This Month

This month, FDA Consumer summarizes some ofthe important developments in the regulation offoods, drugs, and other products during 1972. Thestory is based on FDA's Annual Report and was written by Wallace F. Janssen, a frequent contributor tothese pages and the editor of the Annual Report. Mr.Janssen tells why 1972 was an extraordinary year forthe Food and Drug Administration.

This month we complete a scries of interviews withthe directors of FDA bureaus. The series began inMarch 1972 with an interview of Virgil O. Wodicka,Ph.D., director of the Bureau of Foods. Other bureaudirectors who have been interviewed in this series wereMalcolm W. Jensen, Product Safety, May and June1972; C. D. VanHouweling, D.V.M., Veterinary Medicine, July-August; John Villforth, Radiological Health,September; and Henry E. Simmons, M.D., Drugs,November. In this issue, wc interview Harry M. Meyer,M.D., director of FDA's Bureau of Biologies. Hedescribes how FDA regulates biologicals such as vaccines, serums, and blood in "Biologicals and FDA."

A recent FDA regulatory action to restrict the indications for prescription drugs used in weight reductionprovided the basis for our story, "New Restrictions onDiet Pills." The story describes how FDA went aboutevaluating the cITcctivcness of amphetamines in weightreduction programs, and what the Agency concluded.The story should be of interest to anyone who hastaken these pills, or who might be seeking an easy wayto lose weight (there isn't any).

Other stories this month deal with pop-top cans andan action FDA took to make sure they are safely designed; detergents; and how consumers perceive thesafety of cosmetics. The last story is part two in FDAConsumer's presentation of the results of a consumerperception survey. The initial article was in last month'sissue.

ConsumerF o r u m

Mass Chest X-Rays

We note with interest the growing outcryagainst mass x-ray screening (Mass Chest X-RaysAre on the Way Out, February 1973.) In a numberof situations, the potential benefit of findingunsuspected disease no longer outweighs the riskof damage from radiation.

Most analyses of this subject, however,including yours, contain a curious but significantomission. They do not consider the widely usedchiropractic "spinograph." This 14x36 inch x-rayfilm of the entire spine is taken routinely by manychiropractors. Depending on technical factors,radiation to sexual organs from this procedureis 10 to 1,000 times as that from a routine chestX ray.

This procedure should be made illegal.Considering that the spinograph yields little orno diagnostic information, it is remarkable howlittle publicity its dangers have received.

Stephen Barrett, M.D.Chairman, Board of DirectorsLehigh Valley CommitteeAgainst Health Fraud, Inc.Allentown, Pa.

A r t i fi c i a l S w e e t e n e r

Is there any possibility of a new artificialsweetener being commercially available in thenear future? During the past several years I haveread of Monellin, which sounded very promising,and another sweetener wh ich was iso la ted f rom

hesperiden. Does the research you are conductingon Monellin (and any other sweeteners) lookpromising? If so, when can a new sweetener beexpected?

C h a r l e s R . We l l s

Philadelphia, Pa.

Notice was given in the Federal Register(March 5,1973 page 592) that a petition has beenfiled for aspartame in foods as a nutritive substancewith intense sweetness and flavor enhancingproperties. Other than this, FDA has no petitionsfiled at this time for use of new sweeteners.

After filing, a food additive petition is reviewedby FDA's technical staff to determine whether theadditive proposed by the petitioner would be safeand that it would have the physical or technicaleffect claimed by the petitioner. When FDA issatisfied that these conditions are met, then a foodadditive regulation will be published authorizingthe conditions under which the additive may beused. Food additive petitions often take one totwo years before they are suitable for regulationbecause additional studies may be required.

Quotes

Child Supervision

Regarding the article entitled "Don't LetChristmas Become a Catastrophe" in theDecember-January issue, I can agree with all butitem No. 10 on the l ist . Whoever wrote the art ic le

obviously wasn't a parent or had any childrenunder ten. It is virtually impossible, or at leastvery impractical, for adults to be constantlysupervising children at play, and I believe itcould even be psychologically harmful.

E d w a r d G . F r a n c e l l

Marketing Research ManagerAmes CompanyElkhart, Ind.

On balance, I believe that we are makingsignificant strides in protecting the consumer. Our job, as I see it, is constantly to providethe American public with reasonable regulationsbased on good science and sound judgment. Wemust always be conscious that none of our actionsshould stifle research, initiative, or creativity, orimpede national progress. This is the balance weare seeking in our regulatory activities."

Charles C. Edwards, M.D., Commissioner of Food andDrugs , "On Ba lance , " i n Na t i ona l Bus iness Woman ,national magazine of the National Federation of Businessand Professional Women's Clubs, Inc., April 1973.

2 / April 1973 ! FDA Consumer

Caspar W. WeinbergerSecretary, U.S. Department ofHealth, Education, and Welfare

Charles C. Edwards, M.D.Commissioner of Food and Drugs

C o n s u m e rVOL. 7, NO. 3/APRIL 1973

C h a r l e s H . D i c kA s s t . C o m m i s s i o n e rf o r P u b l i c A f f a i r s

Wayne L. Pines/Editor

Harold C. Hopkins/Editorial Director

Jesse R. Nichols/Art Director

Joan M. Galloway/Managing Editor

1972: An "Extraordinary" Year for FDA

Frederick L. Townshend/Production Mgr. The New Detergents and Their Safe Use

Tom Healy/Photographer

FDA CONSUMER, the official magazine of theFood and Drug Administration, is publishedmonthly, except for combined July-August andDecember-January issues. Subscriptions may beordered from the Superintendent of Documents,Government Printing Office, Washington, D.C.20402, at $6.50 a year ($1.75 additional for foreignmailing).

Address for editorial matters: FDA CONSUMER,PA-20, Food and Drug Administration, 5600Fishers Lane, Rockville, Md. 20852.

Articles published in FDA CONSUMER are inthe public domain and text may be republishedwithout permission. Use of funds for printingthis publication approved by the Office ofManagement and Budget November 1, 1972.

Biologicals and FDA

New Restrictions on Diet Pills

Pop-Top Cans CAN Be Safe

FDA Listens: Cosmetics and Toiletries

M i c r o w a v e O v e n s

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 :

News Highlights

(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 the investigationsof the Department.

Regional Reports

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

Seizures and Postal Service Cases

Notices of Judgment

FDA Consumer I April 19731 3

An *Extraordinaryl^ar' For FDA?

1972New projects and policiesmarked the efforts of the Foodand Drug Administration toimprove its services to theA mer i can consumer i n 1972 .Here are some highlights fromthe Annual Report.

by Wallace F. Janssen

1 Q T 0 ext raord inaryVy ! year for the Food andDrug Administration.

Important changes were made inthe FDA's responsibilities.

The Agency took over some programs and initiated others, providing new consumer protection in almost every area.

FDA's "open door" was openedw i d e r f o r t h e c o m m u n i c a t i o n o fpublic information.

Encouraged by unprecedentedpublic interest in FDA matters, theAgency formed new links with cons u m e r s .

The benefits of large scale, systematic approaches were applied tonumerous enforcement problems.

With more money and manpower, the Agency stepped up itsinspections of the Nation's foodprocessing.

The oldest Federal drug controlprogram, begun in 1902 to insurethe safety of vaccines, serums, antitoxins, and other biological prod

ucts, became a part of the Food andDrug Administration.

Significantly, the move immediately strengthened the regulation ofbiological drugs by applying provisions of the Federal Food, Drug, andCosmetic Act to these products, inaddition to the licensing controlspreviously in effect. The move meanttighter control of blood banks, andFDA began a mass review of the effectiveness of biological drugs.

Testifying on the original 1902legislation, a health officer said: "Ifthe first dose proves worthless, theloss of time may cost the life of thepatient." It is FDA's job to makesure the first dose is not worthless.

A significant chapter in FDA history came to an end with the passage last year of the Consumer Product Safety Act. This law establishesan independent commission to enforce the Federal Hazardous Substances Act and laws dealing with thesafety of toys, appliances, and otherarticles used around the home.

FDA's involvement in fields outside the area of foods, drugs, andcosmetics began in 1927 with theCaustic Poison Act, a law to protectchildren from accidental injury anddeath caused by lye and 10 othercaustic chemicals. In 1960, thousands of other chemical products forhome use came under FDA controlwhen the Hazardous Subs tancesLabeling Act was passed. TheBureau of Product Safety, which

was responsible for enforcing theseActs, remained with FDA until thenew Consumer Product Safety Commiss ion was estab l ished.

The National Center for Toxico-logical Research became a functioning scientific institution in 1972. Administered by FDA, and fundedjointly by FDA and the Environmental Protection Agency, NCTRhas the facilities and over 100 personnel of the former biological warfare laboratories at Pine Bluff, Arkansas. Senior scientists have startedacute (7-day), subacute (90-day),and chronic (2-ycar) studies on thetoxicity of chemicals used in foodsand drugs.

Expanding its program for consumer information, FDA moved todouble the number of consumerspecialists at field offices across theNation. At the end of 1972, 50 consumer specialists were on duty. Thiscorps is the FDA extension s&rvice,providing two-way communicationbetween the Agency and the consumers i t se rves .

The official magazine of theAgency, FDA Papers, was renamed FDA Consumer, and itscontent reoriented to appeal to consumer subsc r i be rs .

Needs in the area of consumerhealth information were documentedin a national Study of Health Practices and Opinions. The 450-pagereport dealt with consumer bel iefsand behavior regarding vitamins.

4 / April 1973 ! FDA Consumer

minerals, and "health foods," theextent of self-diagnosis, the tendencyto prolong self-medication for suchconditions as sore throat, coughs,acid stomach, headache, and skinrash, self-treatment for arthritis andrheumatism, and belief in unprovenremedies fo r cancer.

A series of educational campaignswas launched to help consumerschoose products wisely and use themsafely. These involved intensive useof public service announcements onTV and radio. For the first t ime,FDA contracted with a nationallyknown advertising agency to produce and distribute the films, recordings, and print materials. First in theseries was a toy-safety campaign,launched seven weeks be fo re Chr is tm a s .

Reacting to Government and consumer concern about the safety offood products, FDA doubled itsfood inspection staff. Approximately500 inspectors are now assigned tomonitor the 60,000 establishmentswhich process or handle the bulk ofthe Nation's food supply. To furtherincrease food plant inspections, $4.5m i l l i o n w a s a l l o c a t e d f o r c o n t r a c t sw i th S ta te food law en fo rcementagencies under which they couldcarry out about 30,000 plant inspections in the next three years andreport the results to FDA.

F D A s t a r t e d 9 6 8 f o r m a l l a w e nforcement actions during fiscal 1972(July 1, 1971-June 30, 1972), compared with 845 court cases initiatedthe previous year. Of the 1972cases, 81 were criminal prosecutions, compared with 52 in 1971.

The legal workload by the Agencywas further increased by extensivelitigation in contested cases, and byan increasing number of suitsbrought by both industry and consumer advocates to restrain, or compel. FDA action on various matters.

An apparent decline in the number of recalls of defective productsfrom market channels by manufacturers or packers resulted fromchanges in FDA's monitoring practices. Under the new policy, FDA

supervises only those recalls of products that threaten safety, involveadulteration, or may grossly deceivethe consumer. Only one recall number is assigned for all shipments,package sizes, and buyer's labels ofthe product being recalled, and thesame number is used to identify lotsrecalled by a distributor, wholesaler,or repacker. On this basis, 1,029recalls were supervised in 1972, amajor factor in consumer protection.

Appropr ia t ions inc reased to$121.6 million, from $107.1 millioni n fi s c a l 1 9 7 1 . T h e e s t i m a t e d f u n d

ing for the current fiscal year 1973is $156 million.

An $8 million supplemental appropriation to increase food plant

inspections and improve the qualityof the Nation's food supply was initiated by the Flouse AppropriationsSubcommittee on Agriculture, Environmental and Consumer Protect i o n .

Among the many new regulationspromulgated by FDA during 1972in the interests of consumer protection, these stood out as having themost far-reaching consequences:

• As required by the National Environmental Policy Act, FDA proposed procedures for public reporting of environmental effects thatmight result from official actions,ranging from new drug approvals todestruction of contaminated produ c t s . T h e s t a t e m e n t s w o u l d i n c l u d e

The National Center for Toxicological Research in Pine Bluff, Arkansas,became a functioning scientific institution in 1972. The mouse on thetechnician's glove is one of many thousands used in so-called "megamouse" studies of chemical and drug effects. Photo shows sterile breedingarea where mice are raised inside a plastic enclosure.

FDA Consumer I April 1973 / 5

FDA's National Drug Advisory Council (top photo) met July 25, 1972, todiscuss DES—the first time that meetings of this group were open to thepublic. Opening such meetings was one step FDA took in 1972 toimplement its freedom of information policy.

Announcing FDA's massive nutrition labeling program: Charles C.Edwards, M.D., Commissioner of Food and Drugs (left), with FDAGeneral Counsel Peter Barton Hutt.

a full discussion of any probable impact on ecological systems such aswildlife, fish, and other marine life.They would also point out adverseeffects which cannot be avoided andwould evaluate alternative actions.

• Applying literally the principleso f t h e F r e e d o m o f I n f o r m a t i o n A c tof 1966, FDA took unprecedentedsteps to disclose the records of theAgency to greater public scrutiny.U n d e r a F r e e d o m o f I n f o r m a t i o n

policy proposed May 4, 1972, theAgency moved to:

—make available safety and effectiveness data for food additives,color additives, and antibiotic drugs,previously treated as confidential.

—require manufacturers to identify and justify all claims for confidentiality of data as "trade sec r e t s . "

—make available all correspondence with companies, members ofCongress, and the public; internaloperating manuals; informal enforcement actions; and all completedreports on FDA research.

In general, the FDA policy is thatunder the Freedom of InformationAct all records are to be public,unless specifically exempted by law.

Further steps to implement thenew open-door policy included:

—a decision to issue no regulation or policy statement without firstannouncing it as a proposal andallowing adequate time for publiccomment—60 days as a minimuminstead of 30 days.

—a requirement that all publications in the Federal Register bepreceded by a statement clearly explaining the background and reasonsfor the action to be taken.

—a requirement that all finalorders be accompanied by a summary of the comments received,showing the reasons for accepting,rejecting, or modifying them.

—a decision to consider officiallyall petitions received by the Agencyfrom any member of the public.

—appointment of consumer representatives on FDA advisory commi t tees .

—establishment by the Commis-

6 /April 1973 iFDA Consumer

sioner of an informal advisory committee of representatives from national consumer organizations.

All meetings of FDA advisorycommi t tees w i l l be announced in theFederal Register, and will be openfor public attendance and participation unless they deal with subjectsexempted from disclosure by theF r e e d o m o f I n f o r m a t i o n A c t .

• A m a s s r e v i e w o f t h e e f f e c t i v e

ness and labeling of all nonprescription (over-the-counter) drugs gotunder way. Described by the FDACommissioner as "unprecedented inscope and intensity," this program isplanned to build a permanent systemto assure consumers that every OTCdrug is safe, adequately labeled, andwill do what its manufacturer says itw i l l do . As many as 500,000separate products may be involved—there a re no s ta t i s t i cs on the to ta lextent of the market. To carry outthe project, expert committees arebeing established to review 26 basicOTC drug classes. Each panel willdevelop standards establishing conditions of use under which the drugingredient in that class is recognizedas safe, effective, and not mis-b randed .

• A new program was launched toassu re t he e f f ec t i veness and co r rec t

labeling of medical test kits widelyused to test specimens by physicians,hospital personnel, and clinical laboratories. Proposed regulationscalled for a uniform labeling format,to include product performancecharacteristics, the scientific basis ofthe test, and directions for use. Allmanufacturers of diagnostic kits willbe asked to register their products.

• Significant changes in food labeling will occur in the next severalyears as a result of extensive regulations completed in 1972 and published early in 1973. Many morefood packages will provide nutritioninformation, such as the amount ofprotein, carbohydrates, vitamins,and minerals, in a standard format.Other regulations restrict claimsmade for dietary supplements.

• With other Federal agencies,FDA proposed stronger regulations

The Bureau of Biologies, which became part of FDA in July 1972,administers the regulation of vaccines, serums, antitoxins, and otherbiological drugs. A phase of control testing of human blood products isshown in top photo.

In response to concern over food safety, FDA doubled its food inspectionstaff in 1972 (bottom photo). About one-fourth of the new recruitsw e r e w o m e n .

FDA Consumer I April 1973 I 7

^ > i [ F D A ] O C T O B E R 1 9 7 2

C o n s u m e r

FDA's official voice, FDA Papers, was converted into a consumer magazinein 1972 and renamed FDA Consumer as part of the Agency's newconsumer education effort. This cover from the October 1972 issue,featured the 450-page Study of Health Practices and Opinions, releasedt h a t m o n t h .

t o c o n t r o l t h e u s e o f m e t h a d o n e f o r

treating heroin addiction. Under thenew rules, distribution of methadonewill be limited to approved treatment-rehabilitation programs and tohospitals or specially authorizedpharmacies in remote areas approved by FDA and the States. Inaddition, eligibility of patients formethadone maintenance was limited,and methadone treatment programsare now required to provide counseling and other supportive services.

• A new approach to cosmeticregulation for consumer safety wasundertaken in regulations providingfor voluntary registration of manufacturers and their formulas, basedon proposals made by the industry.A system for passing on consumercomplaints to FDA concerning adv e r s e r e a c t i o n s t o c o s m e t i c s w a s

planned for implementation during1973. The Federal Food, Drug, andCosmetic Act does not require anyof the information covered by thesevoluntary programs. Responding toa petition by the Consumer Federation of America, FDA has publisheda proposed regulation under the FairPackaging and Labeling Act, callingfor mandatory declaration of ingredients on cosmetic labels, to facilitate value comparisons and preventdeception.• Hexachlorophene was bannedas an active ingredient in thousandsof cosmetic products following investigations showing that the antibact e r i a l c h e m i c a l c o u l d b e a b s o r b e d

directly through the skin into theb l o o d a n d a t c e r t a i n b l o o d l e v e l scould cause brain damage.

• DES (diethylstilbestrol) wasbanned as an ingredient in livestockf e e d w h e n i t w a s f o u n d t h a t s o m eanimals could be expected to haveD E S r e s i d u e s i n t h e i r l i v e r s s e v e n

days after the medicated feed waswithdrawn. The law prohibits anysubstance in the food supply which,like DES, causes cancer.

• A Federal standard was promulgated requiring improved radiation control in diagnostic x-rayequipment manufactured after August 15, 1973. Statistical data show

that x-ray protection programs aresucceeding.

• I n a n e f f o r t t o r e s t r i c t f u r t h e r

sources of lead in the environment,FDA banned the interstate shipmentof household paint containing morethan 0.5 percent lead.

• Regulations under the PoisonPrevention Packaging Act calledfor child-resistant packaging foraspirin, certain liquid furniture polishes, methyl salicylate, and drugssubject to abuse. Proposals for child-resistant packaging were made fornumerous o the r subs tances f ound tobe hazardous to ch i ld ren.

Necessarily, this account singlesout new developments that tookplace during the period covered bythe 1972 Annual Report, and makes

no mention of many other ongoingact iv i t ies. The act iv i t ies descr ibedhere are only part of the total FDAconsumer protection program.

Wal lace F. Janssen i s FDA 'shistor ian and the editor of theAnnual Report.

8 I April 1973 / FDA Consumer

The NewDetergentsA n dTheir SafeU eby Robert Burke m i

C B H E B M H L

/

Here are shown a few of the many nonphosphate or low-phosphatedetergents currently on the market.

^■" ^ h e s o l u t i o n o f a n e n v i r o n m e n t a l1 problem frequently involves

trade-offs that were not apparentwhen consumers first took up thei s s u e a n d d e m a n d e d a c t i o n . H o u s ehold detergents are a case in point.When environmental groups chargedthat the phosphates in detergentswere killing our lakes and streams,many consumers demanded thatphosphates be eliminated. But thesubstitutes for phosphate turned outto present a potential danger to theconsumers themselves, and FDA'sBureau of Product Safety had tomove in under the provisions of theF e d e r a l H a z a r d o u s S u b s t a n c e s A c t .

FDA was ab le to m in im ize thehazards by assessing the productsand requiring that their labelingwarn the householder to exerc isecaution in their use and storage.Some judged too dangerous wereseized, and FDA stands ready to banany for which no warning labelwould be adequate.

