NewJersey. Advertising and sale through the mail of the product"Swedish Diet," a booklet containing information representingthe ability to cause weight loss without pills or exercise.

August 12, 1976: Washington Press, Inc., 23480 Park Sorrento,Calabasas, California. Advertising and sale through the mailof a booklet ent i t led "Fat F ighters," conta in ing in format ionrepresenting the ability to cause weight loss.

August 16, 1976: E Pill, Box 6712, Miami, Florida. Advertising andsale through the mail of the product "High Potency Vitamin ETablets," representing the ability to increase sexual ability ofboth sexes.

August 17, 1976: Grace Enterprises, Box 639, Tenafly, New Jersey.Advertising and sale through the mail of the product "PlacentaCream," represent ing the ab i l i t y to nour ish your sk in andsmooth and firm up wrinkles.

August 18, 1976: Select I tems, 1236 S. La Cienega Blvd., LosAngeles, California. Advertising and sale through the mail ofthe p roduc t "L inga Pendu lum, " rep resen t ing the ab i l i t y tostrengthen and enlarge the penis, and strengthen and stiffenm a l e e r e c t i o n s .

August 18, 1976: Omega, P.O. Box 199, Woodland Hills, California.Advertising and sale through the mail of capsules representingthe ability to be aphrodisiac in nature.

August 24, 1976: Lucie! Cosmetics, 5300 Northwest 163rd St., Hia-leah, Flor ida. Advert is ing and sale through the mai l of theproducts "Miracle Loofa Friction Pads and Loofa FrictionOil," representing the ability to remove cellulite on thighs andb u t t o c k s .

False Representation Orders Issued by Judicial Officer Under 39 U.S.C. 3005

August 10, 1976: Against Holt 's Sauna Slimmers, 7471 MelroseAvenue, Los Angeles, California. Advertising and sale throughthe mail of the product "Holt's Sauna Slimmers," representingthe ability to lose inches in just days.

August 17, 1976: Against R & N Distributors, P.O. Box 35445, LosAngeles, California. Advertising and sale through the mail ofa book enti t led Penis Enlargement Techniques, representingthe ability to increase the size of the penis.

August 17, 1976: Against Rancho Distributors, 1242 S. La CienegaBlvd., Los Angeles, California. Advertising and sale throughthe mail of the product "Linga Pendulum," representing theabil i ty to increase the size of the penis and regain sexualstrength and vigor.

August 17, 1976: Against J. S. Collectors, P.O. Box 2411, VanNuys, California. Advertising and sale through the mail of theproduct "Spanish Fly Spice," representing the ability to provideextra exciting results and drive her wild.

August 17, 1976: Against Erotic Book Club, P.O. Box 35301, LosAngeles, California. Advertising and sale through the mail ofthe product "L inga Pendu lum," represent ing the ab i l i t y toenlarge and strengthen the penis and stiffen male erections.

August 17, 1976: Against Miss Linda, Suite 307, 6355 Topanga

Blvd., Woodland Hills, California. Advertising and sale throughthe mail of the product "Nymphos," representing the ability tobe aphrodisiac in nature.

August 19, 1976: Against Sunny Hills Diet, 1818 W. ChapmanAvenue, Orange, California. Advertising and sale through themail of the product "New Grapefruit Pill Diet Plan," representing the ability to cause an easier weight loss without strenuousexerc ise o r s ta rva t ion .

August 19, 1976: Against Grapefruit Growers, 107 Water Street,Henderson, Nevada. Advertising and sale through the mail ofgrapefruit tablets, accompanied by a brochure entitled "Grapefruit Pill Diet Plan," representing the ability to give fast weightloss while eating almost as much as you want.

August 23, 1976: Against Robert, Box 213, Fremont, Ohio. Advertising and sale through the mail of a booklet entitled "PainRelieved and Common Cold Prevention," representing the ability to prevent the common cold and relieve pain in swollenjoints.

August 23, 1976: Against Original Cosmetic Products, Inc., P.O.Box 480, New York, New York. Advertising and sale throughthe mail of various tablets and creams, representing the abilityto be aphrodisiac in nature.


Notices of Judgment

N O T I C E S O F J U D G M E N T o n S e i z u r e A c t i o n s

F O O D / P o i s o n o u s a n d D e l e t e r i o u s S u b s t a n c e s

Halibut, frozen, at Seattle, W. Dist. Wash.Charged on or about 11-19-75: when shipped by Bratten's Fisheries, Salt Lake City, Utah, the article, labeled in part "Swift-sure Frozen Halibut . . . Distributed By Swiftsure FisheriesSeattle, Washington," contained the added poisonous or deleterious substance mercury; 402(a)(1). Consent decree authorizedrelease to Swiftsure Fisheries, Inc., Seattle, Wash., for salvaging.(F.D.C. No. 60549; S. No. 76-53-186; N.J. No. 1)

FOOD/Contaniination, Spoilage, Insanitary HandlingApple juice, at Fairfield, S. Dist. Ohio.

Charged 5-28-76: while held for sale, the article contained adecomposed substance and was contained in swollen cans;402(a)(3). Default decree ordered destruction. (F.D.C. No.60749; S. No. 76-80-892; N.J. No. 2)

Apricots, dried, at Minneapolis, Dist. Minn.Charged 4-16-76: when shipped by J. F. Braun & Sons, Inc.,Lake Success, N.Y., the article contained dirt and insect filth;402(a)(3). Default decree ordered destruction. (F.D.C. No.60714; S. No. 76-30-784; N.J. No. 3)

Beans, yellow, and sweet rice, at New York, S. Dist. N.Y.Charged 5-1-75: while held by Quong Yuen Shing & Co., NewYork, N.Y., the sweet rice contained rodent filth, and botharticles were held under insanitary conditions; 402(a)(3),402(a)(4). Consent decree ordered destruction. (F.D.C. No.60329; S. Nos. 44-190/1 H; N.J. No. 4)

Breading for chicken, at Dallas, N. Dist. Tex.Charged 12-12-75: while held by A1 Semtner Drug Depot, Inc.,Dallas, Tex., the article contained insect and rodent filth andwas held under insanitary conditions; 402(a)(3), 402(a)(4). Consent decree authorized release to The United Paper Service Co.,Youngstown, Ohio, for salvaging. (F.D.C. No. 60559; S. No.76-14-753; N.J. No. 5)

Coffee beans, at Brooklyn, E. Dist. N.Y.Charged 6-30-75: while held for sale, the article contained insect filth and mold; 402(a)(3). Consent decree authorized releaseto Coffee Holding Co., Brooklyn, N.Y., for export to Belgium(F.D.C. No. 60406; S. No. 44-778 H; N.J. No. 6)

Coffee beans, at Dallas, N. Dist. Tex.Charged 5-20-76: while held for sale, the article was held underinsanitary conditions in a railcar in Texas; 402(a)(4). Consentdecree authorized release to the Texas & Pacific Railroad Co.,Dallas, Tex., for salvaging. (F.D.C. No. 60738; S. No. 76-14-895; N.J. No. 7)

Flour, at Bloomington, S. Dist. Ind.Charged 3-29-76: while held by Wetterau Foods, Inc., Bloomington, Ind., the article contained rodent filth and was heldunder insanitary conditions; 402(a)(3), 402(a)(4). Default decreeordered destruction. (F.D.C. No. 60693; S. No. 76-19-155; N.JNo. 8)

Flour, at Mayaguez, Dist. P.R.Charged 8-19-75: while held by Sucrs. de Esmoris & Co., Inc.,Mayaguez, P.R., the article contained insect filth and was heldunder insanitary conditions; 402(a)(3), 402(a)(4). Default decreeordered destruction. (F.D.C. No. 60449; S. No. 76-50-702; N.JNo. 9)

Flour and iodized salt, at Meridian, S. Dist. Miss.Charged on or about 5-24-76: while held by Hasson GroceryCo., Inc., Meridian, Miss., the articles contained rodent filthand were held under insanitary conditions; 402(a)(3), 402(a)(4).Consent decree ordered destruction. (F.D.C. No. 60746; S. No76-33-627 et al.; N.J. No. 10)

Flour blend for pizza, at Dallas, N. Dist. Tex.Charged 9-30-75: while held by Al Semtner Drug Depot, Inc.,Dallas, Tex., the article contained insect and rodent filth andwas held under insanitary conditions; 402(a)(3), 402(a)(4). Con

sent decree authorized release to The United Paper Service Co.,Youngstown, Ohio, for salvaging. (F.D.C. No. 60489; S. No.76-14-928 et al.; N.J. No. 11)

Flour, grits, and cornmeal, at Eunice, W. Dist. La.Charged 2-11-76: while held by Kelly Weber & Co., Inc.,Eunice, La., the articles contained rodent filth and were heldunder insanitary conditions; 402(a)(3), 402(a)(4). Default decreeordered destruction. (F.D.C. No. 60648; S. No. 76-38-612 et al;N.J. No. 12)

Flour, Mt. Olive Special, at Garland, N. Dist. Tex.Charged 7-16-76: when shipped by Mt. Olive Milling Co., Inc.,Mt. Olive, 111., the article had been prepared under insanitaryconditions; and the article's label lacked a quantity of contentsstatement; 402(a)(4), 403(e)(2). Default decree ordered destruction. (F.D.C. No. 60797; S. No. 76-08-853; N.J. No. 13)

Grocery stocks such as sugar, instant potatoes, cake mix, coconut,and dog food, at Dale, S. Dist. Ind.Charged 5-17-76: while held by J. Winkler & Sons, Inc., Dale,Ind., a number of articles, such as those listed above, containedrodent filth; and all the articles were held under insanitary conditions; 402(a)(3), 402(a)(4). Consent decree authorized releaseto dealer for salvaging. (F.D.C. No. 60723; S. No. 76-20-427et al.; N.J. No. 14)

Pecan pieces, Mansura, at Natchez, S. Dist. Miss.Charged 4-14-76: when shipped by Central Pecan Shelling Co.,Inc., Mansura, La., the article contained E. coli and had beenprepared under insanitary conditions; 402(a)(3), 402(a)(4).Default decree ordered destruction. (F.D.C. No. 60711; S. No.76-32-380; N.J. No. 15)

