J U N E 1 9 7 4

^ -

This Month

n rI oday's active, educated, and concerned consumerJL has become a force with which Federal agencies

must deal on a continuing basis. This is particularlytrue of FDA because of the nature of the products itregulates. One Washington-based consumer group active in FDA is Consumer Action for Improved Foodand Drugs. Its executive director is Cathy Sulzberger,who has spent more than a year organizing groups andi n d i v i d u a l s w i t h a n i n t e r e s t i n F D A a c t i v i t i e s . T h i s

month, Ms. Sulzberger, in an interview with the editorof FDA Consumer, presents her views of FDA and ofconsumerism today.

" W h a t d o c o n s u m e r s k n o w a b o u t n u t r i t i o n ? " T h i s

question aptly introduces a four-part series in FDAConsumer reporting on a national nutrition knowledgesurvey taken by FDA in late 1973. The survey reinforces FDA's position that there is a need for continued education programs in the area of nutrition, andreveals some interesting points about FDA's new nutrition labeling program.

Our color story this month is about molluscan shellfish—oysters, clams, and mussels—and FDA's program to make sure they are safe to eat. The story listssome tips for consumers on how to make sure theseshellfish are handled correctly. "Food Ingredient Review: Where It Stands Now" reports on the reviewbeing conducted by FDA's Bureau of Foods of foodadditives and substances that are "Generally Recogn i z e d A s S a f e . "

In April, a survey for FDA Consumer was mailedto a random sampling of our readers to see who theyare and how they use the magazine. More than half ofthose who received the questionnaire filled it out andreturned it. A follow-up telephone survey was conduc ted to confi rm the resu l t s .

The survey information is being tabulated, and wehope in a future issue of FDA Consumer to report onwhat you, our readers, think of FDA Consumer, andhow we intend to react to what the survey showed.

FDA Consumer / June 1974 / 1

VOL. 8, NO. 5/JUNE 1974

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

Charles C. Edwards, M.D.Asst. Secretary for Health

A l e x a n d e r M . S c h m i d t , M . D .C o m m i s s i o n e r o f F o o d a n d D r u g s

A C o n s u m e r L o o k s a t F D A

J o h n T. W a l d e n

Acting Asst. Commissionerf o r P u b l i c A f f a i r s

W h a t D o C o n s u m e r s K n o w A b o u t N u t r i t i o n ?

Wayne L. Pines/Editor

Harold C. Hopkins/Editor ial Director

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

'^Hypoallergenic" CosmeticsJoan M. Galloway/Managing Editor

Frederick L. Townshend/Product ion Mgr.

Tips on Molluscan Shellfish

Food! Ingredient Review: Where It Stands Now

Te e n s Ta k e t o C o n s u m e r E d u c a t i o n

News Highlights

FDA CONSUMER, the official magazine of theFood and Drug Administration, is publishedmonthly, except for combined July-August andDecember-January issues. Subscriptions may beordered from the Superintendent of Documents,Government Printing Office, Washington, D.C.20402, at $5.30 a year ($1.35 additional forforeign mailing).

A d d r e s s f o r e d i t o r i a l m a t t e r s : F D ACONSUMER, HFI-20, Food and Drug Administration, 5600 Fishers Lane, Rockville, Md.2 0 8 5 2 .

Articles published in FDA CONSUMER arein the public domain and text may be republished without permission. Use of funds forprinting this publication approved by theOffice of Management and Budget November1, 1972.

Regional Reports

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

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

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

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

Seizures and Postal Service Cases

Notices of Judgment

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

2 / June 1974 I FDA Consumer

Consumer Foriun

Myths of Vitamins

May I commend you for your efforts in dispellingsome of the lingering nutrition myths discussedso explicitly in the article, "Myths of Vitamins,"appearing in the March issue of FDA Consumer.Articles such as this provide much usefuli n f o r m a t i o n o n t h e n o r m a l r o l e o f v i t a m i n s a n dm i n e r a l s i n n u t r i t i o n .

However, there is a possibility of a communications gap in the sense that readersunfamiliar with such basic facts may also beunfamiliar with FDA policy concerning the roleof vitamin and mineral supplements asimplemented in the new regulations mentionedin your article.

Based on the queries we receive from bothconsumers and the press, we are well aware that

there is considerable misunderstanding on thisquestion. As yet, relatively few persons areclear on the fact that the new FDA regulationsestablish a "standard of identity" for dietarysupplements of vitamins or minerals, thus givingthe consumer the assurance that supplementsare properly formulated with reference to the U.S.Recommended Allowances, and that theseproducts are to be used to help assure completeadequacy of an individual's diet.

While nutritionists are cognizant that, ideally,a balanced diet provides an adequacy of essentialnutrients, they are also becoming increasinglyalert to the reality of modern eating habits, inthat more and more people do not regularlyconsume the idea l d ie t .

You may have seen some of the local pressreports last October at the time we held our

FDA Consumer / June 1974 / 3

annual press seminar. On that occasion, severalspeakers, including Senator [Richard S.]Schweiker [Senator from Pennsylvania, andmember of Select Committee on Nutrition andHuman Needs] and Dr. Paul LaChance,repeatedly referred to the rapidly changingpatterns of nutritional intake in this country. Dr.LaChance, who was the first director of theNASA space food program and is now at RutgersUniversity, emphasized that recent studies ofconsumer habits show that the homemaker islosing control over family nutrition through thegrowing tendency for eating out and for "fastfood snacks." Dr. LaChance also noted increasingsigns that "the ideal or traditional three mealsa day pattern of eating behavior is rapidlydisappearing." While acknowledging that many ofthese fast food meals consist of really goodfoods. Dr. LaChance stated that his own recentstudy of their nutritional content indicatesthat "these meals as eaten are also marginal invitamin A and/or C, as well as calcium andusually iron."

Fortunately, the FDA standard of identitycreates a class of vitamin and mineral productsfor use precisely when there is doubt that agiven diet provides the full spectrum of therecommended amounts o f these essen t ia l nu t r ien ts .

As you undoubtedly recall, this role forproducts marketed under the new regulations wassummarized by FDA Commissioner Schmidtduring hearings on the FDA regulations andrelated legislation before the Rogers Committeeon October 29, 1973. Commissioner Schmidtstated the FDA's policy as follows:

"We recognize, of course, that some peopledo not eat a balanced diet of ordinary foods andthat some people do not know what a 'balanceddiet of ordinary foods' means. This is one ofthe reasons we have published standards ofidentity for dietary supplements. We have noobjection to the promotion of dietary supplementsas 'insurance' against the possibility that theind iv idua l d ie t i s no t ba lanced or does not conta inall the essential nutrients. The regulations inno way prohibit claims of this type."

The value of supplements to insure the vitaminand mineral adequacy of a person's dietaryintake is further highlighted by the recentnutrition status survey released by the Departmentof Health, Education, and Welfare, entitledFirst Health and Nutrition Examination Survey.( H A N E S )

Data on dietary intake of four vitamins andminerals are included in this preliminary report.As you will note, this report covers exactly

the same vitamin-mineral insufficiencies cited byDr. LaChance. The survey shows amongadults 18-44 years of age the followingpercentage failure to meet the dietary standardsused in the survey:

N u t r i e n t M a l e F e m a l e

C a l c i u m 1 9 % 5 8 %I r o n 2 9 % 9 4 %V i t a m i n A 4 8 % 6 6 %V i t a m i n C 4 9 % 5 1 %

These data indicate that many persons fail tomeet the dietary standards used, which in theHANES study were either equal to or lower thant h e U . S . R D A .

Because of current misconceptions aboutnutritional standards, I hope that you will takethe opportunity of clarifying some of these pointsin one of your early forthcoming issues. I amwell aware of the problems of editorial space, butI am certain you will agree that the importanceof this subject matter to the consumer warrantsfu r the r c la r i fica t i on o f t he bas i s on wh ich

your agency spelled out the role of nutritionalsupplements—not as a magic elixir nor as asubstitute for foods, but as a recognized andaccepted means of "nutritional insurance."

Margaret MarkhamE x e c u t i v e D i r e c t o rV i t a m i n I n f o r m a t i o n B u r e a u , I n c .New York, New York

FDA does not oppose any person taking vitaminand mineral supplements. However, food isthe accepted and preferred source of nutrition.Diets based on a selection from a wide varietyof foods can provide an optimal diet. The dailyvitamin and mineral intakes from such diets arewithin the range provided for in the standardin FDA's dietary supplement regulation. If aperson is unsure of the nutrition content of hisdiet, a dietary supplement meeting the newstandard will provide the needed daily intake ofv i t a m i n s a n d m i n e r a l s .

Consumer Forum is an opportunity for you topresent your views about the issues discussed inFDA Consumer. Letters may be of any length,but the shorter, the better. We reserve the rightto edit letters to reduce the length. Send corie-spondence to Consumer Forum, FDA Consumer,HFI-25, Food and Drug Administration, 5600Fishers Lane. Rockville, Maryland 20852.

4 / June 1974 / FDA Consumer

ACofist imer Looks At FDA

7~' he present consumer movement has led to the creat ion

of many groups in Washington thatpresent a "consumer's" view to theFederal Government. As one of thelargest regulatory agencies, FDAhas its share of consumer advocacy.Cathy Sidzberger, executive director of Consumer Action forImproved Food and Drugs, is a24-year-old graduate of TuftsUniversity who has spent over ayear organizitig groups andindividuals who have expressedmte res t i n FDA ac t i v i t i es . I n t h i sinterview with the editor of FDAConsumer, Ms. Sulzbergerdiscusses the goals of the presentc o n s u m e r m o v e m e n t a n d h o w s h eas a consumer perceives FDA.

QMs. Sulzberger, you serve as• e x e c u t i v e d i r e c t o r o f C o nsumer Action for Improved Foodand Drugs. What does this organizat ion do?

A This is a grass-roots organi-. zation that is trying to organize people to have an effect onthe food and drug supply in thiscountry. We organize groups tow o r k w i t h b o t h t h e G o v e r n m e n tand industry to try to effect basicchanges in the food and drug supply.

Q.A .

groups throughout the country. Forexample, there is one group in theBronx that is concerned with drugsand pregnancy. That group startedits activities by looking at diuretics—drugs used to reduce the amountof fluid in the body—and then became interested in the larger question of drugs and drug labeling.

Another group, in Rochester,New York, is concerned with leadi n c o o k w a r e a n d t h e h e a l t h h a z a r dthat results. Through the efforts ofthat group and others, cookwarew i t h l e a d h a s n o w b e e n t a k e n o f fthe market. These are just two examples of the types of groups thatwe deal with and try to assist.

Q

How many groups has yourorganization helped thus far?

Up to this point, we've beena s s o c i a t e d w i t h a b o u t 1 5

Q. H o w d o y o u fi n a n c e y o u ra c t i v i t i e s ?

Do you supply these groupswith money?

A No. Our main help is with. information and legal advice,if they need it. We are in Washington and deal constantly with FDA,so if these groups need somethingfrom the FDA headquarters' office,we can get it for them more easilythan if they try to do it themselves.Or, if they want to deal with industry, they often seek us out for al i t t l e a d v i c e o n w h a t t h e i r fi r s t

meeting should be like.

A Right now we're supported• by a few individuals whohave given us money to sustain ourselves. But we're looking for othersources of support. We're going tostart a consumer magazine that willfocus totally on the food area. Themagazine will report on the activities of consumers, food sellers, andfood regulators, and try to generatea dialog among them. Hopefully,this will become a moneymakingventure as well as a good means ofcommunication. We're also lookinginto other means of support.

I think it's terribly important topoint out that industry in this country spends vast sums of money inWashington to present its view before the Government. Their money,of course, comes from the pricesthat consumers pay for their products. We aren't so fortunate to havesuch an easy means of financingand have to seek different ways tofi n a n c e o u r e f f o r t s .

QYour group is one of several• in Washington that has beenestablished in the past few years tod e a l w i t h F D A o r t h e f o o d a n dd r u g s u p p l y. B r i e fl y, w h a t o t h e rtypes of similar organizations existin Washington?

A Well, let me first point out. t h a t t h e r e a r e b a s i c d i f f e rences between our group and othersin Washington. The other groupsgenerally are concerned with all

FDA Consumer ! June 1974 ! 5

'7 wouldnt say Vm a consumeradvocate, except that I believe thatwhat I advocate is in thec o n s u m e r ' s i n t e r e s t . "

consumer problems. We are simplydedicated to trying to work in thefood and drug area. I believe thatfor us to have a strong affect, wec a n ' t b e c o m e t o o d i v e r s e . W e h a v eto be able to pinpoint what wewant to do and have a real targetand focus . We are a lso d i f fe ren t because we act as consul tants to otherconsumer groups working on FDAissues.

There are many other groupsthat are doing good work. For example, an organization called Concern, which is basically an environmental group, is now getting intofood questions as they relate topesticides, additives, hormones, andother potential environmental contaminants. There is also the Centerfor Science in the Public Interest,where Mike Jacobsen is doing aterr ific amount of work on nitr i tesa n d f o o d a d d i t i v e s . T h e o t h e rpeople in that organization areworking on other things, like energya n d t h e e n v i r o n m e n t .

Ralph Nader's FTealth ResearchGroup does some of the best consumer work in the food and druga r e a . A l s o , t h e C o n s u m e r F e d e r at i o n o f A m e r i c a h a s c o o r d i n a t e dconsumer OTC drug activities, andConsumers Union has a legal staffin its Washington office which isbeginning to do a lot more workwith FDA, especially by submittingpetitions for actions. They recentlysubmitted pet i t ions to FDA onSalmonella and drained weight. Another group, headed by Bob Choate,is coordinating a consumer conference in conjunction with FDA.

Those are the consumer groupsthat come most readily to mind.

QHow much contact do these• groups have with each other?Would you say that the consumergroups in Washington speak withone vo ice?

A Definitely not. Each of us• h a s d i f f e r e n t c o n c e r n s . B u tw e d o c o m m u n i c a t e w i t h e a c hother. Once a month, representatives of about 15 groups get together and try to hash out thethings that happened that month.W e b r i e f e a c h o t h e r o n w h a t w e ' r eall up to.

One purpose of this is that whenwe do deal with an agency likeFDA, we do want to have a unifiedplan. At the very least, we want toknow what each of us is doing sowe won't be springing anything oneach other. But very often we disagree among ourselves on thep r o p e r c o u r s e o f a c t i o n , s o i twouldn't be right to say that wespeak with only one voice. Thesemeetings are held to plan presentations for monthlv meetings whichh a v e b e e n h e l d b e t w e e n c o n s u m e r

groups and the FDA Commissionerfor the past 2 years.

Q Virtually all these Washing-• ton groups have just comeinto being in the past few years.Why this interest in FDA?

A One of the major reasons• that people became involvedi n F D A a c t i v i t i e s w a s b e c a u s e o fJ i m T u r n e r , w h o i s o n e o f t h efounders o f Consumer Ac t ion fo rImproved Foods and Drugs. Jimworked with Ralph Nader back inthe late 1960's and earlier in this

decade. His job was to focus onFDA. While he was working withRalph Nader, Jim wrote a bookcal led The Chemical Feast, whichgot a lot of people concerned andi n t e r e s t e d . M i k e J a c o b s e n t h e nwro te Ea te rs D iges t , and numerous studies were done of the quality,safetv, and price of the food anddrug supply.

I t h i n k t h a t b e f o r e t h a t i n f o r m ation was published, many peoplehad taken for granted that FDAwas really the consumer's friendand was really watching out for thec o n s u m e r . T h o s e b o o k s a n d o t h e r s

brought out that this wasn't quiteso. After that, a lot of groups beganto spring up and become very concerned about the quality and safetyof the food and drug supply in thiscoun t ry.

QYou personally have been• i n v o l v e d i n t h e c o n s u m e r

movement for about a year now.How did you get involved?

A First, I want to say that I• think everyone is involvedin one way or another for theirwhole lives. I've only been activefor about a year, but I've been involved and concerned much longerthan that. When I was in college,I became very interested in thewhole question of health care.After college, I worked for SenatorJ a v i t s a n d s a w m u c h o f t h e c o nsumer legislation that came into theoffice. I also saw enormous pressure—lobbying efforts—that wasgoing on against consumer legislation, and I really didn't understandwhy anyone would lobby, for ex-

6 / June 1974 / FDA Consumer

''People feel they have no access tothe Federal Government. They feelthat they can't affect any type ofpolicy decision. . . /'

ample, against a consumer productsafety commission or consumer protection in general.

Needless to say, my experienceson the Hill really stimulated myinterest. I couldn't understand whypeople would be against more prot e c t i o n f o r t h e c o n s u m e r . S o Idecided to find out more, and to dosomething about it.

QDo you have enough histori-• cal perspective to say howthe p resen t consumer movemen tdiffers from previous ones?

At can't really speak about• c o n s u m e r m o v e m e n t s t h a ttook place before I was born. ButI d o s e e d i f f e r e n c e s b e t w e e n t h e

present consumer movement as itexisted a few years ago, and as itexists now. A few years ago, consumers were merely trying to makethe public and industry aware oftheir concerns and complaints.There was a lot of screaming, a lotof publicity. And I think that wasabsolutely necessary.