The original popularity of detergents containing phosphates wasbased on their superiority over conventional soaps in cleaning ability;they quickly supplanted soaps as theprimary home laundry and cleaningproduct. Another positive aspect ofthese detergents, less widely known.

is that with few exceptions they—like soaps—constitute only a minorthreat to human health if accidentallyingested.

Approximately 5,200 cases ofhuman ingestion of detergents andhousehold cleaners are reported annually on a nationwide basis by then e t w o r k o f P o i s o n C o n t r o l C e n t e r scoordinated by the Food and DrugAdministration. These reports areestimated to represent a ninth to as e v e n t h o f t h e a c t u a l n u m b e r o f i n

gestions. Few of these reports havenoted illness or injury; and of the oneor two reported deaths that were attributed to detergents, phosphatewas not considered the ingredientresponsible.

In early 1970, however, widelypublicized reports charged that phosphates from detergents, as well asfrom other sources, were causing extensive damage to the Nation's waterr e s o u r c e s .

When it ends up in a lake, for example, the phosphorus in detergentsadds to the naturally existing supplyof this key nutrient necessary forthe growth of algae. Lavish proliferation of algae is the most visible signof the first phase of eutrophication,a process in which a lake is graduallytransformed, first into a sl ime-cov-

FDA Consumer / April 1973 / 9

In a laboratory toxicity test, atoxicologist administers a solutionfrom a nonphosphate detergent intothe stomach of a rat.

ered pool and then into a swamp,before disappearing altogether. Alake is by no means the only body ofwater affected by such pollution, buti t i s one o f the ea r l i e r v i c t ims s inceit is a still body of water.

or many people the advantagesof phosphate detergents were nullified by the pollution charges. Env i r o n m e n t a l i s t s a n d c o n s u m e r

groups demanded the immediate removal of phosphates from detergentformulations. Several State governments prohibited the sale of high-phosphate detergents, and a fewlocal governments banned the sale ofdetergents containing any phosphate.

Manufacturers, responding to thispublic demand, have offered newlyformulated detergents with silicates,carbonates , bora tes , and c i t ra tessubstituted for all or part of thephosphorus in the product. The newnonphosphate or low-phosphatedetergents, in that they seem to red u c e t h e e n v i r o n m e n t a l h a z a r d ,provide one possible solution to anunderstandably worrisome problem.

But although the new detergentf o r m u l a t i o n s s e e m e d t o o f f e r r e l i e ffrom the long-range pollution problem, several created a serious immediate problem involving FDA.

Although FDA has no authorityor jurisdiction over the phosphatepollution problem, it does have aresponsibility for consumer protect i o n u n d e r t h e F e d e r a l H a z a r d o u sSubstances Act, to which home laundry, washing, and cleaning productsare subject. Toxicologists at theFDA's Bureau of Product Safetylearned that some of the new formulations containing certain of thehighly alkaline carbonates and silicates were corrosive to the skin,eyes, and mucous membranes, andw e r e t o x i c i n t h e i r c o r r o s i v e e f f e c ton the esophagus and stomach.

The Federal Hazardous SubstancesAct requires products that are toxic,corrosive, irritating, sensitizing,flammable, radioactive, or storedunder pressure to carry suitable andprominently displayed warnings ontheir labels describing the hazardand providing first-aid information.

The law also provides authority toban any product from sale for use inthe home if i t is found to be so hazardous that cautionary labeling is inadequate to prevent serious illness orinjury.

Under the provisions of the Poison Prevention Packaging Act of1970, the FDA also can require special packaging, such as safety closures, for substances that present apotential hazard to young childrenbecause of the way the product ispackaged.

The Bureau of Product Safety feltthat the wide availability of some ofthese new detergent formulationsmight sharply increase the numberand severity of illnesses and injuriesattributable to accidental exposure tohousehold detergents. Of particularconcern was the danger of accidentalingestion of detergent products bys m a l l c h i l d r e n .

Consequently, since early 1971,t h e B u r e a u h a s e x a m i n e d o v e r 1 0 0of the estimated 200 detergent products currently on the market to assure that, if they are hazardous, their

10 I April 1973 / FDA Consumer

The potential of a nonphosphatedetergent for irritating or injuringthe eyes is tested with rabbits. Therabbit's eye shown is undamaged.

-

4

labels will bear appropriate warnings for safe use. Limited Bureauf a c i l i t i e s a n d r e s o u r c e s a n d t h e n umerous tests required for eachproduct (an average of 15 separatetests per product) make this an extended project, and one that willcontinue as long as manufacturerskeep changing detergent formulat ions .

If a marketed detergent producti s found to v io la te the Federa l Hazardous Substances Act, the Bureauhas a number of alternatives available. The manufacturer or distributor can be directed to adequatelylabel future production, a procedureused frequently during the Bureau'scontinuing detergent survey. Occasionally a manufacturer will be askedto voluntarily recall his product orr e m o v e i t f r o m s a l e u n t i l i t i s r elabeled to meet the requirements.FDA can also warn the public directly of a potential hazard throughthe news media .

P r o d u c t s c a n b e s e i z e d w h e n as e r i o u s h a z a r d e x i s t s o r w h e n o t h e r

compliance actions are unsuccessful.

In 1971, three detergents were removed from the market by seizureafter testing showed them to be toxic,corrosive to the skin, and irritatingto the eyes.

In addition, persons violating anyof the requirements of the Act maybe subject to injunction or prosecution.

To this date, it has not been necessary for FDA to ban any householddetergent. This sanction, however,will be invoked if a detergent provess o t o x i c o r c o r r o s i v e t h a t i t c o n s t itutes a serious hazard despite anywarning labeling that could be dev i s e d .

lepresentatives of the Bureau ofProduct Safety have met frequentlywith manufacturers throughout thecountry, advising them of the requirements of the law. As a result,some products have been reformula ted and o the rs r e l abe led .

FDA has not recommended anyparticular class of detergents to consumers. It has left the choice of purchasing phosphate or nonphosphate

detergents to the individual buyer.Some State and local jurisdictionsare maintaining a ban on phosphateformulations, however.

The choice is becoming moreacademic. Most of today's reformulated detergents consist of a reducedpercentage of the highly alkalines i l i c a t e s a n d c a r b o n a t e s c o m b i n e dwith phosphate used at lower conc e n t r a t i o n s .

As long as formulations that maybe toxic or corrosive are used, theBureau of Product Safety will continue its testing to insure that any detergent marketed will be labeledproperly for safe use.

But a warning label, no matterhow strongly worded, cannot be effective if it's ignored. The final responsibility for the safe use of detergents rests with consumers. Parentsof small children arc especially responsible for reading and heedingwarning labels to protect those whoc a n ' t u n d e r s t a n d t h e m .

Rober t Bu rke i s a wr i t e r -ed i to r i nFDA's Bureau of Product Safety.

FDA Consumer / April 1973 /11

Kologicals and

In July 1972, a new function was transferred to FDA; the regulation of biologicalproducts. Previously, they were regulated by the Division of Biologies Standards inthe National Institutes of Health. To direct the new Bureau of Biologies, FDA selectedHarry M. Meyer, Jr., M.D., who joined the Division in 1959 and who was chief of itsLaboratory of Viral Immunology. Dr. Meyer, a pediatrician, is an eminent scientist, having won numerous awards for his role in the development of the rubella vaccine. In thisinterview with the editor of FDA Consumer, Dr. Meyer discusses:

• The role of his Bureau • The safety and efficacy of biologicals • FDA's newest efficacy review • Vaccines now being developed • What consumers should know about biologicals

12 j April 1973 / FDA Consumer

"I think it is important for parents to be informed and participate in decisionsregarding vaccination of their children."

Dr. Meyer, your Bureau is responsible for regulating biological products.Would you please define the term ''biological."

/v. Certainly. Biologicalsinclude a wide variety of medical products, such as bacterial and viral vaccines, blood and blood products,products to treat allergies, and some diagnostic products. Biologicals are derived from or made with the aidof living organisms.

• O f a l l t he p roduc t syou regulate, vaccines and blood products probablyhave the most public visibility. Precisely what do youdo in the area of vaccines?

We are responsible formaking sure that the vaccines available to the Americanpublic are safe, effective, and properly labeled. Our control is over the manufacturer. We begin by monitoringhis work during the experimental phase. Then he mustapply for a license for his establishment and a separatelicense for each product that he proposes to manufact u r e .

To obtain the licenses, he must be inspected and musthave demonstrated his capability to make a product thatwill meet all standards. His staff, buildings, equipment,and methods are all evaluated. Even after the licenseshave been issued, he must submit complete records andsamples to us from each batch of vaccine prepared. Tomaintain his licenses to manufacture, he must be re-inspected one or more times annually.

H o w a b o u t b l o o d a n dblood products? What do you do in this area?

In past years our control was exercised by the same licensing mechanism applied to vaccines, but was limited to those products involved in interstate shipment. This covered establishments processing 60 to 70 percent of the blood collectedeach year.

Since becoming a part of the FDA, we have begunthe process of extending our control to the smallerintrastate blood banks as well. The mechanism here isa little different, since it is based on the provisions ofthe Federal Food, Drug, and Cosmetic Act rather thanthe licensing authority of the Public Health Service Act.

However, the results are similar.Blood banks must register, must conform to stand

ards, and must be inspected to assure compliance withthe standards. As this action is completed over thecoming months, it will bring essentially all of the bloodand blood products used in the United States underuniform regulatory control. We consider this one of ourmost important actions, since blood is a life-savingproduct that yet has a great potential for causing harmif improperly processed or misused.

In August 1972, soonafter the responsibility for regulating biologicals wastransferred to FDA from the National Institutes ofHealth, your Bureau announced that it was going toreview for effectiveness all the biologicals that had previously been licensed. We had a story on this in theDecember/January issue of FDA Consumer. Couldyou describe briefly how that review came about?

T h i s r e v i e w i s o n e o four big projects and one that we're very enthusiasticabout. To explain it briefly, biologicals were regulatedunder the Public Health Service Act, which did not givethe Division of Biologies Standards specific authority toassure that these products would be effective. Theycould only require safety, purity, and potency—and apotent product is not necessarily effective.

Obviously, the effectiveness of any product is fundamental, both to the physician and, more importantly,to the patient. After we transferred to FDA, biologicalsalso came under the umbrella of the Federal Food,Drug, and Cosmetic Act, which requires that each drugsold in the United States be effective. The same requirements for effectiveness could be required of biologicals,since they are legally defined as drugs. So, under theprovisions of the Food, Drug, and Cosmetic Act, we arenow proceeding with a systematic review of all previously licensed biological products.

How do you intend tocarry out this review?

A. Well, before answering this question, let me first say that we have learneda lot about the mechanisms for reviewing products fromthe Bureau of Drugs, which has been evaluating theeffectiveness of drugs marketed between 1938 and1962. So we are going into this project with some backg r o u n d . ( c o n t i n u e d )

FDA Consumer / April 1973 /13

"In general, we think the review will indicate that most biologicals now beingsold are effective as well as safe."

We have broken biologicals into categories. Viralvaccines is one, allergenic extracts, blood and bloodproducts are others. There are eight or so categories inall. For each of these categories, we will ask the manufacturer to submit all the data which might be applicable to effectiveness and safety. Any other interested partyis also invited to send in information. These data willthen be reviewed. At the same time there will be a careful look at the labeling of these products, to make sureit is comprehensive and accurate.

To make this review impartial and to see that it isdone in the most expert fashion, panels of experts willbe appointed. These panel members will be selectedfrom experts nominated by all interested groups—professional organizations, consumers, and manufacturers.They will be charged with the responsibility for reviewing all the data. They will also be able to call on expertw i t n e s s e s a n d t o r e v i e w t h e s c i e n t i fi c l i t e r a t u r e . I nother words, the panels will review all the availablematerial about biological products.

The experts will then make recommendations to usas to whether the products are safe and effective, andwhat constitutes proper labeling. In some cases thepanels may tell us what types of additional data areneeded to prove or disprove the effectiveness of a produ c t .

Y o u m e n t i o n e d t h a t

you would he looking at safety data as well as effectiveness data. Hadn't you reviewed safety data in the past?

Yes, of course we had.But in any review of effectiveness, one must take intoaccount safety as well. The two are inseparable. Whatwe're going to do is to take a look at all the availabledata about a product.

T h e r e v i e w s t h a t F D Ais now undertaking or has performed in the past—suchas prescription drugs, over-the-counter drugs, and nowbiologicals—raise a question in the public mind aboutthe safety and effectiveness of these products right now.Just how good are the biological products that are nowavailable? Should the public be concerned about theirsafety and effectiveness?

Well, I think we shouldall be concerned about the safety and effectiveness ofproducts that are as important to the public health as

biologicals. We are concerned enough to undertake thismajor review project.

As to the question of how safe and effective biologicals are, let me say that, in general, we think the reviewwill indicate that most biologicals now being sold areeffective as well as safe. But there is a need for this typeof review, particularly for some of the older products.

We a lso wan t to take a c lose look a t each ind iv idua l

product. There is a special sort of problem here withproducts such as allergenic extracts. Take house dustfor example. It is one of the products that an allergistmay use to desensitize a patient with hay fever. Let'sassume that doctors find a particular house-dust productto be e ffec t ive . Can one then conc lude that a l l manufactured versions of house dust are effective? Answeringthis sort of question will take a really penetrating reviewnot only of clinical data but also of each firm's manufacturing process.

When your Bureauannounced the review, you said no manufacturer wouldbe asked to prove the impossible. What did you meanby that?

A Let me give you anexample. With smallpox vaccine, we have a fairlysimple test of effectiveness. We know that it works,because people who have been vaccinated don't catchsmallpox. With most biologicals, one can get this sortof straightforward proof.

But with some few products, the proof would be alot more complicated. Again, the best example wouldbe the allergenic extracts category. If someone has hayfever and seems to be allergic to ragweed, then injections of ragweed extract could be effective. However, the desensitization is not immediate; it is no one-shot treatment. It could take several years of periodicinjection of the extract to get a response.

And then there are other potentially confusing circumstances. Hay fever is often due to more than onekind of allergy. Maybe the person's symptoms are theresult of an allergy to both ragweed and house dust. Theragweed extract is injected and actually does the job onthe ragweed allergy, but the hay fever continues because of the house dust problem. This chain of eventswould make an effective ragweed extract look as if itwere ineffective.

What I'm saying is, that for certain products, it'sgoing to be really tough to develop guidelines to proveeffectiveness. For a tough job, you want the very bestexperts, and that's what we plan to get. (continued)

14 ! April 1973 ! FDA Consumer

"In the area of virology, there is a decent possibility of a hepatitis vaccine."

Usual ly when FDAevaluates a product—be it a drug or a microwave oven—it applies the benefit-risk concept. That is, a product'sbenefits must outweigh the risks. Does your Bureau usethis same principle?

.A.® Absolutely. I mightadd that every practicing physician uses the same principle. All products, and for that matter all medical procedures, are associated with a certain amount of risk,and so one must continually evaluate the benefit to thepatient. Hopefully, as a regulatory agency, we are constantly bringing the latest and the best informationabout risk and benefit to bear in the evaluation of produ c t s .

You mentioned beforethe effectiveness of smallpox vaccine. In late 1971 thePublic Health Service recommended that smallpoxvaccinations no longer be given routinely. Could youdiscuss that?

Al. This is an excellentexample of how the benefit-risk equation applies. Smallpox, as everyone knows, once was a widespread,dreaded disease. The benefits of taking the vaccinationwere overwhelmingly larger than the risks associatedw i t h v a c c i n a t i o n .

Today, smallpox has been eradicated in North andSouth America and Europe and is being rapidly broughtunder control in Asia and Africa. This changing patternhas been followed carefully, and by 1971 the evidencehad become conclusive. We had reached the pointwhere the risk of taking the vaccine—and let me addthat the risk is very small—was greater than the risk ofcontracting smallpox for the average American child.

Therefore, it was recommended that the practice ofvaccinating all children routinely be discontinued. Nowlet me add that there are still groups of people whoshould receive the vaccine—for example, people goingto areas where smallpox still exists and people such asmedical personnel who, if the disease were reintroducedin the United States, might be exposed before they couldbe warned and vacc inated.

Now let's move the time frame several years ahead.If worldwide attempts to eradicate the disease arecompletely successful, then the benefit-risk ratio wouldhave changed again. When and if that happens, thenanother shift in public health policy would be made.

This is what we and others in FDA must constantlydo: assess the latest information on benefits and risks,and translate it in a meaningful way into recommendations about a particular product.

In the past few yearsthere have been many new vaccines developed to combat previously common childhood diseases, such asmeasles, mumps, polio, and rubella. You are known,of course, for having contributed to the development ofthe rubella vaccine. Is there any question about the effectiveness of some of these vaccines, particularly sincethe Federal Government has never before had the specific authority to assure the effectiveness of biologicals?

A. I don't think there'sany problem here. Even though the Government lackedthe legal authority to concern itself with biologies effectiveness before 1972, it had an interest which wasshared by the public and the scientific community. Backin the 1950's, field trials were conducted to evaluatepoliomyelitis vaccine effectiveness before the productwas licensed. In 1966, three years before rubella vaccinewas licensed, our research team conducted an experiment showing that vaccinated volunteers were protected. The same sort of proof was obtained withmeasles and mumps vaccines.

Here you have a situation where an informed publicand scientific community expected and got somethingbefore the legal machinery was finalized—because itwas logical. I would be less than honest, however, notto add that we in biologies regulation could have beena lot more active in pressing for the authority so as tobe able to apply these same effectiveness standards tothe older products.

Why has there beensuch a flurry of new vaccines over the past few years?

.Al. I think this can be attributed to the general explosion in scientific knowledgei n t h e b i o m e d i c a l fi e l d t h a t w e ' v e w i t n e s s e d o v e r t h e

past two decades. Viruses grow only in living cells, andthe older vaccines were prepared by inoculating animalsand then using their infected tissues to make thevaccine. Many viruses won't grow in animals though,and others grow poorly.

Thus, in the biologies area, the big scientific breakthrough came in the 1950's, when Dr. John Enders and

FDA Consumer / April 1973/15

"I believe I can do more to advance the quality of medicine in this countryhy serving here."

his colleagues at Harvard won the Nobel Prize forshowing the potential for using tissue cultures—bottlescontaining living cells—for growing vaccine viruses.This led to the development of an array of newvaccines. Polio, measles, mumps, rubella—they are allin that category.

• W h a t v a c c i n e s a r e

now being developed that hold some real potential?

A. There are several —although none of the sure bets at the present time wouldhave as much visibility as, say, the polio vaccine, whichhas had the widest use of any vaccine developed in thiscentury.

In the area of virology, there is a decent possibilityof a hepatitis vaccine. With a little luck, a breakthroughcould come within a few years. Several vaccines againstrespiratory diseases are in the clinical trial stage. Thisgroup includes vaccines for diseases such as croup,virus pneumonia, and even the common cold. Scientists are also field-testing improved types of vaccinesfor influenza and rab ies .

The bacterial vaccine area has been just as active.Significant progress has been made in work on meningitis, pneumonia, and dysentery vaccines. There iseven the possibility of developing a vaccine againstgonorrhea.

One can never be sure of the outcome of experimental work, but odds are that some of these will reach thestage of license and public availability in the next fewy e a r s .

W h a t a b o u t a v a c c i n e

against cancer?

AThat's a hard ques

tion, because at this point, we really don't knowenough to make a prediction without doing a certainamount of guessing. I would say that many millions ofdollars are being spent in this country on cancer research, and a great deal of that money is being spenton the assumption that cancer may, at least in part, becaused by infectious agents such as viruses. If thisproves true, then it is conceivable that vaccines couldbe developed.

Most cancers of animals do seem to be virus-induced,and one kind of animal cancer has already been controlled by a cancer-virus vaccine. All this makes the

cancer researchers optimistic. The area is so importantthat in the Bureau we are gearing up our researchteams to be ready to regulate cancer vaccines when andif the big breakthrough comes.

• L e t ' s t u r n n o w t o

what the consumer ought to know about vaccines.Could you comment on this?

A. I think one of thecontinuing needs in our society is to educate consumersabout all areas in which they are affected, and no areais more important than health. We'd like consumers toknow more about benefit versus risk factors. Only inthis way can persons participate meaningfully in decisions involving their health.

Would you advise theparents of a young child to run through the gamut ofvacc ines w i t hou t r ese rva t i ons?