Pistachio nuts, dried apricots, ginger, walnuts, filberts, sunflowerseeds, paprika, dried niushrooins, and other warehouse stocks,at Jersey City, Dist. N.J.Charged 11-20-75: while held by Harborside Terminal Co., Inc.,Jersey City, N.J., some of the articles contained rodent filth,and all the articles were held under insanitary conditions;402(a)(3), 402(a)(4). The dealer initially claimed the articleson behalf of the thirty-two owners of the articles, denied thecharges, and asserted that the complaint filed in the actionfailed to state a proper charge. Since the dealer was subsequently unwilling to enter into a consent decree, a numberof owners of the goods entered their own claims for theart ic les, and par t ia l consent decrees author ized re lease ofsome of the articles to their owners for reconditioning. Ultimately, consent decrees of condemnat ion were entered intoby the dealer and the owners of the remaining goods, whichdecrees authorized release for salvaging or reconditioning.(F.D.C. No. 60090; S. No. 58-309 H et al.; N.J. No. 16)

Popcorn, at Paintsville, E. Dist. Ky.Charged 4-6-76: while held by Williams Wholesale Grocery Co.,Paintsville, Ky., the article was held under insanitary conditions; 402(a)(4). Default decree ordered destruction. (F.D.C.No. 60696; S. No. 76-34-116; N.J. No. 17)

Popcorn, bulless, white, at Los Angeles, C. Dist. Calif.Charged 1-12-76: while held for sale, the article containedinsect fi l th ; 402(a) (3) . Defau l t decree ordered des t ruc t ion .(F.D.C. No. 60623; S. No. 76-26-653; N.J. No. 18)

Potato chunks, dehydrated, textured protein granules, and dehydrated potato slices, at Plainfield, N. Dist. 111.Charged 12-22-75: while held by the Naperville National Bank& Trust Co., Naperville, 111., the articles contained rodent filthand were held under insanitary conditions; 402(a)(3), 402(a)(4).Default decree ordered destruction. (F.D.C. No. 60585; S. Nos.76-10-528/30; N.J. No. 19)

Potatoes, dehydrated, at Chicago, N. Dist. 111.Charged 2-11-76: while held by Hammond Refrigerated Warehouse, Chicago, 111., the article was held under insanitarycondit ions; 402(a)(4). Consent decree author ized release toCommodity Warehousing Corp., Chicago, 111., for reconditioning and subsequent donation to charitable organization. (F.D.C.No. 60649; S. Nos. 76-10-443, 76-10-445; N.J. No. 20)


Rice, at Boston, Dist. Mass.Charged 11-5-75; while held by Port Terminals, Inc., Boston,Mass., the article contained insects, and had been held underinsan i ta ry cond i t ions ; 402(a) (3 ) , 402(a) (4 ) . Defau l t decreeordered destruction. (F.D.C. No. 60539; S. No. 76-05-472; N.J.No. 21)

Spices and other warehouse stocks, at Brooklyn, E. Dist. N.Y.Charged 12-5-75: while held by J. Raphael & Sons, Inc.,Brooklyn, N.Y., some of the articles contained rodent filth, anda l l o f the a r t i c les were he ld under insan i ta ry cond i t ions ;402(a)(3), 402(a)(4). Consent decree authorized release to dealerfor salvaging. (F.D.C. No. 60560; S. No. 76-41-221 et al.; N.J.No. 22)

Sugar and flour, at Lohman, W. Dist. Mo.Charged 2-19-75: while held by Lohman Milling Corp., Lohman, Mo., some lots of the flour contained insect filth, and allof the articles were held under insanitary conditions; 402(a)(3),402(a)(4). Consent decree ordered destruction of the flour andrelease of the sugar to dealer for reconditioning. (F.D.C. No.60168; S. No. 73-919 H et al.; N.J. No. 23)

Sugar, light brown, and flour, at Berea, E. Dist. Ky.Charged 1-29-76: while held by Davidson Bros. & Co., Berea,Ky., the articles were held under insanitary conditions; 402(a)(4). Default decree ordered destruct ion. (F.D.C. No. 60637;S. No. 76-33-315 et al.; N.J. No. 24)

Sugar, nonfat dried milk, and chocolate-flavored powder, at NewHaven, E. Dist . Mo.Charged 3-26-76: while held by Pepsi Cola Bottling Co. ofNew Haven, Inc . , New Haven, Mo. , the ar t ic les conta inedrodent filth and were held under insanitary conditions; 402(a)(3), 402(a)(4). Default decree authorized donation to a Stateconservation commission for use other than human consumption. (F.D.C. No. 60698; S. No. 76-24-001 et al.; N.J. No. 25)

Tapioca flour, at Houston, S. Dist. Tex.Charged 11-24-75: while held by Dixie Cone ManufacturingCorp., Houston, Tex., the article contained rodent filth andwas held under insani tary condi t ions; 402(a)(3) , 402(a)(4) .Defaul t decree ordered dest ruct ion. (F.D.C. No. 60546; S.No. 76-22-802; N.J. No. 26)

Wafers, vanilla, pretzel sticks, and strawberry-flavored wafers, atMulberry Grove, S. Dist. 111.Charged 6-15-76: while held by Midwest Commodities, Inc.,Mulberry Grove, 111., the wafers contained rodent filth, andal l the art ic les had been held under insani tary condi t ions;402(a)(3), 402(a)(4). Default decree ordered destruction. (F.D.C.No. 60754; S. Nos. 76-11-046/8 et al.; N.J. No. 27)

FOOD/Economic and Label ing Violat ionsCandy roll, at Memphis, W. Dist. Tenn.

Charged 5-5-76: when shipped by Stuckey's, Inc., Eastman, Ga.,the article, labeled in part "Stuckey's Pecan Log Roll . . .Manufactured By Stuckey Stores Division, Pet IncorporatedEastman, Georgia," had had artificial pecan pieces substitutedin part for pecan pieces; 402(b)(2). Default decree authorizeddonation to charitable organizations. (F.D.C. No. 60725; S.No. 76-32-011; N.J. No. 28)

V I T A M I N S / S P E C I A L D I E T A R Y F O O D S

Hoffman's Energol germ oil concentrate, Super Hi-Proteen drinkmix. Blue Ribbon Beef Hi-Proteen tablets, Hi-Proteen powdersand tab le ts o f var ious flavors (choco la te , carob , coconut ,vanilla, & plain). Quick Gain Weight powder, and ProteinFrom The Sea powder, at South San Francisco, Calif.Charged 2-25-74: when shipped by Bob Hoffman, York BarbellCo., Inc., York, Pa., the articles' labels contained false andmisleading claims as follows: Energol germ oil concentrate—the article's name and other label statements falsely and mis-leadingly represented that the article, when used as directed,had special dietary value as a special source of vigor andenergy for athletes, body builders, growing children, and hardworking and active adults; Super Hi-Proteen drink mix—labelstatements falsely and misleadingly represented that use of thearticle as directed would significantly improve the nutritional

status and well-being of persons of any age, prevent proteindeficiency, stunted growth, lack of muscular development, andlack of resistance to disease, and provide strength, endurance,health and general well-being, and that the article was aneconomical source of essent ial nutr ients; Blue Ribbon BeefHi-Proteen tablets—the vignette captioned "Bob Hoffman," andspecified label statements, falsely and misleadingly representedthat the ar t ic le, when used as d i rected was adequate andeffective to build an extremely strong athletic body withprominent muscles; the vignette of a steer head bearing aprize ribbon, together with the article's name, falsely andmisleadingly represented that the article was high qualityprotein from the muscle of steers, when the article's declaredingredients were defatted glandular meat and isolated soyproteins; label statements falsely and misleadingly representedthat it was necessary and useful to supplement the ordinarydiet with amino acids, and label statements of the article'sprotein and fat composition were inconsistent and contradictory; New Improved Hi-Proteen powder and tablets (4 lb.boxes)—the label vignettes captioned "John Grimek," "SteveStanko," and "Bob Hoffman," and label statements such as"A Muscle-Town Product," "The Food of Champions," "Ifyou want to be like the champs . . . you must exercise andeat like the champs," falsely and misleadingly represented thatthe article, when used as directed, was adequate and effectiveto build an extremely strong, athletic body with prominentmuscles; the label statements contained various other specifiedfalse and misleading claims of special nutritional value;Hi-Proteen powder (1 lb. cans) and tablets (30-oz. cans)—^thelabel vignette captioned "Bob Hoffman," and specified labelstatements such as "This superior protein-rich food is formulated by U.S. Olympic Weightlifting Coach Bob Hoffman" and"The Food of Champions" falsely and misleadingly representedand suggested that the article had special dietary value suchas in the diets of athletes to increase strength, muscles, andenergy; the label statements with respect to the protein, fat,and carbohydrate content of the article in tablet form wereinconsistent and contradictory; Quick Gain Weight—the nameof the article and the label statement "A Crash Program ToHelp Those Who Want To Gain Weight" falsely and misleadingly represented the article for gaining body weight; andother label statements and the vignette captioned "Bob Hoffman" falsely and misleadingly represented the article forbuilding muscles and extremely strong athletic bodies withprominent muscles; Protein From The Sea—the vignette captioned "Bob Hoffman" and a number of specified label statements falsely and misleadingly represented the article forbody building and other similar special dietary value; otherlabel statements made false and misleading claims concerningthe quality of protein in sea vegetation, the significance ofsuch protein in the diet, and the necessity and usefulness tosupplement the usual diet with amino acids; 403(a). Thelabels of some of the Energol Germ Oil Concentrate (8 oz. &16 oz.), Hi-Proteen powder, the Quick Gain Weight, and the

Protein From The Sea were in violation of the Fair Packagingand Labeling Act, since the quantity of contents statementsof the Energol Germ Oil Concentrate (8-oz. & 16-oz. sizes), theHi-Proteen powder (1 lb. cans), and Protein From The Seawere in a type size too small for the area of the principaldisplay panels; the quantity of contents declaration of theQuick Gain Weight was not separated from label informationabove and .below the declaration; and the quantity of contentsdeclaration of the Protein From The Sea was not within thebo t tom 30 percen t o f the p r inc ipa l d i sp lay a rea and wasexpressed as "1 lb. Net Weight" instead of "Net Weight 16 Oz.(1 Lb.),"—15 U.S.C. 1453(a)(3)(C)(i), 1453(a)(2), 1453(a)(3)(A)(i). The label of the New Improved Hi-Proteen powderand tablets in 4-lb. boxes, Hi-Proteen powder in 1-lb. cans, andt a b l e t s i n 3 0 - o z . c a n s l a c k e d t h e c o m m o n o r u s u a l n a m e o feach ingredient since "natural sweeteners" was not the commonor usual name of an ingredient; the label of the Blue RibbonBeef Hi-Proteen lacked the common or usual name of eachingredient, since "defatted glandular meat" was not the common or usual name of that ingredient; the label of the QuickGa in We igh t l a cked t he common o r usua l name o f eachingredient s ince "sucrose" and " isolated mi lk prote in" were


not the common or usual names of such ingredients; and thel a b e l o f t h e P r o t e i n F r o m T h e S e a l a c k e d t h e c o m m o n o r u s u a lname of each ingredient, since "animal proteins (fish)" and"sea vegeta t ion" were no t the common or usua l name o fingredients; 403 (i) (2).

