fda consumer, may 1980 · tuning in on hearing aids hearing losses can be socially, economically,...

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Pat r ic ia Rober ts Har r is

Secretary, U.S. Department ofHeal th and Human Serv ices

Julius B. Richmond, M.D.Assistant Secretary for Health

Jere E. Goyan, Ph.D.Commissioner of Food and Drugs

Wayne L. PinesAssoc ia te Commiss ionerfor Pub l ic Affa i rs

Roger W. Miller/Editor

Harold C. Hopkins/Editorial Director

Jesse R. Nichols /Ar t Di rector

FDA Consumer (436210) is the official magazineof the Food and Drug Administration, Rock-ville, Md. 20857, and is published monthly, except for combined issues for July-August andDecember-January. Subscriptions should beordered from and made payable to SUPERINTENDENT OF DOCUMENTS, GovernmentPrinting Office, Washington, D.C. 20402, at$12.00 a year ($15.00 foreign mailing). Second-class postage paid at Washington, D.C., andadditional mailing offices. POSTMASTER:Send address change to FDA Consumer/HFI-20, 5600 Fishers Lane, Rockville, Md. 20857.

Address fo r ed i t o r i a l ma t te rs : FDA Consumer,HFI-20, Food and Drug Administration, 5600Fishers Lane, Rockville, Md. 20857.

Text of articles published in FDA Consumermay be republished without permission. Creditto FDA Consumer as the source is

appreciated.Use of funds for printing this publication approved by the Office of Management andBudget November 1, 1972.

FDA Consumer was previously known as FDAPapers .Section 705 [375] of the Food, Drug, and Cosm e t i c A c t :

(a) The Secretary shall cause to be publishedfrom time to time reports summarizing alljudgments, decrees, and court orders whichhave been rendered under this Act, includingthe nature of charge and the dispositionthe reo f .(b) The Secretary may also cause to be disseminated 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 investigations of the Department.

Cover Design: Zeb Rogerson

VOL. 14 NO. 4 M A Y 1 9 8 0

Cellulite: Hard To Budge Pudge

Certain beauty salons and ads in many women's magazineswould lead one to believe that fat known as cellulite can beburned away, washed away, maybe even brushed away. Awriter examines these claims and the stuff called cellulite.

Tuning In on Hearing Aids

Hearing losses can be socially, economically, and personally devastating. But, as this article points out, hearing aidscan do much to cut those losses.

Stubborn and Vexing, That's Acne

What causes that long, adolescent nightmare known as acneand what can be done about it are looked at in this article.

Inhalants: Quick Route to Danger

The endless, age-old quest for thrills has caused many tosniff at mind-altering substances, for inhaling offers a fastroute to the bloodstream. But that fast track can also meana quick trip to the emergency room.

More Cups Lifted Sans Caffeine

Decaffeinated coffee drinking is on the upswing. This articlelooks at the phenomenon and at the decaffeinating process.

1 0

1 4

1 8

2 3

Update

T h e N o t e b o o k

Investigators' Reports

Se izu res and Pos ta l Se rv i ce Cases

Notices of Judgment

2

2 6

2 8

3 3

3 6

Inside Front Cover; Questions about the health effects of caffeine havecaused numerous coffee drinkers to switch to decaffeinated coffee.Chemicals are used to remove caffeine from coffee and, therein, lie someother health questions.

FDA Consumer / May 1980 /1

update

L a e t r i l e D e c i s i o n R e v e r s e d

On June 18, 1979, the U.S. Supreme Court ruledthat drugs for terminal patients must meet the samestandards as other drugs and thus in effect supported FDA's position prohibiting the marketing ofLaetrile, the controversial cancer ''cure," in interstate commerce. The history of efforts by Federaland many State officials to head off the persistentillegal marketing of Laetrile was discussed in TheCourts, Terminal Patients, and UnapprovedDrugs, in the November 1979 FDA Consumer.Here's an update.

The Tenth Circuit Court of Appeals in Denverh a s r u l e d i n f a v o r o f t h e F e d e r a l G o v e r n m e n t i nthe case of Rutherford v. United States. In a decision handed down on February 19 the court of appeals reversed an earlier decision by the U.S. Dist r i c t C o u r t f o r t h e W e s t e r n D i s t r i c t o f O k l a h o m a .That decision had held that Laetrile was exemptfrom FDA's new drug provisions because it was"grandfathered" and because patients have a constitutional right of privacy to obtain Laetrile.

O n t h e fi r s t i s s u e t h e c o u r t s a i d : " T h e r e c o r ddoes not support a conclusion that the several conditions in [the 1962 Drug Amendments] have beenmet to permit the application of the grandfatherexceptions." The court also said that the propon e n t s o f L a e t r i l e " d i d n o t c o n d u c t t h e r e s e a r c hand the laboratory testing required under the prevailing procedures" and thus did not meet theirbu rden to es tab l i sh t ha t t he subs tance i s sa fe andeffective. "These standards are impressive, butthey can be and are regularly met by the pharmaceutical houses," the court said.

In regard to the right of privacy issue the courtsaid: "The decision by the patient whether to havea treatment or not is a protected right, but his selection of a particular treatment, or at least a medication, is within the area of governmental interestin protecting public health. The premarketing requirement of the FD&C Act is an exercise ofCongressional authority to limit the patient'sc h o i c e o f m e d i c a t i o n . "

The legal rules provide procedures under whichthis decision by the court of appeals can be eitherchallenged by interested parties or implementedby the district court. Until these procedures arecompleted, the affidavit system that allows terminally ill patients to obtain personal supplies of

Laetrile remains in effect without change. The system was established in December 1977 by the U.S.D i s t r i c t C o u r t f o r t h e W e s t e r n D i s t r i c t o f O k l a h o m a .

Approved Laser Variance RequiredLaser light shows, often an accompaniment to

popular rock music groups, can be spectacular, butthere is a chance that audiences can be exposed toharmful laser radiation. In 1978, FDA issuedguidelines for manufacturers and assemblers ofthese shows to assure that the equipment was beingused in a safe manner. What the guidelines coveredwas outlined in Entertainment Lasers: ApproachWith Care, in the September 1978 FDA Consumer. Here's an update.

FDA's Bureau of Radiological Health has sentlaser product manufacturers a letter informingthem that effective May 1, 1980, all manufacturersor assemblers of Class III or IV laser light shows,displays, and related devices manufactured or assembled after August 1, 1976, must have an approved variance from the Federal laser productperformance standard before these items are introduced into commerce or their operation continued.

The laser standard divides these products intofour classes based on the intensity of the radiationand potential for producing biologically harmfuleffects. Class III products emit visible light raysstrong enough to cause damage to human tissuefrom one short, direct exposure. Class IV productsproduce laser beams that could cause biologicaldamage by diffuse reflections as well as direct exp o s u r e .

Present FDA policy allows the assembly andcontinued operation of any laser light show, display, and/or device without an approved varianceif a specified set of conditions, including operational safety criteria, are satisfied. At the time thispolicy was issued, processing an application for avariance was a lengthy procedure. Since then theprocessing time has been shortened, and a variance application form to assist laser light showmanufacturers has been developed. Thus, there isno longer any reason to permit laser light shows,displays, or devices that don't comply with the requirements for demonstration lasers to be introd u c e d i n t o c o m m e r c e u n l e s s a v a r i a n c e h a s b e e no b t a i n e d .

Since manufacturers may be given a short lead

2 / May 1980 / FDA Consumer

time to produce a show and are required to havean approved variance before the show may be produced, FDA's letter urged them to apply for avariance for all the types of laser light shows, displays, or devices they are planning. The letter alsoreminded them of the need to submit reports foreach show or display and asked that the Agencybe notified of any planned installations or toursand any change in them at least 30 days in advance so inspections can be arranged and local aut h o r i t i e s n o t i fi e d .

A v a r i a n c e m u s t b e a m e n d e d o r w i t h d r a w n i fFDA determines the conditions of an approvedvariance are insufficient to protect the publichealth, the letter said.

Contraceptive Claims Scaled DownWhat a panel of experts had to say about the in

gredients and labeling of nonprescription vaginalcontraceptives was the subject of an article, VaginalContraceptives: Available But—, in the February1980 FDA Consumer. Here's information aboutthe advertising of vaginal contraceptives.

The Federal Trade Commission (FTC) hascharged three manufacturers of over-the-counter(OTC) vaginal contraceptive suppository productswith false, misleading, and deceptive advertising.Charged were American Home Products—makerof Semicid, Morton-Norwich Products, Inc.—maker of Encare Oval, and Jordon-Simner, Inc.—maker of S'Positive. FTC said the three misrepresented the effectiveness of their products by comparing them to The Pill or lUD's, when in facttheir effectiveness is about the same as vaginalfoam contraceptives in actual use.

The three companies agreed, without admittingany wrongdoing, to change their advertising toeliminate exaggerated claims such as "highly" or"extremely" effective and to say their products arenot as effective as The Pill or lUD's when comparative claims are made. Future advertising alsomust contain certain "affirmative disclosures," including: "For best protection against pregnancy, itis essential to follow package instructions" and "Ifyour doctor has told you that you should not become pregnant ask your doctor if you can use(product name)."

In add i t ion, Mor ton-Norwich and Amer icanHome Products will be required to distribute an

information pamphlet to consumers discussing theadvantages and disadvantages of various OTC contraceptive methods.

New Use for Aspirin

Painkillers: Their Uses and Dangers, in the September 1977 issue o/FDA Consumer, reviewed thefindings of an expert advisory committee on aspirinand similar painkillers. These over-the-counterdrugs are not to be taken lightly, the panel said, especially for self-treatment of rheumatism or arthritis. There is a new use for aspirin, according toFDA, and it is described in this update.

Aspirin is effective in reducing the risk of recurrent transient ischemic attacks (TIA's) in males,FDA's Peripheral and Central Nervous SystemDrugs Advisory Committee has concluded. A TIAis a kind of little stroke affecting the brain or retina of the eye. It clears up after a period of up to2 4 h o u r s .

A report on the committee's findings was publ ished in FDA's Drug Bu l le t in , wh ich i s d is t r ibuted to 1 million doctors and other health professionals. The Agency will publish guidelines tomanufacturers to distribute to health professionalsfor this use of aspirin according to the Drug Bulletin. The following wording will be recommended:

"There is evidence that aspirin is safe and effective for reducing the risk of recurrent transient isc h e m i c a t t a c k s o r s t r o k e i n m e n w h o h a v e h a dtransient ischemia of the brain due to fibrin platel e t e m b o l i .

"There is no evidence that aspirin is effective inreducing TIA's in women, or is of benefit in thetreatment of completed strokes in men or women.

"Patients presenting [exhibiting] . . . signs andsymptoms of TIA's should have a complete medicaland neurologic evaluation.

"Consideration should be given to other disord e r s w h i c h r e s e m b l e T I A ' s .

"It is important to evaluate and treat, if appropriate, other diseases associated with TIA's andstroke such as hypertension and diabetes."

Health professionals should note that aspirin,U.S.P., is the only form of the drug that can berecommended for use in the prevention of recurrent TIA's in men, the Drug Bulletin advised.The recommended daily dose is 1,300 mg a day(650 mg twice a day or 325 mg four times a day).

FDA Consumer / May 1980 / 3

Cellulite: Hard To Budge Pudge

Best described as that waffly looking fat found onwomen's hips and thighs, cellulite is the subject of manyadvertisements. Supposedly it's unusual fat that can be removed only in unusual ways. But just as a rose is a rose isa rose, so fat is fat is fat, as the author of this piece pointso u t .

by Louise Fenner

4 4X/0U don't have to be overweight to have cellulite,"X warns the advertisement. "Try the cellulite pinch

test. No matter how thin you are, those ugly bumps justwon't go away."

So thousands of women pinch the backs of their legs,watch the skin dimple and pucker until it resembles orange peel, and send away for the cream or pill or spongethat works like magic to take the "cellulite" away.

"Cellulite" (pronounced cell-u-leet) is a term coined inEuropean salons and spas to describe those deposits offat on women's thighs and buttocks that seem to stubbornly resist diet and exercise. It is alleged to be a special type of "fat-gone-wrong," a combination of fat,water, and toxic wastes that should have been eliminatedfrom the body but wasn't. Cellulite theorists claim thatcellulite afflicts nearly eight out of ten women, whilem o s t m e n a r e n ' t a f f e c t e d b e c a u s e o f t h e i r d i f f e r e n t h o rmones and physical makeup. Because cellulite isn't "ordinary" fat, these self-styled experts claim, only extraordinary treatments will be effective.

Although the word "cellulite" was popular in European health spas back in the early 1900's, it didn't become well known in the United States until publication in1973 of a book t i t led Cellul i te: Those Lumps, BumpsA N D B u l g e s Y o u C o u l d n ' t L o s e B e f o r e . T h e a u t h o rwas a Frenchwoman, Nicole Ronsard, owner of a beautysalon in New York City specializing in skin and bodycare, including cellulite treatment. Her book sold morethan 200,000 hardcover copies, and several books on cellulite by other authors quickly followed. Articles debating the pros and cons of treatment for cellulite appearedin many popular women's magazines, particularly in themid-1970's, and numerous beauty salons featuring "European-styled" cellulite treatments opened up around thecountry.

Advertisements for mail-order products to banish cellulite still appear in such publications as Cosmopolitan.Among products promoted as sure-fire cellulite remediesare "loofah" sponges, cactus fiber washcloths, horsehairmitts, creams that "dissolve" cellulite, vitamin-mineralsupplements with herbs, exercise books, liquids to beused in the bath, massagers, rubberized pants, brushes,rollers, and toning lotions. The costs can mount quickly.

especially for a complete cellulite "program," such as a$10 bottle of vitamin-mineral tablets and a $15 jar ofc r e a m .

Although these mail-order items can easily ruin a $20bill, their cost pales in comparison with beauty salontreatments for cellulite. For instance, one skin and bodycare center in Chevy Chase, Md., offers 10 appointmentsfor $250 to $280, and a New York establishment provides12 treatments for $475. Visitors to such salons may findthemselves hooked up to electrical muscle stimulators, vibrating machines, whirlpool baths, inflatable hip-highpressurized boots, tubes that shoot streams of warm air,and other marvelous gadgets. Some salons offer "hormone" or "enzyme" injections, thermal treatments withwarm wax or heating pads, or vitamin-mineral supplements. Massage is particularly popular, and customersare generally given diet and exercise plans. However,even with the $200 to $500 investment they require, thesalons offer no guarantees.

Before walking into one of these salons or sendingmoney for a mail-order cellulite remedy, consumersshould consider this: There is no medical evidence thatthese remedies work. In fact, it is difficult to find scientific evidence that cellulite even exists. None of threemedical dictionaries published since 1974 (Dorland's,Steadman's, and Gould's) lists cellulite. Although theAmerican Medical Association (AMA) has taken no position, a brief statement in the June 21, 1976, issue ofAMA's journal (JAMA) says flatly: "There is no medicalc o n d i t i o n k n o w n o r d e s c r i b e d a s c e l l u l i t e i n t h i s

country."A position paper from the Medical Society of the

County of New York agrees with AMA and also says:"It is our opinion that . . . books [on cellulite] exploitwomen through a gimmick .... The truth is that fat isfat, and wherever it may be located in the body, it maint a i n s i t s c o m m o n c h a r a c t e r i s t i c s . "

Nevertheless, the promoters of cellulite claim that thistype of fat is not the ordinary kind and is harder to dislodge. They say the connective tissues holding fat cellsjust underneath the skin's surface become saturated withwater and waste products that aren't properly eliminatedby the liver, kidneys, and other organs. These connectivetissues harden and combine with fat and water to formpockets of a gel-like substance—cellulite—that bulges outto produce the characteristic orange peel appearance onthe skin. Nicole Ronsard's book proposes a six-point program to rid the body of toxic wastes, hence cellulite, involving diet, elimination, breathing, exercise, massage,a n d r e l a x a t i o n .

Plausible as it may sound, the cellulite theory simplydoes not agree with medical knowledge. "There is abso-


Fat seems to land where it wants to, and on somepeople it ends up on hips and thighs. Call it ceiiuiiteor anything else, but it's stiii just plain old fat. Hereare some products advertised as ceiiuiite treatments,including herbal pills, lotions, and the "loofah" inthe top right photo. Nearly $40 worth of promises areshown here, but obesity experts say there's only oneway to get rid of ceiiuiite—diet and exercise.

lutely no medical evidence that the connective tissue orthe fat cells are subjected to toxins in response to the inability of the liver or other organs to function properly,"said the New York County Medical Society in its positionpaper. "To present ceiiuiite as a disorder of the liverand, by confused association, of the kidneys, intestineand skin, is a distortion of science and shows total ignorance of pathophysiology."

Vincent F. Cordaro, M.D., an FDA medical officerw h o h a s w o r k e d w i t h t h e U . S . P o s t a l S e r v i c e o n a n u mber of false representation cases involving cellulite-re-moval products, pointed out that no evidence exists to indicate that wastes or toxins are held in any one part ofthe body. He pointed out that retention of body wastes isassociated with serious health problems, such as kidneyor intestinal diseases. "A person who retained wastes andtoxins would be very ill and could die if not treated," hesaid. "The whole concept is irrational and unscientific."

If ceiiuiite were really different from other fat, somec h e m i c a l o r s t r u c t u r a l v a r i a t i o n s h o u l d b e e v i d e n t . H o w

ever, this is not the case, according to Neil Solomon,M.D., former secretary of Maryland's Department ofHealth and Mental Hygiene and author of a nationallysyndicated newspaper column on health. He conducted adouble-blind study with 100 people at Johns Hopkins

University and City Hospital in Baltimore, in an attemptt o d e t e r m i n e i f c e i i u i i t e i s d i f f e r e n t f r o m c o m m o n f a t .Needle biopsies were taken from people with dimply,lumpy, fatty tissue resembling what the promoters callceiiuiite, as well as from people without ceiiuiite. Pathologists were then asked to compare the samples. Therewas no difference—they all looked like ordinary fat cells.

So if it's just plain fat, why does ceiiuiite look so bumpy?Certain cells in the body have the capacity to store

enormous amounts of fat, and about half of the body'sfat is deposited in these cells immediately beneath theskin. Strands of fibrous tissue connect the skin to deepertissue layers, and also separate the fat cell compartments.When the fat cells increase in size, this apparently causesthe compartments of fat to bulge and produce a waffledappearance of the skin.

I n h i s b o o k E n e r g e t i c s : Y o u r K e y t o W e i g h t C o n

trol, Dr. Grant Gwinup, director of research on obesityand related disorders at the University of California at Irvine, says: "Fat under the skin has a characteristic appearance which makes its identification an easy matter. Itproduces a waffled appearance which is similar to thepattern of irregularities on the surface of an orange andbecomes more apparent when the skin fold is compressedlightly between the fingers." He also points out that most


I ts Not There!

cel. lo .phane \ 'se l -3- , fan\ n [F, f r. ce l lu lose + -phane (as in d ia-phane diaphanous, f r. ML diaphanus)] : a t ransparent t issue ofregenerated cellulose used chiefly for packaging

cel.lu.lar \ 'sel-y3-l3r\ adj [NL cellularis, fr. cellula l iving cell, fr. L,dim. of cella small room] 1 : of, relating to, or consisting of cells2 : containing cavities : having a porous texture — cel«lu*lar»i*ty\ . se l -y3 - ' l a r -3 t -e \ n — ceMu. la r - l y \ ' se l -y3 - l3 r - le \ adv

cel . lu . lase \ 'se l -y3- , las , - , laz \ n [ ISV ce l lu losQ + -ase} : an enzyme that hydrolyzes cellulose

ceLlule \ 'sel-(,)yu(9)l \ « [L cel lulal : a small cel lce l . l u . l i . t i s \ , se l -y9 - ' l l t -3s \ n [NL , f r. ce l lu la ] : d i f fuse and esp .

s u b c u t a n e o u s i n fl a m m a t i o n o f c o n n e c t i v e t i s s u ecel. lU' loid \ 'sel-Cy)3-,16id\ n [ fr. Cel luloid, a trademark] : motionspicture fi lm — ceiluloid adj

Cel lu lo id t rademark — used for a tough f lammable thermoplast iccomposed essentially of cellulose nitrate and camphor

ce l . lu . lose x 'se l -yo- . los , - , loz \ n [F, f r. ce l lu le l iv ing ce l l , f r. NLcel lu la] : a complex polymer ic carbohydrate (C6Hio05)x y ie ld ingonly glucose on complete hydrolysis, constituting the chief part ofthe cel l wal ls of p lants, and yielding many fibrous products

cellulose acetate n : any of several compounds insoluble in waterformed esp. by the action of acetic acid, anhydride of acetic acid,and sulfuric acid on cellulose and used for making textile fibers,packaging sheets, photographic fi lms, and varnishes

cellulose nitrate n : any of several esters of nitric acid formed bythe action of nitr ic acid on cellulose (as paper, l inen, or cotton)

Cellulite may pass easily off the lips of somebeauty salon operators (and stubbornly offthe hips of their clients), but the word has yet towork its way into the dictionary. It seems, alas, theword is as invented as the disease.

Inquiring about the status (or, rather, nonstatus)of the word, FDA Consumer turned to FrederickMish, editorial director of the company that publishes Webster's dictionaries (G. & C. Merriam,Co., Springfield, Mass.). Mish was asked if "cellulite" is a likely candidate for an upcoming editionof a dictionary. After checking his files for citations, he told us: "Right now, I would say celluliteis no better than a borderline candidate for inclusion. It's a possibility, but I can't say it's likely."

Citations are very important in the dictionarybusiness, because they indicate how widely a newword is used, and what meaning people are givingto it. The editors gather citations from literature,newspaper and magazine articles, and even advertisements, both through their own reading and fromsubmitted material. There is no set number of citations required. Ultimately, the editors must make asubjective judgment that people are likely to need tolook up a specific word.

Mish noted that most of his citations for celluliteare clustered around 1974 and 1975, with many references to Nicole Ronsard's 1973 bestseller. Afterthat, the references were fairly sparse. "We try toavoid 'coined' terms," he commented. "The purpose of the dictionary is to record the state of thelanguage at the time it is edited, not to promotenew words. Cellulite might be a vogue term whosevogue is passing."