Now, T think, consumers are becoming well educated about thesubject areas they're dealing with.They realize that they have to comein with good information when theytalk to industry and the Government. They have to try to showthese groups that by doing something different it will really be better business.

Q Ralph Nader Is always• described in the newspapersas a consumer advocate. Would youc o n s i d e r y o u r s e l f a c o n s u m e ra d v o c a t e ?

At don't like to think of my-• self as speaking for anyoneexcept myself. T am a consumer,but T wouldn't say T'm a consumeradvocate, except that T believe thatw h a t T a d v o c a t e i s i n t h e c o n s u mer 's in te res t .

QWhen you convey an opin-• ion to FDA, or to industry,are you speaking only for yourself,or are you trying to convey whatyou believe to be the concerns ofmany other consumers?

At am speaking for myself,• but T'm also speaking withthe knowledge that T've gatheredfrom letters we receive from peoplew h o a r e a l s o c o n c e r n e d a b o u t t h e s e

problems, and from informationfrom people T've spoken to aboutthese problems.

Q Taking this a step further,• there is criticism in Washington among Government employeesand industry that the people whop u r p o r t t o r e p r e s e n t c o n s u m e r s a r ereally representing no one but themselves. Could you comment on thatc r i t i c i s m ?

A Let me begin by saying that. we get a lot of feedbackf r o m w h a t t h e G o v e r n m e n t w o u l dconsider "ordinary" consumers—housewives, men and women whoshop in grocery stores, people withchildren. These people feel theyh a v e n o a c c e s s t o t h e F e d e r a l G o vernment. They feel that they can'taffect any type of policy decisionand can't change any policy.

We know this, because we goout to speak to these people. Forexample, Jim Turner spoke in NewYork and as a result we got 50l e t t e r s . T h a t ' s a l o t o f l e t t e r s f r o mone speaking engagement. Thatmeans that 50 people sat down tow r i t e t o u s a b o u t t h e i r c o n c e r n s .

They're not asking us for information, they're asking what they cando, how they can help. They'reexpressing concern about the foodand drug supply. They ' re conc e r n e d w i t h w h e t h e r t h e i r c h i l d r e na re ge t t ing bad baby food o rwhether they are being injured bydrugs.

So when we speak in Washington, we have some understandingof what the "ordinary" consumers—if T can use that term—really arec o n c e r n e d a b o u t a n d w a n t t o c o n

vey to the Government. So while Tpersonally do not claim to speakfor anyone but myself, T think it'simportant for people in Washingtonto recognize that all of us do havec o n t a c t s w i t h c o n s u m e r s a n d d o

speak with some knowledge aboutwhat people are concerned about.

QAre the people who are writ-• ing letters to you really representative of the way most Americans feel, or are they in a sense aspecial interest group?

At think every mother and• f a t h e r i s c o n c e r n e d w i t h t h e

safety and health of their children.T think every person is concernedw i t h h i s o r h e r o w n h e a l t h . T t h i n k

people are concerned with gettinggood nutrition from food. T thinkpeople are concerned about paying

FDA Consumer / June 1974 / 7

''When people learn that the systemis not all it's cracked up to be . . .they do show a great interest."

high prices for sugar-coated cerealwhen they could just as easily payless and add a teaspoon of sugar.

I think people today are concerned. Not just the well educated,but all people. The recent increasein the price of food caused by inflation is making people even moreconcerned about the safety and nutritional quality of foods.

I also think that most peoplethink that foods are safe, and thatwhen a physician prescribes a drug,he knows what he's doing. Whenpeople learn that the system is notall it's cracked up to be, that peoplel i k e u s h a v e r e a l c o n c e r n s a b o u tthe quality and safety of the foodin this country and about the waydrugs are being used, they do showa great interest.

Let me give you a few specificexamples. There was a petition filedconcerning the way the contraceptive drug Depo-Provera was beingadministered and the way peopleare informed. People were beingdeceived about what was beingdone to them and the risks theywere taking.

The group in the Bronx I spokeo f e a r l i e r b e c a m e c o n c e r n e d a b o u tdiuretics after a pregnant womanhad taken a dosage jour times aslarge as she should have. After shehad the baby, she didn't lose anyweight, and began to think thatthere was something wrong. It wassoon discovered that the pharmacist misread the prescription, andthe physician never bothered checking.

Another example involves Label,a group we work very closely with.A few years ago they filed a peti

tion to require full ingredient labeling on foods. This petition generated 7,000 personal letters toFDA in support of the petition,plus many, many others to us directly—and massive press coveragethroughout the country.

So, to answer your question, yes,I do think we represent a specialinterest group. We try to representspecial interests of the consumer.This is people expressing concernfor things over which they have nocontrol themselves, but over whichthey would like control, throught h e i r G o v e r n m e n t .

QYou have indicated that peo-• pie seem frustrated by theirinability to have an impact on Government. To what do you attributethis frustration?

A I think people are frustrated• because whenever they seethe news or read a newspaper, theyget the feeling that the only peoplewho really have an impact are thepoliticians or the lawyers who represent special interests. I thinkmany people today really feel impotent. This is especially true ofpeople outside Washington, whow a n t t o a f f e c t h o w t h e G o v e r n m e n treacts but who feel that they reallyc a n ' t .

For example, with respect toFDA, a lot of people feel that theyreally can't have any effect on whatFDA is doing. They can't afford tohave a high-priced lawyer or Washington representative. They don'th a v e a t r a d e a s s o c i a t i o n . A n d h o woften can they see their Congressman, and have that Congressman

really address himself to an issue?I t h i n k t h e r e i s r e a l f r u s t r a t i o n i n

this country about the Government.One of the things we're trying to dois to show people that they canhave an impact. We want to showthem that it's not just up to theirCongressman or other leaders. Theyt h e m s e l v e s c a n l e a r n a b o u t a s u b

ject, and learn there are ways to approach things which can have justas much effect as do the ways ofanyone else.

QDo you believe that the• regulatory system is working?

Alt's not working very well.• It works at a very slow rate—and it works for special interestsa lot of the time. You know, lobbyists in Washington who representi n d u s t r i e s h a v e i n c r e d i b l e a m o u n t sof money behind them, and they'reable to have their voices heard. Thec o n s u m e r s i n t h e fi e l d d o n ' t h a v ethat kind of money. They don'th a v e t h e c h a n c e t o c o m e t o Wa s h

ington and be heard. We want tom a k e s u r e t h a t c o n s u m e r s d o h a v ethe opportunity to be heard inWashington and have as much influence on what's going on as industry does.

QThe way the Government is• set up, FDA itself is supposed to represent the public interest. Do you believe that it does?

A I think an organization like• FDA has problems built intoit. FDA is influenced to a large extent by the industries it regulates.

8 / June 1974 / FDA Consumer

' 'An organization like FDA hasproblems built into it. . . . We haveto try to make FDA understandthe kinds of issues consumers thinkare important."

It is natural for an industry regulated by any agency of the FederalGovernment to try to influence itsd e c i s i o n s .

What we're trying to do is toc o u n t e r a c t s o m e o f t h a t i n fl u e n c e

by bringing to FDA's attention thev i e w s o f c o n s u m e r s . W e h a v e t o

try to make FDA understand thekinds of issues consumers think areimportant. We have to impressupon the people at FDA that theregulated industries are not theonly ones who care about what isbeing decided about foods anddrugs. Consumers care, too.

W e w a n t F D A t o h a v e c o n s u m e r

interpretations of what needs to bedone, and also whatever information consumers can supply to FDAwhich will make its decisions morein the public interest. I think atpresent some of the available inf o r m a t i o n n e v e r r e a c h e s F D A .Other information rel ied on byFDA comes from heavily biased in-dustrv sources. We're trying toequalize the balance of power.

There are other ways also thatFDA can be helped to better represent the public interest. We canoften be an innovative force by giving FDA new ideas about issuest h a t c o n s u m e r s a r e c o n c e r n e d w i t h .We can give FDA support for extremely hard decisions that mayhave a strong economic impactagainst what industry wants. I thinkt h a t f o r F D A t o w o r k o n s o m e i ssues it needs to have a strong consumer input, and that's what we'retrying to give it.

QWhat do you hope to ac-• compV.sh by your efforts?

A The goal, of course, is to• assure a safe food and drugsupply. We're also trying to makethe Government more responsive tothe needs of the consumer, and tomake the consumer voice strongenough so that Government knowswhat those needs and concerns are.

I think it's important to point outthat while we're dealing with FDAon these issues, we're also dealingwith industry in the same manner.We want our local groups to workwith industry on economic andmarketing issues, so that we canconvey our views to all sides.

One thing that we do want to dois to establish consumer food anddrug groups in all 119 cities wherethere are FDA offices or res identinspection posts. The purpose ofthese groups would be to serve aswatchdogs over the industries inthese areas and to tingle the nervee n d s o f F D A .

We also want to make sure thatevery time industry tries to influence FDA, we have a chance toanswer it. This is not to say thatwe are always opposed to what industry wants. In fact, we want towork with industry where possibleto ensure the safety and quality offoods and drugs. But we do wantt h e G o v e r n m e n t t o k n o w t h a t t h ec o n s u m e r w a n t s a v o i c e i n w h a tthe Government is doing.

QAs a result of your activities,• do you think FDA is moreresponsive to your needs?

A Some of FDA's new policies• are working. For example, Ithink it's very helpful that FDA has

e s t a b l i s h e d a n A d H o c C o n s u m e rC o u n c i l t h a t m e e t s w i t h t h e F D AC o m m i s s i o n e r o n c e a m o n t h t od i s c u s s i s s u e s t h a t i n t e r e s t u s . T h i s

gives us a chance to present to thehighest FDA officials, including theCommissioner, our concerns and toask questions. I don't think anyvital information is passed or anyvital decisions made, but i t is important that contact and interactiontakes place.

B u t I s t i l l t h i n k F D A h a s t omake more of an effort to bringconsumers and outside scientific experts into the highest levels of itsdecision-making.

Another area where FDA needsto improve is in the release of information to the public. FDA nowsays that 90 percent of the informat i o n i n i t s fi l e s c a n b e r e l e a s e dunder the Freedom of In format ionAct. Unfortunately, FDA has implemented this policy in such a wayas to make it very hard for consumers to u t i l i ze the in format ion.Some of our requests involve agreat expense to us.

I t h i n k w e ' d l i k e t o f e e l t h a tFDA was saying, "Here's the information, we'll try to help you useit and collate it. We'll try to giveyou direction if you want it. We'lltrv to show vou where things are."This is what FDA can do if it reallywants to open up its decision-making processes to scrutiny by cons u m e r s . W e V e e v e n m a d e a d etailed proposal for such an effortand have waited more than a yearfor an FDA reply.

QWhat else would you do to• improve FDA as it relates

FDA Consumer / June 1974 / 9

"We also want to make sure that

every time industry tries toinfluence FDA, we have a chanceto answer i t . "

t o the consumer?

A In a bureaucratic structure• like FDA, things tend to bestaid and not to move too quickly.They tend to work along existingguidelines and existing patterns. It h i n k t h a t s o m e h o w F D A h a s t obreak out of its patterns and guidel ines and become more flex ib le .

Also, I think it's extremely important that someone at the highestlevels of FDA represent the consumer viewpoint. The tendency forFDA has been to say that it repr e s e n t s t h e c o n s u m e r a n d i t n e e d sno further consumer representation.I think that's not so, and I'd like tosee someone in high levels at FDAwhose sole job is to represent cons u m e r s .

I th ink a lo t o f the mis t rus t abou tF D A s t e m s f r o m t h e f a c t t h a t anumber of high FDA officials comefrom industry. They come from thefood industry, the drug industry, orare lawyers who have representedthe industry and are now comingto FDA and claim to represent thepublic interest. I think it's very unrealistic for us to accept the factthat people who have worked withone point of view for so long canall of a sudden change their perspective and work effectively on behalf of the public interest.

I'm not suggesting that the people who come from industry towork for FDA are in any way dishonest. Usually, they're not. But 1do think that people from industrycome to FDA with biases, and thenm a k e d e c i s i o n s b a s e d o n t h o s eb iases.

Also, these people who once

w o r k e d f o r t h e i n d u s t r i e s h a v ef r i e n d s i n t h o s e i n d u s t r i e s a n d t e n dto be sympathetic toward them.Thev get a, lot of their informationfrom those people because theyk n o w a n d t r u s t t h e m . T h a t r e s u l t si n a n i m b a l a n c e o f i n f o r m a t i o n a n d

perspective which we're trying tocorrect bv bringing another viewpoint to FDA.

Qlt is a fact that some FDA• employees have worked forindustry. But you do want peoplewidi experience in food and drugproduction, because they have thebest backgrounds to understand theissues confronting FDA, Do youwant FDA to hire people who areunfamiliar with the industries regulated by the Agency?

A Not at all. We do want the• best experts in the food anddrug area. But it seems to me thatsomeone whose total work experience has been in industry has a bias,and i t wou ld be a be t t e r a l t e rna t i veto trv to hire people who don'thave any biases. There are a goodmanv people outs ide of the foodand drug industries who have expertise, skill, and knowledge todeal with these problems. Thereare State and local food and drugofficia ls, many of whom have excellent qualifications to be Federalregulators. There are research scientists throughout Government—att h e N a t i o n a l I n s t i t u t e s o f H e a l t h o rat the Agricultural Research Service, for example—who are highlyskil led in detailed aspects of foodand drug regulation. There are citypublic health officials who increas--

inglv find themselves working withconsumer groups to correct foodand drug health problems. There iseven a growing number of professionals who have aligned thems e l v e s d i r e c t l v w i t h c o n s u m e r a n dpublic interest groups, such as theEnvironmental Defense Fund, Publ ic Ci t izen, Inc. , and CommonC a u s e .

None of these sources is tappedin anv meaningful wav for FDA orother regulatory agency employment . Indus t ry i s cons is ten t l ytapped. This raises serious questions about FDA's understanding ofits obligation to protect and represent the public interest.

QAre there any specific issues• that voiFre dealing with nowon which you think FDA is wrong?

A Let me just mention two.• One i s the who le i ssue o ffood labeling. I believe the lawshould require full ingredient labeling for all foods, including a listingof the type of colors, flavors, andspices, both artificial and natural,in the product. There are manypeople who are allergic to certainkinds of foods, and many otherp e o p l e w h o w a n t t o a v o i d s o m ekinds of ingredients.

If FDA feels that it needs morelegislative authority to carry out itsfood labeling authority more responsibly, then I think FDA shouldask Congress for that authority.

The second is the issue of foodadditives. Many of these additivesmay cause cancer. I believe stronglythat the public should know it isbeing exposed to a potential cancer

10 ! June 1974 ! FDA Consumer

''Industry has to recognize quitesimply that positive reaction toconsumer needs is really goodbusiness. . .

risk. It seems to me that anyones h o u l d h a v e a c h o i c e o f t h e k i n d sof food they want to eat, but at thesame time, they should be awareof the potential dangers of thosef o o d s .

People don't know about nitritesand nitrates. They don't know ofthe possible problems of certainartificial colors and flavors. Theydon't even know what foods they'rein. FDA just doesn't seem to be asconcerned abou t th i s who le i ssue asw e a r e .

Q You've spoken about how• you perceive FDA and itsreact ion to consumer needs. Howwell does industry respond to yourpositions?

At think industry does per-• ceive the need of consumersfor certain things, but very often isafraid of what's going on becauseof what might happen to its economic position or security. Thisis why industry often thwarts goodregulations.

I th ink that industry has torecognize quite simply that positivereaction to consumer needs is reallygood business, and that the companies that are going to make themost profits are those that respondmost progressively to what consume r s w a n t . T h i s i s t r u e a l s o i n t h earea of regulation. A company thatfavors industry-wide regulation fav o r a b l e t o c o n s u m e r s w i l l i n t h e

long run do better than a companythat opposes every attempt at regulation. Surprisingly, in some instances we've found industry to bemore responsive than FDA.

Now, there are specific caseswhere I think industry is still backwards. For example, in the wholearea of prescription drugs, the public is clamoring for informationabout prescript ion drugs. EvenFDA is talking about having patient package inserts so that consumers will know about prescription drugs. But the industry reaction is to increase the warnings onthe labeling that goes to doctorsand to ignore the fact that this isn'thelping the patient, because doctorsjust don't have enough time anymore to talk to patients aboutprescription drugs.

Another example: There was anenormous argument by the food industry when nutrition labeling wasbeing developed on how the labelss h o u l d b e w r i t t e n . T h e f o o d i n d u s -trv was scared of saying on thelabel that a particular food has nov i t a m i n A o r v i t a m i n C o r a n o t h e rnutrient. What we were fighting forw a s a s t a n d a r d i z e d l a b e l t h a t w o u l dtell the consumer exactly what was,and what wasn't, in the food product, and industry fought very hardagainst that kind of honest andforthright labeling.

