mr ' i

T h i s M o n t h

This month, we look at some of the false beliefsabout health held by the average American. Dowe all need vitamin pills? Do copper bracelets reallyhelp arthritis? Is a bowel movement essential everyday? If you are typical, you're probably misinformedabout one or more of these issues. But you're ingood company, because so are a large number ofAmericans. Our story is based on a 426 -page studythat explored what Americans think about health.Some of the results of the study may surprise you,some may dismay. But all should make you thinkagain about some of your beliefs about health.

Also in this issue we take a fresh look at the DESI

project. Our author is Dr. Paul A. Bryan, who hasheaded DESI since its inception. DESI stands forDrug Efficacy Study Implementation. It's a review ofall the new prescription drugs initially sold between1938 and 1962. The study told FDA a lot about prescription drugs, information which will be passedon to the American public in the form of bettermed ic ines .

Our color story this month is on lead in paint-what FDA and other Government agencies have doneto reduce the l ikelihood that your child wil l bepoisoned by lead paint, and what you can do toprotect your child from this avoidable hazard. Thousands of children each year are injured from eatingpaint chips containing lead. (See photo at left.)

A recent report submitted by FDA to Congress onflammable clothing provided the basis for our story,''When Clothing Ignites." The report identified whoare likely to be the most seriously injured victims ofclothing fires, and what you ought to be alert forwhen you're buying clothes.

FDA Consumer / October 1972 I 1

QUOTES

The National Center for Toxicological Research (inPine Bluff, Ark.) represents a significant advancein FDA's research program. The Center will examinethe means whereby the biological effects of a numberof chemical substances which are found in man's surroundings, such as pesticides, food additives,and therapeutic drugs, are evaluated. The research programwill also include an examination of comparative responses of various test systems, a procedure whichwill increase the validity of extrapolations from various animal species to man. We need to know theextent to which experiments conducted in animalsare predictive of the response in man.

"In addition, this Center will afford an opportunityto undertake studies aimed at an understanding ofdose-response relationships, especially realisticallylong exposures to low doses of chemicals. This willgive the Agency a capability it now substantiaUy lacksto assess the cumulative impact of small amounts ofchemicals, including substances used in food, over along period of time."

Charles C. Edwards, M.D., Commissioner of Food and Drugs,before the Select Committee on Nutrition and Human Needs,United States Senate, September 20,1972.

It has been a long time since most consumers in thiscountry produced their own food. Now in increasing numbers they not only do not produce it but donot prepare it. As a result, they are getting the feelingthat they are no longer masters of their destiny in thisarea and are casting about for some way to regainc o n t r o l .

"There is a theory of government that says thatgovernment should do for the people what they cannot do for themselves, or what it can do better andcheaper. This obviously assumes that the activity inquestion is something that the people want done.

"There seems to be little doubt that a large segmentof our people want more control over what they eatwithout losing the freedom of choice and low costthat they now have. In large numbers they are looking to government to achieve this control."

Virgil O. Wodicka, PKD., Director, Bureau of Foods, at theInternational Association of Milk, Food and EnvironmentalSanitarians, Milwaukee, Wisconsin, August 22,1972.

2 / October 1972 j FDA Consumer

El l io t L . Richardson

Secretary, U.S. Department ofHealth, Education, and Welfare

Merlin K. DuVal, M.D.Asst. Secretary for Healthand Sc ien t i fi c A f f a i r s

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

C h a r l e s H . D i c kA s s t . C o m m i s s i o n e rfo r Pub l i c A f fa i r s

^ M f d a

(JONSUMERVOL 6, NO. 8 / OCTOBER 1972

Wayne L. Pines/Editor

Harold C. Hopkins/Editorial Director

Jesse R. Nichols/Art Director

Joan M. Galloway/Managing Editor

Frederick L Townshend/Production Mgr.

FDA CONSUMER, the official magazine of theFood and Drug Administration, is publishedmonthly, except for combined july-August andDecember-january issues. Subscriptions may beordered from the Superintendent of Documents,Government Printing Office, Washington, D.C.20402, at $3.50 a year ($1.00 additional for foreignmailing).

A d d r e s s f o r e d i t o r i a l m a t t e r s : F D A C O N S U M E R ,PA-20, Food and Drug Administration. 5600Fishers Lane, Rockvi l le, Md. 20852.

Articles published in FDA CONSUMER are intbe public domain and text may be republishedwithout permission. Use of funds for printingthis publication approved by the Director ofthe Office of Management and BudgetNovember 22, 1971.

FDA CONSUMER was previously known asF D A P A P E R S .

Section 705 [375] of the Food, Drug, andCosmet i c Ac t :

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

(b) The Secretary may also cause to bedisseminated information regarding food, drugs,devices, or cosmetics in situations involving, inthe opinion of the Secretary, imminent dangerto health, or gross deception of the consumer.Nothing in this section shall be construed toprohibit the Secretary from collecting, reporting,and illustrating the results of the investigationso f t h e D e p a r t m e n t .

A m e r i c a ' s H e a l t h :Fallacies, Beliefs, Practices

D E S I W h o ?

When Clothing Ignites

Getting the Lead Out of Paint

FDA and Hurricane Agnes

Canned Foods

News Highlights

Regional Reports

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

Seizures and Posta l Serv ice Cases 35

Notices of Judgment

FDA Consumer / October 1972 I 3

Those Cancer "Cures "It was not surprising that few cancervict ims were encountered in a randomhousehold survey, considering that thedisease is incapacitating and mostvict ims were not available forinterviews. Not enough followers ofany practice that might be judgedquestionable were found to make anygeneral conclusions.

Instead, the survey concentrated ona hypothetical "cancer cure"controversy similar to instances in thenews in recent years. The respondentswere asked to take sides between"most scientists and doctors," whosay the hypothetical "cure" isworthless, and the patients of a "fewdoctors" who say it saved their lives.Nearly one-fourth of the sample sidedwith those who claimed a cure, andanother 18 percent said they did notknow. Thus 42 percent of the sample,representing over 50 million adults,were unconvinced by what waspresented as nearly unanimous expertopinion. Only 45 percent of the samplethought such an unproven remedyshould be banned by law. Thereseemed to be widespread unawarenessof the harm done when ineffect iveremedies are at large on the market, asthey were in the "patent medicine" j

Self-Diagnosis and MedicationVirtually everyone in the United Stateshas been a patient of a medical doctorat some time. About a fifth of the

population have visited a chiropractorand about one-half of one percenthave seen a naturopath. This last grouptends to be older and composedmostly of women.

Self-diagnosis of ailments, however,is far from uncommon. Over a fourthof the respondents who said they hadarthritis, rheumatism, or some similarailment said the condition had neverbeen diagnosed or treated by amedical doctor or osteopath. Of thosereporting asthma, allergies, orhemorrhoids, 10 to 20 percent said aphysician had never diagnosed thecondition. Heart trouble, high bloodpressure, and diabetes, on the otherhand, were self-diagnosed by very fewpeople-only four percent or less ofthose reporting the ailments.Apparently, about 16 millionAmericans who believe they have one

or another of these ailments have neverhad a qualified diagnosis.

About 16 million people also saidthey would self-medicate for longerthan two weeks for one or more of the

following ailments: sore throat, coughs,sinus trouble, head colds, hay fever,skin problems, sleeplessness, acid orupset stomach.

Any self-medication for hearttrouble, high blood pressure, ordiabetes is questionable, as isself-medication of asthma, allergies, orhemorrhoids if a cure, rather thansymptomatic relief, is expected.Seven percent of the population fallinto this category of usingself-medicat ion for ser ious ai lments.This represents about nine millionpeople-more men than women.

There are no medic inal "cures"for any of the six ailments, but manypersons expected cures, ranging fromfour percent for diabetes sufferers to20 percent for asthma patients. In themajority of cases the supposed curewas said to have come from a physician.It cannot be determined from the datain the survey whether doctors areactively contributing to patientexpectations in this area, but it doesappear that many patients do notunderstand the nature of the therapy.

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8 / October 1972 I FDA Consumer

Your Health, Better or Worse?All persons in the national survey wereasked to compare their health withthat of "most people their age."Clearly, many more people rated theirhealth as better than average. Men weresomewhat more positive than women,and older people were considerablymore positive than younger ones. Thelatter finding is particularly interesting.It may be that the longer a person lives,with increasing awareness of mortalityamong his peers, the more he isinclined to congratulate himself for hisgood health.

The question of how much peopleworry about health also was explored,with similar results. The great majorityreported little worry, men indicatingless worry than women. Here, again,people 65 years of age or older showedless worry (70 percent) than theyounger respondents.

Another observat ion that can bemade from the survey about olderpeople is that they are more critical ofdoctors and the medical profession,but are less inclined than youngerpeople to rely on their own judgmentwhen it conflicts with that of a

physician. Older people seem moreskeptical than young ones about theefficacy of nonprescription remedies,and prolonged self-medication forcommon ai lments is more characterist icof young than old people.

Treatment by "Trial and Error"After the questionnaires were tabulated,a number of general attitudes andopinions were drawn from the data.For instance, the survey indicatedthat a sizable part of the population issusceptible to unethical or questionablehealth practices and advertising. Thenegative opinions of many aboutdoctors and the medical professionwere considered striking. Thereappeared to be a widespread lack ofunderstanding of the potential dangersof ineffect ive treatment and a marked

tendency for many to rely on theirown judgment over that of a physician.

The survey found that although aperson may follow a questionablepractice in one area of health he didn'tnecessarily do the same in other areas.And those who held what wasconsidered to be faulty health beliefs

"Older people considered theirhealth to be better thanyounger people did."

I t ®D J i \

M M

did not necessarily put these beliefsinto practice. Many people apparentlyengage in questionable practices justbecause it seems "worth a try," ratherthan from any definite belief.

If health practices do not followfrom health beliefs, how are they to beexplained?

The report suggests that when aperson is faced with an unfamiliar doorand someone else's key ring, he isinclined to try all the keys hoping tofind one that works. Many people seemto follow a similar system in theirhealth practices. The survey calls it"rampant empiricism," — tryingrandom alternatives to see if they work.Not realized are the overwhelmingodds against discovery of an effectivetreatment by such a process.

It's a truism in the medical

profession that what works best forone patient may not be the mosteffective for another, and a goodphysician may try several alternativesuntil he finds something to which thepatient responds. But his choices arecircumscribed by reason and priorknowledge, while the layman is notable to impose rational limitations onhis choice of treatments.

Another characteristic of popular

N*i* * . *. «* . . . r

but faulty thinking about healthproblems is the way it applies thepsychosomatic concept—the mind'sinfluence on the state of the body. Thetest question on the "cancer cure"controversy, described earlier, is anexample. Many said both sides wereright. In explaining how that could be,the idea of individual physiologicalresponses to medicine emerged, as didthe idea that, if people have faith in amedicine, this in itself can make itbeneficial. Unfortunately, such aneffect will not arrest the progress ofc a n c e r .

Spontaneous unaided recovery ornatural abatement of symptoms,which occurs with many conditions,also contribute to the persistence offallacious beliefs and practices.

The depth interviews in the surveyled to the suspicion that healtheducat ion offered in the schoolscontributes to an overemphasis ondiet and nutrit ion as the answer tohealth problems. The drilling thatpeople have received on "basic foodgroups," how to balance a meal, andthe sources and benefits of the variousvitamins and minerals, has succeededin impressing them. (continued)

FDA Consumer / October 1972 / 9

Of Claims and QuacksSubstantial numbers of people believethat advertisers in the health field andelsewhere are watched and regulated soclosely that serious distortions areunlikely and outright fabrications arenearly impossible. There is a feelingthat ''they wouldn't dare" make up"evidence" to support a claim, orfalsify testimonials because "they wouldbe caught." Most fail to realize howeasy it is for an unscrupulous advertiserto manufacture implications ofbenefits and get away with it for a longperiod of time.

The popular use of the word"quack" may have served no good end.The word itself is humorous, andquacks have become the object ofhumor in countless jokes. Labelingfraudulent practitioners so handily as"quacks'' seems to have created anassumption that quackery is easilyrecognizable. The depth interviews inthe survey indicated that even thosewho may have visited such individualsstill maintained that they didn't "goto quacks." Obviously no one likes toadmit he's gullible but it's far morelikely that many persons simply fail torecognize present-day healthmisinformation as quackery.

"Labeling fraudulent practitioners so handily as 'quacks' seemsto have created an assumptionthat quackery is easily recogniz a b l e . "

Complete report copies including thesurvey questionnaire are available fromthe National Technical InformationService, Springfield, Virginia 22151.Orders should specify ''Accession No.210-978, A Study of Health Practicesand Opinions." Checks ($6.00 percopy) may be made payable to"NTIS. ** Microfiche film copies are alsoavailable at 95 cents.

J. W. Buchan is a free-lance writer.

10 ! October 1972 j FDA Consumer

Ten years ago the Congress enacted a new law giving the Foodand Drug Administration authorityto regulate medicines on the basisof efficacy as well as safety. Fewwould have thought then that Congress' mandate would lead to afresh look at the entire prescriptionand over-the-counter drug market.But it did. Here's how FDA undertook to review prescription drugs,and what the 1962 Drug Amendments mean to the American pat i e n t .

by Dr. Paul A. Bryan

Consumers who look at the organization chart of the Food and DrugAdministration's Bureau of Drugs maybe mystified by one box that is connected to the Office of the Director.

In that box are four capital lettersthat spell DESI. The question isusually; DESI who?

It's not a typographical error. Noris i t a reference to a well-known television actor. DESI is an acronym thatstands for Drug Efficacy Study Implem e n t a t i o n . T h i s i s o n e o f t h e m o s t

important projects-perhaps THE mostimpor tan t one-ever under taken toimprove the quality of prescriptiondrugs in the United States.

As a result of the Drug EfficacyStudy, hundreds of ineffective prescription drugs have been or will beremoved from the marketplace. Thousands more wi l l be re labeled to more

accurately reflect their real therapeuticqualities.

T h i s m e a n s t h a t t h e A m e r i c a n

patient, more so than ever before, willreceive safe and effective drugs whenhe goes to his doctor and gets a prescr ipt ion. Because whi le the mostimmediate effects of the DESI project

are on the makers of drugs and on themedical community, the ultimatebeneficiary is the American patientwho buys and takes prescription medic i n e s .

As a result of the DESI project, theAmerican patient will also be assuredt h a t d o c t o r s h a v e m o r e r e l i a b l e a n dmore objective labeling information onwhich to select their prescriptiondrugs.

Side effects of the Drug EfficacyStudy also have or will affect therapeutics in the United States. One sideeffect from this project was a newlook at combination drugs—drugswh ich comb ine more t han one ac t i ve

ingredient. The DESI project led tonew criteria for the marketing of combination drugs, some of which in thepast have posed more of a hazard thana benefit to patients.

A n d a l s o b e c a u s e o f t h e D E S I

project, FDA has developed a newmethod for getting a handle on thethousands of unapproved drugs thathad been marke ted w i t hou t FDAknowledge. Not only does this meanthat drugs will be regulated more carefully than ever before, but also that adoctor soon will be able to prescribeany drug with assurance that it is safeand effect ive.

"To understand how the DESIproject came about, and how theseimportant side effects took place, onemust go back briefly to 1906, whenthe first Federal Food and Drugs Actwas passed by the Congress. This Actgrew out of recognition by theCongress that, among other abuses inthe marketplace, thousands ofuntested, worthless, and sometimesharmful drugs were being sold to thepublic. The law prohibited interstatecommerce of all foods, drinks, and

drugs that were falsely labeled or contained adulterating substances.

One of the detects in this law wasthat a product had to cause injurybe fo re the Federa l Governmen t cou ldseek i ts removal. This defect was corrected in 1938, when the present Food,Drug, and Cosmetic Act was passed.Under this law, drugs had to be provedsafe before they could be marketed.They also had to be properly labeled.Studies to demonstrate safety had tobe performed by the manufacturersand submitted to FDA in New DrugApplications (NDA's).

The 1938 law still did not assurethe American patient that he wasgetting the best drugs. So in 1962Congress amended the Food, Drug,and Cosmetic Act providing thatmanufacturers be required to provetheir drugs work, in addition to beingsafe.