The Webster's people add about two dozen newwords and senses (new meanings for establishedwords) to their New Collegiate Dictionaryevery year. It is published annually, in contrast tothe ponderous Webster's Unabridged, whichcomes out about "once a generation." The last wasin 1961. Although some addendum sections haveappeared since then, cellulite wasn't in them.

The fact that FDA Consumer found several citations about cellulite not collected by his staff ledMish to comment: "That suggests we ought to keepour eyes on it. Whatever the reality of the word is,whether it refers to a real thing or not, if it's incommon use we will consider it for inclusion."

"After all," he said, "we put words like unicornin the dictionary, too."

Americans carry substantially more fat than is good fort h e m .

If there is any excess fat, it has to be stored somewhere. Several factors influence this, with sex and heredity two of the most important. Men tend to deposit fat inthe abdomen, while in women, the breasts, hips, buttocks, and thighs are the choice spots.

Individuals vary in their patterns of fat distribution,and offspring are likely to follow the same pattern astheir parents. A good example of this was reported bytwo German physicians in the Journal of Dermato-LOGic Surgery and Oncology (March 1978). Theywere able to study the course of so-called cellulite incombination with obesity in four generations: an 8-year-old girl, her 33-year-old mother, 59-year-old grand

mother, and 79-year-old great grandmother. The 8-year-old's buttocks had a waffled appearance when pinched—this was designated the "mattress phenomenon"—and ineach older generation this characteristic became morepronounced and highly visible without pinching.

The mattress phenomenon was defined as a "compression and bulging of the upper fat cell chamber systemthat causes the overlying skin to protrude."

The German researchers found certain characteristicsin women's skin and underlying tissue that they suggestedwould explain why women exhibit the phenomenon andmen generally don't. For one thing, the connective tissuebeneath women's skin creates large, round fat cell chambers, while in men the fat cell chambers are divided intosmall, polygonal units that don't readily bulge when


/t's hard to describe the boots I was wearing.Long, plastic hip-high boots that alternately blewup like a balloon and then suddenly deflated with awhoosh. I saw the needle on the air compressor,which was attached to the boots by hoses, going upand up, past 30, 40, 50, and finally stopping at 60milligrams per square centimeter pressure. My legsinside the boots started feeling the squeeze, and Iwondered if the things would ever stop inflating.The boots got bigger. The squeezing got tighter,then suddenly, whoosh! The air rushed out. Thishappened first to one leg and then the other for 15minutes as 1 sat with just a towel around me. Thetimer on the air compressor finally buzzed, the attendant unhooked me, and the boots came off. 1could leave. My cellulite treatment was over.

This was my experience at a New York salon thatspecialized in cellulite treatment claiming ''the mostup-to-date approach to total bodycare ever conceived.'' Trying out a cellulite treatment had seemedlike good background for this article, so I selectedthis salon from scores listed in the ManhattanYe l l o w P a g e s . / c a l l e d a n d w a s t o l d I c o u l d h a v ean appointment that afternoon.

Inside the salon the carpet was deep and plush,and on the wall were huge photos of a very slimyoung model going through the various treatmentsthe salon had to offer. Why were there no "beforeand after" pictures? "Oh, but they wouldn't showyou anything. You would have to know when theywere taken, how long the treatment had been. Youwouldn't learn anything just looking at pictures,"was the answer. What did the treatments cost, then?There was no uncertainty about this: One appointment was $45 and there was a special rate of 12treatment sessions for $475.

A fortyish woman with a French accent, attractive, but not especially trim herself, showed me to aprivate room and looked at my legs and buttocks."Oh, yes, the cellulite is starting here and here andhere," she said pointing. Apparently it was creepingdown my legs to my knees, and for some reason

my left thigh was worse than the right. She said Iperhaps needed to lose some weight, too. At 5'3"and 112 pounds I was rather startled to hear that,although I had to acknowledge that the women inmy family seem to have chubby thighs no matterwhat we weigh.

A n o t h e r a t t e n d a n t c a m e i n a n d t h e t r e a t m e n tstarted with a "subaquatic massage"—a whirlpoolbath—in a brightly colored tub with lots of dialsand hoses at one end. As soon as I stepped into thetub, jets of water started spurting from the sides,and the attendant tried to guide me so the jetswould hit my thighs. We then went into a curtain-lined cubicle, where she started in on my cellulitewith a vengeance. A green, gel-like material wasmassaged into my skin by hand, and then she usedan electric massager that had three different heads.The third head had rotating spiky points andlooked like a torture instrument. Although it feltbumpy rolling up and down my leg, it was notpainful.

The piece de resistance came next—those inflatable hip boots. While I was immobilized insidethem, the woman with the French accent returnedwith instructions on a diet to follow and exercises todo at home. Most of the exercises amounted tobouncing on the floor on my buttocks and occasionally beating my knees together. The diet suggested I eat lots of fresh fruits and vegetables, drinkeight glasses of water a day, and cut down on sod i u m t o r e d u c e w a t e r r e t e n t i o n .

Along with this came a warning that 1 could failto get rid of all the cellulite if I didn't keep exercising at home and coming back for monthly follow-up treatments.

"Cellulite has to be attacked on all fronts—diet,exercise, massage," she said as she unhooked mefrom the hip boots. "It takes discipline and persistence. You have to do your part. That's very important. "

What she was actually saying was that even for$475, there were no guarantees.


filled. In addition, certain outer layers of skin inwomen—the epidermis and corium—are thinner thanmen's and more likely to reveal any bulging of fat cellsunderneath. These layers become even thinner and lesselastic with age.

It is important to avoid being overweight from childhood on, the research team advised. "Where there is noobesity there is no so-called cellulite. We make this statement without qualification."

Since obesity—excess fat—is seen as the major culpritin forming cellulite it is not surprising that the suggestedtreatment for it is to lose weight. "The only effectivemeasure, from our studies, is weight loss by means oflow-calorie diets and exercises," the German researchersreported. There was one qualification, however: For theweight loss therapy to be effective, it should be donewhen the skin is still elastic enough to spring back whenthe volume of fat is reduced (that is, before 35-40 yearsof age).

The same remedy for cellulite was recommended bySolomon, who now runs a private practice specializing inweight control at Baltimore. "The treatment is the samein all cases—diet and exercise," he said. He emphasizedthat in his studies of weight loss in overweight peoplewith significant dimpling of the skin on their thighs andbuttocks, "those who lost weight lost some of the dimpling."

Unfortunately, dieting and exercising aren't easy solutions and many people are lured by unproven remedies.They are destined to be disappointed. For example, enzyme injections have been shown in European double-blind studies to be no more effective than a placebo (aninert, nonactive substance). A recent study conducted bySolomon at his Baltimore clinic, using diet, exercise, andvitamin-mineral injections similar to a formula popular inFrance, showed "absolutely no difference" between patients who received the formula and those who receivedinjections of a placebo.

Another sure disappointment are the tablets claimingto use "all-natural" ingredients to remove cellulitebulges. These usually consist of a few vitamins, minerals,and herbs with possible diuretic properties, which maycause a temporary loss of water that makes the body appear slimmer. As soon as any liquid is consumed, the effect is reversed. Furthermore, no diuretic should be usedwithout advice from a physician.

Mail-order creams and lotions that are claimed to becapable of dissolving cellulite contain essentially the sametype of ingredients as common lubricating lotions: water,emollients, emulsifying agents, preservatives, colors, andfragrances. An interesting addition to some creams iscapsicum, or hot pepper, which can act as a local irritantand cause the skin to redden and tingle. This sensationmay help convince the purchaser that the product is morethan an ordinary lotion, even when no proof of any cellu-lite-dissolving effect is offered.

In the past few years, the U.S. Postal Service has filedcomplaints against more than a dozen promoters of cellulite treatments for obtaining money through the mails byfalse representation. Most signed consent agreementspromising to cease representing that their products couldcause weight loss and control cellulite. In addition,money sent by prospective purchasers was returned.

The Food and Drug Administration works with the

Postal Service in false representation cases by reviewingthe products and advertisements in question and providing advisory opinions about whether the product will perf o r m a s c l a i m e d .

On another front, FDA routinely obtains imports ofcellulite-reducing devices. In recent years the Agency hasa l s o c a u s e d t h e s e i z u r e a n d d e s t r u c t i o n o f a n u m b e r o f

weight-control and "body-altering" products, includingtwo cellulite treatment devices that had been importedprior to the restriction and were in use in New York Cityand Helena, Mont. The Italian-made machines, whichhad been leased to salons specializing in cellulite treatment, combined a heating pad, electrical muscle stimulator, and iontophoresis device (normally used in skincare). On the machines' labeling and literature wereclaims that the device could reduce and reproportion thebody, help destroy thick fat deposits, improve circulation, and provide benefits to the muscles equivalent to 9hours of exercise. A U.S. district court found the deviceswere misbranded because of false and misleading claimsand inadequate directions for use, including failure tobear adequate warnings against unsafe use.

Obesity experts agree that no equipment, exercise, ortreatment can remove fat exclusively from a single areaof the body. Ironically, some studies have shown thatspot exercises can sometimes make the exercised limbslook bulkier instead of slimmer. In one study at UC Irvine, Gwinup compared the arm circumference and fatpad (fat measurement using special calipers) on the armsof tennis players to determine if their more active armcarried less fat. Not only did the fat pad measure exactlythe same on both arms, but the arm used more often bythe players had a larger circumference because the muscles were bigger.

In another study, Gwinup measured the fat pad andcircumference of the thighs of a group of slightly obesegirls, then required them to exercise only one leg in agym for 13 weeks. At the end of that period he remeas-ured the fat pad and found no difference between the exercised and non-exercised legs. However, the exercisedlegs were larger in circumference because the size of them u s c l e s h a d i n c r e a s e d .

This is not intended to discourage exercising to helplose weight. Exercise uses up energy, and if the bodydoes not obtain enough energy from food, it will eventually turn to its own fat deposits. Exercise can also improve appearance by tightening and strengthening themuscles—for example, it can be easier to hold in yourstomach when the muscles are in good shape. However,most obesity experts agree with Gwinup: "There's nosuch thing as spot reducing. The only way to get rid offat on your thighs is to get rid of it all over your body."

Obviously, there are no easy answers. Dieting and exercise require much discipline and the appeal of effortlessslenderizing promised through other means is understandable. Unfortunately scientific and medical evidencedoesn't support the fantasies these remedies offer.

It's enough to make you wish for the days when round,well-fed figures were being glorified by the Flemishpainter Peter Paul Rubens. His voluptuous models werethe ideal of womanhood back in the early 1600's. Youcan be sure they didn't worry about cellulite.

Louise Fenner is a member of FDA's public affairs staff


Tuning In On Hearing Aids

A word goes unheard. Sounds are subdued. Another'sspeech is suddenly slurred. Those are all signs of hearingloss. And hearing loss can be a blow to the self-esteemand the pocketbook. However, help is often available,sometimes in the form of drugs or surgery, sometimesfrom hearing aids. This article examines hearing problemsand how hearing aids can help.

Hearing impairment can be more devastating thanother sensory loss. Hearing is essential to spokencommunication and helpful in writing. People with hearing impairments may encounter psychosocial problems—limit their socializing, curtail their activities, and becomealienated from family, friends, or business associates.Communication and psychological disorders precipitatedby hearing loss can affect health and social well-being.

Whether to get a hearing aid is a question many Americans have asked themselves or their physicians. About15 million people in this country suffer from some kindof hearing impairment, representing a substantial part ofthe population. The medical and physical natures and degrees of hearing deficiencies vary considerably among individuals. Normally these deficiencies can be properlyevaluated and treated only by physicians and other experts. Besides medical and physical aspects, several otherfactors may help to determine whether a hearing aid isthe answer for a particular hearing problem.

A hearing aid is not always the answer. Depending onthe cause and the type of hearing loss, the treatment mayrequire drugs or surgery, or a combination including ahearing aid. First, it is essential to recognize that a hearing loss has in fact occurred. Such a loss is not alwayseasy to detect. Some of the telltale signs:

• Words may be difficult to distinguish.• Sounds appear to be subdued.• Another person's speech seems mumbled or slurred.• Certain sounds—the ticking of a watch, the dripping

of a faucet, or the high notes of a violin—are difficult orimpossible to hear.

• A continual hissing or ringing background noise maybe heard against normal sounds.

Some people, because of fear, vanity, or lack of information, are reluctant to acknowledge that they havehearing problems. Wearing a hearing aid is a socialstigma for some. The dread of finding a major illness ora need for surgery deters others from seeking help. Also,many people are under the impression that most hearingimpairments cannot be helped or that assistance is toocostly. Such fears are unfounded in view of the modernadvances i n med ica l sc ience .

Recognizing a hearing disorder in a child is particularlydifficult. Changes in behavior, such as refusal to participate in group activities, slowness, inattention, or poor attitude may be signals of defective hearing. If a child doesnot appear to be trying to talk by the age of 1 year, aqualified ear specialist (otologist, otolaryngologist, orotorhinolaryngologist) and an audiologist should examinethe youngster. Some children are born with defectivehearing; others may experience it through illness or accident. Even a minor undetected problem can seriously affect a child's total personality and development. Casesare still found of children thought to be and treated asdull or mentally retarded when the problem is actuallyhearing loss. Early detection and treatment are extremelyimportant especially today when even very young children can be treated successfully by use of hearing aidsand speech therapy devices.

Hearing impairments have a variety of causes. "Conductive" impairments result when there is a blockage ofthe passage of air or injury to the mechanical movementof the outer or middle ear. If caused by medically treatable conditions, such as infection, wax build-up, physicalblockage, or rupture of the eardrum, it is not uncommonfor the listener to recover normal hearing. "Sensori-Neural" or "nerve" impairments cannot usually be corrected by treatment. Hearing loss either stays the sameor gets worse; it seldom, if ever, gets better. Such impairments are caused by damage to the delicate nervemechanism of the inner ear. The usual causes are birthdefects, illness producing high fever, extended exposureto high noise levels, use of drugs (such as quinine andsome antibiotics), head injuries, vascular problems, or tumors. German measles occurring in pregnancy can causehearing damage to an unborn child. Impairment can alsodevelop as part of aging.

Where and How to Seek HelpPeople suffering from hearing loss should have a medi

cal evaluation by a licensed physician, preferably onewho specializes in diseases of the ear. Ear specialists candiagnose and treat hearing impairments. They can tellwhether the problem can be treated with surgery, medicine, or by use of a hearing aid. The importance of establishing the cause and type of loss, and thus the treatment, cannot be overstated. Too often, people withremediable ear disease fail to get proper attention untilthe condition is beyond medical help. In some cases, particularly where surgery is recommended, the patient maywant to seek a second medical opinion.

Once medical or surgical treatment is ruled out or


There are four basic types of hearing aids. They are:all-in-the-ear, behind-the-ear, eyeglass type, and bodyaid. The body aid has a carrying case connected bycord to the receiver. The all-in-the-ear, as shownabove, fits directly into the ear and extends part wayinto the ear canal. This type has no external wires andis more suitable for compensating for mild hearing losses.

completed, the ear specialist may refer patients to an au-diologist for tests and recommendations. On a physician'sadvice, it is particularly important for children with hearing impairments to see an audiologist.

Audiologists are professionally trained and in someStates must satisfy specific requirements for a license.The American Speech and Hearing Association (ASHA),whose members are speech and language pathologists,audiologists, and speech and hearing scientists, awardscertificates of clinical competence to members who meetspecific requirements and pass a comprehensive nationale x a m i n a t i o n .

Various sounds may be used to test hearing—thevoice, the ticking of a watch, tuning forks, noisemakers,handclaps—but the principal testing instrument is an audiometer, which emits electrically controlled sounds. Itprecisely measures and records a patient's hearing threshold. Physicians may use audiological test results to diagnose specific hearing problems. This testing is particularlysignificant because it can be repeated over time to detectchanges in hearing.

The audiologist may help the physician evaluate testdata to determine whether the patient would benefitfrom a hearing aid and in some cases may recommend aparticular type. Alternatively, a physician may determine

that consultation with an audiologist is not warranted andrefer the patient directly to a hearing aid dispenser for ahearing aid evaluation.

Role and Responsibilities of the DispenserA dispenser sells, leases, or rents hearing aids. The

dispenser may or may not be a medical doctor or an audiologist. A dispenser's functions include giving the patient hearing tests for selection and fitting of hearingaids, encouraging prospective users to try amplification,making impressions for ear molds, counseling hearing-impaired people on adapting to a hearing aid, and repairingdamaged hearing aids.

In most States hearing aid dispensers are licensedunder standards of competence and a strict code of ethics. The National Hearing Aid Society has a voluntarycertification program for qualified dispensers.

An FDA regulation effective August 25, 1977, imposesconditions for the sale of hearing aids to help preventmisrepresentation and to assure adherence to propermedical standards. Hearing aid dispensers must obtain awritten statement from the patient signed by a licensedphysician stating that the patient's hearing has been medically evaluated and that the patient is considered a candidate for a hearing aid. This medical evaluation musthave taken place no longer than 6 months before thedate of sale. The dispenser must give the patient writteninstructions for using the hearing aid selected and checkwith the patient for understanding.

Dispensers must also advise patients to consult a physician or ear specialist promptly if the dispenser finds anyof these conditions: visible congenital or traumatic deformity of the ear; history of active drainage from the earwithin the previous 90 days; acute or chronic dizziness;unilateral hearing loss of sudden or recent onset withinthe previous 90 days; visible evidence of a significant accumulation of wax or the presence of a foreign body inthe ear canal; pain or discomfort in the ear; or audio-metric air-bone gap equal to or greater than 15 decibelsat 500 Hertz, 1000 Hertz, and 2000 Hertz. (Hertz is ameasurement of sound wave frequency.)

Patients 18 or older may waive the medical evaluationrequirement, but the dispenser is required to warn themb e f o r e h a n d t h a t i t i s n o t i n t h e i r b e s t h e a l t h i n t e r e s t s .The dispenser must avoid encouraging patients to waivethe medical examination. Whenever a patient chooses towaive, the dispenser is required to obtain his signatureon the following statement:

"I have been advised by (hearing aid dispenser's name)that the Food and Drug Administration has determined that my best health interest would be served if Ihad a medical evaluation by a licensed physician (preferably a physician who specializes in diseases of theear) before purchasing a hearing aid. I do not wish amedical evaluation before purchasing a hearing aid.(patient's name) (date)."The dispenser must keep a copy of each patient's med

ical evaluation or a signed waiver on file for 3 years.For patients under 18, medical evaluation before sale

of a hearing aid is mandatory. Children with a hearingloss should also be directed to an audiologist becausehearing loss may cause problems in their language devel-


opment, education, and social growth and they maytherefore have need for special rehabilitation or speechtherapy programs.

Types of Hearing AidsA hearing aid is a miniature amplifying system de

signed to compensate for hearing loss. It consists of:• A microphone that picks up sound waves and con

verts them into electrical signals.• An amplifier to increase the strength of the signal.• A battery providing energy to operate the hearing

a id .• A receiver, which changes the electrical signals back

to sound waves .• A specially fitted ear mold that connects the receiver

to the ear canal .There are basically four types of hearing aids:• The "all-in-the-ear" aid fits directly into the ear, and

extends partly into the ear canal. This aid has no externalwires and is light in weight. It is used mostly in cases ofmild hearing loss.

• The "behind-the-ear" unit is small and fits snuglybehind the ear. Microphone amplifier and receiver are inone unit connected to the ear mold by a short plastictube. This type of aid is suitable for losses ranging frommild to severe.

• The "eyeglass" type of aid is similar to the "behind-the-ear" model except that it is built into an eyeglassf r a m e .

• The "body" aid has a larger microphone, amplifier,and power supply in a pocket carrying case connected bya cord to the receiver, which is attached directly to theear mold. The "body" aid is most suitable for peoplewith severe hearing loss.

One type of receiver, not widely used but practical forcertain clinical conditions, involves conduction of soundthrough a bone behind the ear instead of amplification.

A "monaural" system consists of a hearing aid for oneear; a "binaural" system uses two hearing aids, one foreach ear. Costs of hearing aids depend on the range ofthe instrument and its special features, such as telephonepickup, or adjustable tone and volume control.

The prospective user should not be overly influencedby price or appearance. The most expensive or attractive-looking aid may not be the best for him. No single hearing aid is suitable for all types of hearing loss. No hearing aid can either cause or prevent additional loss, orcure an existing loss.

Hearing aids can be sold through the mail, providedthey meet FDA regulation requirements. A FederalTrade Commission (FTC) ruling requires that a firm shipmail orders 30 days from purchase or by the agreed-upontime in the contract. Failing this, the firm must informthe purchaser of the delay. Purchasers may cancel ordersif a company changes the date of shipment without not ice.

In buying a hearing aid, the purchaser should keep inmind that he is the best judge of which aid is most comfortable and provides the most help.

Many hearing aid manufacturers offer trial-rental orpurchase option plans, usually up to 30 days. The purpose is to allow the purchaser enough time to judge theinstrument's effectiveness and benefits. Prospective wear

ers who take advantage of such trial programs should stillhave the medical evaluation examination even if theyfind the aid improves their hearing during the trial per i o d .

The purchaser should be patient and unhurried in making judgments. It takes time to get used to wearing anaid. The dispenser can provide help in adapting to theaid, as well as provide any needed mechanical and electronic adjustments. In selecting an aid, it is imperative toshop for quality of service in addition to quality of produ c t .

P r o b l e m s W i t h P r o d u c t sConsumers who have problems with or complaints

about hearing aids or dispensers should report theseproblems to authorities. For example, if a dispenser misrepresents or fails to observe FDA's conditions-of-salerequirements, the consumer should contact the nearestFDA District Office listed in his local telephone directoryor write to the Agency.

FDA investigators follow up on such complaints. Theywill visit the dispenser involved and audit the requiredconditions of sale—records of medical evaluations orwaiver slips—and the labeling of hearing aids. Under theFood, Drug, and Cosmetic Act violations can bring jailor fines. For a first offense, the penalty is a maximum ofa $1,000 fine or 1 year in jail, or both.