Here, I 'm giving amore or less personal opinion, speaking as a scientist,a pediatrician, and as a father. As we've discussedearl ier, there is a benefit-r isk factor involved in theuse of any vaccine, even though the risk may be verysmall. Parents can assume that if we in FDA are doingour job, then the vaccines available are acceptably safeand effective when used in the approved fashion.

This may sound a bit mealymouthed, so let me givean example. A series of rabies vaccine shots is fully indicated for the child bitten by a rabid animal. However, rabies vaccination is not recommended as a matter of routine for children, since the inconvenience andrisks would outweigh the very remote chance of gain.

Vaccines are prescription drugs, so one can expectt o o b t a i n a d v i c e a b o u t c h i l d h o o d i m m u n i z a t i o n f r o mthe family doctor or pediatrician. Physicians have attheir disposal the recommendations of vaccine experts.E a c h v i a l o f v a c c i n e d e l i v e r e d t o t h e d o c t o r i s a c c o m

panied by what we call the "package circular." This isa concise summary approved by the FDA and suppliedby the manufacturer to guide the physician in appropriate use of the product and warn him about use considered inappropriate or dangerous.

Expert advice is also provided by various government and professional groups. The U.S. Public HealthService Advisory Committee on Immunization Practices and the American Academy of Pediatrics' Com-

16 / April 1973 ! FDA Consumer

"We'd like consumers to know more about benefit versus risk factors."

mittee on the Control of Infectious Diseases regularlyr e v i e w t h e s t a t u s o f v a c c i n e s a n d m a k e r e c o m m e n d ations regarding vaccine use. While these recommendations are addressed primarily to informing the physician,the information can be made available to parents. Ifrequently send a copy of the Public Health ServiceCommittee recommendations to persons writing for info rmat ion abou t a vacc ine .

I hope from all this you are getting the message thatI think it is important for parents to be informed andparticipate in decisions regarding vaccination of theirc h i l d r e n .

Turn ing fo r a moment to the ro le of the Bureau wi th in FDA. You'venow had more than half a year to work within FDA.Flow effective has the transfer of biologies regulationfrom NIH to FDA been?

iAc. Well, perhaps I'mprejudiced on this subject, since I was made directorof the Bureau of Biologies when the transfer tookplace. But I do think it has gone extremely well. I thinkal l o f us wi th in the Bureau bel ieve that th is t ransfer was

really a wise move.

Could you elaborateon that?

A. The atmosphere within the National Institutes of Health is primarily scientific. This is the atmosphere in which the Division ofBiologies Standards operated. But our job at FDA isnot just one of science, it's also one of regulation.

Science, of course, is an extremely important part ofregulation, because regulatory decisions have to bebased on hard scientific facts. But regulation is a lotmore than just science. It's an interplay between thelaw, science, and public concern.

Being a large regulatory agency, the FDA has manyof the skills that we in the Bureau of Biologies need.In my judgment, we now have the best of both worlds.We are part of the FDA organization and are profitingby this association as a member of the regulatory team,yet we are located on the NIH campus where our scientists have the stimulation of working contact with otherscient is ts.

Yo u r B u r e a u d o e s e xtensive re.search in the area of biologies. Is there any

eonfliet between the developmental research that you doand yoKr role as a regulator?

A. Well, in almost anything you do there is a potential for a conflict of interest. We always have to be on guard. But I firmlybelieve we are better regulators because we are involvedin research .

We target our research so as to obtain needed information on matters relating to product safety and effectiveness. We try to stay away from actual productdevelopment. Our scientific efforts keep our people inconstant touch with university research teams andothers working in areas pertinent to biologies. This insures that the very latest knowledge is brought to bearin our regulatory decision-making process. A bureauwith no scientific expertise would be hard put to meetits responsibility for protecting the public.

Dr. Meyer, you havebeen a prominent research scientist, and your work inthe development of the rubella vaccine is well known.As director of the Bureau of Biologies, you have tospend cons iderab le t ime on admin is t ra t i ve mat te rs .Don't you regret being away from the laboratory?

Well, of course I stillhave some opportunity to keep my hand in lab workand work with patients. But right now I believe I cando more to advance the quality of medicine in thiscountry by serving here as director of the Bureau ofBiologies. The effectiveness review we talked aboutearlier, for example, is very significant. There's somuch other work that needs to be done, and I feel that,for the present, I can make a valuable contribution inthis capacity.

Harry M. Meyer, Jr., M.D.

FDA Consumer j April 1973 /17

'New RestrictionsO n D i e t P i l k

FDA undertook a review to seewhether diet pills really areeffective. Here's what FDA found,and the actions it took as a result.

It's a disease that afflicts more than3 0 m i l l i o n A m e r i c a n s b e t w e e nthe ages of 21 and 65, and every oneo f t h e m k n o w s i t . M o s t w a n t t o d o

something about it, but seldom permanently get rid of it. In fact, fewthink of it as a disease.

It's a disease people joke about.Ye t i t i s k n o w n t o r e d u c e t h e l i f e

expectancy of those afflicted with it.It's a disease whose underlying

causes may be rooted in the psychological makeup of the individual.Genetics may also play a role. Wedon't know for sure why it afflicts somany people.

The disease is known to^ the medical profession as "obesity." Laymencall an obese person "fat" or overweight. Technically, such a person isone whose weight is more than 20percent above the ideal for his or herheight, weight, sex, age, and build.Ideal weight for mature adults usually approximates that at age 25.

Like the never-ending search foreternal youth, some people continually look for a quick and easy wayto keep their weight down. Over theyears a variety of methods has beendeveloped to assist people to reduce.

One of the more popular methodshas been the use of prescriptiondrugs. Sl ightly over 26 mil l ionprescriptions for weight-reducing

drugs were filled or refilled in 1971.These prescriptions were given in thecourse of about 23 million patientvisits for obesity.

Some of the drugs that doctorsprescribe for obesity are appetitesuppressants. This is because theyare believed to suppress the appetite—though scientists aren't entirelysure how they work. In the medicalworld, these drugs are known asanorectics. Most of them—thoughnot all—contain amphetamine, achemical with a known potential fordependence.

The Food and Drug Administration has just completed the most extensive review of anorectic drugse v e r c o n d u c t e d . T h e c o n c l u s i o n o fFDA's investigators, and the recommendations based on it, should beenlightening to anyone who has evertried to lose weight permanentlythrough the use of prescriptiondrugs, or anyone thinking about trying them.

FDA concluded that patients receiving anorectic drugs will losemore weight than those who are nottreated with them. But patients whotake the drugs and diet will lose onlya fraction of a pound more a weekthan those who resort only to dietary restriction. And the rate ofweight loss is greatest during theearly stages of taking the pills.

The Agency thus concluded thatanorectics have a very limited usefulness in the treatment of obesity.

But it took no study to learn that

anorectic drugs are habit-formingand have been extensively abused inthe Uni ted States as wel l as in othercountries. Anorectic drugs, particularly those containing amphetamines,have been used as "pep pills." Certain anorectic drugs are sold on theblack market. They can and docreate dependence. They may produce bizarre and even psychotic behavior in those who abuse them, andu s e r s c a n h a v e s e v e r e w i t h d r a w a l

symptoms when they stop taking thedrugs.

Because of the risk, both to theindividual and to society, and thelimited benefits from anorectic drugsin weight reduction, FDA in December 1972 took several steps to bringthe use of these drugs under tightercontrols. FDA announced it was going to change the labeling of theseproducts to make clear the need forextreme care in prescribing them andto describe the l imitations of theirusefulness. FDA's conclusions werepublished in its Drug Bulletin, apublication which is sent to morethan 600,000 physicians, pharmacists, and other health professionals.

In add i t ion , FDA recommendedthat the Justice Department extendits own regulation of anorectic drugsby imposing controls on the distribution of those not already controlled (the amphetamines and phen-metrazine were previously stringently controlled). The Departmentis empowered to establish quotas for

18 /April 1973 j FDA Consumer

the production of any drug that canbe abused.

F D A r e c o m m e n d a t i o n s i n 1 9 7 1led to an 82 percent decrease in thelegitimate production of amphetam i n e s .

In January 1973, FDA recommended that this year's amphetamine production be cut back another60 percent. This would mean a totalreduction in amphetamines of 92percent since 1971.

Two factors led FDA to reappraise all anorectic drugs and to takeor suggest the strict regulatory act ions i t d id .

TX he first factor was FDA's intensive review of all drugs marketed initially between 1938 and 1962. Thisstudy, conducted in cooperation withthe National Academy of Sciencesand its operating arm, the NationalResearch Council, grew out of theDrug Amendments passed by theCongress in 1962 requiring thatdrugs be proven effective as well assafe. Under the 1938 Federal Food,Drug, and Cosmetic Act, only proofof safety was required.

The expert NRC panel that evaluated anorectic drugs expressed rese r v a t i o n s a b o u t t h e i r e f f e c t i v e n e s s .As a result, FDA asked the manufacturers of these drugs to conductadditional tests to demonstrate theeffectiveness of their products. FDAc o n c l u d e d f r o m t h e s t u d i e s t h a tanorectic drugs have a limited usefulness in the treatment of obesity.

As a corollary, FDA decided toreview the safety and effectivenessof all amphetamines, even thosewhich had not previously been subjected to FDA regulation. FDAasked manufacturers of amphetamine-containing drugs to submit applications if they wanted to continuemarketing them. The applicationsc o n t a i n e d e x t e n s i v e s t u d i e s o n t h eeffectiveness of these products. Thestudies were reviewed by FDA.

The second factor leading toFDA's decision to reappraise anorectic drugs was related to dru^abuse, described by many socialr » n m m # a n f - c i f r \ r c o c m r \ c f r t r f ^ k o c i n n

social problem in the United Statestoday. The drug abuse problem ledCongress in 1970 to pass the Comprehensive Drug Abuse Preventionand Control Act, which set up various classes of drugs meriting tightcontrols by the Federal Government.For som.e widely abused drugs, theGovernment could establish production quotas. Other drugs had to beplaced under lock and key in pharm a c i e s .

The law assigns to the Departmentof Health, Education, and Welfare,FDA's parent agency, the responsibility for recommending to theJustice Department which drugsshould be placed under which levelsof control. It also places on HEWthe responsibility for reporting thelegitimate medical and scientificneeds for drugs for which production quotas are to be established.FDA, therefore, plays an importantrole in making decisions concerningbo th o f t hese mat te rs . S ince anorectic drugs are among those being usedunwisely, a review of these drugsobviously was needed.

The review, undertaken by FDA'sNeuropharmacological Drug Division, was unique in its extensivenessand its use of computers. In reaching its conclusions and recommendations, FDA reviewed 206 studiesof anorectic drugs. In evaluating thedrugs, FDA looked not only at theireffectiveness in weight reduction, butalso at the public health risk fromthe i r use .

FDA concluded not only thatanorectic drugs were of limited usefulness in weight reduction, but alsot h a t c o m b i n a t i o n s o f a n o r e c t i c s w i t hother drugs, such as barbiturates andtranquilizers, were no better thanthe anorectic drugs alone. FDA willtake steps to discontinue marketinganorectic drugs containing morethan one active ingredient.

F D A a l s o c o n c l u d e d t h a t t h erisks of injectable forms of theamphetamines outweigh any advantages. The anorectic drugs thus willbe marketed only for oral use. Inaddition, the Agency found the total

• 1 . 1 . . * 1 . _ 1 1 -

today's prescription drugs over theuse of d ie t a lone must be cons ideredsmall. FDA decided to act to de-emphasize the role of anorectic drugsin weight reduction.

Among the well-known drugsevaluated by FDA were amphetamine preparations such as Dexedrine,Biphetamine, and Obotan, andclosely related drugs such as phen-metrazine (Preludin), methamphet-amine (Syndrox, Desoxyn), benz-phetamine (Didrex), phendimetra-zine (Plegine), diethylpropion (Tenu-ate, Tepanil), phentermine (lona-min, Wilpo), and chlorphentermine(Pre-Sate).

In addition, FDA evaluated threedrugs which are expected to bemarketed soon in the United States,and found none superior in effectiveness to any of those now available. These new products are fenfluramine (Pondimin), clortermine(Voranil), and mazindol (Sanorex).

The labeling for all anorecticdrugs will warn physicians to usethem with extreme care, and thenonly as a short-term (a few weeks)adjunct in a regimen of weightr e d u c t i o n b a s e d o n d i e t r e s t r i c t i o n .

T h e t o t a l e f f e c t o f t h e F D A a ctions will be to leave anorectic drugsavailable for use by physicians forcertain patients, while informing themedical profession about the limitations and risks associated with theiruse. It will remain with the individual physician to decide when prescribing these drugs is appropriate.

Js yet, FDA has taken no actionagainst over-the-counter remediessold for weight reduction. Suchdrugs will be reviewed later as partof an overall project to evaluateover-the-counter drugs.

So—the message is: if you'reoverweight, remember that prescription drugs have not been shown tohelp over an extended period oftime, and may help you only a littleo v e r t h e s h o r t t e r m .

Any decision to use them shouldt a k e i n t o a c c o u n t t h e f a c t t h a t t h e

drugs do cause drug dependence and1 1 J _ 1 _ . _ 1 1

f P H A C n n v u m p r / A n r i l 1 Q 7 ^ I / (

Hv-lbp Cans CAN Be Safe!

R e m e m b e r t h e T V c o m m e r c i a lin which the boy took out anindividual can of dessert fromhis school lunch and said, "Thisis going to be big, really big."?

His prediction was correct.Last year food firms startedputting out everything frompudding to beef stew in individualcans that could easily be openedjust by pulling a tab on the topof the can. Just the thing forchi ldren's school lunches. . . .

Until children started cuttingthemselves on the cans' edges.While the cans may have beenfairly safe for adults, children oftenwere careless about the sharp-edgedtops, or even bent the tops infoscoops and used them like spoons.

Incidents of cuts came to thea t t e n t i o n o f b o t h F D A ' s B u r e a uof Product Safety and industry,and together they worked out asolution. They found that aluminumcans, the ones most used forindividual portions of food, couldbe designed to have a triple foldof aluminum on the edge of thetop and on the ledge inside thecan after it was opened. Thistriple fold of aluminum means arounded surface instead of a sharpcutting surface, so the cans nowbeing used are entirely safe, for

I children as well as adults.

This improvement also has beenmade in pop-top cans of nuts,potato chips, and other snackfoods which people remove fromthe can with their handsor fingers.

One of the newest designs -for softdr inks is the But ton-Down can.There is no tab to pull or lift up,but two circular openings which arepushed inward. All edges arerounded, so there is no danger ofbeing cut when drinking from thecan; and this type of can helpseliminate litter, because no tabs arepulled off and thrown away.

What about the pop-top cansof soft drinks that had been onthe market for several years priorto the "pudding cups"? Did theyalso constitute a hazard?

The Bureau found that thistype of easy-to-open pull-tab canposed no hazard. Since the openingson these cans were too small forfingers or hands to dip into, noinjuries had been reported in theuse of these containers.

However, other products beganto appear on the market in cansvery similar to the soda cans,many of which were not intendedfor human consumption. Someof these products, in cans similarin size and color to soda cans,contained products for such usesas flushing the radiator in youra u t o m o b i l e .

T h e F e d e r a l H a z a r d o u sSubstances Act enforced by FDAsays no package that can beidentified as a food package cancontain hazardous products.Obviously, the cans containingfluids for use in automobi lescame under this category. Andagain, the Bureau of ProductSafety and industry cooperatedin seeing that the containers wereredesigned to conform to safetys t a n d a r d s .

As originally designed, the canscould be opened in exactly thesame way as soda cans. A child—mistaking it for soda—could drinkfrom the can. The new designprevents the tab from beingremoved from the can. If a persontries to drink from the can, thetab prevents his getting his faceclose enough to be able to drink.

Because of FDA surveillance,and concern on the part of themajor can manufacturers—suchas American Can, ContinentalCan, and Central States CanCompany—a great deal of progresshas been made in safety.

Whether you call it a pop-top,flip-top, or pull-tab can, the easy-to-open can is here to stay—andgenerally it is safe. However, youshould always be alert to possiblehazards, and report any improperlydesigned cans to the manufacturerand to the Bureau of Product Safety.

Originally, cans had sharpedges; new cans are designed witha triple fold which forms roundededges that do not cut.

Pop-top cans containingdangerous chemicals posed ahazard—children might drink thefluid by mistake. New designprevents this—the tab pulls from theedge, does not come off, and preventsanyone's getting his face closeenough to drink from the can.

T h e n e w B u t t o n - D o w n c a n h a stwo circular openings which arepushed inward. All edges arerounded, so there's no chance ofbeing cut.

FDA Consumer / April 1973 / 21

How safe do consumers believec o s m e t i c s a n d t o i l e t r i e s a r e ?

To learn the public's perceptionsabout these and other products,FDA conducted a national surveyof consumer opinion. The firstarticle on this survey, coveringtoys, appeared in the Marchissue of FDA Consumer. Futurearticles will discuss consumerperceptions of drugs and foods.

by Philip G. Kuehl, Ph.D.,and Mary Ellen Simon

FDA Listens:A Survey OfConsumer OpinionA b o u t T h eSafety Of CosmetlesAnd Toiletries

More Americans, of-both sexes,are now buying and using toil e t r i e s a n d c o s m e t i c s t h a n e v e r b efore. FDA was particularly anxiousto investigate consumers' opinionsabout the safety of these types ofproducts, to help evaluate its presentpolicies and to develop new programs that would be of the mostb e n e fi t t o c o n s u m e r s .

A n O v e r v i e w

To obtain a general understandingabout opinions on safety, consumerswere shown a "safety thermometer"diagram, with 100 degrees labeledas "Most Safe" and 0 degrees as"Most Dangerous." They were askedto place each of the five categories—foods, toys, cosmetics, prescription medicines, and nonprescriptionm e d i c i n e s — o n t h e t h e r m o m e t e r i nterms of safety. Cosmetics and toiletries were ranked third in safety,after foods and prescription medicines, and ahead of toys and over-t h e - c o u n t e r m e d i c i n e s .

Ta b l e 1 s h o w s h o w c o n s u m e r s

placed cosmetic products on thethermometer scale, the majority ofthem indicating they believe cosmetics and toiletries are quite safe.

Two other survey questions provide general understanding and insight into the safety ranking ofc o s m e t i c s . W h e n c o n s u m e r s w e r easked if people "worry about the

Ta b l e 1

Placement of Toiletries and Cosmetics on the Safety Thermometer

M o s tSafe

8 0 - 1 0 0 °

6 0 - 7 9 °

4 0 - 5 9 °

2 0 - 3 9 °

0 - 1 9 °

M o s t

Dangerous

134%

2 4 %

2 4 %

^ 1 2 %

6 %

o 1 0 2 0 3 0 4 0

The vertical scale shows "safety temperature" and the horizontal bars showthe percent of consumers who placed toiletries and cosmetics within theindicated temperature range.

22 ! April 1973 / FDA Consumer

safety of the toiletries and cosmeticsthey use," 42 percent said they didnot worry "at all," 43 percent saidthey worry "a little," and only 10percent stated they worry "a lot."When asked how confident they werethat the toiletries and cosmetics theyand their families use are safe, 78percent of the consumers said theywere "definitely" or "reasonably"c o n fi d e n t .

It is apparent that most consumerst h i n k t o i l e t r i e s a n d c o s m e t i c s a r e

reasonably safe, and FDA believesthis is a correct assumption. Reportsof adverse side effects or injury fromthe use of cosmet ics have been rela

tively few and the injuries wereusually minor.

Packaging and Labeling

The subjects of cosmetic packagingand labeling were also examined inthe study. When consumers wereasked if aerosol spray cans for cosmetics and toiletries are safe, 67 percent said they were "definitely" or"pretty much" safe. Only 10 percentdefinitely thought that toiletry andcosmetic spray cans are not safe.

This confidence may provide afalse sense of security. Apparentlyc o n s u m e r s d o n o t r e a d t h e l a b e l so n a e r o s o l c o n t a i n e r s w h i c h w a r n

against hazards from explosion.Consumers need to be alert to suchdangers so they will use cosmeticsprays with appropriate care.

When asked whether cosmet icsand toiletries manufacturers provideenough information about productusage on the label or carton, 53percent of the consumers said adequate product-use information isgiven "most of the time." However,only 14 percent said enough information is given "all of the time."