I think it's very important forc o n s u m e r s t o r e a l i z e t h a t i f w e

really want to effect change, wehave to develop enough of a relationship with industry so that wec a n s i t d o w n w i t h t h e m a n d d i s c u s sour concerns. We're doing fairlywell in the food area, and have hadmany constructive meetings withc e r t a i n t r a d e a s s o c i a t i o n s . W e ' r ealso talking with a number of individual firms, and they're beginning to understand what our con

cerns are. They may even be beginning to respond.

QThe history of consumer• m o v e m e n t s i n t h i s c o u n t r yhas been one of cycles. The consumer movement i n the ea r l y1900's, for example, led to the passage of many laws, but then diedout. So too with the movement ofthe 1930's. What future do you seefor the present consumer movem e n t ?

A The movements in the early• 1900's were real ly smal lbusiness movements. The gains thec o n s u m e r s m a d e i n t h e 1 9 3 0 ' s d i dn o t d i e o u t b e c a u s e o f l a c k o f i nterest, but because the SupremeCourt challenged the legality of certain economic issues that had veryl i t t l e t o d o w i t h r e a l c o n s u m e r i ssues. I think that if the presentmovement is to survive, we have toc o m b i n e o u r f o c u s o n G o v e r n m e n twith a focus on industry. Industryis going to have to develop thetypes of programs and policies thatf a v o r t h e c o n s u m e r.

I 'm not going to predict thatevery group now active in the consumer movement is going to survive.But I haven't seen any die out yet.And I think the movement is getting stronger, because people arebecoming more educated abouttheir rights in the marketplace, andare demanding that Governmentand industry respond to their needs.

I t h i n k a l o t m o r e n e e d s t o b e

done, but a lot has been done, andw h a t I ' v e s e e n t h u s f a r h a s b e e n

encouraging from both industry andG o v e r n m e n t .

FDA Consumer / June 1974 f 11

What Do ConsumersK n o w A b o u t M i t r i t i o n ?by H. Neal Dunning

FDA surveyed consumers to findout what they know aboutnutrition. Most food shoppers werefound to have a workingknowledge, with West Coastshoppers and younger groupsscoring high.

Does where consumers live affect what they are likely toknow about nutrition?

Does age necessarily bring withit nutrition wisdom?

Are there important facts aboutnutrition consumers have neverheard, or maybe don't believe, orsimply disregard?

A n d h o w m u c h d o c o n s u m e r sreally know about nutrition as opposed to how much they think theyk n o w ?

FDA conducted a nationwidesurvey in the last 4 months of 1973to find some of these answers. Thepurpose of the survey was to determine how much nutrition educationthe consumers need, who needs itmost, and how to get it to them.

The results will establish a baseline of current nutrit ion knowledgeand wi l l be used to measure the

effectiveness of programs such asnutrition labeling.

This article presents the firstfindings of the survey. Articles insubsequent issues of FDA Consumer will include more details ofconsumer knowledge, attitudes, andinterest in labeling.

The survey consisted of 92 questions posed to 1,500 persons with

primary responsibility for food purchases for the i r households. Participants were chosen on the basisof probability sampling. In other

words, the participants were selected to represent all consumerswith primary food purchasing responsibility.

The sampling was from every region of the country, representinga l l i ncome and educa t i on l eve l s ,ages, etc. Tt was conducted underan FDA contract with the ResponseAnalysis Corp., Princeton, New.Jersey.

The survey showed that foodshoppers today have a workingknowledge of nutrit ion. Youngershoppers and those with a collegeeducation were most likely to knowm o r e a b o u t n u t r i t i o n .

The survey emphasized that thestrongest educational efforts needto be aimed at the poor, the old,the less educated, and minorities.

Participants were asked to present a "self-concept" of how muchthev thought they knew about nutrition, rating themselves on a scaleof one to 10, with 10 being theknowledge equivalent of a practicing nutritionist. One-fourth ratedthemselves low, one-third high, and43 percent in between.

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

FDA Consumer ! June 1974 ! 13

person has, the more he thinks hek n o w s a b o u t n u t r i t i o n — a n d , i nfact, often does know. How a person rates his own knowledge of nutrition turned out to be a good indicator of actual knowledge.

Where people live had an effecton their nutrition knowledge. Almost half the West Coast shoppersthought they knew "quite a bit"a b o u t n u t r i t i o n — a n d i t t u r n e d o u t

they did. Only 30 percent in thenorth-central part of the countryrated themselves in this group.

About 1 percent of those surveyed have to start their nutritioneducation from scratch. They saidthey'd never heard of protein, fat,calor ies, vi tamin C, calcium, iron,and vitamin A. These few negativeresponses have little statistical significance. More importantly, however, 16 percent were unfamiliarwith riboflavin (vitamin B-2). Niacin was a close second in nonrecog-nition, with 12 percent reportingthev were not familiar with it.

About half the participants saidthey understood everything on asample nutrition label, and three-fourths had heard of all the nutrients listed. And in exploring further .how well consumers will accept nutrition labeling, positive attitudes,knowledge, and eagerness for thelabels were confirmed.

For example, half of all foodshoppers believe they will benefitconsiderably from nutrition labeling, and an additional 35 percentbelieve they will benefit "a little."Younger, better educated, or employed homemakers are the mostinterested in nutrition labeling. Participants stated they believe themost l ikely benefit of nutr i t ionlabeling will be in helping themchoose more nutritious food.

Consumers were also askedabout nutrients they would expectto find in the four major foodgroups (milk, meat, fruit/vegetables, and bread), what their function is for good health, and whatother foods are good substitutes inproviding the same nutrition.

Apparently a lot of consumersrealize "there's a new you comingeveryday," because 76 percent-

knew milk is a good source ofcalcium and that it builds strongteeth and bones. They also werea w a r e t h a t f a i r s u b s t i t u t e s f o r m i l kare cottage cheese, eggs, peanutbutter, and fish. Forty-two percentrecognized milk as a good sourceof vitamin D and protein.

Meat was also an area of highknowledge. Most people realized itsimportance in providing proteinand its value in building bloodcells, muscle tissue for growth, andrepair of body tissues.

Those interviewed were considerably weaker in knowing that meatis also a good source of fat, iron,and calories. But awareness of goodsubstitutes (eggs, peanut butter,navy beans, cottage cheese) waswidespread.

The importance of enrichedbread in the diet seems to be wellaccepted. Nearly half of those sur-veved recognized it as an importantsource of carbohvdrates and calories, 33 percent knew it containedriboflavin and thiamine, and 24percent realize it is a fair source ofniacin and protein. Most peoplealso realized the value of macaroni,oatmeal, and potatoes as substitutes,with a little under half of those interviewed listing rice.

Nutrition knowledge about vegetables was at the bottom. Peas werethe sole subject of questions aboutthe vegetable/fruit group, becauseinterviewers decided peas were the

14 / June 1974 jFDA Consumer

best example of a vegetable leastlikely, for a variety of reasons, tocause some confusion to surveyparticipants. The survey participantsalso appear to have little interest invegetables and fruits. This part ofthe test mav need some rethinkingunless detai led studies show thatthis was a typical response to vegetables in general. Only about aquar ter o f those in terv iewed sa idthev knew peas are a good sourceof carbohvdrates and vitamin A,tha t they con t r i bu te to hea l th o fskin and eyes, and that good substitutes are string beans or carrots.

Not only did the Agency seek tofind out how much consumers already know about nutrition, butalso where they were getting theiri n f o r m a t i o n .

The people who really knew themost about nutr i t ion said theyl e a r n e d a b o u t i t i n s c h o o l . N o t s u r

prisingly, this response was directlyl i n k e d t o e d u c a t i o n a l l e v e l , b u tnearly half who knew the mosta b o u t n u t r i t i o n h a d n o t g o n e t ocollege. School as a knowledgesource ranked highest, with 41 percent of shoppers.

The next largest group (31 percent) said their information sourcesare magazines, while 24 percentl e a r n m o s t a b o u t n u t r i t i o n f r o m

newspapers. "Mother" as a fountof nutrit ional knowledge rankedfourth (14 percent), just ahead oftelevision programs and diet books,each at 12 percent.

The survey confirms the need forfur ther educat ional e ffor ts on nutrition. In a sense, the survey information will be "recycled" andpresented to American consumersin terms of nationwide efforts aimedat the various educat ion levels ofknowledge revealed by the interv i e w s .

Some of these educational effortshave been started by FDA's consumer affairs officers throughoutthe country, who are scheduled tohold some 600 workshops on nutrition labeling this year, directlyreaching about 60,000 persons. Indirectly, however, more will bereached through these programs,because many workshops are for"multiplier groups" such as dieticians, teachers, and extension agents—in other words, people who willlater relay what they learned toother groups and organizations.

Results will also be provided tothe Sena te Se lec t Commi t tee on Nutrition and Human Needs, which islooking into the progress made nationally in nutrition since the WhiteH o u s e C o n f e r e n c e o n F o o d a n d

N u t r i t i o n i n 1 9 6 9 . I t w a s t h i s c o nference that highlighted the needfor programs such as nutr i t ionlabeling and consumer education.

While the survey serves as aguide for future decisions, it hasalso provided feedback on past action by Government. The generalpicture is that consumers feel Government IS doing a lot in the foodfield, but could be doing better.

For instance, 77 percent believeGovernment tries to see that packaged foods are safe, but efforts toensure honest advertising showedsomewhat less confidence, with 56percent believing Government triesto do this. Almost all (97 percent)t h i n k m o r e s h o u l d b e d o n e i n b o t ha r e a s .

About 40 percent of the participants believe Government makessure food is good and nutritious.But, again, 85 percent feel theGovernment should be doing morein this area.

Further findings that will in partshape what more the Governmentwill be doing will be presented insubsequent issues of FDA Cons u m e r .

H. Neal Dunning, Ph.D., Isdirector. Division of ConsumerStudies, FDA Bureau of Foods.

FDA Consumer / June 1974 j 15

^llypoallergefiic''C o s m e t i c s

The prefix ''hypo" means "lessthan" The claim "hypoaller genie"means significantly less chanceof adverse reactions than otherproducts. FDA proposes to requireproof of such claims by comparisontesting.

The jar of cream you're considering is labeled "hypoallergenic."Next to it is a similar product marketed as suitable for "sensitive skin."Another points out it has been "allergy tested." And still another refers to being "less irritating." Theyshare display space with many otherproducts that make no such claim.

Is there necessarily any difference? If so, how much? And if youchoose one for which there's a special claim, specifically what do youexpect to be protected from—andcan you expect complete protection?

The Food and Drug Administration has proposed a definition forthe term "hypoallergenic," whichwill apply to all such similar claims,and has also proposed the claims besubstantiated by appropriate testing.T h e P r o b l e m

During its near-half-century of use,the term "hypoallergenic" has meantdifferent things to different people—consumers as well as manufacturers.

Some consumers took it to mean"nonallergenic," when actually itonly means the product should beless likely to cause adverse reactions. There is no known way todayto produce a cosmetic by whichsomeone somewhere will not be adversely affected.

At the same time, most consumers do not have the medical knowl

edge to distinguish between allergicand nonallergic reactions. They consider a hypoallergenic product asone producing no adverse reactions.

Meanwhile, industry has proceeded with its own varied criteriafor what should constitute a "hypoallergenic" product. Many manufacturers simply omit from their products perfumes or other ingredientsthey believe may cause problems.

Some perform patch testing withthe finished product in various sizesof panels and according to varioustesting procedures and label theirproduct "hypoallergenic" dependingon resu l ts .

Others use the term "hypoallergenic" on the basis of a low rate oftrue allergic reactions, and othersuse it on the basis of all adversereactions encountered during testsor reported by users after marketing.

T h o s e m a n u f a c t u r e r s w h o d ocarry out clinical testing differ greatly in the number of subjects theyuse for tests, and none are knownto test their products in comparisonwith products that do not makesuch claims. Neither are the testsknown to be carried out to establish any statistical significance between hypoallergenic and conventional cosmetics' rates of adverser e a c t i o n .

On top of this range of problemsfor the special claims comes theopinion of the Committee on Cutaneous Health and Cosmetics of theA m e r i c a n M e d i c a l A s s o c i a t i o n t h a tthe term "hypoallergenic" as it pertains to cosmetics has outlived itsusefulness, is misleading, and shouldbe dropped from the labeling of cos

metic products, because most firmshave removed common allergy-causing and primary irritants fromtheir products.T h e S o l u t i o nThese problems fell not on deafears. FDA is attempting to clear upthe whole matter and published aproposal in the Federal RegisterFebruary 25. The proposal says:1. A product may be labeled "hypoallergenic" or may use other descriptions of similar implication("allergy tested," "safe for sensitiveskin," "less irritating," etc.) only ifscientific studies on human subjectsshow a significantly lower rate ofany type of adverse skin reactionwhen compared with other similar-use conventional products.2. The convent ional competingproducts used in the tests musteither be one of the three top salesleaders for the type of producttested or may be a group of severalproducts which combined make upa share of at least 10 percent of themarket volume for the type of product tes ted .3. The tests must be conducted inaccordance with recognized derma-tological testing procedures adequate to determine adverse react i o n s .4. A claim of hypoallergenicity thatis found, then, to be justified will beconsidered valid for 5 years aftertesting provided:

A. There is no change in theformula of the product for whichthe c la im i s made .

B. All tests results are submittedt o F D A .

C. No data submitted by themanufacturer or by any other inter-

FDA Consumer j June 1974 f 17

ested party show the claim isn'treasonab le .5. If a hypoallergenic type claimis found to be unjustified for a product, the product can't continue to beshipped in interstate commerce withsuch claims on the label. However,recalls of the product already ont h e m a r k e t w o u l d n o t b e u n d e rtaken. In other words, stocks thathad already left the manufacturer

before an FDA decision would beallowed to be used up; but replacement stocks would have to carrynew labeling.6. After this ruling is published asa final order, any new products carrying such claims would have to beproven to the FDA as justified before marketing. But products already on the market when the orderis published will have 2 years inwhich to prove the claims.7. Companies will not be able touse FDA approval of a claim toimply Agency endorsement of aproduct.8. No product claims will be allowed to imply complete absence ofadverse reaction potential or complete safety.O t h e r V i e w sPublished by FDA at the same timeas the proposal were reactions proand con f rom the Federa l TradeCommission (FTC) and some fromthe cosmetic industry.

FTC feels the proposed regulation isn't stringent enough andwould l ike to see such terms as"safe for sensitive skin" or "medically proven" dropped entirely because, the Agency says, they gobeyond implications of hypoallergenic and suggest complete safety.FTC also would like to see the following statement included on produc t l abe l s :

''Less likely to cause allergic reactions than some competingproducts. If you have a historyof allergic reactions to cosmetics,your physician can recommendcosmetics most suitable for you.*'On the other side of the coin,

industry opposition, lead notablyby the Almay Corporation, "agrees

that a standard for hypoallergeniccosmetics is desirable but opposescomparative testing." Almay statesthat such an approach is impracticaland unenforceable because: 1) amanufac turer wou ld be unab le todetermine whether competing products used in comparative testinghad changed the i r fo rmula orwhether samples of those productsused were even representativebatches of the competitor's product; 2) a competing productwhich was in fact hypoallergenic byall test standards but simply chosenot to make such a c la im wou ldpreclude use of the claim for othercosmetics in the same product category. In other words, the productcarrying the hypoallergenic claim,when tested against the type mentioned above, might not, in fact,be able to prove it was significantlybetter than the product that didn'tm a k e t h e c l a i m .

Both the Almay Corporation andthe Cosmetics, Toiletry and Fragrance Association (CTFA) statedthat some sort of testing of theproducts would be appropriate.CTFA suggests that a panel of scientists from industry and academiabe convened to determine predictive skin test methods to be used;and Almay l is ted five di fferenttypes of tests to "demonstrate aminimum irritancy commensuratewith the product function."

At issue, then, is whether cosmetics making hypoallergenic and similar claims should be required toprove they're significantly differentfrom products making no suchclaims. Should they be required tocompare their products with othersthat claim no such special qualities?

18 ! June 1974 / FDA Consumer

Tips OilM o l l u s c a n

S h e l l fi s h

Oysters, clams, and mussels addvariety to the diet. But they arehighly perishable and should bebought carefully.

Chances are good that sometimethis year among the items inyour grocery cart will be one whichin its natural growing state "drank"20 quarts of water an hour! Whaton ear th?

Just an oyster.Or you may decide to buy

oysters' "neighbors," clams andmussels, which are also filter-feeding shellfish that pass largequantities of water through theirbodies, absorbing micro-size foodand oxygen and cleaning awayw a s t e .

The condition of the waters inwhich oysters, clams, and musselsgrow, and the safety and sanitationmeasures used in their harvesting,processing, and transportation, areconcerns of the Food and Drug

Administration's National ShellfishSafety Program.

But once oysters, clams, andmussels arrive at your store, yourown vigilance in selecting thesehighly perishable delicacies comesinto play.

The best efforts of Federal, State,and local governments and ofconsumers combine to present afood that is nutritious and awelcome change of pace in the diet.

Before They Come to YouMore than 1,000 Federal, State,and local officials are involved invarious aspects of the NationalShellfish Safety Program to ensurea safe product, both domestic andimported. The States bear the bruntof the responsibility, but fiveactivities are controlled orsponsored by FDA.