Complaints on service rendered by a dispenser shouldbe directed to State agencies such as State attorneys general, hearing aid licensing boards, or local consumeragencies. The National Hearing Aid Society may also becontacted at 20361 Middlebelt Road, Livonia, Mich.48152. Its toll-free Hearing Aid Helpline number is (800)5 2 1 - 5 2 4 7 .

In many areas, speech and hearing centers associatedwith hospitals or universities can also provide assistancein selecting a hearing aid. Most of these centers offer awide range of services, including examination by a physician specializing in diseases of the ear, various types ofhearing tests, a hearing aid evaluation by an audiologist,and additional services, such as training in lip readingand counseling.

More detailed facts on hearing and hearing aids aregiven in the booklet titled: "Facts About Hearing andHearing Aids," a joint publication of the National Bureau of Standards and FDA. Free copies are available bywriting to: FDA/Hearing Aids, 8757 Georgia Avenue,Silver Spring, Md. 20910.

Information on how to recognize hearing loss is available from such organizations as the Better Hearing Institute, 1430 K St., NW., Suite 200, Washington, D.C.2 0 0 0 5 .

Thanks to technology and advances in science andmedicine, hearing loss today is not necessarily the problem for an individual that it was a few generations ago.People with hearing impairments often can lead normallives. Usually, it's merely a case of taking action to seethat proper medical attention is sought as soon as theproblem is recognized.

(Research and writing for this article were done by JoanRudick and Richard Bimonte of FDA's Bureau of Medical Devices.)


Stubborn and Vexing,That 's Acne

Acne can make the awkward age ofa d o l e s c e n c e e v e n m o r e a w k w a r d . A n dit can leave physical and psychological scars for life. Some people seemto have a propensity for it, but thereare some ways to minimize the problem and some preparations useful fort r e a t m e n t .

ZITS . . . Those yucky blackheads,pimples, and sores your mothermore politely calls acne and yourdoctor more graphically terms ''acnevulgaris." At the first sign of a telltale spot on your chin you fear theworst, your looks will be ruined, nobody will go out with you, and you'llbe on the fringes of society for therest of your life.

If it makes you feel any better, thisis one time when you definitely arenot alone. Some 80 percent of thepopulation develops acne to some extent during adolescence—that awkward time when you're older than achild, but younger than an adult.Acne may persist beyond the age of25, particularly in women.

Acne is not something to makejokes about. It is a real disease ofthe skin that can last a long time andoften can lead to severe scarring.And it can have a great effect on thelife of the person suffering from it.

Technically, acne is a disease ofthe pilosebaceous unit in the skin.

The pilosebaceous unit is made upof a hair follicle (A) and a sebaceousgland (B), which are connected tothe surface of the skin by a duct (C)through which the hair passes.("Pilo" comes from the Latin wordpilus, meaning hair.) The sebaceousgland produces sebum, a mixture offats and waxes which travels throughthe duct and spreads over the surfaceof the skin to help keep the skin andh a i r m o i s t .

Acne develops when the sebaceousglands and the lining of the duct begins to work overtime. The glandsproduce more sebum, making theskin more oily. Normally the lining

C l o s e d C o m e d o o r W h i t e h e a d

14 I May 1980 / FDA Consumer

of the duct sheds cells which are carried to the surface of the skin by thesebum. When acne develops, thesecells stick together to form a thicklayer that blocks the duct. More cellsand more sebum pile up behind thislayer and form a plug called a comedo (D).

If the plug stays below the surfaceof the skin it is called a "closed" comedo or whitehead. If the plug enlarges and pops out of the duct it iscalled an "open" comedo. An opencomedo (plural: comedones) isk n o w n a s a b l a c k h e a d b e c a u s e t h e

tip is dark. This is not dirt and itwon't wash away. The discolorationis due to a buildup of melanin, thedark pigment in your skin.

The kind of hair in the hair follicleplays some part in the developmentof acne. If it is thin and small it maynot be capable of keeping the ductopen. Instead, it becomes trapped inthe plug. Heavier hair on the scalpor face may push the plug to the surface of the skin and thus keep thecomedo from forming. Pilosebaceousunits are found all over the body, butthere are more of them on the face,upper chest, and back, which explains why acne usually occurs inthese places.

If all you've got are some whiteheads and blackheads you have whatis called "noninflammatory" acne.B u t i f t h e c o m e d o n e s b e c o m e i nflamed and pimples, papules, andpustules develop, you have "inflammatory" acne. Inflammatory acne almost always begins with whiteheads,n e v e r b l a c k h e a d s . W h e n e x c e s s i v e

pressure within the comedo producesleakage into the surrounding tissue,disfiguring cysts and abcesses canf o r m .

What makes the sebaceous glandsb e c o m e m o r e a c t i v e a n d t h u s c a u s e sacne to develop is not completelyunderstood. However, it is knownthat acne almost always starts whenthe body begins to mature—at aboutage 11 for girls and 13 for boys. Atthis time boys' bodies begin to pro

duce male hormones, called androgens, that stimulate the activity ofthe sebaceous gland. Girls also produce these hormones, but not asmany of them. Acne tends to bemore severe among boys than girls.T h e r e d o e s s e e m t o b e a c o n n e c t i o nbetween a girl's menstrual cycle andthe appearance of acne, perhaps theresult of changes in hormone levels.Some scientists have suggested thatacne may run in families, but no research has been done to prove or disprove this theory.

No germ or virus is known tocause acne, although bacteria thatare normally on the skin do contribute to the development of inflammatory acne by causing the breakdownof skin fats into irritating chemicals.

Bodily changes are not the onlyfactors in the development of acne.The disease can get its start, or certainly can be aggravated, in a number of other ways. For instance, youmay find those nasty pimples formingunder a tight head band or bra strap.Tu r t l e n e c k s h i r t s o r s w e a t e r s t h a t r u bo n t h e n e c k c a n m a k e i t d i f fi c u l t t otreat acne in those areas. If you're inthe habit of resting your chin on yourhand, you may find acne starting upalong the edge of your jaw. Usingcertain cosmetics, pomades (greasyhair dressing), abrasive soaps, andc leanse rs a l so can l ead to acne .

Acne also can result from usingsome drugs, such as hormones, epileptic drugs, and antituberculosisdrugs. Acne-like skin eruptions candevelop from exposure to excessivehumidity, industrial oils and grease,a n d c h e m i c a l s s u c h a s t h e P C B ' s t h a thave been in the news lately. Birthcontrol pills seem to work in both directions. They cause acne in somewomen and help clear it up in others.In fact, The Pill is sometimes used totreat acne in girls and women.

One thing is fairly certain. Chocolate, nuts, cola drinks, and "fastfoods" haven't a thing to do withacne. Neither does long hair, unlessit is particularly oily.

What can you do about acne? Firstoff, it is important to understand thatthere is no "magic bullet" that willdispose of acne once and for all.Acne can't be cured or prevented.There are things you can do andmedicines you can use that will reduce your symptoms and preventugly scarring, but they all take time.Time, indeed, may be the best healeri n s o m e c a s e s o f m i l d a c n e t h a t c l e a r s

up as the individual suffering from itg r o w s u p .

Acne has been with us a long time.Here, for instance, is the treatmentsuggested by one Marcellus of Bordeaux in 350 A.D.: "Watch a fallingstar, then instantly while the star isstill shooting from the sky, wipe thepimples with a cloth or anything thatcomes to hand . Jus t as t he s ta r f a l l sfrom the sky, so the pimples will fallfrom your body, only you must bevery careful not to wipe them withyour bare hand or the pimples willb e t r a n s f e r r e d t o i t . "

On the other hand, your chancesof improvement will be better if youfollow a few simple rules. Don't usef a c i a l c r e a m s o r m o i s t u r i z e r s s i n c e

they may block those pilosebaceousducts. Don't wear tight-fitting garm e n t s s u c h a s h e a d b a n d s a n d t u r t l e -n e c k s w e a t e r s o r s h i r t s . Yo u w i l lwant to clean your skin when it feelsoily, but don't scrub it. This can onlym a k e t h e a c n e w o r s e b e c a u s e i t f u rt h e r i r r i t a t e s t h e s k i n . T h e i d e a i s t omake the skin dry. If the skin feelstight, cut down on the number oftimes you wash.

Ultraviolet light from sunlampsand old Sol himself helps clear upmilder forms of acne. However, youshould stay out of the sun if you aretaking certain drugs, including someacne drugs.

While it may be tempting to pickat pimples and squeeze your blackh e a d s t h e c a r d i n a l r u l e i s — D O N ' T.You can cause injury to the skin andthe underlying tissues. There arem e d i c a l i n s t r u m e n t s c a l l e d c o m e d oe x t r a c t o r s t h a t a r e u s e d t o r e m o v e


blackheads. Some doctors suggestthat their patients use such an instrum e n t t h e m s e l v e s . O t h e r d o c t o r sw o u l d r a t h e r r e m o v e b l a c k h e a d s i nt h e i r o f fi c e o r c l i n i c .

T h e r e a r e a n u m b e r o f m e d i c i n e s

you can get without a doctor's prescription to treat mild acne. Sulfur,resorcinol, salicylic acid, and benzoylperoxide are some of the ingredientsfound in these drug products. Theyare called "peeling agents" becausethey cause a mild irritation and apeeling of the top layer of the skin.This helps keep the pilosebaceousducts open and get rid of the comed o n e s .

Preparations containing benzoylperoxide are usually applied at nightafter the skin has been thoroughlycleaned. Benzoyl peroxide is irritating so you should be careful not to getany on your eyelids, lips, or neck.Don't decide to improve your suntanwhile you're using benzoyl peroxidesince the ultraviolet rays will increasethe irritation to your skin. Some people won't be able to use this medicine at all because it produces a sensitivity reaction.

If you have more than a few pimples and blackheads, you should seea dermatologist—a doctor who specializes in the treatment of skin cond i t i o n s . H e o r s h e w i l l k n o w b e s thow to treat your particular type ofacne. One drug that might be prescribed is retinoic acid, also called" v i t a m i n A a c i d " o r " t r e t i n o i n . " B es u r e t o f o l l o w t h e d o c t o r ' s o r d e r s t othe letter if this drug is prescribed foryou. It can cause excessive skin irrit a t i o n . O t h e r m e d i c a t i o n s h o u l d b eused with caution if you are using retinoic acid. And, what is most important, you should stay out of the sunand avoid using a sunlamp no matterhow pale and pasty you think youl o o k .

W h e n r e t i n o i c a c i d fi r s t c a m e o nt h e m a r k e t i n 1 9 7 1 t h e m a n u f a c t u r e rknew that it would make patientsmore sensitive to sunlight. In recentyears, studies on laboratory animals

have shown that the combination ofretinoic acid and sunlight can increase the chance that you might gets k i n c a n c e r l a t e r i n l i f e .

S o m e a n t i b i o t i c s a l s o a r e u s e d t otreat and to prevent the developmentof pustules, papules, and cysts. Theyare not used to treat whiteheads orblackheads. Tetracycline is the antibiotic most often used. Because it isused over lengthy periods the dailyoral dose is usually low. Once in awhile a girl who is on tetracyclinewill develop an infection called candidal vaginitis. Other side effects thatsometimes develop are irritation ofthe gastrointestinal system and sensitivity to light. Women who are pregnant should never take tetracyclinessince these drugs will affect the developing teeth of their babies. Anytime you take tetracycline, whetherfor acne or some other infection, it isimportant to remember that this drugshould never be washed down with aglass of milk or taken along with anydairy product. The milk interfereswith the effectiveness of the drug.Take this medicine 1 hour before or2 hours after meals.

There also is a topical form of tetracycline, that is, one that is applieddirectly to the skin. Don't be surprised if this drug makes your skinyellow. The color washes off. Youmay find yourself the hit of the discodance if your doctor prescribes topical tetracycline. The drug will maketreated areas of your skin fluoresceunder ultraviolet light.

S u l f o n e s a n d c o r t i c o s t e r o i d s s o m etimes are used to treat very bad caseso f a c n e .

An investigational drug that mayultimately be approved for treatingvery severe cases of acne is a synt h e t i c m e m b e r o f t h e v i t a m i n A f a m

ily known as "13-cis-retinoic acid."R e s e a r c h e r s a t t h e F e d e r a l G o v e r nm e n t ' s N a t i o n a l C a n c e r I n s t i t u t ehave been testing this drug as a possible cancer preventive. They used itto treat 14 people with acne who hadnot been helped by any other medi

c i n e s . T h e r e s u l t s w e r e d r a m a t i c .

However, numerous side effects wereobserved. This drug is still beingt e s t e d a n d i t i s n o t k n o w n a t t h i stime when it might be available forthe general public.

Even though some of the drugsu s e d f o r a c n e a r e r e l a t e d t o v i t a m i n

A, doctors warn that you should nottry to treat yourself with largeamounts of vitamin A that you canbuy in drugstores or health foods t o r e s . S u c h s e l f t r e a t m e n t c o u l d l e a dto serious side effects, including damage to your liver.

In very bad cases of acne the dermatologist may use surgery to drainlarge pustules or abcesses. Anotherform of surgery, called cryosurgery,involves use of liquid nitrogen ors o l i d c a r b o n d i o x i d e t o r e d u c e i nflamed areas of the skin. ("Cryo"means cold, and both liquid nitrogenand solid carbon dioxide are verycold.) Dermabrasion—a techniquethat is like sandpapering the skin—s o m e t i m e s i s u s e d t o r e m o v e s c a r sleft by old acne, but it is not used onn e w i n fl a m e d a c n e s o r e s .

Although it is unlikely that a quickcure for acne is on the way, the prospects that treatments will improveare good, according to a recent report to Congress. The report is called"Analysis of Research Needs andPriorities in Dermatology" and wasprepared by the leading dermatologists in this country. These prospectsdepend on getting financial supportfor basic research on such subjects aswhy the lining of the hair follicle behaves the way it does, how the hormones control the sebaceous glands,and on the relationship between thes k i n b a c t e r i a a n d a c n e . M o r e i n f o rmation is needed on the natural history of the disease and the role ofskin type, menstrual cycle, dietaryfactors (including trace metals), andstress, according to the report. Andthere should be more work done todevelop drugs that can be applied directly to the skin.


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Inhalants: Quick Route To Danger

Inhaling certain substances to get "high''has been risky allthe way back to antiquity, and is no less dangerous inmodern times. Adding to the problem today are a coupleof substances that have enjoyed a certain amount of socialacceptance: butyl nitrite, sold as a "room odorizer," andnitrous oxide, better known as "laughing gas." But there'snothing laughable about the hospital trip that may resultfrom using these and other inhalants.

by Annabel Hecht

In 1978 over 150 people in this country died as a resultof inhaling volatile substances, such as gasoline, spraypaint, paint thinner, or transmission fluid. About 1,800more required emergency room treatment. These deathsdid not occur because of accidental exposure in the workplace. The substances were deliberately inhaled for theirintoxicating effects, with no appreciation for the dangersi n v o l v e d .

While FDA does not have regulatory authority over allvolatile substances, the Agency is very much concernedabout the increasing abuse of two inhaled substances thatare under its control. One is butyl nitrite, a substancebeing sold under the guise of a "room odorizer." Theother is nitrous oxide, a gas with a variety of legitimateuses, including use as an anesthetic. It is sometimescalled "laughing gas."

Because the respiratory system provides a quick routeto the bloodstream, inhaling a volatile substance is likehaving it injected into the body. The effect can be immediate with loss of consciousness, heart irregularities, oreven death. After a time, those who inhale substancessuch as solvents may develop organic brain syndrome, acondition characterized by loss of muscular coordination,lethargy, irritability, confusion, or disorientation. Inhaling volatile substances also can lead to peripheral nerveinjury, and liver and kidney disease. Long-range effects,which may not show up for 10 to 30 years, include an increased risk of developing cancer as well as geneticchanges.

Despite the world-wide extent of inhalant use andabuse, it has been only in the past 30 years that socialscientists have studied this phenomenon in the UnitedStates. One of the early episodes reported involved a local outbreak of gasoline sniffing in Warren, Pa., in 1951.Further public attention was focused on inhalant abuse inthe 1960's when adolescents took to sniffing the glue theywere using to make model airplanes and cars. The popularity of the habit was intensified, some observers say, bysensational press and community campaigns against it.

Completely overlooked in the furor over glue sniffingwas that adolescents also were sniffing an assortment of

other commercial solvents, a variation of drug abuse thatprobably got started in the late 1950's. Swirling in theirheads were the vapors from contact cements, paints, lacquers, drycleaning fluids, transmission fluids, liquidwaxes, shoe polish, lighter fluids, nail polish removers,degreasers, and refrigerants.

Aerosols came along in the sixties, starting with glasschillers and vegetable nonstick fryer sprays. Every typeof aerosol has been abused, including cold weather carstarters, air sanitizers, window cleaners, furniture polishes, insecticides, disinfectants, spray medications, deodorants, hair sprays, and antiperspirants. Clear lacquersand gold and bronze paint sprays also are popular amongs n i f f e r s .

The seventies has seen a surge in the abuse of nitrousoxide—mainly by health professionals and college-ageyouth—and of butyl nitrite, close chemical kin to a drugused to treat symptoms of angina pectoris.

Just who is sniffing this array of substances? Statistically their numbers are small. The National Institute ofDrug Abuse (NIDA) estimates that about 7 million people over the age of 12 have experimented with or arechronic users of inhalants. In contrast, 42 million havetried or used marijuana. However, experts in the drugabuse field believe that many inhalers just don't getcounted. For instance, those most likely to abuse industrial solvents, often school dropouts or truants, aren'tlikely to be covered in school surveys of drug abuse. Inthe past, surveys frequently did not include questionsabout inhalants, or they lumped everything under "gluesniffing." In addition, inhalant users seldom seek medicalattention for problems related to their sniffing habit, sothey don't often show up in emergency room reports.

The largest concentration of inhalant users appears tobe among young adolescents. One study of high schoolstudents nationwide showed that 12 percent of the classof 1978 had sniffed something at some time in their lives.Around 2 percent were current users. These figures represented a slight increase over the previous 2 years. Moreboys than girls indulge in sniffing, but the gap betweentheir numbers is closing.

In contrast to users of illicit drugs, most of whom gottheir start in the last 3 years of high school, a majority ofinhalant users had their first sniff before they got to the10th grade, according to the survey of the class of 1978.It was once thought that this adolescent interest in sniffing glue or other substances fades as the sniffer matures.Actually, recent studies suggest that as they grow older,those who indulge in this type of substance abuse startusing other drugs but only partially cut down on their inhalant use. Current interest in nitrous oxide and butyl nitrite among college students also suggests that inhalant


■ t i e n n i M i

use is not just "kid stuff."Early research pictured the typical sniffer of industrial

solvents as poor and frequently Hispanic. While it remains more prevalent among the poor, inhalant use today does cut across socioeconomic lines, researchers havef o u n d . I n h a l a n t s a r e u s e d m o r e o f t e n i n r u r a l a r e a s t h a nin the city, studies have shown.

Adolescents bent on getting "high" choose volatilesubstances for a number of reasons. The intoxicating effect is immediate, though not long lasting. What theysniff is inexpensive, readily and legally available, andoften found in the home or workplace. Compact packaging makes items such as glue or nail polish remover easyto slip into a pocket or purse. The dangers of sniffing—including the potential danger of death—are ignored.

The health problems of inhalant users have not beenstudied systematically. What is known of the damageu s e r s c a u s e t h e m s e l v e s c o m e s f r o m a l i m i t e d n u m b e r o fmedical histories and from studies of people exposed tosolvents on the job. Such studies have shown, for instance, that chronic exposure to benzene, a component ofsome solvents and of gasoline, can cause leukemia ands e v e r e a n e m i a . G l u e a n d c o n t a c t c e m e n t c o n t a i n n - h e x -ane which can damage the nervous system and causenumbness, loss of touch sensation in the feet, and limbweakness. Ketones in rubber cements, printing ink, andpaint can cause similar nerve damage. This impairmentmay show up sooner after exposure to ketones than afterexposure to n-hexane.

Methylene chloride, used as a solvent in spray paintsand thinners, converts to carbon monoxide in the body,which interferes with the distribution of oxygen. Chloroform, trichloroethylene, and halothane all have the potential to cause cancer if used repeatedly for recreationalpurposes. Death has been associated with exposure tohousehold cleaning fluids containing trichloroethyleneand methylchloroform.

Perhaps some of the greatest inhalant tragedies in thepast were the deaths of many youngsters who sniffed theFreon aerosol propellants in such products as vegetablefrying pan spray. It is estimated that as many as 700deaths may have occurred in the 1970's from inhaling alltypes of aerosols. In many of these cases sudden deathwas caused by heart irregularities brought on when sniffing was followed by vigorous exercise.

Not to be overlooked in the list of the ill effects of inhalant abuse is the damage to the psyche. Youngsterswho get an early start as sniffers may be paying a highprice in terms of their psychological as well as their physical development. Dealing with problems through solventfumes is poor preparation for coping with the normalstresses of life. Furthermore, youngsters who abuse solvents are among the heaviest drug users.

The picture that emerges of the abuse of butyl nitriteand nitrous oxide is much different than that of industriala n d c o m m e r c i a l s o l v e n t s .

Butyl nitrite came on the drug abuse scene in the early1970's. It is closely related chemically and pharmacologically to amyl nitrite, a prescription drug that has beenused in treatment of angina pectoris (pain related toheart ailments) since 1867. Butyl nitrite was investigatedfor drug use in 1880, but has never been used clinicallyto any extent.

When amyl nitrite was made an over-the-counter drugin 1960, it became a prime candidate for abuse. Called"poppers" because of the sound made when the mesh-covered glass vials or ampules were crushed prior to inhalation of the fumes, these drugs gave the user a quick"h igh. "

FDA reclassified amyl nitrite as a prescription drug in1969 and butyl nitrite became more readily available.First popular in homosexual communities, butyl nitrite isnow used both as a sexual stimulant and euphoriant inheterosexual circles. Sold as a "room odorizer" or "liquid incense" under a variety of names that are suggestiveof its odor—Banapple Gas, Locker Room, Rush, JacAroma, Satan's Scent, Locker Popper—butyl nitrite isavailable in novelty stores, some record stores, and"head" shops that cater to drug-oriented youth.