FDA believes more completelabeling—listing of ingredients, forinstance—would be of value in preventing deception and in helpingconsumers make va lue dec is ionsamong products. Regulations proposed by FDA in February 1973 callfor mandatory listing of ingredients

Ta b l e 2

Contributions to Toiletry and Cosmetic Safety

Question: Different groups work to make products safe. Which one ofthese groups do you think does the most to make toiletries andcosmetics as safe as they are?

Percent of Respondents

on cosmetic labels (see FDA Consumer, News Highlights, March1973).

Groups Responsible for theSafety of Cosmetics

When consumers were questionedabout the contr ibut ions of var iousgroups to the safety of toiletries andcosmetics, the results in Table 2w e r e o b t a i n e d .

These findings show that consumers regard the safety of toiletriesand cosmetics as a shared responsibility, between industry. Government, and consumers—and FDA believes this is, for the most part, true.

Safety measures developed bymanufacturers, in cooperation withFDA, have achieved a high degreeof safety in cosmetic and toiletryproducts. The industry trade association, the Cosmetic, Toiletry andFragrance Association (CTFA), hasdeveloped a voluntary programwhich ass is ts FDA's e f fo r ts to assurethat cosmetics are harmless. Already

Group

Companies That Make Toile t r i es and Cosme t i cs

G o v e r n m e n t

Consumer Organization

Companies That Sell Toilet r ies and Cosmet ics to theP u b l i c

Individual People

D o n ' t K n o w

in effect are voluntary registration ofcosmetic manufacturing firms andlisting by cosmetics firms with FDAof product ingredients; a system forreporting adverse experience by cosmetic users will begin this year.

FDA's Authority

One of the most surprising resultsobtained in the survey concernedconsumer opinions about Government jurisdiction in the testing ofcosmetics and toiletries before theyare marketed. Opinions on this quest i o n a r e s h o w n i n Ta b l e 3 .

A great many people believe theF e d e r a l G o v e r n m e n t t e s t s o r r e

quires testing of cosmetics and toiletries before they can be sold. Thisis not entirely true.

FDA itself does not test cosmeticsbefore they are put on the market forsale. But FDA's position is that thelaw requires that manufacturers ordistributors of cosmetics and toiletries have in their file adequate scientific data to substantiate the safety

FDA Consumer / April 1973 j 23

Ta b l e 3

Beliefs About Government Presale Regulation of Cosmetics and Toiletries

Percent o£ public that believes the Government:

Pre tes ts Cosmet ics Requires Manufacturersa n d To i l e t r i e s to Pretest These Products

A l l o f the Time 1 3 . 6 % 3 1 . 7 %

Mos t o f t he Time 2 2 . 9 2 9 . 5

Some of the Time 3 4 . 7 2 1 . 3

None o f the Time 1 3 . 3 5 . 4

D o n ' t K n o w 1 5 . 5 12.1

1 0 0 . 0 % 1 0 0 . 0 %

of the products, unless their labelstates otherwise.

The Federal Government can stopthe sale of unsafe cosmetic productsafter they reach the market, and thesurvey shows that 89 percent of thec o n s u m e r s a r e a w a r e o f t h i s . T h elaw gives FDA authority to takeaction against a cosmetic after itsdangers can be proved in a court ofl a w .

The implications from the survey— f o r F D A a n d f o r c o n s u m e r s — a r ee v i d e n t . C o n s u m e r s n e e d t o b e i nformed about the limited authorityof the Federal Government in theregulation of cosmetic and toiletryproducts, so they can be more alertto their own responsibility in buyingand using cosmetic products safely.Consumers can perform a valuablepublic service by reporting to manufacturers, and to FDA, any adverseeffects or injuries from the use ofcosmetic products. Consumers cansend their reports to Food and DrugAdministration, Division of Colorsand Cosmetics Technology, BF-430,200 C Street, S.W., Washington,D.C. 20204. Keeping cosmetics safemust be a joint effort of consumers,manufacturers, and the FederalGovernment, working together forquality products, accurate labeling,and safe use.

How the study was conducted. A national probability sample of 2,005people was used in the study. This sample was selected to providerepresentation of various geographic areas, types of communities,ages, incomes, and educational levels in such a way that results reflectnational public opinion. The questionnaire, which took about 50minutes to complete, was administered by professional interviewersfrom Response Analysis Corporation, Princeton, New Jersey, duringAugust and September of 1972. Since objective, unbiased responseswere desired, people interviewed were not given any indication thesurvey was being conducted for FDA, nor were they told the purposeof the survey. All the findings reported here are preliminary; a detailedfinal statistical report will be completed later in the year. The readershould keep in mind that this was a survey of opinion. While theanswers describe the opinions held by the public, they may not accurately reflect the truth about the safety of the products.

Philip G. Kuehl, Ph.D., is AssistantProfessor of Marketing at theCollege of Business and PublicAdministration, University ofMaryland in College Park.

Mary Ellen Simon, project officerfor the survey, is a program analystin FDA's Office of the AssistantCommissioner for Planning andE v a l u a t i o n .

24 ! April 1973 ! FDA Consumer

FDA has set radiat ion emissionlimits to assure that microwaveovens are safe for use in the home.Consumer Reports has challengedthese limits. Here are some salientfacts."We do not feel we could consider amicrowave oven acceptable, unlessthere is no radiation leakage detectable, even under the most severe conditions, by generally accepted measuring procedures, and until there issufficient assurance that there will notbe any detectable leakage over the lifeof the oven."

With these conclusions in its April1973 issue, the widely read magazineof the Consumer Union, Consumer Reports, announced that it could not recommend any of the home modelsnow on the market.

The Food and Drug Administration,whose Bureau of Radiological Healthhas set a standard for microwave ovensand tests them for compliance, says

that ovens manufactured today aresafe for use in the home.

Consumer Reports rests much of itscase against microwave ovens on thefact that they leak detectable radiation. But any electronic device generating almost any type of electromagnetic radiation leaks some detectableradiation, no matter how low a level.Even radiation leakages from radiosand televisions, for example, thouglivery low and harmless, are stillde tec tab le .

Demanding zero radiation detect-ability, as Consumer Reports suggests,not only would deprive us of these andother pleasurable features of the electronic age, but certain electrical conven iences as we l l . Shavers , foodmixers, vacuum cleaners, and all otherappliances with electric motors emitdetectable radiation, for example.

The most feasible approach to electronic radiat ion protect ion, say experts of the Bureau of RadiologicalHealth, is to require that electronic

product radiation emissions be keptwel l be low the lowest levels known tocause biological effects.

This was the approach the Bureautook in developing the Federal microwave oven standard. It established, fora l l o v e n s m a n u f a c t u r e d a f t e r O c t o b e r

6, 1971, a maximum emission level ofone milliwatt per square centimeterwhile ovens are still in factory, distributor, or importer inventories, andfive milliwatts per square centimeterfollowing sale and throughout the useful life of the equipment. (A milliwattis 1/1,000 of a watt; a square centimeter is about 15/100 of a squareinch).

Consumer Reports unfavorably compares the FDA standard for microwaveoven emissions with the Russian standard for microwave exposure of anindividual (0.01 milliwatt per squarecentimeter). The magazine mistakenlyconcludes that the Soviet standard is500 times lower and therefore the U.S.standard is too high to be safe.

Such a comparison ignores the distinction between the maximum allowable emission level at the source (theoven) and the actual exposure received. The two are by no means thes a m e .

The FDA performance standard requires ovens to be tested for radiationleakage at a distance of five centimeters, or about two inches, from theoven. Microwave and other forms ofradiation decrease in energy markedlyas distance from the source is increased. If an oven is leaking five milliwatts of radiation per square centimeter at two inches, a person 14inches away would be exposed to nomore than a tenth of a milliwatt persquare centimeter. At four feet, theexposure would drop to a hundredthof a milliwatt. These levels are consistent with the Russian standard.

Furthermore, the Russian standardis for whole body exposure to microwave radiation averaged in terms ofboth duration of exposure and thearea exposed. The Russian limit is foran average whole body exposure for anentire working day of eight hours ormore. If a U.S. microwave oven designed for home use leaked five milliwatts per square centimeter (as meas-

FDA Consumer / April 1973 / 25

ured two inches away) and radiated auniform field, one could stand withinfour feet of it for over eight hours perday or within 14 inches for two hoursa day without reaching Russian exposure limits.

Exposure of the user-an Americanhousewife or restaurant employee, forinstance—for either period of time isunlikely, of course, since relativelylittle time is required for cooking bymicrowaves. Moreover, an oven witheven several points of emission at fivemilliwatts per square centimeter wouldnot radiate a uniform field and, atworst, only a few points on the user'sbody would be exposed at levels approaching the Russian limit for averagetotal body exposure. Thus, the FDAstandard is more stringent than theRussian requirement.

Exposure levels required to produceserious damage to the eye, the mostvulnerable organ to this form of radiation, are many times greater thanmicrowave levels to which an American oven user might be exposed. Forexample, the lowest exposure reportedto have resulted in a cataract in man isestimated to be 100 milliwatts persquare centimeter received intermittently for a year. Contrast this levelwith 0.1 milliwatt 14 inches from anoven leaking no more than permittedby the U.S. standard.

FDA established two emission standards-one milliwatt for ovens beforesale and five milliwatts after sale-toallow for some deterioration of theoven during its useful life. Preliminaryevidence now available however, suggests that ovens may undergo littlechange in radiation control capabilitiesas the result of use.

The evidence includes data recentlycompiled from surveys of 327 ovensmade under the standard. About 26percent of the ovens were in dealer ordistributor inventories. The rest wereabout evenly divided between commercial estabhshments and homes.

Two hundred and ninety-nine of theovens were found to emit less than onemilliwatt of microwave radiation persquare centimeter at the tests distanceof about two inches. Twenty-one ofthe ovens registered less than two mil-hwatts. Leakages from seven ovens

ranged between three and five milliwatts per square centimeter.

One or more samples of each newmicrowave oven model are tested in aBureau laboratory for compliance withthe standard. Seventy-six new ovenshave been tested thus far and all but afew have been found to comply.

Twenty new ovens have been subjected to operational endurance testing. This has involved running ovendoors through repeated opening andclosing cycles-at least 100,000 cyclesfor home ovens and 200,000 for commercial ovens.

The tests simulate eight to ten yearsof oven door use. No oven was foundto leak more than two milliwatts persquare centimeter after endurance testing and some home ovens emitted lessthan one mill iwatt after more than250,000 door opening and closingcycles. A number of ovens leaked lessradiation after the tests than before.

The Bureau of Radiological Health,with the assistance of State and localradiation control agencies,'is now testing microwave ovens for compliancewith the standard at the rate of about1,000 a year. Tests are in homes, commercial establishments, and on dealerand distributor premises. Many of theovens in use will be rechecked forpossible deterioration in radiation control capability.

The Bureau also keeps a close watchon manufacturer quality control andoven testing procedures through regular manufacturer reports and plantinspections. Ovens ready for shipmentto cus tomers a re tes ted fo r s tandard

compliance during these inspections.Ovens found not to meet the standardor made under quality control andtesting programs that are disapprovedby the Bureau are withheld from commerce until product and program corrections are made.

The Radiation Control Act requiresmanufacturers to refund the cost ofelectronic products found not tocomply with a standard or to makerepairs or replacements without costst o o w n e r s .

The microwave oven standard isunder continuing review in the Bureaufor improvements. As a result, anamendment to the standard will be

proposed to require ovens to shutthemselves off in event of a safetyinterlock failure until repairs havebeen made. Each oven is required tohave two interlocks, either of whichcan prevent the oven from beingoperated unless the doors are fullyc l o s e d . A s e c o n d a m e n d m e n t n o wunder consideration would greatly increase the difficulty of defeating aninterlock through tampering.

The Bureau is convinced that the microwave oven standard provides ampleassurance against health effects andthat, indeed, ovens that comply withthe standard are safe. As is the casewith owners of other major electronicappliances, however, the microwaveoven owner can take steps to assureproper operation of the equipment,equipment.

The owner can, for example, followoperating procedures recommended bythe manufacturer, making certain (1)that objects are never inserted throughthe door grill or around the seal; (2)that the seal is frequently cleaned withwater and mild detergent, rather thanabrasives; (3) that the safety interlocksare not made inactive by tampering;(4) that the oven is never operatedwhile empty; and (5) that the oven isinspected regularly by a qualified serviceman for signs of wear, damage, ortampering.

Robert T. De Vore is publicinformation officer for the Bureauof Radiological Health.

Albert Van De Griek is record reviewofficer. Division of ElectronicProducts, Bureau of RadiologicalH e a l t h .

26 I April 19731 FDA Consumer

News Highlights

Pres iden t N ixon Nomina tes Dr. EdwardsAs Assistant Secretary for Health

FDA Unvei ls Second PhaseOf Food Labeling Program

Pres iden t N i xon announced on March 13 h i s i n ten t i on tonominate Charles C. Edwards, M.D., Commissioner of Foodand Drugs, as assistant secretary for health of the Department of Health, Education and Welfare.

Dr. Edwards has been Commissioner of Food and Drugssince December 1969.

Caspar Weinberger, HEW Secretary, said Dr. Edwards"has done much in his three years at FDA to make thatagency an effective tool in the Nation's consumer protection machinery. His nomination comes at a time when reshaping of our health programs requires concerned, intelligent and dynamic leadership."

Dr. Edwards' nomination is subject to confirmation bythe Senate. Dr. Edwards would succeed Merlin K. DuVal,M.D. The assistant secretary for health is responsible forthree HEW health agencies: the National Institutes ofHealth, the Health Services and Mental Health Administration, and FDA.

On March 16, Dr. Edwards named Deputy CommissionerSherwin Gardner as Acting Commissioner of FDA.

FDA has unveiled the second phase of an extensive foodlabeling program. The Agency initiated the first phase inmid-January with a 12-part package of regulations designedto bring about more informative labeling and promotion offood products.

Actions announced March 14 by FDA include:1. A procedure to establish descriptive, non-deceptivecommon names for some foods. Under the procedure, thepercentage of an important ingredient, such as orange juicein diluted beverages, will, when appropriate, be made a partof the common name of the food and be prominently displayed on the label.2. A procedure to establish guidelines for protein, vitaminand mineral content in various classes of food. The guidelines are designed as a safeguard against inadequate as wellas excessive fortification. The first guideline for productsclassified as "frozen dinners" is among specific actionso r d e r e d .3. Final teclmical modifications on four of the 12 actionstoken in January. (continued)

Charles C. Edwards, M.D. Sherw in Gardne r

FDA Consumer ! April 1973 ! 27

The major thrust of the common name action is aimed atmaking some food labels more informative, and eliminatingconsumer confusion caused by either the label or appearance of the food. The first products affected by the actionare diluted orange juice beverages, seafood cocktail, Greenland turbot, crabmeat and bonito. Three other commonname actions were proposed.

The common name action covering orange juice beveragesresolves a key issue in the controversy which, since 1964,has surrounded the setting of standards for diluted orangejuice beverages. Much of the controversy resulted becauseof differences between representatives of the two major orange producing areas over the common names for dilutedorange-juice drinks.

FDA has concluded that the consumer's major interest isin knowing the percentage of orange juice in such productsno matter what the product is called. This will be accomplished by requiring manufacturers to prominently declareas part of the name the percentage of natural orange juicein all diluted orange juice beverages.

Other technical issues involved in establishing identitystandards for juice products will be stayed pending a publichearing.

FDA moved to eliminate consumer confusion about juiceproducts whose color and flavor or whose labeling may leadthe consumer to falsely believe a natural fruit or vegetablejuice is included. FDA is proposing that labels of such products be required to state, as a part of the common name,that the products do not contain natural juice.

Under the common name action the Agency also acted toprevent possible consumer deception from labels whichfalsely imply that important ingredients such as chicken orsteak are included in packaged food products like "chickencasserole" or "pepper steak." The proposal would requirefull listing of the ingredients present, along with an appropriate statement naming the missing ingredient-such asmeat or chicken-which must be added to complete thed i n n e r.

FDA's proposal to establish a common name for "frozendinners" will assure that such products are either comparable to a complete meal or if they are not, to tell consumerswhat foods should be added to make a complete and balanced meal.

The proposal requires that any product represented as a"frozen dinner" must include three separate dishes, selectedfrom meat, poultry, fish, cheese, eggs, vegetables, potatoes,rice, or other cereal based products. It would require thatall of the main components such as meat, potatoes, or peas,

be listed in order of predominance by weight. A Hsting ofother foods which must be added to obtain a complete dinner would be a part of the product's common name.

In addition to the "frozen dinner" guideline, others arebeing developed for breakfast cereals, breakfast drinks, formulated meal replacements and main dishes.

The guidelines will assure that fortification is neither excessive nor inadequate. FDA is especially concerned withehminating any promotional advantage for manufacturerswho might attempt to combine excessive fortification withnutrition labeling.

Manufacturers who choose to make products which meetFDA guidehnes can use the following statement on theirlabels:

"This product provides nutrients in amounts appropriatefor this class of food as determined by the U. S.G o v e r n m e n t . "

When such a statement is used, full nutrition labelingmust also be provided on the package.

Final technical modifications on four regulations announced in January are for nutrition labeling, fat and cholesterol labeling, a standardized information panel forlabels, and requirements for nutrition labeling for somestandardized foods.

Interested persons have 60 days to comment on the proposals for establishing common or usual names for "maindishes," "frozen dinners," and no juice products. Comments should be sent to the Hearing Clerk, Department ofHealth, Education, and Welfare, Room 6-88, 5600 FishersLane, Rockville, Maryland 20852.

281 April 19731 FDA Consumer

Regional Reports

R E G I O N I I R E G I O N I I I

The person who takes his own blood pressure readingat home, as some consumers are doing these days, notonly needs a sphygmotonomcter that's accurate but healso needs to know how to use it. The New York District laboratory, examining one of these devices soldfor home use, found that it was accurate but the directions for use on the labeling were inadequate. Theshipper, U.S. Medical and Surgical Supply Co., Engle-wood Cliffs, New Jersey, was advised to correct labeling to comply with the law.Two inspectors from New York District's DomesticInspection Branch accompanied representatives of theU.S. General Accounting Office to collect samples ofred meat and poultry products from various retailstores and meat markets in New York City. They collected 20 samples from places selected by GAGrepresentatives and sent them for analysis to FDA'sCenter for Microbiological Analysis in Minneapolis,which was asked to prepare a consolidated report onresults of a survey that included nine other FDA districts. The work was done as part of GAO's review ofFDA and U.S. Department of Agriculture programsinvolving Salmonella in foods.A company's voluntary destruction of 150 cartons andfour 50-gallon barrels of outdated pharmaceuticals wasoverseen by members of New York District's DomesticInspection Branch. The drugs, including estrogen,ascorbic acid, and penicillin tablets were crushed andburied by bulldozer in a landfill in Brooklyn. Theybelonged to Avien, Inc., Woodside, New York, formerowners of Davis Edwards Pharmaceuticals, which became bankrupt in 1972.

A recent inspection by San Juan District of the Star-kist Caribe Tuna Cannery, Mayaguez, Puerto Rico,disclosed that regular tap water was being used in aproduct labeled "Fancy Albacore Solid White Tuna inSpring Water." Although there was no health problem with the tuna, there was obvious deception andthe plant was advised to discontinue packing underthis label until real spring water could be obtained andused .

Recent detainment of imports by the New York District included five lots of insect-infested fig paste fromTurkey valued at $20,000, two lots of snail shells fromFrance containing fly residues^ and several lots of froglegs from India and Indonesia contaminated byS a l m o n e l l a .

At the request of the Rutgers University ExtensionService, the Philadelphia District veterinarian, Dr. M.R. Levy, spoke to two regional meetings for poultryproducers in New Jersey. The first was held in Leming-ton and the second in Vineland. Dr. Levy discussed"Poultry Disease Control with Limited Antibiotic andDrug Usage."The Region III radiological health representative, Robert Frankel, presented a two-day seminar on "Radiat i o n P r o t e c t i o n a n d U s e o f C i v i l D e f e n s e I n s t r u m e n t s "to the professional staff in the Philadelphia Districto f fi c e .

Pillsbury Company, East Greenville, Pennsylvania hasrequested inclusion under the self-certification programfor corporations. Philadelphia District is arranging forinspection of the firm and will be accompanied byrepresentatives of the cooperative quality assuranceg r o u p .