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

prompted enactment of this law wasthe thalidomide case. This drug was atranquilizer that had been sold in someEuropean countries, and was tested inhumans in the United States. Tragically, thalidomide could cause birthdefects in babies if taken by pregnantwomen. Many babies in Europe wereborn without arms and with other serious defects as a result of thalidomide.

Fo r t una te l y, t h rough FDA ' sefforts, this drug was never available tothe general public in the United States.B u t t h e t h a l i d o m i d e c a s e d e m o n s t r ated the need for tighter controls overdrugs. The Kefauver-Harris DrugA m e n d m e n t s , w h i c h t o o k e f f e c tOctober 10, 1962, were designed tomeet that need. The amendments alsocorrected many other defects, such asproviding for better controls over prescription drug advertising.

12/October 1972 !FDA Consumer

The Congress spelled out just whatevidence would be required beforeFDA could approve a drug for effectiveness. Studies of the drug wouldhave to be conduc ted in a con t ro l ledmanner by trained experts who coulddraw val id and reasonable conclusionsabout the uses of the drug on the basisof the studies.

The responsibility for reviewing all7,100 of the 1938-62 NDA drugs foreffectiveness was a huge order, sincemany of the drugs had several claimsfor use, each of which had to be carefully judged for effectiveness.

IBecause of its limited resources atthat t ime, FDA asked the NationalAcademy of Sc iences/Nat iona lR e s e a r c h C o u n c i l t o a s s i s t i n t h ereview. The National Academy of Sciences is made up of many of the topscientific experts in the country, eachof whom has to prove his ability before he can be elected to membership.The Nat iona l Research Counc i l i s the

working arm of the Academy.NAS/NRC carefully chose 30 pan

els, composed of six persons each, toconduct the review of the 7,100 drugs.Each panel considered a different category of drugs. That is, there were panels on antibiotics, heart drugs, andother categories. Those chosen foreach panel were considered to beexperts in that particular field.

The next step was for each manufacturer of a drug with a 1938-62N D A t o s e n d t o F D A i t s e v i d e n c e o fthat drug's effectiveness. At the time,only about 3,000 of the 7,100 drugproducts remained on the market. Theothers had been removed earlier or hadnever been sold, despite having beenapproved by FDA.

A l t h o u g h o n l y 3 , 0 0 0 d r u g sremained on the marke t , i t soon

became apparent that the efficacystudy was not limited to that number.First of all, a total of about 16,000claims were made for these 3,000drugs. That is, on the average themanufacturers were claiming that eachdrug had five purposes. Each of thesepurposes-also known as claims orindications—had to be reviewed by theNAS/NRC panels.

Furthermore, for every drug initially sold between 1938 and 1962with approval by FDA, five otherswere sold without FDA approval.Many of these drugs were chemicallyidentical copies of previously approveddrugs, and hence were known as"me-too" drugs. Many others werecombinations of approved ingredients.FDA decided that the efficacy study,to be fair and to accomplish its purpose of improving therapeutics in theUnited States, had to apply as well tothese nonapproved drugs.

Thus, the NAS/NRC study actuallytook into account 80 percent of theprescription drugs sold in the UnitedStates. This included about 3,000 thathad been approved through the NDAprocess between 1938 and 1962 andwere still being sold in 1966, andabou t 15 ,000 s im i l a r o r "me- too "drugs.

Because of the enormousness of thetask before them, the NAS/NRC panels spent considerable time and effortreviewing the data submitted by themanufacturers. The panels considerednot only this evidence, but also them a t e r i a l i n t h e N D A fi l e s a n d i n t h emedica l l i te ra ture .

Each c la im fo r each d rug wasjudged in one of six ways:

Effective: which meant the evidence was adequate to justify the claim.

Effective with reservations: theclaim might be effective, butsome change had to be made,such as in labeling or iningredients.

Probably effect ive: more evidence was needed to supportthe claim, but the likelihoodwas tha t the ev idence cou ldbe gathered.

Possibly effective: the claimneeded more study, but thechances tha t ev idence cou ldbe gathered to prove itseffect iveness were onlym o d e r a t e .

Lacking substantial evidence ofeffectiveness: there was noscientific evidence to supportthe c la im.

Ineffective as a fixed combination: althou^ each of several ingredients in a combination might be effective, combining them did not makethe drug any more usefult h a n i f o n e o r m o r e o f t h e

ingredients were used separately.

The NAS/NRC reports startedcoming to FDA in late 1967 and wereall in by mid-1969. In January 1968FDA formed a Task Force to implement the NAS/NRC reports. This wasthe beginning of DESI.

DESI coordinates the physicians,pharmacologists, and chemists whocarefully study the NAS/NRC recomm e n d a t i o n s a n d o t h e r a v a i l a b l e e v idence. Most often, FDA's experts haveagreed with the NAS/NRC panelists.

Q ce FDA reaches its conclusionsfor each drug, legal experts write therecommendations into language forpublication. If a drug has no claimsevaluated higher than "lacking in sub-

FDA Consumer / October 1972 113

stantial evidence of effectiveness," itm u s t b e w i t h d r a w n f r o m t h e m a r k e tunless positive information is submitted by the manufacturer within 60days. Manufacturers of drugs that arerated " possibly effective" have sixm o n t h s t o s u b m i t e v i d e n c e o f e f f e c

tiveness, although this can be extendedif bona fide studies are planned orunderway. Manufacturers of "probablyeffective" drugs have a year to conduct tests, with reasonable extensionof time when necessary.

All "me-too" drugs get the samet r e a t m e n t .

In July 1969 the NAS/NRC compiled the conclusions of its 30 panelsand submitted a report to FDA. Thisreport pointed out the far-reachingnature of the study:

"The Drug Efficacy Study has beenan audit of the state of the art of drugusage that has been uniquely extensivein scope and uniquely intensive intime. In a period of a little more thantwo years, a large amount of information (about drugs) that constitutemore than 80 percent of the currentm a r k e t h a s b e e n r e v i e w e d a n d c a s tinto a body of informed opinion thatshould be of value not only to government and industry, but also to all whoprescribe, dispense, or administerdrugs, and, indeed, to the generalpublic."

Of the 16,573 drug claims evaluated by the NAS/NRC, 3,493 or 21.1percent were found to be lacking insubstantial evidence of effectiveness orwere found ineffect ive as a fixed combination. Another 7,145 or 43.2 percent were found "possibly effective"and 2,112 or 12.7 percent "probablyeffective." Only 3,823 claims-23 percent of the total-were found flatly" e f f e c t i v e . "

In addition to pointing out that theprescription drug market needed agreat deal of attention, the NAS/NRCstudy raised other issues of import a n c e .

Rst was the combination drugproblem. Many hundreds of drugsbeing marketed in the United Statescombined two or more ingredients.Combination drugs pose an unusualhazard. Any drug not only producesintended or desirable results, but alsocan produce unintended or undesirableresults. For every drug there is achance that the patients will suffer anadverse reaction.

When, then, should two or moredrugs be combined? Obviously, theyshould be combined only when there isa rea l benefi t to be der ived-a benefi tthat outweighs the risk of exposing apatient to a second drug.

This is essentially what FDA said ina policy statement issued on October15, 1971. Each active ingredient in acombination drug, the Agency said,must add to the e ffec t iveness for the

purpose given or to the drug's safety.This policy coincides with good medical practice and provides the best protection for the American patient.

A second problem raised by the efficacy review concerned the "me-too"drugs. These are drugs that are chemically related or chemically identical todrugs for which an NDA had been approved. Very often, the manufacturersof these drugs began to sell them afterthe 17-year Federal patent protectionto the developer had expired on thedrug for which an NDA had beenapproved.

The problem was that no testing inactual patients had ever been conducted on most "me-too" drugs. Medicine is so complex that it cannot be

taken for granted that one drug willperform as well as another made fromthe same chemicals. Such variables asthe size of the chemical particle mayhave an effect on how well the drugperforms.

Two terms have been applied toth is "me-too" problem. One is"generic equivalence." This term isde r i ved f r om the f ac t t ha t mos t "me -too" drugs are sold under their"generic," or common, names. Is the"generic" drug equivalent in performance to the drug which has actuallybeen tested in people?

The second term is "biologicalavailability." This refers to the actionof the drug in the human body. If adrug is biologically available, it meansthat the drug gets to the place in thebody where it is supposed to. Is the"generic" drug as biologically availableas the drug that has actually beentested in people?

These were the questions posed bythe "me-too" drugs. FDA decidedearly in the study that it was notabout to require that each "me-too"drug be tested in patients. This couldtax the Nation's research capabilitiesbeyond reason.

Instead, FDA came up with a solut i o n t h a t h a s b e c o m e k n o w n a s a n"Abbreviated New Drug Application."If a drug, which has been tested inhumans, has been found "effective"for its claims, FDA looks at its background. Has it been used long enoughand frequently enough so that no serious questions of toxicity appear toexist? Are there any difficult problemsin manufacturing or packaging?

If the answers to these questionsare "No," then FDA decides that thedrug may be sold with an AbbreviatedNew Drug Application. This means a

14! October 1972 I FDA Consumer

s e c o n d m a n u f a c t u r e r h a s t o c o n d u c tstudies in humans only when necessary, and then only in limited number.The manufacturer needs merely todemonstrate to FDA that he can makethe drug properly. Usually a companyhas to submit substantial chemistryand manufacturing data. In this way,many manufacturers can sell "generic"or "me-too" drugs without goingthrough the trouble and expense oftesting them in people.

T .bus far, about 1,200 AbbreviatedNew Drug Applications have beenreceived by FDA, many from smallerm a n u f a c t u r e r s w h o c a n n o t a f f o r d t oconduct studies, but who can assurethe FDA that they can make a drugproperly.

Of course, where a drug is difficultto make or could pose an unusual hazard to patients, FDA does not permituse of the Abbreviated New DrugApplication procedure. FDA canrequire that a manufacturer conductstudies to show that he can make thedrug properly and that the drug actsproperly in humans.

Abbreviated New Drug Applications are important because they permit small manufacturers to compete.This competition can also help thepatient economically by lowering thecost of many drugs. AbbreviatedNDA's are also the key to eventualassurance that every prescription drugin the United States can be prescribedw i t h c o n fi d e n c e .

A third problem posed by theNAS/NRC review was with respect toover-the-counter drugs—that is, drugssold without a prescription. Only 15percent of the NDA's approvedbetween 1938 and 1962 were for OTCdrugs, even though there may be asmany as a half mOlion of them on the

market. Because of this sheer volume,FDA decided to adopt a differentapproach toward OTC drugs. InJanuary 1972, the Agency announcedthat all OTC drugs would be classifiedi n t o c a t e g o r i e s w h i c h w o u l d b ereviewed by appropriate panels ofexperts. These panels will come upwith approved formulations and labeling. (See FDA Consumer, then knownas FDA Papers, February 1972 for anaccount of the OTC drug study.)

Now that the initial phase of theDESl project has been completed-theinitial announcement for each drugevaluated has been published—thesecond stage is underway. AbbreviatedNDA's are being reviewed. Manufacturers with drugs of questionableeffectiveness are conducting studieswhich eventually will substantiate therole of these drugs in therapy, or willresult in the drugs being taken off them a r k e t .

Considerable time and resourcesh a v e b e e n d e v o t e d t o t h e D E S lproject. In addition to the problemsdiscussed here, FDA has faced manyothers stemming from the NAS/NRCreview. The Agency has promulgatedmany new regulations as a result. Ithas, for example, stated with greaterscientific precision what it expectsfrom a "well-controlled" study. AndGovernment lawyers have been busydealing with challenges filed by manufacturers who disagree with FDA'sconclusions. Thus far, the Agency hasbeen reasonably successful in court. Ithas, for instance, won the most significant challenge to date, a suit whichinvolved the widely sold antibioticc o m b i n a t i o n P a n a l b a . T h i scombination, which was found to be"ineffective," now is no longer on themarket . That case prov ided cour t

backing for the Agency's basicapproach to "ineffective" drugs.

I he effort being spent by FDA onprescription drugs is well worth it. Inthe early part of this century, medicaleducation was much more primitivethan today. A group of experts headedby Dr. Abraham Flexner studied thesituation and made sweeping recommendations. The Flexner report hashad a profound influence on medicaleducation, even to this day. It broughtm e d i c a l e d u c a t i o n i n t o t h e m o d e r ne r a .

It has been said by many that theDESl project and its ramifications willhave a similarly profound effect onimproving the quality of health care inthe United States. We hope so. TheCongress has signaled its desire thateach and every prescription drug inthis country be safe and effective. TheDESl project, along with the rest ofthe Bureau of Drugs, seeks to accomplish that worthy goal.

Dr. Paul A. Bryanh a s h e a d e d t h e D E S l

project since itsinception.

FDA Consumer / October 1972 jlS

16 / October 1972 j FDA Consumer

WHEN CLOTHING IGNITESby Warren Mathers and Karen Klam

Eight-year-old Patty was sitting in the kitchen. Hermother was outside, and Patty had found a packof matches. She ignited one, and it accidentally fellon her ruffly dress. Six days later, Patty was dead. Shedied of burns suffered when her frilly dress went up infl a m e s .

Nine-year-old Jimmy was also playing with matchesin the kitchen of his home. Jimmy was luckier, though.He suffered only minor burns to his hands when thematchbook ignited. Jimmy is still a normal boy today,wiser perhaps in the way of fire.

These t rue - to - l i f e cases i l l us t ra te one o f t he mos t im

portant problems facing Americans today, but onethat usually receives little visibility: burns. Most peoplenever think about burns, except when fire hits theirhomes or when someone they love is harmed by fire.

About two million people each year suffer burnsthat require medical attention or restrict the individual'sactivity for a day or more. About 75,000 of them require hospitalization.

Fires and burns are the leading cause of death fromnontrafflc accidents to children 1-4 years old and thesecond leading cause of death to people 5-14 and 45and older. Almost 8,000 such fire and explosion deathsoccur each year.

The death rates are higher for nonwhites than whites,higher for males than females, higher for Indians thanfor other nonwhite races, and higher for white foreignborn than the native born. Four out of every five burn-related deaths occur in the home. More than half occurduring the winter months, November through March.

And of the total number of deaths, about 3,000 involve clothing ignition. This is where FDA comes in.The Food and Drug Administration is one of four Federal agencies responsible for enforcing the FlammableFabrics Act, originally enacted in 1953 and amendedin 1967. FDA's responsibility is to gather informationrelating to burns. The Commerce Department setsflammability standards, the Federal Trade Commission enforces the law, and the Treasury Departmenthas jurisdiction over imports.

FDA's Bureau of Product Safety recently completedits Third Annual Flammable Fabrics Report which contained an analysis of 1,245 flammable fabric investigations. The Report pinpoints some of the most seriousproblems posed by clothing ignition and indicates howconsumers can protect themselves to avoid becominga burn statistic. (The 150-page Report is available for$1.75 each from the Superintendent of Documents, Government Printing Office, Washington, D.C. 20402.)

A compilation of burn cases from the National BurnInformation Exchange (University of Michigan, Ann

Arbor), which was incorporated into FDA's Report, ledto some startling conclusions in comparing burn victimswhose clothing ignited, and those whose clothing didnot ignite:

• Clothing-ignition victims were four times morelikely to die than burn victims whose clothing didnot ignite.

• Burns to clothing-ignition victims covered nearlytwice as much body surface.

• Each of the clothing-ignition injured spent an average of 21 more days in the hospital.• Medical costs were $5,000 higher for each clothing-ignition patient than the average no-clothing-ignition victim.• 24 percent of the clothing-ignition patients died inthe hospital.

The important point is that burns are more damagingif clothing ignites.

When all the investigative data was analyzed, theBureau of Product Safety found that three groups inparticular suffered burn injuries more frequently and ofgreater severity than others. These high-risk groups werechildren, the elderly, and the handicapped.

Of the 1,245 cases of fabric ignition investigated byFDA, the age group 5-9 accounted for the largest number of cases of any age grouping. More than a third ofthe total cases involved children below age 15. Andmore than 50 percent of all injured children were burnedseriously enough to require hospitalization, often followed by months or years of restorative care andtherapy.