How many people are using butyl nitrite is difficult tosay. It is estimated, on the basis of sales data publishedin the press, that 4 to 10 million vials of the drug are soldeach year. Primary users are older teenagers and younga d u l t s o f b o t h s e x e s .

The most recent survey of high school students madeby the National Institute of Drug Abuse reveals that 1out of every 9 seniors has tried butyl nitrite; 1 out of 40used it in the month just prior to the survey; and about 1out of every 1,000 students uses it every day.

From what is currently known, there have been somedeaths from butyl nitrite and several of these resultedfrom ingestion of the substance. Users generally experience headaches, dizziness, perspiration, and flushing ofthe face. Less common reactions include nausea, vomiting, and fainting. There is a risk that over a time theheart and blood vessels could be damaged. Inhaling nitrites could be fatal to people with heart disease.

Nitrous oxide is even older than amyl and butyl nitrite.Discovered accidentally in 1773 by Joseph Priestly, nit r ous ox i de was one o f t he fi r s t vo l a t i l e subs tances t o beabused. In the 18th and 19th centuries "ether frolics"and demonstrations of "laughing gas" were common parlor games among the upper classes. The fact that the participants in these events were feeling no pain eventuallyled to the realization that these gases have a legitimateuse in medicine. Ironically, Dr. Horace Wells, the manwho introduced nitrous oxide to dentistry in 1844, died asa r e s u l t o f c h l o r o f o r m a b u s e .

Today, nitrous oxide has a number of commercial uses

20 / May 1980 I FDA Consumer

including that of general anesthetic, particularly in dentaloffices; propellant to manufacture whipped cream; rocketfuel; and leak detector. Only the first two package formsa r e b e l i e v e d t o b e a b u s e d .

Abuse of nitrous oxide as an anesthetic has a long history. One medical historian has recounted cases of misuse of the gas by American medical students in the late19th century.

How many people in the health professions today maybe abusing nitrous oxide is not known, but reports in themedical literature and other sources suggest that anesthesiologists, doctors, nurses, dentists, and inhalation therapists are among those who do.

When nitrous oxide is a propellant for making"whipped cream," it is either in an aerosolized spray canwhere it is considered a legitimate food additive, or in asmall 8-gram metal cylinder, intended to be used with adispensing machine. These cylinders are popularly called"Whippets," since that is the brand name of one versionof this product. The cylinders are being purchased—oftenat "head shops"—by young people, particularly collegestudents, who have no intention of whipping anythingedible. Paraphernalia used with the cylinders include balloons from which the gas is inhaled. One man has comeup with a device called a "Buzz Bomb," which combinesthe nitrous oxide cylinder with a pipe for smoking.

The number of young people abusing this form of nitrous oxide is not known, although an article in the September 12, 1978, issue of Esquire magazine claimed thatproduction of Whippets had tripled in the last few yearsand many legitimate users were unable to get supplies.FDA has not been able to verify these statements. An informal survey of a number of States, made by theAgency last year, seems to indicate that nitrous oxideabuse by young people is not a major problem.

Damage to health from abuse of nitrous oxide is aproblem, however. Death can result if the gas is inhaledwith insufficient oxygen. Abuse of the gas over long periods of time can result in nerve damage, including lossof balance, leg weakness, tingling, and numbness in thefingers and toes. Shortness of breath, nausea, variationsin heartbeat, and hearing loss also have been reported asside effects of nitrous oxide abuse. Studies of healthprofessionals who are exposed to the gas in their work—dentists, dental technicians, anesthesiologists—haveshown that these people have an increased risk of kidneyand liver disease, spontaneous miscarriages, and other serious health problems.

"Doing something" about the small but persistentproblem of inhalant abuse is not simple, since the rangeof products abused is large and patterns of abuse differ invarious community and ethnic groups. Much more needsto be learned about the abusers, particularly in high riskgroups. To fill some of these gaps in understanding inhalant abuse, the National Institute of Drug Abuse is funding research in such areas as laboratory testing of inhalant chemicals and studies of the cause and extent of theproblem in different ethnic groups.

Controlling the abused products is one approach incontrolling inhalant abuse. Obviously it would be impossible to ban industrial solvents that serve a useful purpose, especially since those sniffing these substances willsimply turn to something else. However, other steps canbe taken such as the addition of oil of mustard to air

plane glue to make it smell bad, a move made voluntarilyby glue manufacturers.

Warnings on labels is another way to stop productabuse. FDA took this step in 1975 to curtail abuse ofnonstick frying pan sprays. When it was determined thataerosol cooking sprays were food additives within theAgency's jurisdiction, FDA called for the following warning on such product containers:

"Warning—Use only as directed. Intentional misuse bydeliberately concentrating and inhaling the contentsc a n b e h a r m f u l o r f a t a l . "

This regulation became effective May 30, 1976. Sincethen chlorofluorocarbons, the aerosol propellant responsible for the deaths of young sniffers, has been bannedfrom most consumer spray products because of its effecton the ozone layer in the atmosphere.

The labeling of hazardous household products, such asadhesives, paint thinners and removers, lighter fluids,cleaning solvents, lacquers, and aerosols containing volatile organic solvents is regulated under the Federal Hazardous Substances Act, now administered by the Consumer Product Safety Commission (CPSC). Hazardousproducts must bear a label that identifies any recognizedhazardous substance in the product, the nature of thehazard, and warnings or cautions and first aid instructions. Additional warnings are required for the productsthat present a particular hazard. For instance, volatile organic solvents, such as toluene, xylene, and petroleumdistillates that may be aspirated into the lungs must belabeled "Danger—Harmful or Fatal if Swallowed. Ifswallowed do not induce vomiting. Call physician immediately."

Even though glue-sniffing was popular at the time theHazardous Substances Act was being written, the newlaw did not take into account the potential for deliberateabuse or misuse of household products. Thus, the actcannot be used to make deliberate solvent inhalation anoffense or to take regulatory action against a manufacturer or a product that is deliberately abused.

As for butyl nitrite, manufacturers of the so-calledroom odorizers follow the CPSC labeling requirements tothe letter. Despite extensive labeling and warnings suchas "Avoid prolonged breathing of vapor," sales andabuse have not diminished. It would have to be provedthat injury or illness occurred under recommended conditions of use—that is, as a room odorizer, before CPSCcould take additional regulatory action.

Under the Toxic Substances Control Act, administeredby the Environmental Protection Agency (EPA), manufacturers are required to submit information on substances that present "substantial risk of injury to healthor environment" to the EPA Administrator, who is authorized to regulate any substance he determines to pres e n t " u n r e a s o n a b l e r i s k . " N o i n f o r m a t i o n h a s b e e n s u bmitted by manufacturers of butyl nitrite.

FDA has been aware of the recreational use and abuseof butyl nitrite for several years and is exploring whatcourse of action can be taken to halt this abuse. A keyissue is whether butyl nitrite is a drug within the meaningof the Food, Drug, and Cosmetic Act. Determiningwhether it qualifies depends on how it is labeled.

To FDA, labeling includes not only the materialprinted on or fixed to the container, but other written,


printed, or graphic material. This material does not necessarily have to accompany the product through thec h a n n e l s o f i n t e r s t a t e c o m m e r c e t o b e c o n s i d e r e d l a b e l

ing.A butyl nitrite product properly labeled as a room

odorizer would not be considered a drug, even thoughthe person who bought it did so to get "high." However,if the manufacturer or distributor suggests in labeling thatthe product is an aphrodisiac or euphoriant, the productcould be regulated as a drug.

In the meantime, many U.S. communities are seekingto impose legal bans or at least to limit the sales of thisproduct to adults. Georgia and Connecticut, for example,have established controls on odorizer sales, and Houston,Tex., has banned their sale to minors.

Nitrous oxide as a medicinal gas is regulated as a prescription drug by FDA and many of the States. Nitrousoxide as a whipped cream propellant is regulated byFDA as a food additive. Where the 8-gram cylinders fitis not so clear. As in the case of butyl nitrite, the Agencyis examining the options for controlling nitrous oxideabuse. Early this year a meeting was held with manufacturers of the gas to discuss steps that could be taken on avoluntary basis. Changes in labeling on nitrous oxide

containers are being considered. Materials also are beingprepared to alert the medical community to the dangeror inadvertent or deliberate exposure to this gas.

State and local governments are also concerned aboutnitrous oxide abuse. Legislatures in at least two States,New Jersey and Pennsylvania, have introduced bills thatwould restrict use of the gas. In Oregon, all manufacturers and distributors are being licensed by the State pharmacy board and inspected annually to make sure nitrousoxide tanks are properly labeled. Records of registrantsare being checked to verify legal sales. The Cincinnaticity council debated, but did not ban the 8-gram cylinders. The Kansas City, Mo., Liquor Control Agencyadopted a resolution prohibiting the use of nitrous oxidem a c h i n e s i n b a r s .

Whatever regulatory steps eventually are taken, FDAcau t i ons t hose who have access t o n i t r ous ox i de t o use i t

only as the manufacturer intended. Nitrous oxide is as a f e a n e s t h e t i c i n t h e h a n d s o f t r a i n e d m e d i c a l a n d d e n t a l

personnel and an effective aerosol propellant. But experience now proves that abuse of nitrous oxide is no laughing matter.

Annabel Hecht is a member of FDA '5 public affairs staff.

A Small 'Hif, /by Ed Goetz

4 4TT 7hat's it like?" I asked theW man behind the counter.

" Yo u V e n e v e r t r i e d i t ? " h e a s k e dm e b a c k .

Amidst pipes, rolling papers of allsizes and colors, coke spoons, andsnuff boxes, I was in a Washington,D.C., "head shop" buying a bottle ofbutyl nitrite. "No, I've never triedi t . "

H e r e a c h e d b e h i n d h i m o n t h eshelf and grabbed an open bottle of"Locker Room." He glanced aroundquickly, then handed the bottle tome. "Take a big hit," he told me, indicating that I hold the bottle directlyunder my nose and inhale. "Take abig hit."

I t o o k a s m a l l o n e . I h e l d t h e b o ttle about an inch away from mynose, already smelling the fumes ofthe chemicals without taking the exaggerated sniff that he wanted me to.I inhaled quickly and put the bottled o w n .

I felt it immediately. My head feltlighter and began to swim. It lastedfor 30 seconds or so and graduallyleft. In its place was a headache.

"I'll buy some," I said, and got

Big Headache

out my four dollars to pay."Don't do too much of that," he

warned, recognizing that I didn'tknow what I was doing.

"Why not?""It causes brain damage.""It does?" I asked with eyes big

and, hopefully, a worried look on myface. "Have you ever heard of anybody gett ing . . . "

" H u r t ? " h e fi n i s h e d . " N a h . " H ewas trying to reassure me.

" W h a t ' s t h i s s t u f f m a d e o f ? "

"Butyl nitrite." I silently gave himcredit for knowing at least thatm u c h .

" W h a t ' s t h a t ? "He l ooked a t me l i ke t ha t was a

stupid question. "A chemical.'^ Hewas getting tired of my questions.H i s f r i e n d b e h i n d t h e c o u n t e r c h i m e din, "I think it's some kind of synthetic substance. But it's legal," hesaid with a grin.

"Yeah, I 'm sure," I said. "Areyou selling a lot?"

"Well ... I don't push it, butwhen someone asks fo r i t . . . . " andh i s v o i c e d t r a i l e d o f f . H e l o o k e d a tthe car keys in my hand. "Don't be

doing it when you drive," he warned.I t ' s n i ce tha t he ca res abou t me so

much, I thought. "How long will oneo f t h e s e b o t t l e s l a s t ? "

"A long time.""How long?""Why, are you thinking of buying

a l o t ? ""Oh no, I just want to know." My

act was wearing a little thin by now."It'll last you." Hmmm, I won

d e r e d w h a t t h a t m e a n t .T h e s t u f f I h a d t r i e d w a s " L o c k e r

R o o m " a n d I n o t i c e d o n t h e l a b e l i th a d s a i d " r o o m o d o r i z e r . " S o I

brought that up in the conversation."Yeah, well that's just how they

label it," he said. That's how theyget away with selling it.

The shop was beginning to fill withpeople which was making my friendless talkative, so I clutched my littlebottle of butyl nitrite and left, wondering when the headache would goa w a y .

Ed Goetz got this headache while onassignment for FDA's Office of Public Affairs.


More Cups LiftedSans Caffeine"I'd gladly give up coffee for SankaAnd Sanka, Bianca, for you."

So ran the lines of a love song afew decades ago. People today aregiving up coffee for the decaffeinatedkind. Not for somebody namedBianca, but for their health. They'reconcerned about caffeine. This articlehas a look at those cleaned-up coffeesand how they get that way.

by Chris Lecos

Coffee drinking, like smoking, isnot an easy habit for some people to give up. Like smokers who areconcerned about their health, thereare thousands of coffee drinkers whoworry about the amount of caffeinethey consume. Just as there are former smokers, there are also formercoffee drinkers. And, like smokerswho switch to cigarettes with less tar,there are those who still drink coffee,but with less caffeine. In fact, drinkers of decaffeinated coffee are growing in number, and many are flocking to gourmet and specialty foodstores where they pay premiumprices—up to $6 a pound—for high

quality decaffeinated coffee.Coffee experts—including spokes

men for the industry—concede thatcoffee consumption overall has beenon a downswing almost continuouslyin the United States for the last 30years. But this decline has been accompanied by a gradual thoughsteady rise in the number of Americans drinking decaffeinated coffee.These trends are shown in the annualsurveys of the London-based Interna

tional Coffee Organization of coffeeconsumption in urban and rural areasduring a single winter day. The surveying is done in winter becausethat's when coffee consumption is ata peak. Findings from the thousandsof interviews conducted are projectedto measure coffee consumption patterns among Americans 10 years ofage or older.

In 1950, for example, more thanthree-fourths of the population in theUnited States over the age of 10 wasdrinking coffee (regular and decaffeinated) at a rate of 2.38 cups a person. Last year's winter surveyshowed that 57.2 percent of the over-10 group were drinking coffee at arate of 2.06 cups a person. The dropin consumption, the surveys indicated, is occurring among all agegroups but is most evident amongthose between the ages of 10 and 29,an age group which a National Coffee Association spokesman says isthe largest consumer of soft drinkstoday.

Decaffeinated coffee consumptionwas such a fractional part of the coffee business many years ago that


t he re was no da ta i nc luded in a re

port supplied by the National CoffeeAssociation of New York until 1958.In that year, the report showed thatAmericans drank an average of .04cups a day per person. It was up to.15 in 1970, and .33 cups last year.Such figures are based on coffee consumption averages for the total U.S.population. The same report showsthat 13.7 percent of the populationd r a n k d e c a f f e i n a t e d c o f f e e a t t h e r a t eof 2.4 cups a day per person in 1979compared to 7.3 percent of the population drinking about the sameamount in 1972, the first year suchfigures were available.

The report, supplied by the Nat i o n a l C o f f e e A s s o c i a t i o n o f N e w

York, noted that the decline of overall coffee drinking was "almost exclusively among those drinking regular coffee." Industry spokesmen,coffee dealers, and brokers interviewed cited a variety of reasons forthe decline: The rise in coffee pricesin recent years; a growing demand,in and outside the home, for decaffeinated coffee; the improvement int a s t e o f a n d c h o i c e s o f d e c a f f e i n a t e dcoffee; and the growing publica w a r e n e s s a n d c o n c e r n a b o u t c a ffeine consumption.

Caffeine is a drug that acts as astimulant to the central nervous syst e m . I t s e f f e c t v a r i e s w i t h t h e i n d i v i dual and the amount consumed, butcaffeine can cause nervousness, irritability, sleeplessness, anxiety, andeven heart palpitations. Virtually allage groups are exposed to it in someof the foods and drinks they cons u m e . C a f f e i n e i s a n a t u r a l s u b s t a n c ein coffee, tea, cocoa, and chocolateand is added to many cola- and pepper-type soft drinks, which accountfor 80 to 90 percent of "total dietaryuse of added caffeine," according toFDA officials. In addition, it is an ingredient added to such over-the-counter drugs as headache, cold, allergy, and stay-awake remedies andin such foods as baked goods, frozendairy products, soft candy, gelatins,and puddings.

The Food and Drug Administration was petitioned last year by several consumer groups to remove caffeine from its list of food ingredientsthat are considered "generally recogn i z e d a s s a f e " — t h e s o - c a l l e d G R A Slist—and to require that the labels oncoffee and tea warn pregnant women

of possible risk of birth defects totheir children if they consume caff e i n e . S u c h d e f e c t s h a v e o c c u r r e d i n

laboratory tests with rats and othera n i m a l s .

One of the ironies of history is thatdecaffeinated coffee is a major industry today because a German entrepreneur became convinced in theearly 1900's that his father, a coffeemerchant and taster, had suffered apremature death from the overcon-sumption of caffeine. It led the son.Dr. Ludwig Roselius, to patent in1908 a process for decaffeinating thecoffee bean that is basically the sameas that used today. He founded hisdecaffeination operation, KaffeeH.A.G., in Bremen, Germany, andfrom the French, "sans caffeine," hen a m e d h i s c o f f e e S a n k a .

He initially produced the coffee inGermany and France and then, justbefore World War I, started producing it in the United States. His operations were taken over during thewar by the U.S. Alien Property Custodian. In 1932, the General FoodsCorporation arranged with KaffeeH.A.G. to acquire the Sanka trademark and the process for its exclusiveu s e i n t h e U n i t e d S t a t e s . K a f f e eH . A . G . w a s a w o r l d l e a d e r i n d e c a ff e i n a t e d c o f f e e u n t i l W o r l d W a r I I .

Although it is much more refinedand costly today, Roselius' basicm e t h o d w a s t o h e a t t h e u n r o a s t e dc o f f e e b e a n s w i t h s t e a m t o r a i s e t h e i rm o i s t u r e l e v e l a n d t h e n e x t r a c t t h ec a f f e i n e f r o m t h e c o f f e e w i t h a c h e mi c a l s o l v e n t . B e n z e n e w a s o n e s o l v e n ti n c o m m o n u s e t h e n . T h e b e a n swould be washed, steamed, and thendried before being roasted andground for consumption.

Today, most—if not all—decaffeina t e d c o f f e e m a n u f a c t u r e r s i n t h eU n i t e d S t a t e s u s e c h e m i c a l s o l v e n t sto separate the caffeine. One of twobasic methods are used: Some applythe solvent directly to the bean—thedirect contact method, while othersu s e h e a t e d w a t e r f i r s t — t h e w a t e r e xt r a c t i o n m e t h o d — t o e x t r a c t t h e c a ffeine and then use the solvent to separate the caffeine from the resultings o l u t i o n .

Early last year a large manufacturing firm in Switzerland started producing decaffeinated coffee through apure water processing method inw h i c h n o c h e m i c a l s o l v e n t i s u s e d .Va r i o u s d e c a f f e i n a t e d b e a n s i m

ported and sold in this country,mainly at specialty and gourmet foodoutlets, are produced under thism e t h o d o f c a f f e i n e e x t r a c t i o n . M o s t

major American companies are experimenting with and testing similarmethods, although, industry spokesmen indicated, none are planning toconvert to a pure water system.

Most if not all companies usemethylene chloride to extract caffeine. Trichloroethylene (TCE) waswidely used until the mid-1970'sw h e n t h e N a t i o n a l C a n c e r I n s t i t u t e

(NCI) issued a "memorandum ofalert" that high doses of TCE induced liver cancer in mice. Companies voluntarily stopped using it afterJuly 1975. FDA has proposed banning TCE from use in foods, drugs,and cosmetics; however. Agency officials reported recently that no formala c t i o n h a s b e e n t a k e n b e c a u s e o f t h er e c e n t s u b m i s s i o n o f n e w t e s t d a t afrom Italy that is under review at thepresent time.

Methylene chloride belongs to thesame chemical family of chlorinatedhydrocarbons as TCE and it, too, hasbeen the subject of both ingestionand inhalation tests by NCI. An NCIspokesman said recently that theingestion tests would not be completed before the end of this year

24 / May 1980 I FDA Consumer

and that the inhalation tests wouldnot be done until sometime in 1982.Industry spokesmen say they are concerned over a possible ban of methylene chloride and, as a result, manycompanies have ongoing researchprograms aimed at developing alternate methods of decaffeinating coffee, including those that require noso lven ts .

B e c a u s e a s m a l l a m o u n t o f s o l v e n tis left on the decaffeinated beansduring the extraction process, FDAregulations state that the residue ofmethylene chloride on coffee beansmust not exceed 10 parts per million.Industry spokesmen state that the final amount of solvent residue is substantially below the FDA permittedm a x i m u m .

The manufacture of decaffeinatedcoffee is an automated process thatefficiently produces not only a decaffeinated coffee but also a valuableby-product—pure caffeine—that issold to soft drink companies, pharmaceutical firms and other companies that add it to their products. Inaddition, the manufacturing systemsare so efficient that the used solventis, for the most part, recaptured foruse again.

The direct contact method—of applying the solvent to the bean—is them o r e c o m m o n m e t h o d o f c a f f e i n e e xtraction in the United States. In thatmethod, coffee beans—usually in 5,-000-pound batches—are placed in alarge container and steamed to raisetheir moisture level to about 30 to 40percent. This draws the caffeine tothe surface of the bean. Chemicalsolvent is then poured into the kettle, drained, and recycled throughthe beans until 97 percent of the caffeine is removed. The process, to thispoint, takes about 12 to 18 hours.

The caffeine-laden solvent is thendrained. Steam is then used on thedecaffeinated beans to strip the residue of solvent that has adhered tothe beans. The beans are dried, usually with hot air, and roasted andground for consumption. If left wet,the beans are subject to mold andf e r m e n t a t i o n .

The caffeine removed from thebeans is now part of a sirupy solutioncomprised of solvent, caffeine, andwater. The task is to separate thecaffeine from the solvent. This isdone by boiling the solvent away.The evaporated solvent is condensed.