1 . F D A e v a l u a t e s S t a t e a n d

foreign programs to see that theymeet the guidelines of the National

Shellfish Safety Program. Theseguidelines cover all areas of safetyand sanitation of the product. Theyare constantly being revised toconform with new knowledge, suchas improved methodology forassessing safety or environmentalchanges. FDA provides a mobilelaboratory for on-the-spot fieldstudies and for lending technicalassistance to States.

2. FDA trains State and foreignofficials, as well as workers fromother Federal agencies, inprocedures for surveys of areaswhere shellfish grow, microbiological methods to evaluatetheir safety, and procedures fors a n i t a t i o n c o n t r o l .

3. FDA provides similar servicesto other countries which exportfresh or fresh-frozen products tothis country or are consideringdoing so. Fresh and fresh-frozenoysters, clams, and/or mussels areimported from Canada, the

Republic of Korea, and theHiroshima Prefecture of Japan, allof which have been certified throughthe national program. Consideringparticipation are Mexico, NewZealand, and Iceland.

4. FDA sponsors and conductsresearch to improve criteria andstandards for determining shellfishsafety. This research includeschemistry, microbiology, andtoxicology.

5. FDA publishes lists ofcertified interstate shippers of theseproducts to advise wholesale buyersof approved suppliers. This listgoes to more than 6,000 marketsevery 2 weeks and includes 1,200to 1,500 certified shippers,depending on the season.

Y o u r J o bWhile sanitary control is a task ofGovernment, there are a few rulest h e c o n s u m e r s h o u l d f o l l o wwhen purchasing shellfish.

1. Buy fresh or frozen oystersand clams only from reputabledea le rs .

2. Look for a permanentidentification marking on thecontainer showing a Stateabbreviation followed by a number.This marking is put onto everycontainer produced under propersanitary controls. Never buyshellfish in unmarked containers,or untagged baskets of shelloysters or shell clams.

3. Oysters and clams purchasedin the shell should be tightly closed

and kept under refrigeration, butnot frozen. If they gap and do notclose when tapped, they are notal ive and should not be eaten.

4 . Shucked she l l fish shou ld be

kept under refrigeration, 32° to40° F., at all times and eatenwithin a few days after purchase.Many home refrigerators' maincompartments are above 45 ° F.You can check yours by putting anindoor-outdoor thermometer in aglass of water placed in therefrigerator and reading it thenext day.

5. If you plan to dig or gathershellfish for your own use, becertain the waters and beaches areclean. You can find out whichareas are safe from your local

Enlarged filters on these clamsindicate they are "sick" and shouldnot be eaten.

When buying shellfish, avoid sackswith no identification. Look fortags with a State abbreviation andcode number on each unit,indicating production under propers a n i t a r v c o n t r o l s .

Standards for determining safewaters from which to harvestshellfish are developed jointly byFDA and State governments.Unsafe areas are posted andpatrolled to prevent unacceptableharvesting.

health agency or State shellfishcontrol agency.

6. In the event you shouldexperience any food illnessattributed to eating molluscanshellfish, report the problem to thelocal heath department or nearestF D A o f fi c e .

7. Never buy frozen shellfishdisplayed above the frost line insupermarkets. Frozen shellfishshould be solidly frozen whenpurchased and kept frozen untiljust before preparation. Never thawand refreeze molluscan shellfishbecause the texture and qualityis destroyed.

8. A common misconception isthat oysters and clams should beeaten only in the "R" months. This

old tale came about because in thes u m m e r m o n t h s s h e l l fi s h a r e

spawning and not so plump. Also,in the early days, the lack ofrefrigeration during shipping andslow transportation made it difficultto get a good quality product tosummer markets. Today, modernrefrigeration and good transportation make shellfish more readilyavailable year round.

9. Buy only the quantity of afresh product that you expect touse in a few days.

10. If the supermarket methodof display or label on any molluscanshellfish product seems objectionable, tell the store manager.Molluscan shellfish are highlyperishable.

C o m m e r c i a l Va r i e t i e sO f M o l l u s c a n S h e l l fi s h

Oysters—Pacific or Japanese VarietyEastern VarietyOlympia Variety

C l a m s — S o f t — M a n i n o s eLong NecksS t e a m e r s

Hard—QuahogCherrystoneL i t t l e N e c k sC h o w d e r s

Mussels—Blue Mussel

Waters of shellfish-growing areasare routinely sampled and analyzedto ensure safe products. State healthofficial (left) inspects shellfish andharvest techniques at point ofharvesting.

Dyes are sometimes cast to tracewater currents to determine ifdangerous pollutants are likely toreach the shellfish.

FDA provides technical assistanceto State authorities to analyzeshellfish for contamination. Here,an FDA scientist tests forcontamination in an oyster sample.Raw shucked shellfish areimmediately iced and shouldremain packed in ice until time ofpurchase. Avoid products that havea considerable portion of the canwell above ice in market displays.Shellfish are highly perishable.

Approximate Nutrients in Clams, Oysters, Mussels

4 5 1 1 8 1 . 5 1 . 7 2 0 1U . S . R D A f o r t h i s n u t r i e n t g r a m s g r a m m i l l i - m i l l i - m i l l i - m i l l i - g r a m

g r a m s g r a m s g r a m s g r a m s

C l a m s , c a n n e d , „ .s o l i d s & l i q u i d s i t c ^ a 4 % 1 5 % — 4 % 4 % 1 0 %(3 oz.)

Oysters, canned,solids & liquids(3 oz.)

i ? 1 5 % 2 % 2 5 % 1 0 % 4 % 1 0 %

Oysters, raw,meat only(1 cup)

4 0 % 2 0 % 7 0 % 2 0 % 2 5 % 3 0 % 2 5 %

Mussels, raw,meat only(3 oz.)

1 5 % 6 % 1 5 % 8 % 1 0 % 2 0 %

Notes: United States Recommended Daily Allowances are the amounts of nutrients required by adults to keephealthy. The U.S. RDA system was developed by FDA for use in nutrition labeling.

These approximations may vary slightly from species to species.Oysters, clams, and mussels are also good sources of iodine and possibly of trace minerals.Dashes indicate lack of reliable data for a nutrient believed present in significant amounts.

F o o dIngredientR e v i e w :W h e r eIt StandsV o w

A l u m i n u mC a l c i u mC a l c i u mMagene♦S o d i u

silico'♦SodiuJ

h y d rby Alan T. Spiher, Jr.

A step-by-step progress reporto n F D A ' s s e c o n d l o o k a t t h e

safety of food ingredients.

1">he safety of the food supply,particularly food additives, is ofgreat concern to today's consumer,b u t F D A ' s c u r r e n t r e r e v i e w o f f o o d

ingredients thus far should be reassuring and encouraging.

For the past 4 years, FDA hasbeen double-checking the safety offood ingredients. This check wasordered by President Nixon in 1969following the ban on the artificialsweetener cyclamate based on news c i e n t i fi c t e s t s t h a t i t c o u l d c a u s ec a n c e r .

I t w a s f e a r e d t h e n t h a t o t h e r i n

gredients which had not been subjected to newer test methods coulda l s o b e h a z a r d o u s . S o a l l f o o d i n

gredients were scheduled to comeunder new scrutiny.

This massive project now is Hearing the end of its first phase, havinginvolved expenditures thus far of$11 million. And so far nothing hasbeen found to lead to any furtherbans similar to the one on cyclam a t e . I n f a c t , F D A i s n o w e v a l u a t

ing further evidence on cyclamatesubmitted by the manufacturer,which seeks to get permission tomarket it again.First Things ...The starting point for reviewingfood ingredients was a group ofsubs tances known as the GRAS l i s t .

GRAS stands for "Generally Recognized As Safe." The list includesabout 675 substances that for yearsa n d s o m e t i m e s f o r c e n t u r i e s h a v eb e e n a d d e d t o f o o d s .

The list comprises such familiarsubstances as salt, which was oneof the first preservatives, and sugarand spices used to make food morepalatable, as well as man-made subs t a n c e s l e s s f a m i l i a r t o c o n s u m e r sbut essential to many of the convenience foods in demand today,G R A S R o o t sIn 1958, Congress passed a law torequire premarketing clearance of

s u b s t a n c e s a d d e d t o f o o d — i nother words, "food additives." Thisamendment to the Food, Drug, andCosmetic Act said a person couldpetition FDA to get a ruling as tothe safety of an additive he proposed using in a food product.

In determining safety, FDA wasrequired to consider the followingspecific factors:1. Probable consumption of the additive or any substance formed because of its use;2. Any cumulative effect of the additive on man or test animals;3. The general recognition of its

FDA Consumer ! June 1974 / 23

•Mal ic acid. . .•MethylceUu/

cellmose,c o n t e n t s h \percent an(^percent on

Monoammon i '♦MonopotassiN i t r o g e n . . .• N i t r o u s o x i

Papain.S e > ^ of tl

safety (or lack thereof) by expertsc ien t is ts .

Soon after the law was passed,FDA published a list of ingredientsthat were already at that time "generally recognized as safe" by qualified scientists, or were assumed tobe safe because of a long, unmarredhistory of use in food. This automatically granted permission fortheir continued use, and precludedthe need for separate petitions to befiled to request FDA sanction.

By developing such a list (theGRAS l ist) , FDA was able to devote its limited resources to safety

d e c i s i o n s o n n e w a d d i t i v e s t h a t d i dnot have a history on which to basedecisions. Time could be devotedfully to review of new data on newadditives presented for clearance.

This established, then, two different categories of additives —GRAS and regulated additives.They are distinguishable not bec a u s e t h o s e o n o n e l i s t a r e s a f e rthan than those on the other (theyare not necessarily), but because inthe continuing history of food additives they merely mark a legislativepoint in time.

This may be confusing to many

people because the term "generallyrecognized as safe" sounds saferthan "regulated food additive." Infact, though, more rigorous testinga n d s c i e n t i fi c d a t a l i e b e h i n d t h elist of regulated additives than beh i n d m o s t i t e m s o n t h e G R A S l i s t .T h i s i s b e c a u s e o f t h e 1 9 5 8 c o n

gressional amendment setting forthsafety standards for all additives int r o d u c e d i n t o t h e m a r k e t a f t e r t h a tt i m e .

For this reason, the logical starting point for reviewing the safetyof food ingredients as ordered bythe President was the group of ingredients about which there was theleast detailed scientific safety data.So the first phase was the GRAS listr e v i e w.

The next phase, which is alreadyunderway before the completion ofthe GRAS list review, is a review offlavoring ingredients. Some flavorsare GRAS and others are regulatedadditives, but they are broken downand handled best for review bychemical class rather than by anysort of "list" membership.

The third phase will be a reviewof regulated food additives. But thecompletion of this review will notclose the book on the safety of foodingredients. Just as new scientificmethods today give us better guidelines to work by, and just as theyantiquate earlier criteria for judging safety, so will science later provide other tools to use in judgingsafety.

Not only does scientific progressin safety analysis promise continuing reviews, but such reviews alsowill be required as a result of industrial progress that presents newuses for additives, new processesand cooking times, new packaging,and generally new "engineering" offoods processed for marketing.Steps of GRAS ReviewThe first step in the review of subs t a n c e s o n t h e G R A S l i s t w a s t ocol lect al l avai lable data over thelast 50 years on each of the 675substances, including about 80 substances that had been determinedas GRAS but that did not appear onthe original list. FDA has completed the reviews for the published

24 / June 1974 I FDA Consumer

substances and this year will complete the reviews of the other 80.

T h e l i t e r a t u r e s e a r c h o n t h e 6 7 5substances yielded about 150,000a b s t r a c t s o f s c i e n t i fi c a r t i c l e s r e l a t

ing to the toxicity or analyticalchemistry of the substances. Thesearch on vitamin A alone produced more than 16,000 abstracts.

D a t a c o l l e c t i o n a l s o i n c l u d e d

sending questionnaires to industryt o d e t e r m i n e h o w m u c h o f e a c h i n

gredient is used in food. From thisquestionnaire, along with information on consumer consumption offood, the National Academy of Scie n c e s u n d e r a n F D A c o n t r a c t d e

veloped a way to estimate howmuch of the food ingredient a consumer might eat in one day. Theseconsumption figures then becamekey criteria for deciding how muchi n f o r m a t i o n w a s n e e d e d t o a s s u r e

safety.The next step was to sort and

summarize the data according to individual or groups of ingredients.This work is being done on contract by five independent researchfi r m s .

To determine if these data support continued use of an additiveunder review, a panel of scientistsactive in the appropriate fields hasb e e n e s t a b l i s h e d u n d e r a n F D Ac o n t r a c t w i t h t h e F e d e r a t i o n o fAmerican Societies for Experimental Biology (FASEB). This 62-year-old organization set up a LifeSc iences Research O ffice i n 1962 to

analyze specific problems in biologya n d m e d i c i n e .

Currently its Select Committeeon GRAS Substances, establ ishedfor FDA, comprises 10 membersof the academic community. Theirjudgment will help determine what,if any, new tests may be needed toconfirm safety.

Progress in each of these steps ispresented in the accompanyingtab les .O t h e r C o n s i d e r a t i o n s

Although the 1958 amendment saysa person ''may'" petition FDA for aruling as to whether a substancecan be considered GRAS, it stoppedshort of actually requiring that suchan FDA ruling be obtained. In oth

er words, as the law stands now, aperson could legally decide for himself that use of a particular substance would be generally recogn i z e d a s s a f e . A n d t h a t s u b s t a n c ec o u l d b e a d d e d t o f o o d w i t h o u tFDA necessarily knowing anythinga b o u t i t .

FDA cannot change the law, but

it can discourage use of such loopholes. In this case, it plans to doso through publication in the futureof an FDA-affirmed GRAS l ist ,w i th the "FDA-a ffi rmed" p refixused to indicate that all components on the list are recognized byFDA as complying with Agencycriteria for acceptance as "gener-

Statiis of Food Ingredients Safety Review

T o t a l G R A S s u b s t a n c e s p u b l i s h e d 5 9 2G R A S s u b s t a n c e s u n p u b l i s h e d 8 3

T o t a l G R A S s u b s t a n c e s u n d e r r e v i e w 6 7 5Less GRAS flavors under separate review 236

To t a l G R A S s u b s t a n c e s ( l e s s fl a v o r s ) 4 3 9

Status of Scientific Literature Reviews (nonffavor)

62 reviews on hand covering58 reviews in preparation covering

Reviews in contract stages coveringTo t a l G R A S s u b s t a n c e s i n s c i e n t i fi c

l i t e r a t u r e r e v i e w s

2 1 2 s u b s t a n c e s1 4 4 s u b s t a n c e s

8 3 s u b s t a n c e s

S t a t u s o f E v a l u a t i o n b v FA S E B

19 review evaluations completed43 review evaluations in process coveringTotal 62 review evaluations covering

2 5 s u b s t a n c e s1 8 7 s u b s t a n c e s2 1 2 s u b s t a n c e s

S t a t u s o f F l a v o r R e v i e w

F D A G R A S fl a v o r s 2 6 8 *

R e g u l a t e d fl a v o r s 9 4 3T o t a l fl a v o r s w i t h F D A s t a t u s 1 2 1 1F l a v o r s i n u s e w i t h o u t F D A s t a t u s 3 2 9T o t a l fl a v o r s t o b e r e v i e w e d 1 5 4 0*32 of these flavors have been subject also of separate scientific liter

a t u r e r e v i e w s .

Scientific Literature Reviews (Flavors)

Reviews in preparation coveringReviews under negotiationsBalance to be arrangedN o fl a v o r e v a l u a t i o n s h a v e b e e n s c h e d u l e d a s v e t .

2 7 6 s u b s t a n c e s6 2 2 s u b s t a n c e s6 4 2 s u b s t a n c e s

An estimated 102 scientific literature reviews (nonflavor) covering411 substances should be completed by the end of 1974. Evaluationof 288 nonflavor substances will have been received by then and 57substances will have been the subject of the Federal Register orders.The end of 1975 should see the completion of the review task on all439 nonflavor GRAS substances. The completion of the GRASfl a v o r r e v i e w w i l l t a k e m u c h m o r e t i m e b e c a u s e i t w i l l b e d o n e w i t h i nt h e f r a m e w o r k o f a t o t a l fl a v o r r e v i e w .

FDA Consumer / June 1974 j 25

E t h y l♦G l u t a m i c♦Glutamic ac id hytoGlycer inGlyceryl mcAHel ium..^♦Hydroch/SB♦Hydrogd™L a c t i c

♦Lecithlj BMagne^^HM a g n / j ^ ^ B

H d e

ally recognized as safe."F o r a f o o d m a n u f a c t u r e r t o d e

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

sidering adding to food is FDA-approved, he can refer to the affirmed GRAS list, the RegulatedFood Additives Regulations, or toa l i s t o f subs tances tha t we re sanctioned by FDA for use in food inresponse to individual queries bef o r e 1 9 5 8 . T h i s l a t t e r l i s t i s c a l l e dthe "prior sanctioned" list.