Judith O. Guinan, Philadelphia District consumer specialist, participated in a meeting of the PhiladelphiaConsumer Protection Coordinating Committee. Othermembers included representatives from consumer protection offices, such as the Commonwealth of Pennsylvania, office of the mayor of Philadelphia, FederalTrade Commission, State of Delaware, and Montgomery County. Miss Guinan also, with representativesfrom Radio Station KYW in Philadelphia, the Bureauof Consumer Protection, and the Better BusinessBureau, gave presentations on consumer protection toa group of 600 students at a Philadelphia high school.Jeanne Devers, assistant to the Regional director forconsumer affairs, FDA Region III, has returned to thePhiladelphia Field Office after AV2 months detail toWilkes-Barre as head of the President's Consumer AidCenter. The Center handled 3,714 complaints. It wasreported to be the first federal emergency-disasterconsumer protection office in the country. Mrs. VirginiaKnauer, Consumer Affairs Advisor to the President,will recommend that other operations of this kind beopened in disaster areas in the future.

R E G I O N I V

A consumer's quest for beauty can often be painful. Soit was for a young Alabama woman, who alerted anAtlanta District post after experiencing extreme hyper-

FDA Consumer / April 1973129

vitaminosis due to prolonged use of vitamin A for treatm e n t o f a c n e .

The woman's dermatologist had prescribed 75,000to 100,000 units of vitamin A daily, which she continued to take on her own for two years.

After 2 years, she developed a condition in whichshe could hear her pulse in her ear when at rest. Inthe year following, she began to develop symptomswhich included thinning of hair and recurring baldspots, mouth ulcers, fatigue, and anemia.

After consulting with a physician, she discontinuedvitamin A therapy. The anemia disappeared but someother symptoms remained. Still later, an eye examination detected an inflammation of the optic nerve, aswell as increased intercranial pressure. The condition,which was not caused by tumor, is known as pseudot u m o r c e r e b r i .

Vitamin A intoxication was not suspected until another patient entered the same hospital with similarsymptoms. This patient's history included intake oflarge amounts of vitamin A. At this point vitamin Apoisoning became suspected as a cause of the increasedintercranial pressure. All other symptoms of the patientwere indicative of hypervitaminosis A.

The woman first suspected vitamin A poisoningwhen she heard through various news media aboutFDA's proposed regulation to limit the amount of vitamin A in over-the-counter vitamin pills. She hasoffered her case for study as possible background datafor the proposed regulation and stated she is doing soto help prevent similar situations for others.

Several manufacturers in Region IV have takenvoluntary action to comply with the law.The Management of Charles L. Gray Co., RockyMount, North Carolina, voluntarily destroyed a 1,170-pound lot of various types of dry beans which FDA inspectors found to be defiled by rodents. Samples werecollected for seizure consideration but the companydestroyed the lot before the inspection was completed.Another inspection uncovered extensive contaminationof ice cream raw materials by rodents. This resultedin voluntary destruction by Atlanta Dairies Co., Atlanta, Georgia, of over five tons of nonfat dry milk,dried whey, and ice cream mixes. The approximateworth was $3,200.Electro Sedation Units, misbranded under the Food,Drug, and Cosmetic Act, were seized by Deputy U.S.Marshall John Hines in Greensboro, North Carolina,in January.

The devices, discovered after an inspection of themanufacturer's establishment, were found in the possession of Mayrand, Inc., Greensboro. They had beenshipped in interstate commerce by Tri-Tronics Laboratory, Inc., Euless, Texas.

Labeling and literature accompanying the devicefalsely suggests, among other claims, there is "substan

tial scientific evidence that the devices are safe andeffective to soothe crippling tensions and to ease stressrelated il lness."

The labeling does not carry adequate directions foruse nor adequate warnings against use under certainconditions or by children. There is no adequate warning against unsafe dosage and duration of the methodo f s e d a t i o n .

R E G I O N V

Fines were imposed against a Michigan bakery, itssubsidiary, and the president of the subsidiary plantfor operating a bakery infested by insects. The companies, in FDA's Detroit District, pleaded guilty toFDA charges and the pleas were accepted by JudgeThomas P. Thornton in Federal Court at Bay City.

Schafer Bakeries Inc., Lansing, and its subsidiary,Gase Baking Co., Saginaw, were fined $1,000 togetheron each of six counts, $3,000 payable immediately and$3,000 suspended unless there is another violation during a three-year probationary period. Joseph Bianchini,Gase president, who was fined $100 on each of sixcounts and placed on probation for two years, wassentenced by Judge Thornton at Flint.

The caption, "Gingerbread Boys Were Dirty Old Men,"headed an article on the front page of the CincinnatiPost and Times Star on January 19. The article commented that the Federal Bake Shop, Inc. was tryingto recall about 20,000 rodent-contaminated gingerbreadmen sold during the Christmas season.

Inspection of the bakery by FDA's Cincinnati District disclosed insanitary conditions. Samples of thegingerbread men from six returned lots were found upon laboratory analysis to be contaminated by mousepellets or urine or both.Dr. Homer R. Smith, Detroit Distr ict veterinarian addressed the Young Farmers of Frederickton, Ohio,concerning the use of drugs in food-producing animals.He also spoke to the 50th annual Alumni Reunion andPost Graduate Conference for Veterinarians at Michigan State University and visited Michigan State feedc o n t r o l o f fi c i a l s .

Dr. Smith attended a meeting of the Indiana StateVeterinary Medical Association in Indianapolis inJanuary.A Minnesota wholesale grocery company was orderedto cease doing business within 45 days and an operating official was fined $4,000 in a court hearing inwhich the defendants were charged with violation ofprobation. Inspection by FDA's Minneapolis Districtof a warehouse operated by Security Wholesale Grocery Co. Inc., St. Paul, last November indicated thatfoods were still being subjected to infestation by rodentsand insec ts .

Chief Judge Edward J. Devitt of the District of

30 I April 19731 FDA Consumer

Minnesota, sitting in St. Paul, fined Maurice C. Man-ton, Sr., secretary-manager, $4,000, which he was instructed to pay within 24 hours or to go to jail, andplaced him on an additional probationary period ofone year. Both the company and Mr. Manton wereordered to cease doing business within 45 days andtold that only canned goods, which are not susceptibleto rodents and insects, can be handled in the intervening time.

The company and Mr. Manton had been prosecutedin 1958 and again in 1972. During the hearing, Mr.Manton admitted, in answering a series of probingquestions, that he had violated his probation.A Wisconsin dairy products distributor compliedwith a request by FDA's Minneapolis District that itvoluntarily destroy products damaged by water andsmoke during an explosion and fire. The explosion andfire destroyed the warehouse of the Sanna Dairy Distribution Center, Menomonie, Wisconsin, with all itscontents, and resulted in one death and four injuries.

A Minneapolis District inspector investigating thewarehouse destruction found that some 450 cases ofSwiss Miss chocolate drink and 12 cases of Sanalacinstant milk were damaged by fire and smoke. The inspector watched as the destruction was carried out ata l o c a l l a n d fi l l .

R E G I O N V I I

Julia S. Hewgley, consumer specialist, has been transferred from FDA's Region VIII in Denver to theRegion VII in Kansas City. Following a six-monthorientation with Lorena Meyers in the Kansas CityDistrict, she will be assigned to the Omaha ResidentPost. Mary-Margaret Richardson serves the St. LouisInspection Station.Lorena Meyers, Kansas City District consumer specialist, has completed a series of six taped 20-minute"Life Protection" television programs to be used in theShawnee Mission School system, consisting of 65schoo ls .

The program will also reach an adult audience ofapproximately 10,000 families on cable television(CATV). The series is to be stored in the audio-visuallibrary serving the school system and will be availablefor repeated use.

R E G I O N I X

In a prosecution case initiated by FDA's Los AngelesDistrict, Certified Grocers of California, Ltd., Corona,California, and Charles Bemis, former manager of thatfacility, pleaded guilty to one count of a three-countcriminal information. The information was filed againstthe firm and Mr. Bemis on December 20 and chargedholding of foodstuffs in an insanitary condition.

The company and Mr. Bemis initially attempted toenter pleas of nolo contendere before U.S. MagistrateJames Penne. The pleas were opposed by Paul Sweeney, assistant U.S. attorney, and guilty pleas werethen entered and accepted. The company was fined$1,000. Mr. Bemis was given a suspended sentenceand placed on probation for 30 days.

Elaine Roentgen, consumer specialist for the LosAngeles District, participated in the Annual UniversityDays for Women program in Las Vegas, Nevada. Eachyear women of the community enroll at the Universityof Nevada for a three-day session to update their consumer expertise.

In FDA's San Francisco Distr ict, Marbo Quali tyFoods, Inc. and its president, Martin N. Berberian,pleaded nolo contendere to the third in a three-countindictment charging adulteration of foods stored onthe firm's premises. Judge M. D. Crocker sitting atFresno, California, assessed an overall fine of $750.T h e fi r s t t w o c o u n t s w e r e d i s m i s s e d o n m o t i o n o f t h eU.S. Attorney.

Se izu res i n the San F ranc i sco D is t r i c t : A To f tnessRadiation Detector Device was seized in Reno, Nevada.FDA charged its labeling carried inadequate directionsfor use and that such adequate directions could not bewritten. A Diapulse Device was seized in Oakland,Cal i forn ia. A Mark VI I Thermat ic Device was seizedin the possession of a physician in Honolulu. FDAcharged misbranding because of false and misleadingclaims, inadequate directions for use, and danger to

J i e a l t h .A total of 780 units of "Nitro-Uterokare" syringes,

valued at over $1,000, were seized in Escalon, California, on charges that the Connecticut manufacturerhad failed to adequately fill the containers.

Comb honey valued at $1,210 was seized at an Oakland, California, honey processor, where it was adulterated with chlordane dust being used for ant control.

A total of 5,400 pounds of rice was seized in thepossession of a warehouse at Emeryville, California, oncharges the product contained rodent urine and hadbeen held under insanitary conditions.

Approximately $400 worth of imported Indian chutney was seized in San Francisco on charges its labelfailed to comply with the Federal Food, Drug, andC o s m e t i c A c t .

Seizure of Schilling Dinner Mexicana Taco Casserole,valued at $50, was made at Sparks, Nevada. The vignette on the container of the product displayed a meatingredient, although none was present and it is necessary to add meat for the product to be a taco cassero le .

Of a total of 233 import samples collected duringJanuary, 106 were detained. Of these 41 were mailsamples and the remainder commercial entries.

FDA Consumer / April 1973 / 31

State Actions

Food Inspectors BusyOregon food sanitarians had a busyyear in 1972.

The Dairy and Consumer ServicesDivision of the State Department ofAgriculture made 1,058 sanitationinspections at 396 food processingplants in the state. They made 553inspections of warehouses and 4,571inspections of retail food markets.

Random inspections of eggs moving to the consumer covered 10,580lots of eggs. Sanitarians made 796inspections of bakeries and bakerydistributors and 96 inspections ofnonalcoholic beverage plants.

Retail meat inspections weretransferred to the Dairy and Consumer Services Division on July 1,a n d f r o m t h e n u n t i l t h e e n d o f t h e

year the division made 2,125 inspections. More than 2,000 food sampleswere checked during the year to seewhether the ingredients met labelclaims and if they were contaminated. And 165 samples of Oregon-grown dairy products, fruits andvegetables were checked for pesticideresidues. None of these samplesviolated state standards.

Pet Turtles RegulatedThe Arkansas State Board of Healthhas banned the sale and distributionof pet turtles. The amphibians are asignificant source and reservoir ofSalmonella bacteria, which can causeillness in humans.

The Arkansas regulation forbidsthe sale and distribution or even offering as a gift to the public anylive turtle, tortoise or terrapin undersix inches long, or any other amphibious reptile.

Anesthetic embargoedThe Pennsylvania State Health Department has embargoed ethylchloride spray used by ear-piercingshops as a local anesthetic. BothState and Federal law require that

the preparation be used under aphysician's direction. The preparation will either be destroyed underthe health department's supervisiono r r e t u r n e d t o t h e d i s t r i b u t o r .

To m a t o e s i n I n d i a n aT h e I n d i a n a S t a t e B o a r d o f H e a l t hhas taken a number of steps toprevent decomposed tomato products from reaching the marketplace.During a two-month period the stateordered disposal of eight lots ofcatsup totaling 1,090 cases. Fouradditional lots of catsup and three oftomato juice were ordered held pending laboratory examination. Two lotsof canned whole tomatoes totaling408 cases were destroyed after theBoard of Health found a high percentage of mold in the packingm e d i a .

Green coffee seizedMore than 1,700,000 pounds ofgreen coffee beans worth $926,640w e r e d e t a i n e d w h e n o f f e r e d f o r e n

try through the Port of New Orleans. The coffee was on board avessel which coll ided with anothership near the mouth of the Mississippi River. The vessel carrying thecoffee sustained a hole in its sideand took on river water which contaminated some of the coffee.

After investigations were completed, the owners, brokers, andthe salvage company determinedthat about half of the coffee wascontaminated and could not be allowed into this country.

Year-old margarineThe Division of Weights and Measures of Westchester County, NewYork, cooperated with FDA in acase involving aged margarine. Acting on a consumer's complaint thatcar tons o f R ichmond Brand margarine being sold by Finast Supermarkets contained a promotional

offer that expired in March 1972,N e w Yo r k D i s t r i c t r e f e r r e d t h e c a s eto the county division, which visitedt h e s t o r e a n d c o n fi r m e d t h a t s t o c k sin the dairy department were notbeing rotated. The store suspendedthe manager for a week.

Wiscons in Mi lk S tandardsNew standards for milking and milk-hauling equipment went into effectin Wisconsin January 1 and applyto both grade A and manufacturingmilk producers.

Prior to January 1, all plans forthe installation, construction, andreconstruction of milking and milk-handling systems and equipment atgrade A farms used to be submittedto the State Agriculture Departmentfor approval before work wasstarted. The new standards requirei n a d d i t i o n t h a t t h e i n s t a l l e r f u r n i s hthe purchaser with a signed statement that the equipment has beeninstalled in full compliance withregulations.

Seafood plant closedAlleman's Seafood of Pierre Part,Louisiana, was closed by the Louisiana State Department of Healthafter a joint inspection by the Stateand the Food and Drug Administration disclosed that the plant wasoperating under insanitary conditions conducive to bacteriologicalcontamination of its product.

New Consumer OfficeThe City Council of Kansas City,Missouri, has approved the establishment of a Division of ConsumerAffairs within the Community Service Department to provide consumereducation, community coordination,and research. The City has alsopassed a consumer protection ordnance which provides enforcementpowers to regulate those procedureswhich are illegal.

32 / April 19731 FDA Consumer

Seizures and Postal Service Cases

SEIZURE ACTIONS charging violation of the Federal Food, Drug, and Cosmetic Act and the Federal Hazardous Substances Act are published when they are reported by the FDA District Office.

A total of 103 actions to remove from the consumer market charges concerning contamination, and 8 involved chargesproducts charged to be violative was reported in January. concerning economic and labeling violations. Other seizuresThese included 43 seizures of foods: 3 involved charges con- included 4 of drugs (including 2 of veterinary and medicatedcerning poisonous and deleterious substances, 32 involved feed), 53 of medical devices, and 3 of hazardous substances.

PRODUCT. PLACE & DATE SEIZED DEALER*(Dr

FOOD/Poisonous and Deleterious Substances

Alfalfa hay, baled/Corona, Calif., and Garin Co./Postan, Ariz. (Grower) Contains "DEP." (S,S,S,-tributyl phosphorotrithioate),O n t a r i o , C a l i f . 1 2 / 1 9 / 7 2 a p e s t i c i d e c h e m i c a l n o t i n c o n f o r m i t y w i t h r e g u l a

t ions .Leaf lettuce/Detroit, Mich. 12/26/72 W. Zurowski/Cleveland, Ohio (Grower, S) Contains parathion, a pesticide chemical not in con

formity with regulations.Ultra-Fat/Northampton, Pa. 1/12/73 Ultra Life Laboratories, Inc./E. St. Louis, Contains dieldrin, a food additive not in conformity

M o . ( M , S ) w i t h r e g u l a t i o n s .

FOOD/Contamination, Spoilage, Insanitary Handling

Beef stew/Woburn, Mass. 12/14/72

Brazil nuts/San Francisco, Calif. 12/20/72California large lima beans, black-eye

beans, red kidney beans/Greensboro,Fla. 1/19/73

Candy bars (Goo Goo clusters)/Montgomery,Ala. 12/29/72

products, mixed cases/Oakdale, Calif.1 2 / 1 / 7 2

Cashews/Chicago, III. 1/10/73

Cheese food/Columbus, Ohio 1/10/73

stix/Liberty, Mo. 12/4/72Cherries, canned/Lima, Ohio 1/3/73

Coconut/Birmingham, Ala. 12/6/72Coffee beans/Duluth, Minn. 1/11/73Corn syrup, potato flakes/Knoxville,

Tenn. 12 /18 /72

Donut mix/Akron, Ohio 1/9/73Fish sticks, Mr. Boston/Boston, Mass.

1 / 2 2 / 7 2Flour, sugar/Lebanon, Tenn. 12/15/72

Inst-Pup mix/Union City, Calif. 12/12/72

Pillsbury bakery/Saulte Ste. Marie, Mich.1 2 / 6 / 7 2

Plee-Zing, Quaker Masa Marina, Sunshine,Aunt Jemima yellow cornmeal,Sunshine white cornmeal mix/Kenosha, Wis. 12/20/72

Whole wheat, yellow corn, cornmeal,bakery improved, N. Dakota finest,Dakota Maid, yeast raised donut mix/Detroit, Mich. 12/15/72

Menu Matics, Inc., Chuck Wagon FoodsDiv./Woburn, Mass. (D)

Unknown (S)

Shepard's Mill/Greensboro, Fla. (D)

Standard Candy Co./Nashville, Tenn.(M,S)

Truck Trailer-Van/Oakdale, Calif.

J. F. Braun & Sons, Inc./Lake Success,N.Y. (S)

Kaukauna Dairy Products/Kaukauna, Wis.(M,S)

Guy's Foods, Inc./Wichita, Kans. (M,S)USP Corp./Salem, Oreg. (S)

Sander and Co./Birmingham, Ala. (D)Ceres, Inc./Duluth, Minn. (D)Institutional Packers of America (syrup)/

Smyrna, Ga. (M); HIR Food Distributors,Inc. (potato flakes)/Knoxville, Tenn. (D)

Kistlers, Inc./Akron, Ohio (D)Iceland Products/Camp Hill, Pa. (M,S)

Bradley Candy Manufacturing Co./Lebanon,Tenn. (D)

Cheney Bros. Food Products, Inc./UnionCity, Calif. (D)

Pillsbury Co./Minneapolis, Minn. (M,S)

Kenosha Wholesale Grocery Co./Kenosha,Wis. (D)

Bedell Flour Co., Inc./Detroit, Mich. (D)

Name "Beef Stew" false and misleading since articlecontains less than 25 percent of beef.

Insect-contaminated, moldy, rancid nuts.Held under insanitary conditions.

Prepared and packed under insanitary conditions;false and misleading label statement "A NourishingLunch."

Damaged by fire, smoke, and water; held underinsanitary conditions.

Insect infested.

Prepared and packed under insanitary conditions.Moldy, decomposed cherries; swollen, leaky cans; not

in conformity with definition and standard of identity for canned cherries; not in conformity with theFair Packaging and Labeling Act.

Insect and rodent contaminated.Held under insanitary conditions; rodent contaminated.Not in conformity with the Fair Packaging and Labeling

Act (corn syrup); held under insanitary conditions(potato flakes).

Held under insanitary conditions; rodent contaminated.Prepared and packed under insanitary conditions.

Held under insanitary conditions.

Held under insanitary conditions; rodent contaminated.

Rodent contaminated.

Held under insanitary conditions; insect contaminated.

Held under insanitary conditions.

FDA Consumer /April 1973/33

PRODUCT, PLACE & DATE SEIZEDMANUFACTURER (M), PACKER (P),

SHIPPER (S), DEALER (D)

FOOD/Contamination, Spoilage, Insanitary Handling (cont'd)

Flour, lupini beans, garbanzo beans/Chicago, III. 12/22/72Henkel's Capt. Kidd, Town Crier/

South Bend, Ind. 12/29/72Garbanzo beans B & P brand, Calif.