The article was claimed by the York Barbell Co., Inc., York,Pa. The claimant moved to dismiss, or in the alternative toremove the action to the Middle District of Pennsylvania orthe Dis t r ic t o f New Jersey, arguing that the c la imant wassubject to a Middle District of Pennsylvania consent decreeof permanent injunction, that the Middle District of Pennsylvania had retained jurisdiction to enforce the decree, that bycorrespondence it was agreed not to institute contempt proceedings for v io lat ion of the in junct ion wi thout not ice, thatsuch notice had been given, that contempt proceedings had beeninstituted, that label changes had been made, that such newlabels were among those subject to this seizure action, thatthe FDA presented to the Judge of the Middle Dis t r ic t o fPennsylvania i ts posi t ion on the manner in which the newlabels allegedly violated the Act and the consent decree; thatthe judge remarked that at least one point was "farcical" andothers were of dubious merit; that the Government was forumshopping; that the seizure, wi thout a pr ior hear ing, was adenial of due process; that the Government should have broughtthe action in Pennsylvania; that the action should be removedto the Midd le Dis t r ic t o f Pennsy lvan ia ; and that on ly onepackage was necessary to maintain in rem jurisdiction, andthat the balance of the goods might be released. After a hearing,the court denied the claimant's motion to dismiss, ordered thecase removed to New Jersey, and denied a motion by thecla imant to convene a three- judge court . Jn i ts order, thec o u r t s a i d :

"Jn February, 1974, the government se ized a var ie ty o f'health foods' manufactured by York Barbel l Co. Jt claimedtha t these foods were m is labe led i n v io la t i on o f 21 U .S .C . § 334in that their labels indicated they had curat ive powers andother healthful attr ibutes they did not in fact possess. Yorknow makes a variety of motions.

"First, it argues that the issues in this case are identicalwith those previously litigated in the Middle District of Pennsylvania, and that the case should therefore be d ismissedbecause the government was guilty of forum shopping. Jn 1964,the government inst i tuted an act ion to enjoin simi lar representations in the Middle Distr ict of Pennsylvania where theprincipal place of business of the manufacturer, York BarbellCo., is located. Jn 1968, the court in that case entered aconsent decree that provided the court would retain jurisdictionto enforce the decree and that the government would notifyYork of any proposed contempt act ions before undertakingthem. Jn February, 1972, according to York, the United StatesA t t o r n e y f o r t h e M i d d l e D i s t r i c t o f P e n n s y l v a n i a n o t i fi e dYork that he was contemplating filing a petition for contemptproceedings unless York changed certain labeling practices.Thereafter, counsel for York and the United States Attorneyagreed that York would change its practices by June 1, butdue to circumstances beyond its control, York was unable tocomply until June 8, 1972. Jn January, 1973, the governmentfiled contempt proceedings. Jn August of that year, during adiscussion in chambers, the judge, according to York, describedsome of the government 's content ions as ' fa rc ica l . ' York 'smotion to dismiss the contempt proceedings is still pending att h i s d a t e .

"York claims that the government determined to seize theseitems only after learning the attitude toward its claims of thecourt in the Middle District of Pennsylvania. While the overlapbetween the two cases is rather unclear to the court, it doesnot feel that the extreme remedy of dismissal is in order.Dismissal seems inappropriate because the Pennsylvania casewas terminated six years ago by a consent decree, although thecourt there did retain jurisdiction to enforce its decree. Additionally, the court feels that charges of forum shopping ares ingu la r l y i napp rop r i a te i n ac t i ons i n r em, l i ke t h i s one .Whatever wasteful effects any overlap might cause should bedealt with through res judicata principles, not by dismissal.

"Second, York believes that a three judge court should bec o n v e n e d t o c o n s i d e r w h e t h e r s e c t i o n 3 3 4 c o n fl i c t s w i t h t h e

due process clause as interpreted in Fiientes v. Shevin, 407 U.S.67 (1972). Jt points to section 334(a)(1)(B), which permitsmultiple seizures .... The constitutionality of this section wasupheld in Ewing v. Myt inger & Casselberry, Inc. , 339 U.S.594 (1950), a case with facts remarkably similar to the factsin this case. The products there seized were capsules thatcontained alfalfa, watercress, parsley and mineral tablets. Therewas no claim that they were harmful or dangerous to health,but only that the advertising that accompanied them wasm i s l e a d i n g t o t h e c u s t o m e r b e c a u s e i t c l a i m e d f o r t h e mcurative powers they did not possess. Nevertheless, the government had made eleven separate seizures of these capsules;the producer sought to enjoin any further seizures, have themult ip le seizure provis ion declared unconst i tut ional , and recover all but the first-seized capsules. The Court upheld thea d m i n i s t r a t i v e d e c i s i o n m a k i n g i n t h e s t a t u t e . . . . F u e n t e scited Ewing with apparent approval, 407 U.S. at 92 n. 27, andthe Supreme Court has reiterated its approval of Ewing sinceFuentes. . . . Thus, there is no substantial constitutional question as to the multiple seizure provisions of section 334.

"Nevertheless, York contends that Ewing is dist inguishablebecause in this case there was only one seizure and apparentlyno administrative determination. As the Court noted in Ewing,339 U.S. at 599, the ultimate decision whether to seize is withinthe discretion of the Attorney General, not the Secretary. Thus,it is difficult to understand why the decision of the Secretaryis essential to the constitutionality of the Act: since the Secretary's decision to permit multiple seizures can be made withouta hearing, the Attorney General should similar ly be able tomake a single seizure without a hearing. The court thereforeconcludes that York has not presented a substant ia l issuejustifying convocation of a three judge court.

"York also argues that, under Fuentes, the statute shouldbe read to permit only mul t ip le seizures wi thout a hear ingsince i t is only with reference to mult iple seizures that thes t a t u t e m e n t i o n s h e a r i n g s . T h e c o u r t i s u n a w a r e o f a n yprocedure for hear ings before s ing le se izures, and cannotunderstand how sensible statutory construction would lead tothe resul t that York proposes—that there may be unl imi tedmultiple seizures without a hearing but that a single seizurerequires one. Jt therefore rejects this argument also.

"Th i rd , York and the government w ish tha t the case ber e m o v e d . Y o r k w o u l d l i k e t h e c a s e t o b e r e m o v e d t o t h eMiddle Distr ict of Pennsylvania, and the government to theDistrict of New Jersey, which is York's second choice. Wherethe parties have not stipulated to removal to a certain district,the court may, upon application, remove the case to 'a district of reasonable proximity to the claimant's principal placeof business.' 21 U.S.C. § 334(a)(1). This provision is designedto ameliorate the hardship caused by seizure of products farfrom the producer's place of business. United States v. UnitedS ta tes D is t r i c t Cour t , 226 F.2d 238 , 241 (8 th C i r. 1955 ) .Nevertheless, it is interpreted to preclude removal to the districtin which the producer's principal place of business is located.See United States v. United States District Court, supra; UnitedStates v. 600 Units containing "Nue-Ovo," 60 F. Supp. 144,145 (W.D. Mo. 1945). Since the Middle District of Pennsylvania is the producer's principal place of business, the courtwill order the case removed to the District of New Jersey.

"F ina l l y, Yo rk seeks re tu rn o f a l l bu t one o f t he i t emsseized on the theory that the court needs only one to supportits in rem jurisdiction. Jt cites no authority indicating it has aright to return of the goods prior to final adjudication of thecase. Moreover, its proposal seems inconsistent with the court'sp o w e r t o d i s p o s e o f c o n d e m n e d g o o d s u n d e r 2 1 U . S . C .§ 334(d), since the court cannot dispose of goods it no longerpossesses. This request will be denied."

The claimant filed a notice of appeal from the above order.Accordingly, upon request of the above court, the District ofNew Jersey ordered the retransfer of the action to the NorthernDis t r ic t o f Ca l i fo rn ia . The Government moved for summaryaffirmance of the contested order and partial dismissal of theclaimant's appeal. A subsequent review of existing law by theclaimant indicated that the claimant's only remedy was by wayof a pet i t ion for mandamus; and, accord ingly, the c la imantmoved to voluntar i ly d ismiss the appeal and to pet i t ion for


mandamus. The appeal was dismissed and the pet i t ion formandamus was denied. Meanwhile, upon motion of the claimant who asserted that moths had been seen in the storage areaof the articles and that the articles had an average shelf life ofone year, the court issued an order to show cause why thearticles should not be destroyed as adulterated. The Government opposed the destruction of the article without an adjudicat ion of the misbranding charges. After a hear ing, the U.S.D i s t r i c t C o u r t f o r t h e N o r t h e r n D i s t r i c t o f C a l i f o r n i a o r d e r e d :that the claimant's motion, insofar as it was based upon thedeteriorated condition of the goods, was denied; that, insofaras it was based upon the case being moot, the motion wasdenied without prejudice; and that the entire file in the case bet r a n s m i t t e d t o t h e U . S . D i s t r i c t C o u r t f o r t h e D i s t r i c t o f N e wJersey, as previously ordered.