When burned, children were most often playing withmatches (boys) or playing near open fires (girls).

Clothing-ignition-related deaths appear to be a greater problem among those 65 and older than in any othersingle age group. Persons over 65 account for nearly15 percent of the fabric-ignition cases in FDA's studies,while this same age group represents less than 10 percent of the Nation's population.

The reasons for the great number of deaths in thisage group seem to be the natural effects of aging andreduced income levels, leading to cheaper forms ofhousing and noncentral heating. Cigarettes, stoves, andspace heaters are the primary sources of ignition amongthese elderly victims.

Most accidents in this age group occur to womencooking in kitchens and wearing long, loose, frillyclothing, such as housecoats or robes.

Because their reaction time is slower, the elderly oftensuffer more severe burns. The greater severity ofburns, coupled with older persons' inability to tolerate

FDA Consumer / October 1972 / 17

acute and long-term effects of burns, perhaps accountfor the fact that the elderly have about a 50 percentchance of surviving fabric ignition accidents.

Handicapped persons also are a major category ofvictims of flammable fabric burns-especially olderhandicapped individuals. The probable reasons are thatcommon, everyday tasks are more difficult for handicapped individuals, and the victims' ability to respondpromptly and effectively is more limited once a fabricignition has occurred.

The Report also showed that• Most burn injuries, 66 percent, occur to individ

uals in their own homes during the day. Themost dangerous time with regard to fabric ignition burns is the morning, followed closely byt h e a f t e r n o o n .

• The kitchen is the single most dangerous locationfor fabric-ignition accidents.

• Accidents associated with smoking materials-such as falling asleep while smoking and usingmatches or lighters—are common to all ages ofa d u l t s . P e r s o n s 6 5 a n d o l d e r a c c o u n t f o r m o r ethan a quarter of these reported accidents.

Statistics in the Report point out areas where greaterprotection and remedial action are needed. Perhapshighest on the priority list is the need to make clothingless flammable—particularly clothing designed for children, handicapped persons, and the elderly.

Steps have already been taken toward establishingmore stringent flammability standards for clothing andhousehold fabrics, such as carpets and rugs, children'ssleepwear, and mattresses.

The Report mentioned, however, that clothing is involved in more than 80 percent of fabric-ignition accidents and that the Children's Sleepwear Standard callsfor sleepwear to be flame-resistant only up to size 6X.Since children under age ten wearing clothing otherthan sleepwear or sleepwear larger than size 6X, andpersons over age 65, account for more than one-thirdof all reported cases and nearly two-thirds of the deathsassociated with fabric-ignition accidents, it is clear thatadditional standards are necessary to reduce the number of fabric ignition burn injuries and deaths.

Consumers can play a major role in protecting themselves from fires caused by clothing ignition. Parentsshould be especially aware of their children's activities.Make sure they don't play with matches. Older peopleand handicapped people likewise have to make sure theya r e c a r e f u l a r o u n d fi r e a n d h e a t s o u r c e s .

When purchasing clothing—especially for children,handicapped individuals, or the elderly—check for:• a well-tailored, well-fitting garment. Regardless of

the weave or weight of a fabric, avoid long loosesleeves or flowing frills. They have a greater chanceof coming in contact with an ignition source.

* a heavy-weight material. Such materials generallyare not as easy to ignite and usually burn moreslowly than light-weight fabrics.

• Try to purchase clothing that will be easy to remove in case of clothing ignition.

You, the consumer, can take other steps to makesure that the chances of your clothing catching fire arer e d u c e d ;

• Keep matches away from children.• Don't smoke in bed.• Avoid leaning against or standing near gas and

electrical appliances, especially in the kitchen.• Don't wear loose or frilly sleeves while cooking.• When using flammable liquids-and many common

household liquids contain a warning on the labelstating that they are flammable-make sure you donot pour or store them near open flame and othersources o f hea t .

• Keep a fire extinguisher in the kitchen and knowhow to use it. Remember that fires caused by greaseshould be extinguished with baking soda and notwith water. Water will splash the grease, spreadingt h e fl a m e s .

• If possible, buy flame-resistant clothing. Children'ssleepwear through size 6X now must be flame resistant. I f i t isn't , i t must be labeled to indicatethat it doesn't meet the new Children's SleepwearStandard. Flame-resistant clothing may cost more,but it's well worth it. You may have to follow speciallaundering instructions for flame-resistant clothes,bu t t h i s t oo i s wo r th i t .

• Remember—practically all fabric material burns,b u t s o m e m a t e r i a l s a r e l e s s fl a m m a b l e t h a n o t h e r s .Some of the major types of less flammable fabricsa n d fl a m e - r e s i s t a n t fi b e r s a r e :1. chemically treated cotton and rayon2 . w o o l

3. modacrylic fibers4. high temperature resistant nylon5. materials made of blends offlame-resistant fibers

and flammable fibers6. materials of glass fibers

W a r r e n M a t h e r s i s

acting chief of theB u r e a u o f P r o d u c tSafety 's FlammableF a b r i c s B r a n c h .

K a r e n K l a m i s a n

i n f o r m a t i o n o f fi c e r i n

t h e B u r e a u o f P r o d u c t

Safety.

18 / October 1972 / FDA Consumer

FDA is acting to provide childrenbetter protection from poisoning bylead in paint, but there areprecautions parents can and shouldtake for child safety.

The presence of lead in paintposes a hazard becauseyoungsters eat chipped paint.These photographs show twoways in which children canswallow paint chips. At left, achild picks some paint off adoor. Below, a child gnaws at aw i n d o w s i l l .

If you live in a house with old, peelingpaint containing lead, your childrenmay be quietly poisoning themselves.

By eating only a small number oflead paint chips a day, a young childcan consume enough to poison himselfor cause permanent brain damage.Lead poisoning, known as plumbism,kills about 200 children a year andcauses the l i fe - t ime ins t i tu t iona l izat ionof 150 more who suffer severe mentalre ta rda t i on .

An estimated 600,000 children inmetropolitan areas have elevated bloodlead levels, however. And about 2.5million children are exposed to thedanger of being poisoned from leadpaint.

The problem of lead paint poisoning came about because many yearsago, lead-containing pigments wereused extensively to give paint itscolors. Anywhere from 10 percent to50 percent of the actual paint, after ithad dried on the wall, constituted aform of lead. As layer after layer ofpaint was applied, the walls becameveritable lead mines. They also becamesources of poison for young children.

The use of expensive lead becameincreasingly uneconomical. Shortly before World War II a substitute for lead

pigments was developed, and the useof lead in paint gradually decreasedthereafter. Since 1955, paint manufacturers have limited the lead in their interior paints to one percent.

Thus, any housing in this countrybuilt before the mid-1950's is a potential lead hazard. For the hazard to bereal, two other ingredients are needed.

One is poor maintenance, whichpermits paint to peel and flake. Thesecond is the presence of small children who might pick paint from thewall or floor and put it in theirmouths. By eating a paint chip the sizeof a fingernail, a young child can swallow as much as 100 t imes more thanhis body can safely handle. Over a period of weeks or months, children canslowly poison themselves.

T h e m o s t s e r i o u s h a z a r d s a r e i ncities where most of the housing wasb u i l t b e f o r e t h e 1 9 5 0 ' s a n d i s n o w

poorly maintained. This includes mostof the ghetto areas of America. TheDepartment of Housing and Urban Development estimates there are sevenmil l ion of these old run-down houses.

Although most lead poisoning occurs in dilapidated houses, even awell-maintained house can be a hazardfor small children. For example, if a

child bangs a crib or toys against a walland old paint chips off, it could contain lead. Even in the best of homes, achild can chew on a windowsill painted with lead paint.

Lead poisoning poses a particularhazard for children between the agesof 1 and 6 because of an eating abnormality called pica. This is a craving toeat things which are not food. Children with pica will eat anything withinreach-cigarette butts, matches, dirt,newspapers, clay, plaster...and paint.

Pica is an old phenomenon, observe d a l l o v e r t h e w o r l d . T h e R o m a n s

many centuries ago named the condition "pica" after the magpie whichpicks up a wide variety of objects in itsbeak out of hunger or curiosity.

The dominant characteristic of picais its compulsive hold on children. Amother can be hard put to prevent herchild from eating nonfood substances.

D o c t o r s k n o w l i t t l e a b o u t t h ecauses of pica, and are a long wayfrom finding a cure, if there is one.Studies have shown that up to 40 percent of children around one year oldhave pica. The tendency decreases asthe child gets older, and averages a-round 20 percent for the entire agegroup of 1 to 6 years.

Chipped paint containing leadcan be found in any part of thehome or other buildings. Thephotograph at upper left shows aw i n d o w s i l l t h a t s h o u l d b e

scraped and repainted. Thephotograph at the lower left iso f a r a d i a t o r t h a t h a s b e e n

painted, and which is beginningto chip. The two photographs atthe right show pipes withchipping paint. Even a pipe onthe ceiling, as in the photographat the lower right, should bescraped and repainted, becausethe paint chips fall on the floor,where chi ldren can eat them.

If a child does become poisoned byeating lead paint, medicines can be adm i n i s t e r e d t o r e m o v e t h e l e a d f r o mthe body. Medicines keep the mortality rate down from lead paint poisoning to 5 percent of the humanvictims. However, one out of four survivors of acute lead poisoning sufferspermanent brain damage, and haslearning difficulties, mental retardation, or epilepsy.

The only effective way to fight leadpoisoning is to remove the child fromcontac t w i th the source o f lead. Th iscan be accomplished in two ways:

1. Take the child away from thel e a d .

2. Take the lead away from thec h i l d .

Where housing is scarce, the firstsolution will in the long run only be aform of musical apartments. Whiche v e r c h i l d m o v e s i n t o t h e r e s i d e n c ewith lead paint on the walls becomes" i t . "

Only the second solution deals withthe problem in a permanent way. Theobstacle here is money. Lead paintcannot just be painted over, because itwould still be present in any paintchips which might flake off.

T h e o n l y r e a l l y p e r m a n e n t

s o l u t i o n s a r e t o r e m o v e a l l t h e o l dpaint by blow torch, scraping, or othermethod, or to cover up old paint withwallboard or another covering. Thetotal nat ional cost has been est imated

by the Department of Housing andUrban Development at up to $70b i l l i o n .

Because of the increasing concernabout lead paint poisoning, theFederal Government in recent yearshas taken several steps to combat theproblem. The Lead-Based Paint PoisonControl Act enacted by Congress in1971 authorized the Department ofHealth, Educat ion, and Welfare tomake grants to set up local programsto prevent lead poisoning from paint.The laws call on the Department ofHousing and Urban Development' tofind methods for removing or coveringover lead paint in houses. The Act alsoprohibits the use of lead-basedpaints-those with more than onepercent lead- in houses bu i l t w i thF e d e r a l a s s i s t a n c e .

Congress is now considering ana m e n d m e n t t o t h e L e a d - B a s e d P a i n tP o i s o n C o n t r o l A c t . T h e a m e n d m e n t ,which passed the Senate on June 14,1972, not only would increase the allocations to fight lead poisoning, but

a l s o w o u l d l i m i t t h e a m o u n t o f l e a dallowed in household paints to 0.5 percent as of January 1, 1973, and ,06percent as of January 1974. The bill isawaiting House action.

The focal point for much of the Federa l Gove rnmen t ' s ac t i v i t i es w i th re

spect to lead in paint rests with theBureau of Community EnvironmentalManagement in HEW's Health Servicesa n d M e n t a l H e a l t h A d m i n i s t r a t i o n .The bu reau coo rd ina tes an ex tens i ve

program designed to reduce the likelihood that children in metropolitanareas will be exposed to paint thatcontains lead.

The Food and Drug Administrationalso has acted to alleviate the problemposed by lead paint. FDA derives itsauthority in this area from the Hazardous Subs tances Ac t . Under th is law,FDA has authority to place restrictions on any household product thatmay pose a hazard to children.

On November 2, 1971, FDA published a proposed regulation to restrictthe use of lead in interior paints. Alsopublished on the same day was a petition from concerned citizens who suggested an alternate regulation.

FDA's proposal was to limit the a-moLint of lead in interior paints to 0.5

percent. Paints containing more thanthat would have to carry a warning label, under FDA's proposal.

The citizens' petition suggested thatinterior paints be allowed to containonly minute traces of lead, at a level ofno more than .06 percent.

Public response to the proposalsfavored the .06 percent limit submitted by the concerned citizens. Thislimit had been suggested by the American Academy of Pediatr ics, wl i ichderived this figure after calculatingthat a child who ate an average of onesquare inch of paint a day would besafe only if the paint had no morethan .06 percent lead. The Academysaid the FDA proposal of 0.5 percentlead would be unsafe.

The supporters of the alternate proposal also commented that the warning labeling proposed by FDA wouldbe ineffective for several reasons:• Once the paint is applied, there isno label on the wall and subsequentoccupants do not know if the painthas more or less than 0.5 percent lead.• Many people living in high-riskareas do not read English.• Experience has shown that peopleoften ignore labels.

Representatives of the paint in

dustry agreed to go along with the 0.5percent limit, but protested the .06percent ceiling. They claimed that thelower limit would cause hardship, particularly to smaller companies, inchanging to and testing new kinds ofpaint.

The main problem cited by theindustry revolves about the use of leadas a drying agent in paint. Theindustry admit ted that lead dr ierscould be, and in some cases alreadya r e , e l i m i n a t e d f r o m l a t e xpaints-although the materials thatwould be substituted as driers have notyet been proven nontoxic. Some bigcompanies, however, said they wouldhave no trouble meeting the .06percent limit.

O n M a r c h 1 1 , 1 9 7 2 , F D Apublished a revised regulation to setthe limit in household paints at 0.5percent as of January 1, 1973, and.06 percent as of January 1974. Thesea m o u n t s c o i n c i d e w i t h t h e

requirements of the amendments tothe Lead-Based Pa in t Po ison Con t ro lAct now being considered by theCongress, and the .06 percent figure isthe one supported by the AmericanAcademy of Pediatrics.

On August 9, FDA announced it

These photographs show someof the steps that can be taken toremove paint containing leadfrom the home. The paint can bescraped from the surface with aputty knife, as in upper twophotographs. Once the paint isscraped off, the surface shouldbe repainted, as in two lowerphotographs. Painting overprevious coats of paint mightnot be sufficient, as both coatscould chip eventually.

had rejected an industry request for ahearing that could have delayed implementation of the March 11 regulation. The Agency said the 0.5 percentlimit would take effect January I,1973, and a decision would be madelater on the request for a hearing onthe .06 percent limit scheduled to takeeffect a year later.

No matter what Congress or FDAdoes, however, it will at the presenttime affect only future paint. For thisreason, consumers ought to be awareof the lead-in-paint problem in theirown homes and communi t ies .

Here are some steps which parentscan take to prevent their children frombeing poisoned by lead:1. Never allow your child to eat paintor plaster.2. Be alert for several of the sympt o m s l i s t e d b e l o w .

Symptoms of lead poisoning:• decreased appetite• i r r i t ab i l i t y• c l u m s i n e s s• unwillingness to play• h e a d a c h e• abdominal pain• d r o w s i n e s s

• v o m i t i n g

Now under development areportable instruments which willbe useful in detecting paintcontaining lead. This instrumentuses the x-ray fluorescencetechnique.

3. If your child has several of thesesymptoms or you suspect he or shemay be eating paint, your child shouldbe tested. Call your local healthdepartment to find out if your city hasa lead poisoning prevention program.If it does, ask the program officerswhere to take your child for a blood-lead test.

If your community does not have alead poisoning prevention program,take your child to a doctor or clinicand explain that you want to find outif he or she has lead poisoning. If theblood test shows your child has toomuch lead, make sure the doctorreports this to the local health department so It can test the paint in yourhome to find out whether i t should be

replaced or covered over. In manycities the landlord can be ordered bythe c i ty to remove or cover overdangerous paint.4. To eliminate the lead hazard, youought to take precautions. Remove allpeeling plaster or paint from walls orceiling. Do as much as possible bybrushing or scraping. When sanding isnecessary, get lots of ventilation sincebreathing lead paint dust can also bedangerous. If the peeling is caused bymoisture from a leaky pipe, fix it.