Bean Growers Association, Heart ofCalif, brand dark red kidney beans, redkidney seed beans/Eaton, Ind. 12/26/72

Honey/Lancaster, Pa. 1/11/73Kidney beans, red/North Rose, N.Y. 1/2/73

Matzo crackers/St. Louis, Mo. 1/18/73Milk, nonfat, dry/Philadelphia, Pa. 1/15/73Norwegian Flat-Bread/New York, N.Y.

1 2 / 2 7 / 7 2Peanuts, unshelled/La Crosse, Wis.

1 / 1 0 / 7 3Scallops, frozen/Los Angeles, Calif. 1/9/73Split peas, yellow. Speedy Cook'N brand/

Minneapolis, Minn. 1/15/73Walnut meats/Los Angeles, Calif. 12/18/72

California, shelled, corn sugar/Boston,Mass . 1 /11 /73

Garofalo Co./Chicago, III. (D)

Simon Bros., Inc./South Bend, Ind. (D)

Meridian Foods, Inc./Eaton, Ind. (D)

William Lindsay/Bedford, Va. (M,S)O.A. Skutt Co., Inc./North Rose, N.Y. (M,S)

Return shipment from Springfield, III.N. Comensky Grocer Co./St. Louis, Mo. (D)Holt Warehouse/Philadelphia, Pa. (D)Reliable Kirschbaum Warehouse Corp./New

York, N.Y. (D)A. J. Sweet of La Crosse/La Crosse, Wis. (D)

Baja Scallops/Ensenada, Mexico (P,S)National Warehouses, Inc./Minneapolis,

Minn. (D)Triangle Nut House/Spokane, Wash. (S);

Gilbert Nut Co./Los Angeles, Calif. (M)Ace Baking Co., Inc./Boston, Mass. (D)

Held under insanitary conditions; rodent contaminated.

Rodent hairs and insects.Live and dead insects.

Held under insanitary conditions.Held under insanitary conditions; rodent contaminated.Held under insanitary conditions; rodent contaminated.

Decomposed.Held under insanitary conditions; moldy, decomposed.

Insect excreta pellets, insect webbing, and insectfragments.

Held under insanitary conditions; insect contaminated.

Cheese and nut ball/Los Angeles, Calif.1 2 / 1 3 / 7 2

spread, cheese fondue, Welsh rarebit/Arabi, La. 12/11/72

Chutney (lndian)/San Francisco, Calif.1 / 2 / 7 3

Nuts, mixed/La Crosse, Wis. 1/18/73

Peaches, Calirose Elberta yellow freestone/St. Paul, Minn. 1/18/73

Real Whip, non-dairy whipped topping/Norman, Okla. 1/18/73

Strawberry beverage base, fruit-flavoredbase/Gallup, N. Mex. 12/4/72

T.V. Cookies/Cincinnati, Ohio 12/26/72

Economic and Labeling Violations

Original Herkimer County Cheese Co., Inc./ LHerkimer, N.Y. (M)

Holly World Foods, Inc./San Francisco,Calif. (D)

Fisher Nut Co./St. Paul, Minn. (M,S)

A. M. Beebe Co./San Francisco, Calif. (S);TriWalley Growers Plant #7/Modesto,Calif. (M)

Presto Food Products, Inc./Kansas City, Mo.(M,S)

First Foods Co., Inc./Dallas, Tex. (M); Nobel,Inc./Dallas, Tex. (S)

Imperial Baking Co./St. Louis, Mo. (M,S)

Labeling not in conformity with standard of identity-should have read "Cold Pack Cheese Food with Walnuts"; not in conformity with the Fair Packaging andLabeling Act.

Labeling not in conformity with required regulations;moldy.

Not in conformity with the Fair Packaging and LabelingAct.

False and misleading label statement "contains 60%peanuts," since the article contains more than 60percent peanuts; fails to conform to the standardof identity.

False and misleading label statement "In HeavySyrup," whereas article is packed in light syrup.

Inaccurate label statement "Net Wt. IOV2 oz."; not inconformity with the Fair Packaging and LabelingAct.

False and misleading label statements "Contains Vitamin C" and "Enriched with 3696 mg. Ascorbic Acid(Vit. 0," since the articles contain no detectableamount of vitamin C; labels fail to bear common orusual names for beverage bases and ingredients.

Not in conformity with the Fair Packaging and LabelingAct.

Progesterone injection/Dallas, Tex. 1/4/73Protamide ampuls/Bristol, Pa. 12/14/72

Animal feed premix/McCook, Nebr.1 2 / 5 / 7 2

Customer beef premix/EI Paso, Tex.1 2 / 4 / 7 2

DRUGS/Human Use

Elkins-Sinn, Inc./Cherry Hill, N. J. (M,S)Delaware Valley Hospital/Bristol, Pa. (D)

Veter inary/Medicated Feed

Feed Products, Inc./Denver, Colo. (M,S)

Below National Formulary standard for strength.New drug without effective New Drug Application

adequate directions for use.

New animal drug without effective New Animal DrugApplication.

34 / April 1973 / FDA Consumer

PRODUCT, PLACE & DATE SEIZED MANUFACTURER (M), PACKER (P),SHIPPER (S), DEALER (D)

Diapulse/Hays, Kans. 12/2/72

Wichita, Kans. 12/6/72Stockton, Kans. 12/6/72Smith Center, Kans. 12/6/72Kansas City, Kans. 12/5/72Kingman, Kans. 12/29/72Lamed, Kans. 12/19/72Junction City, Kans. 12/30/72Sylacauga, Ala. 12/7/72Brownsboro, Ala. 1/5/73Columbus, Ohio 1/8/73Newark, Ohio 1/5/73Cambridge, Ohio 1/5/73De Vola, Ohio 1/11/73Princeton, III. 1/10/73Redondo Beach, Calif. 1/18/73

Detroit, Mich. 1/4/73Detroit, Mich. 1/4/73Clarkston, Mich. 1/5/73Saginaw, Mich. 1/3/73St. Louis Park, Minn. 1/4/73

New Ulm, Minn. 1/26/73

Faribault, Minn. 1/26/73Wichita, Kans. 1/22/73Senath, Mo. 1/5/73Iowa City, Iowa 1/5/73

Davenport, Iowa 1/5/73Phoenix, Ariz. 12/14/72Indianapolis, Ind. 12/14/73

Indianapolis, Ind. 12/1/73Otterbein, Ind. 1/4/73Unionville, Mich. 12/11/72

New Orleans, La. 12/21/72

New Orleans, La. 12/12/72Deltona, Fla. 12/7/72

Jacksonville, Fla. 12/14/72Jacksonville, Fla. 12/14/72Santa Barbara, Calif. 12/21/72Rose Hill, N.C. 1/4/73Oakland, Calif. 12/20/72Kent, Ohio 12/20/72

Mount Eaton, Ohio 12/20/72Bridgeport, Conn. 12/21/72

Stratford, Conn. 12/21/72Watertown, Conn. 12/21/72Cameron, La. 1/17/73Columbia, La. 1/17/73Baton Rouge, La. 1/10/73Manchester, N.H. 12/19/72

Harrisburg, Pa. 1/18/73

Thibodaux, La. 12/6/72Columbia, Tenn. 1/9/73

MEDICAL DEVICES

America/New Hyde Park, Inadequate directions for safe use by laymen; falseand misleading claims.

Inadequate directions for safe use by laymen.

" (M,S)

Remington Rand Div. Sperry Rand forDiapulse Corp. of America {M,S)

Diapulse Corp. of America/New Hyde Park,N.Y. (M)

Inadequate directions for safe use by laymen; falseand misleading claims.

Diapulse Corp. of America/New Hyde Park, inadequate directions for safe use by laymen; falseN . Y . ( M ) a n d m i s l e a d i n g c l a i m s .

Remington Rand Corp. Div. orSperry Rand/New York, N.Y. (M)

Diapulse Corp. of America/New Hyde Park,

" (S)

Unknown M and S

Inadequate directions for safe use by laymen; falseand misleading claims.

Inadequate directions for safe use by laymen; falseand misleading claims.

" to be e f fec t i ve as t rea t

ment for infections, fractures healing, bursitis, arthritis, low back pain.

Inadequate directions for safe use by laymen.

Inadequate directions for safe use by laymen; falseand misleading claims.

False and misleading claims.

Inadequate directions for safe use by laymen; falseand misleading claims.

Inadequate directions for safe use by laymen; falseand misleading claims to be effective as treatmentfor infections, fractures, bursitis, arthritis, low backpain.

Inadequate directions for safe use by laymen.

FDA Consumer / April 1973/35

PRODUCT, PLACE & DATE SEIZEDMANUFACTURER (M), PACKER (P),

SHIPPER (S), DEALER (D)C H A R G E S

MEDICAL DEVICES (cont'd)

Sculptura body suit/Woodland Hills,Calif. 12/21/72

Slim & Trim Manufacturing, Ltd./Montreal, Canada (M,S)

Inadequate directions for safe use by laymen.False and misleading claims to be effective in con

touring and toning the body, preventing wrinkles,rash, pimples, and other skin eruptions,- label failsto bear established name of each ingredient (massage cream).

HAZARDOUS SUBSTANCES

Clown accordion, squeaker toy/New Hope, Made in Hong Kong. Unknown M and S.Minn. 1/5/73

Santa Claus dolls /Fridley, Minn. Sterling Supply Co./Kansas City, Mo.1 2 / 2 9 / 7 2 ( M , S )

Wood bleach (oxalic acid)/Mundelein, Triple-X Chemical Laboratories, Inc./I I I . 1 2 / 4 / 7 2 M u n d e l e i n , I I I . ( D )

Banned hazardous toy; mechanical hazard.

Label fails to bear the word "Poison" and a conspicuous statement of the principal hazard.

U.S. POSTAL SERVICE actions taken in medical cases as authorized in the Mail Fraud Statute (18 U.S.C. 1341)and/or the False Representation Statute (39 U.S.C. 3005) as reported by the Assistant Postmaster General—Inspection Service.

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

December 14, 1972: False Representation Order issued against Tru-Line and Canadian Physical Culture Center, P.O. Box 146 andUnit 10, 158 Kennedy Road S., Brampton, Ontario and P.O.Box 100, Norval, Ontario, Canada. Advertising and sale by mailof a "new slimming secret" which allegedly will enable thepurchaser to lose significant amounts of weight "without hit andmiss dieting, strenuous exercises, drugs or pills."

December 26, 1972: False Representation Order issued against TheLiftee Co., Box 608, Church Street Station, New York, New York.Violation of Compromise Agreement on advertising and sale ofa product called "Hair-Thic."

December 26, 1972: False Representation Order issued against KaineEnterprises, Box 239, Hartford, Connecticut 06101. Solicitationsand sale by mail of "Marula Pips," "Marula Pip Tea Bags," and"Marula Concentrate," represented as effective aphrodisiacs orsexual s t imulants for both men and women.

December 26, 1972: False Representation Order issued against CaineEnterprises, Box 799, Springfield, Massachusetts 01101. Solicitations and sale by mail of "Marula Pips," "Marula Pip TeaBags," and "Marula Concentrate," represented as effectiveaphrodisiacs or sexual stimulants for both men and women.

December 26, 1972: False Representation Order issued against R & CEnterprises, Box P, Marlborough, Massachusetts 01752. Solicitations and sale by mail of "Marula Pips," "Marula Pip TeaBags," and "Marula Concentrate," represented as effectiveaphrodisiacs or sexual stimulants for both men and women.

December 26, 1972: False Representation Order issued againstBob's Import, and Bob's Imports, P.O. Box 1415, Lowell, Massachusetts 01853. Solicitations and sale by mail of "MarulaPips," "Marula Pip Tea Bags," and "Marula Concentrate,"represented as effective aphrodisiacs or sexual stimulants forboth men and women.

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

November 28, 1972: New England Labs, Inc., 2 Belden Avenue, Box308; Box 651 at Norwalk, Connecticut 06852. Advertising andsale by mail of "New Slim Plan Caps."

November 28, 1972: Weightmaster Systems, Box 548, Tenafly, NewJersey 07670. Advertising and sale by mail of "Skini-Ettes"diet plan.

December 6, 1972: M.O.I, of India and Ruthie, 6915 So. VernonAvenue, Chicago, Illinois 60637 and M.O.I., P. 0. Box 239,Gary, Indiana 46401. Advertising and sale by mail of a productcalled "Instant Erection," represented to be effective as asex st imulant.

December 12, 1972: Waist Trimmer, P.O. Box 188, Carpinteria, California 93013 and P. 0. Box 3286, South Lake Tahoe, California95705. Advertising and sale by mail of product represented tobe effective when worn in reducing the user's girth and weight.

December 18, 1972: Spectron Ind., P. 0. Box 17200, San Diego,California 92117. Advertising and sale by mail of a productrepresented to be effective as a hair restorer.

December 22, 1972: Slimtyme Co., 7920 W. 3rd Street, Los Angeles,California 90048. Advertising and sale by mail of an inflatableplastic belt represented to be effective in weight reduction.

December 22, 1972: Thomas Laboratories, Inc., P. 0. Box 24460,New Orleans, Louisiana 70124. Advertising and sale by mailof a product called "Legend Lengthener," represented tolengthen the male sexual organ.

December 26, 1972: Adam York Co., 89 Worth Street, New York,New York 10013. Advertising and sale by mail of "EuropeanLove Drops 5," represented as an effective aphrodisiac orsexual s t imulant .

S6 /April 1973 /FDA Consumer

Notices of Judgment

NOTICES OF JUDGMENT on Seizure Actions

FOOD/Poisonous and Deleter ious Substances

Cotton seed, at Artesia, C. Dist. Calif.Charged 7-14-71: when shipped by W. H. Haggard & Sons, Inc., Buckeye,Ariz., the article contained the added poisonous and deleTerious substanceaflatoxin; 402(a)(1). Default decree ordered destruction. (F.D.C. No. 57313;8. Nos. 26-750/1 E; N.J. No. 1)

Meat and bone meal, at Hicksville, N. Dist. Ohio.Charged 6-15-71: when shipped by Hoham, Inc., Auburn, Ind., the article,labeled in part "Eagle's 50% Meat & Bone Meal . . . Eagle Products, Inc.,Mishawaka, Ind.," contained the added poisonous and deleterious substance Salmonella micro-organisms; 402(a)(1). Default decree ordereddestruction. (F.D.C. No. 57261; S. No. 93-527 E; N.J. No. 2)

Swordfish steaks, frozen, at New York, S. Dist. N.Y.Charged 7-8-71: when shipped by Kanematsu-Gosho Ltd., Yokohama, Japan,the article contained the added poisonous and deleterious substancemercury; 402(a)(1). Default decree ordered destruction. (F.D.C. No. 57273;S. No. 66-284 D; N.J. No. 3)

FOOD/Contamination, Spoilage, Insanitary HandlingAlmond pieces, shelled almonds, and shelled peanuts, at Milwaukee, E. Dist.

Wis.Charged 11-30-71: while held by Milwaukee Cold Storage Co., Milwaukee,Wis., the lot of almond pieces and three lots of peanuts contained rodentfilth, and all lots of the articles were held under insanitary conditions;402(a)(3), 402(a)(4). Consent decree authorized release to the dealer forsalvaging. (F.D.C. No. 57663; S. Nos. 35-224 E & 41-554/58 E; N.J. No. 4)

Cassia, at Brooklyn, E. Dist. N.Y.Charged 7-7-71: when shipped by unknown shipper, the article, labeled inpart "Fadjab Cassia Ka New York 2 Produce Indonesia," contained insectsand mold; 402(a)(3). Consent decree authorized release to Purity MaidPacking Corp., Brooklyn, N.Y., for salvaging. (F.D.C. No. 57291; S. No.16-001 E; N.J. No. 5)

Cornmeal, cornmeal mix, rice, and peanuts, at Carthage, E. Dist. Tex.Charged 3-6-72: while held by Magnolia Grocery Co., Carthage, Tex., thearticles were contaminated with filth and were held under insanitaryconditions; 402(a)(3), 402(a)(4). Default decree ordered destruction.(F.D.C. No. 57856; S. Nos. 35-503/8 F; N.J. No. 6)

Eggs, frozen, at Roxbury, Dist. Mass.Charged 5-21-71: when shipped by Easy Eggs, Inc., Whitesboro, N.Y., thearticle contained decomposed eggs; 402(a)(3). Default decree ordered destruction. (F.D.C. No. 57212; S. No. 4-990 E; N.J. No. 7)

F e n n e l s e e d a n d r i c e , a t S t . P a u l , D i s t . M i n n . „ , ^Charged 7-20-71: when shipped by Empire City Sales Co., New York, N.Y.,the fennel seed contained insect, rodent, and bird filth; and while held byItalian Variety Foods, St. Paul, Minn., the articles were held under insanitary conditions; 402(a)(3), 402(a)(4). Default decree ordered destruction. (F.D.C. No. 57312; S. Nos. 41-307/8 E; N.J. No. 8)

Fruit cocktail, canned, 3 seizure actions at Louisville, W. Dist. Ky., Raleigh,E. Dist. N.C., and West Jacksonville, M. Dist. Fla.Charged 3-2-72, 3-2-72, and 3-6-72: when shipped by Institutional Warehouses, Inc., E. Stockton, Calif., the article, labeled in part "Astor FruitCocktail ... The Monterey Canning Co. San Francisco, Cal.," containedmold from machinery, and had been prepared and packed under insanitaryconditions by F. G. Wool Packing Co., Inc., San Jose, Calif.; 402(a)(3),402(a)(4). Default decrees in the Raleigh and West Jacksonville actionsordered destruction. Consent decree in the Louisville action ordereddestruction. (F.D.C. Nos. 57848, 57850/1; S. Nos. 16-940 E, 73-502 F &73-501 F; N.J. No. 9)

P e a n u t s , a t M o n t g o m e r y , M . D i s t . A l a . . x mCharged 7-30-71: while held by Fadge Food Service, Montgomery, Ala.,the article was held under insanitary conditions; 402(a)(4). Default decreeordered destruction. (F.D.C. No. 57356; S. No. 22-635 E; N.J. No. 10)

Peanuts, shelled, at Chicago, N. Dist. III.Charged 4-20-72: while held for sale, the article contained rodent filth;402(a)(3). Consent decree authorized release to E. J. Brach & Sons, Div.of American Home Products Corp., Chicago, III., for salvaging. (F.D.C.No. 57955; S. No. 19-866 F; N.J. No. 11)

Peanuts, shelled, at St. Joseph, W. Dist. Mo.Charged 12-14-71: while held for sale, the article was held under insanitary conditions; 402(a)(4). Consent decree authorized release to GoldKist, Inc., Atlanta, Ga., for reconditioning. (F.D.C. No. 57700; S. No. 44-775 E; N.J. No. 12)

Pecans, unshelled, at Robertsdale, S. Dist. Ala.Charged on or about 4-2-70: while held by Robert Berner Co., Roberts-

dale, Ala., the article contained rodent filth and was held under insanitary conditions; 402(a)(3), 402(a)(4). Consent decree authorized releaseto dealer for reconditioning. (F.D.C. No. 56352; S. No. 078-200 D et al-N.J. No. 13)

Soups, tomato aspic, Bon Vivant, and green turtle, Ancora, 2 seizure actions atSt. Louis, E. Dist. Mo.Charged 10-19-71 and 11-11-71: when shipped by Bon Vivant Soups, Inc.,N e w a r k , N . J . , t h e a r t i c l e s w e r e u n fi t f o r f o o d i n t h a t s o m e c a n s o f t h e s efoods had been found to be de fec t i ve and abnormal and in tha t the manufacturing procedures used did not assure proper sealing of the cans oradequate heat treatment of the sealed cans to prevent contamination andspoilage; and the articles had been prepared and packed under insanitaryconditions whereby they may have become contaminated with filth orwhereby they may have been rendered injurious to health; 402(a)(3),402(a)(4). Default decree ordered destruction. (F.D.C. No. 57572; S. No.65-045 E; N.J. No. 14)

FOOD/Economic Vio la t i ons

Cheese sticks, Guy's, at Wichita, Dist. Kans.C h a r g e d 2 - 2 2 - 7 2 : w h e n r e t u r n e d f r o m L i b e r t y, M o . , t o G u y ' s F o o d s , I n c . ,W i c h i t a , K a n s . , t h e a r t i c l e w a s s h o r t w e i g h t ; 4 0 3 ( e ) ( 2 ) . C o n s e n t d e c r e eauthorized release to dealer for rebagging. (F.D.C. No. 57816; S. No. 41-446 F; N.J. No. 15)