In the New Jersey Court, the claimant moved to withdrawits notice of claim, alleging as follows: that its notice of claimhad been filed for the express purpose of raising technicalobjections to the seizure; that claimant had not filed an answerto the complaint but might do so in the event its motion wasdenied; that claimant's principal and other witnesses would beat Olympic games at scheduled time of trial; that by allowingclaimant to withdraw, claimant could be al lowed to consentany further multiple seizure on the facts as well as the law;that claimant's labels had undergone further revision; that theFederal Trade Commission had recently proposed regulationsappl icable to prote in supplements; that "Prote in From TheSea" and "Beef Hi -Proteen" had been d iscont inued by theclaimant; that claimant had no interest in defending, in theDistrict of New Jersey, the labels under seizure; that the shelflife of the goods had expired; and that the goods were of noeconomic value to any one; and that claimant prayed: that thewithdrawal of its claim be allowed, or that the trial be stayeduntil the FTC Regulations became final, or that a continuancebe granted, or that case be dismissed for lack of prosecutionon the part of the Government since claimant had filed noanswer. After a hearing, the court denied the claimant's motion.Meanwhile, the Government moved for entry of default of theclaimant for failure to file an answer. Thereafter, claimant filedan answer to the complaint. After further litigation, a consentd e c r e e o f c o n d e m n a t i o n w a s e n t e r e d w h i c h c o n d e m n e d t h earticles, limited the adjudication against use of the picture ofBob Hoffman and other athletes to use in conjunction withwords identical to those in the complaint, limited the effect ofres judicata to the labels in the complaint, and ordered thegoods destroyed. (F.D.C. No. 59642; S. No. 93-314 G et al.;N.J. No. 29)

F O O D A D D I T I V E

Grease, yellow, for use in animal feed, at Pearl, S. Dist. Miss.Charged 3-4-76: while held for sale, the article contained thenonconforming food additive endrin; 402(a)(2)(C). Consent decree authorized release to Ryan Rendering Co., Inc., Memphis,Tenn., for use or sale for nonfeed purposes only. (F.D.C. No.60681; S. No. 76-32-993; N.J. No. 30)

D R U G S / H u n i a n U s e

B-coinplex with vitamin C, B,2, iron, and diluent combination forinjection, at Mayaguez, Dist. P.R.Charged 8-19-75: while held for sale, the article's quality fellbelow its purported quality, since, for a significant number ofunits of the article, the diluent for the active ingredients failedto pass into the unit 's lower compartment for reconsti tut ionof the active ingredients for injection, in accordance with thearticle's directions and instructions, thus making the intendedproduct unavailable for injection; and the labeling of the articlecontained false and misleading claims of adequacy and effectiveness for the article's intended uses, since the majority ofunits of the article tested according to the article's instructionsand directions failed to reconstitute their contents into the drugintended for injection; 501(c), 502(a). Default decree ordereddestruction. (F.D.C. No. 60446; S. No. 23-234 H; N.J. No. 31)

Phentermine HCI capsules, Ona-Mast, at Erie, W. Dist. Pa.Charged 6-28-76: when shipped by M. M. Mast & Co., South

Euclid, Ohio, who had repacked the article, the circumstancesof the art icle's packing fai led to conform with Current GoodManufactur ing Pract ice Regulat ions; the ar t ic le 's box labe llacked the name and place of business of the manufacturer,packer, or distributor, lacked a quantity of contents statement,lacked the established name of the drug, and lacked the quantity of active ingredient; the labeling of the article lackedadequate directions for use and was not exempted therefrom,since the box label lacked the prescription legend, the quantityof active ingredient, the recommended or usual dosage, and therequ i red ident i fy ing lo t o r cont ro l number ; and the ar t i c lewas a new drug w i thou t an e f fec t i ve approved New DrugApplication; 501(a)(2)(B), 502(b)(1), 501(b)(2), 502(e)( l)(A)( i) ,502(e)(l)(A)(i i ) , 502(f)(1), 505(a). Default decree ordered destruction. (F.D.C. No. 60759; S. No. 76-45-238; N.J. No. 32)

Royal jelly and dangshen combination tonic, and Renshenfengwang-jiang ginseng and royal jelly combination tonic, at Ann Arbor,E . D i s t . M i c h .Charged 1-29-76: when shipped by Welfare Trading Co., NewYork, N.Y., the art ic les, labeled in part "Peking Royal Jel ly(Oral Liquid) . . . fresh Royal Jelly, together with Dangshen. . . Peking Chemical and Pharmaceutical Works . . . PekingChina" and "Renshenfengwangjiang . . . Each Ampule Contains. . . Ginseng And . . . Royal Jelly . . . Produced by the ThirdPharmaceutical Manufactory Harbin, China," were new drugswithout effective Approved New Drug Applications; the labeling of the Peking tonic contained false and misleading claimsfor l iver diseases, rheumatoid arthritis, anemia, nodular phlebitis, gastric ulcer, degenerative conditions, loss of body weight,loss of appetite, weakness after illness of childbirth, weaknessin mental and physical energy, overtaxation, and general weakness; and the labeling of the Harbin tonic contained false andmisleading claims for poor appeti te, insomnia, neurasthenia,undernourishment, lowered energy, hepat i t is, anemia, pept iculcer, asthma and restoring the function of the stomach witha gastric ulcer, under-growth, senility and debility after conva lescence and ch i ldb i r th , rheum ar th r i t i s and rheumato idarthritis; and the labeling of both articles lacked adequatedirections for use for such purposes and conditions; 505(a),502(a), 502(f)(1). Default decree ordered destruction. (F.D.C.No. 60616; S. Nos. 76-20-177, 76-20-179; N.J. No. 33)

D R U G S / Ve t e r i n a r yEyewash for veterinary use, at Omaha, Dist. Nebr.

Charged on or about 5-28-76: while held by ABS Corp.,Omaha, Nebr., who manufactured the article using boric acidand ant ipyr ine sh ipped in in ters ta te commerce, the ar t ic lelacked its represented purity and quality of being sterile, andits labeling was false and misleading as to sterility, since it contained viable microorganisms; 501(c), 502(a). Default decreeordered destruction. (F.D.C. No. 60752; S. No. 76-54-414; N.J.No. 34)

M E D I C A L D E V I C E S

Contact lenses (finished & unfinished) of gas-permeable plastic,RX-56, and cellulose acetate butyrate beads, at Floral Park, E.D i s t . N . Y.Charged 8-1-75: while held by Rynco Scientific Corp., FloralPark, N.Y., who was using the beads as components in themanufacture of the lenses, the accompanying labeling containedfalse and misleading claims that substantial scientific evidenceconsisting of adequate and well-controlled studies was availa b l e t o e s t a b l i s h t h a t t h e l e n s w a s s a f e a n d e f f e c t i v e f o r i t sintended uses, or was otherwise generally recognized amongexperts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, as safe and effectivefor use under the conditions prescribed, recommended, or suggested in the labeling; the labeling of the articles lacked adequate directions for use and was not exempted therefrom, sincethe articles were new drugs without effective approved NewDrug Applications; and the articles were manufactured, prepared, compounded, and processed in an unregistered drugproducing establishment; 502(a), 502(f)(1), 502(o).

The art icle was claimed by Rynco Scientific Corp., Floral


Park, N.Y. The claimant moved to dismiss the action, alleging:that there was an insufficient basis in interstate commerce; thatthe seized printed material had not accompanied the goods ininterstate commerce and was therefore not "labeling" for thegoods; that the gravamen of the action was the allegation thatthe seized contact lenses were "drugs"; but FDA had just issueda proposed rule on that question, so that a seizure prior topromulgation of a final rule was premature and unlawful. Aftera hearing, the court denied the claimant's motion in all respects,except that the seized printed material was ordered released"to the custody of the defendant-claimant, provided the counselfor Rynco shall provide two specimens or reproductions ofeach item of said materials to counsel for the Government."After additional litigation, the Medical Device Amendments of1976 were enacted adding a section which was applicable tothe seized articles. Accordingly, the parties stipulated that theclaimant would not use or distribute any of the article, exceptupon notification of an FDA approval of the article and exceptthat the article was in accordance with all applicable provisionsand conditions of such FDA approval. Based on such stipulation and upon consent of the parties, the action was dismissedwithout prejudice. (F.D.C. No. 60424; S. Nos. 76-39-501/2;N.J. No. 35)

C O S M E T I C S

Lipstick and eye shadow, at Santurce, Dist. P.R.Charged 3-4-76: when shipped by Fernando Roque, c/o Euro-cosmetic S.A., Barcelona, Spain, the articles, labeled in part"Henryette Lapiz de Labios . . . Dist Henry-Colomer" and"Sombreador De Parpados Henryette . . . Made in Spain Distr.Henry-Colomer," contained nonconforming color additives,since the lipstick contained Fast Crimson OR C.I. No. 18050and an unidentified yellow color that failed to match thespectra of any permitted color additive, and the eye shadowcontained Rhodamine B C.I . No. 45170; the art ic les' labelslacked quantity of contents statements, and the label lacked theplace of business of the manufacturer, packer, or distributor;601(e), 602(b)(2), 602(b)(1). Default decree ordered destruction.(F.D.C. No. 60657; S. Nos. 76-50-663/4; N.J. No. 36)

N O T I C E S O F J U D G M E N T o n C r i m i n a l A c t i o n s

F O O D

J. C. Curry & Co., Inc., Bessemer, N. Dist. Ala.Charged 4-17-76: salt, four lots of flour, and two lots of pintobeans were he ld under insan i tary condi t ions in a bu i ld ingaccessible to rodents, and all the articles, except one lot offlour, was contaminated with rodent filth; 402(a)(3), 402(a)(4).Guilty plea; fine. (F.D.C. No. 60516; S. No. 117-923 H et al.;N.J. No. 37)

Hal! Bros. Mi l l ing Co., and Roy H. Hal l , partner, Columbia, M.D i s t . A l a .Charged 6-30-76: when shipped, cornmeal , labeled in par t" H a l l ' s E x t r a F i n e E n r i c h e d W h i t e C o r n M e a l . . . S t o n eG r o u n d M f g . B y H a l l B r o t h e r s C o l u m b i a , A l a . , " h a d t h evaluable constituents riboflavin, niacin [or, in one count, iron],and calcium omitted or abstracted; the cornmeal failed to conform to the definition and standard for enriched cornmeal; andthe labeling of the cornmeal was false and misleading as tothe article's supply of riboflavin, niacin [or, in one count, iron],and calcium, since the cornmeal was deficient in such const i tuents ; 402(b) (1) , 403(g) (1) , 403(a) . Gu i l ty p leas ; fines.(F.D.C. No. 60520; S. Nos. 76-00-040/3; N.J. No. 38)

Harborside Terminal Co., Inc. , Richard A. Gage, president, andPhilip Greenhaum, vice president, Jersey City, Dist. N.J.Charged 3-26-75: dr ied apr icots (counts 1 & 7), p istachios(counts 2, 4, 10, 12, 14, 17, & 18), walnuts (count 3), ginger(count 5), filberts (counts 6 & 8), paprika flakes (count 9), pinekernels (count 11), cashews (count 13), diced pepper flakes(count 15), and paprika (counts 16, 19, & 20) were exposed tocontamination by rodents resulting in the articles being heldunder insani tary condi t ions; 402(a)(4) . Nolo contendere byindividuals to count 1; fines. Nolo contendere by corporationto counts 1-20; fine. (F.D.C. No. 60090A; S. No. 58-309 H

et al.; N.J. No. 39)

Michigan Fast Food Supply Corp., and Harry C. Commodore, president, Detroit, E. Dist. Mich.Charged 2-10-76: cake mix was held in a building accessible toinsects and was contaminated with insects; 402(a)(3), 402(a)(4).Nolo contendere plea by corporation; fine. Guilty plea by individual; fine. (F.D.C. No. 60511; S. No. 10-147 H; N.J. No. 40)

N O T I C E S O F J U D G M E N T o n I n j u n c t i o n A c t i o n sInternational Drug, Inc., t/a Carroll Chemical Co., and Lawrence J.