I f t h e s u b s t a n c e u n d e r c o n s i d e r ation is on none of these, the manufacturer should submit a petitionfor FDA approval of use. On thebasis of such a petition, FDA willt h e n a l l o w c o m m e n t f r o m i n t e r e s t e d

persons. At this point, the publica n d t h e s c i e n t i fi c a n d m e d i c a l c o m

munities will have the opportunityto provide any pertinent data tosupport or oppose the decision.

After reviewing all commentsand making any needed changes inthe proposal, FDA will publish afinal decision. These proceduresshould allow a literal, accurate definition of "generally recognized ass a f e . "So Far . . .Based on resu l t s t hus fa r i n t he re

view, the following actions haveb e e n t a k e n :1 . S a c c h a r i n — S w i t c h e d f r o m t h eGRAS list to the interim regulateda d d i t i v e s l i s t . T h e i n t e r i m l i s t i s

composed of items for which FDArequires more research before newregulatory action or affirmation as

GRAS is taken. Saccharin wil l remain on this list until the NationalAcademy of Sciences presents anevaluat ion of research which wasperformed by industry to determinei f saccha r i n can cause cance r.

Consumers should know that i ffirst results from research provethere may be a serious publichealth risk, the substance is removed f rom the l is t , even as resea rch con t i nues .2. Two other substances, glycineand brominated vegetable oil, formerly of GRAS status, have alsobeen placed on the interim listwhile research is being done onpossible toxicity.3. Carrageenan, a vegetable gumderived from red seaweed, was rem o v e d f r o m t h e G R A S l i s t a n d

placed on the regulated additiveslist to allow FDA to define permiss ib le sou rces fo r t he subs tance .4. Carob bean gum was removedfrom the GRAS list and also placedon the regulated additives list toestablish permissible levels for itsuse. All natural gums are scheduled for the same action. Feedingof carob bean gum to test animalsat extremely high levels revealedtoxicity. Although levels requiredt o r e a c h t o x i c e f f e c t s w e r e f a r

higher than any foreseen use inhuman diet, FDA's action was takento prevent any major change of itsuses in the future.5 . A l s o m o v e d f r o m t h e G R A S t othe regulated additives list wereamino acids, used to increase thequality of protein in certain foods.P e r m i s s i b l e l e v e l s o f u s e w e r e e st a b l i s h e d b e c a u s e t o x i c e f f e c t s o n

laboratory animals were discoveredat extremely high levels of consumption.6. Four substances have been proposed by FDA as the first cons t i t u e n t s o f t h e F D A - a f fi r m e d G R A Slist described earlier in the story.They are mannitol and sorbitol,used as sweeteners, and methylparaben and propyl paraben, whichare preservatives.

Alan T. Spiher, Jr., is director oft h e G R A S R e v i e w B r a n c h , B u r e a uo f F o o d s .

26 / June 1974 / FDA Consumer

TeensI h t e l bC o n s u m e rE d u e a t i o nA new FDA program, the Neighb o r h o o d Yo u t h C o n s u m e rEducation Project, is designedto involve America's young peoplein consumer group activities.

by Donald A. Coleman

In El Paso, Texas, teenage students are telephoning homemak-ers to give them some helpful tipson the new nutrition labels on foods.

In Baltimore, a YWCA group ismaking local appearances in a skitwhich it produced on the safe useof cosmet i cs .

And in Minneapolis, teenagersare operating a booth in theirs c h o o l t o d i s t r i b u t e F D A i n f o r m ation on a variety of consumer-oriented subjects.

These are just a few of the activities being carried out by the.Neighborhood Youth ConsumerEducation Project, an FDA program begun in 1972.

Actually, the program originatedw i t h P r e s i d e n t N i x o n ' s 1 9 7 1 C o nf e r e n c e o n Yo u t h , w h i c h r e c o mmended that Government programsbe developed which would be moreresponsive to the needs of youngpeople. This led to the development of a plan for the Food andDrug Administration, as part of theDepartment of Health, Education,and Welfare, to utilize students andyouth groups in its programs forimproving health services and consumer health practices.

The pilot project was structuredso that selected youth organizationsw o u l d w o r k w i t h F D A c o n s u m e raffairs officers to design and implement a consumer education pro

gram, based on consumer information needs in tbe areas of healthand safety.

To conduct the NeighborhoodYo u t h C o n s u m e r E d u c a t i o n P r oject, contracts were issued to twoyouth organizations. One was theNational Board of the Young Women's Christ ian Associat ion, whichselected three of its chapters to implement the project. The other wast h e Yo u t h S e r v i c e B u r e a u o f E lPaso, Texas.

These organizations demonstrated that not only could youth groupswork with a regulatory agency suchas FDA, but that they could be animmense help to FDA in helpingto conduct consumer education programs in neighborhoods which hadvery specific and unique needs. Inits first year of operation the program was an apparent success, andthe number of cities conductingsuch projects was increased to givea be t te r ind ica t ion to FDA as towhether this program should beconducted on a nat ionwide basis.The program was increased fromfour sites to seven, with an increasein funding from an original $20,000to $45,000 for fiscal year 1974.

The two groups originally selected for the project were entirelyd i f f e r e n t . T h e N a t i o n a l Y W C A i sa national organization, whereas theYo u t h S e r v i c e s B u r e a u o f E l P a s o

Charles Childers of Clark CollegeMass Communicat ions Departmentin Atlanta discusses with membersof FDA's Neighborhood YouthProgram how to make a film. Theteens were preparing to produce afilm on nonprescription medicinest o b e s h o w n i n t h e A t l a n t a a r e a .

is local, sponsored by the city.Youths who work on the projectthrough the YWCA are paid $1.80a n h o u r f o r a m a x i m u m o f 7 5hours per year, while the El Pasoyouth work as volunteers, and fundsare al located to administrative andprogram services. Although theyoung people in the El Paso groupdo not receive wages, the projectdirector, Frank Daley — with theassistance of Assistant Director Roman Salas, and Consumer AffairsO f fi c e r H a z e l Wa l l a c e , o f F D A ' sDallas office — has organized 850v o l u n t e e r s .

In its six locations, the YWCAhas 120 paid teen workers, with amaximum of 20 in each group. Atpresent, the program is being conducted in Atlanta, Baltimore, Cleveland, Minneapolis, Pittsburgh, andQueens, New York.

While the overall program is administered from FDA headquarters,each group plans and implementsits own local programs. So far, thesehave ranged from handing out pam-

FDA Consumer / June 1974 j 27

Geraldine Fisher, r ight, directorof the Neighborhood Youth Program in the Atlanta YIVCA,reviews some nutrit ion labelinginformational pamphlets being produced under the FDA-sponsoredprogram. With her are two teenleaders in the program, AngelaWright, left, and Iris Bland.

phlets to producing audiovisual presentations. In each locale, the program has been the outgrowth ofwhat the young people consideredthe needs of the community to beand their own capabilities in meeting those needs.

In the summer of 1973, for example, the EI Paso group made presentations to high school studentsexplaining its purpose and plans.Many FDA leaflets were translatedinto Spanish for distribution toSpani.sh-speaking households.

In addi t ion, a 2-hour te levis ionprogram was produced on videotape for the Black Student Coalitionat the University of Texas El Pasocampus, on the objectives of theprogram. A survey was made tod e t e r m i n e h o w m u c h t h e c i t i z e n so f E l P a s o k n o w a b o u t F D A a n dwhat information about the Agencyw o u l d b e u s e f u l t o t h e m .

In the closing months of 1973,a c t i v i t i e s i n t h e E l P a s o a r e a i ncluded securing the volunteer services of artists to design a series ofposters on FDA; the presentationof a number of programs to highschool students on such subjects assafe food handling in the home; andthe presentation of consumer messages on radio station KELP.

In 1974, these activities havebeen followed up by the opening oftwo new Neighborhood Youth Of

fices, press releases in the El Pasonewspapers, a meeting with PlannedParenthood to secure their cooperation in distributing FDA publications on The Pill, and continueddevelopment of a consumer quest i o n n a i r e .

The Baltimore youth group firstzeroed in on the subject of cosmetics. After organizing its plan ofaction (each N.Y.P. gets FDA approval for its plan), participantswrote skits and designed posters onthe safe use of cosmetics. The groupa l s o m a n n e d a b o o t h a t t h e S t a t eF a i r i n B a l t i m o r e a n d d i s t r i b u t e dF D A l i t e r a t u r e o n t h e s a f e u s e o fcosmetics. In subsequent months,t h e B a l t i m o r e t e e n s b e c a m e i nvolved in promoting informationabout quackery.

In Queens, New York, the emphasis has been on nutrition labeling training sessions; press releaseson nutrition labeling; production ofa movie on nutrition labeling, andnutrition labeling posters to be displayed in schools, libraries, and atthe hea l th fa i r.

In Atlanta, the teens did somebrainstorming on the format for afilm script, assembled an FDA Bulletin Board for their schools, pres e n t e d a n F D A s l i d e s h o w t o a

group of parents at a local day-carecenter, and produced a brochure onfood fo r teens .

In other cities. NeighborhoodYouth Project activities have included workshop discussions on thesafe use of medicines; seminars onnutrition labeling; promotion of theFDA Consumer Phone, which provides timely messages to consumerseach week; presentation of an original skit on foodborne illnesses;preparation of radio spot announcements on subjects related to foodand drugs; health care displays inshopping malls; and programs fors e n i o r c i t i z e n s o n m e d i c i n e m i s u s e .

Plans are being developed for theorganization of additional Neighborhood Youth Projects in otherc i t i e s . T h e e f f e c t i ^ ' e n e s s o f t h e fi r s tt e e n e f f o r t s h a s d e m o n s t r a t e d h o wmuch can be accomplished byyoung people, to bring worthwhilec o n s u m e r i n f o r m a t i o n t o t h e c o m

munity and to promote better understanding of the consumer's rolein using correctly the products regulated by FDA.

The program is providing an opportunity for young people to bec o m e b e t t e r i n f o r m e d c o n s u m e r s

themselves, and to participate in acivic program that will help othersto learn better consumer practices.

Donald A. Coleman, FDA's youthliaison officer, is project officer forthe Neighborhood Youth ConsumerEducation Project.

28 / June 1974 f FDA Consumer

News Highlights

Newly Licensed Vaccine To Be UsedIn Epidemic Meningitis Situations

The Food and Drug Administration has approved thelicensing of a vaccine for immunization against onetype of spinal meningitis for use in epidemic situations.

Early shipments of the newly licensed vaccine willgo to the Brazilian Government for use in Sao Paulo,where the type meningitis against which the vaccine iseffective has been epidemic since 1971.

Spinal meningitis is a highly contagious bacterialinfection which, in this country, has been largely confined to military recruits. In recent years, routine useof the vaccine during military basic training has virtually eliminated the disease from this group.

The newly approved vaccine is effective against aspecific type of bacteria—meningococcus-meningitisgroup C. No epidemics of the disease caused by thisbacteria have occurred in civilian populations in thiscountry in recent years.

The vaccine was developed in 1967 by the WalterReed Army Institute of Research. Merck, Sharpe &Dohme, West Point, Pennsylvania, has furnished thevaccine, under contract, to the Defense Department.The company has now been licensed to produce it foruse in other population groups with similarly documented epidemic risk.

FDA Acts Against Use of Vinyl ChlorideIn Agency-Regulated Aerosol Products

The Food and Drug Administration has initiated actionto insure that vinyl chloride is not used in any aerosolized food, drug, or cosmetic product.

Vinyl chloride is a gaseous substance used to produce a type of plastic called polyvinyl chloride (PVC).It has also been used as the propellant in aerosol products. The substance has been associated with 10 casesof a rare liver cancer among U.S. industrial workersexposed to the chemical over extended periods of time.

Use of vinyl chloride in aerosol products regulatedby FDA has been minimal. FDA is unaware of anypast or present use of the substance in aerosolizedfood products. Such use would require prior FDAapproval, and no such approvals have been given.

FDA is also unaware of any present use in aerosolized cosmetic or drug products. The Agency has, however, learned of two cosmetic manufacturers and onedrug manufacturer who used vinyl chloride as a pro

pellant before June of 1973. Although little is likelyto remain on the market, FDA is requesting the manufacturers to recall the products as a precautionarymeasure. (Specific details on any products being recalled will be provided as they are developed and published on FDA's Weekly List of Recalls.)

FDA will use the Drug Listing Act of 1972 to require manufacturers of drugs to provide informationon any aerosolized drug products which contain vinylchloride. The Agency has also written to all knowncosmetic manufacturers requesting them to identifyproducts which contain the substance. Recalls will berequested if necessary.

The use of PVC as a food packaging material hasbeen under active FDA investigation since May of1973, when the Agency learned that VC monomerwas leaching from plastic liquor bottles into the liquor.FDA immediately proposed to ban PVC packaging ofalcohol-containing food or beverages and, concurrently, the Bureau of Alcohol, Tobacco and Firearmsended the experimental use of such bottles for packaging liquor.

FDA is currently reviewing data and commentswhich have been submitted in response to the Mayproposal. The Agency is also looking at other foodspackaged in PVC containers to determine if a similarleaching problem exists.

Canned, Imported Oysters Recalled;Underprocessing Indicated

FDA announced May 8 the recall of 8-oz. cans ofoysters imported from Korea and distributed to retailstores in four southern U.S. States under four privatelabels. The products were manufactured by Han NamFisheries Co., Ltd., Seoul, Korea, and imported anddistributed by C. Itoh & Co., New York, New York.

The recall was initiated because analyses of samplesof the product revealed the presence of micro-organ-isms indicating underprocessing.

The products recalled are: "Sun Bell," distributedby C. Itoh in North Carolina and South Carolina; "GulfKist" and "Blue Plate," distributed by Southern Shellfish Co., Harvey, Louisiana, in Louisiana; and "Victor," distributed by Mavar Shrimp & Oyster Co., Ltd.,Biloxi, Mississippi, in Mississippi.

FDA advises consumers who may have these products to not eat them or throw them away, but to returnthem to the store where purchased.

FDA Consumer / June 1974 1 29

Regional Reports

R E G I O N I

During National Nutrition Week, Marilyn Douglas,c o n s u m e r a f f a i r s o f fi c e r i n t h e F D A B o s t o n F i e l d O f fi c eresident post at Hartford, Connecticut, handed out hundreds of pieces of literature at supermarkets in herarea. Newspaper and television coverage describedFDA's nutrition labeling program to Connecticut consumers. Food management students from ManchesterCommunity College and nutrition students from St.Joseph's College assisted in handing out FDA educat i o n a l m a t e r i a l s .

R E G I O N I I

In FDA's New York District, a shipment of salmon andsablefish from Seattle valued at $110,000 was embargoed by the New York City Health Department atFDA's request after National Cold Storage, Brooklyn,reported to the consignee. Acme Smoked Fish, Brooklyn, that the shipment had arrived under inadequaterefrigeration. Acme, after inspecting the shipment, refused to accept it because of apparent decomposition.FDA field examination of the shipment by an organoleptic specialist disclosed decomposition, and sampleswere collected by the FDA District's ComplianceB r a n c h f o r d i r e c t a c t i o n s e i z u r e r e c o m m e n d a t i o n .

Leader Candies, Inc., Brooklyn, and two of its officers.Jack Kastin, president, and Leon Kastin, secretary-treasurer, pleaded guilty and were fined in the U.S.District Court at Brooklyn for manufacturing candyunder insanitary conditions and shipping adulteratedcandy in interstate commerce. The charges resultedfrom investigation by FDA's New York District of acomplaint by a Boy Scout organization that candy itreceived from the company contained wood chips,scraps of paper, and nondescript material resemblingfloor sweepings. The company pleaded guilty to allfour counts and was fined $250 on each count. Theindividuals pleaded guilty to two counts and were fined$250 each on one count and given 1 day's probationon the other.

Eight shipments of chocolate Easter candy products,valued at $92,288 and manufactured by Regent Chocolate Ltd., St. Hyacinth, Quebec, were detained byFDA's Buffalo District at Champlain, New York, onthe basis of a recall of other shipments of the com

pany's products which had been distributed in thiscountry and caused nearly 50 cases of illness becauseof contamination by Salmonella.

A shipment of whole peeled plum tomatoes from Spainwas seized by the Government at a food producer inRochester, New York, on charges by FDA's BuffaloDistrict that the product was unfit for food because ofbeing packed in rusty, dented, and leaking cans. Theshipment totaled 2,249 cases, valued at $8,000.

R E G I O N I I I

A d d i t i o n a l " F D A t e a c h e r s c o n f e r e n c e s " h a v e b e e nscheduled following apparent success of and recognition by the Pennsylvania State Office of Education of aseries of similar conferences sponsored jointly by thePhiladelphia School District and FDA's PhiladelphiaDistrict. The conferences, involving educators from afive-county area in southeastern Pennsylvania, featuredtalks by top FDA headquarters and District officials onsuch topics as over-the-counter drugs, radiologicalhealth, nutrition labeling, nutrition and public health,laws administered by FDA, and recalls. After the Stateoffice found "an appreciable evidence of FDA's involvement in the schools," the additional FDA teachersc o n f e r e n c e s w e r e s c h e d u l e d i n s e v e r a l c o u n t i e s a c r o s sthe State.