Some escapes into the atmosphere,but most is captured for reuse. Ther e c o v e r e d c a f f e i n e b e c o m e s a b r o w nish sludge that is sent to a refiningplant for purification. Purified caffeine is a white, crystalline powder.It looks like sugar but is lighter andfl u f fi e r .

T h e w a t e r e x t r a c t i o n m e t h o d w a s

developed more than 30 years ago toavoid leaving caffeine residues on thecoffee bean. In this method, hotwater, at controlled temperatures, isrecycled continuously through thebeans until—once again—97 percento f t h e c a f f e i n e i s r e m o v e d . I n o t h e r

words, the water itself draws the caffeine out. The caffeine-free beans aresteamed and dried for roasting andgrinding. The water extraction process produces a caffeine-laden solutionthat requires the use of methylenechloride (other chlorinated solventswork, too) to draw the caffeine fromthe water. The extracted caffeine isrefined and purified, as previouslydescribed. The caffeine-free waterextract has only trace amounts of thechlorinated solvent. The water is recirculated and used again to extractcaffeine from fresh batches of greencoffee beans. Thus, even though thesolvent was not used directly on thebean, as in the other system, thet r a c e a m o u n t o f s o l v e n t i n t h e e x t r a c tstill must be stripped away. Steamingstrips all but minute amounts of solvent from the decaffeinated beans.The beans then can be dried andr o a s t e d .

Because the process of decaffeinating beans modifies and adversely affects the flavor of natural coffee,many companies use less expensiveBrazilian and African beans (namely,the beans of the species Coffea ro-busta). Robusta has twice the caffeine content of the milder Coffea ar-abica beans, according to MichaelSivetz, a chemical engineer and coffee industry consultant from Corval-lis, Oreg., and the author of severalbooks on coffee technology. Notingthat "secrecy has been a policy of almost all coffee bean decaffeinators,"Sivetz writes:

"Decaffeinated coffees have alwaysbeen second class in taste and aromaproperties, as well as appeal. Thereasons fo r th i s l i e i n the severetreatment to which the green coffeebeans are exposed. The steam wetting, the chlorinated solvent rinsing,

and the many hours of steaming tod i s t i l l o f f t h e l a s t r e s i d u e s o f s o l v e n ttend to destroy the factors that cont r i b u t e t o n a t u r a l c o f f e e b e a n a r o m aand flavor. . . . The green beans suffer further in the final step of dryingto restore a shippable green bean.

The entire process, he noted, alsoalters the basic color of the greenbeans so that they vary in shades—from dark brown and black, to darkgreen (at best), to reddish brown.The acidity and alkalinity of greencoffee beans also affect their colorand appearance. The final color is oflittle consequence except perhapswhere the consumer purchases hiso w n r o a s t e d d e c a f f e i n a t e d b e a n s .Sivetz says that vacuum drying isconsidered the best way to dry abean, but this process, according toindustry sources, is quite expensiveand hardly any manufacturer does itthat way.

Although many refuse to reveal actual sales figures, coffee roasters,brokers, and distributors in NewYork, New Jersey, and the Washington, D.C., metropolitan area indicatet h a t d e c a f f e i n a t e d c o f f e e s a l e s a r e o nthe rise—anywhere from 12 to 15percent higher last year than 5 yearsago—and that more and more companies are marketing decaffeinatedcoffee today. A major outlet for thehigher-priced decaffeinated coffeebeans—those selling anywhere fromabout $5.50 a pound to $6 a pound—are gourmet and specialty foodstores. The higher quality domesticbrands generally sell for around$4.75 a pound.

Several dealers, citing increaseddemand from office and other institutional outlets, said they are now selling decaffeinated teas that were notavailable 18 to 24 months ago. Onedealer described his tea, manufactured in Germany, as being "99.6percent caffeine free," the result of aprocess which, he said, also requirest h e u s e o f s o l v e n t t o e x t r a c t t h e c a ffeine. Another Washington-areadealer said he was selling six types ofdecaffeinated teas and is planning toadd "25 to 30 more types" in thenear future. He said the tea had lessthan one part per million solvent resi d u e i n i t .

Chris Lecos is a member of FDA'spublic affairs staff


T h e N o t e b o o k

■ The second edition of the Cosmetic IngredientDictionary, published by the Cosmetic, Toiletry andFragrance Association (CTFA), has been recognized,in part, by FDA as an official source for cosmetic ingredient labeling nomenclature. Use of the new dictionary, with some deletions, along with supplementsand new editions of other compendia, began February19. Recognition of current sources of ingredient namesends July 18 of this year.

Excluded from use in cosmetic labeling were thenames of 34 coal-tar dyes because information ontheir chemical composition is not disclosed in theCTFA dictionary. Sixteen names were adopted on thecondition that the monographs be revised.

■ FDA wants ice cream and frozen custard that contain the dye FD&C Yellow No. 5 (tartrazine) to say soon the label. In a Federal Register notice, published January 29, the Agency proposed a rule amending the standard of identity for these frozen desserts torequire label declaration of the yellow dye. Last yearFDA issued a regulation requiring the label declaration of FD&C Yellow No. 5 when used to color foodand ingested drugs because of growing evidence thatmany consumers are allergic to the dye.

Under current regulations artificial colors do nothave to be listed on ice cream labels. FDA proposesto make the listing of FD&C Yellow No. 5 effectiveJuly I, 1981.

■ FD&C Red No. 2 is definitely out. In the January25 Federal Register the Commissioner of Food andDrugs issued the final decision on a petition requestingpermanent listing of FD&C Red No. 2 as a color additive. The Commissioner affirmed FDA 's administrative law judge's decision issued March 30, 1978, denying the petition by the Certified Color ManufacturersAssociation. Effective date of this decision is April 24.

■ ''Fast Track" in FDA's Bureau of VeterinaryMedicine (BVM) doesn't mean a good racecourse. It'sa new system to speed the review of applications for"breakthrough" animal drugs. To qualify for the "fasttrack" status, a new animal drug must be a new chemical entity not already on the market in the UnitedStates, alone or in a combination, and must appear tobe safer or more effective or have some other advantage over currently marketed drugs.

A sponsor may request "fast track" status for a

New Animal Drug Application or the Bureau may assign such status after its initial screening. Such applications will be placed ahead of all other New AnimalDrug Applications under review. Safety and effectiveness criteria for approval remain the same. The BVM"fast track" system, similar to one used for humandrugs, was initiated February 1.

■ A new, objective, and entirely impartial source ofdata to help determine the actual exposure to radiationof people in the vicinity of Three Mile Island (TMl)has been developed—photographic film. FDA's Bureau of Radiological Health collected six rolls of unexposed high-speed color film from five shops locatedwithin 5 miles of the TMl site. The film is sufficientlysensitive to ionizing radiation to be able to detect, byfogging, as little as 5 millirems of exposure.

Comparison of the TMl film with control films obtained in Rockville and Frederick, Md., showed theaverage level of fogging of the TMl film to be slightlylower than that of the film from Maryland. Thus, itappears that if any radiation released during the TMlaccident reached the stores where the sample filmswere s tocked i t was too l i t t le to be measured. Becausethe sensitivity threshold of the film is known, exposureis known to have been less than 5 mi l l i rems a t thosel o c a t i o n s .

The FDA study confirms the low-dose estimatesmade earlier by the Federal Ad Hoc Population DoseAssessment Group, which concluded that the averagedose to typical people living within 10 miles of theplant was 8 millirems and the average dose for peoplewithin 50 miles was 1.5 millirems. A person standingoutdoors continuously from March 28 to April 7 atthe point of highest offsite dose would have received atotal cumulative dose of less than 100 millirems.

■ Dr. Ronald W. Hart has been sworn in as directorof the National Center for Toxicological Research, aresearch arm of FDA located in Jefferson, Ark.NCTR was created in 1972 to test the long-term, low-dose safety of chemicals for their potential to causecancer and birth defects. Formerly Professor of Radiology, College of Medicine, the Ohio State University in Columbus, Dr. Hart is an expert on the effectsof environmental factors on biological systems.

■ Primary responsibility for protecting human subjects involved in testing medical devices for safety and


effectiveness lies with the manufacturer, the personconducting the investigation, and local review boardsin hospitals and universities where such tests are conducted. These responsibilities were spelled out in newregulations issued January 18 by FDA under the Medical Device Amendments of 1976.

Under the new rules, the amount of control a manufacturer must exercise over an investigation varies withthe degree of risk to the patients. He would be responsible for selecting qualified investigators, monitoringthe study properly, and making sure adequate recordsare kept. Investigators are required to explain to theresearch subjects what the investigation is all aboutand what risks or discomforts can be expected, and toget their consent to participate in the study. For high-risk devices, this information must be presented in awritten document to be signed by the subject.

■ When it comes to performance standards for medical devices, FDA says it will rely on voluntary standards developed by non-Government standard-settingorganizations. Under rules published in the February1 Federal Register, the Agency will review thesestandards and, if satisfactory, will endorse them. Amandatory standard will be developed by FDA onlywhen needed for public health protection. FDA estimates that voluntary standards eventually will be developed for about 90 percent of the 1,200 types ofmedical devices for which standards are appropriate.

■ '7 have asked the Bureau (of Veterinary Medicine)to prepare a public notice which will revoke our 1967policy that states the Agency does not sanction thefeeding of animal waste,'' Commissioner J ere Coy antold a meeting of the International Poultry Conference. Goyan proposed this change in FDA 's positionregarding recycled animal waste, after learning fromBVM staffers that animal waste is not a product thatroutinely moves in interstate commerce, it is not labeled and sold as a feed ingredient, but provides nutrition to animals when mixed with other usual feed ingredients. Furthermore, no ill effects to animals havebeen reported from feeding them processed animalwaste, and State feed controls officials already areproviding guidance and regulating the use of animalwaste as a feed ingredient within their State.

■ Food, animal feed, fertilizer, and pesticide companies have been asked to check their plants for electrical equipment containing PCB's and remove theequipment when special incinerators, approved by theEnvironmental Protection Agency (EPA), are available to dispose of the chemical. The request, madejointly by FDA, EPA, and the U.S. Department ofAgriculture, was the result of a recent incident in the

northwestern United States in which PCB's from atransformer stored at a Montana meatpacking plantaccidentally contaminated animal feed ingredients alsobeing made there.

The three agencies asked that these initial actions betaken voluntarily to protect the public until regulations, now under consideration, can be issued. Suchregulations may require replacement of PCB-contain-ing equipment.

■ Cyclamates were dealt another blow by FDA's Administrative Law Judge Daniel J. Davidson, when heruled on February 4 that Abbott Laboratories failed todemonstrate that the artificial sweetener is safe. He denied the company's petition to put the Abbott productb a c k o n t h e m a r k e t .

FDA banned the sale of cyclamates in 1970. In 1973Abbott Labs sought to remarket the sweetener, and itspetition was denied in 1976, but a formal evidentiarypublic hearing was requested and conducted. Onceagain the petition was denied by Davidson but theproceeding was reopened for further hearing to let theparties more fully develop the record. It is the reevaluated record that Davidson found falls short of showing cyclamates to be safe.

■ There's a call out for nominations for membershipon the Science Advisory Board of the National Centerfor Toxicological Research (NCTR) in Jefferson, Ark.Five vacancies will occur on the board as of June 30.The term of office is 3 years. The board provides theextra-Agency review to ensure that research programsand methodology development at NCTR are scientifically sound and pertinent to environmental problems.Send nominations to Executive Secretary, Science Advisory Board, National Center for Toxicological Research, Jefferson, Ark. 72079.

■ FDA is considering safety performance recommendations for radiation devices used in combination witha psoralen drug in treating psoriasis, a disfiguring andoften incapacitating skin disease. The treatment—PUVA therapy, using ultraviolet-a radiation (UVA)along with the drug—has been effective in treating ahigh percentage of psoriasis patients, many of whomdid not respond to other types of treatment.

In a Federal Register notice, published February8, FDA outlined items that are expected to form thebasis for the proposed recommended standards, including guidelines on oral PUVA therapy; optical radiation emissions from lamps; uniformity of exposure;dosimetry, i.e., a means for measuring the level ofUVA radiation; time control; eye protection; temperature control; electrical hazards control; and othermeasures to protect the patient.


Investigators' Reports

M o r e T h a n J u s t P o o r R e c o r d s

Excerpt from a letter (dated November 5, 1976) to the U.S.Attorney's Office for the District ofNew Jersey from Richard A. Merrill,former chief counsel, Food and DrugA d m i n i s t r a t i o n :

''We request that your office convene a Grand Jury investigation intoapparent violations of Title 18,U.S.C., Section 1001, involving thewillful and knowing causing by Bio-metric Testing, Inc., or individuals inits employ of false and fictitious statements and representations [to bemade] to the Food and Drug Administration in the form of reports of preclinical studies . . .

FDA first inspected Biometric Testing, Inc. (of Fnglewood Cliffs, NewJersey), in June 1973. The firm hadbeen organized SVi years previouslyto conduct testing programs for pharmaceutical and cosmetic products andfood additives, as well as industrialplant toxicology and air and waterpollution.

W h a t c o n c e r n e d F D A w a s t h e

firm's animal testing facility in Whip-pany. New Jersey, which was conducting preclinical animal studies forsubmission to FDA by drug sponsorsin support of Notices of Claimed Investigational Exemption for NewDrugs (IND's) and New Drug Applications (NDA 's). Data from thesestudies are used by FDA in determining whether the Agency should approve a drug for marketing. Incorrectdata could lead to an ineffective ordangerous drug being allowed on them a r k e t .

At the time, FDA was not routinelymonitoring animal testing facilities.However, the Agency might select cert a i n l a b o r a t o r i e s a t r a n d o m a n d c o nduct a general surveillance inspection,and might inspect others if there werequestions about the labs' test data.Biometric was inspected at the request

of the Bureau of Drugs after the bureau's Division of Scientific Investigations discovered some minor discrepancies in an IND application. Theinspection revealed certain deficienciesin animal room construction and,foreshadowing things to come, somepoor recordkeeping practices. But onthe whole, according to the inspectionreport filed by the Newark District,"this firm's animal testing facility inWhippany, New Jersey, is satisfactory. "

In April 1975, Newark District Investigator Keith Fhrlich and AdrianGross, D.V.M., representing the Scientific Investigations staff, made ajoint inspection, again at the requestof the Bureau, because the firm wassuspected of submitting faulty data foran IND study.

Excerpt from Establishment Inspection Endorsement (April 7 & 8,1975):" . . . Current inspection revealed

serious discrepancies in the firm's reported Hematology, FKG, and BloodPressure monitoring of [certain studies] . . . that are sufficient to castdoubt upon the validity of the submiss i o n ." . . . personnel performing autopsies lack sufficient experience and supervision to reliably perform this task

Fhrlich also noted the departurefrom the firm of Richard Goldhamer,vice president and director of animaltesting. Goldhamer was fired, according to the new animal laboratory director, because of incompetence. Hewas, however, retained by the firm asa consultant to complete studies underhis direction at the time of the firing.

Fhrlich made a followup inspectionin November 1975. Excerpt from hisinspection report:

"Current inspection found firm operating with a generally unsatisfactory

recordkeeping system in all phases ofits operation ....

"Management attributed all observed discrepancies to past employeesof the firm and pleaded ignorance ofthem. . . .

"Current conditions in the firm'sanimal testing facility were adequate."

In February 1976 an inspection wasmade of an animal laboratory medicaltechnologist doing hematology, bloodchemistry, and urine analysis forB i o m e t r i c ' s a n i m a l s t u d i e s . T h e t e c h

nologist had no records which couldbe used to va l i da te t he B iome t r i c s tudies in question.

The first week in March (1976)found Investigator Fhrlich back inWhippany.

Excerpt from his inspection report:" . . . Inspection was based upon

questionable findings discovered [bythe Scientific Investigations Branch]upon review of two-year carcinogenicity studies in rat and mouse on Catrix. . . performed by the firm. . . .

"Inspection revealed a number ofserious deficiencies which make alldata submitted in support of thesestudies ... of questionable value. . . .

At that point the problem at Biometric looked to the Scientific Investigations staff like considerably more thana simple case of poorly kept records.Staff member Ron Britten, after analyzing the studies on Catrix and several other drugs, concluded that datafrom the same rats was used in twoseparate 2-year toxicity studies andthat it was likely the rats had neverbeen dosed with any drug. In fact,Britten said, the animals in the studyappeared to be the same surplus animals used for teaching autopsy techniques to the firm's new autopsy technicians. Mention of "fraud" and"criminal proceedings" began to appear in Scientific Investigations staffmemos about the firm.


Excerpt from a letter to the firmfrom Carl M. Leventhal, deputy director of the Bureau of Drugs (datedMarch 30, 1976):

"We find that preclinical studiesperformed by your firm and incorporated into new drug applications submitted to the Food and Drug Administration are unacceptable in that theyare substantially unsupported by thepresence of authenticating raw data,and contain inaccurate and false data." we are inviting you to an in

formal conference in the Bureau ofDrugs to explain the deficienciesfound in your . . . studies."

The meeting convened April 21,1976, with a Biometric official andBureau of Drugs' staff. The officialsaid the firm was conducting an in-house investigation of its testing practices and would give the Agency acopy of the report. But neither themeeting nor the report explained thediscrepancies in the studies to FDA'ssatisfaction.

Excerpt from April 26, 1976, memofrom the associate director for newdrug evaluation to all FDA divisiond i r e c t o r s :

"Recent inspections of BiometricTesting, Inc., have found evidencethat preclinical data submitted by thefirm was false. Regulatory actionagainst the firm has begun .... Thematter has been referred to the Bureau's compliance unit for consideration of action for fraud.

"Each Division should promptlysubmit... a list of all new drug applications which contain preclinical,clinical, or bioavailability studiesdone by or arranged by Biometric."

On July 27, 1976, Don Kilburn,/rom tKe Bureau's ComplianceBranch, requested that Newark District investigate further to find outwho at the firm had responsibility forthe questionable studies. Investigator

Fhrlich interviewed a number of thefirm's employees and former employees. The information he got indicatedthat "substantial amounts of the clinical chemistry reported in the varioussuspect cases was never performed,"b u t h e c o u l d n ' t d i s c o v e r w h o a t t h e

firm was responsible for submittingthe fraudulent data.

Excerpt from November 5, 1976,letter to the U.S. Attorney's Officefrom Richard A. Merrill:

"The firm's representatives cannotor will not provide information otherthan the documents and explanationswhich it has [already] provided. . . .We believe that a Grand Jury, withthe ability to subpoena witnesses anddocuments, and to elicit sworn testimony, will provide the best, and perhaps the only, means to confirm thesuspicions raised in ourinvestigation."

In December 1976 Investigator Fhrlich went again to the Whippany lab.There was a "To Let" sign in thefront yard.

In early 1977, the Bureau of Drugswrote to the drug firms that Biometrichad done research for, advising themof the problem. Since all Biometricpreclinical research was now suspect,the firms would have to either validateall Biometric studies, repeat them, orwithdraw NDA's including the studies.

The investigation of Biometric Testing, Inc., spanned a time when problems with preclinical laboratoriescame to a head. Biometric was onlyone of many firms submitting faultyor deliberately falsified data, but itwas the Biometric investigation thatdemonstrated conclusively to FDAthat better regulation of these facilitieswas a necessity. About the time thestage was being set for the grand juryinvestigation into the Biometric case,FDA implemented its new Bio-Research Monitoring Program, to deal

with the larger problem of ensuringthat such preclinical laboratory data isreliable. Under the new program.Good Laboratory Practices weredrawn up and a compliance programrequiring regular inspections of thesetesting facilities was begun.

In March 1977 the grand jury, assisted by FDA investigators, began a2-year investigation of the chargesagainst Biometric. The investigationproduced evidence to support whatFDA had suspected but had not beenable to substantiate. On May 30,1979, the firm and its principal officers were formally charged with conspiracy to submit and submission offalse data on at least three studies andwith fabricating reports to cover upthe fact that these tests had never beendone. On November 16, 1979, in theU. S. District Court for the District ofNew Jersey, Biometric Testing, Inc.,was found guilty on three of fourcounts of conspiracy and submissionof false research reports and was subsequently fined $15,000. Three officials were acquitted of all charges.Two months later, Steven Carson(former vice president of scientific affairs) and Samuel Posner (former executive vice president), who pleadedguilty to one charge of conspiracyprior to trial, were placed on probation for 3 years. Richard Goldhamer(former vice president and animallaboratory director) also pleadedguilty prior to trial to conspiracy andwas sentenced to 3 years in prison,with the last 2% years suspended. TheBiometric case—which was responsible, in part, for the creation of theBio-Research Monitoring Program—was, appropriately, the first court caseruled on after the program had beenimplemented.

(continued on next page)


Investigators' Reports presents information on inspections, product seizures, court proceedings, and otheradministrative and regulatory actionsby Federal, State, and local food anddrug agencies across the country toprovide health and economic protection to consumers of foods, drugs,cosmetics, and medical devices.

P h a r m a c i s t F i n e d

The New York Board of Pharmacyfined pharmacist Laurence C. Hertz,Hauppauge, New York, $300 after aState inspector turned up evidencethat he was illegally repackagingdrugs in dosages and with labelingthat were also illegal.

During a routine visit to the pharmacy, the inspector noted some inv o i c e s t h a t s e e m e d t o i n d i c a t e H e r t zwas repackaging bulk quantities ofs o d i u m fl u o r i d e i n t h e b a c k r o o m o fhis pharmacy. Aware that the pharm a c i s t w a s n o t l i c e n s e d t o m a n u f a cture or repackage drugs, the inspect o r n o t i fi e d F D A ' s N e w Yo r k D i s t r i c t .

A District inspection confirmedthat Hertz was indeed illegally repacking bulk sodium fluoride—therepackaging was done by a staff ofteenagers—into several dosage sizes,all too large for approved use. Themarketing of sodium fluoride is approved by FDA only for preventionof dental caries. Hertz was promoting the drug as being effective fortreating the hardening of bones inthe aged—a claim not substantiatedby scientific evidence.