Duhow, president, Lonnie L. Smith, vice president and generalmanager, and Edward T. Goldstein, vice president, Smyrna, M.D i s t . Te n n .Charged 3-25-75 in complaint for injunction: that the defendants engaged, at their Smyrna plant, in inanufacturing, processing, packing, labeling, holding, and distributing in interstatecommerce various drugs, and in holding for sale some of suchdrugs after interstate shipment of their components; that FDAinspection showed that circumstances used for the manufacturing. processing, packing, labeling, and holding of such drugsfa i led to con fo rm to Cur ren t Good Manufac tu r ing Prac t i ceRegulations in a number of specified instances; that samples ofa number of the defendants' drugs differed in strength or purityfrom the U.S.?., the N.F., or the drug's own standards; thatthe labeling of a number of drugs was false and misleadingwith respect to 44entity, strength, quality, and purity; that anumber of specified recalls of drugs manufactured by the defendants had been made; and that the defendants were wella w a r e t h a t t h e i r a c t i v i t i e s w e r e i n v i o l a t i o n o f t h e l a w ;501(a)(2)(B), 501(b), 501(c), 502(a). The court initially deniedthe Government's application for a temporary restraining order.Subsequently, upon consent of the parties, a temporary restraining order was entered that temporarily enjoined the defendants from shipping in interstate commerce any drug manufactured at their plant, and from manufacturing, processing,packing, or labeling at their plant any drug containing interstate components. A consent decree of preliminary injunctionwas subsequently entered enjoining the complained of violations and similarly enjoining the interstate shipment of theirdrugs until the circumstances for the manufacture, processing,packing, and labeling of their drugs conformed with a numberof specified Current Good Manufacturing Practice Regulations.Subsequently, the defendants brought their plant into compliance and the Government agreed to a stipulation dismissing theaction and vacating the injunction. (Inj. No. 693; S. No. 3-392G et al.; N.J. No. 41)

Titan Pharniacal Co., Rhinecliff Laboratories, Inc., R. C. Gutierrez,pres ident of both corporat ions, John Y. Leinau, d i rector ofqua l i ty cont ro l , Theodore Tvrdek, product ion manager, LosAngeles, C. Dist. Calif.Charged 6-18-75 in complaint for injunction: that the defendants, at their Los Angeles plant, engaged in the manufacturing,process ing, pack ing , ho ld ing , and d is t r ibu t ion in in ters ta tecommerce of various drugs, which had components shipped inin ters ta te commerce and which were represented as be ingster i le; that FDA inspect ions showed a number of specifiedinadequacies in the circumstances used in the manufacture,processing, packing, and holding of such drugs; that the circumstances used for the manufacture, processing, packing, andh o l d i n g o f t h e d r u g s f a i l e d t o c o n f o r m t o C u r r e n t G o o dManufactur ing Pract ice Regulat ions; and the defendants arewell aware that their activit ies were in violation of the law;501(a)(2)(B).

Subsequently, a consent decree of injunction enjoined theinterstate shipment of drugs represented as being sterile, andthe production of such drugs having components which hadbeen shipped in in terstate commerce, unless and unt i l theplant's production circumstances were in conformity with Current Good Manufacturing Practice Regulations and such drugson hand were examined, necessary recalls made, and all suchdrugs were brought into compliance; and, after the above conditions were met, the defendants were enjoined from any ofthe complained of violations. (Inj. No. 702; N.J. No. 42)


Bureau of Narcotics and Dangerous Drugs) of the Departmentof Justice. FDA, on the other hand, has the responsibility ofmaking the initial decision, based on all available medicaland scientific data, as to whether a particular new drug issafe and effective for its intended use. While the functions ofFDA and DBA are not entirely exclusive of one another, acertain division of authority and responsibility was clearlyintended by Congress and must be recognized by this Courtin order to preserve the integrity of the legislative scheme.Under these circumstances, the relative merits of FDA's planto control the distribution of methadone, a controlled substance,must first be passed upon by Congress."

The Government appealed. The Court of Appeals for theDistrict of Columbia affirmed the judgment on the basis of theopinion of the District Court. One of the three judges of theCourt of Appeals, concurring in the result, wrote an opinionin which he stated, in part:

"Although 1 concur in affirming the District Court, I findunpersuasive two theories advanced in its opinion, and appellees' failure to rely upon them on appeal appears to reflectmy own doubts.

"In my view, the critical issue is whether, as appelleesargue, the regulations at issue fall outside the scope of theauthority delegated by Congress to the FDA. The Commissioner of the FDA has himself expressed some uncertainty onthis score. . . . Upon examining this question, I have concluded—not with great difficulty—that appellees should prevail.

"The pivotal provision of the Federal Food, Drug andCosmetic Act is 21 U.S.C. § 355(d), which prohibits the approval of a new drug application unless there are adequatedata to establish that the 'drug is safe for use under the conditions prescribed, recommended, or suggested in the proposedlabeling thereof . . . .' The FDA contends that where thereexists a documented pattern of drug misuse contrary to theintended uses specified in the labelling, the drug is unsafe forapproval unless controls over distribution are imposed. As acorollary, it asserts that for a drug such as methadone, forwhich there is substantial evidence of misuse, the FDA musthave the power to restrict distribution to avoid the dilemmaof either disapproving a drug with important therapeutic benefits or of placing on the market a drug likely to be misused.The FDA claims that section 355(d) authorized restricting distribution to a prescription-only basis before the FDA wasexplicitly granted that authority in 1951, and that the regulations at issue differ only in degree from a prescription-onlyr e s t r i c t i o n .

"Although these arguments have some weight, I do not findthem ultimately convincing. The word 'safe' in section 355(d) is,to my mind, best interpreted as requiring the labelling toinclude the evidence from drug testing, and the inferencestherefrom, indicating the therapeutic benefits, possible dangers,and uncertainties involved in use of a drug, as an aid to aconscientious physician in determining appropriate medicaltreatment. That view seems to me to accord with both themost reasonable interpretation of the statutory language andthe common understanding of the FDA's mission. Thus, methadone is safe for its intended use notwithstanding the possibilitythat it will be employed in unintended fashions.

"The controls on distribution here are different in kindfrom prescription-only restrictions. The latter restrictions prevent self-diagnosis by the layman. If such restrictions had notbeen permitted before 1951, drug labelling would have hadto include both specific medical evidence about a drug and allthe general medical knowledge that a physician must possessin order to decide, after reading a labelling, whether toadminister a drug. Although one might contend in theorythat any drug is safe for its intended use if the labellingcontains enough information, it is evident that a laymancannot be expected to digest a mass of complicated medicalinformation and bring to bear upon it the medical judgment ofa practicing physician. Thus, restrictions to a prescription-onlybasis are necessary to ensure that persons intending to usedrugs in accordance with the implications of medical evidencegathered by the FDA and contained in a drug labelling can doso. The restr ic t ions on methadone involved here are qui tedifferent. Without them an informed and sound medical judg

ment about medical safety and effectiveness can still be made.They are designed instead to control drug misuse by personswho have no intent to try to use drugs for medical purposes.

"There would be almost no limit to the FDA's authoritywere its view adopted. If, for example, it had concluded before1970 that without restrictions on methadone of the sort nowcontained in the Controlled Substances Act, ... the possibilityof drug misuse remained high, there would be no barrier underits argument to its having established a regulatory scheme ofthe complexity of that ultimately [was] adopted in that Act. . . .

"Physicians and state-licensed pharmacists have not beenuniformly responsible in dealing with methadone, and the FDAundoubtedly has genuine cause to believe that, with respectto both narcotic and non-narcotic drugs, effective regulationin the public interest necessitates authority on its part to restrictdistribution channels when the risk of unintended uses is greatand the consequences of misuse are very harmful. Under thepresent statutory framework, however, I believe that argumentmust be addressed to Congress." (Misc. No. 237; N.J. No. 43)

Regulations of FDA concerning Administrative Practices and Procedures, and the promulgation of such regulations in final formwithout prior publication in the form of a proposal, Washington, Dist. Columbia.Charged: 7-23-75 by American College of Neuropsychopharma-cology, Boston, Mass., against H.E.W. Secretary Caspar W.Weinberger and FDA Commissioner Alexander Schmidt, M.D.,in complaint for injunction and declaratory relief: that, in theFederal Register of May 27, 1975, FDA issued regulationsentitled "Administrative Practices and Procedures"; that, contrary to standard administrative agency rulemaking procedures,the regulations were issued in final form, rather than as aproposal, with an effective date of July 28, 1975; that publiccomment was solicited for submission to FDA until July 28,1975; that FDA relied upon the Administrative ProceduresAct exceptions to the publication of a general notice of proposed rulemaking; that the regulations failed to meet thecriteria for such exceptions because the regulations were notrules of agency organization, procedure, or practice and FDAhad not found that notice and public procedures were impractical, unnecessary, or contrary to the public interest; thatthe regulations had a substantial impact on the regulatedindustry, physicians, patients, and general public; that plaintiff'sprocedural rights before FDA were substantially impaired andrestricted, in comparison with existing procedures and practicesof FDA, and procedural rights as provided by the Administrative Procedures Act were denied; that such denials were anunconstitutional denial of due process; that failure to stay theeffective date of the regulations and to allow them to bepromulgated as final would result in immediate and irreparableinjury to the plaintiff; that plaintiff prayed to the court for apreliminary injunction requiring a published notice of proposedrulemaking, for a declaration that Administrative PmceduresAct exceptions were inapplicable to the FDA regulations; andthat FDA had abused its discretion and authority by failingto issue the regulations with notice and opportunity for publiccomment prior to the final promulgation of such regulations.

At a hearing before the court, FDA agreed, pursuant to arequest of the court, to delay the effectiveness of the regulations pending a decision by the court in the plaintiff's motionfor a preliminary injunction. After full argument, the courtgranted a preliminary injunction, and stated in the court'sc o n c l u s i o n s a s f o l l o w s :

"1. This Court has jurisdiction of this matter pursuantto 28 U.S.C. § 2201 and 28 U.S.C. § 2202 and 5 U.S.C.§§ 701-706.

2. Defendants' regulations, because of their complexityand pervasiveness, cannot be classified merely as 'interpretative rules, general statements of policy or rules of agencyorganization, procedure or practice' as set forth in Section553(b)(A) of the APA [Administrative Procedures Act].