An agreement signed by Governor Sherman Tribbitt ofDelaware and FDA's Region 111 last November providing for complete elimination of duplicative regulatoryeffort in all areas of mutual State-FDA obligation hasbeen followed up by individual agreements betweenFDA's Philadelphia District and Delaware agriculture,health, and pharmacy officials. They provide for sharing of inspectional activities in the regulation of medicated feed, food, and'drugs in that State.

R E G I O N I V

Imported food products have been detained by FDA'sAtlanta Regional Office in three instances in Florida.Two shipments of 40 and 200 cartons of turtle meatfrom two different packers in Ecuador were detained atJacksonville after samples taken by Patricia McQueen,consumer safety officer of the Orlando Section, werefound to contain Salmonella bacteria. A shipment of100 cartons of smoked sweet paprika from Spain wasdetained at Miami after samples taken by Stephen J.

30 / June 1974 / FDA Consumer

Tunks, consumer safety officer of Orlando Section'sIVIiami Resident Post, were found to contain rodentexcreta and hairs and insects. A shipment of shrimpfrom Indonesia represented to be cooked and peeledwas detained at Jacksonville after collection of samplesby Marie Falcone and Robert Bowers, consumer safetyo f fi c e r s o f t h e O r l a n d o S e c t i o n . D e t e n t i o n w a s m a d ewhen Carl Ponder and Don Thompson of FDA's Atlanta laboratory found that the samples contained bothcooked and raw shrimp, that the raw shrimp was decomposed, and that the cooked shrimp was probablydecomposed before cooking.

Reconditioning of a lot of "Pro-Nuts," a soybean foodproduct similar to peanuts, was carried out by TrophyBrands, Inc., Monroe, North Carolina, under the termsof a consent decree of condemnation filed in the U.S.Distr ict Court for Western North Carol ina, Ashevi l le.The lot of 393 50-pound bags had been seized by theGovernment after the product was found, during aninspection by Loyd W. McEwen, consumer safety officer of the FDA Atlanta Section's Charlotte ResidentPost, to be defiled by rodents and damaged by fire. Mr.McEwen was on hand to monitor the reconditioning.

The Government seized 442 100-pound bags of "American Beauty Raised" doughnut mix, valued at $12,000,at the Mobile docks because it was contaminated bymold. James A. Sandelin, consumer safety officer atthe At lanta Sect ion 's Mobi le Resident Post , accompanied the U.S. marshal making the seizure. Alsoseized by the Government at the same time was 183cases of Starkist canned sardines, valued at $1,800,because of shipping damage and defective cans. FDAlearned about the moldy doughnut mix from the steamship line which was scheduled to transport the merc h a n d i s e .

R E G I O N V

Seizure of two lots of biological drugs was made by theGovernment at McKesson & Robbins Drug Co., Cincinnati, as a result of investigations by FDA's Cincinnati District, which charged that they were adulteratedby being held under conditions violative of GoodManufacturing Practice regulations. The seizure wasbelieved to be the first such action brought by FDAagainst biological products since FDA assumed regulatory responsibility for these products upon the transfer of the Bureau of Biologies to the Agency. The drugs.I n fl u e n z a V i r u s Va c c i n e a n d Te t a n u s To x o i d F l u i dU.S.P., were stored by the company at temperatures inexcess of the labeled recommended temperature andof the recognized acceptable temperature for optimumsafety and efficacy.A canner of low acid foods in Terre Haute, Indiana,at which consumer safety officers of FDA's DetroitDistrict made two inspections and then warned the

company about deficient control practices, has nowmade plant improvements costing about $250,000 during a 3-month period, that District reports.The Government has seized 495 cases of tomato catsup, found by FDA's Detroit District to contain excessive mold and rot. The catsup, manufactured by FettigCanning Corp., Elwood, Indiana, was seized at a warehouse in Grand Rapids, Michigan.

Import shipments of leaf lettuce from Canada weredetained after being found to contain illegal residuesof pesticides by FDA's Detroit District. Canadian foodand drug officials identified the grower, and the Districtreached an agreement with the officials that futureshipments of leaf lettuce from the distributor shall include a certificate of analysis or list the name of thegrower. The District notes that the last two shipmentsof leaf lettuce offered for entry into the United Stateshave been found free of excessive pesticide residues.

At FDA's Minneapolis District, Blanche Erkel, consumer affairs officer, began a program to inform oldercitizens about FDA's new nutrition labeling regulations, including those concerning vitamins and minerals,and about other FDA consumer protection activities.The program was started in response to numerous complaints by older people to staffers running an FDAexhibit at the Minnesota State Fair during the summerthat "FDA is taking our vitamins away from us." Theprogram was started to counteract this kind of misinformation and negative reaction. Since then WinifredDekoski, consumer affairs technician, has conductedregular programs for older people living in apartmentdevelopments. She and Roma Krause, consumer safetyofficer, also are participating in seminars sponsored bythe American Federation of Labor-Congress of Industrial Organizations (AFL-CIO) to work with senioraides, who in turn carry the FDA information back toc i t i z e n s i n t h e i r o w n c o m m u n i t i e s .

R E G I O N V I

An entire railcar of flour totaling 80,000 pounds,packed in 5-, 10-, and 25-pound bags, was seized atthe Santa Fe Railway Co. in Oklahoma City becausepart of the bags were gnawed by rodents and all werebeing held under insanitary conditions whereby theymay have become contaminated with filth. The actionresulted from investigation by FDA's Dallas District.F D A ' s D a l l a s D i s t r i c t d e t a i n e d s e v e n e n t r i e s o f d r i e dchile peppers totaling 319,000 pounds from Mexico atEl Paso, Texas, because of mold and insect infestation.

R E G I O N V I I

Acting on pleas of nolo contendere, the U.S. DistrictCourt for Western Missouri, Kansas City, fined Radial

FDA Consumer / June 1974 131

Warehouse Co., Kansas City, $500, and Jerry Ink,vice president for operations, and Richard H. Schons,warehouse manager, $100 each on charges by FDA'sKansas City Field Office that foods in the warehousew e r e a l l o w e d t o b e c o m e c o n t a m i n a t e d w i t h r o d e n t fi l t h .

Seizure by the Government of $9,300 worth of variousbagged nuts and popcorn was made at United Fruit andProduce Co., St. Louis, on charges the products in thewarehouse were being contaminated by rodents andother filth. FDA's Kansas City Field Office first receivedi n f o r m a t i o n f r o m t h e M i s s o u r i S t a t e D i v i s i o n o f H e a l t hthat division staffers had noticed apparent violationswhile visiting the warehouse on other business. Theseized foods totaled more than 16,000 pounds.

R E G I O N I X

The U.S. District Court for Central California, LosAngeles, remained unconvinced, following an FDA re-inspection, of claims by the Three Star Smoked FishCo., Los Angeles, and its general manager, HowardKlein, that insanitary plant conditions which hadresulted in their conviction had been improved. Thedefendants had been convicted, but Judge Albert L.Stephens, Jr., withheld sentencing pending a reinspec-tion by FDA. The FDA Los Angeles District's DonaldPohl and Stephen Kendall, consumer safety officers,assisted by Derrell Hill, chemist, manning one of theDistrict's mobile laboratories, returned to the plant andfound that numerous insanitary practices were continuing. The company was given a suspended fine of $1,000and placed on 2-years' probation, and Mr. Klein received the same suspended fine and 3-years' probation. They had pleaded nolo contendere. Two othercounts against each defendant were dismissed.

Seizure by the Government of $180,000 worth of imported nutmeg and green coffee was made at FarmerBrothers Co. warehouse, Torrance, California, afterFDA's Los Angeles District charged that the nutmegwas contaminated by uric acid and bird droppings andthe coffee was infested and damaged by insects.FDA's Los Angeles District detained several entries ofproduce offered for import from Mexico after analysisshowed residues of pesticides not registered for use onthe crops involved. They included the pesticide Monitor on green beans, Dimethoate on caribe peppers,Azodrin on anaheim peppers, and Phosvel on snow-peas. The District arranged to notify Mexican authorities of the findings and the source of the violativeproducts.About 8,000 interested citizens were drawn during 2days to the first Nutrition Expo conducted by the LosAngeles District of the California Dietetic Associationin conjunction with Good Nutrition Week. ElaineRoentgen, consumer affairs officer of FDA's Los Angeles District, spoke on "The New Look in Food

Labels" during the program, presented to educate thepublic on sound nutrition and to counteract prevalentmyths about nutrition.FDA's San Francisco District issued 51 detentions in arecent month against import entries, one involving$2,616 worth of cocoa beans from Malaysia in a defective container which had been stored on the topdeck of a ship. The contents had sustained waterdamage during a stormy ocean crossing.A trade complaint that two companies in the San Jose,California, area were repacking dried apricots fromIran and Turkey without declaring the country oforigin on the label resulted in an investigation byFDA's San Francisco District, which verified the complaint. The District determined that the U.S. CustomsService has jurisdiction over this type of label declaration and referred the case to that agency.A diathermic medical device remained under Government seizure in Honolulu while the physician ownermade corrections agreed to under a consent decreefiled in the U.S. District Court for Hawaii, Honolulu.The Honolulu Resident Post of FDA's San FranciscoDistrict had charged that a Thermatic Mark VII devicewas ineffective at the lower of its two frequency rangesand the device was thus misbranded because its labeling was false and misleading, directions for use wereinadequate, and it constituted a danger to health. Thephysician owner agreed to deactivate the lower frequency and relabel it to indicate effectiveness only atthe higher frequency range.

R E G I O N X

The Major Italian Foods Co., Inc., Seattle, and its president, Ernest A. Merlino, Sr., were fined $6,000 and$2,000 respectively by Judge Morrell Sharp of theU.S. District Court for Western Washington, Seattle,after being found guilty of interstate commerce shipment of two lots of macaroni products containing insect fragments and of manufacturing the product underinsanitary conditions. Mr. Merlino was placed on probation for 3 years. The convictions resulted fromcharges brought by FDA's Seattle District.After changing their pleas from not guilty to guilty onone count of a five-count Government information.Kitchen Maid Bakery, Seattle, and one of the partnersin the concern. Aril D. Johnson, were fined $500 eachby Magistrate John L. Weinberg in the U.S. DistrictCourt for Western Washington, Seattle. Investigationby FDA's Seattle District had resulted in charges thatbreads manufactured under insect-infested conditionshad been shipped into interstate commerce. The company's fine was suspended on condition it does notviolate the law for 6 months. The four other countsagainst each defendant were dismissed on the Governm e n t ' s m o t i o n .

32 / June 1974 / FDA Consumer

State Actions

Spud ShortcomingsOne Michigan company has beenfined and another given a suspendedsentence, after a statewide surveyof the quality and net contents ofbagged potatoes by the MichiganDepartment of Agriculture's FoodInspection Division. The State inspectors checked 407 lots, totaling338,496 pounds, at 286 establishments, and seized 16 lots totaling30,000 pounds for failure to meetthe declared grade and 7 lots totaling 2,800 pounds for being short ofdeclared weight.

Salmonella in Frog LegsWhen routine sampling and analysisby the Florida Department of Agriculture and Consumer Services ofimported frog legs at a dealer inCarrabelle, Florida, found Salmonella contamination, and when additional sampling and analysis againshowed Salmonella, the State placeda stop sale on the product andasked FDA to follow up becausethe imported product had been dist r i b u t e d i n i n t e r s t a t e c o m m e r c e .John M. Head, consumer safety offi c e r o f t h e O r l a n d o S e c t i o n o fFDA's Region IV traced the froglegs, imported from India, to aJ a c k s o n v i l l e d i s t r i b u t o r a n d t h e n c eto a company in Phi ladelphia.FDA's sample and analysis foundcontamination of the product by thebacterial species arizona, related toSalmonella and included by somescientists in that genus. The distribution of the rest of the imported shipment was ascertained by FDA'sPhiladelphia District and reportedto appropriate FDA District offices

for checks. The FDA investigationindicated the product was not sampled at time of entry, as is normallythe case.

S a l m o n e l l a P r o b l e mA blended cheese product wasfound to be contaminated by Salmonella upon laboratory analysisby the Indiana Board of Health

Bureau of Food and Drugs. Themanufacturer voluntarily recalledthe cheese f rom the marke t andconverted it to fishbait. The 4,711pounds involved was estimated tobe worth $3,500.

I o w a F o o d R e v o c a t i o nThe State of Iowa revoked the operating license of S.E. Brickner &Son, Decorah, Iowa, after an inspection of the company's threef o o d w a r e h o u s e s r e v e a l e d e x t e n s i v er o d e n t i n f e s t a t i o n a n d a d u l t e r a t i o nof a number of food products. Thecompany vo luntar i ly dest royedflour, far ina, cornmeal, var iousbaking mixes, sugar, and poultryseasoning totaling 25,000 poundsand animal feeds totaling 45 tons,and diverted 7,000 pounds of salt

to nonfood use. Earl Revell, chiefo f F o o d P r o d u c t s C o n t r o l , I o w aDepartment of Agriculture, said thea c t i o n s r e s u l t e d f r o m t h e . S t a t e ' s

inspection, in which Spencer Soren-son, consumer safety officer at theCedar Rapids Resident Post ofFDA's Kansas City Field Office,a s s i s t e d b e c a u s e o f t h e i n t e r s t a t e

aspects of some of the company'soperation.

N e w Yo r k P e n a l t i e s

The New York State Departmentof Agriculture and Markets collected more than $16,000 in civilcompromise penalties during a recent month in settling 209 casesinvolving violations of the State'spure food and economic fraudlaws, according to Frank Walkley,commissioner of agriculture, in areport. An additional 92 cases inwhich agreement could not bepromptly reached between the department and the person or company involved have been referredto the State attorney general fors e t t l e m e n t .

F o o d C o n t a m i n a t i o nA lot of 3,441 cases of chewinggum, candy, and cough drops wason its way back to the LifesaverCo., Holland, Michigan, after release from seizure by the OregonDepartment of Agr icul ture. Theproducts, valued at $99,000, hadbeen seized by the department att h e H o l m a n T r a n s f e r C o . , P o r tland, because of contamination resulting from a train wreck. Ther e l e a s e w a s o n c o n d i t i o n t h a t t h eitems be returned to the shipper.

FDA Consumer / June 1974 j 33

Seizures and Postal Service Cases

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

A t o t a l o f 2 0 a c t i o n s t o r e m o v e f r o m t h e c o n s u m e r m a r k e tproducts charged to be violative was reported in April. Theseincluded 16 seizures of foods: 1 involved charges concerningpoisonous and deleterious substance, 15 involved charges

concerning contamination. Other seizures included 1 of foodadditive, 2 of drugs (including 1 of veterinary and medicated feed), and 1 of medical devices.

PRODUCT. PLACE & DATE SEIZED ''''''SHIPPER fs). ^DEALE^D? CHARGES

FOOD/Poisonous and Deleterious Substance

Frog legs/Carrabelle, Fla. 3/19/74 X L Seafoods/Cockin & Madras, S. India Contain the added poisonous and deleterious sub-(M); Liberty Fish Co./Philadelphia, Pa. stance Arizona micro-organisms.

Contamination, Spoilage, Insanitary Handling

Anchovies/Atlanta, Ga. 4/11/74

Barley, pearled; Michigan navy beans;pinto beans/Greeley, Colo. 2/4/74

Catsup, canned tomato/Elkhart, Ind. 3/18/74

Cherries, frozen whole/Albany, N.Y. 4/8/74

Creecy greens/Kernersville, N.C. 4/1/74

Coconut, desiccated/St. Louis, Mo. 4/5/74

Coffee/New Orleans, La. 3/20/74 and4/1/74

Egg noodles, lasagne, salad macaroni,spaghetti/Salt Lake City, Utah 4/10/74

Flour, hard wheat/New Orleans, La. 4/2/74grits/New Orleans 4/18/74

Crackers, Wheat Toasts, Rye Toasts/Poplar Bluff, Mo. 3/28/74

Oranges, canned mandarin/Nashville, Tenn.8/24/73

Pancake-waffle mix. Glaze Powder/Detroit,Mich. 3/29/74

American Roland Food Corp./New York, Contained in swollen, rusty, and leaking cans.N.Y. (Distributor, S)

D & D Bean Co./Greeley, Colo. (D) Held under insanitary conditions; insect contaminated (barley).

Lake Erie Canning Co./Sandusky, Ohio (M, Contains mold.S)

Pet, Inc., Musselman Div./St. Joseph, Decomposed.Mich. (M, S)

Monticello Canning Co., Inc./Crossville, Contain cockleburrs.Tenn. (M, S)

B&L Drayage & Warehouse Co./St. Louis, Held under insanitary conditions.Mo. (D)

Retia Steamship Co., Inc./New Orleans, Bird contaminated.La. (D)

Porter-Scarpelli Macaroni Co./Portland, Prepared and packed under insanitary conditions;O r e g . ( M , S ) l a b e l s f a i l t o b e a r t h e n a m e a n d p l a c e o f b u s i n e s s

of the manufacturer, packer, or distributor.Texas Transport Terminal/New Orleans, La. Moldy.

