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MARCH 1971

CONSUMER EDUCATION

AND INFORMATION

ADVERSE REACTION

SURVEILLANCE

THE L�B SCIENTIST

AND IDIP

,. '

"We ore carefully to preserve that life which the Author of

nature hos given us, for it was no idle gift."

f'J"":'e real tragedy about the deaths of and injuries.l �� children from accidental poisoning ( see page

14) is that most of them didn't have to happen. A child's curiosity is one of the best assurances we havethat mankind will prevail and it's doubly saddening to realize that some children who possessed this trait inthe greatest degree paid an undeserved penalty-simplybecause Nature didn't make them mature enough earlyenough to negotiate the treacherous terrain of our manmade chemical environment. As adults, we have beenremiss in not moving sooner to take some of the relatively simple actions needed.

Now the Congress has taken a major step to remedythis intolerable situation by authorizing FDA to require,through safety packaging, that containers for toxicsubstances be made difficult for little fingers to open.This will not cure the basic trouble-that of adultcarelessness in leaving toxic substances where the youngand curious can reach them; for this problem, there isprobably no complete and lasting solution.

Nevertheless, we at FDA believe the new law willbe one of the most effective pieces of health legislationever enacted. Frankly, once the law has been fullyimplemented, we expect those melancholy child poisoning statistics to plummet.

Harvey W. Wiley, 1844-1930

Father of the Federal Food and Drugs Act of 1906

From his commencement address "Life and the Coming Time"

Hanover College, 1867

FDA Papers I March 1971 I 1

quotesiin the past decade, health care has seen aphenomenal increase in the development anduse of medical devices. Heart valves, intensivecare monitoring equipment, and plastic implantsare examples of devices that have saved or prolonged thousands of lives. While it is clear thatmost devices serve very useful purposes, it is alsobecoming evident that some devices are potentialhazards and can cause injury or death if notproperly designed and manufactured. Althoughthe magnitude of these hazards is very difficult todetermine, most experts agree that the problemis becoming serious enough to warrant Government attention. It is our goal to develop, in cooperation with industry and the medical profession,the scientific methods and procedures that willresult in the protection of the consumer while atthe same time encouraging innovative developmento f m e d i c a l d e v i c e s . "

Charles C. Edwards, M.D., Commissioner of Food andDrugs, to the American Association for the Advancement of Science, Chicago, Illinois, December 30, 1970.

E l l i o t L . R i c h a r d s o nSecretary, U.S. Department ofH e a l t h , E d u c a t i o n , a n d W e l f a r e

R o g e r O . E g e b e r g , M . D .A s s t . S e c r e t a r y f o r H e a l t ha n d S c i e n t i fi c A f f a i r s

C h a r l e s C . E d w a r d s , M . D .Commissioner of Food and Drugs

H o w a r d R . D e n t zA s s t . C o m m i s s i o n e r f o rE d u c a t i o n a n d I n f o r m a t i o n

H a r o l d C . H o p k i n s / E d i t o r i a l D i r e c t o r

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

Dan O'Toole/Photographer

Joan M. Galloway/Managing Editor

Frederick L. Townshend/Product ion Mgr.

FDA PAPERS, the official magazine of the Foodand Drug Administration, is published monthly,except for combined July-August and December-January issues. Subscriptions may be orderedfrom the Superintendent of Documents,Government Printing Office, Washington, D.C. 20402,at $3.50 a year ($1.00 additional for foreign mailing).

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

Articles published in FDA PAPERS are in thepublic domain and text may be republishedwithout permission. Use of funds for printing thispublication approved by Director of the Bureauof the Budget August 15, 1966.

V V that we shall probably be given the fa-cilities at what has been the Pine Bluff Arsenal inA r k a n s a s t o c r e a t e t h e N a t i o n a l C e n t e r f o rToxicological Research. The main emphasis ofthis facility will be in the strengthening of thescience of toxicology, particularly in the area ofchronic low-dose studies. We hope to arrive atfirmer and more definitive criteria for safety, particularly for foods, but in view of the fact thatthe facility will be a national center, also for otherenvironmental hazards. The Environmental Protection Agency is also being funded for work in,this facility. No doubt other Government Departments wOl also have needs along these lines. Assoon as these facilities can be converted and madeavailable for this type of study, we shall be starting on the studies of food additives, on pesticides,and on other environmental chemicals that cometo us by way of our food supply."

Virgil O. Wodicka, Ph.D., Director, Bureau of Foods, atthe USDA/ARS National Agricultural Outlook Con-ference, Washington, D.C., February 23, 1971.

Section 705 [375] of the Food, Drug, andC o s m e t i c A c t .

(a) The Secretary shall cause to be publishedfrom time to time reports summarizing alljudgments, decrees, and court orders which havebeen rendered under this Act, including the natureof the charge and the disposition thereof.

(b) The Secretary may also cause to be disseminatedinformation regarding food, drugs, devices, orcosmetics in situations involving, in the opinionof the Secretary, imminent danger to health, orgross deception of the consumer. Nothing in thissection shall be construed to prohibit the Secretaryfrom collecting, reporting, and il lustrating theresults of the investigations of the Department.

A d v i s o r s t o t h e E d i t o r *

H. Nelson Fitton, Department of Agriculture;George Creel; Department of Housing andUrban Development; William J. Cotter, PostOffice Department; Henry Scharer, Departmentof Commerce; Dr. Milner B. Schaefer,Department of the Interior; Dr. Sam Kaim,Veterans Administration; Dr. Peter V. Siegel,Federal Aviation Agency; Dr. Spofford G.English, United States Atomic EnergyCommission; Dr. Harve J. Carlson, NationalScience Foundation; Howard J. Lewis,National Academy of Sciences; Arthur Settel,B u r e a u o f C u s t o m s .

♦The Food and Drug Administration is solelyr e s p o n s i b l e f o r t h e c o n t e n t s o f F D A PA P E R S . T h eA d v i s o r s t o t h e E d i t o r a r e c o n s u l t a n t s o n m a t t e r srelating to the functions of the Federal Departmentsa n d A g e n c i e s l i s t e d .

2 / March 1971 / FDA Papers

F D A P A P E R SVOL 5, NO. 2/MARCH 1971

Consumer Education and Information Making the consumer aware of 4the protection available to him.

Drug Surveillance for Adverse Reactions Discovering, assessing, 6and deaiing with adverse reactions from drugs.

The Lab Scientist and IDIP How the chemist and microbiologist 10contribute to a successful Intensive Drug Inspection Program.

The Poison Prevention Packaging Act Reducing poisonings by umaking it harder for smail children to get at packaged toxic substances.

Playing Safe in Toyland Protecting children from injuries associated with toys 17is a responsibility shared by industry, FDA, and parents.

Field Reports 22

Product Safety Report 25

News Highlights 27

Sta te Ac t ions 30

Seizures and Post Office Cases 31

Notices of Judgment 34

1 4

<X)NSUIVER EDUCATIONA ^ D I N F O R M A n O N

by Mervyn Silverman, M.D.During the past decade the Foodand Drug Administration has cond u c t e d a c o n s u m e r e d u c a t i o n a n dinformation program based on the"rights of consumers." FDA's consumer education program is basedon the premise that an informedconsumer is better prepared to protect himself, and FDA has been responding to this need to inform thec o n s u m e r .

In today's complex environment,there is an even more urgent neednot only to inform consumers aboutFDA programs and policies, butalso to counsel consumers so theycan protect themselves in the marketplace and at home. It is equallyimportant to measure the needs andexpectations of the consumer.

This need is being increasinglymet through programs conducted byFDA's Office of Consumer Affairs.With the support of a small butdedicated staff in Washington and20 Consumer Specialists in 17 FDADistrict Offices, the Agency provides an educational program reaching all parts of the Nation at thegrassroots level.

Although the Food and Drug Administration has been in the field ofconsumer protection since its inception in 1907 and maintained a constant vigil in behalf of the consumer,it was in 1952 that it began to actively seek the counsel of citizenswhen it first employed ConsumerSpecialists. They gather regularlyin Washington several times a yearto maintain contacts between theheadquarters staff and the field, andto obtain the latest consumer information. Their mission is to serveas a communications l ink betweenthe FDA and consumers, either asindividuals or as groups.

In Washington the Office of Consumer Affairs replies to thousandsof consumer inquiries in a timelyand in fo rma t i ve manner. F low ing

into FDA's headquarters in Rock-ville, Maryland, are an average ofa hundred letters a day from consumers, plus numerous telephonecalls inquiring about all kinds ofproblems involving food, drugs,medical devices, cosmetics, and env i r o n m e n t a l s i t u a t i o n s .

These 2,000-3,000 letters received monthly are not a one-waystreet. They provide viewpoints andinformation of great value to FDA.This data, combined with the inputreceived from Consumer Specialistsin the field, gives essential informat i o n f r o m w h i c h F D A c a n b a s e i t seducation and information programs. At the same time the inputprovides consumers with an effect i v e v o i c e i n s i d e F D A b e c a u s e o fthe product intelligence provided bytens o f t housands o f conce rned cons u m e r s .

To strengthen the input intoF D A ' s O f fi c e o f C o n s u m e r A f f a i r s ,a continuing liaison is maintainedwith Virginia Knauer, Special Ass i s t a n t t o t h e P r e s i d e n t a n d D i r e ct o r o f t h e O f fi c e o f C o n s u m e r A f

fairs, and Patricia Hitt, AssistantSecretary for Community and FieldServices, and Barbara Burns, Deputy Assistant Secretary for Consumer Services, both in the Departm e n t o f H e a l t h , E d u c a t i o n , a n dWelfare; the Federal Trade Commission; the Department of Agriculture; and other interested Federal agencies and consumer organ i z a t i o n s .

In establ ishing an FDA fieldcorps of Consumer Specialists, ouraim was to provide on-the-spot informat ion and ass is tance to ind ividual inquiries from consumersand to meet with organizations andgroups seeking educational information at the local level. The specialists now provide a direct chann e l o f c o m m u n i c a t i o n f o r c o n s u mers so that a flood of opinions andquestions reaches FDA every day.They provide an invaluable sourceof knowledge about how FDA'sprograms are working in the field.Further, this evaluation helps FDAlearn what other problems concernc o n s u m e r s . A l l o f t h i s i n f o r m a t i o nhelps to provide guidance to FDA


so that it can provide future constructive responses to the consumers who buy and use products manu f a c t u r e d a n d d i s t r i b u t e d u n d e rregulations for which FDA is responsible.

Consumer Specialists also workclosely with many organized publicgroups. Many belong to professional organizations such as theA m e r i c a n H o m e E c o n o m i c s A s s ociation, the American Dietetic Association, and the American PublicHealth Association. They meet withlocal community leaders in education and health, and work with themto provide additional informationfor transmittal to large numbers ofconsumers in the form of pamphlets,brochures, news releases, specialstatements, announcements, exhibits, etc. Community participation ineducational projects sponsored byF D A a n d i t s D i s t r i c t C o n s u m e r

Specialists often involves large numbers of consumers. This was the casewhen a one-day conference on thesubject of "Drugs and Our Society"attracted over 20,000 people. Theyalso work with other governmentagencies in their districts who havecollateral interests, such as the Administration on Aging of the Department of Health, Education, andWelfare, and the Department ofAgriculture's Co-operative Extension Serv ice.

To achieve mass communication,the Consumer Specialists have beenespecially effective in working withthe news media. Large amounts oftime and space have been providedby radio, television, and newspapers. The Consumer Specialistsr e a c h m i l l i o n s o f A m e r i c a n s w i t h

messages of importance concerningtheir health and welfare. Most recently, during the month of March,programs were developed fromWashington headquarters and thefield for television, radio, and theprinted media involving "PoisonPrevention." In an average monththe consumer program may provideas many as 100 radio spot announcements and interviews, over50 television appearances, and 20news releases on some meaningfulsubject for the consumer. Often ex

hibits are set up in locations wherelarge numbers of consumers congregate to provide information thatmay range from fair packaging andlabeling to health frauds.

One of the most important functions of the Consumer Specialists isto help "educate the educators"—the leaders in local government andthe educational system. The specialists are on a virtually continuousc i r c u i t o f c o n f e r e n c e s a n d w o r k

shops with health departments,boards of education, public healthnutritionists, dietitians, nurses, andwomen's clubs. Many other groupsbring the Consumer Specialists intocontact with leaders in the professions who, in turn, are responsiblefor Influencing the education of theconsumer constituency jn their respective professional fields. In anaverage month over 130 speechesare given by the specialists On suchtopics as "Your Health Protectiona n d F D A , " " F o o d A d d i t i v e s , ""Flammable Fabrics," "Poison Prevention," and "Our Health Needsa n d N u t r i t i o n . "

In addition to public speakingbefore the "educators" the specialists also give talks to various consumer groups. The volume of inputmay be gauged in a single month'sactivities. During this period, theyreached an audience of 27,600.

The average consumer who mayn o t h a v e h a d d i r e c t a c c e s s t o s o m eof the Consumer Specialists' moreformal presentations still has accesst o F D A ' s e d u c a t i o n a l a c t i v i t i e sthrough the use of the ConsumerP h o n e . I n t h e c i t i e s w h e r e F D A h a s

them, one needs only to dial a number made public by the news mediat o r e c e i v e i n s t a n t a c c e s s t o c u r r e n tinformation on subjects of interestto consumers—ranging from mercury in tunafish to the use of artificial sweeteners. Prior to September1970, there were Consumer Phonesin six cities; Chicago, Los Angeles,Dallas, New York, Minneapolis,and New Orleans. Over a one-yearperiod, 108,676 calls were made byc o n s u m e r s w h o c o u l d l i s t e n t o r ecorded messages on topics of interest, such as the proper storage ofdrugs in the home and the safe use

of potentially dangerous householdc l e a n e r s . B e c a u s e o f t h e s u c c e s s o fthis program, FDA has establishedConsumer Phones i n 12 o the r c i t i e s .

Today the Consumer Specialistsprovide the vital link between thecomplex activities of the Food andDrug Administration and more than2 0 0 m i l l i o n A m e r i c a n c o n s u m e r s .

B u t w h a t o f f u t u r e c o n s u m e r e d ucation? In the near future we hopeto strengthen FDA's national program with consumer educationalmaterials that will encompass morepublic communication of the DrugEvaluation Study Implementationprogram, and FDA's responsibilityfor informing youth of the rationalefor proper use of drugs under theAgency's jurisdiction. We also hopeto develop a program to communicate FDA's function of assuring thesafety of the American food supplythrough surveillance, testing, andinspection. Another phase of activity could involve education aboutFDA's voluntary nutritional guidel i n e s t h a t w o u l d s t i m u l a t e c o n s u m e rawareness and understanding of nutritional labeling.

Despite the fact that we are in anera of dynamic consumerism, it isunlikely that any regulatory program mounted by the Governmentfor consumers in the marketplacecan provide 100 percent protection.Therefore, the Food and Drug Administration feels that it should provide enough information so that thec o n s u m e r c a n m a k e a w i s e d e c i s i o nwhile shopping, and also acquireenough knowledge to properly usea product after it is purchased.

Mervyn Silverman, M.D., director, Officeof Consumer Affa i rs , s ince September1970, joined FDA in July 1969 as spec i a l a s s i s t a n t t o t t i e c o m m i s s i o n e r . H epreviously served as a commissionedo f fi c e r i n t h e P H S .

FDA Papers / March 1971 / 5

by Charles Anello, Sc.D.and Charles Hanson, M.D.

D r u gS u r v e i l l a i i c eFoo* AdverseR e a c t i o n s

The chemical and biological functions of the human body are specifically adapted to maintain each indiv idua l in a s ta te o f homeostas is or

biological equilibrium. Disease occurs when this balance is upset bysome i n te rna l o r ex te rna l f o r ce . The

physician treating diseases may administer drugs to try to restore theequilibrium. If the appropriate medication exists, it must be given at theright time by a suitable route, andin a proper amount and dosage formto obtain the desired response.

Even with properly administereddrugs, biological variation beingwhat it is, particular sets of conditions existing in some individualsmay produce untoward events, thatis, unfavorable responses not intended by the prescribing physician,at least not to the degree theyo c c u r r e d .

These untoward events may occurrelatively often with administrationof the drug, as a rash followingtreatment with penicillin, or withrelative infrequency, as blood dys-c r a s i a a f t e r a d m i n i s t r a t i o n o f c h l o r

amphenicol. Even though the risk ofuntoward events can be anticipated,their occurrence in a particulartreatment situation is usually unpredictable and somet imes isthreatening to health or life.

The FDA has the responsibilityof keeping a constant vigil to uncover adverse drug effects, to estimate the degree of risk, and to takeremedial regulatory action whereindicated. Our objective here is toreview the kinds of adverse reactiondata currently available to the EDA,to describe some additional kinds ofadverse reaction data needed by theAgency to safeguard the publichealth, and to summarize some ofthe major problems that must beresolved to obtain such addit ionald a t a .

Manufacturers' Reports. Reportsof adverse experience with drugsfor human use are required as partof a New Drug Application underSection 130.4, of the New DrugRegulations, and as a part of asupplemental new drug applicationunder Section 130.9. For the pur

poses of the New Drug Regulationsthe term "adverse experience" refersto "any adverse experience associated with the use of the drug,whether or not considered drug-related," and includes "any sideeffect, injury, toxicity, or sensitivityreaction, or significant failure ofexpected pharmacological action."

The information, except for investigational study Phase I and IIreports (early pharmacological andclinical studies of a drug) and literature reports, should be reported onStandard Form ED-1639, Drug Experience Report, or, alternatively, inan approved computer-generated report. The identical information elements are required in either case;these elements include the date sentto FDA and designation as initial orfollow-up report, and the patient'sinitials, identification number, sex,height, weight, date of birth, racialorigin, the date of reaction onset,source of report and source's address, description of the suspectedreaction, reaction outcome, listing ofall drugs in order of suspicion to-


gether with dosage form, total dailydose, route of administration, duration of therapy and dates of administration, reason for use of the drug,substantiating laboratory studies,potentially noxious or environmentalfactors, existing or prior disorders,past drug reaction or allergic history,and reproductive history.

The time requirements for reporting depend on the content of thereports. The general requirements,if the drug is intended for administration to man, are that routinereports shall be submitted at intervals of three months during the firstyear that begins with the date ofapproval of the application; at intervals of six months during the secondyear; and at yearly intervals thereafter. The regulations require, however, within 15 days of receipt bythe applicant, complete records orreports of information concerningany unexpected side effect, injury,toxicity, or sensitivity reaction orany unexpected incidence or severityo f s u c h c o n d i t i o n s a s s o c i a t e d w i t hclinical uses, studies, investigations,or tests, whether or not determinedto be attributable to the drug. Forthe purposes of this regulation,"unexpected" refers to conditions ordevelopments not previously submitted as part of the New DrugApplication or not encountered during clinical trials of the drug, orconditions or developments occurring at a rate higher than shown byinformation submitted as part of theNew Drug Application.

Spontaneous, Voluntary Reporting. Besides the reports from themanufacturer required by regulation,t h e r e e x i s t s e v e r a l o t h e r s o u r c e s o fadverse drug effect informationwhich depend on the spontaneous,voluntary, direct reporting of untoward events believed to be drug-related. These sources generallyinclude clinical investigators, practicing physicians, other medicalworkers, participants in paid hospital-reporting programs and patientsthemselves. These additional "spontaneous voluntary reporting" sourcesserve as an alerting system for thoseu n t o w a r d e v e n t s i n w h i c h t h e e f f e c tcan be easily related to the drug

responsible. Usually such untowardevents are acute and quickly followadministration of the drug, anaphylaxis to penicillin, for example. Asimplified reporting form is beingdeveloped that will be convenientto use and will encourage reportingof adverse drug experiences.