Based on the FDA investigator'sreport, the Board of Pharmacy helda hearing and charged Hertz withselling an unapproved drug and repackaging drugs without a license todo so. Hertz promised in the futureto res t r i c t h is ac t i v i t ies to the sa le o f

drugs. He recalled the improperly repackaged sodium fluoride from hiscustomers, removed remaining stocksfrom his shelves, and destroyed it allunder State supervision.

Moldy and Toxic

Not all molds produce toxins, buta firm in Atlanta, Georgia, wasn't

taking any chances with 337 mold-covered bags of guar gum powder itreceived by a delivery truck. Theburlap bags apparently got wet during transportation, and the mold-likes u b s t a n c e t h a t c o v e r e d t h e m c a u s e dthe firm to suspect the lot was cont a m i n a t e d .

Guar gum powder is derived fromthe seed of the guar plant. It produces a gum which is used as a thickening agent in foods and as sizingmaterial for paper and textiles.

The firm, a distributor of food stabilizers, rejected the lot and alertedF D A ' s A t l a n t a D i s t r i c t t h a t i t w a s r e

turning the food additive to FalleckChemicals, the New York brokeragefirm that owned the product. TheA t l a n t a o f fi c e c o n t a c t e d N e w a r k D i strict investigators, who visited thebroker's New Jersey warehouse andw e r e i n f o r m e d t h a t t h e l o t h a d b e e nsent to the Honig Chemical & Processing Corp., Newark, New Jersey,for reconditioning and repacking.

At Honig Chemicals, samples werecollected by FDA investigators ands e n t t o t h e N e w Yo r k D i s t r i c t l a b o r a

tory for analysis. The analysis revealed that the guar gum powdercontained the mold Aspergillus fla-vus, which produces the naturally occurring contaminant aflatoxin. AtNewark District's request, a U.S.marshal seized the entire lot, worthabout $22,000.

F a t C h a n c e f o r D e v i c e

Offer a way to stay fit and trimwithout exercise and many peoplea r e s u r e t o b e c u r i o u s . M e n t i o n f amous names as your clientele andmany won't be deterred by a fee of$35 per half hour.

The Bio-body Centers of Americain New York used these advertisingmethods in promoting its Vitatone2000E Muscle Stimulizer, which theyclaimed was a muscle toner and spotreducer. The ads brought numerousinquiries about the validity of thec l a i m s t o F D A ' s N e w Yo r k c o n s u m e r

complaint coordinator, promptingNew York District investigators tov i s i t t h e fi r m ' s t w o s a l o n s i n M a n h a tt a n a n d G r e a t N e c k .

The device, the firm claimed,would tone the body by electricallycontracting muscles through contactpads while the client lay passive.FDA, however, said that the machine was simply another version ofthe Relaxacizor, an electrical muscles t i m u l a t o r s o l d o v e r t h e c o u n t e r u n t i l

1970, when FDA won a court decision permanently prohibiting its saleto the general public.

T h e D i s t r i c t r e c o m m e n d e d s e i z u r eof the stimulizer based on evidence,s i m i l a r t o t h a t i n t h e R e l a x a c i z o rcourt case, that the machine operator's ignorance of the physical ande m o t i o n a l s t a t e o f t h e c l i e n t a n d t h emechanical and electrical phenomenainvolved presented a potential hazardto people with pre-existing disorders.In the recommendation, the Districtwarned that the device could aggravate pre-existing gastrointestinal,dermatological, and gynecologicalproblems, such as ulcers, hernias,and varicose veins, and might evencause miscarriage. The District further charged the machine mightcause muscle pains, spasms, localizedskin infections, and emotional disturbances because of repeated electrical shocks to the body.

T h e s e i z u r e r e c o m m e n d a t i o n w a s

approved by the Bureau of MedicalDevices, and District investigatorsaccompanied U.S. marshals to thesalons, witnessing seizure of all six ofthe machines, valued at $400 each.

Morphine Sub RecalledPenick Corp., Newark, New Jer

sey, notified FDA's Newark Districtthat it was recalling bulk shipmentsof morphine sulfate US? powder because of subpotency. The problem, aP e n i c k o f fi c i a l t o l d t h e F D A r e c a l lcoordinator, had been reported tothe firm by one of its consignees,Boston University School of Medic i n e . S t u d e n t s h a d d i s c o v e r e d t h e

drug was subpotent when conversionof it in a laboratory test failed toyield the appropriate amount of morphine alkaloid.

Morphine, a narcotic derived fromcrude opium, is a powerful painkillerand central nervous system depres-

30 / May J980 / FDA Consumer

sant and is tightly restricted underSchedule II of the Federal ControlledSubstances Act. Fenick Corp., whichmanufactures the drug in bulk quantities, distributes it to drug manufacturers, hospitals, and medical schoolsfor use as an active ingredient in prescription drugs.

The Fenick official said that analysis by the firm had shown the drughad been replaced in part with powdered lactose and the firm concludedthe missing quantity of the drug hadbeen stolen just prior to shipment.The firm contacted the five hospitalcenters that had received the subpo-tent drug, requesting its return.

But, after a visit to the firm, aNewark investigator found otherproblems. Collecting recall information, the investigator found evidencethat the firm had violated GoodManufacturing Fractice regulations(GMF's) by releasing one batch ofmorphine sulfate without reviewingthe batch records, and by failing totake a representative sample of thedrug before preparing it for shipping.From looking at the firm's records,the investigator said, it was impossible to tell when the lactose substitut i o n w a s m a d e .

He discussed the problems withFenick officials, explaining that theGMF violations might have contributed to the firm's failure to detectthe problem before the drug was distributed. The firm promised to makethe appropriate corrections.

B e e r B u s t

Three consumer complaints within3 weeks about mold in 12-ouncenonreturnable bott les of Wiedemannand Blatz beer had FDA's NashvilleDistrict perplexed. Froblems withmold in bottled beverages are usuallyfound in returnable bottles whichhave been inadequately cleaned.

The beer is brewed by G. HeilmanBrewing Co., Inc., which also produces Blatz, Sterling, Ffeiffer,Drewry's, Falls City, and HeilmanLight, all popular beers in severalmidd le and eas te rn S ta tes .

The firm owns seven breweries, including one in Newport, Kentucky,

that produces all seven brands ofbeer. Since FDA inspections of Kentucky firms are performed under acontract with the Kentucky Department of Human Resources, FDAasked that agency to join in an investigation of the complaints.

In inspecting the firm's glass line,investigators found no evidence ofhow mold got into the bottles, butnoticed that the bottle filling machinewas malfunctioning. A cone-shapedn o z z l e a t t a c h e d t o t h e b o t t l e fi l l e rwas slightly out of line and wasbreaking some of the bottles. Investigators took some finished productsfor analysis, which revealed pieces ofchipped glass in some of the bottles.

Although they never found anymold, the investigators speculatedthat the mold consumers complainedabout may have occurred from airentering because of loose fitting capson the bottles. The firm voluntarilyrecalled more than 500,000 cases ofall seven brands of beer from its distributors at both the wholesale andretail levels, and the Kentucky Department of Human Resources issueda news release warning consumersabout the possible presence of glassi n t h e b o t t l e s .

No injuries were reported and thebeer that was returned was destroyedat the Kentucky brewery.

Acu-Dots and Kisses

Not a pill, not a drug, it's Acu-Dot, the amazing magnetic devicethat relieves aches and pains. According to the manufacturer—Acu-Dot Corp. of Akron, Ohio—themagnetic analgesic patches, whichare applied to the skin, were testedon 200 Akron citizens and found effective 90 percent of the time.

But FDA and U.S. Dis t r ic t Cour tJudge Thomas D. Lambros didn'tbuy. Judge Lambros, who ruled January 30, 1980, that the devices weremisbranded, commented: "A kissfrom mother on the affected areawould serve just as well to relievepain, if mothers' kisses were marketed as effectively as the Acu-DotD e v i c e . "

Since 1976, when the firm first re

quested information from FDA's Bur e a u o f M e d i c a l D e v i c e s a b o u t m a r

keting procedures, the bureau hadsent Acu-Dot Corp. three letterspointing out that the product had noadequate directions for use and thatthe labeling was false and misleading. Records from the Akron studywere incomplete, the bureau said.However, in late summer of 1979 thecorporation introduced the device,which had already been marketed inJapan, into the U.S. market. When anational retail drug chain launched aconcentrated advertising campaign—offering a package of 10 Acu-Dotpatches for $5.59—FDA's CincinnatiDistrict initiated seizure of $25,000worth of the product at a Clevelandwarehouse. The firm contested theseizure and brought legal action toforestall further seizures. In the U.S.Distr ict Court for the Northern District of Ohio, the firm contended thatAcu-Dots " ionize molecules in theskin area under the magnets," thusproviding relief from pain.

Judge Lambros, in his final adjudication memorandum, said there maybe, in fact, some marketable value ina harmless device with a "strong"placebo effect, such as Acu-Dots;nonetheless, he ordered that the devices be returned to the firm for destruction in conformity with the FDCA c t .

As a result of a subsequent complaint by the assistant U.S. attorney,all stocks of Acu-Dots, valued atabout $7,000, were seized by U.S.marshals at three Cleveland drug-c h a i n w a r e h o u s e s .

Supplements SeizedA product's labeling can change it

legally from one product into another, and this can have serious consequences, as WBZ Feed Additivesof Mansfield, Ohio, learned.

The firm manufactures and distributes a variety of animal feed products, including "WBZ Brand HorseFeed Additive" and "Vita-Zyme 1-4-1 for Catt le." These are nutri t ionalsupplements intended to be added tothe daily feed rations of horses, cattle, and sheep. They contain a vari-


ety of vitamins and minerals. As feedsupplements they present no problemf o r F D A .

B u t t h e b r o c h u r e s t h a t a c c o m

panied the two products made therapeutic claims and when such claimsare made the products must be considered drugs. Drugs must be approved by FDA as safe and effective.Feed supplements require no suchapproval.

A Cincinnati District investigatorinspected the firm at the request ofthe Bureau of Veterinary Medicineand collected samples of the productsand accompanying brochures. Theclaims in the brochures pushed theproducts over the line from "feedsupplements" to "drugs." Accordingto the brochures, the additives werecapable of promoting superior skeletal growth, good health, a high conception rate, and greater endurance;could treat (among a long list of adverse conditions) anemia, diarrhea,labored breathing, Stiff Lamb Disease, White Muscle Disease incalves, nervousness, weak legs, anorexia, dehydration, "seizures," hepatitis, foot rot, nephritis, and breedingproblems; and could prevent suddend e a t h .

The District sent a regulatory letter to the firm's owner, advising himto either withdraw all claims for theproducts and market them as nutritional supplements or submit datasupporting the claims as drugs. Theowner replied several days later thathe intended to withdraw the offending brochures.

But a reinspection several monthslater found only slight alterations inthe brochures, which still promotedthe products for treatment of diseasec o n d i t i o n s i n h o r s e s a n d c a t t l e . A tthe District 's recommendation, aU.S. marshal thereupon seized approximately 54 pails of "WBZ BrandHorse Feed Additive," seven bags of"Vita-Zyme 1-4-1 for Cattle," andapproximately 2,000 violative broc h u r e s .

Overbleeding HaltedT h e l i c e n s e o f C o l u m b i a D o n o r

Center, Inc., Columbia, Missouri, tomanufacture and ship human plasmaw a s r e i n s t a t e d a f t e r t h e c e n t e r t o l d

FDA's Bureau of Biologies it wouldstop the practice of overbleeding itsd o n o r s .

The bureau had suspended thecenter's lieense in December 1979,thus prohibiting it from shippingproducts in interstate commerce, following a routine inspection by anFDA Kansas City District investigator. As part of the inspection, the investigator checked the firm's recordsand found it was taking too muchwhole blood from up to 11 percent ofits donors during plasmapheresis proc e d u r e s .

Plasmapheresis is the method usedto obtain the plasma fraction fromwhole blood. It involves removingwhole blood from the donor, separating the plasma from it, and returningt h e r e d b l o o d c e l l s t o t h e d o n o r . A c

cording to FDA regulations, 500milliliters (ml) of whole blood can betaken from a "light" donor (a personweighing 174 pounds or less) and 600ml from a "heavy" donor (a person175 pounds or more). Taking morethan these amounts can endanger thed o n o r .

The investigator discussed theproblem with center officials, notingalso some minor recordkeeping violations, and left a list of his observations with them. Four days later thecenter received notification of its license suspension and stopped operat i o n s . T h e b u r e a u r e i n s t a t e d t h e l ic e n s e w i t h i n a f e w w e e k s — i n

response to written assurance fromthe firm's president that the problemh a d b e e n c o r r e c t e d — a n d s c h e d u l e d a

foliowup inspection. When the District investigator checked the firm'srecords in February, there was no indication of overbleeding or any otherproblem.

PCB Spill Contained

I t c o u l d h a v e b e e n d i s a s t r o u s w h e na capacitor in an Iowa meat-packingplant overheated and began leakingPCB's, a chemical both toxic andcarcinogenic, into the firm's sewagesystem. Sioux Preme Packing Co., ahog slaughtering operation in SiouxCenter, recovers and salvages fatsand grease from its sewage system.The salvaged fats are used as animalfeed ingredients, and are distributed

t o a n u m b e r o f o t h e r fi r m s s u c h a s

poultry producers. PCB-contami-nated products could have gotteninto the food system very quickly ifthe incident had gone undetected.

But it didn't. The leaking capacitorwas discovered by the plant's management on December 20, 1979. Assisted by a U.S. Department of Agriculture inspector stationed at theplant, the firm placed a hold on themeat scraps and edible grease salvaged from the sewage systema r o u n d t h a t t i m e a n d c o l l e c t e d s a m

ples of these products. The sampleswere sent to two private laboratorieswhose analysis showed that onlysewer grease produced on December20 was contaminated with PCB's.

USDA in fo rmed FDA 's KansasCity District of the spill and the results of the laboratory analysis. TheDistrict requested that the firm continue to hold the products, and an investigator collected additional samples of grease, meat scraps, and feedingredients produced by the firm.Analysis by the FDA laboratory inKansas City confirmed the findingsof the private laboratories that onlythe sewer grease contained PCB's.

T h e E n v i r o n m e n t a l P r o t e c t i o n

Agency and Iowa Department of Environmental Quality were notified ofthe accident and assumed responsibility for monitoring proper disposal ofthe contaminated sewer grease,either by burial or incineration.

Problems with Returnable Bott les

What's ecological is frequently noteconomical, as the Michigan Department of Agriculture is discovering.Since the State's year-old returnablebottle law for beverages—which bansthrowaway bottles—went into full effect January 1, 1979, thedepartment's Food Inspection Division has received a 142 percent increase in complaints about bottledbeverages. The complaints rangefrom reports of illness to funny tastesto foreign material in the bottles.This material, the division speculated, apparently is left by a previousu s e r i n b o t t l e s t h a t a r e t h e n i n a d e

quately cleaned. The division has hadto devote extra time to dealing withbeverage problems.


FILED SEIZURE ACTIONS charge violations of the Federal Food, Drug, and Cosmetic Act and are initiated based upon FDArecommendations. A seizure is commenced by the filing in the U.S. district court where the goods arelocated. A U.S. marshal is then directed by the court to take possession of the goods, removing theproduct from commerce, until the matter is resolved.

A total of 32 actions to remove from the consumer market products charged to be violative was reported in March. These actions included 16 of foods:1 involved a charge concerning poisonous and deleterious substances, and 15 involved charges concerning contamination. Others included 1 of animalfeed, 12 of drugs (including 2 of veterinary), and 3 of medical devices.

PRODUCT, DISTRICT & DATEF I L E D

F I R M & P L A C E O F B U S I N E S S C H A R G E S

FOOD/Poisonous and Deleterious Substances

To m a t o e s / U . S . D i s t r i c t C o u r t f o r t h eNor thern D is t r i c t o f Texas 11 /29 /79

Agri Sales/Oceanside, Calif. Contains the nonconforming added pesticide chemicalacephate.

FOOD/Contamination, Spoilage, Insanitary Handling

Apples, evaporated/U.S. District Courtfor the Eastern District of Pennsylvania11/6/79

Breadcrumbs, Japanese-style/U.S. Dist r i c t C o u r t f o r t h e E a s t e r n D i s t r i c t o f

Virginia 12/5/79Clams, shelled, frozen/U.S. District Court

for the Western District of Washington12/6/79

Dextrose, beans, and tapioca/U.S. Distr ic t Court for the Distr ic t of New Jer

sey 11/29/79Flour/U.S. District Court for the District

o f South Caro l ina 11/23/79Flour/U.S. District Court for the District

of Puerto Rico 1/30/80Flour, macaroni, and rolled oats/U.S.

District Court for the Western Districtof Louis iana 1/21/80

Guar gum/U.S. District Court for theDistrict of New Jersey 1/10/80

Kidney beans/U.S. District Court for theNor thern D is t r i c t o f Texas 12 /4 /79

Mullein leaves, stoneroot, and stocks ofo ther herbs /U.S. D is t r i c t Cour t fo r theWes te rn D is t r i c t o f New York 1 /7 /80

Noodles, oriental, chicken-flavored, witha soup base/U.S. District Court for theSouthern D is t r ic t o f Texas 12/10/79

R ice /U .S . D i s t r i c t Cou r t f o r t he Eas te rnDistrict of Virginia 1/8/80

Shrimp, peeled, frozen/U.S. District Courtf o r t h e N o r t h e r n D i s t r i c t o f Te x a s12/4/79

Tomatoes, canned/U.S. District Court fort h e W e s t e r n D i s t r i c t o f N e w Y o r k1/25/80

Shipped from Wenatchee, Wash.

Parks Seafood, Inc./Portsmouth, Va.

Imported from Ladysmith, Canada.

Bascom Food Products/Paterson, N.J.

Munford, Inc./Columbia, S.C.

Panaderia Sabana Seca, Inc./Toa Baja,P . R .

Shreveport Warehouse Service, Inc./Shreveport, La.

Imported from India.

Blount Agriculture/Elwell, Mich.

Clarks Natural Herbs/Chaffee, N.Y.

Imported from Taipei, Taiwan.

Fancy Foods of Virginia, Inc./Norfolk,V a .

Bryant Fisheries, Inc./Bayou LaBatre,A l a .

Shipped from Hanover, Pa.

Held under insanitary conditions; contains metal frae

Held under insanitary conditions.

Contains decomposed clams.


Held under insanitary conditions; rodent contaminated.

Held under insanitary conditions; insect and/or rodentc o n t a m i n a t e d .

C o n t a m i n a t e d w i t h m o l d .

Held under insanitary conditions; insect contaminated.

Held under insanitary conditions; some herbs rodentc o n t a m i n a t e d .

Con ta ins ranc id o i l .


Prepared, packed, and held under insanitary condit i o n s .

Unfit for food due to deteriorating can linings.


PRODUCT, DISTRICT & DATE FILED F I R M & P L A C E O F B U S I N E S S C H A R G E S

Wheat, bullc/U.S. District Court for theWeste rn D is t r i c t o f Ok lahoma 11 /26 /79

Shipped from Byron, Nebr. R o d e n t c o n t a m i n a t e d .

Dog food chunks/U.S. District Court forthe Eastern Distr ic t of Tennessee 12/5/7 9

Feed additives for horses. Vita Zyme 1-4 - 1 / U . S . D i s t r i c t C o u r t f o r t h e N o r t hern D is t r i c t o f Oh io 12 /20 /79

A n i m a l F e e d

Ouality Foods, Inc., Humphrey's & Co.Who lesa le D i v i s i on /G reenev i l l e , Tenn .

W B Z B r a n d F e e d A d d i t i v e s / M a n s fi e l d ,O h i o

Held under insanitary conditions; rodent contaminated.

New animal drug and no New Animal Drug Applicationin effect with respect to its use or intended use.

Aspirin tablets, enteric coated, 2 actions/U . S . D i s t r i c t C o u r t f o r t h e E a s t e r nDistrict of Michigan 1/11/80

Beta-Val cream, chlorthalidone tablets,and other drugs/U.S. District Court forthe District of New Jersey 12/26/79

Chlorthalidone tablets, allopurinol tablets, furosemide tablets, and trimethoprim with sulfamethoxazole tablets/U . S . D i s t r i c t C o u r t f o r t h e W e s t e r nDistrict of Kentucky 1/23/80

Chlorthalidone tablets, hydroxyzine HCItablets, allopurinol tablets, diethylpro-pion HCI, furosemide tablets, spirono lac tone t ab le t s /U .S . D i s t r i c t Cou r tfor the District of Massachusetts 1/25/80

Chlorthalidone tablets, allopurinol tablets, diethylpropion HCI tablets, furosemide tablets, hydroxyzine pamoatecapsules, spironolactone tablets, andtrimethoprim with sulfamethazine tabl e t s / U . S . D i s t r i c t C o u r t f o r t h e N o r t he rn D is t r i c t o f Ok lahoma 1 /28 /80

Doxine, doxylamine succinate with pyri-dox ine HCI tab le t s /U .S . D is t r i c t Cour tfor the Dist r ic t o f Puerto Rico 1/3/80

Furosemide 50-ml injection syringes/U.S.D is t r i c t Cour t fo r the Weste rn D is t r i c to f New York 1 /8 /80

Furosemide tablets, Dynalase chlorpropamide tablets, and other new drugs/U . S . D i s t r i c t C o u r t f o r t h e W e s t e r nD is t r i c t o f New York 1 /25 /80

N i t rous ox ide /U .S . D is t r i c t Cour t f o r t heDis t r i c t o f U tah 11 /16 /79

Phenobarb i ta l t ab le t s /U .S . D is t r i c t Cour tfor the Western District of Kentucky12/11/79

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

Tablicaps, Inc./Franklinville, N.J.

Premo Pharmaceut ica l Laborator ies, Inc. /Sou th Hackensack , N .J .

Pharmadyne Laboratories, Inc./ElmwoodPark , N .J .

Premo Pharmaceut ica l Laborator ies, Inc. /Sou th Hackensack , N .J .

International Medications Systems, Ltd./El Monte, Calif.

Pharmadyne Laboratories, Inc./ElmwoodPark , N .J .

U.S. Welding, Inc./Salt Lake City, Utah

Marshall Pharmacal Corp./South Hackensack , N .J .