5. After all loose paint has beenremoved, cover the walls. It is important that the walls be scraped smoothof peeling paint and any grease iswashed off because peeling paint or agreasy wall makes it difficult for anycovering to stick to the wall. There areseveral ways to cover the walls: Youcan repain t them wi th an in ter iorpaint. A latex paint is appropriate.Yo u c a n a l s o c o v e r t h e m w i t h w a l l

paper, contact paper, or paneling.R e m e m b e r t h a t a c h i l d c a n c h e w

right through a new coat of paint onedges like windowsills, banisters, anddoor edges. These should either becovered with contact paper or scrapeda n d s a n d e d d o w n t o t h e w o o d t oremove the lead paint. Replaster anyholes in the wall so they make asmooth surface, flat with the rest ofthe wa l l . Th is w i l l make i t harder fo rchildren to grab onto the plaster andpull off pieces to put into theirm o u t h s .

Lead poisoning from paint is aserious and difficult problem which aprevious generation inadvertently created for our children. Once lead paintis on the walls, it is difficult and costlyto remove. This is why a limit on theamount of lead in paint is so impor

tant, why you must use reasonablecaution today, and why the Congressand FDA have taken action to protectt h e c h i l d r e n o f t o m o r r o w.

In carrying out these steps to preventlead poisoning, you should bear thesefacts in mind to direct increased attention where it is needed:

• Although children get lead poisoning between the ages of I and 6, themost vulnerable are those around 1 or2 years old. They should be watchedwith special care.

• The vast majority of lead poisonings occur during the summer months.Children should be carefully watchedduring the summer to prevent themfrom eating lead paint.

• The most likely place in an apartment to have high lead content is thewindowsill, which is often paintedwith a different kind of paint than thewalls. The windowsill is also one placewhere children can gnaw on the painteven if it is not peeling. Make sure toremove or cover any paint on the windowsill which might contain lead.

Steven Bussard is a free-lance writer.

FDA Consumer / October 1972 / 23

HurricaneAgnes and FDAFDA's Philadelphiaoffice digs in to helpPennsylvania dig outf rom the e f fec ts o f a

devastating flood.^ r

5 -

The damaging floods wrought byHurricane Agnes in the Middle AtlanticStates in late June did their worst inthe State of Pennsylvania, and FDA'sPhiladelphia District was on the job toassist that State in protecting thepublic from ruined or damaged foodand drugs.

On June 23, when the storm centerbecame stationary over north centralPennsylvania, the District put its planfor natural disasters into effect. I tconferred with the PennsylvaniaDepartments of Health and Agriculturetwice daily and made District manpower available for the State to use asit saw tit.

By June 26 the floodwaters hadreceded to a point where entry intothe flooded areas was possible. TheDistrict assigned 38 inspectors andchemists to the State, 15 to work withthe Department of Health in six geographical regions primarily along theSusquehanna River, where the damagewas worst, and the rest with the Department of Agriculture, working outof three regional State offices in northcentral Pennsylvania.

Acting in an advisory capacity only.

the FDA people visited manufacturing,wholesale, and retail establishmentsone by one to evaluate damage andanswer questions about disposition ofdamaged goods and possible reconditioning. Questionable practiceswere reported to the State departmentsat their request. The FDA peopleworked alongside State representativesthrough the week of June 26 until theState decided their services were no

longer needed for the final cleanup.FDA has responsibility for food

and drugs and certain other productswhen they are involved in interstatecommerce, but its regulatory actionsmust go through the courts, even inthe case of seizures, to remove unfitor dangerous products from the market. Often time is important, and during emergency conditions created bynatural disaster the public healthcan be protected in a more timelyway through invocation of Statelaw, including the power of embargo, by State and local healthand other officials.

These officials can invoke Statelaws not only against products involvedin interstate commerce but also thosein intrastate commerce. Therefore,each FDA District has an advance planproviding the essentials for handling

various natural disaster health problems.These plans are usually worked out inconsultation with the appropriateState o ffic ia ls .

During actual disaster conditionsthe District, and often FDA headquarters, develops further plans withresponsible State officials to accountfor unforeseen condi t ions. Thismethod takes full advantage of theState and local enforcement machineryand their officials' knowledge of andfamiliarity with existing conditions.

Philadelphia District personnelcovering about 40 cities or communities inspected 461 establishments.Of these 239 or 51 percent reportedno damage from flooding, wlrile theremainder reported damages of $10million, including almost $7 millionin food items and $3 million in drugproducts.

The Wilkes-Barre area suffered the

greatest damages to food and drugproducts, according to the FDA compi-

24 / October 1972 / FDA Consumer

lations, with losses of nearly $2.5million. The Harrisburg-Hummelstownarea was next with losses of $2.2million. More than $ 1.9 millionlosses was reported in the Milton areaand more than $1 million in Forty-fort. All are on the SusquehannaR i v e r.

There were 44 deaths reported incommunities along this river as adirect resul t of the flood. GovernorMilton Shapp estimated statewideproperty damages at $1 billion.Since then various reports in newspapers have mentioned figures up to$10 b i l l i on .

Nat ional Guard uni ts scheduledfor their annual summer encampmentwere diverted to dhty in the Wilkes-Barre region to protect property,enforce curfews, and direct traffic.Air Nat ional Guard uni ts a i r l i f ted

heavy equipment into the area forcleanup operations, and shipmentsof water, food, and clothing weresent into the area when the roadswere opened. Although Stateofficials anticipated epidemiologicaldisease problems, none was reported.

A major problem in the Wilkes-Barre area was lack of transportationto remove damaged and destroyedgoods because of the lack of vehicles,and in some cases damaged goodsand refuse from business establishments remained on curbsides forseveral days. There were reports ofscavengers walking the streets withwheelbarrows. Pharmacies and

grocers interviewed by FDA inspectors explained that they wanted toget back in business as soon aspossible and that it was first necessaryto remove damaged goods the onlypossible way, by pushing them intot h e s t r e e t s .

In Wilkes-Barre nine FDA inspectorsworking in one part of the city wereevacuated by the National Guard alongwith others when a chlorine gas leakdeveloped at one company's plant.Telephone communication betweenthe FDA inspectors in Wilkes-Barreand the Philadelphia District office wasvirtually impossible for several daysafter the storm because of damage totelephone lines. Reports had to bemade from Scranton which, because ofheavy traffic around Wilkes-Barre,required P/i to 2 hours for the 30-miletrip. When telephone service in Wilkes-Barre was reestablished, calls were

l imited to three minutes because of

heavy demand on the circuits.The floodwaters gouged out a sec

tion of a cemetery in the Wilkes-Barrearea, scattering caskets, and one FDAinspector's relative living in this areafound a casket in her basement whenshe went downstairs to clean up.

In two areas controversy developedconcerning sanitary landfill sites fordisposing of debris when nearby residents objected to the use of thedesignated sites for this purpose. Thisrequired loaded trucks to sit idle whilethe controversies were sett led.

The Pennsylvania area still has notcompletely recovered from the devastation wrought by Hurricane Agnes.But the assistance offered by FDA'sPhiladelphia District hopefully helpedavoid some of the more serious healthhazards that can develop when an areais hit by damaging floods.

FDA Consumer / October 1972 j 25

Canned FoodsCanning is one of the moretraditional ways of preserving foods. It makes many foodsavailable after the growing season and allows us to transportthem long distances withoutrefrigeration.

But improper canning, handling,or storage can result in deterioration and spoilage of the foods.FDA's regulation of commercialcanning, transport, and storageof canned foods assures qualityand safety, but consumersfrequently ask about the purchase and handling of cannedfoods to prevent deteriorationand spoilage.

Many consumers ask why thedate of canning is not on thelabel. The law does not requiredating on canned goods, butmost packers use a code thatindicates the product and packing date. These codes are notnormally decipherable by thec o n s u m e r b u t a r e u s e f u l w h e n al o t i s f o u n d i n v i o l a t i o n o f t h el a w s - b o t h f o r t h e m a n u f a c t u r e r ' sr e c a l l o f s u c h l o t s a n d f o r F D A t o

bring action against these lotsf o r v i o l a t i o n s .

The code is normally stampedo r e m b o s s e d i n t h e b o t t o m o r

top of the can. A consumerreporting a suspected violationof the law to FDA involvingc a n n e d f o o d s h o u l d i n c l u d e t h i scode along with other information.

The consumer buying cannedfood need not necessarily bec o n c e r n e d a b o u t r u s t o r d e n t s o nt h e c a n i f t h e r e i s n o l e a k . B u tif it's leaking, the ends bulge orswell, or if the contents have anabnormal odor or appearance,they should be discarded withouttasting the contents, sincespoilage may have taken place.

S o m e t i m e s t h e i n s i d e o f t h ecan is discolored-caused by ther e l e a s e o f s u l f u r f r o m c e r t a i nfoods during processing. Thesebrown, blue, or black stains aren o t h a r m f u l t o t h e f o o d .

Cans containing fruit juicess o m e t i m e s h a v e a n " e t c h e d "

pattern, but this does not meanthe contents have been harmed.The law prohibits the use offood containers that could transfer a poisonous or other harmful substance to the food andFDA feels consumers can relyon the safety of the cans foundin the marketplace.

Canned food should be storedin a dry place where it will bemoderately cool but neverwhere it will freeze. Avoid storingnear steam pipes, radiators,furnaces, kitchen ranges, oro t h e r h e a t s o u r c e s .

The maximum time cannedf o o d s s h o u l d b e s t o r e d d e

pends on several factors, including the type of food, itsprocessing, handling, and theconditions of storage. Generally,if a can appears normal, the foods h o u l d s t i l l b e w h o l e s o m e . A

regular turnover of canned foodsabout once a year is recommended, however, since thequality of some canned foodsdeteriorates over a long period.

When cans freeze, this maycause a slight breakdown of texture in some products; otherthan this, a single freezing doesn o t h a r m c a n n e d f o o d s . S o m e

creamy foods may curdle orseparate on freezing, but heatingusually restores original consistency. During freezing, thecontents expand and put a strainon the can seams, causing theends to bulge. Inspect the can

after thawing to make sure thee n d s h a v e r e t u r n e d t o t h e i rnormal flatness. If they haven't,i t m e a n s t h e c o n t e n t s h a v e b e e n

exposed to air and will spoil.Using a can opener sometimes

produces tiny metal slivers thatfall into the food. Investigationby Government agencies andindustry scientists have shownthat these are not injurious tohealth. But they are still undesirable, and you should try tokeep them out of foods. Keepyour can opener sharp, clean,and in good working order.

Once the can is opened, thefood may be left in the can ifdesired, but it's important to putit in the refrigerator if not usedright away. Acidic foods such asgrapefruit juice may dissolve alittle iron from the can if itstands in the refrigerator a longtime. This iron is not harmfulto health, but may give the fooda metallic taste. If you don'tplan to eat an acidic food in ashort time, empty the contentsof the can into a glass jar oro t h e r c o n t a i n e r .

Open canned food should berefrigerated just as any othercooked food, but if it is to beheld for a substantial time, itshould be tightly covered andfrozen until use. Use of plasticfreezer bags will help excludeoxygen and minimize drying,but there may be some softeningo f f o o d t e x t u r e .

26 / October 1972 I FDA Consumer

news highlights

FDA to Review Vaccines, BiologicaisFor Safety, Efficacy, and LabelingFDA has initiated a comprehensive review of the effectiveness, safety, and labeling of all vaccines and other biological products for human use.

In announcing the new program, to be conducted byFDA's Bureau of Biologies, Charles C. Edwards, M.D.,Commissioner of Food and Drugs, said:

"Our purpose is to reassure ourselves, the medical community, and the American consumer that all vaccines andother biological products licensed over the past 70 years aresafe and effective when measured against the latest andmost modern sc ient ific cr i ter ia .

"Our purpose is not to deny the medical profession orthe medical consumer the benefits of good and useful products now available," Dr. Edwards emphasized.

He pointed out that the review will for the first timeutilize for biological products the explicit legal authority ofthe FDA to require proof of effectiveness.

All biological products previously were regulated solelyunder authorit ies of the Public Health Service Act. This Actdoes not contain explicit authority to act against a biological because it is ineffective or misbranded.

The former Division of Biologies Standards which regulates biological products was transferred to FDA from theNational Institutes of Health on July 1, 1972, and is nowFDA's Bureau of Biologies.

The first group of products to be reviewed under the

program announced today will be those bacterial vaccineslabeled, "No U.S. Standard of Potency." There are 31products in this category.

A preliminary review of these products was authorized bythe National Institutes of Health in March 1972, before thetransfer of DBS to FDA. The present proposal supersedesthis preliminary plan.

For each category of biological products to be examined,an advisory panel comprised of experts representing professional, consumer, and industry interests will be formed.Products to be studied include antitoxins; immune serumglobulins; blood and blood derivatives; bacterial vaccines;toxoids, toxins; viral and rickettsial vaccines; diagnosticsubstances for skin tests; allergenic extracts; antivenins;poison ivy extracts; and venoms.

The review panels will develop standards and methodology for effectiveness of each category and determinewhich of the specific products are safe, effective, and properly labeled. Based on these evaluations, FDA will determine which product licenses will be confirmed, revoked, orpermitted to remain in effect pending further study.

"FDA is fully aware of problems involved in applying therequirement of 'substantial evidence of effectiveness' tobiological products," said Dr. Harry Meyer, Director of theBureau of Biologies. "No one will be expected to providethe impossible. The advisory panels will be prepared toaccept reasonable alternative methods for demonstratinge f f e c t i v e n e s s i f c o n v e n t i o n a l c o n t r o l l e d s t u d i e s a r e n o tdeemed feas ib le . "

FDA Consumer / October 1972 / 27

New Standard Requires ImprovedDiagnostic X-Ray Equipment

FDA has acted to make x-ray examinations safer for millions of Americans by establishing new radiation protectionstandards for diagnostic x-ray machines and components.

The requirements are set forth in an FDA standard specifying improvements manufacturers must make to reducepatient and operator x-ray exposures from diagnostic x-rayequipment produced after August 15,1973.

The standard, issued under the Radiation Control forHealth and Safety Act, was proposed for public commentOctober 8, 1971. The final version appeared in the FederalRegister Augmi 15.

FDA's Bureau of Radiological Health estimates that 130million Americans receive diagnostic x rays yearly. This useof X rays is the source of most man-made radiation exposure in the United States.

Charles C. Edwards, M.D., Commissioner of Food andDrugs, said that "although the standard represents substantial progress in x-ray control, it cannot be emphasized toostrongly that the benefits of x-ray diagnosis, as practicedwith today's equipment, far outweigh the risks." He added,however, that "all unnecessary x-ray exposure must beavoided because science knows of no x-ray dose so small asto lack public health significance."

The standard will reduce substantially the importance ofexcessive beam size as a cause of unnecessary x-ray exposure by requiring that all types of equipment be capable ofrestricting the beam to the size of the x-ray film or fluoro-scope receptor. Beam restriction in general purpose stationary x-ray machines would have to be effected either automatically or by devices to prevent the equipment frombeing operated until the beam is restricted manually.

The need for repeat x-ray examinations, also a majorcause of unnecessary exposure, will be reduced by a requirement that equipment incorporate features that willmake it possible for the operator to obtain, more consistently than now, a desired image quality at given machinesettings for voltage, current, and time. Film retakes—and

patient reexposures—frequently occur because operatorstake several films at different equipment settings to be certain of producing a usable picture.

The limit established by the standard on the amount ofleakage from x-ray tube assemblies reflects recommendations of national and international radiation protectionauthorities. Under specified conditions, the standard states,the leakage shall not exceed 100 milliroentgens in one hourat a distance of one meter from the tube assembly.

X-ray equipment assemblers are regarded as manufacturers under the standard and will be required to certifythat producers' instructions were followed and that certified components used in assembling equipment were of thetype required by the standard. Similar certifications mustbe made by radiologists, physicians, and other x-ray equipment users if they install or replace components producedunder the standard.