Major deficiencies exist in the voluntary reporting programs, whetherhospital-based or based on individual physicians. These include:

1. Reports are likely to identifyonly those events already familiar;

2. Diagnosis of drug reactionsmay be mistaken and misleading;

3. Reports do not establish theincidence of untoward events;

4. Delayed effects tend to remainunattributed to the drug; such effectsinclude, for example, potentiallyserious hazards, such as phocomeliaas related to thalidomide, or aplastica n e m i a a s r e l a t e d t o c h l o r a m

phenicol.The British use of voluntary re

porting systems seems more advanced than our own. W. H . W.Inman, reporting at the InternationalConfe rence on Adverse Reac t ionReporting Systems in October 1970,noted that the basic elements of theBritish approach include: (a) acomputer based printout, (b) motivation of the physicians to reportsuspected untoward events, (c) ahighly qualified team of medicalinvestigators to validate the report,(d) a good system of drug utilization data, and (e) a feedback procedure to the practicing physiciansand other professionals to encouragethe medical community to participate in the national drug monitoringp r o g r a m s .

But this system, like its Americancounterparts, is subject to bias anda substantial degree of underreporting of untoward events, since manyevents that occur can go unrecognized. Particularly likely to be overlooked are those subtle drug-relatedevents that occur in an outpatientenv i ronment and those for wh ichthe time between drug administration and effect is long. For assurancethat we have comprehensive surveillance, spontaneous reporting mustbe supplemented by intensive sur

veillance programs and controlledc l i n i c a l t r i a l s .

Existing Intensive SurveillanceSystems. Hershel Jick, at the recentI n t e r n a t i o n a l C o n f e r e n c e o n A dverse Reactions, defined the term"intensive drug surveillance" as astudy in which a defined populationis continuously monitored to determ i n e :

1. the frequency with which certain events are associated with drugadministration;

2. whether a causal relationshipbetween the drugs and event islikely; and

3. whether there are subpopula-tions at greater risk, namely, moresusceptible to reaction to the drugthan is the general population.

T h e e s s e n t i a l c r i t e r i a f o r a n i ntensive surveillance program, sodefined, is that: (a) the target population is clearly defined; and (b)standardized and routine procedurese x i s t f o r t h e c o l l e c t i o n o f i n f o r m ation on patient characteristics, drugsadministered or d iscont inued, andchanges in the patient's condition(even ts ) .

Intensive hospital monitoring hasalready revealed that the incidenceof adverse reactions is higher thansuspected from voluntary reportingstudies. Depending upon the institution and the investigational methodsand the defin i t i ons used , the inc i d e n c e o f a d v e r s e r e a c t i o n s i n

patients during hospitalization hasbeen reported in a range of valuesincluding 13.6 percent, and 30.9percent (some of which were judgednontrivial).

The Food and Drug Administrat ion, the National Inst i tutes ofHealth (National Institute of General Medical Sciences), and othersover the past few years have sponsored programs designed to improvethe Nation's monitoring and drugsurveillance capabilities. These programs have included both outpatientand inpatient populations. The requirements for the outpatient systemare somewhat more complex andthis system will take longer to perfect. Both of these types of intensivesurveillance programs bear resemblance to the model suggested by


D. J. Finney in a proposal foran "International Drug SafeguardPlan," published in 1964. Thismode l ca l l s f o r t he co l l ec t i on o fdrug use and medical history dataon a total population of patientswithout regard to whether a part i c u l a r m e d i c a l c o n d i t i o n i s b elieved to be a consequence of adrug. The medical history data usedfor drug monitoring should also inc lude i den t i fica t i on o f t he the rapeutic indication for starting thedrug and the reasons for stoppinga particular treatment regimen.These two facts appear to be helpfulfor the proper interpretation of theuntoward effects of drugs. Finally,in this proposed model, informationis compiled and analyzed by a central computer, which determines incidence rates or suspicious correlat i o n s .

Three monitoring programs thathave been developed over the pastfew years represent prototypes ofpotentially expandable intensivesurveillance programs. The in-hos-pital intensive programs primarilycover patients in selected hospitalm e d i c a l w a r d s . I n t h e Tu f t s U n i v e r

sity program, pertinent informationis recorded by nurse monitors, whilein the University of Florida programpharmacists record the data. Theoutpatient program developed atK a i s e r - P e r m a n e n t e i n C a l i f o r n i a h a s

employed on-line entry of pharmacyrecords of prescriptions filled, optical scanning of forms containingphysician diagnoses obtained during outpatient visits, and othermodes of putting in data as directlyrecorded in patient care activities.

These programs differ substantially in "intensity" of monitoring,reliability of the information obtained, duration over which surveillance is possible, and capability forsearching the computer records forunsuspected drug reactions. Eventaken together, and not denyingtheir merit, these programs fall farshort of filling the total nationaln e e d s f o r s u r v e i l l a n c e . W . H . W .

Inman, in his report mentionedearlier, has pointed out that themajority of serious or fatal drugreactions are rare, with an incidence

ranging from perhaps 1 in each1,000 to 1 in each 1,000,000courses of treatment. The existingintensive surveillance systems do nothave adequate numbers of patientsu n d e r t r e a t m e n t t o d e m o n s t r a t e r eac t i ons o f such i nc idence .

General Problems in Design. Thefundamental issues related to designof drug surveillance arise with theselection of an appropriate population to be monitored, the selectionof drugs that because of their extensive use or relative recent entry intothe physicians armamentarium require intensive or special monitoring, and the selection of those vari-ates which need to be observed ands c r e e n e d t o a v o i d s e r i o u s c o n s e

quences to the drug-consumingpublic.

To d a t e l i t t l e a t t e n t i o n h a s b e e n

given to the characteristics whichwould make a population appropriate for a national drug surveillanceprogram. Size and proximity to quality medical institutions have beenviewed as essential characteristics,but these are not sufficient in identifying a target population. Mostindividuals take medication at somepoint in their lifetimes, and thespecific drugs taken and duration ofconsumption vary greatly.

Hospital populations are convenient for surveillance because theycan be intensively monitored andtheir medical records are readilyaccessible. In the hospital situation,however, the administration of drugsis carefully controlled and the choiceof drugs is not representative of thepattern of drug administration in anoutpatient environment. A comprehensive drug surveillance programmust ensure that most sectors of thedrug-consuming population are represented. The population under surveillance should include those subjected to less than the highest levelof medical care. Attention should begiven to the effects of drugs on theoutcome of pregnancy.

Since it may not be economicallyfeasible to monitor all drugs overan extended period of time, someselection of drugs may be necessary.It is clear that those drugs which willbe used by patients for an extended

period of time, those which aretaken just prior to or during pregnancy, and those which are givento a large segment of the populationmust be kept under surveillance. Therecent studies with oral hypoglycemic agents have shown thatmany years may elapse before onecan establish the existence of trendsor identify possible adverse effectsattributed to a specific drug. Thereshould also be a procedure for terminating specific surveillance onceconfidence in a drug's safety hasbeen established. This, however, isdifficult to identify.

Considerable thought must begiven to the particular biologicale f fec ts tha t mus t be mon i to red as am i n i m u m . A l i s t o f s u c h e f f e c t sc o u l d b e a l m o s t u n l i m i t e d . I t i ncludes mortality, selected morbidity,signs, diagnoses, symptoms, andlaboratory findings. Not only musta decision be made concerningwhich variables are to be observed,but a decision also is needed on the

timing of an observation. In the past,potentially drug-related events wererecorded as part of the standardmedical practice and little attentionwas given to drug surveillance objectives. The recent trend suggests thatfuture programs, inpatient or outpatient, will provide for more intensive monitoring specifically designedto detect untoward events that maybe shown to be related to drug intake. The outpatient situation, morecomplex than the inpatient situation,will require considerable thoughtand study. This is particularly truebecause, unlike hospital situations,the health status of an outpatientcannot always be ascertained. Themost that can be expected of a drugsurveillance program is that it provide sufficiently intense screeningto detect significant morbidity andmortality which would not be detectable through other programs,such as spontaneous and voluntaryreporting.

Several important issues need tobe considered, assuming agreementcan be reached on the populationto be brought under surveillance,the var ia tes tha t shou ld be observedas a minimum, and the drugs that


must be included in the monitoringprograms. The major issues include:(a) quality of the data, (b) size ofpopulation, (c) estimate of attributable risk, (d) use of retrospectiveand prospective studies, and (e) roleof sampling.

First, as with all of science, thequality of information used to makeinferential statements about a popula t ion must be defined and i ts c red i

bility established; otherwise, therecan be no confidence in the findingsor conclusions. To this generalscientific requirement, however, wemust add that findings relating drugsto adverse effects can have important medical, legal, and economicconsequences. Therefore, the usefulness of a comprehensive surveillance program will depend to a largeextent on the reliability and thedefensibility of the data and thesubsequent findings. Every effortm u s t b e m a d e t o e l i m i n a t e k n o w nor potential sources of bias andunsubstantiated subjective inferences. Intensive surveillance programs augmented by special clinicalor animal studies should produce adata base acceptable to the medicalprofession, the academic community, and the drug-consuming public.

A n o t h e r i s s u e c o n c e r n s t h e s i z eof the population needed to providean adequate basis for inference.Those trained in biometry know thatthis depends on the size of the population at risk, the expected frequencyof an adverse effect, and significanceattaching to a possible error. Intensive hospital monitoring programshave not covered large populationswith diverse drug exposures. Theyhave for the most part been restricted to medical wards. Clearly,any expansion in existing programsmust include a greater variety ofdrug exposures. The outpatient environment, l ike the program atKaiser-Permanente, offers an opportunity to keep large populations under surveillance (specifically, subscribing members of a prepaid medical program). But "under surveillance" is not the same as "exposedto drugs," and it is the size of thepopulation exposed to the drug thatmust be cons idered when one is

attempting to specify surveillancep r o g r a m s .

An important objective for anycomprehensive drug surveillanceprogram, in addition to identifyingwhether a specific untoward effectmay be related to the administrationof a particular drug, concerns theneed to estimate the magnitude oft h e e x c e s s r i s k a t t r i b u t a b l e t o t h a t

drug. The attributed risk can beexpressed in a variety of ways (forexample, a relative risk or an excessr i s k m e a s u r e d f r o m a s u i t a b l e c o ntrol group). In addition, a surveillance system should be capable ofproviding estimates of the benefitthat can be attributed to the drug.A n e s t i m a t i o n o f r i s k w i t h o u t a ne s t i m a t i o n o f b e n e fi t i s a n i n s u f ficient basis for making regulatorydecisions on marketed drugs.

Recent evidence of drug effectshas been generated by both retrospective studies (thromboembolismand oral contraceptives) and prospective controlled studies (the recently reported University GroupDiabetes Program). Once a surveillance program has alerted us to thepotential hazard of a drug, con-firmational investigation must bei n i t i a t e d . O f c o u r s e t h e r e v e r s ecould also possibly occur: the finding could first be generated by controlled experiments, and confirma-tional evidence might be obtainedthrough the intensive monitoring orother surveillance programs. Thiscross-checking of findings is necessary to assure the scientific objectivity of research in this difficulta r e a .

Finally, we should consider anewthe role of survey sampling in support of a national drug surveillance

system. Good information on drugutilization appears to be essentialif the magnitude of any drug-relatedbenefi t o r haza rd i s t o be v i ewed i n

proper perspective. Interpretation ofdrug usage data is complicated because some patients do not takedrugs as prescribed, and tend toingest many drugs based on theirown evaluation of the therapeuticeffect. A complete monitoring program will take into account thetotality of drugs and devices andview them in the light of actuallevels of consumption.

Those making efforts to deal witha d v e r s e r e a c t i o n h a z a r d s s h o u l d

recognize that some such hazardswill inevitably persist. They will persist even though the appropriatem e d i c a t i o n h a s b e e n a d m i n i s t e r e dat the right time by a suitable route,in a proper amount and dosageform, because of the intrinsic variability of biological response topotent drugs. But adverse reactionscan be minimized by foreknowledgeof the risks. This knowledge, if it cannot always be established prior to approval of the drug for marketing, canbe derived from post-marketingdrug experience data. Such data ispresently provided to the FDA inthe form of spontaneous, voluntaryreports, either transmitted by themanufacturer or submitted directlyand voluntarily to the Agency fromthe observer of the reaction. Theseisolated reports in themselves do notconstitute an adequate method ofsurveillance; intensive surveillanceprograms and controlled clinicaltrials are also required. Our objective is a comprehensive drug monitoring program to safeguard thepublic health.

Charles Anel lo, Sc.D. ( left) , director ofthe Division of Statist ics, Office of theA s s i s t a n t D i r e c t o r f o r S c i e n t i fi c C o o r d ination, Bureau of Drugs, joined FDA inApril 1969.

Char les Hanson, M.D. , medical o fficer.Divis ion of Biometry and Epidemiology,O f fi c e o f S c i e n t i fi c C o o r d i n a t i o n , B u r e a uof Drugs, joined FDA in October 1969.


An FDA microbiologist (right) reviews the company'sproduct specifications with a plant microbiologist.

A company chemist(left) reads the

methodology beforebeginning an analysis

as the FDA chemistlooks on .

A technician (right)examines a drug tablet

for conformance to thefirm's weight

specifications as anFDA chemist observes

the procedure. A plant microbiologist(left) shows an FDAmicrobiologist thecompany's incubatorcon t ro l s .

T H EL A B O R A T O R Y

S C I E N T I S TA N D I D I P

by Matthew H. Lewisand Anthony Duran

One of FDA's most ambitious field activities is theIntensified Drug Inspection Program, popularly calledthe IDIP. This program had its beginnings with the 1962Kefauver-Harris Drug Amendments to the Federal Food,Drug, and Cosmetic Act. The goal of the IDIP is toensure that manufacturers produce quality drug productsthrough adherence to the Current Good ManufacturingPractices regulations published in the U.S. Code ofFederal Regulations, Title 21, Part 133. The IDIP isintended to achieve compliance, when possible, througha cooperative effort by the FDA and the drug industry.

The new concept of intensified inspections was initiated in fiscal 1969. Unlike the more limited establishment inspections normally conducted in FDA operations, the Intensified Drug Inspection may last severalmonths. Another significant difference is that the inspection is made by a team of FDA experts. This teamconsists of one or more inspectors (one of whom is theteam leader), a chemist experienced in drug chemistry,and, when the firm deals with sterile products, a microbiologist. For the chemist and the microbiologist to befully effective members of the team, they participatewith the inspectors in the pre-IDIP meeting between


An FDA chemist (right) observes the procedure as afirm's chemist performs a Karl Fischer test for determiningmoisture content in a drug product.

A drug plant analyst (left) discusses his worksheet on acompleted analysis with his quality assurance supervisor (right),while the FDA microbiologist (center) monitors the discussion.

Storage conditions of thedrug company's referencestandard chemica ls arechecked by FDAmicrobiologist (right) and aplant quality assurancerepresentative.

the firm's management and FDA personnel. They accompany the inspectors on the early stages of theinspection that takes them into all areas of the plant.This is the first time in recent history in which laboratory scientific personnel have been actively involved indrug plant inspections.

It is the objective of the IDIP to improve the qualityof drugs manufactured or distributed in this country.This objective is to be achieved through a twofoldapproach: (1) To work with drug manufacturers in ajoint effort to improve manufacturing practices to assuredrug quality and (2), when that fails, to take legalsteps to discontinue the distribution of those drugs thatare not produced in a manner and under conditionsthat assure quality. Fortunately the first part of thisapproach has generally been effective. In the greatmajority of inspections, drug manufacturers have cooperated with, and in fact welcomed the IDIP team.

The selection of a manufacturer for intensified inspection is determined from a careful review of these threefactors: (1) history of violations and unsatisfactoryconditions noted during past inspections; (2) unusualprocesses; and (3) significance of drugs produced.

The effectiveness of this new inspectional programhas. been due in large part to the saturation coveragethe inspected firm receives. Until the inspection isterminated or temporarily suspended, the IDIP teamis in the plant daily. Every department, every process,every procedure is observed and evaluated, not by one

expert but by several. The inspectors, the chemist, andthe microbiologist all bring their respective experienceand expertise to bear on the firm's total operation. EachIDIP team member has the opportunity to find procedural weaknesses or potential hazards that his background enables him to recognize.

In the New York District the Intensified Drug Inspection is conducted in four phases. The entire scientific team of inspectors, chemist, and microbiologist isnormally involved in all four phases.

First Phase. The first phase of the IDIP is the pre-inspection conference. The management of the firm isi n v i t e d t o t h e D i s t r i c t o f fi c e t o m e e t w i t h t h e m e m b e r sof the IDIP team. At this meeting the purposes andorganization of the inspection are explained, and thefirm has an opportunity to ask questions. Usually themanufacturer is asked to designate a responsible staffmember as management liaison with the IDIP team.

S e c o n d P h a s e . O r i e n t a t i o n o f t h e I D I P t e a m c o m

prises the second phase of the inspection. The teams t u d i e s t h e a d m i n i s t r a t i v e a n d f u n c t i o n a l s t r u c t u r e o fthe firm, observes the manufacturing operations, and becomes familiar with the plant layout and the flow ofrecords and materials. This phase, sometimes referredto as a "tour," may require several days to two weeks,depending on the size and the complexity of the firm.

Third Phase. The third phase constitutes the comprehensive inspection of the firm. Each department isstudied thoroughly. Actual operations such as tableting.

F D A P a p e r s / M a r c h 1 9 7 1 / I I

coating, packaging, and labeling are carefully observed.Conditions under which the operations are performedare critically viewed. Since the team is accompanied bya member of management, any existing or potentialproblems are brought to his attention immediately.On-the-spot conferences are held with the departmentheads. In addition, a weekly meeting is held with thecompany's top management at which a written reportof the week's observations is presented by the teamleader. This report is discussed with a view to initiatingc o r r e c t i v e m e a s u r e s .

Fourth Phase, The final phase of the IDIP is thepreparation of a written report by the members of theIDIP team. This comprehensive report describes thefirm and its operations in detail and summarizes all thathas occurred during the inspection. Critical observationsare discussed, conferences with management are described, and the responsiveness of management in termsof corrective actions is described. The final report ist h e n s u b m i t t e d .

During the actual inspection, the chemist is mostconcerned with the activities of the quality controllaboratory and the adequacy of testing of raw material,in-line product, and final dosage forms. The concernof the microbiologist is focused on microbiologicaltesting and on the structure of "sterile" areas and theperformance of sterile operations.

Aside from their areas of primary attention, laboratory-oriented team members have on numerous occasions pointed out dangerous practices in other areas ofoperation. One chemist, for example, noticed that priorto filling, bottles were rinsed with a solvent but notadequately drained and dried. The solvent in this casewas methyl alcohol, and the person responsible for theoperation was unaware that this solvent is a highlypoisonous substance. On another occasion a dangerouslycombustible organic solvent was found stored in openbottles next to an infrared lamp. Again the responsibleparty did not realize the potential explosive hazard.Another FDA chemist, because of his laboratory experience with methylcellulose was able to determine whya plant using methylcellulose in product formulation,was getting low assay results. The company did notrealize that this substance prevented complete extractionof the active ingredient, in this case, barbiturates.