3. No 'good cause' has been advanced to support defendants' claim that issuance of the regulations as a proposal is 'impracticable, unnecessary or contrary to thepublic interest' as set forth in Section 553(b)(B) of theA P A .

4. Defendants illegally promulgated the regulations in


Park, N.Y. The claimant moved to dismiss the action, alleging:that there was an insufficient basis in interstate commerce; thatthe seized printed material had not accompanied the goods ininterstate commerce and was therefore not "labeling" for thegoods; that the gravamen of the action was the allegation thatthe seized contact lenses were "drugs"; but FDA had just issueda proposed rule on that question, so that a seizure prior topromulgation of a final rule was premature and unlawful. Aftera hearing, the court denied the claimant's motion in all respects,except that the seized printed material was ordered released"to the custody of the defendant-claimant, provided the counselfor Rynco shal l provide two specimens or reproduct ions ofe a c h i t e m o f s a i d m a t e r i a l s t o c o u n s e l f o r t h e G o v e r n m e n t . "After additional l it igation, the Medical Device Amendments of1976 were enacted adding a section which was applicable tothe seized articles. Accordingly, the parties stipulated that theclaimant would not use or distribute any of the article, exceptupon notification of an FDA approval of the article and exceptthat the article was in accordance with all applicable provisionsand conditions of such FDA approval. Based on such stipulation and upon consent of the parties, the action was dismissedwithout prejudice. (F.D.C. No. 60424; S. Nos. 76-39-501/2;N.J. No. 35)

C O S M E T I C S

Lipstick and eye shadow, at Santurce, Dist. P.R.Charged 3-4-76: when shipped by Fernando Roque, c/o Euro-cosmetic S.A., Barcelona, Spain, the articles, labeled in part"Henryet te Lapiz de Labios . . . D is t Henry-Colomer" and"Sombreador De Parpados Henryette . . . Made in Spain Distr.Henry-Colomer," contained nonconforming color additives,since the lipstick contained Fast Crimson OR C.I. No. 18050and an un iden t i fied ye l l ow co lo r tha t fa i l ed to match thespectra of any permitted color additive, and the eye shadowcontained Rhodamine B C.I . No. 45170; the art ic les' labelslacked quantity of contents statements, and the label lacked theplace of business of the manufacturer, packer, or distributor;601(e), 602(b)(2), 602(b)(1). Default decree ordered destruction.(F.D.C. No. 60657; S. Nos. 76-50-663/4; N.J. No. 36)

N O T I C E S O F J U D G M E N T o n C r i m i n a l A c t i o n s

F O O DJ. C. Curry & Co., Inc., Bessemer, N. Dist. Ala.

Charged 4-17-76: salt, four lots of flour, and two lots of pintobeans were held under insanitary conditions in a buildingaccessible to rodents, and all the articles, except one lot offlour, was contaminated with rodent filth; 402(a)(3), 402(a)(4).Guilty plea; fine. (F.D.C. No. 60516; S. No. 117-923 H et al.;

N.J. No. 37)Hall Bros. Milling Co., and Roy H. Hall, partner, Columbia, M.

D i s t . A l a .Charged 6-30-76: when shipped, cornmeal, labeled in part"Ha l l ' s Ex t ra F ine Enr i ched Wh i te Corn Mea l . . . S toneGround Mfg. By Hall Brothers Columbia, Ala.," had thevaluable constituents riboflavin, niacin [or, in one count, iron],and calcium omitted or abstracted; the cornmeal failed to conform to the definition and standard for enriched cornmeal; andthe labeling of the cornmeal was false and misleading as tothe article's supply of riboflavin, niacin [or, in one count, iron],

and calcium, since the cornmeal was deficient in such constituents; 402(b)(1), 403(g)(1), 403(a). Guilty pleas; fines.(F.D.C. No. 60520; S. Nos. 76-00-040/3; N.J. No. 38)

Harborside Terminal Co., Inc., Richard A. Gage, president, andPhilip Greenbaum, vice president, Jersey City, Dist. N.J.Charged 3-26-75: dried apricots (counts 1 & 7), pistachios(counts 2, 4, 10, 12, 14, 17, & 18), walnuts (count 3), ginger(count 5), filberts (counts 6 & 8), paprika flakes (count 9), pinekernels {count 11), cashews (count 13), diced pepper flakes(count 15), and paprika (counts 16, 19, & 20) were exposed tocontamination by rodents resulting in the articles being heldunder insanitary conditions; 402(a)(4). Nolo contendere byindividuals to count 1; fines. Nolo contendere by corporationto counts 1-20; fine. (F.D.C. No. 60090A; S. No. 58-309 H

et al.; N.J. No. 39)Michigan Fast Food Supply Corp., and Harry C. Commodore, presi

dent, Detroit, E. Dist. Mich.Charged 2-10-76: cake mix was held in a building accessible toinsects and was contaminated with insects; 402(a)(3), 402(a)(4).Nolo contendere plea by corporation; fine. Guilty plea by individual; fine. (F.D.C. No. 60511; S. No. 10-147 H; N.J. No. 40)

N O T I C E S O F J U D G M E N T o n I n j u n c t i o n A c t i o n sInternational Drug, Inc., t/a Carroll Chemical Co., and Lawrence J.

Dubow, president, Lonnie L. Smith, vice president and generalmanager, and Edward T. Goldstein, vice president, Smyrna, M.D i s t . Te n n .Charged 3-25-75 in complaint for injunction: that the defendants engaged, at their Smyrna plant, in manufacturing, processing, packing, labeling, holding, and distributing in interstatecommerce various drugs, and in holding for sale some of suchdrugs after interstate shipment of their components; that FDAinspection showed that circumstances used for the manufacturing, processing, packing, labeling, and holding of such drugsfailed to conform to Current Good Manufacturing PracticeRegulations in a number of specified instances; that samples ofa number of the defendants' drugs differed in strength or purityfrom the U.S.?., the N.F., or the drug's own standards; thatthe labeling of a number of drugs was false and misleadingwith respect to identi ty, strength, qual i ty, and puri ty; that anumber of specified recalls of drugs manufactured by the defendants had been made; and that the defendants were wella w a r e t h a t t h e i r a c t i v i t i e s w e r e i n v i o l a t i o n o f t h e l a w ;501(a)(2)(B), 501(b), 501(c), 502(a). The court initially deniedthe Government's application for a temporary restraining order.Subsequently, upon consent of the parties, a temporary restraining order was entered that temporarily enjoined the defendants from shipping in interstate commerce any drug manufactured at their plant, and from manufacturing, processing,packing, or labeling at their plant any drug containing interstate components. A consent decree of preliminary injunctionwas subsequently entered enjoining the complained of violat ions and similarly enjoining the interstate shipment of theirdrugs until the circumstances for the manufacture, processing,packing, and labeling of their drugs conformed with a numberof specified Current Good Manufacturing Practice Regulations.Subsequently, the defendants brought their plant into compliance and the Government agreed to a stipulation dismissing theaction and vacating the injunction. (Inj. No. 693; S. No. 3-392G et al.; N.J. No. 41)

Titan Pbarniacal Co., Rbinecliff Laboratories, Inc., R. C. Gutierrez,president of both corporations, John Y. Leinau, director ofquality control, Theodore Tvrdek, production manager, LosAngeles, C. Dist. Calif.Charged 6-18-75 in complaint for injunction: that the defendants, at their Los Angeles plant, engaged in the manufacturing,processing, packing, holding, and distribution in interstatecommerce of various drugs, which had components shipped ininterstate commerce and which were represented as beingsterile; that FDA inspections showed a number of specifiedinadequacies in the circumstances used in the manufacture,processing, packing, and holding of such drugs; that the circumstances used for the manufacture, processing, packing, andholding of the drugs failed to conform to Current GoodManufacturing Practice Regulations; and the defendants arewell aware that their activities were in violation of the law;501(a)(2)(B).

Subsequently, a consent decree of injunction enjoined theinterstate shipment of drugs represented as being sterile, andthe production of such drugs having components which hadbeen shipped in interstate commerce, unless and until theplant's production circumstances were in conformity with Current Good Manufacturing Practice Regulations and such drugson hand were examined, necessary recalls made, and all suchdrugs were brought into compliance; and, after the above conditions were met, the defendants were enjoined from any ofthe complained of violations. (Inj. No. 702; N.J. No. 42)


N O T I C E S O F J U D G M E N T o n M i s c e l l a n e o u s A c t i o n s

Methadone distribution limitations prescribed by FDA regulationsand validity of such regulations, Washington, Dist. Columbia.Charged 7-24-73 by Amer ican Pharmaceut ica l Assoc ia t ion,Washington, D.C.; Robert L. Masse (Don's Pharmacy), Richmond, Calif.; Frederick S. Mayer (Sausalito Pharmacy), Sausa-lito, Calif.; Logan Wallace (Logan Wallace Prescriptions), Portland, Greg.; and Richard S. Blum, M.D., New Hyde Park, N.Y.,against H.E.W. Secretary Caspar W. Weinberger, FDA Commiss ione r A lexande r M . Schm id t , M .D . , A t t o rney Gene ra lE l l io t L . Richardson, and Drug Enforcement Admin is t ra t ionAdministrator John R. Bartels, Jr., in suit for judicial review,declaratory judgment, and injunction: that American Pharmaceutical Association (APhA) was a professional association ofmore than 50,000 members, including practicing pharmacists incommunity and hospital pharmacies, and teachers and studentsof pharmacy; that Richard S. Blum was a licensed doctor ofmedicine, was registered by the Drug Enforcement Administration (DEA) to prescribe methadone, and was the director of aMethadone Maintenance Treatment Program; that the otherindividual plaintiffs were licensed pharmacists and were registered by DEA to dispense methadone; that methadone was regulated as a "new drug," a "prescription drug," and a "controlledsubstance"; that methadone was safe and effective and therewas substantial evidence of its effectiveness: (a) for analgesiain chronic and acute states of severe pain, (b) for antitussiveuse, and (c) for detoxification of persons addicted to heroin;that FDA approvals of New Drug Applications for methadoneunder such conditions had become effective before March 15,1973, when FDA's final regulations establishing special conditions of use for methadone became effective; that the physician(Blum) prescribed methadone for analgesic use, and the pharmacists (Masse, Mayer, & Wallace) and pharmacist members ofAPhA practicing in community pharmacies obtained and dispensed methadone; that FDA's final regulations purportedto restr ict the distr ibut ion of methadone (a) to direct shipments by manufacturers, and (b) only (i) to approved maintenance treatment programs, (i i) to approved hospital pharmacies, and (iii) to approved selected community pharmacies; thatcommunity pharmacies would be authorized to receive shipments o f methadone for d ispens ing for ana lges ia on ly " inremote areas" or "in certain exceptional circumstances wherethere are no approved hospitals," and only "upon the recommendation of the State authority and after consultation withthe Bureau of Narcotics and Dangerous Drugs, although community pharmacies might serve as dispensing facilities for outpatient subjects in approved maintenance treatment programs;that many hospital pharmacies had not sought approval todispense methadone pursuant to the FDA regulations; thatmany other pharmacies refused to dispense methadone to outpatients; refused to dispense to patients of physicians who didnot enjoy privileges at that hospital, refused to dispense methadone except to patients appearing personally at the hospitalpharmacy and except at severely restricted hours; that many, ifnot most or all, patients for whom methadone was prescribedas an analgesic were bedridden, or do not have ready accessto public or private transportation necessary to visit an approved hospital pharmacy, and were therefore unable personallyto appear at such a pharmacy to obtain methadone prescribedby their physicians; that FDA's final regulations were unlawful,unconstitut ional, and invalid for the fol lowing reasons: suchregulations exceeded FDA authority to control and restrict thedistribution channels for a new drug; such regulations exceededFDA authority in denying the right of pharmacists registeredby DEA to dispense the DEA-controlled drug methadone; suchregulations denied due process and exceeded FDA authority byinterfering with the practice of medicine by licensed physicians; such regulations were arbitrary, capricious, and an abuseo f d i s c r e t i o n i n t h a t t h e f a c t s b e f o r e t h e F D A C o m m i s s i o n e rand the findings of the FDA Commissioner as set forth in thefinal order were inadequate; such regulat ions were promulgated without due process, since they were based upon findjngsof facts made without an adequate hearing; such regulationsdenied due process in discriminating against community pharmacies not in remote areas, against physicians (and the patientsthereof) who did not enjoy pr iv i leges at hospi tals wi th ap