(D)George W. Groetsch Wholesale Grocer/New Held under insanitary conditions.

Orleans, La. (D)Bluff City Beer & Produce Co./Poplar Bluff, Held under insanitary conditions; insect contami-

M o . ( D ) n a t e d .M a n u f a c t u r e r u n k n o w n . D e c o m p o s e d ; c o n t a i n e d i n r u s t y, l e a k i n g c a n s .

Lakeshore Warehouse, Inc./Detroit, Mich. Held, under insanitary, conditions; rodent gnawed( D ) ( p a n c a k e - w a f fl e m i x ) .

34 / June 1974 / FDA Consumer

P R O D U C T, P L A C E & D AT 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 )

Sugar, brown/Detroit, Mich. 4/19/74

Whey powder/St. Louis, Mo. 4/4/74

Contamination, Spoilage, Insanitary Handling (cont'd)

Lakeshore Warehouse, Inc./Detroit, Mich. Held under insanitary conditions.(D)

Roma Grocery Co., Inc./St. Louis, Mo. (D)

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

Measuring cups/New York, N.Y. 3/27/74 Pfaff Tool & Manufacturing Co./Kearny, Contain D&C Red No. 30, an unsafe food additive.N.J. (M, S)

DRUGS/Human Use

Septisol Surgical Scrub/Livonia, Mich. 2/ Vestal Laboratories, Div. of Chemed Corp./ Lacks adequate directions for use; lacked Rx legend.2 7 / 7 4 S t . L o u i s , M o . ( M , S )

Veterinary/Medicated Feed

Stilbestrol Repository/Spencer, Iowa 4/4/ Veterinary Laboratories/Lenexa, Kans. (M) New animal drug without approved New Animal Drug7 4 A p p l i c a t i o n .

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

Diapulse device/Moberly, Mo. 3/29/74 Diapulse Corp. of America/New Hyde Park,N.Y. (M); United Medical Equipment Co./Kansas City, Mo. (S)

nadequate directions for use.

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

No in format ion avai lab le for th is issue.

FDA Consumer / June 1974 / 35

Notices of JudgmentNOTICES OF JUDGMENT on Seizure Actions

FOOD/Poisonous and Deleterious SubstancesCorn, at Laurinburg, M. Dist . N.C.

Charged 5-24-73: while held for sale, the article contained the addedpoisonous and deleterious substance aflatoxin; 402(a)(1). Default decree ordered destruction. (F.D.C. No. 59251; S. No. 1-225 G; N.J. No. 1)

Mahi Mahi fish fillets, frozen, MMD & MSD Brands, 2 seizure actions, atLos Angeles, 0 . Dis t . Cal i f .Charged 6-28-73 and 8-1-73: when shipped by Empacadora Shayne, Cia.Ltda., Guayaquil, Equador, the article contained the poisonous and deleterious substance histamine; 402(a)(1). Default decrees ordered destruction. (F.D.C. Nos. 59335, 59400; S. Nos. 52-382 G; 52-504 G; N.J.No. 2)

Yeast, dried, debittered, brewer's, N.F., at Orange, C. Dist. Calif.Charged 10-2-73: while held for sale, the article contained the poisonousand deleterious substance Salmonella; 402(a)(1). Default decree ordereddestruction. (F.D.C. No. 59504; 3. No. 55-223 G; N.J. No. 3)

FOOD/Contamination, Spoilage, Insanitary HandlingBeans, black-eyed, dried, at Barceloneta, Dist. P.P.

Charged on or about 11-29-73: while held by Casera Foods, Inc.,Barceloneta, P.P., the article contained insects and was held under insanitary conditions; 402(a)(3), 402(a)(4). Consent decree authorized releaseto dealer for salvaging. (F.D.C. No. 59554; S. No. 95-084 G; N.J. No. 4)

Beans, pinto, and navy, at Burbank, C. Dist. Calif.Charged 4-30-73: while held by Burbank Canning Co., Burbank, Calif.,the pinto beans contained rodent filth, and both articles were held underinsanitary conditions; 402(a)(3), 402(a)(4). Consent decree authorized release to dealer for salvaging. (F.D.C. No. 59185; S. Nos. 52-605/6 G; N.J.No. 5)

Catsup, at Wichita, Dist. Kans.Charged 12-19-73: when shipped by Fettig Canning Corp., Elwood, Ind.,the article, labeled in part "Shurfine Tomato Catsup . . . Distributed byShurfine Central Corporation, Northlawe, III. "contained decomposed material; 402(a)(3). Default decree ordered destruction. F.D.C. No. 59571;S. No. 51-745 G; N.J. No. 6)

Cheese, at San Francisco, N. Dist. Calif.Charged 5-10-73: while held by J. A. Jenks Co., Inc., San Francisco,Calif., the article contained rodent filth and was held under insanitaryconditions; 402(a)(3), 402(a)(4). Consent decree authorized release todealer for salvaging. (F.D.C. No. 59198; S. Nos. 91-639/40 G; N.J. No. 7)

Cocoa beans , a t Bur l ing ton , E . D is t . Wis .Charged 8-8-73: while held by Nestle Co., Inc., Burlington, Wis., thearticle was held under insanitary conditions; 402(a)(4). Consent decreeauthorized release to dealer for salvaging. (F.D.C. No. 59377; S. Nos.60-934/5 G; N.J. No. 8)

Cocoa cake, at Chicago, N. Dist. III.Charged 4-2-73: while held by Calumet Harbor Terminals, Inc., Chicago,III., the article was held under insanitary conditions; 402(a)(4). Consentd e c r e e a u t h o r i z e d r e l e a s e t o C o o k C h o c o l a t e C o . , C h i c a g o , I I I . , f o rsalvaging. (F.D.C. No. 59127; S. Nos. 23-690/1 G; N.J. No. 9)

Coconut, shredded, dried, at Atlanta, N. Dist. Ga.Charged 8-29-72: while held by J. M. Henson Co., Atlanta, Ga., the articlecontained insects and was held under insanitary conditions; 402(a)(3),402(a)(4). Default decree ordered destruction. (F.D.C. No. 58216; S. No.5-277 F; N.J. No. 10)

Coffee beans, at Homewood, N. Dist. III.Charged 4-17-73: while held by Illinois Central Gulf Pailroad Co., Home-wood, III., the article was held under insanitary conditions; 402(a)(4).Consent decree authorized release to Industrial By-Products, Inc., Kalamazoo, Mich., for salvaging. (F.D.C. No. 59149; S. No. 23-443 G; N.J.No. 11)

Coriander, at Madison, W. Dist. Wis.Charged 11-2-73: when shipped by Sokol & Co., Countryside, III., thearticle contained insect filth and was held under insanitary conditions;402(a)(3), 402(a)(4). Default decree ordered destruction. (F.D.C. No.59536; S. No. 59-463 G; N.J. No. 12)

Coriander, mustard seed, white pepper, ginger, and oregano, at Torrance,C. D is t . Ca l i f .Charged 2-23-73: while held by Farmer Bros. Co., Allied Products Div.,Torrance, Calif., the articles were held under insanitary conditions;402(a)(4). The articles were claimed by the dealer who denied the charge.The Government served written interrogatories on the dealer. Thereafter,a consent decree of condemnation authorized release to the dealer forsalvaging. (F.D.C. No. 58915; S. No. 46-769, F et al.; N.J. No. 13)

Coriander seed and mustard seed, at Torrance, C. Dist. Calif.Charged 8-25-72: while held by Farmer Bros. Co. (Allied Products Division), Torrance, Calif., the articles contained rodent filth and wereheld under insanitary conditions; 402(a)(3), 402(a)(4). Consent decreeau tho r i zed re lease to dea le r fo r sa l vag ing . (F.D .C . No . 58208 ; S . No . 45 -845 F; N.J. No. 14)

Cumin seeds and oregano, at San Antonio, W. Dist. Tex.Charged 7-20-73: while held by Bolner's Fiesta Products, Inc., SanAntonio, Tex., the art ic les were held under insanitary condit ions;402(a)(4). Default decree ordered destruction. (F.D.C. No. 59382; S. Nos.35-119/20 G; N.J. No. 15)

Flour, a t Casper, D is t . Wyo.Charged 5-16-73: while held by Casper Distributing Co., Casper, Wyo.,t h e a r t i c l e c o n t a i n e d r o d e n t fi l t h a n d w a s h e l d u n d e r i n s a n i t a r y c o n

ditions; 402(a)(3), 402(a)(4). Consent decree authorized release to dealerfor salvaging. (F.D.C. No. 59216; S. No. 45-123 G; N.J. No. 16)

Flour, at Chicago, N. Dist. III.Charged 9-7-73; while held by Hong Kong Noodle Co., Chicago, III., thearticle contained rodent filth and was held under insanitary conditions;402(a)(3), 402(a)(4). Default decree ordered destruction. (F.D.C. No.59451; S. Nos. 25-045/6 G; N.J. No. 17)

Flour, at Denver, Dist. Colo.Charged 8-29-72: while held by Colorado Specialty Foods Corp., Denver,Colo., the article was held under insanitary conditions; 402(a)(4). Consent decree ordered destruction. (F.D.C. No. 58200; S. No. 33-751 F;N.J. No. 18)

Flour and cornmeal mix, at Caneyville, W. Dist. Ky.Charged 11-7-73. while held by Otis Bryant & Son Milling Co., Caneyville,Ky., the articles contained rodent filth and were held under insanitaryconditions; 402(aK3), 402(a)(4). Default decree ordered destruction.F.D.C. No. 59533; S. No. 3-723 et al.; N.J. No. 19)

Flour and sugar, at Detroit, E. Dist. Mich.Charged 4-13-73: while held by D.S.M. Food Products, Inc., Detroit,Mich., the articles were held under insanitary conditions; 402(a)(4). Cons e n t d e c r e e a u t h o r i z e d r e l e a s e t o d e a l e r f o r r e c o n d i t i o n i n g . ( F. D . C . N o .59124; S. Nos. 40-628 G, 40-630 G; N.J. No. 20)

Garlic bulbs, garlic juice, and garlic oil, at Chicago, N. Dist. III.Charged 7-10-73: while held by Prairie State Gold Storage Ltd., Chicago,III., the garlic bulbs contained insects, and the garlic juice and garlicoil were prepared under insanitary conditions; 403(a)(3), 402(a)(4). Default decree ordered destruction. (F.D.C. No. 59364; S. Nos. 24-260 G,25-260 G, 25-020 G; N.J. No. 21)

Mahi Mahi fish fillets, frozen, at San Francisco, N. Dist. Calif.Charged 3-21-73: when shipped by Continental Enterprises Co., Taipei,China, the article contained decomposed fish; 402(a)(3). Consent decree ordered export to original shipper. (F.D.C. No. 59231; S. No. 91-243G; N.J. No. 22)

Mushroom buttons, at Detroit, E. Dist. Mich.Charged on or about 5-31-73: when shipped by Asia Food Corp., Taipei,China, the article contained maggots; 402(a)(3). Default decree ordereddestruction. (F.D.C. No. 59150; S. No. 98-643 F; N.J. No. 23)

Mushroom pieces and stems, canned, 2 seizure actions, at Houston, S. Dist.T e x .Charged on or about 9-14-73: while held for sale, the articles werecontained in swollen, leaking, rusty, and dented cans, and some of thearticles contained decomposed mushrooms; 402(a)(3). Default decreesordered destruction. (F.D.C. Nos. 59463/4; S. Nos. 36-131 G, 36-132 G,36-149 G; N.J. No. 24)

Nuts, mixed, at Seattle, W. Dist. Wash.Charged 10-25-73: while held by Commission Co., Seattle, Wash., thearticle had been held under insanitary conditions; 402(a)(4). Default decree ordered destruction. (F.D.C. No. 59521; S. No. 100-082 (a; N.J. No. 25)

Oat cereal, quick-cooking, at Fresno, E. Dist. Calif.Charged 11-7-73: while held by Robb-Ross, Inc., Fresno, Calif., the articlecontained rodent filth and was held under insanitary conditions; 402(a)(3),402(a)(4). Default decree ordered destruction. (F.D.C. No. 59540; S. No.93-581 G; N.J. No. 26)

Potato flakes and corn syrup, at Knoxville, E. Dist. Tenn.Charged 12-13-73: when the potatoes were shipped by American Potato Co., Pocatello, Idaho, and when the corn syrup was shipped by Institutional Packers of America, Inc., Atlanta, Ga., the articles' labelsfailed to bear the name and place of business of the manufacturer,packer, or distributor; and some of the corn syrup failed to bear a labelcontaining a statement of the quantity of contents, and the name ofthe food—403(e)(1), 403(e)(2), 403(i)(l); and while held by HIR FoodDistributors, Inc., Knoxville, Tenn., the potato flakes were held underinsanitary conditions—402(a)(4). Consent decree authorized release todealer of the corn syrup for relabeling, and ordered destruction of thepotato flakes. (F.D.C. No. 58647; S. Nos. 7-724/6 F; N.J. No. 27)

Peanut pieces, at Des Moines, S. Dist. Iowa.Charged 10-18-73: when shipped from Gratton Warehouse, Omaha, Nebr.,t h e a r t i c l e c o n t a i n e d i n s e c t fi l t h a n d h a d b e e n h e l d u n d e r i n s a n i t a r yconditions; 402(a)(3), 402(a)(4). Default decree ordered destruction.F.D.C. No. 59524; S. No. 48-943 G; N.J. No. 28)

Peanuts, shelled, at Hartford, M. Dist. Ala.Charged 11-19-73: when shipped by Anderson's Peanuts, Inc. (Div. Alabama Farmers Co-op, Inc.), Hartford, Ala., the articles contained rodenta n d i n s e c t fi l t h a n d w a s h e l d u n d e r i n s a n i t a r y c o n d i t i o n s ; 4 0 2 ( a ) ( 3 ) ,402(a)(4). Consent decree authorized release to shipper for reconditioning.(F.D.C. No. 59557; S. No. 1-248 G; N.J. No. 29)

Peanuts, unshelled, at Pueblo, Dist. Colo.Charged 11-29-73: while held by McCormick Distributing Co. (Carl M.McCormick), Pueblo, Colo., the article was held under insanitary conditions; 402(a)(4). Consent decree authorized release to the dealer forsalvaging. (F.D.C. No. 59567; S. Nos. 48-256/7 G; N.J. No. 30)

Peaches, spiced, canned, Argo, at Hopkins, Dist. Minn.Charged 12-18-73: when shipped by Del Monte Corp., Oakland (Fruitvale),Calif., the article contained foreign material resembling paint chips;402(a)(3). Consent decree ordered release to shipper for salvaging.(F.D.C. No. 59578; S. No. 59-792 G; N.J. No. 31)

Pecans, unshelled, and almonds, unshelled, at Seattle, W. Dist. Wash.Charged 6-2-73: while held by Commission Co., Seattle, Wash., the articlesw e r e h e l d u n d e r i n s a n i t a r y c o n d i t i o n s ; 4 0 2 ( a ) ( 4 ) . C o n s e n t d e c r e e a ut h o r i z e d r e l e a s e t o d e a l e r f o r s a l v a g i n g . ( F. D . C . N o . 5 9 2 9 8 ; S . N o s .