Nuts, mixed, at Huntington, S. Dist. W. Va.Charged 7-13-71: when shipped by Jerissa Nut Co., Inc., Brooklyn, N.Y.,the article, labeled in part "Golden Roast Vacuum Packed Mixed Nuts. . . Bachman Foods, Inc. General Offices Reading, Pa.," failed to conformto the definition and standard of identity for mixed nuts, since the articlecontained filberts in a quantity of less than 2 percent and peanuts in aquantity of more than 80 percent by weight—403(g)(1); and the articlewas in violation of the Fair Packaging and Labeling Act, since the quantityof contents was not duplicated on the alternate principal display panel—15 U.S.C. 1453(a)(2). Default decree authorized donation to charitableand governmental institutions. (F.D.C. No. 57308; S. No. 6-870 E; N.J.No. 16)

Pancake mixes, imitation strawberry, pecan-crunch and blueberry flavored,Burrus, and biscuit mix, Burrus Butterflake, at Shreveport, W. Dist. La.Charged 5-19-71: when shipped by Burrus Mill and Elevator Co., Div.Burrus Mills, Inc., Fort Worth, Tex., the pancake mixes' label statementsand vignettes (depicting whole strawberries, whole pecan nuts, whpleblueberries, and pancakes apparently containing particles of such berriesand nuts) were false and misleading as applied to articles which contained artificial flavors and artificial colors (berry mixes), in l ieu ofberries and nuts—403(a); and the biscuit mix's label statements "ButterFlake" and "With Real Butter" and the biscuit mix's vignette depictingyellow, butter-like flakes on the biscuits were false and misleading asapplied to the article which contained artificial flavor and artificial colorthat had been substituted in part for butter—403(a). Default decreeordered destruction. (F.D.C. No. 57216; S. Nos. 24-593/6 E; N.J. No. 17)

Quince jam, at Chicago, N. Dist. III.Charged 7-31-71: when imported by Reese Finer Foods, Chicago, III., thearticle, labeled in part "Veron Quince Jam Product of Switzerland . . .Exclusively imported by Reese Finer Foods, New York, Chicago, LosAngeles," was in violation of the Fair Packaging and Labeling Act, sincethe quantity of contents declaration was not within the bottom 30percent of the principal display panel area, the quantity of contentsstatement was expressed as "Net Weight 1 Lb." instead of ' Net wt.16 Oz. (1 Lb.)," and the quantity of contents appearing on the principaldisplay panel area of more than 5 square inches was in a type size lessthan 1/8 inch high; 15 U.S.C. 1453(a)(2), 1453(a)(3)(A)(i), 1453(a)(3)(C)(i).Default decree authorized donation to charitable institution. (F.D.C. No.57315; S. No. 74-138 E; N.J. No. 18)

Shrimp Newburg, frozen. Freezer Queen, at Buffalo, W. Dist. N.Y.Charged 5-19-71: while held by Freezer Queen Foods, Inc., Buffalo, N.Y.,who prepared the article from shrimp shipped in interstate commerce,the article's label vignette depicting 18-19 shrimp or shrimp pieces wasfalse and misleading, since the article contained less shrimp than tnst—403(a); and the article was in violation of the Fair Packaging and Labeling Act, since the quantity of contents statement, in the principal display panel area of more than 25 square inches, was in a type size lessthan 3/16 inch high—15 U.S.C. 1453(a)(3)(C)(i). Consent decree authorizedrelease to dealer for relabeling. (F.D.C. No. 57198; S. No. 77-740 E;N.J. No. 19)

Sweetcorn nuts, Krunchy-Nuggets, at Bismarck, Dist. N. Dak.Charged 4-20-72: when shipped by Vinton Popcorn Co., Vinton, Iowa, thearticle was short weight; 403(e)(2). Default decree authorized donationto charitable institution. (F.D.C. No. 57958; S. No. 33-815 F; N.J. No. 20)

Syrup, Blackburn-Made White Label, at Shreveport, W. Dist. La.

FDA Consumer / April 1973 / 37

Charged 6-3-71: when shipped by T. J. Blackburn Syrup Works, Jefferson,Tex., the article was in violation of the Fair Packaging and Labe ing Act,since the quantity of contents was expressed as "1 Qt. 11 Fl. Ozs. insteadof "Net 43 Oz. (1 Quart 11 Oz.)"; and the quantity of contents statement,on the principal display panel area of more , han 5 square mc ^in a type size less than Vs inch high; 15 U.S.C. 1453(a)(3)(A)(i), 1453(a)(3)(C)(i). Default decree authorized donation to charitable organization.(F.D.C. No. 57227; S. No. 24-599 E; N.J. No. 21)

VITAMINS/SPECIAL DIETARY FOODSProtein supplement tablets, at Phoenix, Dist. Ariz. „ . ^ « .-x

Charged 5-16-72: when shipped by Strong Cobb Arner, Sunland, Calif., thearticle, labeled in part "Honey-Pro Honeyed Protein . . . Apotheca-Arizona Phoenix, Arizona . . . Distributor," had the label statements"Honey-Pro," "Honeyed Protein," "Tasty protein supplement" and"Can also be chewed between meals for appetite or hunger appeasement"that falsely and misleadingly claimed special dietary value for the articleas a protein supplement, hunger and appetite appeasement, and enhancement of the special dietary value by honey—403(a); and the article wasin violation of the Fair Packaging and Labeling Act, since the quantity ofcontents declaration was not within the bottom 30 percent of the principal display panel—15 U.S.C. 1453(a)(2). Default decree ordered destruction. (F.D.C. No. 57915; S. No. 45-059 F; N.J. No. 22)

A N I M A L F E E D S

Animal feed liquid, 32% Deluxe Plain, at Mound City, W. Dist. Mo.Charged 3-28-72: when shipped by Standard Chemical Manufacturing Co.,Omaha, Nebr., the article contained diethylstilbestrol, a new animaldrug, and no approval of a New Animal Drug Application was in effectwith respect to the use and intended use of the drug; 402(a)(2)(D). Cons e n t d e c r e e o r d e r e d d e s t r u c t i o n . ( F. D . C . N o . 5 7 8 9 0 ; S . N o . 4 1 - 5 1 0 F ;N.J. No. 23)

Animal feed supplement liquid, Mol-Mix 32, 2 seizure actions at Henderson,Dist. Colo., and Waverly, W. Dist. Mo.Charged 1-28-72 and 3-15-72: while held for sale after manufacture byNational Molasses Co. of Denver, Colo., Piper, Kans., and Willow Grove,Pa., the article contained the new animal drug diethylstilbestrol, andthere was no approval of a New Animal Drug Application in effect withrespect to the use and intended use of the drug; 402(a)(2)(D). Consentd e c r e e a u t h o r i z e d r e l e a s e t o t h e m a n u f a c t u r e r o f t h e a r t i c l e s e i z e d a tHenderson for salvaging. Default decree ordered destruction of the articleseized at Waverly. (F.D.C. Nos. 57837, 57872; S. Nos. 33-944 F et al;41-449 F; N.J. No. 24)

Dog food, canned, at Washington, Dist. Columbia.Charged on or about 12-16-71: when shipped by Quaker City Packing Co.,Allentown, Pa., the article, labeled in part "Misty Dog Food . . . ChunkBeef By-Products in Gravy" and "Guard Dog Watch Dog formula . . .Distributed by Tuck Distributing Co., Washington, D.C.," contained thenew animal drug methyltestosterone, and there was no approval of a NewAnimal Drug Application In effect with respect to the use and intendeduse of the article—501(a)(6); and the label contained false and misleading claims for enhancement of aggressive characteristics and bolsteringaggressive traits in shy dogs, guard dogs, and watch dogs—502(a). De-fault decree ordered destruction. (F.D.C. No. 56875; S. No. 9-815 D; N.J.

DRUGS/Human Use

Cetyl dimethyl ethyl ammonium bromide, aminobenzoates, tetracaine hydro-chlonde,and benzalkonium chloride pressurized spray, at Long Island City,Charged 6-28-71 and amended on or about 12-10-71: when shipped byNational Spray Can Filling Corp., Elizabeth, N.J., the article, packaged orintended to be packaged in containers labeled in part "Cetacaine TopicalAnesthetic . . . Cetyilte Industries, Inc., ... New York," was a newdrug without an effective approved New Drug Application—505(a); andthe labeling of the article lacked adequate directions for use, and thearticle failed to comply with the exemption for prescription drugs—502(f)(1) Consent decree authorized release to Cetylite Industries, Inc.,Long Island City, N.Y., for relabeling the article with appropriate provisional labeling bearing adequate information for use by licensed practitioners. (F.D.C. No. 57259; S. No. 38-703 E; N.J. No. 26)

Chlorpromazine HCI injection, at Oakdale, W. Dist. PaCharged 7-14-71: when shipped by Generix Drug Sales Co., Hollywood,Fla., the article, labeled in part "Klorazine (Chlorpromazine HCI) . . .Myers-Carter Laboratories, Inc., Phoenix, Ariz.," was a new drug withoutan effective approved New Drug Application; 505(a). Default decree ordereddestruction. (F.D.C. No. 57311; S. Nos. 10-148/9 E; N.J. No. 27)

Diiodohydroxyquin vaginal suppositories, at St. Louis, E. Dist. Mo.Charged 7-12-71: while In transit, the article was held under insanitaryconditions whereby it may have been rendered injurious to health, sincea container of a corrosive inhibitor chemical reportedly ruptured intransit spilling its contents in the truck transporting the article of drug-501(a)(2)(A). Default decree ordered destruction. (F.D.C. No. 57309; S No'43-509 E; N.J. No. 28)

Madasphere emergency oxygen kits, at Pittsburgh, W. Dist. Pa.Charged 7-7-71: when shipped by Mada Medical Products, Inc., Hacken-sack, N.J., the article's labeling contained false and misleading claimsfor containing oxygen for one hour's use, for containing 200 percentmore usable oxygen, providing an average flow rate of 6 liters per minutefor no oxygen being wasted, and for providing 115 liters of "BreathableOxygen ; and the labeling lacked adequate directions for use for cardiacemergencies, asthma, croup, exhaustion, smoke inhalation, hangoverand motion sickness, and for which uses the article was intended andfor which adequate directions for use by untrained laity cannot bewritten. Consent decree ordered destruction. (F.D.C. No. 57290; S. No9-970 E; N.J. No. 29)

Phenylbutazone base, N.F., at St. Louis, E. Dist. Mo.Charged 5-25-71 and amended 12-3-71: when shipped by Benzian A. G.,Luzern, Switzerland, the article was a new drug without an effective approved New Drug Application—505(a); and, while held by Jamieson-Mc-Kames Pharmaceuticals, Inc., St. Louis, Mo. (who was using the article

to make capsules), the labeling of the article lacked adequate directionsfor use and was not exempted therefrom, since it was in bulk packageand lacked the prescription legend and the manufacturing-p oc ^ ^ ^repacking legend, and since it was intended for use in "janufacturmg,processing, or repacking as a finished new drug, no New Drug Application was held by Jamieson-McKames Pharmaceuticals, Inc., and tjje useof the article was not limited to investigational use as P''°)['ded byregulations—502(f)(1). The article was claimed by Jamieson-McKamesPharmaceuticals, Inc., St. Louis, Mo., who denied the charges. The partiesserved written interrogatories on each other. Thereafter, a consent decreeordered destruction. (F.D.C. No. 57226; S. No. 43-605 E; N.J. No. 30)

Prednisone tablets, U.S.P., at Oakmont, W. Dist. Pa.Charged 7-27-71: while held by Zemnier Co., Oakmont Pa., th%article squality fell below the U.S.P. standard, since it failed the U.S.P. tabletdissolution requirement; 501(b). Default decree ordered destruction.(F.D.C. No. 57333; S. No. 54-129 E; N.J. No. 31)

Provitamin B,,, (pangamic acid) capsules, at Richardson, N. Dist. Tex.Charged'"on or about 3-24-71: when shipped by Krebs Laboratories, SanFrancisco, Calif., the article was a new drug without an effective approved New Drug Application; 505(a). Default decree ordered destruction.(F.D.C. No. 57053; S. No. 34-022 D; N.J. No. 32)

Warm Up methyl salicylate aerosol spray, at Kansas City, W. Dist. Mo.Charged 4-11-72; when shipped by Dyruss International, Grandville, Mich.,the article was a new drug without an effective approved New Drug Application; the labeling contained false and misleading claims for keepingmuscles loose and joints flexible; the label lacked the established nameof the drug; the label lacked adequate directions for use for the article'sintended purposes; and the labeling lacked adequate warnings, since itlacked the conspicuous warnings prescribed by regulations for drugscontaining more than 5 percent methyl salicylate and regulations forsuch drugs for use as a counter-irritant or rubefacient—505(a), 502(a),502(e)(l)(A)(i), 502(f)(1), 502(f)(2); and the article was in violation of theFair Packaging and Labeling Act, since its label lacked an accuratestatement of the general pharmacological category of the drug or theprincipal intended action of the drug—15 U.S.C. 1453(a)(1). Default decreeordered destruction. (F.D.C. No. 57929; S. No. 97-748 E; N.J. No. 33)

DRUGS/VeterinaryB.E.L.L. drops for adult horses and cattle, at Webster, Dist. Mass.

Charged 2-12-68: while held by Dr. A. C. Daniels, Inc., Webster, Mass.,wh9 repacked the article from bulk shipped in interstate commerce, thearticle's bottl^ and carton labels contained false and misleading claimsfor colic in horses and cattle, and for being "Proven in Canada"; andthe. listing on the bottle and carton labels of the ingredients AconiteFluid Extract, Belladonna Root Fluid Extract, and Digitalis Fluid Extractwas false and misleading in implying and suggesting that the value ofthe article as a bitters to aid digestion was enhanced by the presenceof such ingredients; 502(a). The article was claimed by the dealer whodenied the charges. The Government served interrogatories on the claimant..Thereafter, the claim and answer of the dealer were withdrawn anda default decree ordered destruction. (F.D.C. No. 55205; S. No. 7-072 C;N.J. No. 34) .

Digitoxin, aminophylline, and potassium chloride veterinary tablets, at BatonRouge, E. Dist. La.Charged 4-30-71: when shipped by Linden Laboratories, Los Angeles,Calif., the article was a new animal drug, and no approval of a NewAnimal Drug ;ApplIcation was in effect with respect to the use and in-

501(a)(5). Consent decree ordered destruction.(F.D.C. No. 57159; S. No. 24-141 E; N.J. No. 35)Dipyrone veterinary injection, at Tulla, N. Dist. Tex.

Charged 3-6-72: when shipped by Whittney & Co., Inc., Denver, Colo., thearticle, labeled in part "AVC Dipyrone Veterinary . . . Manufactured forAffiliated Supply Company Tulia, Texas," was a new animal drug, andno approval of a New Animal Drug Application was in effect with respectto the use and intended use of the drug; 501(a)(5). Default decree ordereddestruction. (F.D.C. No. 57855; S. No. 32-513 F; N.J. No. 36)

Hardy's Hoof Conditioner dressing, at Richmond, E. Dist. Va.Charged 2-23-72: when shipped by Hardy, Inc., Farmington, Conn., thearticle (in pint, quart, and gallon containers) was a new animal drugand no approval of a New Animal Drug Application was in effect withrespect to the article's use and intended use; the article's labels contained fa se. and misleading claims for use on horses hoofs to retard lossof natural moisture, to prevent nail cracking, to smother thrush, to softenhard hoofs, to harden spongy hoofs, and to act as a "conditioner" forhorses hoofs generally—505(a), 502(a); and the article in the pint andquart containers was also in violation of the Fair Packaging and LabelingAct, since the quantity of contents was not stated on the alternate principal display panels, the quantity of contents statements on the sidesof the containers, which had principal display panel areas of more thangand 25 square inches, respectively, were in type sizes less than Va and3/16 inch high, respectively; and the quantity of contents was not ex-pressed m ounces with identification by liquid measure and followed Inparenthesis by a declaration of the largest whole units l*! li r

tF^rfr Default decree ordered destruction.(F.D.C. No. 57821; S. No. 60-646 E; N.J. No. 37)Ideal Calf Booster boluses, at Modesto, E. Dist. Calif.

Charged 4-21-72: while held by Western Feed Supplements, Inc., d/b/ameal Laboratories, Modesto, Calif., who manufactured the article usingdried rumeri bacteria and neomycin sulfate which had been shipped ininterstate commerce, the article was a new animal drug for which noapproval of a New Animal Drug Application was in effect with respect tothe use and intended use of the drug; 501(a)(5). Default decree ordereddestruction. (F.D.C. No. 57959; S. No. 73-544 F; N.J. No. 38)

Stimulant tablets for dogs, at Cockeysvllle, Dist. Md.Charged 4-26-72: when shipped by Ormont Drug & Chemical Co., Inc.,Englewood, N.J., the article, labeled in part "Cardiotabs . . . Distributedby A. J. Buck & Sons, Inc., Cockeysvllle, Md. . . . Digitalis Leaves . . .Strophanthm . . . Sparteine Sulfate . . . Nitroglycerine . . . Ext. CactusGrandiflora, was a new animal drug, and no approved New Animal Drug

38 / April 19731 FDA Consumer

Application was in effect with respect to its use and intended use; andits labeling contained false and misleading claims for use in dogs generally as a circulatory stimulant and "tonic," to treat certain types ofcardiac weakness, and as a general stimulant; 501(a)(5), 502(a). Defaultdecree ordered destruction. (F.D.C. No. 57950; S. No. 9-255 F; N.J. No. 39)

MEDICAL DEVICESCSK Resuscitator, at Dublin, E. Dist. Pa.