Chemist's Responslhility, The chemist spends most ofhis time in the quality control department of the drugfirm. At the very least, this department will consistof a laboratory that analyzes raw materials, intermediate products, and finished dosage forms. Moreoften today this department is called "Quality Assurance" and has considerably expanded duties. Forexample, stability studies may be handled by a unitin this department. Containers may be tested forsuitability by the quality assurance department, andmethods development for new products may also beundertaken. Appropriately, the quality assurance department is responsible for making certain that no

substandard product leaves the plant. To discharge thatresponsibility fully, this department must have considerable independence, authority, and a wholesomebudget. All of these factors can create situations thatmay exasperate other departments in the firm; forexample, "rush" shipments of dosage forms may bedetained awaiting completion of analysis. The independence and power of this department are essentialif it is to resist the natural pressures put on it. Thesequalities are observed and evaluated by the IDIPchemist just as carefully as are the firm's analyticalm e t h o d s .

Most firms understand that their quality control department serves as their first checkpoint as well as theirlast line of defense. Since the FDA cannot sample eachbatch of drugs produced in the country, these qualitycontrol departments more often serve as the consumer'slast line of defense. For this reason these departmentsare given a considerable amount of careful and criticalattention during an IDI.

The importance of the quality control departmentcan be related to drug recalls initiated by a firm at therequest of FDA or the firm. Our experience so farindicates that the majority of these recalls would nothave been necessary had the deficiency been detectedby the quality control department.

The most common deficiencies found in quality control departments reflect the use of inadequate or inappropriate methods, the inadequacy of or complete lackof specifications for product or raw material, and poorrecord-keeping procedures. Examples of some of theworst conditions observed:

1. A nonspecific analytical method was used that wasaffected by one of the excipients, giving apparent highpotency results for the active ingredient. On the basisof the analysis, the production department reworked thetablets and diluted the active ingredient. The resultingproduct, of course, was subpotent.

2. Reference standards (chemicals certified for identity and purity) were stored improperly and as a resultdeteriorated with time. The firm, unaware of this instability, used the standards for chemical analysis. Someof the subsequently marketed products were found tobe substandard by the FDA.

3. Average weight and weight variation tests werebeing performed by a high school graduate who couldnot handle simple arithmetic. These weight figures wereused to determine the running weight for manufacturingand to release products for sale.

4. A consulting laboratory was employed for qualitycontrol testing. The laboratory performed an inadequatenumber of tests to determine the strength, purity, andidentity of the active ingredient. The consulting laboratory would inform the firm only that the product had"Passed" without specifying what tests were performedor supplying any raw analytical data. The firm, on theother hand, had no written product specifications.(NOTE: The operations of commercial laboratories


that do work for drug firms under investigation areincluded for inspection under the IDIP.)

5. A part-time chemist was hired who worked duringregular hours for another firm. He brought standardsolutions from his regular job to use on his part-timejob without bringing or developing the necessary standardization data. When a problem arose concerning aproduct, the firm could not review and adequatelyexplain its analysis because this data was lacking.

6. A product was manufactured which, availablerecords on file indicated, passed the disintegration testat the time of manufacture. The IDI team discovered,however, that the same product, after standing fourdays, no longer passed this test. No studies had beendone by the firm of the effects of aging on this product.

7. A consulting laboratory employed on a part-timebasis a high school student who was performing chemical assays without adequate supervision. On one occasion this employee ran a sample in duplicate andobtained results of 80 percent and 120 percent. Theaverage of the results was reported as 100 percent.

8. One firm, in sampling its raw materials for assay,did not use a trier, but instead sampled only from thetop of the drum. This firm also neglected to mix thedrum's contents before sampling. The sampling personnel apparently failed to realize the dangerous implications of assaying a nonuniform sample.

Microbiologist's Responsibility. The microbiologistmember of the IDIP team must examine the construction of sterile areas in drug plants to determine if theyare adequate for the job.

Among the many factors a microbiologist must consider in evaluating a sterile area are location of majorsources of air pollution, air currents, area of the sterilefacility, number of people working in the area, typesof products handled in the area, amount of traffic inand out of the area, and number and size of openingsinto the sterile area. The last factor is important becausemost sterile areas are operated under positive pressure.

A person entering a sterile environment can contaminate through the normal shedding of bacteria from hisskin and by carelessness. This carelessness may resultfrom an incomplete understanding of the precautionsnecessary to preserve the sterile condition. The sheddingof bacteria is controlled by the use of sterile, lint-freegarments, gloves, hoods, and overshoes. Carelessness,however, is much more difficult to control. At one drugfirm an IDI microbiologist observed a maintenance man

entering the sterile area only partially gowned andcarrying nonsterile tools. Two minutes later a technicianentered the same sterile area without changing his non-sterile uniform. Further, examination of the dressingrooms, where sterile gowns are donned prior to enteringthe sterile area, revealed that there was no soap in thedispensers.

At another firm a laboratory worker was observedwith a pencil placed between his cap and head. Heremoved the pencil periodically to mark objects underthe sterile filling hoods. This, of course, subjected ther o o m t o b a c t e r i a l c o n t a m i n a t i o n f r o m t h e m a n ' s h a i rand scalp.

Firms have been observed to have sterile areas thatranged from a semienclosed space of only 30 squarefeet to a completely enclosed area of over 6,000 squarefeet. One plant used only a home air-conditioning unitto filter the air entering the sterile area. In another, itwas discovered that the ceiling of the sterile roomopened into a manufacturing room where tabletingand other processing was going on. This firm was repacking sterile penicillin powder. Thus, in addition toproducing a penicillin product that was not sterile, theplant was allowing other drugs to be subjected to cross-contamination by this potent antibiotic.

One drug plant was especially careful in its sterileoperation. Air was filtered through a prefilter, a pre-cipitron, past ultraviolet radiation, and then througha bank of Cambridge filters into the sterile area. Somemanufacturers operated their entire sterile area undera laminar flow air system.

Examples of poor chemical and microbiologicallaboratory practices are mentioned because of theirextremes. Most firms are found to have well-plannedand well-executed quality control programs, substantialsterile rooms, and excellent sterile room technique.

Firms that effectively monitored themselves and thosefound to be lax in their procedures generally respondedwell to the IDIP and agreed that the intensified inspection had been beneficial. In any event, the laboratoryscientists of the FDA found an essential role in theIntensified Drug Inspection Program and have usedit to teach and to learn. An exchange between FDA andindustry has been established with, in most cases, a substantial degree of trust on both sides. The laboratoryscientists by this exchange have had a large share inthis joint effort by Government and industry to insureconsumer protection.

Matthew H. Lewis, recently transferredto Boston District as a supervisory chemist from New York District, joined FDA in1 9 6 4 .

A n t h o n y D u r a n , m i c r o b i o l o g i s t ,York District, joined FDA in 1966.

N e w


THE POISONP R E V E N T I O NPaCKAGMG APT by James J. CorriganAmong the important bills signed of averting such incidents through legislation, these recommendedinto law by the President during the the use of safety closures was high- standards would be expected to beclosing days of the 91st Congress lighted in testimony by a pediatri- raised as new test data becomeswas the Poison Prevention Packaging cian in the Army Medical Corps, available. Containers should also beAct of 1970 (P.L. 91-601), which Treated cases of accidental poison- capable of being opened by 90 per-will be administered by FDA. The ings were down from 251 to 175 at cent of adults 45 years old andbasic concept of the legislation is to the Madigan General Military younger.protect children from accidentally Hospital serving approximately 100,- However, in view of the evidenceingesting toxic substances by requir- 000 persons in the Tacoma, Wash- of the accidental ingestions occur-ing safety closures and other safety ington, area the first year (1967) ring yearly and the failure of previ-packaging. that safety containers were used by ous efforts to produce widespread

In 1967, the last year for which the hospital pharmacy and to 108 use of safety closures, the Congresscomplete figures are available, the the succeeding year. determined that legislation wasNational Center for Health Statistics Enactment of the Poison Preven- needed to foster the use of child-of the Public Health Service re- tion Packaging Act is the culmina- resistant packaging,ported that 325 children died from tion of a legislative effort that began The legislation is aimed specifi-accidental poisoning. Over 116,000 in 1966 with the introduction of the cally at protecting children underaccidental ingestions of drugs and Child Safety Act (H.R. 13886, 89th five years of age—an age groupother toxic materials were reported Congress), which would have made particularly vulnerable because ofto the poison control centers in the use of safety closures mandatory, their inability to read, their natural1969. Children under five years of This legislation, which was not curiosity, and the "Pica phenome-age accounted for 76,155 of these enacted, was the impetus for FDA's non," namely the tendency amongaccidents and 3,844 hospitalizations convening the Conference on Pre- young children to eat nonfood items,occurred within this group. Although vention of Accidental Ingestion of Coverage of the Act extends be-drugs account for approximately 50 Salicylate Products by Children in yond that of the Federal Hazardouspercent of the reported accidental 1966 in an effort to stimulate volun- Substances Act and includes all haz-ingestions, many other common tary methods on the part of indus- ardous substances, economic poi-household chemicals are associated try to reduce the incidence of sons, foods, drugs, cosmetics, andwith these tragedies. For example, poisonings. The Conference, includ- household fuels in portable contain-reports of 782 ingestions of petrol- ing representatives of the medical ers in the regulated category ofeum distillate furniture polish were community and industry, resulted in "household substances." The limi-received by FDA in 1968. the limitation of children's aspirin tation to products intended for

FDA has already acted under the grain) to 36 per bottle, ordi- household use in the FHSA isFederal Hazardous Substances Act narily less than a lethal dose. A abandoned so that coverage in theagainst certain liquid drain cleaners subcommittee on safety closures was Poison Prevention Packaging Act iscontaining more than 10 percent also formed and has since been de- extended to items customarily storedsodium or potassium hydroxide by veloping methods for evaluating around the household even whenpublishing a proposal to require safety closures. such products may not be destinedchild-resistant packaging. Products The subcommittee filed its report for use around the household. Thus,failing to comply would be classified with the Commissioner of Food and boat maintenance items, model air-as banned hazardous substances. Drugs on December 7, 1970, sped- plane fuels, and products of this ilk

Dramatic testimony before the fying closure testing methodology, are clearly within the jurisdictionSenate Commerce Committee's Con- The standards proposed by the sub- of the Act.sumer Subcommittee in 1969 de- committee call for packages that will The bill authorizes the Secretaryscribed the pain and suffering that resist the efforts of 65 percent of of Health, Education, and Welfareresulted when a curious child gained children between 42 and 52 months to establish special packaging stand-access to a packaged dishwashing and 50 percent of such children ards for virtually all household sub-detergent. The 18-month-old boy after a demonstration of how to stances after consultation with aunderwent a tracheotomy to permit open the container. The standard technical advisory committee, uponbreathing and a tube was inserted recommended was the result of test- a finding that the degree or naturein his stomach so that he could re- ing only three closures. With the of the hazard to children, in theceive nourishment. The possibility increased efforts stimulated by the availability of a substance to them


because of its packaging, is suchthat special packaging is requiredto protect children from access toquantities that could cause seriouspersonal injury or illness. He mustalso find that the proposed standardis technically feasible, practicable,and appropriate. By "feasible" it ismeant that the technical expertiseexists to produce such packaging,and therefore the Secretary is underno obligation to promulgate standards that can be easily met. Thus,this proviso does not mean that thestandard must be gauged to thelowest level of technological skill

available or even the average levelpackaging technology. Adaptabilityto modern methods of mass production is the criterion for fulfilling therequirement that the standard be"pract icable." in finding that astandard is "appropriate," the Secretary should determine that the packaging will not be detrimental to theintegrity of the substance.

The Act also directs the Secretaryto give consideration to the reasona b l e n e s s o f t h e s t a n d a r d , r e l e v a n tmedical and engineering data, manufacturing practices, and the natureand use of the substance. Although

Among safety closures underdevelopment is this one with aconvex, flexible top (left) whichdefies attempts to open untildepressed firmly in the center whilesimultaneously unscrewing the cap(right).

This safety closure has a hingedplastic tab firmly recessed flush withthe top and almost unnoticeable(left). The end of the tab must bepried upward to loosen it and thecover may then be removed bypulling on the tab (right).

This two-piece safety closure (left)has a plastic free-turning outerprotective ring that must be pulleddown w i th modera te fo rce so tha tthe common screw cap may begrasped for turning (right).

In opening this safety closure thekeyed markings on the bottle capand its outer ring (left) must be linedup to allow the outer ring to bedepressed, thus releasing the innercap for opening (right).

no formal finding is required withregard to these guidelines, they areincluded to insure that evidence onthese factors cannot be excluded inissuing packaging standards. Publication of all the findings of theSecretary, the reasons therefor, andcitation of applicable provisions ofthe law are required in promulgatinga s t a n d a r d .

Special packaging standards neednot be restricted to safety closuresand may require packages of suchdesign or construction as to makeit difficult for a youngster to obtaina t o x i c a m o u n t o f a s u b s t a n c e i n a


This firmJy locked safety closure (left)defies opening unless moderatelyheavy pressure is applied from thetop, as with the heel of the hand,and it is turned simultaneously (right).

This safety closure (left) employs thefree-turning outer ring, which mustbe pulled down with one hand whilethe top is removed with the other.

This closure consists of a detachable

"key" part containing prongs thatmust be inserted into thecorresponding holes in the bottlecap to open (right).

torn'

1 ^ - j s m

Strip packaging provides individualwrapping of each dosage unit, andindividual opening. Although anormal small child may be able toopen them, he must do so one at atime. Young children must workslowly and are likely to lose patiencebefore they obtain a quantitysufficient to be dangerously toxic.

Young children, especially thoseunder five, find that opening awell-designed safety closure isfrustrating work. Some toddlers, evenwhen shown how to do it, do nothave the strength in their tiny fingersto employ the moderate forcenecessary to open most of theenc losures .

reasonable period. The requirementthat the packages be difficult forchildren under five years of age toobtain a toxic amount from withina r e a s o n a b l e t i m e d o e s n o t n e c e s

sarily mean that all such childrenwill be unable to open or otherwiseobtain a toxic amount. Of course,the packaging standard cannot besuch that normal adults are unableto use the product. Special packaging can also include packaging whichl imits the amount chi ldren wi l l beable to ingest, such as strip packaging or bottle caps that permit only afew drops at a time. The Secretary

may also prohibit packaging thatis unnecessarily attractive to children in a regulation establishing special packaging for a substance.

To i n s u r e t h a t i n n o v a t i o n i s n o tstifled the law specifically prohibitsthe Secretary from prescribing specific designs, package quantity,content, or labeling. This provisionis to make i t c lear that containerperformance standards are intendedto be established under the Act.

One of the major controversiesthat had arisen over this legislation,if not the only controversy, relatedto the exemption permitted for the

benefit of the elderly and handicapped. It was pointed out duringthe congressional deliberations onthe legislation that debilitated orhandicapped persons might be unable to cope with the special packaging because of wrist infirmities orother lack of dexterity. The Senate,recognizing this contingency, provided that one size of a productcould be marketed in noncomplyingpackages for this purpose if suchpackages bore a label stating thatthe noncomplying packages are intended for households without youngc h i l d r e n .

16 / March 1971 / FDA Papers cont'd, on p. 21

Some squeeze toys have easilyremovable squeakers which childrenmay pull out and put in their mouths.

Noise-making rattles of flimsy plasticcan be broken easily to expose wireprongs which can puncture skin or

jab eyes.

(Haying SafeInTqylanf)

by Carol YoungCarol Young is a staff writer in theBureau of Product Safety.

Gifts of toys are tokens of love. Itis important that they be chosen withcare. It is tragic when a toy, meantto bring happiness, seriously injuresa ch i ld .

Protecting children from unsafetoys is one of the responsibilities ofFDA's Bureau of Product Safety.The Child Protection and Toy SafetyA c t o f 1 9 6 9 — w h i c h b e c a m e e f f e ctive in January 1970—empowers theFood and Drug Administration toremove and keep from the markettoys and other children's productswith electrical, mechanical, and therm a l h a z a r d s .

How big is the hazardous toy problem? How many children are injured? Toy-associated injuries accounted for less than 5 percent ofover 120,000 reported injuries inand around the home compiled fora year's period from FDA's injurysurveillance system. This system includes reports from 130 hospitals in31 States.

Bicycles were involved in the majority of the toy-associated injurycases. Other vehicle-type toys, suchas roller skates, sleds, and tricyclesw e r e l i n k e d w i t h m o s t o f t h e r e s t o fthese injuries. Dolls, homemakeritems such as toy stoves and irons,stuffed animals, chemistry sets, andmolding equipment accounted for

Riding in wagons is fun, butch i ld ren shou ld be caut ioned notto ride in streets.

Finding a place softer than thesidewalk to fall to is a good ideawhen skating. Parents should taketime to give their children a fewbasic "tips" such as this to helpthem avoid painful injuries.

m L

Staying up on skates is a challengeto many girls and boys. Parentsshou ld cau t ion the i r ch i l d renagainst skating in the street andunnecessary roughness, such aspushing.

less than 1 percent of the reportedc a s e s .

Almost half of the total reportedinjuries to persons involved live animals, personal use items, and envir o n m e n t a l f a c t o r s . N e x t i n n u m b e rwere injuries associated with buildings and their fixtures and furnishings.

No law can protect a child completely from all dangers. Completesurveillance of the toy market is impractical due to its size. There areapproximately 1,200 toy manufacturers in the country producing anestimated $2.5 to $3 billion in toyseach year and there are approximately 83,000 entries of importedtoys each year.

With limited money and manpower resources diverted from otherproduct safety programs to toy safety activities, FDA has obtained voluntary modifications or removal of

24 toys from the market. In addition, about twice this number arenow under investigation for possiblevoluntary action. FDA also conducted a retail level toy survey acrossthe country in December which resulted in the banning of 39 toys fromsale.

Protecting children from unsafetoys is a parental as well as a governmental responsibility. Consumersshould exercise sound buying judgment. Consideration should be givento the age and size of the child, hisabi l i ty, and the area in which heplays with his toys. The ages of otherchildren in the family also should beconsidered. A toy that is safe forone child may be dangerous in thehands of an unsupervised and lessskillful younger brother or sister.

Toy buyers in the family shouldreject those with obvious hazards—sharp points; rough or unfinished

surfaces; small, detachable parts thatmay be swallowed; brittle plastic orglass that breaks easily and leavessharp edges that may cut; poorlyconstructed toys with sharp spikes orpins that are exposed when the toyis pulled apart by a curious child;toys with triggers, gears, or otherparts activated by a spring or motorthat may pinch fingers or catch hair.

Toys that feature exposed flamei n u s e o r a r e m a d e o f c o m b u s t i b l em a t e r i a l s s h o u l d b e a v o i d e d . C h e m

istry sets, rocket ki ts, and similartoys should be bought only for children old enough to handle them wisely. The minimum age recommendedby the manufacturers of such toysshould be heeded.

Since wires can wear through,electric toys such as trains and"home appliances" for little girlsshould be checked periodically. Suchtoys should not be purchased for the

Sledding is a favorite winter sportfor many girls and boys. Parentsshould caution children againstthe risks involved in this activity.

J Tricycles, like wagons, should notbe ridden in the streets.

Bicycle riders should be taughtcommonsense rules for riding. Abicycle should be adequatelyequipped and the right size for thechild to handle properly.

veiy young. A child should be shownhow to insert a plug safely into anelectrical outlet and how to unplugthe eord.

Special care must be taken withtoys that have trailing loops andcords. A child should be taughtnever to put these loops or eordsaround him in such a way that theymay trip or choke him. Toy arrowsshould be tipped with some softsubstance that cannot be removed.Care must be taken with suction tips.They can come off and expose dangerously sharp ends.