FDA Acts to ImproveRegulation of Blood BanksA two-pronged program for improving and extendingFederal regulation of blood banking throughout the Nationhas been initiated by the Food and Drug Administration.The plan encompasses;

1. Registration and inspection of up to 5,000 bloodcollection facilities not presently operating under Federall icensure.

2. Federal licensing of about 200 plasmapheresis centersengaged in the collection and processing of plasma as asource of blood products.

Charles C. Edwards, M.D., Commissioner of Food andDrugs, said: "When joined with the existing interstatehcensure program and with the continuing leadership andresources of such groups as the American Red Cross and theAmerican Association of Blood Banks, the two programswe are announcing will provide a uniform, nationwidesystem to more fully protect the American public againstunsafe blood and blood products."

"Such a system," he emphasized, "is essential, not onlyfor the protection of patients against blood from unhealthydonors, but also for the protection of donors against exploit a t i o n . "

The proposed new programs will be carried out by FDA'sBureau of Biologies. According to BoB Director, Dr. HarryM. Meyer, Jr., "Only 530 of the estimated three to fivethousand collection facilities in this country presentlyoperate under Federal licensure authorizing them to shipblood and blood products in interstate comerce. Theselicensed banks, however, supply approximately 85 percentof whole blood collection in this country.

"The other 15 percent is collected by agencies operatingintrastate and governed by State laws which vary widely.Only eight States," he pointed out, "have laws requiringlicensing and inspection."

The move to register intrastate blood banking facilities ismade possible by the application of the Food, Drug, andCosmetic Act which provides clear authority for suchaction. The program will require annual registration and

28 / October 1972 / FDA Consumer

inspection once every two years. Failure to register is acriminal offense. In addition to community blood banks,the registration and inspection requirements will also applyto hospitals, clinics, and public health agencies involved incollecting and processing blood.

Plasmapheresis, developed in the early 1950's, is a procedure whereby a unit of blood is drawn, the plasmaretained, and the red cells returned to the donor in a singleoperation. There are now approximately 200 plasmapheresis centers collecting source plasma for licensed producersof fractionated blood products. To this time, all plasmapheresis centers have been exempt from direct Federallicensure on the basis they are engaged in partial manufacture of products delared in "short supply."

An estimated 80-90 percent of all plasma used for fractionated blood products is collected by these centers. Theother 10-20 percent comes from out-dated whole blood.

Fractionated products include gamma globulins (plasmacontaining antigens for specific diseases such as tetanus,measles, and whooping cough); fibrinogen (treatment ofhemorrhage in surgery and childbirth); antihemophilic factor (treatment of hemophilia); and serum albumin (treatment of shock).

FDA's proposals for this program were published in theFederal Register August 26. Interested persons have 60days to comment in writing on both proposals to theHearing Clerk, DHEW, Room 6-88, 5600 Fishers Lane,Rockville, Maryland 20852.

FDA Proposal Requires Talc BeAsbestos-Free for Certain Uses

FDA has proposed that talc used in food or food packagingmust be free of asbestos particles.

Talc is one of a number of substances used in food whichreceived written approval prior to the 1958 Food AdditiveAmendments, which gave FDA authority to require pre-c learance of food addi t ives. Concurrent w i th i ts ac t ion on

talc, FDA is revising its food additive regulations to providea format to deal with all "prior sanctioned" substancesapproved for use before 1958.

Similar actions have been taken with substances that were

generally recognized as safe (GRAS) in connection with thecurrent review of the GRAS list.

Talc was first approved for use, under the Food and DrugAct of 1906, as a coating for polished rice. Other uses forwhich it was later approved are in paper and paperboardand cotton and cotton fabrics used in dry food packaging,in chewing gum base, and as an anti-sticking agent in formsused in molding various food shapes.

Recently pubhshed studies, which have been confirmedby FDA tests, identified asbestos particles in polished ricecoated with talc.

Talc and asbestos are different forms of a naturallyoccurring mineral known as magnesium silicate usuallyfound intermixed in the same ore deposits. Asbestos, however, has been found to be carcinogenic when inhaled.

An announcement on the use of talc with asbestos particles in cosmetic and drug products is being prepared.

Manufacturers of Vacuum BottlesAgree to Improve Safety

FDA has announced that manufacturers have voluntarilyagreed to improve the safety of vacuum bottles with specialemphasis on containers intended for use by children.

In meetings with officals of FDA's Bureau of ProductSafety, representatives of the vacuum bottle industry haveagreed that vacuum bottles under 16 ounces intended foruse by children (indicated by labeling, cartoons, pictures,etc.) will be required to pass a drop test to make sure thatbroken glass cannot pose a hazard to the young user. Thetest will consist of dropping a fOled vacuum bottle fourtimes from a height of 3 feet on an impact medium ofspecified hardness.

FDA and industry also have agreed to add label warningsto vacuum bottles not specifically for child use to warn ofthe possible hazard from glass liners.

The industry also agreed to print warning statements onreplacement fillers for the bottles.

Manufacturer's representatives said the new voluntaryprogram will become effective April 1, 1973.

FDA Warns Western ConsumersA b o u t C o n t a m i n a t e d V i t a m i n Ta b l e t s

F D A h a s w a r n e d c o n s u m e r s i n n i n e We s t e r n S t a t e s t h a t

daily multiple vitamin tablets with iron under ten brandnames were being recalled after the tablets were found tobe contaminated with significant amounts of amobarbital.

Amobarbital is a sedative belonging to the barbituratefamily. It can seriously depress breathing and can be fatalto certain persons with marked sensitivity to barbiturates,particularly alcoholics, heavy drinkers, and individuals withemphysema and other serious pulmonary diseases.

FDA Consumer / October 1972 / 29

The States included in the recall are California, Washing- ever, it is possible that of those which have been sold, manyton, Oregon, Kansas, Idaho, Montana, Utah, Colorado, and are still in the possession of consumers. FDA advised con-Wyoming. However, purchasers may live in other nearby sumers to check any tablets they may have to assure thatS t a t e s . t h e y a r e n o t a m o n g t h e l o t s b e i n g r e c a l l e d .

A batch of 1,944,800 of the tablets were manufactured The contamination was initially discovered during a rou-in 1971 by Strong Cobb Arner of Los Angeles, a subsidiary tine military test for possible drug abuse. This test disclosedof International Chemicals and Nuclear Corporation of Sun barbiturates in the urine of one of those tested. FoUowupValley, California. They were repacked and distributed be- by the military implicated the vitamin tablets as the source,ginning October 27, 1971, under ten different brand names FDA followup confirmed the presence of amobarbital inby Simpac Corporation of Seattle, Washington. the product.

It is estimated that 10 percent or less of the suspect lots These are the brand names under which the tablets arehave not been sold and are still on the retail market. How- being sold, their distributors, and the lot numbers.

B R A N D N A M E D I S T R I B U T O R L O T N U M B E R S

1 CO-TAB LET BOTTLES

C l i n i c Howe Products Inc.,Seattle, Wash.

67753, 68340,68441,67306 ,67763

Bonded Pay 'N Save, Seattle 67754,67305, 67764

Grigg's Grigg's Department Store(Drug Dept.) Pasco, Wash.

68381

Alp ine Alpine Laboratories,Seattle, Wash.

68349, 68268,68005,68433

B i ' M a r t Bi'Mart Drugs,Eugene, Oreg.

68481,68491

2 5 0 - TA B L E T B O T T L E S

Bonded Pay 'N Save, Seattle 67754,67305, 67764

C l i n i c Howe Products Inc.,Seattle, Wash.

67753,68340, 68441,67306 ,67763

P'Ns Corporation P'Ns Corporation 67538 ,68154

House of Values House of Values, Seattle 6 7 8 3 8

A H A&H Stores, Inc.Renton, Wash.

6 7 9 2 7

Olympic B&B Wholesale DrugsOlympia, Wash.

6 8 0 8 1

Alpine Alpine LaboratoriesSeattle, Wash.

68349,68268,6 8 0 0 5 , 6 8 4 3 3

H i H o Hi Ho PharmacyPuyallup, Wash.

6 8 3 1 3

B i ' M a r t Bi'Mart DrugsEugene, Oreg.

68481,68491

30 / October 1972/ FDA Consumer

regional reDOits

ATLANTA FDA personnel from the resident post atMontgomery, Alabama, have supervised the destruction of a half-railcar-load of toys, valued at $13,000caught in the floodwaters of Hurricane Agnes. TheT.G.&Y. Stores, Montgomery, received the toys July12 and asked for FDA's position regarding the sale ofsuch toys. The Bureau of Product Safety said thatcleaning and sanitizing would be necessary before thetoys could be sold. Rather than do this, the companyand the railroad involved chose to destroy the shipm e n t .

CINCINNATI A food-processing firm in central Ohiohas voluntarily shut down operations for a completecleanup after an inspection by District inspectors, whofound widespread violations of good manufacturingpractices. The firm expressed concern over thefindings, and is working to eliminate heavy insectinfestation. It has voluntarily destroyed 12,000 poundsof raw materials and in-process foods. FDA surveill a n c e w i l l c o n t i n u e u n t i l t h e fi r m i s i n c o n f o r m a n c ew i t h t h e l a w.

The District has detained two lots of imported cannedfood contaminated by sulfamic acid crystals accidentally spilled in the hold of the ship in which the foodwas carried. It was necessary to detain the lots to assure that prompt, effective salvage procedures wouldbe used for cleanup.

DALLAS Personnel from the District office recentlyhelped a Texas State agency successfully bring to aclose a State seizure action against a violative feed firm.Early in the year, the Texas Feed and Fertilizer Control Service had seized two lots of meat-and-bone mealheld by the firm, Barvin Packing Co., Houston, because the product was adulterated with residues of thepesticide aldrin. FDA's follow-up investigation revealed that the meal had been packed in used bagsthat had previously contained aldrin-treated seed rice.T h e fi r m h a d c o n t e s t e d t h e a c t i o n .

DETROIT Ferndale Laboratories, Inc., Ferndale, Michigan, a manufacturer of prescription and nonprescription drugs, entered into a consent decree of preliminaryinjunction July 19. The firm was charged with disre

garding FDA's Current Good Manufacturing Practiceregulations in manufacturing drugs. The injunctive action was taken after seizure of 43 gallons of SpecialFormula 3039 which the firm had manufactured underdeficient control procedures.A consumer in the Detroit area recently reported tothe District that one lens of her new impact-resistantglasses had exploded. FDA inspectors who went to thelocal optical laboratory to investigate found that thelaboratory did not have the required records to showthat proper treating and testing of the pregroundlenses had been performed. As a result, the firm hasdiscontinued all manufacturing operations.

Acupuncture sets from Japan were among 14 importdetentions made by the District during June. Otherswere canned olives and canned tomatoes from Spain,fresh white bass from Canada, and mushrooms fromTaiwan, with a total value of approximately $53,000.

KANSAS CITY An anonymous complaint about insanitary practices at a bakery in Omaha resulted in a recent cooperative inspection by officials from FDA andfrom the Omaha-Douglas County Health Department.Although the inspectors could find no evidence in theplant to substantiate the complaint, they did find metalshavings in a liquid-chocolate tank on a small cakeline. As a result, 300 pounds of liquid chocolate plusthe entire day's production of the small cakes, almost60,000 units, were destroyed.

Further investigation revealed that the metal shavings were caused by a metal scraper cutting into themetal drum roller of a machine. The firm replaced themetal scrapers with Teflon scrapers not only at itsOmaha plant but at its other plants throughout thecountry.

M I N N E A P O L I S T h e D i s t r i c t a n d l o c a l a u t h o r i t i e s a r e

investigating a recent accident resulting from illegallysold fireworks. A Minneapolis man lost his left footafter he stepped on a lighted firecracker a friend hadtossed near him. The victim was walking in bare feetat his summer home at Lake Francis, near Litchfield,Minnesota, when the accident occurred. The investigation disclosed that the friend tossed a lighted SilverSalute firecracker near the victim, then yelled a warn-

FDA Consumer / October 1972 j 31

ing to him, causing the victim to step directly on thefirecracker, which exploded, mangling his foot sobadly that amputation at the ankle was necessary. Thevictim is contemplating litigation.

Thus far the investigation has not uncovered thesource of the illegally sold firecrackers.

NEW ORLEANS A grand jury in New Orleans has returned a true bill against Sars of Louisiana, a BatonRouge rendering plant. FDA alleges that the firm'splant and equipment are contaminated with Salmonella as are interstate shipments of finished productmeatscrap meal. The firm was tried and convicted of asimilar offense less than a year ago.Of all the District detentions made in July, the largestwas of over one million pounds of insect-damagedgreen coffee beans from Sierra Leone and Cameroun.The coffee was valued at $440,300.

NEW YORK Theatrical shows, dancing, music, andfood have taken to the streets in greater New York, asi n o t h e r c i t i e s a c r o s s t h e N a t i o n . N e w Yo r k ' s H a r l e ma r e a c l i m a x e d i t s s u m m e r f e s t i v i t i e s w i t h a Yo u t h F e stival involving at least 5,000 residents and many visitors. FDA was represented by Naomi Driver, assistantconsumer specialist, and Lillie Taylor, a chemist withthe Bu reau o f Sc ience . The FDA 'e rs "manned" anAgency booth with new exhibits and giveaway materials, and answered many consumer questions. Another District employee, Mercedes De Quesada,helped with the Spanish-speaking participants.

PHILADELPHIA FDA's Region III selected the Pennsylvania League for Consumer Protection as the organization to provide volunteers for the Agency's consumer deputy program. The League is affiliated withall voluntary consumer organizations in the State.Therefore, in choosing this organization, FDA will beengaging representatives of varied backgrounds thatwill cover a broad area in consumer protection.The District office conducted a recent all-day consumer orientation seminar at Harrisburg, Pennsylvania, for the American Association of Retired Personsand the National Retired Teachers Association to acquaint them with the regulatory jurisdiction of theAgency. The 200 attending are volunteers who willman an FDA-sponsored consumer information desk atHarrisburg to refer consumer complaints from thepublic. There are now five other consumer information desks in the country operated by AARP/NRTApersonnel. The success of these desks has far surpassedexpectations.

FDA with its orientation seminar was the only Fed

eral Government agency represented on a 10-weekschedule of programs.

SAN FRANCISCO In a case in wh ich U.S . D is t r i c tJudge Sherrill Halbert sitting at Sacramento, California, had deferred sentencing of three defendants andordered them to return to court with their guilty pleasin written statements, fines were imposed on a company and two of its officials for preparing and packingshelled and in-shell walnuts under insanitary conditions thereby causing them to become contaminatedwith insect filth. The defendants were the ContinentalNut Company, Chico, California, which was fined$500, and Gerald Stiefvater and Frank Pangburn,president and manager respectively, fined $250 each.

During July the District caused seizure of two lots offrozen fish which, FDA charged, contained mercury, apoisonous substance, in excess of action guidelines;two lots of imported canned sardines that had entereddomestic commerce and which FDA charged contained decomposed fish caused by cans with leakingseams; and one lot of a bicycle chain lubricant thatfailed to carry warnings of toxicity and flammability asrequired by the Hazardous Substances Act.

Seizure was made in San Francisco on July 10 of frozen ladyfish (199 cases, each containing two 25-poundcartons) valued at $4,975 and processed and shippedby Anderson Seafood Company, Panama City, Florida, and, on the same day, of frozen skipjack (274cases, each containing two 25-pound cartons) processed and shipped by A. A. Richards & CompanyInc., Mobi le, Alabama.

Seizure of the sardines was made in Honolulu afterthe products, imported from Denmark and valued atover $40,000, had entered domestic commerce. Theseincluded 1,722 cases of Beach Cliff Brand and 3,034cases of Billow Brand sardines, each case containing50 four-ounce tins. Field examination by the FDA hadrevealed faulty .can seams throughout both lots, leading up to sampling that showed decomposed sardines,and subsequent seizure.