Charged 6-15-72: when shipped by CSK-lnvent A/S Industrivej, Copenhagen, Denmark, the article's labeling contained false and misleadingclaims that the article could be operated by anyone without training,that it was ideally suited to revive breathing whenever the hazard ofasphyxiation may occur, and that the article was virtually imperviousto all ambient atmospheres, including cold; the labeling lacked adequatedirections for use for the conditions offered in the labeling, such as forasphyxia due to electric shock, smoke inhalation, drowning, inhalationof dangerous fumes, shock from physical impact, heart seizure, andother causes, and adequate directions for safe use by untrained laity forthese conditions cannot be written; the labeling lacked adequate warning against unsafe uses; and the article was dangerous to health whenused as directed; 502(a), 502(f)(1), 502(f)(2), 502(j). Default decreeordered destruction. (F.D.C. No. 58047; S. No. 66-705 F; N.J. No. 40)

Diapulse electromagnetic energy generators, at San Diego, S. Dist. Calif.Charged 9-11-72: when shipped by unknown shipper after manufacture byDiapulse Corp. of America, New Hyde Park, N.Y., the labeling of the articlelacked adequate directions for use, and neither adequate directions foruse nor adequate information for use by licensed practitioners can befurnished; 502(f)(1). Default decree ordered destruction. (F.D.C. No.58230; S. No. 44-158 F; N.J. No. 41)

CDSMETICS/Beauty ProductsDubl Duck hot-air styling comb with attachments, including a natural bristle

brush, at Jamaica, E. Dist. N.Y.Charged 5-23-72: when shipped by Keiko Trading Co., Ltd., Tokyo, Japan,the article's natural bristle brush contained nits; 601(b). Consent decreeauthorized release to Pearlduck, Inc., Jamaica, N.Y., for salvaging. (F.D.C.No. 58004; S. No. 56-545 F; N.J. No. 42)

Trylon Conditioning Egg Shampoo, at Oklahoma City, W. Dist. Okla.Charged 5-18-72: when shipped by Trylon Products Corp., Chicago, III.,the article's name, "Egg Shampoo," was false and misleading in representing that the article contained one egg or its equivalent in thatquantity of the article which would be used in one shampooing of thehair, since according to the article's label, the article contained theequivalent of 2 percent whole egg—602(a); and the article was in violation of the Fair Packaging and Labeling Act, since the quantity of cpn-tents was not separated from other printed label information appearingto the left and right of the declaration; and the quantity of contentsstatement, appearing on the principal display panel area of more than 5square inches, was in a type size less than Vs inch high—15 U.S.C. 1453(a)(2), 1453(a)(3)(C)(i). Default decree ordered destruction. (F.D.C. No.58021; S. No. 29-430 F; N.J. No. 43)

HAZARDOUS SUBSTANCES

A G B o n d r e - s i l v e r i n g p o l i s h , a t D e n v e r , D i s t . C o l o . ,Charged 7-26-72: when shipped by Chem-Glo Marketing International,Minneapolis, Minn., the article was a banned hazardous substance containing soluble cyanide salts in a concentrate of cyanide greater tha^n 25parts per million; 2(q)(l)(B). Default decree ordered destruction. (H.S.L.No. 1259; S. No. 33-593 F; N.J. No. 44)

Cherry bombs, silver salutes, and M-80 fireworks, at Taylor E. Dist. MoCharged 7-1-71: while held at fireworks stand, Taylor, Mo., the articleswere banned hazardous substances intended to produceby a charge of more than 2 grains of pyrotechnic composition; 2(q)(l)(B).(H.S.L. No. 1155; 8. Nos. 43-883/4 E; N.J. No. 45)

Cherry salutes, at Mississippi County, E. Dist. Mo. nn..n+v/Charged 7-1-71: while held at State Souveniers Stand, Mississippi Co untyMo., the article was a banned hazardous substance intended to Pi oduceaudible effects by a charge of more than 2 grains of Pyotechnic coni-position; 2(q)(l)(B). Default decree ordered destruction. (H.S.L. No. 1151;S. No. 27-840 E; N.J. No. 46)

Clown d o ns, atiMetm ^ sale, the article was a toy which wasa flammable solid and v;hich was a hazardous substance banned byregulations; 2(q)(l)(B). Default decree ordered destruction. (H.S.L. No.1209; S. Nos. 35-794/7 E; N.J. No. 47)

Concern detergent liquid, two seizure actions, at Buffalo, W. Dist. N.Y., and£gedU-2n'and 'll- ^ while held for sale the article (which hadbeen manufactured by H. T. Developments Co., Inc., Buffalo, N Y. fromTergitol shipped in interstate commerce) was a toxic and irritant substance which lacked a number of required conspicuous ' bel staternents;2(p)(1)(B,C,E,F,G & J). Consent decrees authorized release to Lobiaws Co.,Buffalo, N.Y., for relabeling. (H.S.L. Nos. 1194/5; S. Nos. 78-125 E &20-933/4 E; N.J. No. 48)

Drain opener and cleaner liquid, at Southgate, C. Dist. Calif.Charged 12-27-71: while held for sale, the article was a liquid dramcleaner containing more than 10 percent sodium hydroxide and was ahazardous substance banned by regulations; 2(q)(l)(B). Default decreeordered destruction. (H.S.L. No. 1197; S. No. 89-858 E; N.J. No. 49)

Silver salutes, at Clark County, E. Dist. Mo. * n i pCharged 7-1-71: while held at Big K fireworks stand, Clark County,the article was a banned hazardous substance intended to produce audileffects by a charge of more than 2 grains of pyrotechnic compositii2(q)(l)(B). Default decree ordered destruction. (H.S.L. No. 1158; S. in43-890/1 E; N.J. No. 50)

NOTICES DF JUDGMENT on Criminal Actions

Central Grocers Cooperative, Inc., and William M. Tarpey, vice president and

general manager, Franklin Park, N. Dist. III.Charged 4-28-72: flour was held in a building accessible to rodents andcontaminated with rodent filth; 402(a)(3), 402(a)(4). Guilty plea by corporation; fine. Nolo contendere plea by individual; fine. (F.D.C. No. 57183;S. Nos. 27-821/2; N.J. No. 51)

Del Campo Baking Manufacturing Co., and Alphonso E. Del Campo, president,Wilmington, Dist. Del.Charged 3-9-72: when shipped, sandwich rolls contained whole insects andinsect fragments and had been prepared under insanitary conditions-402(a)(3), 402(a)(4). Guilty plea by corporation; fine. Guilty plea by individual; fine and probation. (F.D.C. No. 57733; S. No. 46-663 E; N.J.No. 52)

Lassen Foods, Inc., Wayne W. Schlotthauer, and Conrad L. Craft, manager.Paradise, E. Dist. Calif.Charged 10-12-72: wheat-germ meal was held in a building accessible torodents and was contaminated with rodent filth; 402(a)(3), 402(a)(4).Guilty pleas; fines and probations. (F.D.C. No. 58139; S. No. 73-685 F;N.J. No. 53)

Richards Brothers, and Edward Richards, partner, West Plains, W. Dist. Mo.C h a r g e d 11 - 1 - 7 1 : p o p c o r n w a s h e l d i n a b u i l d i n g a c c e s s i b l e t o r o d e n t sa n d i n s e c t s a n d w a s c o n t a m i n a t e d w i t h r o d e n t a n d i n s e c t fi l t h ; 4 0 2 ( a ) ( 3 ) ,402(a)(4). Nolo contendere pleas; fine. (F.D.C. No. 57324; S. No. 27-733E; N.J. No. 54)

Sars of Louisiana, Inc., and Felix R. Sapp., president. Baton Rouge, E. Dist. La.Charged 7-27-72 by grand jury: when shipped, dried meat-scrap meal contained the added poisonous and deleterious substance Salmonella microorganisms, and the dried meat-scrap meal had been prepared and heldunder insanitary conditions whereby it may have been rendered injuriousto health; 402(a)(1), 402(a)(4). Guilty plea by corporation; fine and probation. Guilty plea by individual; probation. (F.D.C. No. 57727; S. No. 16-650 E et al; N.J. No. 55)

D R U G S

Dalton Docter Feed Lot, Inc., Amherst, Dist. S. Dak.Charged 12-10-71: when shipped, a beef steer contained, in its edibletissue, residues of oxytetracycline (a new animal drug) in excess of thetolerance of zero, and the use of the new animal drug was not in conformity with an effective approved New Animal Drug Application; 402(a)(2)(D). Guilty plea; fine. (F.D.C. No. 57317; S. No. 76-370 E; N.J. No. 56)

Denver Veterinary Laboratories, Inc., Denver, Dist. Colo.Charged 6-30-71: when shipped. Dextrose Injection had been preparedand packed under circumstances lacking current good manufacturingpractice, and the quality and purity of the Dextrose Injection fell belowthe U S.P. standard, since the article contained numerous fibrous anddirt-like particles; 501(a)(2)(B), 501(b). Guilty plea; fine. (F.D.C. No. 57033;S. No. 71-554 D; N.J. No. 57)

Nathan Frank, vice president of Denver Veterinary Laboratories, Inc., Denver,

Charged 6-8-71: when shipped. Dextrose Injection had been preparedand packed under circumstances lacking current good manufacturingpractice, and the quality and purity of the Dextrose Injection fell belowthe U S.P. standard, since the article contained numerous fibrous anddirt-like particles; 501(a)(2)(B), 501(b). Nolo contendere plea; fine. (F.D.C.No. 57033; S. No. 71-554 D; N.J. No. 58)

Industrial Laboratories Co., and David Paul Ochs, chief chemist, Denver, Dist.

Charged 4-20-71 by grand jury: conspiracy (Count 1) to ship, with intentto defraud and mislead, adulterated Dextrose Injection, part of whichconspiracy was the furnishing, to the Canadian consignee of the De*trpseInjection, of false and misleading reports to the effect that the articlehad been analyzed by Industrial Laboratories Co. for purity in accordancewith the U.S.P. test—18 U.S.C. 371; and, when shipped with intent todefraud and mislead. Dextrose Injection (Counts 2 & 3) had been preparedand packed under circumstances lacking currentpractice; and the quality and purity of the Dextrose Injection fell belowthe U.S.P. standard, since the article contained numerous fibrous anddirt-like particles-501(a)(2)(B), 501(b). After trial before court and jury,the jury returned a verdict of guilty. Thereafter, the court dismissed theconspiracy charge (Count 1) and sentenced the corporationeach on Counts 2 and 3 and the individual to pay $250 each on2 and 3 and to be placed on probation for 1 year. Thereafter the defend-"in ?eve rsing the judgment of the District Court and remanding the

cause with directions to enter convictions on the misdemeanor counts, the°'%he s o r question presented is whether the trial court failed to in

struct the jury adequately on the question of the specific intent require-" "TheVewere'two s ^^ which were found by the jury to have beenadulterated. The defendants had for some time been performing analysesfor Denver Veterinary Labs, Inc. particularly of a substance known asDextrose Solution 50% [Dextrose Injection] which Denver produced forshipment to Viobin Veterinary Products, Ltd. of Canada. Prior to March1967, Industrial Laboratories performed but one test on the substance,but in March 1967, Viobin notified Denver by letter that the test resultsin that form would no longer be considered sufficient to satisfy the standards of the Canadian government. Certain other tests were requested.Following receipt of this letter a discussion was had between the DenverLaboratories director and Ochs, and following this a new report wasdevised. This listed several other tests. But the evidence estaW'shedthat Industrial Laboratories continued to perform only he test that h adoreviousiy been performed. Furthermore, the evidence established thatthe two lots of drugs that are referred to in the indictment were in fact^"Thever'dicts were clear enough. The two forms on which the jury returned verdicts of guilty called for a finding that there was an intentto defraud or mislead. Hence there could have been no question on thepart of the jury that they had to find existence of he intent and sot^he only question is whether the instruction clearly delineated to thejSfy the necessity for finding a specific intent to defraud and also

FDA Consumer I April 1973 1 39

whether the jury was told in clear terms the meaning of intent in this°"¥he trial court referred to the necessity for proof of intent when it

told the jury about the lesser included offense of introducing into interstate commerce without any intent to mislead or defraud. It thus differentiated the two grades of offense and went on to say that if thejury was convinced that the defendants caused the drugs to be shippedin interstate commerce without the intent to mislead and defraud, thejury was at liberty to find the defendants guilty of a lesser included° "manning out the elements of the felony charge the jury was toldthat in order for it to find the defendant guilty it must find beyond areasonable doubt first that the drug involved was shipped in commerce;second, that it was adulterated, describing what constitutes adulteration;third, as to the defendant Ochs, that he had a responsible position andwas responsible for the preparation of an analyses report showing thatcertain tests were performed. But there was no mention of intent as anessential element. At another place in the charge the court stated thatanyone who causes an adulterated drug to be introduced into commerceknowingly violates the law. The court went on to say that the government did not have to prove that the defendant knew that the drug wasadulterated and that it was not necessary for the government to provethat the defendant intended to v io late the law.

"As we view it, there was reason for misunderstanding and confusionas to the necessity to find the existence of a specific intent to defraudo r m i s l e a d . Th e j u r y w a s t o l d g e n e ra l l y t h a t t h e g o ve rn me n t w a s n o t r equired to prove a specific intent to violate the law. Undoubtedly this wasdirected to the lesser included offense. However, its inapplicability tothe felony count was not pointed out. We must hold that it was essentialt h a t t h e j u r y b e t o l d t h a t u n d e r § 3 3 3 ( b ) i n t e n t t o m i s l e a d o r d e f r a u dw a s a n e s s e n t i a l i n g r e d i e n t . T h e j u r y s h o u l d h a v e b e e n f u r t h e r d i r e c t e dt h a t i t w a s n e c e s s a r y f o r i t t o fi n d t h a t t h e d e f e n d a n t k n e w t h a t t h eseveral tests had not been made, that Ochs intentionally misrepresentedthat they had, and that he did so for the purpose of misleading andd e f r a u d i n g t h e c o n s i g n e e a n d t h e C a n a d i a n a u t h o r i t i e s t h a t s u c h s e v e r a ltests had in fact been performed. The jury should have been furtherinstructed that an act is done willfully if done voluntarily and intentionally, and with specific intent to do something the law forbids, that is tosay, with bad purpose either to disobey or to disregard the law.

" W e c o n c l u d e t h a t s i n c e i n t e n t i s a n e s s e n t i a l e l e m e n t o f t h e c r i m eand since the instructions do not contain a clear and unambiguousdescription of specific intent as an essential element, and do not contain a definition of intent in this context, the court's instructions andomission to instruct on intent are to be regarded as plain error withinthe meaning of Rule 52(b).

"We see no need for a retrial in this case since the only effect ofthis decision is to nullify the jury finding that there was an intent todefraud or mislead. See 28 U.S.C. § 2106 . . . This section has beeninterpreted as authorizing federal courts to modify a judgment in acriminal case by reducing the conviction to that of the lesser includedoffense. . . .

"The judgment of the district court is reversed and the cause is re-rnanded with directions to enter convictions of the misdemeanor counts,that IS to say, 21 U.S.C. §§331(a) and 333(a). The cause is remanded tothe district court for reconsideration, if it wishes, of the sentences inthe l ight o f th is cour t 's ac t ion. "

In accordance with the order of the Court of Appeals, the originalsentences were vacated and the corporation was then fined a total of$1,000, and the individual was fined a total of $400 and placed on probation for 1 year. (F.D.C. No. 57033; S. Nos. 71-554/5 D; N.J. No. 59)

NOTICE OF JUDGMENT on Miscellaneous ActionColor additives, cosmetics, diluents, hair dyes, inspections, and definitions

hereof, suit for declaratory judgment and injunction, New York, S. Dist.Charged 11-15-63 by the Toilet Goods Association, Inc., and 39 individualcosmetic manufacturers and distributors in suit for declaratory judgmentand injunction against H.E.W. Secretary Celebrezze and FDA CommissionerLarrick: FIRSTLY—that the FDA Commissioner promulgated Color Regulations which prescribed the color licensing system for color additives foruse in food, drugs, and cosmetics, and expanded the definition of theterms to include lipstick, rouge, eye makeup colors, and related cos-rnetip; that by so defining the term "color additive" to include thefinished product and not merely color ingredients, such regulations arem excess of the statutory jurisdiction, authority, and limitations of thedefendants; that compliance with the Color Regulation would requireplaintiff companies to change established business practices, woulddisrupt their businesses, would require disclosure of secret ingredientsand would apparently require a $2,600 fee for each product and eachshade of each product; SECONDLY—that the FDA Commissioner promulgates Color Regulations which also defined the term "color additive"to include diluents and not merely the color ingredient and which regulations were similarly beyond the authority of the FDA Commissioner andworked similar hardship upon the plaintiffs; THIRDLY—that the FDA

promulgated Color Regulations which changed and limitedthe 1938 Act coal-tar hair dye exemption only to ingredients in hair dyeproducts, rather than to the entire products and by subjecting hair dyeproducts and other hair dye ingredients to premarketing clearance andto the color licensing system, which regulations were similarly beyondthe authority of the FDA Commissioner and worked similar hardship uponvarious of the plaintiffs; FOURTHLY—that Color Regulations concerningFDA inspection and certification of manufacturers of color additives weresimilarly beyond the authority of the FDA Commissioner and provided forunauthorized and illegal access to processes and formulae of finishedcosmetics; and that the plaintiff prayed for a judgment declaring suchColor Regulations null and void, and to enjoin the defendants from enforcing such regulations.

The parties cross-moved for summary judgment. The District Courtdenied both motions (235 F. Supp. 648). A year later the Government

'js fTiotion to dismiss. The District Court again denied the mo-tioii' but did certify the issues for an interlocutory appeal on the groundsthat controllmg questions of law as to which there were substantialgrounds for difference of opinion were involved, and that an immediate

appeal might materially advance the ultimate determination of the litigation. The Court of Appeals affirmed the judgment of the District Courtthat jurisdiction existed to hear the suit as to three of the challengedregulations, but sustained the Government's contentions as to the fourthregulation which concerned inspection by FDA (360 F.2d 667).The parties appealed to the Supreme Court. , , .

The Supreme Court affirmed the action of the Court of Appeals sustaining the Government's contentions as to the fourth regulation andaffirming the judgment of the District Court as to the first three regulations. In sustaining the Government's contentions, the Supreme Courts a i d :

"The petitioners maintain that this regulation to permit duly authorizedemployees of the Food and Drug Administration free access to all manufacturing facilities, processes, and formulae involved in the manufactureof color additives and intermediates is an impermissible exercise of authority, that the FDA has long sought congressional authorization forfree access to facilities, processes, and formulae. ... but that Congresshas always denied the agency this power except for prescription drugs.§ 704, 21 U.S.C. § 374. Framed in this way, we agree with petitionersthat a "legal" issue is raised, but nevertheless we are not persuadedthat the present suit is properly maintainable.

"In determining whether a challenge to an administrative regulationis ripe for review a twofold inquiry must be made: first to determinewhether the issues tendered are appropriate for judicial resolution, andsecond to assess the hardship to the parties if judicial relief is deniedat that stage.

" A s t o t h e fi r s t o f t h e s e f a c t o r s , w e a g r e e w i t h t h e C o u r t o f A p p e a l sthat the legal issue as presently framed is not appropriate for judicialresolution. . . .

"The regulation serves notice only that the Commissioner may undercertain circumstances order inspection of certain facilities and data,and that further certification of additives may be refused to those whodecline to permit a duly authorized inspection until they have compliedin that regard. At this juncture we have no idea whether or when suchan inspection will be ordered and what reasons the Commissioner willgive to justify his order. The statutory authority asserted for the regulation is the power to promulgate regulations 'for the efficient enforcement' of the Act, § 701(a). Whether the regulation is justified thusdepends not only, as petitioners appear to suggest, on whether Congressrefused to include a specific section of the Act authorizing such inspections, although this factor is to be sure a highly relevant one, but alsoon whether the statutory scheme as a whole justified promulgation ofthe regulation. ... We believe that judicial appraisal of these factorsis likely to stand on a much surer footing in the context of a specificapplication of this regulation than could be the case in the frameworkof tJie generalized challenge made here.

"This is not a situation in which primary conduct is affected—whencontracts must be negotiated, ingredients tested or substituted, or specialrecords compiled. . . . Unlike the other regulations challenged in thisaction, in which seizure of goods, heavy fines, adverse publicity fordistributing 'adulterated' goods, and possible criminal liability mightpenalize failure to comply ... a refusal to admit an inspector herewould at most lead only to a suspension of certification services to theparticular party, a determination that can then be promptly challengedthrough an administrative procedure, which in turn is reviewable by acourt. Such review will provide an adequate forum for testing the regulat ion in a concre te s i tua t ion . "

In holding that the plaintiffs' action was maintainable on the firstthree regulations, the Supreme Court said:

"The issue as framed by the parties is a straightforward legal one:what general classifications of ingredients fall within the coverage ofthe Color Additive Amendments? Both the Government and the respondents agree that for any color additive, distribution is forbidden unlessthe additive is (1) listed in a Food and Drug Administration regulationas safe for use under prescribed conditions, and (2) comes from acertified batch, unless specifically exempted from the certification re-

qumement. The only question raised is what sort of items are 'coloradditives. The three regulations outlined above purport to elaborate thestatutory definition; they include within the statutory term certain classesof Items, e.g., diluents, finished cosmetics, and hair dyes, that respond-ents assert are not within the purview of the statute at all. We agreewith the District Court and the Court of Appeals that this is not a situation in which consideration of the underlying legal issues would necessarily be facilitated if they were raised in the context of a specific attempt to enforce the regulations. Rather, 'to the extent that they purport to apply premarketing requirements to broad categories like finishedproducts and non-coloring ingredients and define the hair-dye exemptionthey appear, prima *acie, t o be susceptible of reasoned comparison withthe statutory mandate without inquiry into factual issues that ought tobe first ventilated before the agency.' 360 F. 2d, at 685.

"For these reasons we find no bar to consideration by the courts ofthese issues in their present posture." (Misc. No. 58; N.J. No. 60)

Notices of Judgment are given pursuant to section 705 of the Federal FoodDrug, and Cosmetic Act and section 13 of the Federal Hazardous SubstancesAct. Notices of Judgment report cases involving seizure proceedings, criminalproceedings, and injunction proceedings. Seizure proceedings are civil actionstaken against goods aMeged to be in violation, and criminal and injunction proceedings are against firms or individuals charged to be responsible for vio-

cases generally involve foods, drugs, devices, cosmetics, orhazardous substances which were alleged to be adulterated or misbranded orotherwise violative of the law when introduced into and while in interstatecommerce, or while held for sale after shipment in interstate commerceOffic°e'ofth°e GeSr 'ins t DHEW.''''

Published by direction of the Secretary of Health, Education, and Welfare.Charles C. Edwards, M.D., Commissioner of Food and Drugs

Washington, D.C. April 1, 1973

40 / April 1973! FDA Consumer liU.S. GOVERNMENT PRINTING OFFICE: 1973-515-080/60

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