Circumstances used for manufacture and processing notin conformity with current good manufacturing practice. Labeling is false and misleading since data tosupport labels' expiration dates is lacking.

Labeling fails to bear adequate directions for use dueto new drug status; new drugs without effective approved New Drug Applications.

New drugs without effective approved New Drug Applications.

New drug without an effective approved New DrugApplication.

New drugs without effective approved New Drug Applications.

Circumstances of processing, packing, and holding notin conformity with current good manufacturing practice; quality and purity below that which it is represented to possess.

Strength differs from and quality falls below U.S.P.s tandards .

Hemo-Tol vitamin-mineral preparation,St ress-Eze so lu t ion , E lec t robo l e lec t ro

lyte suppIement/U.S. District Court forthe D is t r i c t o f South Caro l ina 11 /29 /79

DRUGS/Veterinary

Ve t - A i d L a b o r a t o r i e s / A i k e n , S . C . Hemo-Tol and Stress-Eze were manufactured and processed in an unregistered establishment; all the articlesare new animal drugs and no New Animal Drug Applications in effect with respect to their use or int e n d e d u s e .


PRODUCT, DISTRICT & DATE FILED F I R M & P L A C E O F B U S I N E S S C H A R G E S

Ni t ro furazone so lu t ion /U.S. D is t r i c t Cour tfor the Central District of California 11/9 /79

Vet Products Co./Kansas City, Mo. New animal drug and no New Animal Drug Applicationin effect with respect to its use and intended use.

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

Acu-Dot magnetic analgesic patches, 2a c t i o n s / U . S . D i s t r i c t C o u r t f o r t h eNor the rn D is t r i c t o f Oh io 12 /20 /79

Cleaner for contact lenses, C-clear/U.S.D i s t r i c t C o u r t f o r t h e D i s t r i c t o f C o lorado 12/20/79

Acu-Dot Corp./Akron, Ohio

R. M. Laboratories, Inc./Denver, Colo.

False and misleading claims for the temporary relief ofoccasional minor aches and pains of muscles andjoints. Fails to bear adequate directions for use.

Circumstances of manufacture, packing, and storing notin conformity with current good manufacturing practice; quality and purity of one lot falls below represented quality and purity, because lacks sterility; labeling is false and misleading as to sterility.

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

Complaints Filed by Law Department Under 39 U.S.C. 3005 (False Representation)No informat ion avai lable for th is issue.

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

October 25, 1979: Against Scientific International, Inc., P.O. Box 25147,Houston, Texas. Satisfactory evidence was presented to the PostalService that Scientific International, Inc., and their agent are engagedin conducting a scheme or device to obtain money by means of falserepresentation. This firm was advertising "Skin Magic Miracle AcneCure," representing the ability to cure acne.

October 30, 1979: Against Eric Lawrence, Inc., 5 N. Park Avenue, Rock-ville Centre, New York, New York. Satisfactory evidence was presented to the Postal Service that Eric Lawrence and their representatives are engaged in conducting a scheme or device to obtain moneyby means of false representation. This firm was advertising the product"Jojoba Energizer and Super De Jojoba Hair and Scalp Energizer,"representing the ability to stop hair loss and cause new hair growth.

October 31, 1979: Against AIM, 154 Prospect Street, Passaic, New Jersey.Satisfactory evidence was presented to the Postal Service that AIMand their agents are engaged in conducting a scheme or device toobtain money by means of false representation. This firm was advertising "Fasst Diet Mouth Spray," representing the ability to neutralizetaste buds and release your taste sensitivity causing you to lose yourdesire for food and your excess weight.

November 13, 1979: Against Veldix Treatment, 507 Fifth Avenue, NewYork, New York. Satisfactory evidence was presented to the PostalService that Veldix Treatment and their agents are engaged in conducting a scheme or device to obtain money by means of false representation. This firm was advertising "Veldix Hair Remover Treatment," representing the ability to remove hair instantly and lastingly.The product guarantees the radical elimination of the hair roots.

November 14, 1979: Against Davinol Products, Box 530-745, MiamiShores, Florida. Satisfactory evidence was presented to the PostalService that Davinol Products and their representatives are engagedin conducting a scheme or device to obtain money by means of falserepresentation. This firm was advertising the product "Davinol Tablets and Methods" and "Vivita-min Tablets," representing the abilityto cause weight loss. Product states, "You can have fat no more withc o n t i n u e d u s e . "

November 27, 1979: Against Skandia Distributors, P.O. Box 430, NewYork, New York. Satisfactory evidence was presented to the PostalService that Skandia Distributors and their agents are engaged inconducting a scheme or device to obtain money by means of falserepresentation. This firm was advertising various aphrodisiacs, sexstimulants, and sexual aids.

November 27, 1979: Against Basic Health Aids, P.O. Box 517, New York,New York. Satisfactory evidence was presented to the Postal Servicethat Basic Health Aids and their representatives are engaged in conducting a scheme or device to obtain money by means of false representation. This firm was advertising various aphrodisiacs, sex stimulants, and sexual aids.

December 26, 1979: Against Nature's Edge Products, P.O. Box 1831,Bridgeview, Illinois. Satisfactory evidence was presented to the PostalService that Nature's Edge Products and their agents are engaged inconducting a scheme or device to obtain money by means of falserepresentation. This firm was advertising the product "Weight ControlTablets," representing the ability to cause weight loss and controlc e l l u l i t e .


Notices of Judgment

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

FOOD/Poisonous and Deleter ious Substances

Fishmeal, at Ankeny, S. Dist. Iowa.Charged 1-15-79: when shipped by Schilling Fish Co., Inc., Oconto,Wis., the article, labeled in part "Wisconsin Trawlers, Inc. . . .Oconto, Wis. . . . Lake Fish—Fish Meal," contained the added poisonous or deleterious substance polychlorinated biphenyls in excessof the 2 ppm tolerance prescribed by regulation (i.e., contained approximately 2.3 ppm); 402(a)(2)(A). Default decree ordered destruction. (F.D.C. No. 62084; S. No. 79-164-451; N.J. No. 1)

Swordfish steaks, frozen, at Utica, N. Dist. N.Y.Charged 5-30-79: when shipped by Slade Gorton & Co., Inc., Boston,Mass., the article, labeled in part "Fish Steaks Portion Controlled. . . Sword Fish . . . Packed by Meredith Fish Co., Sacramento,Calif.," contained the added poisonous and deleterious substancemercury, in a quantity which might render it injurious to health;402(a)(1). Default decree ordered destruction. (F.D.C. No. 62266;S. No. 79-154-900; N.J. No. 2)

Tomatoes, at Decatur and Forest Park, N. Dist. Ga.Charged 11-30-79: when shipped by Agri Sales, Oceanside, Calif.,the article, labeled in part (18-lb. flats) "Ocean Star California PoleTomatoes Grower & Shipper Ocean View Farms San Luis Rey . . .Ca.," contained the nonconforming added pesticide chemical Ace-phate (approximately 0.37 ppm); 402(a)(2)(̂ B). Consent decree ordered destruction. (F.D.C. No. 62721; S. No. 80-194-838; N.J. No.3)

FOOD/Contamination, Spoilage, Insanitary HandlingAnnatto seeds, dried red kidney beans, dried pink beans, and rice, at Rio

Piedras, Dist. P.R.Charged 4-18-79: while held by Monllor & Boscio Sucrs., Inc., RioPiedras, P.R., the articles contained insect filth and had been heldunder insanitary conditions; 402(a)(3), 402(a)(4). Default decree ordered destruction. (F.D.C. No. 62252; S. Nos. 79-157-507/10; N.J.No. 4)

Basil, sage, other spices, and Toor-Dall beans, at Brooklyn, E. Dist. N.Y.Charged 4-26-77: while held by Purity Millers, Inc., Brooklyn, N.Y.,the Toor-Dall beans contained rodent filth, and all of the articles hadbeen held under insanitary conditions; 402(a)(3), 402(a)(4). Consentdecree authorized release to the dealer for salvaging. (F.D.C. No.61146; S. Nos. 77-14-967/8, 77-14-970/3, 77-14-976; N.J. No. 5)

Bread crumbs, and frozen stuffed crabs, at Mobile, S. Dist. Ala.Charged 2-16-79: when the bread crumbs were shipped by TexasCrumb & Food Products, Inc., Dallas, Tex., and while the stuffedcrabs were fabricated by Carrington Foods Co., Inc., Dallas, Tex.,using the bread crumbs, the bread crumbs contained insects, and thestuffed crabs had been prepared under insanitary conditions; 402(a)(3),402(a)(4). Default decree ordered destruction. (F.D.C. No. 62114;S. Nos. 79-100-075, 79-100-077/8; N.J. No. 6)

Cocoa beans (3 lots), at Philadelphia, E. Dist. Pa.Charged 3-13-78: while held by Delaware Operating Co., Div. LavinoShipping Co., Philadelphia, Pa., the article contained rodent filth andhad been held under insanitary conditions; 402(a)(3), 402(a)(4). Onelot of the article was claimed by Van Leer Chocolate Corp., JerseyCity, N.J. Another lot was claimed by Gill & Duffis, Inc., New York,N.Y. The remaining lot was claimed by the dealer. Consent decreesauthorized salvaging of the article. (F.D.C. No. 61655; S. Nos. 78-144-004/6; N.J. No. 7)

Coffee beans, at San Francisco, N. Dist. Calif.Charged 7-13-79: when shipped by Prieto, S.A., San Salvador, thearticle contained extraneous material (i.e., sticks, stones, black beans,etc.) and poor quality beans (i.e., worse than Grade 8 of the N.Y.Green Coffee Association standards); 402(a)(3). Consent decree author ized release to Hi l ls Bros. Coffee Inc. , San Francisco, Cal i f . , forsalvaging. (F.D.C. No. 62359; S. No. 79-144-828; N.J. No. 8)

Cornmeal, and dried peas and beans, at Ponce, Dist. P.R.Charged 2-9-79: while held by Monllor & Boscio Sucrs., Inc., Ponce,P.R., the articles contained insect and/or rodent filth and had beenheld under insanitary conditions; 402(a)(3), 402(a)(4). Consent decreeauthorized release to the dealer for salvaging. (F.D.C. No. 62162; S.No. 79-157-543; N.J. No. 9)

Crabmeat, pasteurized, at Roanoke, W. Dist. Va.Charged 9-26-79: when shipped by Atalanta Corp., New York, N.Y.,the article, labeled in part "Southeast Brand Special Pasteurized CrabMeat . . . Product of Mexico . . . Packed by Dumas Seafood, Inc.,Brownsville, Texas . . . Distributed by Harrison Seafood, Inc., Newport News, Va.," contained decomposed crabmeat; 402(a)(3). Defaultdecree ordered destruction. (F.D.C. No. 62463; S. Nos. 79-205-927/8; N.J. No. 10)

Crabmeat, Shell Key, at Philadelphia, E. Dist. Pa.Charged 10-17-79: when shipped by Shell Key Packing Co., Baldwin,La., the article had been packed and held under insanitary conditions;402(a)(4). Default decree ordered destruction. (F.D.C. No. 62661;S. No. 80-221-134 et al.; N.J. No. 11)

Flour, cracked wheat flour, and flour mixes, at Buffalo, W. Dist. N.Y.Charged 10-17-79: when returned in an insect-infested railcar to Buffalo, N.Y., one lot of flour contained insect filth, and all of the articleshad been held under insanitary conditions; 402(a)(3), 402(a)(4). Consent decree authorized release to International Multifoods Corp.,Buffalo, N.Y., for salvaging. (F.D.C. No. 62632; S. No. 79-191-002et al.; N.J. No. 12)

Gelatin dessert mixes, canned papaya slices, and oriental noodle soup mixes,at Puerto Nuevo, Dist. P.R.Charged 5-16-79: while held by Puerto Rico Supplies, Inc., PuertoNuevo, P.R., all of the articles except the papaya slices containedinsect and rodent filth, the papaya slices were contained in swollen,leaking, and damaged cans, and all of the articles had been held underinsanitary conditions; 402(a)(3), 402(a)(4). Default decree ordereddestruction. (F.D.C. No. 62309; S. Nos. 79-157-398/400, 79-157-882;N.J. No. 13)

Hushpuppy mix, and other grocery stocks, at San Francisco, N. Dist. Calif.Charged 7-27-79: while held by Far West Food Co., Inc., San Francisco, Calif., the hushpuppy mix contained rodent and insect filth,and all of the articles had been held under insanitary conditions;402(a)(3), 402(a)(4). Consent decree authorized release to the dealerfor salvaging. (F.D.C. No. 62394; S. No. 79-150-328 et al.; N.J. No.14)

Peas, rice, whole gram, and other foodstocks, at Corona, E. Dist. N.Y.Charged 3-6-75: while held for sale, all articles, except one 130-baglot of rice and a 6-bag lot of gram, contained rodent filth, and all ofthe articles were held under insanitary conditions; 402(a)(3), 402(a)(4).Consent decree authorized release to House of Spices, Inc., Corona,N.Y., for salvaging. (F.D.C. No. 60228; S. Nos. 43-608/15 H; N.J.No. 15)

Raisins, at Collegedale, E. Dist. Tenn.Charged 5-T-77: while held for sale, the article contained rodent andinsect filth; 402(a)(3). Claims and answers to the Government's complaint for forfeiture were filed by the Argentine exporter, the localimporter, and the dealer. The claimants disputed among themselvestheir responsibilities. However, the claimants entered into a consentdecree condemning the article and ordering the articles destroyedunless one of the claimants filed a motion to permit reconditioning.When it appeared that none of the claimants would attempt reconditioning, the exporter and local importer secured an order authorizingthat eight boxes of raisins be retained for the purpose of the civil suitbetween the claimants. The remaining 5,920 boxes of raisins weredestroyed in accordance with the consent decree. (F.D.C. No. 61177;S. Nos. 77-69-838, 77-22-581; N.J. No. 16)

Raisins, at Plattsburgh, N. Dist. N.Y.Charged 8-27-79: while held for sale in Plattsburgh, N.Y., the articlecontained insect filth; 402(a)(3). Consent decree authorized releaseto Plattsburgh Grocery Co., Plattsburgh, N.Y., for salvaging. (F.D.C.No. 62319; S. No. 79-155-526; N.J. No. 17)


Rice, at Stuttgart, E. Dist. Ark.Charged 4-25-77: while held by Commercial Warehouse Co., Oklahoma City, Okla., and subsequently returned to Stuttgart, Ark., thearticle contained rodent filth and was held under insanitary conditions;402(a)(3), 402(a)(4). Consent decree authorized release to ArkansasRice Growers Cooperative Association, t/a Riceland Foods, Stuttgart,Ark., for salvaging. (F.D.C. No. 61198; S. Nos. 77-66-282/4; N.J.No. 18)

Salt, at Lewisville, Dist. Idaho.Charged 6-18-79: while held by Idaho Fresh-Pak Inc., Lewisville,Idaho, the article had been held under insanitary conditions; 402(a)(4).Default decree ordered destruction. (F.D.C. No. 62298; S. No. 79-175-680; N.J. No. 19)

Soy sauce, thick, at New York, S. Dist. N.Y.Charged 5-3-78: when shipped by Dah Chong Hong, Ltd., HongKone, the article (a combination of molasses, salt, and soybean extract) was offered for sale under the name "Thick Molasses"; and,while held for sale, the article was contained in swollen, leaking, anddented cans; 402(a)(3), 403(b). Consent decree ordered destruction.(F.D.C. No. 61732; S. No. 78-146-883; N.J. No. 20)

Starch from wheat, at San Francisco, N. Dist. Calif.Charged 7-11-79: when returned to R. J. Whitman Sales Co., SanFrancisco, Calif., from Seattle, Wash., the article (in 50- and 100-pound bags) contained rodent filth and had been held under insanitaryconditions—402(a)(3), 402(a)(4); and the label of the article in 50-pound bags, labeled in part: "Paygel-90 Wheat Starch," lacked thename and place of business of the manufacturer, packer, or distributor—403(e)(1). Consent decree authorized release to the dealer forsalvaging. (F.D.C. No. 62371; S. Nos. 79-176-598/9; N.J. No. 21)

F O O D / C O L O R A D D I T I V E S

Marzipan candies, at North Bergen, Dist. N.J.Charged 11-15-79: while held by Ernst H. Luppa, t/a Biermann Marzipan Co., North Bergen, N.J., who had manufactured the articlesusing interstate sugar, the articles contained the nonconforming coloradditives FD&C Red No. 2 and External D&C Orange No. 3; 402(c).Consent decree authorized release to the dealer for salvaging (i.e.,replacement of the banana-shaped marzipan in the fruit basket assortment, replacement of the carrot- and turnip-shaped marzipan inthe vegetable basket assortment, and destruction of such marzipanitems containing the nonconforming additives). (F.D.C. No. 42446;S. No. 79-189-761; N.J. No. 22)

Shale rock, ground, at Howard, Dist. Kans.Charged 5-22-79: when shipped by Odor Suppressant Materials Co.,Boonsville, Mo., the article, labeled in part "Odor Suppressant forLivestock and Poultry . . . Feeding Instructions . . . Produced byHaldiman Enterprises Inc., McCallen, Texas," was a nonconformingfood additive, and the article's label failed to bear the common orusual name of the food; 402(a)(2)(C), 403(i)(l). Default decree ordered destruction. (F.D.C. No. 62315; S. No. 79-164-953 et al.; N.J.No. 23)

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

Bacteriostatic sodium chloride injection, U.S.?., at Miami, S. Dist. Fla.Charged 6-9-72: when shipped from Rockville, Md., the circumstances of the article's manufacture, processing, packing, and holdingfailed to conform with current good manufacturing practice; the article's quality fell below the U.S.P. standard since the pH was approximately 4.1; and the label of the article, which read in part "Sterile. . . Iso ton ic Sodium Chlor ide So lu t ion . . . Sod ium Chlor ide . . .Benzyl Alcohol," failed to bear the official title of the drug in thecompendium, namely. Bacteriostatic Sodium Chloride Injection;501(a)(2)(B), 501(b), 502(e)O)(A)0). Default decree ordered destruction. (F.D.C. No. 58042; S. No. 8-389 F; N.J. No. 24)

Diethylpropion hydrochloride T.D. tablets, at Livermore, N. Dist. Calif.Charged 10-31-79: when shipped by Pharmadyne Laboratories, Inc.,Hackensack, N.J., the article was a new drug without an effective

approved New Drug Application; 505(a). Decree ordered destruction.(F.D.C. No. 62407; S. No. 79-179-662; N.J. No. 25)

Natural estrogenic substance sterile suspension; dexamethasone acetate suspension and estrogenic substance in oil; and dexamethasone acetatesuspension and natural estrogenic substance sterile suspension; 3 seizure actions, at City of Industry, Fullerton, and Los Alamitos, C.D i s t . C a l i f .Charged 7-27-78, 7-27-78, and 7-27-78: when shipped by Carter-Glogau Laboratories, Inc., Glendale, Ariz., the articles, labeled inpart as follows: (at Fullerton, Calif.) "Sterile suspension . . . FemoneAq.-2 (Natural Estrogenic Substance) . . . Manufactured for Prev-entix Pharmaceutical Co., Inc., Fullerton, Calif."; (at Los Alamitos,Calif.) "Dexamethasone Acetate Suspension [or "Sterile Injection. . . Estrogenic Substance in Oil"] . . . Carter-Glogau LaboratoriesDivision of Chromalloy Pharmaceuticals, Inc., Glendale, Arizona";and (at City of Industry, Calif.) "Dexamethasone Acetate Suspension[or "Sterile Suspension . . . Natural Estrogenic Substance"] . . .Carter-Glogau Laboratories Division of Chromalloy Pharmaceuticals,Inc., Glendale, Arizona," were new drugs without effective approvedNew Drug Applications; 505(a). The articles were claimed by theshipper who denied the charges. After a number of written interrogatories, requests for admissions, and requests for the production ofdocuments, the actions were consolidated by stipulation. Subsequently, the claimant's claim and answer, as to the dexamethasoneacetate suspension were withdrawn by stipulation, and a default decree o f condemnat ion ordered the des t ruc t ion o f the dexamethasoneacetate suspension. After additional discovery by the parties the claimant, by stipulation, totally withdrew its claims and answers in the threeactions, and a default decree of condemnation and destruction wasentered against the remaining articles. (F.D.C. Nos. 61836/8; S. No.78-127-796 et al.; N.J. No. 26)

Pangamic acid capsules, and amygdalin solution, at Spokane, E. Dist.Wa s h .Charged 2-6-75: when shipped by John A. Richardson, M.D., Albany, Calif., the capsules' label statements—"Pro-Vitamin B15 (Pan-gametin or Pangamic Acid) a non-toxic water soluble accessory foodfactor. A nutritional supplement"—were false and misleading, sincepangamic acid was not an identifiable substance and was neither avitamin nor a pro-vitamin, since there was no accepted scientific evidence to identify a deficiency of pangamic acid in man or other animals, and since the safety of pangamic acid had not been demonstrated—403(a); and the amygdalin solution was a new drug withoutan effective approved New Drug Application—505(a). The articleswere claimed by the shipper who denied the charges and filed a counterclaim. After additional litigation the articles were destroyed.(F.D.C. No. 60206; S. Nos. 27-442/3 H; N.J. No. 27)

Spironolactone with hydrochlorothiazide tablets, at Philadelphia, E. Dist.P a .