Care also must be taken with balloons—they can choke a child if accidentally taken into the windpipe.Whistles and toy instruments shouldnot have parts (mouthpieces, for example) that can be easily detaehed.Children should be taught to sit orstand still when playing toy musiealinstruments. A push or fall can cause

serious mouth or throat injury.A large number of bieycle injuries

result from misuse and could be prevented if parents took the time toteaeh their chi ldren some of the commonsense rules for riding. Bicyeleriders should be taught to obey allappropriate traffic regulations, lights,stop signs, and one-way streets; toslow down at interseetions, look bothways, and proceed with caution; togive pedestrians the right-of-way; toride single and single file; to "playit straight" in traffic and leave stuntriding and racing for open areas freeof traffic; and to never hitch a rideon other veh ic les .

In a special study conducted onbicycle injuries, "horseplay" and colliding with obstructions were the twoleading factors found to contributeto accidental injuries among thegroup studied.

P a r e n t s s h o u l d m a k e c e r t a i n t h a t

a bicycle is the right size for thechild to handle properly and that it'sequipped with headlight and reflee-tor, if it's to be ridden after dark.It also should have a bell or horn,chain guard, brakes, pump, and mirror. And it should be kept in goodc o n d i t i o n .

FDA currently is developing safety standards for electrical, mechanical, and thermal toys and will insure compliance by monitoring factories and retail outlets where toysare sold. The Agency also is working with manufacturers to correctpossible structural or design hazardsreported by consumers.

With these activities, and witheonsumers exercising sound judgment in making their selections, andgiving proper instruction to childrento use toys and games as they wereintended to be used, toys can be thesource of enjoyment instead of tears.

Toy arrows (upper left) should betipped with some soft substance thatcannot be removed. The child's ageshould determine whether or not heplays with this kind of toy.

Teddy bears (upper right) and otherstuffed animals are dear companionsto small girls and boys. Make certainthat eyes, which may be pulled off,do not have sharp barbs.

Dolls (lower left) are a part of everylittle girl's growing-up years. Dollswith hair and hair ribbons should bechecked to determine if there aresharp pins holding the hair andribbons and if they can be removedeasily.

THE POISON PREVENTION PACKAGING ACT cont'd, from p. 16T h e C o m m i t t e e o n I n t e r s t a t e a n d

Foreign Commerce of the House ofRepresentatives also sought to acc o m m o d a t e h o u s e h o l d s w i t h o u t c h i ldren from one to five years of age;it was estimated that 75 percent ofthe households in this country haveno children in this age category.The House, therefore, reported legislation that would require specialpackaging to be available only in onepopular size, thereby making specialpackaging the exception rather thanthe ru le .

T h e S e n a t e - H o u s e C o n f e r e n c eC o m m i t t e e r e s o l v e d t h e m a t t e r i nfavor of the Senate version, andb o t h t h e S e n a t e a n d H o u s e l a t e r

agreed to this version. The law thuspermits only one size to be used fornoncomplying packages for thebenefit of the handicapped, provided the product is available in atleast one other size utilizing thespecial packaging and provided thenonstandard packages conspicuously bear the legend, "This packagefor households without young children." Other suitable language canbe designated by the Secretary forpackages too small to accommodateth i s l abe l .

In authorizing the one size fornoncomplying packages the SenateCommerce Committee report emphasized that it expects manufacturers to make every effort to assureadequate distribution and advertising of special packaging so the publ i c w i l l b e c o m e f a m i l i a r w i t h i tand said manufacturers are also expected to insure that the one sizeof conventional packages will bedirected only to those for whom itis intended. In pursuance of thisconcept the Senate Committee doesnot expect the manufacturers to exacta premium price for the specialpackaging. Testimony indicated thatthe cost of special closures would beapproximately one-half cent percontainer at the manufacturer's level.If a manufacturer (or packer) failsto make special packaging availablein a popular size, the Secretary mayrequire marketing exclusively inspecial packaging after giving themanufacturer a chance to comply

and if, after an opportunity for ahearing, he determines that the exclusive use of safe packaging isnecessa ry.

Prescription drugs for which as t a n d a r d i s i n f o r c e a r e t r e a t e d alittle differently. Noncomplying containers will be available only on order of the prescribing practitioneror by request of the purchaser. Thelegislative record again reveals theexpectation by the Congress thatpharmacists as professionals willdemonstrate the operation of theclosure and will encourage the useof safe packaging.

Regulations for the establishmentof standards may be issued pursuantto informal rulemaking proceduresunless the Secretary elects the formal procedures of the Federal Food,Drug, and Cosmetic Act. If the informal route is followed, adverselyaffected parties may within 60 daysappeal to an appropriate court ofappeals for judicial review. If thepetitioner shows that additional evidence is material and that there wasno opportunity to adduce such evidence, the court may order additional evidence to be taken by the Secretary. The Secretary may, on the basis of the additional evidence, amend,modify, or set aside the standard.The court may void the standard ifit is not supported by substantialevidence, and appeal to the SupremeCourt is provided in the legislation.

Establishment of a technical advisory committee of up to 18 members by the Secretary is mandatoryunder the Act and consultation withthe committee prior to making findings and in establishing standards isrequired. The committee shall include representatives of the Department of Health, Education, and Welfare; the Department of Commerce;manufacturers of products subject tothe Act; scientists with expertise inthis area and licensed medical practitioners; consumers; and manufacturers of packages and closures. Thelegislative history suggests that theDepartment of Commerce representatives should be from the NationalBureau of Standards and that thechairman of the committee shouldbe one of the nonindustry members.

The legislation provides for accomplishing enforcement by amending the misbranding sections of theFederal Insecticide, Fungicide andRodenticide Act; the Federal Food,Drug, and Cosmetic Act; and theF e d e r a l H a z a r d o u s S u b s t a n c e s A c t .

The law also includes a preemption provision prohibiting Statesfrom adopting special packaging requirements for substances subject toa F e d e r a l s t a n d a r d u n l e s s t h e S t a t estandards are identical, includingany exemptions.

The Act became effective upon enactment (December 30, 1970), butregulations issued under it shall notbe effective sooner than 180 daysafter an order is made final, but inno event shall the final order specifyan effective date later than one yearfrom that date. This provision is included to permit inventories of packaging and containers to be exhausted.A "grandfather" clause provides thatt h e s t a n d a r d w i l l n o t b e e f f e c t i v e

against any substance already packaged prior to the effective date orthe Standard. The Secretary may, forgood cause, stipulate an effectivedate prior to 180 days if he determines this to be in the public interest and publishes his reasons fort h e d e t e r m i n a t i o n .

FDA's Bureau of Product Safetyis developing plans for implementingthis new responsibility. The Bureauwill be the focal point for this program as well as those associated withhazardous substances, children's toysand other articles, burn injury investigations associated with fabrics, andinjuries associated with consumerproducts of an electrical, mechanical, or thermal nature.

James J. Corrigan, legislative analyst withthe Office of Legislative Services, joinedF D A i n 1 9 6 4 .


field reports

BALTIMORE DISTRICT On a charge brought by theFDA, a U.S. marshal in December seized $900 worthof Dextrocell No. 2 Tablets and accompanying labelingwhile the drug was being held for sale by a dealer,Jones & Vaughan, Inc., Richmond. The firm had repacked and labeled the drug after shipment in interstatecommerce. FDA charged the article was a new drugwithout an approved New Drug Application and wasmisbranded while held for sale because the labelingcarried false and misleading claims for effectiveness,based on the products thyroid components, in treatinga variety of clinical conditions.

Also in December, FDA caused seizure of 133 cansof Misty Dog Food while it was held for distributionat Washington, where the product had been shippedby the manufacturer, Quaker City Packing Co., Allen-town, Pennsylvania. FDA charged the food was notsafe for use because it contained the new animal drug,methyltestosterone, and no New Animal Drug Application has been approved by the Agency for the use andintended use of animal feed containing this drug. FDAcharged that false and misleading statements in theproduct's labeling represented the feed as adequate toenhance aggressive characteristics and bolster thesetraits in shy dogs and in guard and watch dogs.

BOSTON DISTRICT A small lot of aminophyllinesolution manufactured by Leplar Laboratories, Inc.,Brookline, Massachusetts, was seized there after District analysis disclosed that the active ingredient waspresent at 109 percent of the declared potency. Duringan inspection at the manufacturer's plant, FDA inspectors had found that the drug was being produced entirelyfrom memory, with neither master formulas nor batchrecords in use. They found that the product also failedto comply with Current Good Manufacturing Practiceregulations in that individual units did not bear identifying lot or control numbers, and that directions for usewere inadequate.

A consumer complaint about decomposed frozen solefillets led to two recalls in December—one by a localsupermarket chain, Star Market Co., Cambridge,Massachusetts, and the other by the distributor, TopcoAssociates, Skokie, Illinois. Both firms agreed to recalloutstanding stocks of "Top Frost Sole Fillets" in 1-pound packages after FDA notified them that sampleanalyses showed more than 40 percent decomposition.An estimated 900 cases were placed under recall.

representing the remainder of a 928-case lot originallyimported from Canada in August.

BUFFALO DISTRICT Charged with operating a foodstorage establishment under insanitary conditions, thefirm of William Griffith & Sons, Utica, New York, andits operator, William Griffith, were fined $1,000 inFederal Court at Syracuse on December 14 followinga guilty plea to two of the five counts of an informationfiled by FDA earlier in the year. When Judge EdmundPort imposed the fine, he remarked that he believed afine was necessary to impress not only the defendants,but other persons, with the necessity of operatingw i t h i n t h e l a w.

A flour mill/warehouse in Buffalo has diverted about62,000 pounds of insect-infested flour and cake mixesto animal feed and destroyed about 53,000 pounds ofsimilar products because of rodent contamination. Theinsect and rodent contamination was discovered duringa cooperative inspection by District inspectors and aState inspector. The unfit food materials were valued atapproximately $10,000.

CHICAGO DISTRICT When the District opened itsnew resident station in Rockford, Illinois, it represented the culmination of an agreement proposed byt h e I l l i n o i s B u r e a u o f E n v i r o n m e n t a l H e a l t h ' s D i v i s i o n sof Milk Control and of Food and Drugs, and theChicago District's inspection branch. Under the agreement the State milk control and food and drug inspectors will assume inspectional responsibility for all foodcommodity processors, including complaint followup inthe nine-county Rockford travel area, regardless ofinterstate status of the products. FDA's resident foodand drug inspector, Delbert Porter, will give inspectional coverage to all drug, device, and hazardous substances obligations regardless of their interstate status.

Facilities for the resident post, housed in the StateRegional Office Building, are provided by the State atn o c o s t t o F D A .

C I N C I N N A T I D I S T R I C T W h e n t h e D i s t r i c t n o t i fi e dthe Frank Tea & Spice Co., Cincinnati, that Salmonellaorganisms had been found in ground black pepper thatit produced, the firm impounded 12,000 pounds ofthe material in its plant and initiated a voluntary recallof the pepper from the market. The recall lot consistedof 49,000 pounds and was packed under several labels.


The contamination appears to have resulted from alot of contaminated pepper corns, and the firm is working on a method for sterilizing these goods.

DALLAS DISTRICT FDA has terminated its prosecution case against McCraw Candies, Inc., Farmersville,Texas, and its secretary-treasurer, Ben Cohen. TheGovernment charged the defendants had held a lot ofpeanuts under insanitary conditions under which theybecame rodent contaminated and had shipped intointerstate commerce candy contaminated with insectand rodent filth. Judge Wayne Justice, in the EasternDistrict of Texas, sentenced Mr. Cohen to one yearin jail; however, he later reduced this sentence to oneyear's probation. The corporation was placed on twoyears' probation and fined $3,000, of which $2,000was suspended for two years.

DETROIT DISTRICT Alan L. Hoeting, deputy regional food and drug director in Detroit, is representingt h e D i s t r i c t o n t h e F e d e r a l T r a d e C o m m i s s i o n ' s C o nsumer Protection Committee, which was formally established December 9. The committee, composed of allFederal and State regulatory agencies concerned withconsumer protection, will exchange information nationwide and serve as a one-stop consumer complaintservice. Frank Kelly, attorney general for the State ofMichigan, is chairman.

KANSAS CITY DISTRICT George L. Vinz, assistantto the District director, will serve as secretary on theslate of officers elected for 1971 for the MetropolitanKansas City Conference of Food and Drug Officials.Others named to serve are Armin W. Schannuth,sanitarian. Independence, Missouri, City Health Department—president; Don Rice, sanitarian, KansasCity, Missouri, Health Department—first vice president;and Perrin L. Fairleigh, compliance officer. Complianceand Evaluation Staff, U.S. Department of Agriculture,Kansas City—second vice president.

Finis was recorded in December to part of the aftermathof an accident which had occurred in early July 1970on a Nebraska dairy farm, when a mislabeled fly spraycontaining dieldrin was used on the dairy herd. Persistent residues of the pesticide were found in milk aslate as December, resulting in the destruction andburying of 50 animals during the week of December 13.

Kansas City District officials, along with State foodand drug officials from Nebraska, Kansas, and Missourihad taken prompt action when they found, followingthe accident, that milk from the contaminated herd wasused with other producers' milk in the manufacture ofcheese. Through their cooperative effort, 31,000 poundsof natural cheese and almost a half-million pounds ofprocessed cheese were recalled and are being heldpending destruction. Approximately 2,000 pounds ofcontaminated whey cream for use in the manufacture

of ice cream mixes was destroyed earlier under thesupervision of Kansas dairy officials.

LOS ANGELES DISTRICT FDA ordered a recent seizure at San Pedro, California, of 8,000 pounds offrozen kingfish found to contain DDT. The fish, inpossession of a wholesale fish dealer, had been caughtoff the southern California coast, outside the U.S.continental limits, and was therefore subject to Federaljurisdiction. This particular lot was found by Districtinspectors during a surveillance sampling of the fishproducts to determine if high pesticide residues werepresent. Sampling of the kingfish showed an amountof DDT and related chemicals about four t imes theaction level of 5 parts per million.

MINNEAPOLIS DISTRICT Because a wholesale grocerin St. Paul continued to hold for sale products sweetened with cyclamate after the FDA deadline banningthe sale of such products, a U.S. marshal seized 268cases of various canned cyclamate-sweetened fruitsand cranberry juice in possession of the firm. As aresult of this action ordered by FDA, plus a notice ofhearing regarding lots of rice, prunes, and pancake mixthat the firm had permitted to become badly insectinfested, the respondent stated at the hearing that thefirm will go out of business by June 30.

NEW ORLEANS DISTRICT Nev is Cook , D is t r i c t d irector, David Bryant, District workshop coordinator,and Charles Price, FDA resident inspector at FortSmith, Arkansas, conducted a canners and freezersworkshop in December at Fayetteville, Arkansas. Theworkshop was sponsored by the Ozark Canners andF r e e z e r s A s s o c i a t i o n .

A variety of articles offered for import were detainedby the District in December. Among them were mis-branded biscuits, canned sardines, drugs, and artichokehearts, with a total value of over $6,000; adulteratedblack pepper and frozen shrimp—total value, over$13,000; and insect-damaged green coffee, valued at$96,000.

NEW YORK DISTRICT A recent cooperative effortinvolving the New York District and the New JerseyDepartment of Health typifies the kind of joint enforcement activity that has become routine in New Jersey.District inspectors assigned to the Newark office hadinspected a local bakery and found gross rodent andinsect infestation. When officials from the Newark officecontacted the State Health Department at the conclusionof the inspection, they learned that a State inspector hadinspected the bakery several weeks earlier and had alsofound it operating under filthy conditions. The State hadissued a 30-day "clean up or close up" letter as afollowup to the earlier inspection. To facilitate furtheraction, FDA delivered by courier to Frank Timko,


chief, Bureau of Food and Drugs, NJDH, photographsand written inspectional observations describing current conditions at the firm. Based on this evidence, Mr.Timko immediately issued a closure order, which wasserved jointly by a State and an FDA inspector. At thesame time, the State embargoed the entire stock of foodin the bakery as well as a trailer truckload of bakedgoods about to be shipped. This material was subsequently destroyed because of rodent and insect defilement. The State Department of Health notified the Statesof Pennsylvania and New York, both of which licensethe Newark bakery, that the firm had been orderedclosed because of filthy conditions. FDA then orderedseizure of a large lot of the firm's fruitcake awaiting saleat Salem, Virginia, after the Agency found the lota d u l t e r a t e d w i t h r o d e n t a n d i n s e c t fi l t h .

PHILADELPHIA DISTRICT Lemmon Pharmacal Co.,Sellersville, Pennsylvania, has voluntarily destroyed 4million tablets and 700,000 capsules of Obestat, whichthe firm recalled following several FDA-ordered seizures(see FDA Papers, December 1970/January 1971).Obestat is a thyroid-central nervous system drug foundby FDA to be unsafe and ineffective in the treatmentof obesity for which it was indicated in its claims. Therecalled lot, valued at $125,000, was destroyed bytrenching and burning. Approximately 9,168,000Obestat tablets for which the firm has entered claim arebeing held under attachment by the U.S. marshalfollowing seizure.

SAN FRANCISCO DISTRICT Meredith Fish Co.,Sacramento, California, and the firm's president, JosephLloyd Turnacliff, Sr., were fined a total of $245 onFebruary 23 at Sacramento for introducing into interstate commerce shrimp meats which contained coagu-

lase positive staphylococci and which had been prepared and packed under insanitary conditions. FDAhad filed the information against the defendants onDecember 15, with arraignment on December 30.

SEATTLE DISTRICT James Shoemake, detailed fromthe Special Programs Branch, HEW Region V, to SeattleDistrict as a regional milk and food consultant, wasin Idaho when radioactive dust accidentally escapedduring an underground nuclear test shot in Nevada onDecember 18. The Southwest Regional RadiologicalLaboratory requested that Mr. Shoemake immediatelyactivate Idaho's standby milk radiological network.Following the activation, raw milk samples were submitted to the laboratory over a seven-day period beginning December 27 and pasteurized milk samplesduring the weeks of December 21 and 28. Rain andsnow samples were also collected in the State. Tentativelaboratory reports indicate one raw milk sample hada level of 30 pico curies Iodine 131, which laboratoryofficials indicate is not considered significant from ahealth standpoint.

F D A D 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 LT 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

BOSTON 585 Commercial St.B o s t o n . M a s s . 0 2 1 0 9

B U F FA L O 5 9 9 D e l a w a r e Av e .B u f f a l o , N . Y. 1 4 2 0 2

CHICAGO Main Post Office BIdg.R m . 1 2 2 2 / 4 3 3 W. Va n B u r e n S t .Chicago, Hi. 60607CINCINNATI 1141 Central 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 4

DENVER New Customhouse BIdg.R m . 5 6 0 4 / 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 2

DETROIT 1560 E. Je f fe rson Ave.D e t r o i t , M i c h . 4 8 2 0 7

KANSAS CITY 1009 Cherry St.Kansas City, Mo. 64106

LOS ANGELES 1521 W. Pico Blvd.Los Angeles, Calif. 90015

MINNEAPOLIS 240 Hennepin Ave.Minneapolis, Minn. 55401N 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

NEW YORK 850 3rd Ave. (at 30th St.)Rm. 700/Brooklyn, N.Y. 11232

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. 19106SAN FRANCISCO Federal Office BIdg.R m . 5 1 8 / 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 2

SEATTLE Federal Office BIdg.R m . 5 0 0 3 / 9 0 9 F i r s t A v e .