The 153 cases of Chain Lube bicycle chain lubricant, each case containing 12 four-ounce cans, werevalued at $1,400. FDA charged that the product, manufactured and shipped by McGlaughlin Oil Company,Columbus, Ohio, was misbranded under the Hazardous Substances Act because it did not carry adequatelabel warnings concerning toxicity and flammability.

During July the District made 54 detentions, includingthree mail parcels, for various violations. One lot ofdried black beans consisting of 50 100-pound bags andvalued at $1,100 was held because the product contained the pesticides endrin and dieldrin.

32 / October 1972 / FDA Consumer

F D A R E G I O N A L A N DD I S T R I C T O F F I C E S

ATLANTA 60 Eighth St . , N.E.A t l a n t a . G a . 3 0 3 0 9

B A L T I M O R E 9 0 0 M a d i s o n A v e .B a l t i m o r e , M d . 2 1 2 0 1

B O S T O N 5 8 5 C o m m e r c i a l S t .Boston, Mass. 02 1 09

B U F F A L O 5 9 9 D e l a w a r e A v e .B u f f a l o . N . Y 1 4 2 0 2CHICAGO Main Post Office BIdg.R m . 1 2 2 2 / 4 3 3 W . Va n B u r e n S t .Chicago, III. 60607CINCINNATI 1141 Cent ra l Pkwy.C i n c i n n a t i , O h i o 4 5 2 0 2

DALLAS 3032 Bryan St .D a l l a s , Te x . 7 5 2 0 4DENVER New Customhouse BIdg.R m . 5 1 3 / 2 0 t h & C a l i f o r n i a S t s .D e n v e r , C o l o 8 0 2 0 2D E T R O I T 1 5 6 0 E J e f f e r s o n A v e

D e t r o i t , M i c h 4 8 2 0 7

K A N S A S C I T Y 1 0 0 9 C h e r r y S t .Kansas City, Mo 64106

L O S A N G E L E S 1 5 2 1 W . P i c o B l v d .Los Angeles, Calif 90015MINNEAPOLIS 240 Hennep in AveM i n n e a p o l i s , M i n n , 5 5 4 0 1N E W O R L E A N S U S C u s t o m h o u s eR m . 2 2 2 / 4 2 3 C a n a l S t .N e w O r l e a n s , L a 7 0 1 3 0

N E W Y O R K 8 5 0 3 r d A v eBrooklyn, N.Y. 1 1 232N E W A R K R m 8 3 1 , 9 7 0 B r o a d S t .N e w a r k , N J 0 7 1 0 2

P H I L A D E L P H I A U . S . C u s t o m h o u s eR m . 1 2 0 4 / 2 n d & C h e s t n u t S t s .Philadelphia, Pa. 1 9 1 06

SAN FRANCISCO Federal Office BIdgR m . 5 1 8 / 5 0 F u l t o n S tS a n F r a n c i s c o , C a l i f 9 4 1 0 2S A N J U A N P 0 B o x 4 4 2 7S a n J u a n S t a t i o n , P R 0 0 9 0 5

SEATTLE Federal Office BIdgR m 5 0 0 3 / 9 0 9 F i r s t A v e .S e a t t l e , W a s h 9 8 1 0 4

H E W R E G I O N A L

O F F I C E S l - X

BOSTON J.F Kennedy Federal BIdg.B o s t o n , M a s s 0 2 2 0 3

N E W Y O R K 2 6 F e d e r a l P l a z aN e w Y o r k , N Y 1 0 0 0 7

P H I L A D E L P H I A 4 0 1 N o r t h B r o a d S t

Philadelphia, Pa 19108A T L A N T A 5 0 7 t h S t . , N . E .R m 4 0 4 / A t l a n t a , G a 3 0 3 2 3

CHICAGO New Post Office BIdg433 W Van Buren St /Chicago, III.6 0 6 0 7

D A L L A S 1 1 1 4 C o m m e r c e S t .R m 9 11 / D a l l a s , Te x . 7 5 2 0 2

K A N S A S C I T Y 6 0 1 E 1 2 t h S t .K a n s a s C i t y . M o 6 4 1 0 6

DENVER Federal Office BIdg1 9th & Stout Sts / Denver, Colo. 80202

SAN FRANCISCO Federal Office BIdgR m 4 1 6 / 5 0 F u l t o n S t

S a n F r a n c i s c o . C a l i f 9 4 1 0 2S E A T T L E A r c a d e P l a z a B I d g1 3 2 1 2 n d A v e , S e a t t l e . W a s h 9 8 1 0 1

FDA Consumer / October 1972 / 33

state act ions

B a k e r i e s O c c a s i o n a l b a k e r s w h osell to the public in Oregon may doso without licensing or State inspection of premises on or afterSeptember 1 under the State Department of Agriculture's intendedrule change scheduled to becomeeffective on that date. Irvin Mann,Jr., director, said his departmentwould rule that the legal definitionof "bakery" shall not apply tot h o s e w h o b a k e n o m o r e t h a n o n c ea w e e k . T h e s e o c c a s i o n a l b a k e r swho sell to the public must displaya sign or placard informing thepublic that their bakery productswere not prepared, processed, ormanufactured at premises licensedor inspected by the Department ofAgriculture.

Nearly 50 licensed bakers, actingunder departmental procedures,have objected to the planned actionand the department had scheduleda hearing in Salem on September14.

Earlier departmental regulations,effective for the past five years,required baked goods to be prepared in a separate kitchen andrequired a $25 inspection permit.Recent application of these rulesbrought an end to sales ofhome-baked bread, pastries, andsimi lar products a t the SalemPublic Market and precipitated thenew departmental rule change. Nohealth problems had been encountered from these sales. OregonG o v e r n o r To m M c C a l l i n a n n o u n c

ing the rule change in July said it isimportant to find a way to allowthe infrequent sale of home-bakedproducts because this is one waythe producers may supplement incomes that are often meager.

Drug Labels The package labels ofdrugs sold in Maryland must nowcarry the name of the actual manuf a c t u r e r u n d e r a n e w S t a t e l a w .

Maryland follows California andKentucky in imposing this requirement. The legislation, signed byGovernor Marvin Mandel , a lsorequires manufacturers, packers,and distributors, on request, toprovide the State data on biologicalavailability and clinical performance for prescription-legenddrugs and any comparative data fordrug products of the same establ ished name f rom other manufacturers, packers, or distributors.

Fire Damage Burial of animal feedand pesticides damaged by firetook place after a fire at Odell

Farmers Union Co-op ElevatorCompany, Odell, Nebraska. Eight e e n t o n s o f a n i m a l f e e d s a n d 5 t o6 tons of pesticides were stored atthe company at the time of the fire.The loss was estimated by the company management at $30,000—$35,000.

The salvage of 22,750 bushels ofwheat, 1,215 bushels of rye, and4,000 bushels of corn for use asanimal feed took place after firedamage at Benkelman, Nebraska.The grain, stored at IndependentElevators Company, was releasedto Morrison Grain Company,Topeka, for salvage. Other grain, inupright steel bins, was undamagedby the fire.

' -■ . «■j i 8 .

V. £•

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34 / October 1972 I FDA Consumer

seizures & postal service cases

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

A total of 30 actions to remove from the consumer market prod- violations. Other seizures included 1 of food additives, 4 of vita-ucts charged to be violative was reported in July.These included 8 mins and dietary food, 10 of drugs (including 8 of veterinary andseizures of foods: 1 involved charges concerning poisonous and medicated feed), 1 of medical devices, 3 of cosmetics, and 3 ofdeleterious substances, 2 involved charges concerning contamina- hazardous substances,tion, and 5 involved charges concerning economic and labeling

MANUFACTURER (M), PACKER (P)P R O D U C T. P L A C E & D AT E S E I Z E D S H I P P E R ( S ) , D E A L E R ( D )

FOOD / Po isonous and De le te r i ous Subs tances

Viva egg pastina/E. Hartford, Conn. Viva Foods, Inc./Lawrence, Mass. (M,S) Contains chlordane and Diazinon residues, pesticide chemicals7 / 1 7 / 7 2 n o t i n c o n f o r m i t y w i t h r e g u l a t i o n s .

Contamination, Spoilage, Insanitary Handling

King Cole diet pack peas/Virginia Draper-King Cole, Inc./Milton, Del.(S) Partly decomposed; flipper, springer, swelled cans.Beach, Va. 6/22/72

Lea Lac spray. Maple Island spray dried McMurry's Warehouse/Memphis, Tenn. (D) Held under insanitary conditions; rodent contaminated.buttermilk/Memphis, Tenn. 6/13/72

C H A R G E S

Creamer, frozen, nondairy/Omaha,Nebr. 6/20/72

Grape juice concentrate/Pittsburgh,Pa. 6/13/72

Honey, Algarroba, Dessert Blossom/Cambridge, Mass. 7/14/72

Orange juice drink/E. Hartford, Conn.7/17/72

Sorghum molasses/Fort Worth, Tex.7/5/72

Economic and Labeling Violations

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

Welch Foods, Inc./Westfield, N.Y. (M,S)

Millers Honey Co./Colton, Calif. (M,S)

Sunny Orange, Inc./Orlando, Fla. (M,S)

Renfro Foods, Inc./Fort Worth, Tex.

Not in conformity with the Fair Packaging and Labeling Act.

Statement "New family size makes yi gallon" is false and misleading; fails to comply with dual net content declarationrequirement.

Not in conformity with the Fair Packaging and Labeling Act.

False and misleading label "Sorghum Molasses; product isactually made of sorghum, cane molasses, cane sugar, andcitric acid, substituted for pure sorghum molasses.

FOOD ADDIT IVE

Coffee mugs/Philadelphia, Pa. 6/26/72 Factory Secia, Caldas de Rainha/Portugal Lead leaching.(M,S)

V I TA M I N S - D I E TA R Y F O O D

'Aspen Natural Go-Tabs," "Aspen Natural Medi-Kay Laboratories, Inc./Lenexa, Kans. False label statement and pictures representing articles to beVitamins & Minerals," "Aspen High Potency C (D) of special nutritive value as dietary supplements and tow / L e m o n B i o fl a v o n o i d s ' V L e n e x a , K a n s . p r o v i d e i n c r e a s e d e n e r g y a n d s t a m i n a .6 / 1 4 / 7 2

FDA Consumer / October 1972/35

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

VITAMINS-Dietary Food (confd)

Blue Ribbon bread/Baltimore, Md. 7/13/72

Liver extract, liquid/Richmond, Va.6/27/72

"Vit-Ra-Tox #21," "Vit-Ra-Tox #21

w/Vegetable Calcium," "SpringreenNatural Food #33," "Sonne's No. 12,""Vit-Ra-Tox #22," "Springreen NaturalFood #30," "Springreen Natural Food#33," "Sonne's Green Life No. 10" /Kansas City, Mo. 6/19/72

Schmidt Baking Co., Inc./Baltimore, Md.(M,S)

Valentine Co., Inc./Richmond, Va. (D)

VitaLab Co./Kansas City, Mo. (D)

False and misleading claims to provide more protein, more vitamin B and iron to satisfy dietary needs; fails to bear alabel specifying the identity of the article on the principaldisplay panel.

Deficient in vitamin B-2 (in excess of 22 percent); labelstatement "3 Tablespoons Contain Riboflavin 5.5 mg." isfalse and misleading.

Falsely represented to be of special nutritive value as dietarysupplements.

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

Chorionic gonadotropin injection and Kennedy Diet Center/Chicago, III. (D) New drug without effective approved New Drug Application;b a c t e r i o s t a t i c w a t e r f o r i n j e c t i o n , c h o r i o n i c i n a d e q u a t e d i r e c t i o n s f o r u s e .gonadotropin injection-reconstituted,literature/Chicago, III. 6/5/72

Special Formula 3039/Detroit, Mich. 6/6/72 R. N. Tassie, M.D./Detroit, Mich. (D) Not in conformity with good manufacturing practice.

Veterinary / Medicated Feed

AVC HEMO-STOP/Tulia, Tex. 6/22/72

Pet vitamin-mineral protein tablets/Temple, Tex. 6/9/72

Stilbestrol repository (DES vet prep.)/St. Joseph, Mo. 6/14/72

Super Dry Cow mastitis treatment/Lititz, Pa. 6/15/72

Tetrachlorethylene/Picayune, Miss.6 /14 /72

Theralin Prenatal and puppy tablets,vitamin-mineral tablets, VETS Co.Confidential Catalog 712/Temple, Tex.6 / 9 / 7 2

Wil-Gro-Matic (bone builder mineral),medicated/Fort Morgan, Colo. 7/12/72

Zirin's Stamin-Atom, Hi-Cee tablets/Temple, Tex. 6/9/72

Wittney & Co., Inc./Denver, Colo. (S)

Bandy Laboratories, Inc./Temple, Tex. (D)

Philips Roxane, Inc./St. Joseph, Mo. (D)

Pharm-House, Inc./Taftville, Conn. (M,S)

Chloride C. P. Co./Picayune, Miss. (D)

VETS Co./Temple, Tex. (D

Wilhelm Feed Lots Co./Fort Morgan, Co(D)

VETS Co./Temple, Tex. (D)

New animal drug without effective approved New Animal DrugApplication.

"; falsely represented to be effective in dogs,cats, and fur-bearing animals to promote full growth, soundteeth, strong bones, a "show coat," increased resistance todisease, and a sound nervous system.

New animal drug without effective approved New Animal DrugApplication.

False and misleading claims to be endorsed by veterinaryscientists for the removal of hookworms and roundwormsand that it has had wide tests for safety in enormous overdoses; inadequate directions for use; fails to bear warningto "consult a veterinarian should toxic symptoms of staggering or dizziness occur."

New animal drugs without effective approved New AnimalDrug Application; falsely represented to promote optimumgrowth and development of the fetus, good bones, adequatelactation in dogs and cats.

New animal drug without effective approved New Animal DrugApplication; inadequate directions for use; false and misleading claims.

New animal drugs without effective approved New AnimalDrug Application; false and misleading claims to be effective to promote stamina, to function as a therapeutic tonicand to maintain normal hemoglobin in small animals (Stamin-Atom); to increase the blood-building factors, to combatvitamin C deficiency (Hi-Cee tablets).

36 / October 1972 / FDA Consumer

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

MEDICAL DEVICE

Sav-A-Life emergency oxygen kits,Universal Life Enterprises/Lansdowne, Pa. 7/14/72

Castle Tool Specialty Co./Lansdowne, Pa.(D)

Oxygen is not sufficient to maintain proper supply for emergency use; inadequate directions for use; inadequate warnings.

C O S M E T I C S

Boar bristle brushes/Homewood, III.6 /22/72

Hot Air styling combs/Jamaica, N.Y.6/1/72

Selectric Air styling brush kit/CarlePlace, N.Y. 6/14/72

Apollo Mini Car/Ontario, Greg. 6/22/72

Drain cleaner/St. Louis, Mo. 6/14/72

Scotty Ross plush toys/Chicago, III.7/5/72

H. Krull & C. s.n.c./Treviso, Italy(M,S)

Keiko Trading Co., Ltd./Tokyo, Japan(M,S)

H A Z A R D O U S S U B S TA N C E S

Chenfuh Toys Manufacturing Co., Ltd./Taiwan, China (M)

Camp Chemical Co., Div. Camp Labs, Inc./Brooklyn, N.Y. (M,S)

R & R Toy Manufacturing Co., Inc./Pen Argyl,Pa. (M,S)

Contain nits.

Banned hazardous toy; contains sulfuric acid which is corrosive.

Banned hazardous substance; contains more than 10 percentby weight of potassium hydroxide and sodium hydroxide.

Banned hazardous toy; mechanical hazard.

UQ PHQTAI QFPl/IPF taken in medical cases as authorized in the Mail Fraud Statute (18 U.S.C. 1341) and/or the.O. rUOIML ocnviuc. Representation Statute (39 U.S.C. 3005) as reported by the Assistant Postmaster General-Inspection Service.

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

May 31, 1972: False Representation Order issued against Easy Diet, P.O. Box742, and P.O. Box 752, Encino, California 91316. This is a supplement toan Order dated February 15, 1972, issued against Easy Slim, P.O. Box 742,Encino. New promotion related to the same product, a grapefruit diet, butwith a variation in the nanie and the post office box number.