Charged 6-29-79: when shipped by Premo Pharmaceutical Laboratories, Inc., South Hackensack, N.J., the article was a new drug without an effective approved New Drug Application; 505(a). Defaultdecree ordered destruction. (F.D.C. No. 62357; S. No. 79-204-305;N.J. No. 28)

DRUGS/VeterinaryDipyrone injection, prednisolone sodium phosphate injection, ammonium

sulfate injection, and Tri-gom aqueous, at Fort Collins, Dist. Colo.Charged 8-14-79: when shipped by Anthony Products, Co., El Monte,Calif., Triple Crown Pharmacal, Inc., Havre de Grace, Md., andChromalloy Pharmaceuticals, Inc. (Carter-Glogau Div.), Glendale,Ariz., the articles were new animal drugs, and no approved NewAnimal Drug Applications were in effect with respect to their use andintended use; 501(a)(5). Default decree ordered destruction. (F.D.C.No. 62403; S. No. 79-198-135 et al.; N.J. No. 29)

Scopolamine hydrohromide soluble tablets, for veterinary use, at OklahomaCity, W. Dist. Okla.Charged 6-26-79: while held for sale for use in horses, the labelingof the article lacked adequate directions for use and was not exempted

FDA Consumer / May 1980

as a human prescription drug (as intended by the manufacturer), sincethe possessor had not been a person lawfully engaged in handlingprescription drugs and because the article was neither held for saleto, or on order of, a veterinarian nor did the label bear a veterinaryprescription legend; 502(f)(1). Default decree ordered destruction.(F.D.C. No. 62340; S. No. 79-181-750; N.J. No. 30)

Sulfachloropyridazine powder, dexamethasone powder, and sulfadime-thoxine powder, at Hilmar, E. Dist. Calif.Charged 12-30-74 and amended on or about 4-6-76: when shipped bySchuyler Laboratories, Inc., Rushville, 111., the articles were new animal drugs, and no approval of a New Animal Drug Application wasin effect with respect to the use and intended use of such drugs; thelabeling of the articles lacked adeauate directions for use; and thelabel of the sulfadimethoxine failed to state the name and place ofbusiness of the manufacturer, packer, or distributor; 501(a)(5),502(b)(1), 502(f)(1).

The articles were claimed by Hilmar Animal Hospital, Rushville,111. The parties served written interrogatories on each other. TheDarties litigated the answering of the interrogatories. The claimantlied a motion for summary judgment.

The claimant moved for summary judgment on the grounds thatthe pleadings and interrogatories established that the drugs' "labelingdid not state the conditions prescribed, recommended, or suggestedfor their use," and therefore the court could not determine whetherthe drugs were new animal drugs under the law. The court denied thec l a i m a n t ' s m o t i o n .

After trial by the court, the court condemned the articles and ordered them destroyed. (F.D.C. No. 60127; S. Nos. 25-841/2 H, 27-560 H; N.J. No. 31)

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

Diapulse electromagnetic energy generator, at Medford, Dist. Oreg.Charged 9-29-72: when shipped by Diapulse Corp. of America, NewHyde Park, N.Y., the artic e's labeling lacked adequate directions fortheir intended uses, since neither adequate directions for lay use noradequate information for use by licensed practitioners could be furnished; 502(f)(1). Initially a default decree of condemnation was filed.However, Milton R. Snow, M.D., Medford, Oreg., claimed the articleand moved that such decree be put aside. Upon the reopening of theaction, the Government served written interrogatories on the claima n t . A c o n s e n t d e c r e e o f c o n d e m n a t i o n a u t h o r i z e d r e l e a s e t o t h eclaimant for salvaging. Pursuant to stipulation, the decree was modified to delay completion of salvaging operations until 6 months afterthe failure of claimant's bond. Subsequently, at the request of theclaimant, a hearing was held before the court on March 17, 1975, todiscuss the procedures involved in bringing the condemned article intocompliance with the law. At the conclusion of the hearing, the courtruled that if the article was not brought into compliance with the law,the court would entertain a motion to dispose of the matter. As aconsequence of the claimant's failure to bring the article into compliance, the court ordered the article destroyed. (F.D.C. No. 58304;S. No. 79-192 F; N.J. No. 32)

Oxygen mask for emergency use, at Louisville, N. Dist. Ohio.Charged 12-28-70: when shipped from Los Angeles, Calif., the device's accompanying leaflet and flyer contained false and misleadingclaims for a 10-minute supply of oxygen; the labeling lacked adequatedirections for use by the untrained laiety for heart attack, drowning,stroke, asthma, shock, and smoke inhalation, since such directionscould not be written; and the labeling lacked adequate warningsagainst unsafe use; 502(a), 502(f)(1), 502(f)(2). Default decree ordered destruction. (F.D.C. No. 56877; S. No. 31-828 D; N.J. No. 33)

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

F O O D

Barnett & Sons Salvage, Ltd., of Opelousas, La., Jesse P. Harnett, Jr.,secretary & treasurer, and Billy D. Hicks of McGehee, Ark., at Tunica, N. Dist. Miss.

Charged 5-23-77 by grand jury as described in N.J. No. 35 of February1978 FDA Consumer. Following the defendants' convictions, theyappealed to the Court of Appeals, Fifth Circuit. The court of appealsaffirmed the convictions, saying:

"When Theodore Roosevelt was President of the United States,the misbranding and harmful adulteration of foods had become ofsuch nationwide moment that Congress enacted the first Food andDrug Act, 1906.

* * *

"From time to time the Act has been amended in the light of newdevelopments and with a view to more effectively protecting the general public from foods which may be harmful or which have beenmisbranded. We have no doubt that the various provisions of the Actare plain, that they suffer from no ambiguity amounting to impermissible vagueness, and that they do not violate the Constitution.

"The grand jury for the Northern District of Mississippi indictedJessie P. Barnett, Jr., Billy D. Hicks, and Barnett & Sons Salvage,LTD., for criminal violations of these statutes, as well as for a conspiracy to commit those violations.

"A jury convicted all three defendants on all six counts.* * *

"The action began on September 1, 1975, when Hicks made anarrangement with the Planters Oil Mill, Inc., of Tunica, Mississippi,in which it was agreed that the Mill would receive cottonseed whichhad been poison-treated for planting purposes, process it into cottonseed meal, and deliver the meal to the railroad agent at Tunica fortransportation to various customers in Interstate Commerce. It wasfurther agreed that from this operation the cost of processing andshipping would first be deducted, after which the parties would splitthe profits, if any. Shipment of the treated seed to Planters began onSeptember 2, contained in bags, marked 'Poison-treated—^Do not usefor food, feed, or oil'.

"In the meantime. Hicks had made a separate arrangement withJessie P. Barnett, Jr., of Barnett & Sons Salvage Company, LTD.,in which Barnett agreed that his Company would find buyers for themeal processed from the treated planting cottonseed.

"On September 9, Barnett made a contract with Southern FeedIngredients Company, a company which deals solely in componentsfor animal feed, by which Barnett was to sell Southern 1,000 tons ofcottonseed meal. The record is not clear as to whether Barnett knewinitially that the meal was to be manufactured from treated seed, butthere is no doubt that he soon learned of it. The serious aspect of thiscase is that Barnett never informed Southern at any time that themeal was to be processed from cottonseed which had been poison-treated for planting purposes.

"At various times and on various dates, within the time periodalleged in the indictment. Planters processed the treated cottonseed,loaded the resulting meal onto railroad cars, and consigned the carsto the railroad agent at Tunica. The bills of lading contained thewarning. Fertilizer use only. Copies of those bills of lading were sentto Barnet t & Sons and to Southern.

"It was during this period that Mr. Barnett really stuck his handin the fire by representing to Southern that the warnings appearingon the bills of lading were erroneous, that the meal was fit for animalfeed. The invoices from Planters, sent to Hicks and to Barnett & SonsSalvage Company, LTD., bore the warning 'Fertilizer, chemical orindustrial use only'. Not stopping at this. Planters notified both Hicksand Barnett & Sons, by certified letter, return receipt requested, thatthe Mill had begun consigning meal to the railroad agent and that 'wewant it fully understood that the products from these seed are onlygood for fertilizer, chemical or industrial use.'

"On the dates alleged in the indictments Southern directed therailroad agent to ship the meal to various customers, as thereincharged.

"Matters lost no time in coming to a head. One of Southern'scustomers complained 'that the meal had a burned or dark color, anda burned smell.' Southern then told Planters to send a sample of themeal to a laboratory in Memphis for analysis. On September 19 thesamples were sent. On September 25, the laboratory reported thatthe samples contained 'less than .01 parts per million' of Disyston.

38 i May 1980 i FDA Consumer

The report, however, did not indicate that any test had been conductedfor mercury or for PCNB.

"The customer also submitted samples of the meal to the statelaboratory at Mississippi State University. On September 22, this laboratory notified the customer that the meal samples contained Di-syston. The customer then recalled all of the meal that could be tracedand shipped it back to Southern. It informed Southern of the situationand also informed Mississippi feed inspectors, as well as investigatorsfor the Food and Drug Administration, that the meal was tainted.

"The Food and Drug Administration investigators took samples ofthe meal at Planters, in Tunica, and from all places to which the mealhad been shipped or at which could be found in transit. Tested byFood and Drug Administration laboratories, these samples revealedthe presence of mercury, PCNB, and Disyston.

H I C K S"Mr. Hicks complains first that the statutes in question are uncon

stitutional. . . . We agree that, most assuredly, criminal statutes mustfairly apprise those who are subject to them as to the conduct whichis proscribed. Even so, 'no more than a reasonable degree of certaintyc a n b e d e m a n d e d ' . . . .

"We can attribute no merit whatever to the contention that thestatutes left the defendants without fair warning that their acts wereillegal. 21 U.S.C. § 331(a) prohibits the 'introduction or delivery forintroduction into interstate commerce of any food . . . that is adulterated . . . .' 21 U.S.C. § 342(a)(1) defines an adulterated food asone bearing or containing 'any poisonous or deleterious substancewhich may render it injurious to health'. 21 U.S.C. § 321(f) specifiesthat the term ' "food" means . . . articles used for food or drink forman or other animals . . . .'

"Hicks testified that only by analysis could it be determined whetherit would be safe to feed the meal. This does not help him. The cottonseed meal in this case was sold for feed prior to analysis and thiswas done with Hicks' knowledge. The facts, as previously statedherein, reflect the warnings received by Hicks that the product wasunfit fo r an ima l feed .

"Mr. Hicks complains that he was prejudiced by overly extensiveexpert testimony adduced on behalf of the government with referenceto the harmful effects of mercury, PCNB, and Disyston. Our evaluation of the trial record, however, leaves us with the firm convictionthat the rulings of the trial court on the materiality and relevancy ofthis testimony were well within its discretion. United States v. Grimm,5 Cir. 1978, 568 F.2d 1136, 1138; United States v. Brown, 5 Cir. 1977,547 F.2d 1264, 1266. Indeed, if Hicks thought that the extensivenessof the proof as to these rather indisputable facts would put the caseout of focus, to his prejudice, he could easily have eliminated thehazard by merely stipulating the harmfulness, putting an end of thematter. On the other hand, if there was any doubt about it, thegovernment was entitled to nail it down.

B A R N E T T"Jessie P. Barnett, on his own behalf and that of Barnett & Sons

Salvage, LTD., urges reversal of their convictions on the grounds ofimproperly admitted evidence, an allegedly improper notice of anevidentiary fact, insufficient evidence, and improper consideration ofa pre-sentence report.A. Admissibility of Evidence

"Twelve railcars of meal were shipped from Planters. By the timethe FDA could obtain samples for its tests, meal from three of thesecars had been commingled with meal from other sources. Over objection, the District Court admitted samples from all twelve cars,including the three cars containing commingled meal. Barnett contends that the samples taken from the three commingled cars wereirrelevant and the admission of the samples constitutes reversible error. We disagree.

"This argument tries to slough off the fact that there were ninecarloads of meal in which there had been no commingling and evenas to the three in which there had been commingling, some of themeal had been processed from the Hicks-Barnett treated cottonseed.The samples from all twelve cars revealed the presence of the deleterious substances in question. Even if it was error to admit the samples from the three commingled cars, it was obviously harmless beyond

a reasonable doubt and we need not pause for a prolonged discussionof this point.B. Insufficient Evidence

"Barnett maintains that due to his good faith reliance on the Bar-row-Agee test that there was insufficient evidence of intent to commita felony and therefore that his motion for judgment of acquittal shouldhave been granted.

"Viewed in the light most favorable to the government, Glasser v.United States, 315 U.S. 60, 62 S.Ct. 457, 86 L.Ed. 680 (1942), thefacts simply do not support this argument. Barnett had received copiesof bills of lading, invoices, and a letter from Planters, warning inunequivocal terms that the meal was not to be used for animal feed.Barnett assured Southern that the copies of bills of lading bearing thewarning 'Fertilizer use only' were in error and that the meal was goodfor feed use.

"Moreover, the record shows that samples were not sent to Barrow-Agee for analysis until September 17, 1975, where they were receivedon September 19. The Barrow-Agee report was not issued until September 25, 1975. Barnett's assurance to Southern that the meal wassafe for feed use took place prior to September 19. All twelve railcarshad been shipped from Planters by the time the Barrow-Agee reportwas issued. Barnett could not have been relying on the Barrow-Ageereport when he misled Southern because the report was not yet ine x i s t e n c e .

"The argument that Barnett acted in good faith cannot, on thisrecord, be sustained.C. Judicial Notice of the Absence of Tolerance Standards

"At the close of the government's proof in rebuttal, and at thecontinued behest of the prosecution, the District Court told the jury:'Now, members of the jury, the court takes judicial notice that noregulations prescribed by any governmental agency provide for standards or tolerances relating to the presence of mercury, PCNB, anddisyston as components, as allowable components, to be containedin cot tonseed meal manufactured and intended to be used for animalfeed, that there are no regulations on the subject that have beenprescribed allowing the presence of these elements in cottonseed mealintended for consumption in animal feed.'

"On cross-examination of government witnesses, the defendantsattempted to create the impression that there is a government-authorized tolerance level for mercury, PCNB, and disyston. They neverproffered evidence of any such tolerances but they repeatedly cross-examined government witnesses as to whether there were such standards. At one point, pursuant to the government's request, the Courtdirected defense counsel to present the tolerance standards if theywere available. Barnett's counsel responded that he only had 'somenotes' but wanted to ask some questions concerning tolerances 'forthe later testimony'. The Court permitted him to continue.

"At the conclusion of the expert testimony, the government movedthe Court to take judicial notice of the absence of tolerances because'it has been made an issue of fact on some of the cross-examination.'Barnett's counsel protested .... The Court deferred ruling until itcould examine the regulations. At the conclusion of the government'scase-in-chief the government again moved the Court to take the desired judicial notice. An extended discussion ensued in chambers. TheCourt again deferred ruling. During a weekend recess the Court studied the statutes and regulations and, after the close of rebuttal prooffor the government, gave the instruction as above quoted.

"In the calmness of judicial review we do not understand exactlyhow the trial court allowed the government to prevail in this requestthat it take judicial notice. The defendants had offered no proof thatthe tolerance standards existed. There was nothing to rebut. Thedefense had a right to cross-examine the government witnesses in asearch for evidence that such standards might exist, but this was farfrom establishing that they did exist. The defendants having whollyfailed to establish the existence of any standards, it would seem hardlynecessary that the Court should have entered the lists on the side ofthe government by informing the jury at the close of the evidencethat, as a matter of fact, the standards did not exist. If the governmentthought that the failure of proof carried with it significantly adverseconsequences, it should have had no real trouble producing a qualified


witness, in chief, who could have testified that an examination of theFederal Register failed to reveal the existence of any such standards. All of this is especially true when it is remembered that it is notnecessary for the government to prove a negative ...."We do not approve the procedure followed here, but, for severalreasons, we decline to reverse these convictions on this point.

"In the first place, there is not the slightest contention that whatthe District Court told the jury was incorrect. In the second place, thedefendants provoked the situation by pursuing the point on cross-examination when they knew, or by investigation of the FederalRegister should have known, there were no such tolerance standards.Lastly, it may be said that since the statement was true and the government was under no obligation to prove it in the first place, theerror was harmless beyond a reasonable doubt.D. Sentencing Procedure

"The pre-sentence report contained information relative to a priorsale by Barnett of soybean meal which had been processed from beansthat had been treated with mercury. A copy of the report was furnishedto Barnett and counsel prior to sentence. The trial court thoroughlyexplored the subject matter of the report with Jessie P. Barnett, Jr.and his counsel. Barnett pointed out that there had been no convictionas a result of this incident, but he did not dispute the basic facts asreported. He claimed that the poisoned soybean meal had been mixedwith untreated meal and thereafter shipped to a customer by a thirdparty without Barnett's consent. Barnett said that he had fully cooperated with FDA investigators concerning the matter. Thereupon,the District Court announced that it wou d request the probationservice to make a further investigation into the matter and would givefurther consideration to the sentence imposed on Count 1 should theCourt learn anything 'substantially different' within the next thirtydays.

"Barnett's counsel subsequently filed a motion for reduction ofsentence. This motion was supported by affidavits to the effect thatthe earlier incident occurred through the unintentional and unauthorized intermingling of meal processed from treated beans, withmeal processed from uncontaminated beans.

"On December 27, 1977, the District Court denied the motion onthe ground that there was 'no basis in fact for the alteration' requested.

"It is undisputed that the sentencing procedure followed by theDistrict Court was in accordance with the requirements of Rule32(c)(3)(A) of the Federal Rules of Criminal Procedure. Barnett contends, however, that F.R.Crim.P. 32(c)(3)(A) failed to accord Barnettthose safeguards required as a matter of due process. Specifically, hesays that 'consideration of the unsworn accusations of a governmentalinvestigative agent over Defendant's total denial of such accusations'contravenes the requirements of the Fifth Amendment to the UnitedStates Constitution; that anything less than a full evidentiary hearingconstitutes a denial of due process.

"These arguments must be rejected."A sentencing judge 'may appropriately conduct an inquiry broad

in scope, largely unlimited either as to the kind of information he mayconsider, or the source from which it may come'. . . .

"The Williams Court [Williams v. New York, 337 U.S. 241, 69 S.Ct. 1079, 93 L.Ed. 1337 (1949)], of course, did not hold that thesentencing judge's discretion is unlimited. A defendant has a right to'at least minimal safeguards to insure that the sentencing court doesnot rely on erroneous factual information'. . . . Thus we have heldthat where a defendant disputes information considered in imposinga sentence, the defendant must be given 'at least some opportunityto rebut that in format ion ' . . . .

"The right of rebuttal does not require that the sentencing hearingbe t ransformed in to a second t r ia l . . . . At a min imum i t is suffic ientif the sentencing judge affords the defendant an opportunity to 'comment on any alleged factual inaccuracy.' . . .

"Barnett does not contend that he was not afforded an opportunityto rebut the information contained in the pre-sentence report. Whathe claims is that he 'did rebut' it. He therefore argues that the rightof rebuttal was insufficient; 'anything less than a full evidentiary hearing constitutes a denial of due process'. This argument, of course, isknocked from its feet by Williams v. New York, supra. * * *

"As a matter of due process, a defendant about to be sentenced isnot entitled to the same evidentiary protections, such as the right to

cross-examine adverse witnesses in a sentencing proceeding, as areavailable in a trial on guilt or innocence.

"In this case, Barnett was fully informed of the contents of the presentence report. He was given every opportunity to state his versionof the matter, and he did so. That is the end of it."

Billy D. Hicks petitioned for a writ of certiorari, but his petitionwas denied. (F.D.C. No. 60777; S. No. 76-00-154 et al.; N.J. No.34)

Biirs Institutional Commissary Corp. of Mississippi, and Homer Pierce,Jr., vice president, and James P. Langston, general manager, Flo-wood, Dist. Miss.Charged 10-1-79: farina cereal (count 1), bread wafers, sugar, nonfatdry milk, peanut candy bars, and mint candy bars were held underinsanitary conditions in a building accessible to rodents, and the farinacereal, the bread wafers, and the sugar had been contaminated withrodent filth; 402(a)(3), 402(a)(4). Nolo contendere pleas by corporation and vice president; $5(jO fines on count 1 and suspended finesof $5,000 on other counts and 18-months probations. Nolo contendereplea by general manager; $300 fine. (F.D.C. No. 62092; S. No. 77-22-546; N.J. No. 35)

NOTICE OF JUDGMENT on Injunction ActionUnivar Corp., t/a Continental Mills, James H. Wiborg, president, T. Frank

Kawlinson, corporation vice president & mill president, John Wing-field, mill production vice president, and Dan F. McAllaster, millsuperintendent, Portland, Dist. Greg.Charged 10-22-75 in a complaint for injunction: that the defendantshad been engaged at their food processing and warehousing facilitiesin Portland, Greg., in milling interstate wheat into flour and in packaging, holding for sale, and distributing in interstate commerce foods,such as flour, flour products, dried peas, beans, popcorn, and rice;that a number of such foods were prepared, packed, and held underinsanitary conditions; that a number of such foods contained insectfilth; that FDA inspections disclosed the existence of a number ofspecified insanitary conditions; and that the defendants had been repeatedly warned of their insanitary conditions and practices; 402(a)(3),402(a)(4).

A consent decree of permanent injunction enjoined the complainedof violations and enjoined the preparing, packing, holding, and inters ta te d is t r ibu t ion o f de fendants ' foods un less and un t i l a numberof specified conditions were met.

Initial compliance with the terms of the consent decree enabled thedefendants to resume operations on November 7, 1975. After 3 yearsof compliance, the defendants petitioned that, because the terms ofthe decree had been fully complied with and because the firm hadshown through its actions a commitment toward maintaining and improving high sanitary levels, the decree should be vacated. FDA didnot oppose the motion, and the court vacated the injunction. (Inj.No. 711; S. No. 76-52-255 et al.; N.J. No. 36

Notices of Judgment are given pursuant to section 705 of the FederalFood, Drug, and Cosmetic Act. Notices of Judgment report cases involvingseizure proceedings, criminal proceedings, and injunction proceedings.Seizure proceedings are civil actions taken against goods alleged to be inviolation, and criminal and injunction proceedings are against firms orindividuals charged to be responsible for violations. The cases generallyinvolve foods, drugs, devices, or cosmetics which were alleged to be adultera ted or misbranded or o therwise v io la t ive o f the law when in t roducedinto and while in interstate commerce, or while held for sale after shipmentin in te rs ta te commerce.

Notices of Judgment are prepared by Food and Drug Division, Gfficeof the General Counsel, HHS.

Published by direction of the Secretary of Health and Human Services.

Jere E. Goyan, Commissioner of Food and DrugsWashington, D.C., May 1, 1980

40 / May 1980 / FDA Consumer ☆ U.S. GOVERNMENT PRINTING OFFICE; 1980-311-254/65

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Copyright 1980, G. B. Trudeau; distributed by Universal Press Syndicate

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