S e a t t l e , Wa s h . 9 8 1 0 4

HEW REGIONAL OFFICES l-XBOSTON J. F. Kennedy Federal BIdg.B o s t o n , M a s s . 0 2 2 0 3NEW YORK 26 Federal PlazaN e w Yo r k , N . Y. 1 0 0 0 7

PHILADELPHIA 401 North Broad St.Philadelphia, Pa. 19108ATLANTA 50 7th St., 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 BIdg.433 W. Van Buren St./Chicago, III. 6G607DALLAS 1114 Commerce St.Rm. 911/Dallas, Tex. 75202KANSAS CITY 601 E. 12th St.Kansas City, Mo. 64106DENVER Federal Office BIdg.19th & Stout Sts./Denver, Colo. 80202SAN FRANCISCO Federal Office BIdg.

R 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 2

SEATTLE Arcade BIdg. Mezzanine1319 2nd Ave., Seattle, Wash. 98101

PRODUCT SAFETY STUDIESThe Division of Consumer Product Safety of FDA'sBureau of Product Safety operates a hospitalreporting system to determine the number, type, andseverity of injuries treated in hospitals throughoutthe country. The system includes reported informationfrom hospital emergency room records in136 hospitals located in 33 States. The informationis being used to identify types of productsthat—because of improper design, assembly,construction, labeling, or consumer use—are associatedwith injuries.

One of the more serious injury problems is relatedto large areas of glass, such as are used insliding glass doors and storm doors. Because ofdeceptive lighting and age or behavior patterns ofindividuals, an increasing number of people,especially children, are reported as walking or runningthrough glass panels, resulting in serious andsometimes fatal injuries.

Available data indicates that over 250,000 personsare injured each year in the United States fromdoor glass of all types. Based on past trends, up to100,000 persons can be expected to receiveinjuries from accidental impact with sliding glass doorsduring the coming year. Most victims think thedoors are open and try to go through them,often while in a hurry. Children frequentlyare the vict ims.

Although sliding glass doors opening onto patiosare involved in a large number of these accidentalinjuries, storm doors and other structural doors withglass panels—as well as glass enclosures forba th tubs and showe rs—are a l so i nvo l ved .

Between July 1, 1969, and June 30, 1970,the Division received reports of approximately 121,000injuries involving products of all types.Of this number, 570 involved doors containing glass;165 of this 570 specified that the injury involvedglass storm doors and 14 specified involvement oftub or shower enc losures .

A review of the 570 reports reveals that thepercentage of persons injured varies by age and sex.Of the cases, 12 percent involved children four years oldand under and 38 percent involved the5-14 years age group. Over 75 percent involved persons24 years old and under. Table 1 indicates the numberof injuries received according to age and sex.

Table 1: Age and Sex of Victim

A g e S e x T o t a l

M a l e / F e m a l e

T O T A L 3 3 1 2 3 9 5 7 0

U n d e r 5 4 5 2 5 7 0

5 - 1 4 1 2 3 9 7 2 2 0

1 5 - 2 4 8 6 5 4 1 4 0

2 5 - 4 4 5 6 4 1 9 7

4 5 - 6 4 1 3 1 6 2 96 5 a n d o l d e r 5 5 1 0U n k n o w n 3 1 4

Data collected concerning the day of the weekof the injury is not significantly revealing. Accidentsdue to glass in doors and panels occur at much the samefrequency each day of the week. Injuries, however,appear to occur more frequently during warm monthst h a n c o l d m o n t h s .

Table 2 shows the disposition of injuries throughoutthe day. Of the accidents, 4-6 percent occurredduring late afternoon and early evening hours.


Table 2: Time of Day of Injury Table 4: Most Frequently Mentioned Injuries*

N u m b e r P e r c e n t

5 7 0 1 0 0

4 0 7

4 6 86 2 1 1

11 3 2 01 4 9 2 6

5 4 9

1 0 6 1 9

T O T A L

Miclnight-8;59 a.m.9 : 0 0 - 11 : 5 9 a . m .Noon- 2:59 p.m.3:00 - 5:59 p.m.6:00 - 8:59 p.m.9:00 -11:59 p.m.U n k n o w n

Data collected during this period—-July 1969 throughJune 1970—did not reveal any fatalities due toinjuries received from broken glass doors orglass panels. Table 3 shows patient disposition asa result of injuries.

Table 3: Patient Disposition

N u m b e r

T O T A L

Hospital izedT r e a t e d & R e f e r r e d t o

M.D. or OutpatientDepartment

T r e a t e d & R e l e a s e dO t h e r o r U n k n o w n

5 7 0

1 5

2 3 1

3 1 77

Table 4 shows the number of injuries by body part.Slightly over 60 percent of the injuries reportedinvolved hands and wrists (34.8 percent) andlower arms and elbows (26.2 percent).

N u m b e r

H a n d / W r i s t 2 1 0

L o w e r A r m / E l b o w 1 5 8

Finger 7 5

Lower Leg/Knee 5 0

Upper Arm/Shouider 4 0

F a c e 3 7

H e a d / S k u i i 3 3

*More than one body part may be involved per case.

P e r c e n t

1 0 0

2

4 1

5 61

Summary

Based on past trends, it is estimated that about100,000 persons will receive injuries from impactwith sliding glass doors during the coming year.Data from the hospital reporting system shows that50 percent of those injured are under 15;over 75 percent are under 25.Data collected indicates more injuries occur duringwarm weather months. Of all the reported injuriesof this type, nearly half occurred in late afternoonor early evening hours.Over 60 percent of these injuries were to hands,wrists, lower arms, and elbows.

Safety Suggestions

Encourage the adoption of State and local lawsand ordinances requiring safety glazing inn e w c o n s t r u c t i o n .Install and replace with safety glass in youro w n h o m e .Do not allow running or "horseplay" in areas nearglass doors and panels.Watch where you are going.Identify glass doors and panels with decals orcolored tape that is easily visible at eye level.Arrange furniture to protect glass doors and panels.Install safety bars or grills.Use rubber mats or safety strips in tubs and showers.


n e w s

Health-Related Items Industry InvitedTo Apply for Labeler Code DesignationsManufacturers and repackagers of health-related itemshave been invited by FDA to apply for labeler codedesignations under the National Health Related ItemsCode System (NHRIC).

Applications should be sent to the FDA's Center forDrug Information (BD-124), 5600 Fishers Lane,Rockville, Maryland 20852.

Items affected include bandages, surgical dressings,syringes, needles, intravenous administration sets,wheelchairs, and any other products used in the careof patients. Drugs are covered under the National DrugCode System (NDC). This system is now being expanded to include distributors as well as the manufacturers and repackagers of pharmaceutical products.

Both the NHRIC and NDC systems will make itpossible for manufacturers, distributors, retailers, hospitals, and insurance companies to process their transactions related to these articles on computers. Thisautomated processing is expected to promote efiBciencyand economy throughout the entire health industry.

Both systems were designed by FDA with the assistance and cooperation of drug and health-related itemmanufacturing and distribution industries.

Approximately 50 pharmaceutical firms have placednational drug code numbers on their product labels.Another 250 firms are preparing to take similar action.These 300 firms represent more than 95 percent of thedollar volume of the prescription drug market.

Exemptions Lifted for 19 Radioisotopes,FDA Proposes to Require Filing of NDA'sNew Drug Applications would be required for 19radioactive isotopes used for a wide variety of diagnostic and body function studies under a proposal byFDA in the January 27 issue of the Federal Register.Several of these radioisotopes also are used to treatv a r i o u s f o r m s o f c a n c e r.

Interested persons were given 30 days from thepublication date to file written comments.

The isotopes are produced by nuclear reactors. FDAofficials said these products have been used largely inresearch and have been exempted from the Agency'sregulations as long as they meet the Atomic EnergyCommission's requirements for such research.

More extensive use of the 19 isotopes in recent yearscaused the FDA, in cooperation with the AEG and theDivision of Biologies Standards of the National Institutes of Health, to review the exemption.

The three Agencies concluded that the exemptionshould be lifted for the 19 products and that they shouldbe labeled for uses for which safety and effectiveness canbe demonstrated by New Drug Applications or throughlicensing by the DBS in the case of biologies.

Manufacturers or distributors of the 19 isotopeshave been given 90 days within which to submit NewDrug Applications containing evidence that the drugsare safe and effective. The applications must be approved by FDA to permit continued shipment of thedrugs in interstate commerce.

An alternative procedure is to file a detailed planto test one or more of the isotopes on humans, inaccordance with the FDA's investigational drug requirements.

If the drug is a biologic, the investigational planor an application for a license should be submitted tothe Division of Biologies Standards, National Institutesof Health, Building 29, 9000 Rockville Pike, Bethesda,Maryland 20014.

Mercury in Frozen Fish Blocks FoundWell Below FDA's Guideline of 0.5 ppmFDA and the Department of Commerce's NationalOceanic and Atmospheric Administration announcedthat tests on frozen fish blocks (compressed fish) haveshown mercury levels well below the FDA guidelineof 0.5 parts per million. Frozen fish blocks are a sourcefor several popular convenience fishery products such asfish sticks, fish portions, fish cakes, and fish for frozendinners. The announcement was made February 1.

FDA and NCAA are conducting a cooperative program to determine the level of mercury in fish andfishery products.

In more than 80 different fish blocks sampled byNOAA's National Marine Fisheries Service, the averagelevel of mercury was 0.06 ppm. The highest was 0.16ppm and this was found in only one sample. Thesamples were selected from seven U.S. processors andoriginally came from four countries that export largequantities of fish blocks to the United States.

Frozen fish blocks are made only from the edibleportion of several species of fish, primarily from theNorth Atlantic, such as cod, haddock, flatfish (flounder,sole, etc.), and pollock. Some 270 million pounds areutilized in this country each year. Of this amount,approximately 98 percent is imported from nationssuch as Canada, Iceland, Norway, Poland, Denmark,a n d G r e e n l a n d .

Te s t r e s u l t s f r o m C a n a d a c o r r o b o r a t e t h e F D A a n dNCAA findings, the Agencies said.


Tuna on Shelves Within FDA's LimitsFor Mercury, Violative Percentage Low

FDA announced completion on February 5 of a massiveprogram of testing tuna for mercury and reported thatstocks of the fish presently marketed in the UnitedStates are within the Agency's 0.5 parts per millionguideline for mercury content. FDA said tuna exceedingthis guideline, estimated at between 3 and 4 percentof the country's domestic and imported supply, hadb e e n w i t h h e l d f r o m s a l e o r r e m o v e d f r o m t h e m a r k e t .

The testing program, carried out since mid-Decemberby FDA and the tuna industry, involved examinationcovering approximately 3 million cases of importedand over 5 million cases of domestically packed tuna.During the program FDA conducted the testing ofimported tuna, while the industry, supervised by FDAand coordinated by the National Canners Association,e x a m i n e d d o m e s t i c s t o c k .

FDA said 3.6 percent of 4,000 imported can codesexamined exceeded the 0.5 ppm guideline and is underrecall by the importer or distributor of record. MalaysianBig Eye Tuna, representing only a minor share of thetotal imported pack, accounted for one-third of theviolative codes exported to this country, the Agency said.

As of February 1, 1971, the domestic sampling program, conducted by industry and audited by FDA,involved analysis of some 1,000 master lots comprising269 million cans from 12,000 codes. A total of 39of the master lots representing 378 codes (180,400cases), or 3.6 percent of the canned tuna tested, werefound to exceed the guideline. This tuna either has beenrecal led or wi thheld f rom sale. A master lo t is one made

up of fish of the same species taken from a commoncatch point by a single boat.

Commissioner of Food and Drugs Charles C.Edwards, M.D., expressed gratification that final statistics showed the problem of mercury in tuna to beless serious than had been feared initially. Originalsamples, he noted, had been taken from the mostsuspicious lots of tuna. Only when these fragmentaryresults became part of the total data did they take onproper perspective.

In announcing results of the tuna surveillance program, FDA said it has now turned its major laboratoryresources to completing the program of testing sword-fish for mercury. This program was first announced byDr. Edwards December 23. Approximately 87 percentof 297 swordfish samples analyzed to date exceed themercury guideline. The sampling program as ofFebruary 1 was about half completed. Total samples tobe tested are 667. The swordfish industry is beingcalled upon to withhold all uncleared shipments voluntarily. Where voluntary compliance is not effective,FDA is using its seizure authority.

FDA also announced today that it had begun asurvey of 19 other fish species to monitor for possiblemercury content. The program, initiated January 29,will cover fresh, frozen, processed, and canned fish of

commercial significance in this country. This will supplement work also in progress at the National Oceanicand Atmospheric Administration of the Department ofCommerce. The species selected will be collected atwholesale warehouses throughout the United States.Samples of 40-year-old frozen fish are also being testedby the Agency to try to determine any possible historicaltrend in mercury contamination.

Dr. Edwards said he was confident that the 0.5 ppmmercury guideline, recently reevaluated and reaffirmedby a Department of Health, Education, and Welfare taskforce, offered a broad margin of safety and is adequateto protect consumers. He said he is optimistic thatthe Agency through its testing and surveillance canassure consumers a safe supply of fish products.

FDA, in Efficiency Move, ReorganizesIts Bureau of Veterinary Medicine

The Bureau of Veterinary Medicine has been reorganized as part of the continuing program to streamlineand improve the efficiency of the Food and Drug Adm i n i s t r a t i o n .

"The reorganization will create two new Divisions—the Division of Compliance and the Division of Nutrit ional Sciences—to absorb increased workloads andnew responsibilities which have grown out of earlierFDA structural changes," according to Commissionerof Food and Drugs Charles C. Edwards, M.D. Thereorganization took place in November 1970.

Dr. C. D. Van Houweling, Director of the Bureauof Veterinary Medicine, announced the appointmentof two Bureau staff members to be acting directorsof the new Divisions. James O. Gesling, assistant director for regulatory and administrative management, willbe acting director of the new Division of Compliance.Dr. Richard P. Lehmann, now assistant to the directorfor statistical and program analysis, will be actingdirector of the Division of Nutritional Sciences.

Dr. Van Houweling said the Division of NutritionalSciences will review all New Animal Drug Applications(NADA's) and Investigational New Animal DrugApplications (INADA's) for drugs used in medicatedfeeds . He sa id t he new D iv i s i on o f Nu t r i t i ona l Sc ienceswill allow the existing Division of New Animal Drugsto concentrate on and give faster action to the applications for disease control and therapeutic uses of animaldrugs. The Division of Nutritional Sciences also willbe responsible for the computerized information storageand retrieval systems and provide statistical service tot h e e n t i r e B u r e a u .

The Bureau of Foods will continue to evaluate, forthe Bureau of Veterinary Medicine, the safety of foodderived from animals and to review data to assurethat no unauthorized residues will be present in theedible products of animals fed medicated feeds.

The new Division of Compliance will assume theregulatory compliance responsibilities of the Bureau


of Veterinary Medicine. The Division will also beresponsible for the administrative management anddocument handling duties for the entire Bureau.

The Bureau's present three Divisions, VeterinaryMedical Review, New Animal Drugs, and VeterinaryMedical Research, will remain intact. A new IndustryInformation Branch in the Division of Veterinary Medical Review will handle the voluntary compliance activi t i es o f t he Bureau .

FDA Warns Consumers It's IllegalTo S e l l S e c o n d h a n d R e l a x a c i z o r s

The sale of secondhand Relaxacizors is illegal, FDAhas warned .

The warning was issued in January after reports thatowners of the electrical devices were attempting todispose of them by offering them for sale in newspaperc lass i fied adve r t i semen ts .

The devices provide electrical shocks to the bodythrough contact pads. They were declared dangerousto health in a California court ruling last April againstRelaxacizor, Inc., the distributor. In his decision. JudgeWilliam P. Gray said the devices could cause miscarriages and could aggravate many preexisting medicalconditions, including hernia, ulcers, varicose veins, andepilepsy.

More than 400,000 units have been sold for exercising and reducing. After Judge Gray's decision, manyconcerned owners wrote to the distributor requestinga refund. In seeking to allay their fears, the firm saidit had filed an appeal and was confident the rulingwould be reversed. The appeal was dismissed lastNovember 25, by agreement between the firm and theGovernment, thus ending the case.

FDA has supplied posters to all post ofl&ces warningagainst use of the devices. In its warning to both sellersand prospective purchasers of the devices, the FDA saidsuch sales are in violation of the Food, Drug, andCosmetic Act and the devices are subject to seizure.The Agency recommended that owners of the deviceseither destroy them or render them inoperable to avoidany possibility of harm to unsuspecting users.

Proposal Would Allow Fixed Combo DosesOnly if Advantageous Over SeparatesFDA has published a proposed agency policy thatwould result in improved patient care through insuringthat drugs composed of more than one ingredient combined in fixed dosage form (a pill, capsule, teaspoon-ful) are used only when they offer the patient a therapeutic advantage over any one or more of the components administered separately.

The proposed new policy, published in the FederalRegister on February 18, affects up to 40 percentof the most widely sold prescription drugs and mostover-the-counter drugs—those sold without prescription.

In announcing a formal declaration of proposedpolicy. Commissioner of Food and Drugs Charles C.Edwards, M.D., said, "FDA fully recognizes that somecombinations have a legitimate place in medicalpractice."

He continued: "Our purpose is to insure that fixedcombination drugs not only are safe and effective butare formulated so they can be used rationally and indosages matching concurrent therapy needs of thepatient."

As a result of FDA's Drug Efficacy Study andImplementation program (DESI), the Agency hastaken a number of actions to make clear its attitudetoward combination drugs. Some combinations alreadyhave been declared ineffective on the basis of DESI.

The statement in the Federal Register stems directlyfrom the FDA experience with DESI to date. In addition to formalizing currently effective policy, the proposal is expected to provide useful guidance to industryin considering the introduction of future combinationproducts.

The policy proposal sets several criteria for newdrugs coming to the marketplace as combinations andfor old combination drugs remaining on the market.FDA would approve combinations where there isproof that each active ingredient contributes to theeffects claimed for the fixed combinations.

Each added ingredient would have to enhance:• effectiveness of the drug by increasing potency

or prolonging its effects; or• safety of the drug by decreasing or reducing

severity of adverse effects; or• prevention of possible misuse or abuse.When two or more drug components are given,

instead of one, the advantages of the combinationswould have to apply for schedules and durations of user e c o m m e n d e d .

"FDA has found combination drugs present a uniqueproblem," said Dr. Edwards. "They sometime haveadvantages for the patient of convenience, economy,and better adherence to medication-taking schedules."

But they frequently have disadvantages which include:• lack of flexibility for physicians to adjust dosage

of each component to patients' needs;• possible exposure of patients to unnecessary drugs

when one ingredient would be effective alone;• increased possibility of adverse reactions without

inc reased e f f ec t i veness .Since 1966 the National Academy of Sciences-

National Research Council has reevaluated for theFDA the claims of effectiveness for all drugs marketedbetween 1938 and 1962. The Academy found limitations in medical practice of many fixed combinationdrugs. The DESI program, including the FDA positionon combination products, stems largely from the NAS/NRG evaluation program.

Interested persons were given opportunity to comment within 30 days after publication of the proposalin the Federal Register,


Pesticide Controls Tightened TheState of Wisconsin Department ofAgriculture has adopted more stringent regulations on the registration,sale, and use of pesticide chemicals.In addition to tightening departmental control over the distribution,application, and disposal of pesticides in general, the regulations est a b l i s h " P r o h i b i t e d U s e " a n d " R estricted Use" pesticide classifications.Prohibited use pesticides includeDDT, DDD, and endrin. Only theState Pesticide Review Board mayauthorize permits for research, experimental, or emergency use ofD D T a n d D D D . R e s t r i c t e d u s epesticides may be registered, sold,and used only for specified purpose,or for research, experimental use,or emergency use by special permit.They include aldrin, benzene hexa-chloride, dieldrin, heptachlor, lindane, and alkyl mercury compounds.