June 22, 1972; False Representation Order issued against Doyle Sales Corporationat 3415 N.E. 2nd Avenue, Miami, Florida 33137. Advertising and sale bymail of a product called "Body Magic Cream," represented as a muscledeveloper.

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

May 17, 1972: Institute for Weight Control, 20 N. Van Brunt Street, Englewood,New Jersey 07631. Advertising and sale through the mails of "Skini Mini"capsules guaranteed as enabling subscribers to lose 10 pounds in twoweeks.

June 8, 1972: Baslee Products Corp., 618 Broadway and P.O. Box 288 at Bay-onne. New Jersey 07002. Advertising and sale by mail of "Marvex Formula"promising dramatic weight losses.

June 8, 1972: Vigor and Vitality Products, 7008 S.W. 4th Street, Miami, Florida33144. Advertising and sale by mail of a product called "SX-71," represented to be effective as a sex stimulant for men.

June 8, 1972: Vigor and Vitality Products, 7008 S.W. 4th Street, Miami, Florida33144. Advertising and sale by mail of a product called "HEP-72," represented to be effective as a sex stimulant for men.

June 8, 1972: Vigor and Vitality Products, 7008 S.W. 4th Street, Miami, Florida33144. Advertising and sale by mail of a product called "Instant ErectoCream," represented to be effective as a sex stimulant for men.

June 8, 1972: Embraceable U Method, 509 Fifth Avenue, New York, New York10017. Advertising and sale through the mails of a breast developer course.

June 14, 1972: Amazing Grapefruit Plan, 9056 Santa Monica Boulevard, Los Angeles, California 90069. Advertising and sale by mail of the Amazing Grapefruit Plan, which promises a loss of 10 pounds in 10 days.

June 16, 1972: Natural Imports, P.O. Box 1900, General Post Office at Newark,New Jersey 07101; P.O. Box at Rye, New Hampshire 03870; Box 21, EssexStation at Boston, Massachusetts 02112; P.O. Box 1023 at Peabody, Massachusetts 01960; and 266 Middle Street at Portsmouth, New Hampshire03801. Solicitations and sale through the mails of "Marula Pips," "MarulaPip I'ea Bags," and "Marula Concentrate" as effective remedies for malesexual impotence and female frigidity.

June 20, 1972: Stanford Research Corp., 19 North Harrison Street, and P.O. Box1013 at East Orange, New Jersey 07019. Solicitations and sales through themails of "Slim-Tabs 33" tablets promising specific refund guarantees tosubscribers who fail to attain desired weight losses.

June 22, 1972: Taines Research Corp., 218 Cortelyou Road, Brooklyn, New York11218. Solicitations of orders and sales through the mails of "Smoke-StopTablets" guaranteed as enabling subscribers to end the smoking urge forever within four days.

June 26, 1972: Slim-Wrap at Farmingdale, New York 11735. Advertising and saleby mail of "Slim-Wrap" method guaranteed as enabling subscribers to trimaway the inches they couldn't lose with diet or exercise.

June 26, 1972: Marshall D. R., Inc., P.O. Box 188, Forest Hills, New York 11375.Advertising and sale through the mails of reducing pills-B-Slim Caps, andweight gain pills-Lynne's Way Tabs.

FDA Consumer / October 1972 j 37

notices of judgment

NOTICES OF JUDGMENT on Seizure Actions

FOOD/Poisonous and Deleterious Substances

Bonita chunks, canned, Eatwell, at Milwaukee, E. Dist. Wis.Charged 5-6-71: when shipped by Star Kist Foods, Inc., Terminal Island,Calif., the article contained the added poisonous and deleterious substancemercury: 402(a)(1). Default decree ordered destruction. (1)

Feed for catfish, Purina Catfish Chow, at Jackson, S. Dist. Miss.Charged 8-18-71: when shipped by Ralston Purina Co., Memphis, Tenn., thearticle contained the added poisonous and deleterious substance polychlori-nated biphenyl compound; 402(a)(1). Default decree ordered destruction. (2)

Fish fillets, red snapper, frozen, at Milwaukee, E. Dist. Wis.Charged 4-29-71: when shipped by National Cold Storage Co., Brooklyn, N.Y.,the article, labeled in part "Geisha Brand Frozen Formosan Malabar Red Snapper .. . Fillets . . Product of Taiwan, Reputlic of China," contained theadded poisonous and deleterious substance mercury; 402(a)(1). Consent decree authorized release to Nozaki Associates, Inc., New York, N.Y., for exportto original foreign supplier. (3)

Fish meal, at Winterville, M. Dist. Ga.Charged 8-17-71: when shipped by Simpson Grain, Inc., Marshville, N.C., thearticle contained the added poisonous and deleterious substance polychlori-nated biphenyl compound; 402(a)(1). Default decree ordered destruction. (4)

Oats, at Willmar, Dist. Minn.Charged 7-23-71: when shipped by Farmer's Grain Co., of LaBolt, S.Dak., thearticle contained a pesticide chemical (a mercurial compound) for which therewas no tolerance or exemption on oats; 402(a)(2)(B). Consent decree authorized release to shipper for salvaging. (5)

Swordfish chunks, swordfish fillets, swordfish steaks, and whole swordfish, frozen,at Ipswich, Dist. Mass.Charged 10-1-71: when shipped from China and japan, the articles containedthe added poisonous and deleterious substance mercury, 402(a)(1). Defaultdecree ordered destruction. (6)

FOOD/Contamination, Spoilage, Insanitary HandlingArtichoke hearts, canned, at Charlotte, W. Dist. N.C.

Charged 9-3-71: while held for sale, the article was decomposing; 402(a)(3).Default decree ordered destruction. (7)

Dreader and fry-mix, at Bowling Green, W. Dist. Ky.Charged 9-22-71: while held for sale, the articles contained insects;402(a)(3). Default decree ordered destruction. (8)

Candy, Freakies and Squirt Rabbits, at North Bergen, Dist. N.J.Charged 7-29-71: when shipped by R. L Albert & Son, Inc., Bronx, N.Y., theFreakies candy contained insect fragments and lacked the common or usualname of the food; and both the Freakies candy and the Squirt Rabbit candycontained textile fibers, metal fragments, wood fibers, and plastic pieces, andtheir labels lacked a statement of the quantity of contents-402(a)(3),403(i)(l), 403(e)(2); and both articles were in violation of the Fair Packagingand Labeling Act, since their principal display panels lacked a declaration ofthe quantity of contents-15 U.S.C. 1453(a)(2). Default decree ordered destruction. (9)

Caraway seeds and poppy seeds, at Kansas City, W. Dist. Mo.Charged 9-29-71: while held by Vienna Bakery, Inc., Kansas City, Mo., thearticle was held under insanitary conditions; 402(a)(4). Default decree ordered destruction. (10)

Cocoa beans, at Camden, Dist. N.J.Charged 7-26-71: while held for sale, the article contained insects, and damaged, and moldy cocoa beans; 402(a)(3). Default decree ordered destruction.(11)

Crabmeat, at Philadelphia, E. Dist. Pa.Charged 8-27-71: when shipped by Sea Garden Seafoods, Inc., Valona, Ga.,the article had been prepared and packed under insanitary conditions;402(a)(4). Default decree ordered destruction. (12)

Greens, poke-salad. Griffin's, at Dallas, N. Dist. Tex.Charged 8-9-71: when shipped by Griffin Manufacturing Co., Muskogee, Okla.,the article contained grass, plant stems, and pieces of gauze-like cloth;402(a)(3). Default decree ordered destruction. (13)

F e n n e l , a t C h i c a g o , N . D i s t . I I I . .Charged 10-6-71: while held for sale, the article contained insects;402(a)(3). Default decree ordered destruction. (14)

Flour, at Maumee, N. Dist. Ohio.Charged 9-9-71: while held by Seaway Food Town, Inc., Maumee, Ohio, thearticle contained rodent filth and was held under insanitary conditions;402(a)(3), 402(a)(4). Consent decree authorized release to dealer for salvaging. (15)

Peanuts, shelled, at Eldon, W. Dist. Mo.Charged 10-1-71: while held by Dye Candy Co., Eldon, Mo., some of the article contained rodent filth, and all lots of the article were held under insanitary conditions; 402(a)(3), 402(a)(4). Consent decree authorized release toGold Kist, Inc., Atlanta, Ga., for reconditioning. (16)

Peanuts, shelled, at Springfield, W. Dist. Mo.Charged 9-23-71: while held by Springfield Ice and Refrigerating Co.,Springfield, Mo., the article was held under insanitary conditions; 402(a)(4).Consent decree authorized destruction. (17)

Shrimp, canned, at Houston, S. Dist. Tex.Charged on or about 10-10-71: when shipped from India, the article, labeledin part "Pillar Rock Brand . . . Cocktail Shrimp . . . Distributed by New England Fish Company, Seattle, Wash.," contained decomposed shrimp;402(a)(3). Default decree ordered destruction. (18)

Shrimp, frozen, American Freezerships, at Kodiak, Dist. Alaska.Charged 9-23-71 and amended 9-27-71: when shipped by American Freezer-ships, Division of W. R. Grace and Co., Kodiak, Alaska, and subsequently returned to the shipper, the article had been prepared, packed, and held underinsanitary conditions; 402(a)(4). Consent decree authorized release to W. R.Grace and Co., New York, N.Y., for salvaging. (19)

Shrimp, frozen, at Metairie, E. Dist. La.Charged 9-1-71: while held for sale, the article contained decomposedshrimp; 402(a)(3). Default decree ordered destruction. (20)

Soups of various kinds, at New York, S. Dist. N.Y.Charged 9-10-71: when shipped by Bon Vivant Soups, Inc., the articles, labeled in part "Maison Glass Delicacies Puree Mongolese [or other soup] . . .Distributors Maison E. H. Glass, New York, N.Y." and "Bon Vivant LobsterSauce [or "Ancora . . . Turtle Soup" or other soup] Packed by Bon VivantSoups, Inc., Newark, N.J.," were unfit for food in that some cans were defective and abnormal, and in that the manufacturing procedures used did notassure proper sealing of the cans or adequate heat treatment, and the articleshad been prepared, packed, and held under insanitary conditions; 402(a)(3),402(a)(4). Default decree ordered destruction. (21)

Vegetables, pickled, Schorr's, at Woodbridge, Dist. N.J.Charged on or about 9-13-71: when shipped by Schorr-Stern Food Corp.,Brooklyn, N.Y., the article contained insects, and the label statement "Ingredients . . . tomato" was false and misleading, since the article did not contain tomatoes, and the article lacked its common or usual name "pickledvegetables"; 402(a)(3), 403(a), 403(i)(l). Default decree ordered destruction.(22)

FOOD/Economic and Labeling ViolationsCheese product, at San Jose, N. Dist. Calif.

Charged 9-3-71: when shipped by American Bank & Trust Co., Bauer International Corp., New York, N.Y., the article's label lacked the name and addressof the manufacturer, packer, or distributor, and lacked the common or usualname of the food; 403(e)(1), 403(i)(l). Consent decree authorized release toOzuna Food Products Corp., San Jose, Calif., for relabeling (as Imitation pasteurized process Gouda cheese). (23)

Cherries, pitted, canned, at Tipton, S. Dist. Ind.Charged 9-2-71: when shipped by Stokely-Van Camp, Inc., Hart, Minn., thearticle's quality fell below the standard of quality prescribed for canned cherries, since more than 15 percent of the cherries were blemished; 403(h)(1).Default decree authorized donation to a charitable institution. (24)

Greens, mixed, chopped, Carol Ann, at Grand Prairie, N. Dist. Tex.Charged 8-9-71: when shipped by Allen Canning Co., Siloam Springs, Ark.,the article's label lacked the common, or usual name of each ingredient-403(i)(2); the article was in violation of the Fair Packaging and Labeling

38 / October 1972 / FDA Consumer

Act since the quantity of contents declaration was not duplicated upon eachof the alternate principal display panels-15 U.S.C. 1453(a)(2). Default decreeauthorized donation to charitable institution. (25)

Mangoes, canned, and lime juice solution, at Brooklyn, E. Dist. N.Y.Charged 8-12-71: when the mangoes were shipped by Continental SalesAgencies, Kingston, Jamaica, and the lime, juice solution was shipped by LewisKelly & Sons, Ltd., Jamaica, West Indies, the articles, labeled in part "Jamaican Choice Whole Black Mangoes. . . Packed in Jamaica Exclusively for LouScharf Inc. New York, N.Y.," and "Kelly's Jamaica Lime Juice Sweetened . . .U.S. Importers Lou Scharf Inc. New York Manufactured by: Lewis Kelly &Sons, Ltd., Jamaica, West Indies," were in violation of the Fair Packaging andLabeling Act, since the mangoes' principal display panel lacked a declarationof quantity of contents, and the mangoes' quantity of contents was expressedas "1 Lb. 3 Ozs." instead of "Net Wt. 19 Ozs. (1 Lb. 3 Ozs.)," and since thelime juice solution's quantity of contents was not placed within the bottom 30percent of the principal display panel, the lime juice solution's quantity ofcontents was expressed as "25 Fl. Oz." instead of "Net 25 Fl. Oz. (1 Pt. 9Oz.)," and was in a type size less than H inch high when the principal display panel had an area of more than 5 square inches-15 U.S.C. 1453(a)(2y1453(a)(3)(A)(i), 1453(a)(3)(c)(i); and the article labeled in part "LimeJuice" had had water added to it to increase its bulk and weight and to reduce its quality and strength, and its label failed to declare the ingredientsascorbic acid, benzoate of soda, and sulphur dioxide, nd failed to state thatsuch ingredients were chemical preservatives-402(b)(4), 403(k). Consentdecree authorized release to Lou Scharf, Inc., New York, N.Y., for relabeling.(26)

Seasoning for sausage. Dot, at Houston, S. Dist. Tex.Charged 7-29-71: when shipped by Dbttley's Spice Mart, Inc., McGehee,Ark., the article's label lacked the common or usual name of the ingredientascorbic acid, and some of the article lacked an accurate label statement ofquantity of contents; 403(i)(2), 403(e)(2). Consent decree authorized releaseto the shipper for relabeling. (27)

Soy protein concentrate, 70%, at Dallas, N. Dist. Tex.Charged 9-15-71: when shipped by Dottley's Spice Mart, Inc., McGehee, Ark.,the valuable constituent protein had been in part omitted from the article,and the name of the article "70% Soy Protein Concentrate" was false andmisleading, since the article contained less than 60 percent protein;402(b)(1), 403(a). Default decree ordered destruction. (28)