proved pharmacies, and patients who did not have reasonableaccess to approved hospital pharmacies; that the plaintiffs wereirreparably injured by the FDA regulations and accordinglyprayed that such regulations be declared unlawful, unconstitutional, and invalid, and that the defendants be enjoined fromenforcing such regulations.

The Government moved to dismiss and moved for summaryjudgment of dismissal. The plaintiffs served a request fordocuments and the Government moved for a protection orderas to the requested documents o ther than the documentsin the Certified Record of the administrative proceedings uponwhich the FDA regulations were based. The plaintiffs withdrewtheir request for documents, and moved for summary judgment in their favor. The court ruled in favor of the plaintiffs,declared the FDA regulations to be of no effect, and enjoinedthe Government from enforcing them. The court said:

"This is an action for judicial review of a regulation of theFood and Drug Administration (FDA) which restricts the distribution of methadone to certain specified outlets as set forthin the regulation. In effect, i t prohibits virtual ly al l l icensedpharmacies from dispensing this drug when lawfully prescribedby a physician, despite the fact that methadone was inventedand was first used as a safe, useful and effective agent in thetreatment of severe pain and for antitussive purposes. Decisionis not made easier by the fact that in recent years methadonehas become a widely known maintenance agent in the treatm e n t o f h e r o i n a d d i c t s a n d t h e r e i s e v i d e n c e o f s e r i o u s a b u s e sin the d is t r ibu t ion o f th is d rug. In the i r e f fo r ts to cont ro limproper distr ibut ion of methadone, there are strong publ icpolicy arguments on the side of defendants. At the same time,the popularity of methadone for use as a pain killer has declined because of the introduction of effective new drugs, andas recently as 1972 the plaintiff Association formally recommended that FDA withdraw its approval of methadone for itsindications as an analgesic and antitussive and expressed itsphilosophic non-disagreement with a course of regulation whichwould restr ict the distr ibution and use of methadone to approved methadone treatment programs.

"The challenged regulation, while ruling out most so-calledcommunity pharmacies in the dispensing of methadone for anypurpose, still permits approved hospital pharmacies to dispensemethadone for analgesic and antitussive purposes. Stripped ofthe rhetoric which abounds in the papers before us, this appears to be the basis of plaintiffs' complaint. Whether the FDAhas the authority to enact the challenged regulation depends onthe interplay and connection between two complementary butdistinct statutes, the Food, Drug and Cosmetic Act of 1938and the Comprehensive Drug Abuse Prevention & Control Actof 1970 and the respective roles assigned by Congress to theagencies [FDA & DEA] which administer these Acts. With thisbrief background, we proceed to the issues presented. * * *

I ."The drug methadone, a synthetic substitute for morphine, is

a 'new' drug . . . and, as a new drug, requires FDA's approvalof [an] NDA, filed with the Commissioner of Food andDrugs .... The drug was first approved by FDA in the 1950'sas safe for use as an analgesic and antitussive agent as wellas for short-term detoxification of persons addicted to heroin.Subsequently, investigation of methadone for use in long-termmaintenance of narcotic addicts (methadone maintenance) wasapproved by FDA pursuant to its authority under 21 U.S.C.§ 355(i), the investigational-new-drug (IND) exemption. Section355(i) of the Act empowers FDA to exempt from NDA approval requirements those new drugs 'intended solely for investigational use by experts qualified by scientific training andexperience to investigate the safety and effectiveness of drugs.'F ina l gu ide l ines for long- term main tenance programs werepromulgated by FDA in 1971. . . . A year later FDA determined that 'retention of the drug [methadone] solely on aninvestigational status appears to be no longer warranted' (37Fed. Reg. 6940) and published a notice of proposed rulemakingwhich resulted, with certain modifications, in the regulationsnow in question.

"The final regulation gave notice that pursuant to FDA'sauthority under 21 U.S.C. § 355(c), the Commissioner waswithdrawing approval of all outstanding NDA's because of 'a


l a c k o f s u b s t a n t i a l e v i d e n c e t h a t m e t h a d o n e i s s a f e a n d e f f e ctive for detoxification, analgesia, or antitussive use under theconditions of use that presently exist' . . . Having withdrawna l l app roved NDA 's , t he Commiss ion [e r ] ' s new regu la to ryscheme is presently the exclusive means of distribution for thedrug methadone. The Commissioner has thereby created anadmittedly unique classification for methadone since on the oneh a n d h e h a s d e t e r m i n e d t h a t m e t h a d o n e s h o u l d n o t b e l i m i t e dsolely to investigational status while at the same time concluding that the drug is inappropriate for regular NDA approval.As statutory support for this novel solution to the methadonedilemma, defendants rely on an expansive interpretation of theCommissioner's NDA authority under § 355 of the Act.

I I ."Under the Federal Food, Drug and Cosmetic Act, the FDA

(through the Secretary of HEW) has the responsibility of passing on the merits of NDA's. The grounds upon which an NDAcan be denied approval are explicitly stated in subsection (d)of § 355 and the NDA shall be approved 'if [FDA] . . . findsthat none of the grounds for denying approval . . . applies.'21 U.S.C. § 355(c). The NDA must be supported by 'substantial evidence' defined to mean 'evidence consisting of adequateand well-controlled investigations, including clinical investigations, by experts qualified by scientific training and experienceto evaluate the effectiveness of the drug involved, on the basisof which it could be fairly and responsibly concluded by suchexperts that the drug will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the labeling or proposed labeling thereof.' 21 U.S.C. § 355(d).

"One of the six enumerated grounds for refusing approvalof a new drug appl icat ion (NDA) specifical ly deals with the'methods' or 'controls' used in connection with the proferreddrug. . . . This [§ 355(d)(3)] is the only provision of § 355which speaks of the Secretary's authority with respect to 'controls.' The Congress apparently intended that the Secretary, orhis delegate, FDA, be responsible for the adequacy of premarketing methods and controls inasmuch as the provision delineates the scope of the provision to the manufacturing, processing and packaging stage of a drug's genesis.

"The defendants point out, however, that § 355(d) also givesthe Secretary the authority to refuse to approve an NDA wherethe repor ts o f the invest igat ions submi t ted do not inc ludeadequate tests showing whether the new drug is 'safe for useunder the conditions prescribed, recommended, or suggestedin the proposed labeling thereof.' . . . Defendants argue thatthe term 'safe' should be interpreted with reference not onlyto the inherent qualities of the drug under consideration butalso in the sense of the drug's being secure from possiblemisuse. Such a broad interpretation would, according to defendants' theory, serve as the statutory foundation for FDA'sexercise of authority in restricting methadone's channels ofdistribution because FDA's principal rationale for restrictingdistribution was 'to help reduce the likelihood of diversion.' . . .

"As a general proposition of statutory construction, a generalte rm shou ld no t be cons t rued i n i so la t i on bu t shou ld beinterpreted according to the context of the statute withinwhich it is found. . . . [T]he context of the statute indicatesthat the term 'safe' was intended to include only the inherentsafety of the drug when used in the manner intended. . . .[T]he Court concludes that the term 'safe' was intended torefer to a determination of the inherent safety or lack thereofof the drug under consideration when used for i ts intendedp u r p o s e .

"Finally, the legislative history of the Act fully supports thisconclusion. In enacting the Comprehensive Drug Abuse Prevention and Control Act of 1970, Congress was presentedwith a conscious decision as to how the lines of authorityshould be drawn with respect to the regulation of dangerousdrugs. Congress decided to continue all control authority overthe distribution of dangerous drugs in the Justice Departmentdespite a recommendation of the Prettyman Commission thatthis function be transferred to HEW. The House Committee onInterstate and Foreign Commerce in their report on the Comprehensive Drug Abuse Prevention and Control Act of 1970indicated that Tit le I I of that Act, known as the Control ledSubstances Act, was designed to 'provide authority for the

Department of Justice to keep track of all drugs subject toa b u s e m a n u f a c t u r e d o r d i s t r i b u t e d i n t h e U n i t e d S t a t e s i n o r d e rto prevent diversion of these drugs from legitimate channelsof commerce.' Although it is nowhere specifically stated thatCongress contemplated that the Justice Department would haveexc lus ive au thor i t y to p reven t d i ve rs ion , th i s resu l t wou ldappear logically to follow from a comparison of the functionsdelegated to the Secretary of HEW with those assigned to theAttorney General .

I I I ."In addition to being a 'new' drug and thus within the

jurisdiction of the FDA, methadone is a controlled substancewithin Schedule II of the Controlled Substances Act, 21 U.S.C.§ 812. Under this Act the Attorney General is made responsib le f o r t he reg i s t ra t i on o f any pe rson who manu fac tu res ,distributes or dispenses any controlled substance. 21 U.S.C.§ 822. An applicant may be refused registration if the AttorneyGeneral makes a determination that registering the applicantwould be inconsistent with the public interest. Congress hasalso provided the specific means for revoking or suspendingthe authority of a registrant to distribute controlled substances.... In addition. Congress has specified the precise procedureto be followed by the Attorney General in attempting to revokeor suspend a registration. 21 U.S.C. § 824(c).