Oregon Department Objects Oregon's Department of Agriculture andthe Dairy Relations Advisory Committee to the department have entered their objections to a Food andDrug Administration proposal toestablish four classes of creamedcottage cheese. At a meeting heldNovember 19, department and committee officials studied the proposedstandards, which provide for fourmilk fat content levels for the cheeseand would require the milk fat content to appear on the label. The fourlevels are .5 percent fat, 1 percentfat, 2 percent fat, and 4 percent fat.The latter is the only standard nowused by the FDA.

In entering their objections, bothdepartment and committee haveurged that, instead of the four classes,the FDA adopt the standardized lowfat creamed cottage cheese proposedby the Milk Industry Foundationand the States of Ohio and NewYork. Oregon is one of some 40States endorsing this proposal.

Kenneth Carl, chief of the depart

ment's Dairy and Consumer ServicesDivision, said the MIF proposalwould allow not more than two percent butterfat and 82.5 percentm o i s t u r e i n t h e l o w f a t c r e a m e d

cottage cheese. The standard forcreamed cottage cheese is not lessthan 4 percent butterfat and notmore than 80 percent moisture. Oregon now has a low fat partiallycreamed cottage cheese that allowsnot more than 2 percent butterfat.Mr. Car l sa id most S ta tes have sucha product and feel it is a standardthat the public understands and oneto which it is accustomed.

P l a s t i c M i l k C o n t a i n e r s I f c o nsumers continue to complain, and ifenough conclusive information is developed by a State university project,the returnable opaque plastic milkcontainer may be eliminated. Inspeaking to dairy sanitarians attending the annual Oregon Departmentof Agriculture's Dairy SanitationStaff Conference December 1-4,Kenneth Carl, chief of the department's Dairy and Consumer Services Division, said the division hadup to that time received 23 consumer complaints about the multiple-use container. Of these, 13 were because of the odor in the containeror the taste of the milk. He said itappeared that the mechanical devices used to detect foreign odors inthe containers were not doing anadequate job. The department hasreceived reports of children becoming ill after drinking milk that hadbeen in this type of container andof a foreign odor being detectedwhen it was checked. Mr. Carl toldthe inspectors that if they receivecomplaints of illness from use ofmilk in such containers, they shouldadvise persons involved to immediately notify their local health officerand to see a physician.

Whether the container should beeliminated is based also on information being developed by Oregon

State University, which is now running a project to determine theamount of foreign materials absorbed by the plastic from which thecontainers are made. Reporting onthe project, Floyd Bodyfelt, extension dairy processing specialist atthe university, told the sanitarians itappeared that the plastic was like asponge in absorbing some materials.He said the analyses made bychromatography indicated somec o n t a i n e r s h a d a b s o r b e d 1 5 t o 2 0chemical compounds and one hadas many as 55 peaks, which wasindicative of that many differentchemical compounds.

H e r b i c i d e U s e R e s t r i c t e d I n c o nc u r r e n c e w i t h t h e a c t i o n a n n o u n c e d

by the U.S. Department of Agriculture's Pesticide Regulation Division, John M. Stackhouse, directorof the Ohio Department of Agriculture, on December 10 issued anorder restricting the use of the herbicide 2,4,5-T. The restriction coversuse around lakes, homes, recreationareas, and food crops.

Training for New Post Prior to establishing a new laboratory in SantaFe, the State of New Mexico's Department of Health and Social Services sent the chemist who will be incharge of the laboratory to FDA'sDallas District for further lab training. He spent the week of December13 at the Dist r ic t .

Training Program To improve itsconsumer program, the AlabamaState Department of Agriculture andIndustries has joined with FDA'sAtlanta District in setting up a training program at the District in whichsix State inspectors will participate.Part of the training will be jointinspections with FDA personnel.Three of the inspectors have successfully completed the course. Theothers are scheduled to do so withinthis fiscal year.


seizures and post office cases

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

A total of 51 actions to remove from the consumer market concerning contamination, and 8 involved charges concerningproducts charged to be violative were reported in December, economic and labeling violations. Other seizures included 2These included 30 of foods: 9 involved charges concerning of food additives—dietary food, 9 of drugs (including 3 ofpoisonous and deleterious substances, 17 involved charges veterinary and medicated feed), and 6 of medical devices.

P R O D U C T, P L A C E & D A T E S E I Z E DM A N U F A C T U R E R ( M ) . P A C K E R ( P ) ,

S H I P P E R ( S ) , D E A L E R ( D )

FOOD I Poisonous and Deleterious Substances

Eggs, whole, frozen/Weedsport, N.Y. 11/20/70

Feta cheese/Watertown, Mass. 12/10/70

Dover, N.H. 12/11/70

Kingfish, frozen/Wilmington, Calif. 12/7/70

Lettuce/Utica, N.Y. 11/19/70

Buffalo, N.Y. 11/25/70Syracuse, N.Y. 12/1/70

Pecorino romano cheese/Jersey City, N.J.11/23/70

Shrimp patties, frozen/Mandan, N. Dak.11/18/70

J. Fleishman & Co., Inc./Boston, Mass.(P, S)

Standard Importing Co., Inc./New York,N.Y. (S)

Colombo & Sons Creamery Association, Inc./Andover, Mass. (S) Imported fromYugoslavia.

Fiesta Del Mar Frozen Foods/Wilmington,Calif. (D)

Rala Singh Farms/Toltec, Ariz. (S)

Imported from Italy by N. Dorman & Co./New York, N.Y. (S)

Appert's, Inc./St. ()loud, Minn. (M), Moore'sSeafood Products, Inc./Fort Atkinson,Wis. (S)

Contain Salmonella micro-organisms.

Contains benzene hexachloride, an unsafe food additive.

Contains DDE, DDT, and TDE, pesticide chemicals not inconformity with regulations.

Contains 1.5 ppm parathion, a pesticide not in conformitywith regulations.

Contains 1.8 ppm parathion.Contains 2.0 ppm parathion.Contains high pesticide residue.

Contain Salmonella micro-organisms.

Contamination, Spoilage, Insanitary Handling

Almonds, in shell/Fairhope, Ala, 12/3/70Banana peppers/Omaha, Nebr. 11/12/70

Cashew nuts, shelled/Detroit, Mich.11/4-5/70

Curd cheese/Atlanta, Ga. 11/2/70

Flour, baker's patent/ Cedar Lake, Mich.11/30/70

Kidney beans, dried/Las Vegas, Nev.10/22/70

Nuts, mixed, canned/Denver, Colo. 12/3/70

Johnson's Home Treat/Boise, Idaho11/18/70

Peanuts, No. 1 Spanish, shelled/Charlotte,N.C. 12/8/70

Popping corn/Commerce, Calif. 12/2/70Rice, Texas patna/Sacramento, Calif.

11/13/70

Schermer Pecan Co./Fairhope, Ala. (D)Chicago Pickle Co./Redgranite, Wis. (M,S)

Imported from India by Hollander TradingCorp./New York, N.Y. (S)

Avalon Cheese Co./Leitchfield, Ky. (M,S)

Cedar Lake Foods/Cedar Lake, Mich. (D)

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

and rodent contaminated.Insect contaminated.

Prepared and packed under insanitary conditions; insectcontaminated.

Held under insanitary conditions; rodent contaminated.

Madonna Italian Foods/Las Vegas, Nev. (D) Held under insanitary conditions.

Johnson Nut Co./Hopkins, Minn. (M.S)

Burke County Peanut Co./Waynesboro, Ga.(M,S)

Dart Warehouse Corp./Commerce, Calif. (D)North American Foods Distributors/

Sacramento, Calif. (D)

Prepared and packed under insanitary conditions; insectcontaminated; label vignette depicts pecan nuts, butarticle contains no pecan nuts.

Prepared and packed under insanitary conditions.

Unidentified, live larvae contaminated.

Insect contaminated while held for sale.


PRODUCT, PLACE & DATE SEIZED M A N U F A C T U R E R ( M ) , P A C K E R ( P ) ,S H I P P E R ( S ) , D E A L E R ( D )

Contamination, Spoilage, Insanitary Handling (cont'd)

Sausage links, pork/Oklahoma City, Okla.11/25/70

Scallops, frozen/Seattle, Wash. 11/12/70

Sesame seed, hulled/Detroit, Mich.11/19/70

Shrimp meat, frozen/Seattle, Wash.11/13/70

Snacktime walnuts/Boise, Idaho 11/18/70

Whiting/Gloucester and Boston, Mass.12/11/70

United Refrigeration Services, Inc./Oklahoma City, Okla. (D)

New England Fish Co./Vessel "Flamingo"from Alaskan waters (S)

Brown Bun Baking Co./Detroit, Mich. (D)

Winchester Bay Seafood Co./WinchesterBay, Oreg. (M,S)

Johnson Nut Co./Hopkins, Minn. (M,S)

J. C. Murray/Brooklyn, N.Y. (S)(Imported from Argentina)

Decomposed and rancid.

Contain decomposed scallops.

Held under insanitary conditions; rodent and insectcontaminated.

Prepared and packed under insanitary conditions; staphylococci.

Prepared and packed under insanitary conditions; moldyand insect damaged.

Decomposed.

Cherries, canned/Minneapolis, Minn.10/22/70

Diet Dr. Pepper/Mobile, Ala, 12/4/70

Feta cheese/New York, N.Y. 10/23/70

Lima beans/Greeley, Colo. 12/15/70

Ma Cohen's Home Made Pickled Schmaltz

Herring, Ma Cohen's Imported PartySnack in Wine Sauce/Pittsburgh, Pa.11/25/70

"Old Fashion Candies" Wild Cherry,Sea Coast Mints, Honey Horehound,Butterscotch, Fruit Mix, Spice Mix,Anise/Milwaukee, Wis. 9/8/70

Peanuts, Virginia, blanched, and Spanish,salted/Salt Lake City, Utah 11/30/70

Sent Gurken pickles/St. Louis, Mo.12/3/70

Economic and Labeling Violations

Jebavy-Sorenson Orchard Co./Manistee, tMich. (P,S)

Pepsi Cola-Dr. Pepper Bottling Co./Mobile, FAla. (D)

William Faehndrich, Inc./New York, N.Y. S(D)

Mar-Bo Quality Foods, Inc./Fresno, Calif. h(P,S)

City Smoked Fish Co.(label)/Detroit, Mich.(M)

Arlington Candy Co., Inc./Somerville, Mass.(M,S)

Thrifty Foods, Inc./Salt Lake City, Utah (D)

Atkins Pickle Co./Atkins, Ark. (M,S)

Not in conformity with the Fair Packaging and LabelingAct.

Fails to bear common or usual name of each ingredient;"invert sugar" not declared.

Short weight; active fermentation.

Not in conformity with the Fair Packaging and Labeling Act.

Castor bean meal/Swink, Colo. 11/24/70

Tiger's Milk nutrition booster/Tulsa, Okla.10/16/70

Food Additive—Dietary Food

Plains Cooperative Oil Mills, Inc./Plainview, An unsafe food additive intended for use in fattening cattle.Tex. (M,S)

Plus Products/Los Angeles, Calif. (M,S) False and misleading labeling concerning biotin andpantothenic acid; no minimum daily requirement.

Conjugated estrogens tablets/Baltimore,Md. 12/10/70

Dextrocell #2 tablets/Richmond, Va.12/2/70

Methyl salicylate USP, triethylene glycol/Jacksonville, Fla. 9/1/70

Obestat Ty-Med tablets/Auburn, N.Y.11/6/70

DRUGS I Human Use

DuMont Pharmacal Co., Inc./Philadelphia,Pa. (M,S)

Jones & Vaughan, Inc./Richmond, Va. (D)

U.S. Filtronic/Jacksonville, Fla. (D)

Lemmon Pharmacal Co./Sellersville, Pa.(M,S)

Below labeled potency; 80-83.9 percent of labeled strength.

New drug not approved for safety and efficacy; false andmisleading claims for a variety of clinical conditionsbecause of its thyroid components.

False and misleading claims.

New drug not approved for safety and efficacy.


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

DRUGS/Human Use (cont'd)

Theracort/Hazel Park, Mich. 12/2/70 C & M Pharmacal, Inc./Hazel Park, Mich. (M) Not processed in conformity with good manufacturingpractice.

Vita-Jec A, D, E/Fresno, Calif. 11/23/70 Denver Veterinary Laboratories, Inc./ " ; contains particulate matter; labeling impliesDenver, Colo. (M,S) vitamin E content makes it effective for the prevention

and treatment of avitaminosis.

Veter inary—Medicated Feed

Diethylcarbamazine syrup/Savannah, Ga.10/28/70

Muscle Radiol (M-R)/Oceanside, N.Y.10/26/70

Rabbit feed pellets, chick grow mash, 40%hog concentrate/Colorado Springs, Colo.11/24/70

Babineaux's Pharmacy/Metairie, La. (M,S)

Radiol Chemicals, Ltd./Stepfield WithamEssex, England (M,S)

Simpson & Co./Colorado Springs, Colo. (D)

New animal drug not approved for safety and efficacy.

Rabbit pellets, a new animal drug not approved for safetyand efficacy, contains chlortetracycline, unsafe for useand not declared on label; chick grow mash containsbacitracin, undeclared, and represents to contain procaine penicillin, which is false and misleading; 40%hog concentrate contains undeclared bacitracin and

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

Airox air purifier, Airox water purifier/Dallas, Tex. 10/22/70

Life Breather-Resuscitator/Gardena, Calif.11/2/70

Oxygen device/Jacksonville, Fla. 6/5/70

Port O2 Matic/Elk Grove Village, III.12/8/70

Relaxacizor/Redondo Beach, Calif. 10/21/70Santa Barbara, Calif. 9/17/70

Theramatic device/Indianapolis, Ind.9/16/70

Pollution Control Industries, Inc./Stamford,Conn. (M,S)

General Medical Devices, Inc./Gardena,Calif. (S) Return shipment fromDoylestown, Pa.

Life Aid Products/Toronto, Ont., Canada(M,S)

Erie Manufacturing Co./Milwaukee, Wis.(M,S)

Eastwood Industries/Chicago, III. (M)

Dynapower Systems Corp./Los Angeles,Calif. (M,S)

False and misleading labeling.

False and misleading claims to be effective for resuscitationand as a life-saving device in emergency due to asphyxiation from drowning.

False and misleading claims to provide 15-20 minutes ofmedical oxygen for emergency first-aid; inadequatedirections for lay use under the conditions recommended;inadequate warnings against unsafe methods andduration of application which may be dangerous tohealth.

Claims to be effective for emergency treatment of bodyinjury, electrical injury, exhaustion, and noxious gasinhalation; ineffective for suggested uses and dangerousto health.

Inadequate directions for safe use by laymen; labelingfails to bear warnings against unsafe methods andduration of application which may be dangerous to health.

Inadequate directions for safe use by laymen.

POST OFF ICE DEPARTMENT actions taken in medical cases under provisions of the Postal Fraud Statutes asreported by the Chief Postal Inspector.

False Representation Order Issued by Judicial Officer Under 39 U.S.C. 4005

December 29, 1970: False Representation Order issued against PostShop, P.O. Box 45438, Chicago, III. 60645. Advertising and sale

by mail of a product called "New Super Formula Sex Pep Pill,represented to be an effective aphrodisiac.


notices of jydgm:?"r;NOTICES OF JUDGMENT on Seizure Act ions

FOOD / Poisonous and Deleterious Substances

Chubs, eviscerated, frozen, at Chicago, N. Dist. III.Charged 12-30-69: while held for sale, the article contained the nonconforming food additives, DDT, DDE, DDD, and dieldrin; 402(a)(2)(C).D e f a u l t d e c r e e o r d e r e d d e s t r u c t i o n . ( 1 )

E g g s , f r o z e n , a t G r a n t s v i l l e , D i s t . M d . ^ , oCharged 5-22-70: when shipped by Roof Garden Egg Co., Meyersdale, Pa.,the article contained the added poisonous and deleterious substance.Salmonella micro-organisms; 402(a)(1). Default decree ordered destruct i o n . ( 2 )

Eggs, frozen, at Meyersdale and Somerset, W. Dist. Pa.Charged 6-19-70: when shipped by Roof Garden Egg Co., from Grantsville,Md., the article contained the added poisonous and deleterious substanceSalmonella micro-organisms; 402(a)(1). Default decree ordered destruct i o n . ( 3 )

FOOD / Contamination, Spoilage, Insanitary HandlingCornhusks, at Phoenix, Dist. Ariz.

Charged 6-1-70: when shipped by George Walcher, Weimar, Tex., thearticle contained insect filth and moldy cornhusks; 402(a)(3). Defaultdec ree o rde red des t ruc t i on . (4 )

Cornmeal, yellow, at Oblong, E. Dist. III.Charged 4-27-70: whi.e held by Mont Eagle Mills, Inc., Oblong, III., thearticle was held under insanitary conditions; 402(a)(4). Default decreeorde red des t ruc t i on . (5 )

Eggs, frozen, at Louisville, W. Dist. Ky.Charged 8-11-70: when shipped by IllinI Egg Products, Inc., OIney, III.,the article contained decomposed eggs and had been prepared andpacked under insanitary conditions; 402(a)(3), 402(a)(4). Default decreeo r d e r e d d e s t r u c t i o n . ( 6 )

Flour, rye, at Seattle, W. Dist. Wash.Charged 6-1-70: while in transit and while held in a railroad car, thearticle was held under insanitary conditions; 402(a)(4). Consent decreeauthorized release to Union Pacific R.R. Co., Seatt le, Wash., forsalvaging. (7)

Mi l k , non fa t , d r ied , a t Sa lem, W. D is t . Va .Charged 6-18-70: when shipped by Newman Grove Cooperative CreameryCo., Newman Grove, Nebr., the article, labeled in part "Valley LeeBrand . . . Pasteurized Nonfat Dry Milk Mid-West Producers Creameries,Inc., South Bend, Ind. Distributor," had been prepared and packedunder insanitary conditions; 402(a)(4). Default decree ordered destruct ion. (8)

Onion rings, breaded, frozen, at Wilmington, E. Dist. N.C.Charged 12-24-69: when shipped by Southern Frozen Foods, Inc.,Montezuma, Ga., the article, labeled in part "Gold King Raw BreadedOnion Rings . . . Packed by Gold King Frozen Foods, Inc., Thunderbolt,Ga.," contained E. coli, and bacterial filth, and was prepared and packedunder insanitary conditions; 402(a)(3), 402(a)(4). Default decree ordereddes t ruc t i on . ( 9 )

Orange and grapefruit sections, canned, at Norwood, Dist. Mass.Charged 6-17-70: when shipped by Florida Citrus Canners Corp., PlantCity, Fla., the article, labeled in part "Food Club Pure Florida Grapefruit & Orange Sections . . . Distributed by Topco Associates, Inc.,Skokie, Illinois," had been packed and held under insanitary conditions;402(a)(4). Default decree ordered destruction. (10)

Pecan pieces, at Louisvi l le, W. Dist . Ky.Charged 5-8-70: when shipped by Sunny South Pecan Co., Statesboro, Ga.,the article contained E. coli; 402(a)(3). Default decree ordered destruct i on . ( 11 )

R ice , a t Phoen ix , D is t . A r i z .Charged 6-12-70: while held by Arctic Storage Co., Phoenix, Ariz., thearticle contained rodent filth and was held under insanitary conditions;402(a)(3), 402(a)(4). Default decree ordered destruction. (12)