VITAMINS/SPECIAL DIETARY FOODS

Supplement [SleXtraordinary tablets, at Oklahoma City, W. Dist. Okla.Charged 4-16-71: while being packed for Century 21, Inc., Bethany, Okla.,the articles Vitamin & Mineral tablets ("N.C. 21-VM Formula"), chewablevitamin E tablets ("N.C. 21 Chewable E Formula"), vitamin C tablets (N.C. 21Rose Hip Formula"), protein hydrolysate tablets ("N.C. 21 Amino Acid Formula), and liver & yeast tablets ("N.C. 21 Hematinic-Formula")-some ofwhich articles had been repacked by jhe dealer in 420-tablet cartons containing 180 of the protein hydrolysate tablets, 30 of the vitamin & mineral tablets, and 90 each of the other tablets and some of which were in bulk andintended to be similarly repacked-had accompanying labeling which contained false and misleading claims as follows: Bulk and repacked tabletsgenerally-the words "Supplement extraordinary" which were displayed in amanner whereby they may easily read as "Supplement seXtraordinary," andthe statement "Nutritional Catalyst formulated for today's active living" whichwas displayed in association with said words, suggested and implied that thearticle had some sexually stimulating effect; the carton label statements, "Ourguarantee of the nutritional effectiveness of 'Supplement Extraordinary' willproduce worthwhile improvements in his or her nutritional HEALTH, APPEARANCE and SENSE OF WELL-BEING. If at least one of these satisfying resultshas not already begun to manifest itself upon the completion of the first 30day supply of 'Supplement Extraordinary', the full purchase price paid for thisinitial unit of 'Supplement Extraordinary' will be refunded (Note: This guarantee effective for 45 days from date of first delivery.)", represented and suggested that the article had some therapeutic benefit to improve health, appearance, and sense of well-being within 30 days; statements which represented and suggested that the article contained every known nutritional element, that it was a complete dietary supplement, that it contained the aminoacids necessary for our protein-demanding systems, that the particular balance of vitamins C and E contained in the aiticle prepared the body to copesuccessfully with stress and to increase the effectiveness of the oxygen in theblood, that the Hematinic compound would strengthen the blood; that themultivitamin-mineral preparation was a high-potency formula and would insurereceiving every needed element into the body, that the article would provideutmost help for the mental processes, that it would increase mental efficiencyand power, that it would provide a powerful aid to increased vitality and azest for life, that it would make a person feel great, and that the article was a

natural food; Repacked protein hydrolysate tablets-the listing on the cartonlabel and accompanying brochure of the amounts of amino acids and vitaminsprovided by 30 tablets was misleading, since the suggested daily intake of 6tablets would provide only l/5th of those amounts; name of the tabletsAmino Acid Formula," and the listing of the amino acids Arginine, phenylala-

nine, tryptophan, histidine, methionine, lysine, threonine, leucine, valine, glutamic acid, and cystine, on the carton label and accompanying brochure, rep-resented and suggested that the ordinary consumer should supplement hisdiet With amino acids and, specifically, the amino acids in these tablets andthat such supplementation would be more beneficial to the diet than obtaining such ammo acids as components of ordinary protein; the name of4he tablets Ammo Acid Formula," the statements "Suggested intake as a supplemental source of protein nourishment; Six tablets daily provide two grams ofprotein" and "Protein (NX6-25) 52.5%" and the list of amino acids, borne onthe carton label of the article, represented and suggested that the article contained a significant amount of protein, and that the protein was of significantvalue even in the absence of an essential amino acid, namely, isoleucine;Repacked liver and yeast tablets-the name of the tablets "Hematinic Formula" represented and suggested that said tablets had therapeutic benefits inthat they would cause an increase in the amount of hematin or hemoglobin inthe blood and that the tablets would be of benefit to those suffering fromanemia; the carton label represented and suggested that the tablets were ofsignificant benefit for general food use in the dosage of one tablet per day;which representations were false and misleading since they were contrary tofact; 403(a). Default decree ordered destruction. (29)

Water, purified, at Helena, Dist. Mont.Charged 10-1-71: when shipped by Culligan Water Conditioning Co., SaltLake City, Utah, the article was represented as a food for low sodium diets,and its label lacked required information concerning its dietaryproperties-403(j); and the article was in violation of the Fair Packaging andLabeling Act, since the quantity of contents was not stated on the principaldisplay panel-15 U.S.C. 1453(a)(2). Default decree ordered destruction. (30)

DRUGS/Human Use

Parbocyl sodium saiycylate combination tablets, at Santa Monica, C. Dist. Calif.Charged 8-25-71: when shipped by Paul B. FIder Co., Bryan, Ohio, the quality of the article fell below the purported quality of consisting of enteric-coated tablets, since the tablets showed distinct evidence of disintegrationwhen tested in simulated gastric fluid; 501(c). Default decree ordered destruction. (31)

Progesterone injection, N.F., at San Francisco, N. Dist. Calif.Charged 8-30-71: while held by Invenex Pharmaceuticals, San Francisco,Calif., who manufactured the article from progesterone which had beenshipped in interstate commerce, the article's strength fell below the NationalFormulary standards (approx. 15 percent below the declared potency); 501(b).Default decree ordered destruction. (32)

Progesterone suspension, sterile, N.F., at Chicago, N. Dist. III.Charged 9-22-71: while held by Maizel Laboratories, Chicago, III., who manufactured the article, the article's strength differed from that specified by theNational Formulary; 501(b). Default decree ordered destruction. (33)

Quick-Way home-reducing-wrap kit, and magnesium sulfate, at Houston, S. Dist.Tex.Charged 10-20-71: while held by Slenderwrap International, Inc., Div. Slen-derbolic Health Industries, Inc., t/a R&J Manufacturing Co., Houston, Tex., thelabeling of the magnesium sulfate and the kit (which had been manufacturedand assembled from magnesium sulfate shipped in interstate commerce andother items into a kit containing a magnesium sulfate solution, elastic bandages, a funnel, a measuring tape, a plastic sheet, a pamphlet reading in part"Quick-Way . . . Instructions . . . Follow These Simple Steps to a SlimmerNewer You," chart entitled "Quick Way Home Improvement Chart," and a dietguide reading in part "Quick Way . . . Listed Below are Three NutritionalPrograms You May Consider to Help You keep Your Inch Loss Permanent")contained false and misleading claims for reducing various parts of the body;the label of the solution of magnesium sulfate lacked the established name ofthe drug; and the labeling of the articles lacked adequate directions for useand was not exempt therefrom, since there was no effective approved NewDrug Application and no notice of claimed investigational exemption; and thelabeling of the articles lacked adequate warnings against unsafe use; 502(a),502(f)(1), 502(f)(2). Default decree ordered destruction. (34)

Triple Sulfa sulfathiazole combination tablets, and sulfathiazole lozenges, at Minneapolis, Dist. Minn.Charged 10-7-71: while held for sale, the articles failed to bear adequatedirections for use and were not exempt therefrom, since they were new drugsand there was no effective approved New Drug Application; 502(f)(1). Defaultdecree ordered destruction. (35)

FDA Consumer / October 1972 j 39

Vital Air Oxygen kit with face mask and oxygen, at Philadelphia, E. Dist. Pa.Charged 6-24-71: when shipped by Vital Air Oxygen Co., Cleveland, Ohio, thelabels contained false and misleading claims about containing more than onehour's supply of emergency medical oxygen, the labels lack an accurate statement of the quantity of contents in terms of weight or measure, and the labeling lacked adequate warnings against unsafe use; 502(a), 502(b)(2),502(0(2). Default decree ordered destruction. (36)

VETERINARY/Medicated FeedFurazolidone in bulk and furazolidone medicated premix, at Danbury, Dist. Conn.

Charged 5-4-71: when the bulk furazolidone was shipped by Cotuit ChemicalCorp. Gulfport, Miss., and while the furazolidone medicated premix was heldby Davis-Edwards Pharmacal Corp., Danbury, Conn., who manufactured thepremix from the bulk furazolidone, the articles were new animal drugs withouteffective approved New Animal Drug Applications; 501(a)(5). Default decreeordered destruction. (37)

Dr. Mayfield Pepsin pre-mix for hogs at Troy, S. Dist. Ohio.Charged 9-21-71: when shipped by Dr. Mayfield Laboratories, Charles City,Iowa, the article was a new animal drug without an effective approved NewAnimal Drug Application; and the bag label and the accompanying brochuresentitled "Dr. Mayfield Management Service Guide to Prevention and Treatment of Gut Edema (Enterotoxemia)," contained false and misleading claimsfor enterotoxemia and promotion of digestion in hogs of all the food they caneat; 501(a)(5), 502(a). Default decree ordered destruction. (38)

Phenylbutazone injection, at Cockeysville, Dist. Md.Charged 9-20-71: .while held for sale after manufacture by D-M Pharmaceuticals, Inc., Rockville, Md., from phenylbutazone shipped in interstate commerce, the article was a new animal drug without an effective approved NewAnimal Drug Application; 501(a)(5). Default decree ordered destruction. (39)

Talodex fenthion injectable for dogs, at Honolulu, Dist. Hawaii.Charged 4-28-71: while held for sale, the article was a new animal drug without an effective approved New Animal Drug Application; 501(a)(5). Defaultdecree ordered destruction. (40)

MEDICAL DEVICES

Exo Static overhead head-traction unit, at Warsaw, N. Dist. Ind.Charged 11-3-71: when shipped by Florida Manufacturing Co., South DaytonaBeach, Fla., the article lacked adequate directions for use and was not exempt therefrom as a prescription device, since it lacked the prescription legend, and the labeling lacked adequate warnings against unsafe use; 502(f)(1),502(f)(2). Default decree ordered destruction. (41)

Spoons for medicine, plastic, at Richardson, N. Dist. Tex.Charged 10-18-71: when shipped by Ad-Craft Line, Inc., the quality of thearticle, labeled in part "Unbreakable Plastic Medi-Spoon . . . Graded for oneteaspoon ... 20 Century Prod. Co. N.Y.C. . . . Simpson Barnett Pharmacies," fell below its represented quality, since when filled to the one teaspoonmark, it provided less than one teaspoonful, the label statements "makes giving medicine safe . . . exact," "graded for one teaspoon," and "nothing better for giving medicine" were false and misleading as contrary to fact; andthe article was dangerous to health when used in the directed dosage, frequency, and duration; 501(c), 502(a), 502(j). Default decree ordered destruction. (42)

COSMETIC/BEAUTY PRODUCT

Bubble Club Fun bath product, at Dallas, N. Dist. Tex.Charged 7-21-71: when shipped by Purex Corp., Ltd., St. Louis, Mo., the article contained deleterious substances; 601(a). Default decree ordered destruction. (43)

HAZARDOUS SUBSTANCES

Cherry bombs, M-80 firecrackers, and 1-11/16" firecrackers, at Mercer, W. Dist.Mo.

Charged 6-29-71: while held by a fireworks stand. Mercer, Mo., the articleswere banned hazardous substances intended to produce audible effects by acharge of more than 2 grains of pyrotechnic composition; 2(q)(l)(B). Defaultdecree ordered destruction. (44)

Drain cleaner, liquid, at Los Angeles, C. Dist. Calif.Charged 12-27-71: while held for sale, the article was a banned hazardoussubstance containing more than 10 percent of sodium hydroxide; 2(q)(l)(B).Default decree ordered destruction. (45)

M-80 firecrackers, at South Lineville, W. Dist. Mo.Charged 6-29-71: while held by a fireworks stand. South Lineville, Mo., thearticle was a banned hazardous substance intended to produce audible efifectsby a charge of more than 2 grains of pyrotechnic composition; 2(q)(l)(B).n p f : ) i i l t H p r r p p n r r l p r p H H p c t r i i r t i n n

Travel Ice refrigerant, at New Orleans, E. Dist. La.Charged 8-24-71: when shipped by Unco Products Co., Costa Mesa, Calif.,the article was a toxic substance by reason of its approximately 81.6 peTcei\tammonium nitrate content, and it lacked a number of required conspicuouslabel statements; 2(p)(l)(B,E,F,G & I). Default decree ordered destruction.(47)

NOTICES OF JUDGMENT on Criminal ActionsFOOD

General Host Corp., James E. Wolfe, production vice president, and Joseph Schaferbakery superintendent, Philadelphia, E. Dist. Pa.Charged 3-1-71: when shipped, bread, labeled in part "Bond Wheat Bread. . . ["Special Formula Bread" and "Bond Club Rye Bread"] Bond BakingCompany Div. of General Host Corporation Home Office: New York, N.Y.,"contained a filthy substance and had been prepared under insanitary condi-tions-402(a)(3), 402(a)(4); and rye flour, sesame seed, cracked wheat, andmeal were held in a building accessible to rodents and insects and werecontaminated with filthy substances-402(a)(3), 402(a)(4). Nolo contendereplea by corporation to all counts; fine. Nolo contendere by individuals to allcounts involving bread, and to a count involving meal; fine. (48)

Schafer Bakeries, Inc., John Balan, Sr., plant manager, and Russell E. Kisor, president, Detroit, E. Dist. Mich.Charged 8-10-71: donut flour (two kinds) was held in a building accessible torodents, insects, and birds, and (one kind only) was contaminated with insectand rodent filth; 402(a)(3), 402(a)(4). Nolo contendere pleas; fines. (49)

NOTICE OF JUDGMENT on Miscellaneous Action

Shampoo, Royal Castile, suit for declaratory judgement, Chicago, N. Dist. III.Charged 1-15-71 by Consolidated Royal Chemical Corp., thicago, III., againsiHEW Secretary Richardson and FDA Commissioner Edwards, in suit for declaratory judgment and injunction: That plaintiff manufactured and sold a liquidhair soap consisting of an alkali salt of fatty acids under the trade name ofRoyal Castile Shampoo, that defendants' agents had advised plaintiff that aninvestigation of that product was being conducted to determine whether ornot the product was an adulterated cosmetic, that defendants' agents hadrequested that plaintiff recall all lots of that product; that, if plaintiff did nolrecall the product, defendants would proceed with a seizure, that the FederalFood* Drug, and (iosmetic Act specifically excludes "soap" from the statutorydefinition of the term "cosmetic," that the defendants advised plaintiff thatthe product was an eye irritant and would produce eye anesthesia; that independent experts had tested the product for the plaintiff; that, on the basis ofsuch test, the plaintiff stated that its product did not constitute a hazard tohealth and did not bear or contain any poisonous or deleterious substancewhich might render it injurious to users under conditions of use as were customary or usual; and that, for more than 10 years, plaintiff had not receivedany complaint of eye injury. Accordingly, plaintiff prayed for declaratory judgment that the product was either excluded from the application of the Act orthat the product was not adulterated; and plaintiff also prayed for a temporary restraining order and preliminary injunction pending a hearing.

After a hearing, the court denied temporary relief and dismissed plaintiff'scomplaint. Thereafter, the plaintiff moved to vacate the dismissal on thegrounds: 1) that the court had advised the United States Attorney for theNorthern District of Illinois that it would be reasonable to notify the plaintiffif a seizure action were to be filed and to permit the plaintiff to produce aquantity of Royal Castile Shampoo so as to expedite the resolution of theissues with a minimum interference to plaintiff's business and without unfavorable publicity; 2) that the next day a seizure action was filed in theNorthern District of Ohio against Beacon Castile Shampoo With Lanolin; and3) that such shampoo had been manufactured by the plaintiff, and sold to adistributor who sold it to the dealer in whose possession it was seized. TheDiaint i f f 's mot ion was denied. fSOl

Notices of Judgment are given pursuant to section 705 of the Federal Food, Drugand Cosmetic Act and section 13 of the Federal Hazardous Substances Acf. Notices oJudgment report cases involving seizure proceedings, criminal proceedings, and injunction proceedings. Seizure proceedings are civil actions taken against goods allegedto be in violation, and criminal and injunction proceedings are against firms or individualscharged to be responsible for violations. The cases generally involve foods, drugs, devices, cosmetics, or hazardous substances which were alleged to be adulterated or misbranded or otherwise violative of the law when ntroduceo into and while in interstatecommerce, or while held for sale after shipment m interstate commerce.

Notices of Judgment are prepared by Food, Drugs, and Product Safety Division, Office of the General Counsel, DHEW.

Published by direction of the Secretary of Health tducation. and Welfare.Charles C. Edwards. .VI.D.. Commiss^onei of Food jnd Drugi

- . r v V i n , - - 1 1 Q - T O

4 0 ! i l r t n h p r 1 0 7 ? / f 7 n j ☆ u . s G O W E I R N M F N T P R I N T I N r ^ O F P i r - p - - i Q - 7 - a K t K . n - 7 A / • > j

c o n s u m e r

producti n f o r m a t i o n

an index of selectedfederal publicationson hicw to buy, use,and take care ofconsumer products

consumer productinformation center

fall 1972

A new organization has been formed to make it easier for the consumer to learnwhat the Federai Government knows about family economics, safety and health,medicines, food and nourishment, clothing and fabrics, appliances, automobiles,housing, landscaping, gardening, pest controi, and a number of other subjects inwhich today's consumer has a stake.The Consumer Product information Coordinating Center has compiled a listof 192 publications published by 15 Federal Government agencies that containmany kinds of information useful to the householder. These publications may bepurchased at moderate cost. Many are free.For a free copy of the Consumer Product Information Index of Selected FederalPublications on How to Buy, Use, and Take Care of Consumer Products, sendyour request to; Consumer Product Information, Wasfiington, D.C. 20407. Bulksupplies of the Index will be made available free to organizations for distributiont o t h e i r m e m b e r s .

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