"The Court concludes that Congress intended to create twocomp lementa ry ins t i t u t i ona l checks on the p roduc t ion andmarket ing of new drugs. At the product ion or pre-market ingstage, the FDA is given the primary responsibility in determining which new drugs should be permitted to enter the flowof commerce. The Commissioner must approve or deny everyN D A , o r h e m a y d e t e r m i n e t h a t a p a r t i c u l a r n e w d r u gqualifies for IND status in order to permit addit ional experimentat ion. When an IND exempt ion is approved, the Commiss ioner may, o f course, severe ly rest r ic t the d is t r ibut ionof the exempted drug to bona fide researchers and clinicians.But once a drug is cleared for marketing by way of [an]NDA-approva l , for whatever uses the Commiss ioner deemsappropr ia te , the quest ion of permiss ib le d is t r ibut ion of thedrug, when that drug is a controlled substance, is one clearlywithin the jurisdiction of the Justice Department. The diversionof the particular drug to a use not approved by the Commissioner would be grounds for revocation of the offending distributor's registration. FDA attempts to accomplish preemp-tor i ly by way of i ts chal lenged regulat ion, that which couldonly be accomplished, according to the scheme of the Controlled Substances Act, by way of show-cause proceedingsinitiated by the Attorney General, i.e., revoking the authorityof otherwise duly-registered distributors with respect to thedrug methadone. To allow the challenged portions of themethadone regulations to stand, therefore, would be to abrogate the collective judgment of Congress with regard to theappropriate means of controlling unlawful drug diversion.

"This is particularly true of the regulations' denial ofauthority to the plaintiffs at bar. Although the Attorney General generally has discretion to register applicants wishing todistribute or dispense controlled substances, ... in the caseof 'practitioners' the Attorney General must register them 'ifthey are authorized to dispense under the law of the State inwhich they regularly conduct business.' . . . Congress hasthereby specifically sanctioned the registration of all State-licensed practitioners with the clear intent of permitting themto dispense controlled substances on an equal basis with allo ther approved d is t r ibu to rs . In the face o f such c lear -cu tCongressional intent, it would be anomalous to suggest that anagency, by the mere issuance of a regulation, could modifythese mandated channels of distribution. Accordingly, theCourt concludes that FDA has overstepped the bounds of itspthority in purporting to limit the distribution of methadonein the manner contemplated by its regulations.

I V ."It is undoubtedly true that methadone poses unique prob

lems of medical judgment, law enforcement and public policybut this fact alone cannot justify a federal agency of specifically delimited jurisdiction from implementing equally uniquecontrol solutions not authorized by Congress. The problem ofunlawful diversion is one presently consigned by Congress tothe Drug Enforcement Administration (DEA, formerly the


Bureau of Narcotics and Dangerous Drugs) of the Departmentof Justice. FDA, on the other hand, has the responsibility ofmaking the in i t ia l decis ion, based on al l avai lable medicaland scientific data, as to whether a part icular new drug iss a f e a n d e f f e c t i v e f o r i t s i n t e n d e d u s e . W h i l e t h e f u n c t i o n s o fFDA and DEA are not ent irely exclusive of one another, acer ta in d iv is ion of author i ty and respons ib i l i ty was c lear lyintended by Congress and must be recognized by this Courtin order to preserve the integrity of the legislative scheme.Under these circumstances, the relative merits of FDA's planto control the distribution of methadone, a controlled substance,must first be passed upon by Congress."

The Government appealed. The Court of Appeals for theDistrict of Columbia affirmed the judgment on the basis of theopinion of the District Court. One of the three judges of theCourt of Appeals, concurring in the result, wrote an opinionin which he stated, in part:

"Al though T concur in affirming the Distr ict Court , I findunpersuasive two theories advanced in i ts opinion, and appellees' failure to rely upon them on appeal appears to reflectmy own doubts.

" In my v iew, the cr i t ica l issue is whether, as appel leesargue, the regulations at issue fall outside the scope of theauthori ty delegated by Congress to the FDA. The Commissioner of the FDA has himself expressed some uncertainty onthis score. . . . Upon examining this question, I have concluded—not with great difficulty—that appellees should prevail.

" T h e p i v o t a l p r o v i s i o n o f t h e F e d e r a l F o o d , D r u g a n dCosmetic Act is 21 U.S.C. § 355(d), which prohibits the approval of a new drug application unless there are adequatedata to establish that the 'drug is safe for use under the conditions prescribed, recommended, or suggested in the proposedlabeling thereof . . . . ' The FDA contends that where thereexists a documented pattern of drug misuse contrary to theintended uses specified in the labelling, the drug is unsafe forapproval unless controls over distribution are imposed. As acorollary, it asserts that for a drug such as methadone, forwhich there is substantial evidence of misuse, the FDA musthave the power to restrict distribution to avoid the dilemmaof either disapproving a drug with important therapeutic benefits or of placing on the market a drug likely to be misused.The FDA claims that section 355(d) authorized restricting distribution to a prescription-only basis before the FDA wasexplicitly granted that authority in 1951, and that the regulations at issue differ only in degree from a prescription-onlyr e s t r i c t i o n .

"Although these arguments have some weight, I do not findthem ultimately convincing. The word 'safe' in section 355(d) is,to my mind, best interpreted as requiring the labelling toinclude the evidence from drug testing, and the inferencestherefrom, indicating the therapeutic benefits, possible dangers,and uncertainties involved in use of a drug, as an aid to aconscientious physician in determining appropriate medicaltreatment. That view seems to me to accord with both themost reasonable interpretation of the statutory language andthe common understanding of the FDA's mission. Thus, methadone is safe for its intended use notwithstanding the possibilitythat it will be employed in unintended fashions.

"The cont ro ls on d is t r ibu t ion here are d i f fe ren t in k indfrom prescription-only restrictions. The latter restrictions prevent self-diagnosis by the layman. If such restrictions had notbeen permitted before 1951, drug labelling would have hadto include both specific medical evidence about a drug and allthe general medical knowledge that a physician must possessin order to decide, after reading a labelling, whether toadminister a drug. Although one might contend in theorythat any drug is safe for its intended use if the labellingcontains enough information, it is evident that a layrnancannot be expected to digest a mass of complicated medicalinformation and bring to bear upon it the medical judgment ofa practicing physician. Thus, restrictions to a prescription-onlybasis are necessary to ensure that persons intending to usedrugs in accordance with the implications of medical evidencegathered by the FDA and contained in a drug labelling can doso. The restr ict ions on methadone involved here are qui tedifferent. Without them an informed and sound medical judg

ment about medical safety and effectiveness can still be made.They are designed instead to control drug misuse by personswho have no intent to try to use drugs for medical purposes.

"There would be a lmost no l im i t to the FDA's author i tywere its view adopted. If, for example, it had concluded before1 9 7 0 t h a t w i t h o u t r e s t r i c t i o n s o n m e t h a d o n e o f t h e s o r t n o wcontained in the Controlled Substances Act, ... the possibilityof drug misuse remained high, there would be no barrier underits argument to its having established a regulatory scheme ofthe complexity of that ultimately [was] adopted in that Act. . . .

"Physicians and state-l icensed pharmacists have not beenuniformly responsible in dealing with methadone, and the FDAundoubtedly has genuine cause to believe that, with respectto both narcotic and non-narcotic drugs, effective regulationin the public interest necessitates authority on its part to restrictdistribution channels when the risk of unintended uses is greatand the consequences of misuse are very harmful. Under thepresent statutory framework, however, I believe that argumentmust be addressed to Congress." (Misc. No. 237; N.J. No. 43)

Regulations of FDA concerning Administrative Practices and Procedures, and the promulgation of such regulations in final formwithout prior publication in the form of a proposal, Washington, Dist. Columbia.Charged: 7-23-75 by American College of Neuropsychopharma-cology, Boston, Mass., against H.E.W. Secretary Caspar W.Weinberger and FDA Commissioner Alexander Schmidt, M.D.,in complaint for injunction and declaratory relief: that, in theFederal Register of May 27, 1975, FDA issued regulationsentit led "Administrative Practices and Procedures"; that, contrary to standard administrative agency rulemaking procedures,the regulat ions were issued in final form, rather than as aproposal, with an effective date of July 28, 1975; that publiccomment was solicited for submission to FDA unti l July 28,1975; tha t FDA re l ied upon the Admin is t ra t ive ProceduresAct exceptions to the publication of a general notice of proposed rulemaking; that the regulations failed to meet thecriteria for such exceptions because the regulations were notrules of agency organization, procedure, or practice and FDAhad not found that notice and public procedures were impractical, unnecessary, or contrary to the public interest; thatthe regulations had a substantial impact on the regulatedindustry, physicians, patients, and general public; that plaintiff'sprocedural rights before FDA were substantially impaired andrestricted, in comparison with existing procedures and practicesof FDA, and procedural rights as provided by the Administrative Procedures Act were denied; that such denials were anunconstitutional denial of due process; that failure to stay theeffective date of the regulations and to allow them to bepromulgated as final would result in immediate and irreparableinjury to the plaintiff; that plaintiff prayed to the court for apreliminary injunction requiring a published notice of proposedrulemaking, for a declaration that Administrative ProceduresAct exceptions were inapplicable to the FDA regulations; andthat FDA had abused its discretion and authority by failingto issue the regulations with notice and opportunity for publiccomment prior to the final promulgation of such regulations.

At a hearing before the court, FDA agreed, pursuant to arequest of the court, to delay the effectiveness of the regulations pending a decision by the court in the plaintiff's motionfor a preliminary injunction. After full argument, the courtgranted a preliminary injunction, and stated in the court'sc o n c l u s i o n s a s f o l l o w s :

"1. This Court has jurisdiction of this matter pursuantto 28 U.S.C. § 2201 and 28 U.S.C. § 2202 and 5 U.S.C.§§ 701-706.

2. Defendants' regulations, because of their complexityand pervasiveness, cannot be classified merely as 'interpretative rules, general statements of policy or rules of agencyorganization, procedure or practice' as set forth in Section553(b)(A) of the APA [Administrative Procedures Act].

3. No 'good cause' has been advanced to support defendants' claim that issuance of the regulations as a proposal is 'impracticable, unnecessary or contrary to thepublic interest' as set forth in Section 553(b)(B) of theA P A .

4. Defendants illegally promulgated the regulations in


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