Shrimp, breaded. Trade Winds, at Florence, Dist. S.C.Charged 5-15-69: when shipped by Trade Winds Co., Thunderbolt, Ga.,the article contained coaguiase positive staphylococcus and had beenprepared and packed under insanitary conditions; 402(a)(3), 402(a)(4).De fau l t dec ree o rde red des t ruc t i on . (13 )

Walnut meats, at Seattle, W. Dist. Wash.Charged 6-1-70: when shipped by Willamette Valley Walnuts, McMinnville,Greg., the article contained E. coli; 402(a)(3). Consent decree orderedd e s t r u c t i o n . ( 1 4 )

Whiskey, Seven Crown, a t Relay, D is t . Md.Charged 5-19-70: when shipped by Seagram Overseas Sales Co., NewYork, N.Y., the article had been held under insanitary conditions, sinceit had been inadvertently dropped overboard into the harbor waters atHoboken, N.J.; 402(a)(4). Consent decree authorized release to Joseph E.Seagram & Sons, Inc., New York, N.Y., for reconditioning. (15)

FOOD / Economic and Labeling Violations

Beans, peas, and lentils, dried, at Greeley, Dist. Colo.Charged 6-17-70: when beans, peas, and lentils, labeled in part "Casserole Brand California Baby Lima Beans [or "Split Peas," or "GreatNorthern Beans," or "California Large Lima Beans," or "CaliforniaBlackeye Beans" or "Lentils" or "Whole Peas" or "Split Peas"] . . .American Bean & Pea Growers, Inc., Spokane, Wash.," were shipped byMarbo Quality Foods, Inc., Fresno, Calif., Inland Empire Pea GrowersAssociation, Spokane, Wash., and Big Horn Cooperative Marketing Association, Basin, Wyo., and when beans, labeled in part "High Protein . . .O u t w e s t B r a n d I d a h o R e d B e a n s D i s t r i b u t e d b y O u t w e s t B e a n , I n c . ,Denver, Colo.," were shipped by Bean Growers Warehouse Association,

Filer, Idaho, the articles were in violation of the Fair Packaging andLabeling Act, in that the quantity of contents declaration was not m thelower 30 percent of the principal display panel, in that for all lotsexcept the 4-lb. bags of Great Northern Beans the quantity of contentswas expressed as "Net Wt. 1 Lb." or "Net Wt. 2 Lbs." instead of "NetWt. 16 Oz. (1 Lb.)" and "Net Wt. 32 Oz. (2 Lbs.)," and the principaldisplay panels of the packages had an area between 25 and ICQ squareinches and the statements of the net quantity of contents stated onthe panel contained letters and numerals in a type size less than3/16 inch high; 15 U.S.C. 1453(a)(2), 1453(a)(3)(A), 1453(a)(3)(C)(i). Consentdecree authorized release to Outwest Bean, Inc., Denver, Colo., forrelabeling. (16)

Candies, orange, grape, and coffee flavored, Stix Pak, at San Francisco, N.D i s t . C a l i f .Charged 6-2-70: when shipped by Jolly Rancher, Inc., Wheatridge, Colo.,the articles were in violation of the Fair Packaging and Labeling Act, inthat the principal display panel of the label lacked a declaration of thenet quantity of contents; 15 U.S.C. 1453(a)(2). Default decree orderedd e s t r u c t i o n . ( 1 7 )

Corn, cream-style, canned, Good Pak, at Salt Lake City, Dist. Utah.Charged 5-20-70: when shipped by Big Horn Canning Co., Cowley,Wyo., the article was in violation of the Fair Packaging and Labeling Act,in that the net quantity of contents declaration was not separated fromother printed label information appearing above or below the declaration,in that the net quantity of contents statement was expressed as "NetWeight 1 Pound" rather than "Net Wt. 16 Oz. (1 Lb.)," in that theprincipal display panel had an area of between 5 and 25 square inchesand the net quantity of contents was stated in a type size less thanVs inch high, and in that the label did not state the net quantity ofeach of the servings of label statement "Servings 4"; 15 U.S.C. 1453-(a)(2), 1453(a)(3)[A)(i), l453(a)(3)(C)(i), 1453(a)(4). Default decree authorizeddonation to public institution. (18)

Herring fillets in sour cream, and herring cuts, spiced, Lasco, at Phoenix,D i s t . A r i z .

Charged 5-1-70: when shipped by Los Angeles Smoking & Curing Co.,Los Angeles, Calif., the articles were in violation of the Fair Packagingand Labeling Act in that the declaration of net quantity of contents wasnot in the bottom 30 percent of the principal display panel, and in thatthe principal display panel had an area between 5 and 25 square inchesand the net quantity of contents was stated in a type size less than Vsinch high; 15 U.S.C. 1453(a)(2), 1453(a)(3)(C)(i). Consent decree authorized release to the shipper for relabeling. (19)

Peas, canned, Stokely Van Camp, at Pauline, Dist. Kans.Charged 6-18-70: when shipped by Kuner-Empson Co. (Stokely Van Camp,Inc.), Brighton, Coio., the article was in violation of the Fair Packagingand Labeling Act, in that the declaration of the net quantity of contentswas not in the bottom 30 percent of principal display panel, in that thenet quantity of contents was expressed as "Net Weight 1 Lb. 1 Oz."instead of "Net Wt. 17 Oz. (1 lb. 1 oz.)," and in that the principaldisplay panel had an area between 5 and 25 square inches and the netquantity of contents was stated in a type size less than Va inchhigh; 15 U.S.C. 1453(a)(2), 1453(a)(3)(A)(i), 1453(a)(4). Consent decreeauthorized release to shipper for relabeling. (20)

Pineapple, canned, at Stockton, E. Dist. Calif.Charged 8-5-70: when shipped from Malaysia, the article, labeled in part"Nugget Brand Sliced Pineapple . . . Distributed by Nugget Distributors,Inc., Stockton, Calif.," fell below the standard of quality for cannedpineapple because more than 7V2 percent of the more than 27 unitsin the cans were excessively trimmed; 403(h)(1). Default decree ordereddonation to a charitable organization. (21)

Salad dressing, Flav-O-Rite, at Liberty, W. Dist. Mo.Charged 6-10-70: when shipped by Guy's Foods, Inc., Tulsa, Okla., thearticle lacked conformity to the standard of identity, since it was deficientin vegetable oil; 403(gXl). Consent decree authorized release to shipperfor compliance operations. (22)

VITAMINS / DIETARY FOODS

Iodine dietary supplement tablets, at Grand Rapids, W. Dist. Mich.Charged 10-12-70: while held by Muir Drug Labs., Inc., Grand Rapids,Mich., who manufactured the article from kelp shipped In interstatecommerce, the valuable constituent, iodine, had been in part omitted orabstracted from the article, and the label lacked required informationconcerning the minimum daily requirement for iodine supplied by thearticle; 402(b)(1), 403(j). Default decree ordered destruction. (23)

FOOD ADDITIVES

Flour, at Kansas City, W. Dist. Mo.Charged 8-4-70: when shipped by Wheat Products Co., Inc., ColoradoSprings, Colo., the article, labeled in part "New Improved W.M.C. BakingSpecialty Wolf Unbleached Hard Wheat Flour and Soya Flour," containedthe nonconforming food additives, nitrites and nitrates; 402(a)(2)(C).Default decree ordered destruction. (24)

ANIMAL FEED

Cattle feed, medicated, Hi-Energy Range Cubes, at LaSalle, Dist. Colo.Charged 5-28-70 and amended 6-3-70: while held by John Ewing Co.,LaSalle, Colo., who manufactured the article from a premix which contained neomycin sulfate and had been shipped in interstate commerce,the article was an animal feed containing a new animal drug, and noapproval of an application filed with respect to such animal feed wasin effect; and the label ing contained false and misleading claimsconcerning the efficacy of the article in the prevention of scours incalves by feeding to the mother cow; 501(a)(6), 502(a). Consent decreeauthorized release to the dealer for compliance operations. (25)

Pig feed, medicated, at Horse Cave, W. Dist. Ky.Charged 8-27-70: when shipped by Cooperative Mills, Inc., Cincinnati,


Ohio, the article, labeled in part "SS Pig Starter Medicated . . . SouthernStates Cooperative Inc., Cooperative Mills Div. General Office Baltimore,Maryland," was deficient in arsanilic acid (approx. 90 percent), and itslabeling with respect to its arsanilic acid content was false and misleading; 501(c), 502(a). Consent decree ordered destruction. (26)

DRUGS / Human Use

Amphetamine-barbiturate-vitamin combination capsules, at Mansfield, N. Dist.Ohio.Charged 5-27-70: when shipped by Plymouth Labs., Inc., Plymouth, Mich.,the strength of the article, labeled in part "Amvidex Timecaps . . .Distributed by The Caldwell & Bloor Company, Mansfield, Ohio," differed from that which it purported to possess, and the label declarationof potency was false and misleading, since the article contained only73.3 percent of the deciared amount of dextro-amphetamine sulfate and791 percent of the declared amount of amobarbital; 501(c), 502(a).Default decree ordered destruction. (27)

Bacitracin ointment, U.S.P., at Atlanta, N. Dist. Ga.Charged 5-26-70: when shipped by Abbott Laboratories, North Chicago,III., the article's strength differed from U.S.P. standard, since thearticle was understrength in bacitracin (approx. 24 percent); 501(b).Default decree ordered destruction. (28)

Calcium chloride injection, N.F., at Detroit, E. Dist. Mich.Charged 2-13-70: while held for sale after manufacture locally by AtlasPharmaceutical Labs., Inc., Detroit, Mich., from ingredients shipped ininterstate commerce, the labeling lacked adequate directions for useand did not comply with the Rx drug exemption requirement for disclosure of information; and the article was not packaged as prescribedby the National Formulary, since it was packaged in multiple dosecontainers; 502(f)(1), 502(g). Default decree ordered destruction. (29)

Calstron calcium-gluconate stront ium-bromide combinat ion inject ion, atMableton, N. Dis t . Ga.Charged 6-30-70: when shipped by Farnsworth Laboratories, Inc., ChicagoHeights, III., the article was a new drug without an effective approvedNew Drug Application, and the labeling contained false and misleadingclaims for various types of dermatological conditions; 505(a), 502(a).Default decree ordered destruction. (30)

Cold Sore IVO camphor thymol combination cream, at Minneapolis, Dist. Minn.Charged 6-25-70: when shipped by Walter 8. Wanecke, t/a Ivo Co.,Milwaukee, Wis., the labels of both lots of the art icles lacked aquantity of contents statement, and some labels of one lot of thearticle lacked the established name of each active ingredient; 502(b)(2),502(e)(l)(A)(ii). Default decree ordered destruction. (31)

Formula 1275 Kl and lobelia combination elixir, at Keokuk, S. Dist. Iowa.Charged 5-14-70: when shipped by Ulmer Pharmacal Co., Minneapolis,Minn., the labeling lacked adequate directions for use and did notcomply with the Rx drug exemption requirement for disclosure ofinformation; 502(f)(1). Default decree ordered destruction. (32)

lodinated casein tablets, at Louisville, W. Dist. Ky.Charged 9-11-69: when shipped by Beth Corp., Miami, Fla., the articlewas a new drug without an effective approved New Drug Application;505(a). Consent decree ordered destruction. (33)

Lipo-K lipotropic factor combination injectable, Ossonate Plus mucopolysaccharide extract combination injectable, at Philadelphia, E. Dist. Pa.Charged 10-24-69: when shipped by Marcen Laboratories, Inc., NewRochelle, N.Y., the articles were new drugs without effective approvedNew Drug Applications; 505(a). Default decree ordered destruction. (34)

Lubricating jelly, sterile, at Augusta, S. Dist. Ga.Charged 4-7-70: when shipped by Badger Laboratories, Inc., Jackson, Wis.,the article's quality and purity were deficient and its labeling was falseand misleading, since the article was not sterile; 501(c), 502(a). Defaultdecree ordered destruction. (35)

Pentaerythritol tetranitrate tablets and reserpine tablets, U.S.P., at Chicago,N. D is t . I I I .Charged 4-17-69: while held by G & G Drug Co., Chicago, III., who wasrepacking the articles, their labeling failed to bear adequate directionsfor use and the articles were not exempt from such requirements;502(f)(1). Consent decree authorized release to the dealer for comp l i ance ope ra t i ons . ( 36 )

Thyrodig T-13 tablets and T-32 tablets (thyroid-digitalis combinations), Thyrodiganterior pituitary tablets (thyroid, digitalis, and anterior pituitary combination), and tnyroid 5 gr. tablets, at Houston, S. Dist. Tex.Charged on or about 5-28-68: when shipped by Western Research Labs.,Inc., Denver, Colo., the labeling of the Thyrodig T-13 tablets andThyrodig anterior pituitary tablets contained false and misleading claimsthat thyroid-digitalis combinations were of value in the treatment ofindividuals requiring the thyroid effect and that thyroid safely accelerated cellular metabolic processes increasing the metabolic rate; thelabeling of the Thyrodig T-32 tablets contained false and misleadingclaims that thyroid safely accelerated cellular metabolic processes,increasing the basal metabolic rate, that Western Research Labs., Inc.,had overcome many of the thyroid disadvantages, and that WesternResearch Labs.' thyroid-digitalis preparations were safe arrd effectiveadjuncts in the treatment of obesity; the labeling of the thyroid 5 gr.tablets contained false and misleading claims that such tablets acceleratedcellular metabolic processes, were safe and effective as an adjunct tothe dietary treatment of obesity, and were safe and effective in thetreatment of menstrual disorders, infertility, threatened abortion, andskin diseases; the labeling of the thyroid 5 gr. tablets failed to revealt h e m a t e r i a l f a c t s t h a t s u c h t a b l e t s w e r e n o t s a f e a n d e f f e c t i v e i ntreatment of obesity, menstrual disorders, infertility, threatened abortion,and certain skin diseases except where such conditions were associatedwith hypothyroidism, and that the overwhelming number of personssuffering from such conditions are not afflicted with hypothyroidism; thelabeling of all the articles lacked adequate directions for use and didnot comply with the Rx drug exemption requirement for disclosure ofinformation; all articles were dangerous to health when used in thedosage and with the frequency and duration suggested in their labeling;and all articles were new drugs without effective approved New DrugApplications; 502(a), 502(f)(1), 502(j), 505(a). Consent decree ordereddes t ruc t i on . (37 )

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

Dynatone electronic facial stimulator, at Minneapolis. Dist. Minn.Charged 9-27-67 and amended 6-28-68: when shipped by Dynatone, Inc.,

Wichita, Kans., and while held by Powers Dry Goods Co., Minneapolis,Minn., the accompanying labeling contained false and misleading claimsfor firming and toning key age-revealing areas of the face and neck,firming underlying areas strengthening sagging muscles electronicallyexercising hidden face and neck muscles, firming delicate facial musclesthereby preventing or eliminating double chins, crow's feet, and otherfacial contour problems, and making the user look years younger; thearticle's label lacked the name and place of business of the manufacturer,packer, or distributor, and an accurate statement of the quantity ofcontents in terms of weight, measure, or numerical count; the article'slabeling lacked adequate directions for use, since a number of packagesdid not bear or contain directions for use; and the article's labelinglacked adequate warnings against unsafe use; 502(a), 502(b)(l)(2), 502(f)(1),and 502(f)(2).

The article was claimed by Dynatone Electronic Corp., New York, N.Y.,who denied that the article was misbranded as alleged in the complaint.Thereafter the Government served interrogatories upon the claimant andmoved to amend the complaint to inciude misbranding charges in additionto the original 502(a) charge. The claimant objected to the interrogatories and resisted the motion to amend the complaint. The courtoverruled the claimant's objections to the interrogatories, except where,on the authority of United States v. Article of Drugs, 43 F.R.D. 181(D. Del.1967), the court sustained the claimant's objections to a number ofinterrogatories which depended upon the identification of certain exhibitsa s b e i n g c o p i e s o f b r o c h u r e s s e i z e d i n t h e a c t i o n . T h e c o u r t a l s oconcluded that the Government was entitled to amend its complaintpursuant to Rule 15(a), saying:

"The United States failed to amend its complaint within the timeallowed as a matter of right. Rule 15(a) provides as to amendments onmotion that 'leave shall be freely given when justice so requires.' Theclaimant objects under Rule 7(b)(1) contending that the moving papers lackthe necessary particularity. In fact the moving papers do fail to setforth any reasons for requesting the amendment. However, each proposedparagraph in the amendment alleges the violation of a precise statutoryprovision of the Federal Food, Drug, and Cosmetic Act and the interestsof justice and the lack of showing of any significant prejudice to theclaimant mil i tates in favor of permitt ing the amendment. The newparagraphs of the amendment speak for themselves in alleging violationsof statutory provisions. The grounds for seeking leave to amend areimplicit in the amendment and it is obvious from a quick perusal thatthe United States believes that the device Dynatone infringes additionalstatutory provisions beyond those alleged in the original complaint. Trialdate is some months off and claimant has adequate time to prepare hisd e f e n s e w i t h o u t p r e j u d i c e . "

The case came in for trial by the court. Two expert medical witnessestestified for the Government in a test involving use of the device; and"Before and after" color photos were received in evidence. To the courtand according to the testimony of those experts, there was no distinguishable or observable difference or improvement in facial differencei n a n y o f t h e s u b j e c t s . T h e c o u r t s a i d :

'•More forceful and convincing however than the above experimentwas the medical testimony concerning the effect of aging on the skinand the results not obtained by muscle contraction. One of the aforementioned experts and two other medical experts called by the Government, one a specialist in physical medicine and rehabilitation, the othera dermatologist, testified in summary that facial and neck muscle exerciseor contraction would have no effect on wrinkling of the skin, or ifanything would promote or increase it. The testimony was to the effectthat exercise does nothing for wrinkied skin overlying a muscle. Electricalstimulation, while causing a muscle contraction, will not cause musclegrowth, i.e., hypertrophy, though it might slow down but will not stopmuscle atrophy. Voluntary exercise can cause increase in muscle size,and to that extent would or might stretch the overlying skin and thusr e d u c e w r i n k l e s t h e r e i n t o s o m e e x t e n t . N o s u c h r e s u l t c a n b e o b t a i n e dhowever by artificial electrical musc.e contraction. The testimony wasclear that the use of the device would not be effective to help or reducecrow's feet, double chins, or jowls. These conditions relate to theelasticity of the skin itself and have no relation to muscle tone or theloss thereof nor to weakness or atrophy of facial muscles. Wrinkling isin large part caused by the skin's failure to resume its normal stateafter a bending or folding caused by muscle contraction. Increasedexercise of underlying facial muscles if it affects the wrinkling processat all, probably makes the wrinkles worse. This evidence was veryconvincing to the court and the court finds it to be true."

On the basis of the evidence received at the trial, a study of theparties' memoranda, and in all of the files, records, and proceedings ofthe action, the court found that the article was in violation of 502(a),condemned the article and authorized delivery of the article to FDAfor destruction or use only for exhibition purposes. (38)

O x y g e n m a s k , R e s p i r e x , a t L o s A n g e l e s , 0 . D i s t . C a l i f .Charged 9-5-69: when shipped by Respirex International, Guadalajara,Mexico, the labeling contained the false and misleading claim that thea r t i c l e c o n t a i n e d a 1 0 - m i n u t e s u p p l y o f l i f e - s u s t a i n i n g o x y g e n f o r v i t a lemergency first aid; the labeling lacked adequate directions for use forheart attack, drowning, stroke, asthma, shock and smoke inhalation, andsuch directions could not be written for safe use by the untrained laity;and the labeling lacked adequate warnings against use; 502(a), 502(f)(1),502(f)(2). Consent decree authorized release to the Respirex Corp., LosAngeles, Calif., for export to the original foreign supplier, and perpetuallyenjoined the Respirex Corp., and its agents, servants, employees, andattorneys, and all persons in active concert or participation with themfrom introducing into interstate commerce the Respirex device consisting of a mask and oxygen container purportedly containing 38 litersof oxygen. (39)

R e s p i r a t o r , a t N a s h v i l l e , M . D i s t . Te n n .Charged 7-24-69: when shipped by Crown Products Co., Cleveland, Ohio,the article, labeled in part "For every breathing difficulty . . . Res-Q-AireEmergency Respirator ... A product of Machsa Incorporated Distributede x c l u s i v e l y b y C r o w n P r o d u c t s C o . . . . A D i v i s i o n o f t h e C h i l c o t eC o m p a n y, " b o r e t h e n a m e R e s - Q - A i r e a n d s t a t e m e n t s o n t h e c a r t o n l a b e land attached card which were false and misleading as to the adequacya n d e f f e c t i v e n e s s o f t h e a r t i c l e a s a m e a n s o f r e s u s c i t a t i o n ; t h e l a b e l i n glacked adequate directions for use, and such could not be written, sincet h e a r t i c l e w a s n e i t h e r e f f e c t i v e n o r s a f e f o r i t s i n t e n d e d p u r p o s e ;the labeling lacked warnings against use involving obstructions, aspiratedo b j e c t s a n d d e n t u r e s , a n d i n v o l v i n g i n f a n t s o r c h i l d r e n w h e r e t h e v o l u m eof air would be excessive; and the article was dangerous to health whenused as directed by its labeling; 502(a), 502(f)(1), 502(f)(2), 502(j).D e f a u l t d e c r e e o r d e r e d d e s t r u c t i o n . ( 4 0 )


Theramatic model A-6DT40 electronic instrument, at Daytona Beach, M. Dist.F l a .Charged 5-27-70: when shipped by unknown shipper, the article's labelingcontained false and misleading claims for infections, otit is media,fractures, bone and tissue healing, smooth muscle spasm, bursitis,arthritis, low back pain, headaches—parietal and occipital, urinary tractinfections, ulcers—decubital, prostatitis, and sinusitis; its labelinglacked adequate directions for such uses and adequate directions couldnot be written, since the article was worthless for such uses; and thearticle was dangerous to health when used in the dosage and with thefrequency and duration recommended in its labeling, since it was ineffective for the treatment of the serious disease conditions for whichit was recommended and by reason of its ineffectiveness, it was unsafefor such use; 502(a), 502(f)(1), 502(j). Default decree ordered destruction.( 4 1 )

COSMETICS / BEAUTY PRODUCTS

Hair brushes, at Buffalo, W. Dist. N.Y.Charged 5-18-70: when shipped by unknown shipper from outside theUnited States, the article, labeled in part "Vienna [or "Vienco"] Madein France," contained nits; 601(b). Default decree ordered destruction.(42)

HAZARDOUS SUBSTANCES

Cherry bombs, at Hanna Junction, Dist. Wyo.Charged 6-30-70: while held at a fireworks stand, Hanna junction, Wyo.,the articles were banned hazardous substances, since they were packedi n a f o r m s u i t a b l e f o r u s e i n t h e h o u s e h o l d a n d w e r e i n t e n d e d t oproduce audible effects by a charge of more than 2 grains of pyrotechniccomposition; 2(q)(l)(B). Default decree ordered destruction. (43)

Llme-Elim rust and lime eliminator, at St. Paul, Dist. Minn.Charged 6-10-70: when shipped by Winn-Sol Products, Inc., Oshkosh, Wis.,the article was an irritant substance containing approximately 15 percentphosphoric acid, and it lacked a number of the required conspicuouslabel statements; 2(p)(l)(B,D,E,G,J). Default decree ordered destruction.(44)

NOTICES OF JUDGMENT on Cr im ina l Ac t ions

F O O D

Atlanta Textile Corp., and Isahag Aprahamian, president, at Brooklyn, E,D is t . N .Y.Charged 3-18-70: when received from Brazil and delivered for pay inBrooklyn, N.Y., black pepper contained mold—402(a)(3); and when shippedfrom New York to Illinois, black pepper contained mold—402(a)(3). Guiltyplea by corporation; fine. Nolo contendere plea by individual; fine. (45)

City Sales Co. of Mobile, Inc., and John P. Finlayson, president. Mobile, S. Dist.Ala.Charged 4-7-70 by grand jury-, flour was held in a building accessible tor o d e n t s a n d i n s e c t s a n d w a s c o n t a m i n a t e d w i t h r o d e n t a n d i n s e c t fi l t h ;402(a)(3), 402(a)(4). Nolo contendere pleas; fines. (46)

Hollar & Greene Produce Co., a partnership, and Lige C. Hollar and Dale L.Greene , pa r t ne r s , Boone , M . D i s t . N .C .Charged 4-9-70: when shipped, cabbage contained quantities of toxapheneand parathion in excess of the tolerances; 402(a)(2)(B). Guilty plea bypartnership; fine. Guilty pleas by individuals; fines and probations. (47)

Zatarain's, Inc., and Chloe R. Anderson, president, at Gretna, E. Dist. La.Charged by grand jury 3-26-70: when shipped, Fish-Fri corn flour, Chick-Friseasoned corn flour, and Zatarain's Crab Boil seasoning contained insectfilth and had been prepared and packed under insanitary conditions;402(a)(3), 402(a)(4). Nolo contendere plea by corporation; fine. Nolocontendere plea by indiv idual ; probat ion. (48)

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

Richard Chalaire, t/a Plaquemines Parish Bar, and Murray 0. Latapie, bartender, Braithwaite, E. Dist. La.Charged by grand jury 10-30-69: while held for sale, silver salute fireworks(count 1) were sold to a child, and cherry bombs (counts 2, 3, 4) weresold to FDA inspectors, which resulted in such fireworks being bannedhazardous substances in that they were toys which were flammable substances and generated pressure through explosion when ignited; 2(q)(l)(A).

The defendants pleaded not guilty and moved to dismiss the indictmenton the grounds that (1) the Federal Hazardous Substances Act did notprohibit the sale of banned hazardous substances that have been shippedin interstate commerce and (2) the silver kings and cherry bombs weree x e m p t a s c o m m o n fi r e w o r k s . T h e c o u r t d e n i e d t h e m o t i o n a n d t h e c a s ecame on for t r ia l before the cour t . The cour t found both defendants gu i l ty.In its opinion, the court said:

"A. Defendants Chalaire and Latapie did and caused the doing of anact with respect to a hazardous substance by selling silver kings andcherry bombs."Selling a hazardous substance is 'the doing of any act with respect

to a hazardous substance.' The legislative history of the Act clearly showsthat Congress intended 'to ban the sale of toys and other children'sarticles containing hazardous substances.' 1966 U.S. Code Congressionaland Administrative News 4095 (Emphasis added). The Supreme Court hasso interpreted an analogous provision of the Food, Drug and CosmeticAct. U.S. V. Wiesenfeld Warehouse Co., 376 U.S. 86 (1964). * * *

"Here, the evidence showed beyond a reasonable doubt that the silverking and cherry bombs were (1) flammable, (2) generated pressure throughdecomposition and heat, and (3) may cause substantial personal injuryas a proximate result of any reasonably foreseeable handling or use.

"Both defendants are liable for selling the hazardous substances. Section 1263(b) expressly provides that 'The following acts and the causingthereof are hereby prohibited' (Emphasis added). The evidence that defendant La tap ie persona l l y so ld the cher ry bombs in Counts 2 , 3 and 4 i sundisputed. Defendant Chalaire is liable on all 4 counts because hecaused the sales. U.S. v. Dotterweich, 320 U.S. 277 (1943); Palmer v.U.S., 340 F.2d 48 (5 Cir. 1964). Here, Chalaire admitted that he ownedthe bar, purchased the inventory of silver kings and cherry bombs, advertised them, hired persons to sell them and collected the profits. Thefact that Chalaire did not personally do the selling is immaterial.

"B. The silver kings and cherry bombs were held for sale after shipm e n t i n i n t e r s t a t e c o m m e r c e . * * *"The interstate shipment of a product is proved if the evidence shows

that the product is found within a state, and that the product was eithern o t m a n u f a c t u r e d t h e r e o r w a s m a n u f a c t u r e d i n a n o t h e r s t a t e . P a l m e r v.U.S., 340 F.2d 48 (5 Cir. 1964). Here, the evidence showed that no

Louisiana business had ever been licensed to manufacture silver kingsor cherry bombs. In fact manufacture of those type fireworks (Class B)was prohibited. In addition an expert in the chemical analysis of fireworks testified that the silver kings were manufactured in Ohio and thecherry bombs were manufactured in New jersey. I find beyond a reasonabledoubt that they were so manufactured.

"C. The sale of the silver kings and the cherry bombs resulted in thosehazardous substances being 'banned hazardous substances.' * * *"Silver kings and cherry bombs are 'toys' within the meaning of the

Act. The Act itself expressly excludes Class C (common) fireworks but notClass B fireworks. 15 U.S.C. §1261(q)(l)(ii). Also the legislative historyof the Act clearly shows that Congress intended to include silver kingsand cherry bombs (Class B fireworks) within the definition of toy. 1966U.S. Code Congressional and Administrative News, 4095, 4096, see especial ly 4099.'•"Ihe silver kings and cherry bombs are not exempt from the definitionof banned hazardous substances because (1) they are not common fireworks and (2) they were not intended and used for bona fide agriculturalp u r p o s e . * * *

"Here the evidence showed that the silver kings and cherry bombsproduced audible effects by a charge of more than 2 grains of pyrotechniccomposition. The cherry bombs contained 20 grains and the silver kingsabout 40 grains. The evidence also showed that the fireworks were notintended or used for bona fide agricultural purposes. The buyers werenever asked whether they intended to use the fireworks for agriculturalpurposes and the fireworks never were so used.

"The sale of silver kings and cherry bombs to a child or to an adultwithout first asking the adult whether a child would use them results inthose hazardous substances being a banned hazardous substance. Thepurpose of the Child Protection Act is to protect children. This is accomplished by banning hazardous toys from channels of interstate commerce tha t lead to ch i ld ren . A l l fi reworks are no t abso lu te ly banned. C lassB fi reworks a re no t banned f r om channe l s o f i n t e r s ta te commerce l ead ingto persons who use them for bona fide agricultural purposes. But Class Bfireworks a re banned f rom channe ls tha t lead to ch i ld ren . Of course C lassC fireworks are no t banned a t a l l even i f the channe l leads to ch i ld ren .

"Here, Chalaire is liable for the sale of silver kings to Dolese becauseDolese was a ch i ld a t the t ime o f the sa le . Cha la i re admi t ted tha t Do lesewas a ch i ld and shou ld no t have been so ld C lass B fi reworks as a mat te rof common sense. The fact that the cherry bombs in Counts 2, 3 and4 were sold to an adult is immaterial. The cherry bombs were toys. Noone asked the buyer whether children would use them. The seller hada duty to inquire, cf. U.S. v. Dotterweich, 320 U.S. 277 (1943). BothChalaire and Latapie are liable for this sale.

"D. Knowledge and willfulness are not elements of the offense. But inany event knowledge and willfulness were proved beyond a reasonabledoubt ."Knowledge and willfulness are not an element of 15 U.S.C. §1263(b).

N o w h e r e i n t h e s t a t u t e i s t h i s e l e m e n t m e n t i o n e d . I t i s c l e a r f r o m t h elegislative history of the statute that Congress intended that knowledgea n d w i l l f u l n e s s n o t b e a n e l e m e n t . T h e C h i l d P r o t e c t i o n A c t o f 1 9 6 6amended the Federal Hazardous Substances Labeling Act of 1960. Thep r o h i b i t e d A c t s s e c t i o n o f t h e l a t t e r A c t i s ' p a t t e r n e d a f t e r t h e c o r r esponding section of the Federal Food Drug and Cosmetic Act [21 USC§ 3 3 1 ] ' . 1 9 6 0 U . S . C o d e C o n g r e s s i o n a l a n d A d m i n i s t r a t i v e N e w s 2 8 4 0 .i he Sup reme Cour t and the F i f t h C i r cu i t have i n te rp re ted 21 U .S .C . §331as not requiring knowledge and willfulness. U.S. v. Dotterweich, 320 U.S.277 (1943 ) ; U .S . v. W iesen fe ld Warehouse Company, 379 U .S . 86 (1964 ) ;Palmer v. U.S., 340 F.2d 48 (5 Cir. 1964)." * * * (49)

NOTICES OF JUDGMENT on In junct ion Act ionMaizel Labs, Inc., and Benjamin L. Maizel, president, Chicago, N. Dist. III.

Charged 10-3-69 in complaint for injunction: that the defendants wereengaged in manufacturing, packing, and labeling various drugs, in holdinga n u m b e r o f s u c h d r u g s f o r s a l e a f t e r s h i p m e n t o f o n e o r m o r e o f t h e i rcomponents in interstate commerce, and in distributing a number ofsuch drugs in interstate commerce; that the circumstances of the defendants' manufacture, packing, and holding lacked conformity with current good manufacturing practice; that a number of the drugs differed instrength from, and their quality and purity fell below, the U.S.P. andN.F. standards, or that which the drugs themselves purported and wererepresented to possess; that the labeling of a number of drugs containedfalse and misleading statements concerning the identity, quality, andstrength of the drugs; and that the labeling of a number of drugs lackedadequate directions and did not comply with the Rx drug exemption requirement for disclosure of information; and that the defendants haddistributed a new drug, Robese Gel, without an effective approved NewDrug Application; 501(a)(2)(B), 501(b), 501(c), 502(a), 502(f)(1), 505(a).

A consent decree of permanent injunction was entered enjoining thedefendants from the violations complained of, and enjoined the furtherinterstate shipment and the manufacture of drugs at the defendants' plantunless and until a number of specified good manufacturing practiceswere established, assays were made of drugs in possession of the defendants, recalls were made of such assayed drugs as were necessary, andthe assayed and recalled drugs were destroyed or brought into complia n c e w i t h t h e l a w. ( 5 0 )

N o t i c e s o f J u d g m e n t a r e g i v e n p u r s u a n t t o s e c t i o n 7 0 5 o f t h eF e d e r a l F o o d , D r u g , a n d C o s m e t i c A c t a n d s e c t i o n 1 3 o f t h e F e d e r a lH a z a r d o u s S u b s t a n c e s A c t . N o t i c e s o f J u d g m e n t r e p o r t c a s e s i n v o l vi n g s e i z u r e p r o c e e d i n g s , c r i m i n a l p r o c e e d i n g s , a n d i n j u n c t i o n p r o c e e dings. Seizure proceedings are civil actions taken against goods allegedto be in violation, and criminal and injunction proceedings are againstfi r m s o r i n d i v i d u a l s c h a r g e d t o b e r e s p o n s i b l e f o r v i o l a t i o n s . T h e c a s e sg e n e r a l l y i n v o l v e f o o d s , d r u g s , d e v i c e s , c o s m e t i c s , o r h a z a r d o u s s u bs t a n c e s w h i c h w e r e a l l e g e d t o b e a d u l t e r a t e d o r m i s b r a n d e d o ro t h e r w i s e v i o l a t i v e o f t h e l a w w h e n i n t r o d u c e d i n t o a n d w h i l e i ni n t e r s t a t e c o m m e r c e , o r w h i l e h e l d f o r s a l e a f t e r s h i p m e n t i n i n t e rs t a t e c o m m e r c e .

Notices of Judgment are prepared by Food, Drug, and EnvironmentalH e a l t h D i v i s i o n , O f fi c e o f t h e G e n e r a l C o u n s e l , D H E W .

Publ ished by di rect ion of the Secretary of Heal th, Educat ion, andW e l f a r e .

Charles C. Edwards, M.D., Commissioner of Food and DrugsW a s h i n g t o n , D . C . , M a r c h 1 , 1 9 7 1

36 / March 1971 / FDA Papers U.S . GOVERNMENT PRINTING OFFICE: 1971-435-650 /21

CLEAN HANDS was prepared by FDA for use in thetraining of food plant employees and food handlers.Just 6V2 minutes long, CLEAN HANDS stresses theimportanee of one's hands in food produetion and tellswhy hands must be kept clean and sanitary. Harry, thefood plant worker, demonstrates hand-washing techniques.

35 full-color 35-mm. slides. Taped narration at3% i.p.s. Audible signal.

Price $9.25 per set—includes slides, narration, andpostage.

O r d e r f r o m : S a l e s B r a n c hNational Audiovisual Center (GSA)Washington, D.C. 20409

Check or money order payable to: National Audiovisual Center (GSA)

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H A N D B O O K A V A I L A B L E T h e A m e r i c a nP h a r m a c e u t i c a l A s s o c i a t i o n a n n o u n c e sthat its new, revised 1971 edition of theHandbook of Non-prescript ion Drugs isoff the press and available for immedia te order. In a spec ia l p repub l ica t ionpe r iod tha t ended i n January, nea r l y5,000 copies of the Handbook were sold,APhA said, indicating its exceptional acceptance by pharmacists and other healthprofessionals. The new 202-page Handbook is 20 percent larger than the previous (1969) edition and contains 31 chapters, each devoted to a specific class ofh o m e r e m e d i e s . I t i n c l u d e s t h e f o r m u l a sof more than 1,000 different brand-nameproducts in almost 1,200 dosage forms,and, in addition to a cross-reference product index, it has an index of nearly 300manufacturers, 76 pages containing tablesand charts of products, and a score ofmedical illustrations and scientific graphs.

T h e H a n d b o o k i s a v a i l a b l e a t $ 6 . 5 0

per copy from the Order Desk, AmericanPharmaceutical Association, 2215 Constitut ion Avenue, N.W., Washington, D.C.20037. Orders under $10 must be accompanied by payment.

STATISTICAL SUMMARY OF INDUSTRY PARTICIPATION IN FDA WORKSHOPS,SEMINARS, AND CONFERENCES / JULY 1, 1970—MARCH 31, 1971

District Workshops and In-Plant Seminars

C h e m i c a l C o n t a m i n a t i o nB a c t e r i a l C o n t a m i n a t i o nB a c t e r i a l I n - P l a n tS a n i t a t i o nS a n i t a t i o n I n - P l a n tC o s m e t i c s

Food and Drug LawI n s t i t u t e

A T T E N D A N C E

People

N a t i o n a l C o n f e r e n c e

A T T E N D A N C E

A N N U A L I F T M E E T I N G T h e 3 1 s t A nnual Meeting and Exposit ion of the Institute of Food Technologists will be heldMay 23-27 at the Amer icana Hote l inN e w Yo r k C i t y. I F T ' s N e w Yo r k S e ction will be host and has built its program around the theme, "New York—N e w I d e a s . "

F o r f u r t h e r i n f o r m a t i o n c o n t a c tGeorge R. Foster, Director of Field Services , Ins t i tu te o f Food Techno log is ts ,Suite 2120, 221 North LaSal le Street,Chicago, Il l inois 60601.

These workshops and conference are designed to respond to the needs of the regulated industries for information about various problems in compliance, and toclarify for industry any fine points of the laws administered by the Food and DrugAdministrat ion. Normally, these workshops are init iated in FDA Distr icts becausethey are most familiar with industry's needs in their geographical areas. The Officeof Compliance, Bureau of Foods, is gratified by the cooperation from industry tod a t e i n t h e s e a r e a s .