36 / June 1974 / FDA Consumer

96-574/5 G; N.J. No. 32)

Rice, at Clinton, Dist. Mass.Charged 11-20-73; while held by Van Brode Milling Co., Inc., Cliriton,Mass., the article contained insect filth and was held under insanitaryconditions; and the article's label lacked the name of the manufacturer,packer, or distributor, a quantity of contents statement, and the common or usual name of the food; 402(a)(3), 402(a)(4), 403(e)(1), 403(e)(2),403(i)(l). Consent decree authorized release to dealer for reconditioning.F.D.C. No. 59556; S. Nos. 16-784/8 G; N.J. No. 33)

Rice, at St. Louis, E. Dist. Mo.Charged 11-23-73: while held by B & L Drayage Co., Inc., St. Louis, Mo.,the article contained bird filth and was held under insanitary conditions; 402(a)(3), 402(a)(4). Consent decree authorized release to MackBerger, t/a Berger Grocery Co., St. Louis, Mo., for salvaging. (F.D.C.No. 59566; S. Nos. 46-264 G, 47-426 G; N.J. No. 34)

Rice, at Salt Lake City, Dist. Utah.Charged 10-29-73: while held by Watson Warehouse & Storage Co., SaltLake City, Utah, the article contained rodent filth and was held underinsanitary conditions; 402(a)(3), 402(a)(4). Consent decree authorizedrelease to dealer for salvaging. (F.D.C. No. 59530; S. No. 44-839 G;N.J. No. 35)

Salt, at Mosinee, W. Dist. Wis.Charged 10-15-73: while held by DuBay Finer Foods, Mosinee, Wis., thearticle was held under insanitary conditions; 402(a)(4). Default decreeordered destruction. (F.D.C. No. 59520; S. No. 61-465 G; N.J. No. 36)

Sardines, canned, Jonesport, at Shreveport, W. Dist. La.Charged 11-12-73: when shipped by R. B. & C. G. Stevens Co., Jonesport,Maine, the article contained decomposed sardines and was contained inswollen cans; and the article had been prepared under insanitary conditions; 402(a)(3), 402(a)(4). Default decree ordered destruction. (F.D.C.No. 59542; S. No. 67-724 G; N.J. No. 37)

Shrimp meat, frozen, at Oakland, N. Dist. Calif.Charged 9-7-72: when shipped by Blanco Fisheries, Inc., Port Oxford,Oreg., the article contained coagulase positive staphylococci and hadbeen prepared and packed under insanitary condit ions; 402(a)(3),402(a)(4). Default decree ordered destruction. (F.D.C. No. 58236; S. No.75-636 F; N.J. No. 38)

Soybeans, at Chicago, N. Dist. III.Charged 5-10-73; while held by Calumet Harbor Terminals, Chicago, III.,the article contained rodent filth and was held under insanitary conditions; 402(a)(3), 402(a)(4). Consent decree authorized release to Agricultural Exports, Inc., Hudson, Iowa, for salvaging. (F.D.C. 59108; S.No. 23-964 G; N.J. No. 39)

Tomatoes, canned, at New York, S. Dist. N.Y.Charged 6-25-73; when shipped from Jersey City, N.J., by DeLucia Importing Co., New York, N.Y., the article, labeled in part "ProgressoBrand . . . Peeled Tomatoes . . .Packed ... for Progresso Foods Corp.,Jersey City, N.J." contained decomposed material and was contained Inswollen and leaking cans; 402(a)(3). Default decree ordered destruction.(F.D.C. No. 59311; S. Nos. 71-617/19 G; N.J. No. 40)

Tomato juice, Naas, at Grand Rapids, W. Dist. Mich.Charged 4-24-73: when shipped by Naas Foods, Inc., Geneva, Ind., thearticle contained decomposed tomato material; 402(a)(3). Consent decreeordered destruction. (F.D.C. No. 59181; S. No. 39-301 G; N.J. No. 41)

Vinegar, Shurfine, at Kansas City, Dist. Kans.Charged 10-31-73: when shipped by Speas Co., Kansas City, Mo., thearticle contained insect filth and had been prepared, packed, and heldunder insanitary conditions; 402(a)(3), 402(a)(4). Default decree ordereddestructon. F.D.C. No. 59532; S. No. 50-946 G; N.J. No. 42)

Wheat and chestnuts, at Passaic, Dist. N.J.Charged 11-1-73: while held by Farinella Bros., Importers & WholesaleGrocers, Passaic, N.J., the articles contained rodent filth and had beenheld under insanitary conditions; 402(a)(3), 402(a)(4). Consent decreeordered destruction. (F.D.C. No. 59528; S. Nos. 66-608, 66-612 G; N.J.No. 43)

FOOD/EconomIc and Labeling ViolationsCandies of various kinds, at Liberty, W. Dist. Mo.

Charged 517-73: while held by Guy's Foods, Inc., Liberty, Mo., thearticles were held under insanitary conditions; the case labeling "6 x 6Lbs." was false and misleading in representing that each case contained six 6-pound packages, when the packages were labeled "NetWeight Without Wrappers 5 Lbs. 10.3 Oz."; the labels lacked the commonor usual names of the food, since "Honey, Filled," "Chocolate Filled,"and "Pineapple Briquets" were not the common or usual names forcandy, and the candy labeled "Pineapple Briquets" lacked the common orusual name of each ingredient, since "fruit pulp" was not the commonor usual name of such ingredient; 403(a), 403(i)(l), 403(i)(2). Defaultdecree ordered destruction. (F.D.C. No. 59128; S. No. 47-107 G et al.; N.J.No. 44)

Carbonated beverage, Graf's, at Lake Bluff, N. Dist. III.Charged 5-18-73: when shipped by Graf's Beverages, Inc., Milwaukee,Wis., the article's name "Chocolate Soda" was false and misleading,s ince the a r t i c l e d id no t con ta in choco la te o r cocoa , bu t on l y an a r t i fic ia lflavor as flavorng ; 403(a ) . De fau l t dec ree au tho r i zed dona t ion to char i tab leins t i tu t ion. (F.D.C. No. 59204; S. No. 59-274 G; N.J . No. 45)

Casserole mix. Grand Tour Beef Burgundy, and Grand Tour Casserole ConCarne casse ro le m ix , a t Hono lu lu , D i s t . Hawa i i .Charged 5-24-73: when shipped by Del Monte Corp., San Francisco, Calif.,the names of the articles, "Beef Burgundy" and "Casserole Con Carne,"and the label vignettes depicting (Beef Burgundy) a dish containingchunks o f mea t , ca r ro t s , and nood les , and (Casse ro l e Con Ca rne ) g roundb e e f a n d t o r t i l l a c h i p s w i t h a c h e e s e s a u c e , s u g g e s t e d a n d i m p l i e dt h e p r e s e n c e o f m e a t i n t h e a r t i c l e s , w h i c h n a m e s a n d v i g n e t t e s a r ef a l s e a n d m i s l e a d i n g f o r a r t i c l e s c o n t a i n i n g n o m e a t ; 4 0 3 ( a ) . D e f a u l td e c r e e a u t h o r i z e d d o n a t i o n t o c h a r i t a b l e i n s t i t u t i o n . ( F. D . C . N o . 5 9 2 2 9 ;S. Nos. 90-222/3 G; N.J. No. 46)

Cheese, Swiss, pasteurized process. Honey Creek, at Los Angeles, C. Dist.C a l i f .

Charged 6-1-73: when shipped by Trumpy Cheese Co., Fremont, Wis.,t h e a r t i c l e f a i l e d t o c o n f o r m t o t h e d e fi n i t i o n a n d s t a n d a r d o f i d e n t i t yfor pasteurized process Swiss cheese, since it contained more than 44percent moisture, and its solids contained less than 43 percent milkfat; 403(g)(1). Consent decree authorized release to R. W. Zant Co.,Los Angeles, Calif., for reconditioning. (F.D.C. No. 59269; S. Nos. 52-577/8 G; N.J. No. 47)

Cherries, pitted, canned. Buttons Bay, at Pittsburgh, W. Dist. Pa.Charged 3-14-72: when shipped by Sutton's Bay Packing Co., Detroit,Mich., the article fell below the standard of quality for canned cherries,since more than 15 percent of the cherries were blemished; 403(h)(1).D e f a u l t d e c r e e a u t h o r i z e d d o n a t i o n t o c h a r i t a b l e i n s t i t u t i o n . ( F. D . C . N o .57835; S. No. 66-632 F; N.J. No. 48)

Onion rings from diced onions, at Salem, Dist. N.H.Charged 3-22-73: when shipped by Boston Bonnie, Inc., Boston, Mass.,the name of the article "Onion Rings" was false and misleading, sincesuch name represented and suggested that the article consisted solelyof segments of sliced onion in the shape of rings, when the articleactually consisted of a mixture of diced onions and other food materialsin the shape of a ring; and the article was offered for sale under thename of another food, namely, onion rings; 403(a), 403(b). The shipperclaimed the article. The Government served a written request for admissions on the claimant. Thereafter, the FDA Commissioner publisheda proposal to establish, by regulation, the common or usual name ofthe article. Answers to such request were not supplied, and, upon amotion of the Government, a default decree authorized donation tocharitable institutions. (F.D.C. No. 59040; S. No. 15-547 G; N.J. No. 49)

Shrimp, frozen, at Knoxville, E. Dist. Tenn.Charged 3-23-73: when shipped by Food Distribution Center, Inc., JerseyCity, N.J., the quantity of contents statement was not prominently placedon the article's label—403(f); and the article was in violation of theFair Packaging and Labeling Act, since the quantity of contents declaration was not within the bottom 30 percent of the principal displaypanel area, and the quantity of contents statement was not expressedin pounds—15 U.S.C. 1453(a)(2). Consent decree authorized release toMogelberg Foods, Inc., Jersey City, N.J., for relabeling. (F.D.C. No.59060; S. Nos. 2-202/3 G; N.J. No. 50)

Wafers, pretzel-type, Pletzel, at Worcester, Dist. Mass.Charged 6-13-73: when shipped by Veinna Pletzel Co., Denver, Colo., thearticle was short weight (approximately 4.7 percent); 403(e)(2). Defaultdecree authorized donation to public/charitable institution. (F.D.C. No.59236; S. No. 15-603 G; N.J. No. 51)

Whale meat, canned, at St. Paul, Dist. Minn.Charged 4-24-73: when shipped by Meidi-Ya Co., Ltd., Tokyo, Japan, thelabeling of the article, labeled in part "Gourmet Brand Broiled WhaleMeat . . . Ingredients: Octopus, Soy Sauce, Sugar, Monosodium Gluta-mate Packed for Gourmet Foods, Inc., St. Paul, Minn. Product of Japan,"w a s i n c o n s i s t e n t a s t o t h e a r t i c l e ' s c o m p o s i t i o n ; 4 0 3 ( a ) . C o n s e n t d e c r e eauthorized release to Gourmet Foods, Inc., St. Paul, Minn., for relabeling. (F.D.C. No. 59175; S. No. 60-589 G; N.J. No. 52)

VITAMINS/SPECIAL DIETARY FOODSArwin's Supreme dried egg white and dried milk product combination powder,

at Los Angeles, C. Dist. Cal i f .Charged 9-10-71: when held by Arwin Co., Los Angeles, Calif., who hadhad the article manufactured in California using an ingredient shippedin interstate commerce, the labeling of the article contained a numberof false and misleading claims, as follows: the listing on the label ofthe ingredients, "Proteolyt ic Enzyme (Papain)," "A protein digestingenzyme, papain, has been added for fast and maximum assimilation,""Amino Acids (calculated) Alanine 2.17% -Arginine 2.63% Aspart icA c i d 4 . 9 % G l u t a m i c A c i d 1 4 . 6 5 % G l y c i n e 1 . 6 5 % - H i s t i d i n e2 .0% - I so leuc ine 3 .6% -Leuc ine 6 .37% -Lys ine 5 .45% -Me th ioni n e 1 . 7 5 % - P h e n y l a l a n i n e 3 . 3 % P r o l i n e 7 . 7 2 % S e r i n e 4 . 5 7 %- T h r e o n i n e 3 . 2 7 % - Tr y p t o p h a n e 0 . 8 0 % Ty r o s i n e 4 . 1 2 % - Va l i n e4.77% -Cyst ine 0.2% -Essential amino acids," "Sodium 0.22," and"Chlorine 0.3%," falsely and misleadingly represented and suggestedt h a t t h e n u t r i t i o n a l v a l u e o f t h e a r t i c l e w a s e n h a n c e d b y t h e p r e s e n c etherein of such ingredients; the label statements "Obesity (weight control)—Take one heaping tablespoonful in a glass of skim milk or un-sweented juice one-half hour before meals or whenever feeling of hunger developes," falsely and misleadingly represented and suggested thatthe article, when used as directed, was of value in the dietary management of obesity and in the control of body weight; and the labelstatements "-Arginine . . . Histidine . . . Essential amino acids" falselyand misleadingly represented and suggested that Arginine and Histidinewere essential amino acids for adults, the persons for whom the product is intended—403(a); the article's label lacked the common or usualname of the ingredient dried egg whites—403(i)(2); the article lackedrequired information concerning its mineral properties (i.e., minimumdaily requirements for calcium and phosphorus)—403(j); and the articlew a s a l s o i n v i o l a t i o n o f t h e F a i r P a c k a g i n g a n d L a b e l i n g A c t , s i n c e t h equantity of contents declaration was not placed within the bottom 30percent of the principal display panel area; the quantity of contentsstatement was expressed as "Net Weight 3 Lbs." instead of "Net Wt.48 Ozs. (3 Lbs.);" and the quantity of contents statement, appearing onthe principal display panel area of more than 25 square inches, was ina type size less than 3/16 inch high; 15 U.S.C. 1453(a)(2), 1453(a)(3)(A)(i), 1453(a)(3)(C)(i). Consent decree authorized release to the dealer fors a l v a g i n g . W h e n t h e d e a l e r f a i l e d t o s a l v a g e t h e a r t i c l e , t h e c o u r t o rde red the a r t i c l e des t royed . (F.D .C . No . 57449 ; S . No . 89 -783 E ; N .J . No .53)

Sawall's radish & parsley concentrates tablets, brewer's yeast tablets, ricepolish tablets, vitamin B-1 tablets, niacinamide tablets, dried yeast,Formula 33 tablets, S-N-P okra tablets, and S-N-P alfalfa tablets, atDet ro i t , E . D is t . M ich .Charged 12-16-71: while held by Sawall Health Food Products, Inc., Detroit, Mich., who had repacked the articles from bulk lots shipped ini n t e r s t a t e c o m m e r c e , t h e l e a fl e t " D i s c i p l i n e " a c c o m p a n y i n g a l l t h ea r t i c l e s c o n t a i n e d t h e f a l s e a n d m i s l e a d i n g s t a t e m e n t " B u y m o r e o fy o u r f o o d s i n H e a l t h F o o d S t o r e s w h e r e t h e r e a r e p u r e f o o d s — n o t f o o d scontain ing di fferent k inds of fi l th of which so much has been rep o r t e d i n t h e n e w s p a p e r s l a t e l y , " t h e l e a fl e t " S a w a l l N u t r i t i o n a l N e w s "a c c o m p a n y i n g a l l t h e a r t i c l e s c o n t a i n e d f a l s e a n d m i s l e a d i n g c l a i m s t o

FDA Consumer ] June 1974 j 37

the effect that your health depended entirely upon the quality of foodyou ea t ; t ha t eve ryone was bo rn w i t h some i nbo rn weakness because t hegenes did not possess their full potential as a result of our mothersnot having well-balanced nutrition during pregnancy; that as a result ofour mothers not having well-balanced nutrition during pregnancy, manyof our cells, tissues, and organs were not completely developed, adversely affecting the whole body chemistry and energy, and causing usto have one or more of the following inborn weaknesses: inferior redcorpuscles, inferior antibodies, supersensitive joints, poor endocrinegland functioning, inferior capillary circulation, poor oxidation in manyvital tissues in the body, and subnormal oxidation in the brain cells;and that we can never get rid of these inborn weaknesses, but we cankeep them under control by a strong and complete nutritional programutilizing potent minerals, vitamins, and other concentrated nutrientssuch as Sawall Nutritional Products; the labeling of the brewer's yeasttablets, rice polish tablets, dried yeast, vitamin Bi tablets, niacinamidetablets, and Formula 33 tablets contained additional false and misleading nutritional claims and statements which were contrary to fact; andt h e v i t a m i n B i t a b l e t s a n d t h e n i a c i n a m i d e t a b l e t s f a i l e d t o b e a r c e rtain required special dietary use information—403(a), 403(]); and thearticles were in violation of the Fair Packaging and Labeling Act, sincethe quantity of contents statements of all of the articles, except theFormula 33 tablets, were not within the bottom 30 percent of theprincipal display panel areas; the quantity of contents statements appearing in principal display panel areas of more than 5 square inchesof all the articles, except the alfalfa tablets and Formula 33 tablets,were in a type size less than Vs inch high; the terms "Net Weight" or"Net Wt." were not used in the quantity of contents statement of thedried yeast; and the principal display panel of the Formula 33 tabletslacked any quantity of contents declaration—15 U.S.C. 1453(a)(2), 1453(a)(3)(A)(i), 1453(a)(3)(C)(i). Default decree ordered destruction. (F.D.C.No. 57697; S. No. 13-261 E et al.; N.J. No. 54)

FOOD/COLOR ADDITIVESCherries, sliced, maraschino, Blanke Baer, at O'Fallon, E. Dist. III.

Charged 5-15-73: when shipped by Blanke Baer Fruit & Flavor Co., St.Louis, Mo., the article contained the color additive Ponceau SX, CI No.14700 (certifiable as FD&C Red No. 4) in excess of the permitted 150ppm; 402(c). Default decree ordered destruction. (F.D.C. No. 59208; S.No. 47-706 G; N.J. No. 55)

Chlorella capsules, at Torrance, C. Dist. Calif.Charged 5-25-73: while held for sale and repacking into retail sizebottles by Eriex Co., Torrance, Calif., for Sunset Glare Guard, PalmSprings, Calif., the article, which was in bulk, contained the nonconforming food additive chlorella, and the article's labeling, i.e., the repack bottle label for the article, contained the false and misleadingstatement "Chlorella Growth Factor" that represented the article asbeing essential to growth; 402(a)(2)(C), 403(a). Default decree ordereddestruction. (F.D.C. No. 59232; S. No. 53-293 G; N.J. No. 56)

Spaghetti, Red Cross, at Louisville, W. Dist. Ky.Charged 6-14-73: when shipped by Red Cross Macaroni Co., Chicago, III.,the article contained the nonconforming food additive terpine poly-chlorinates (Strobane), and it had been prepared, packed, and held underinsanitary conditions; 402(a)(2)(C), 402(a)(4). Default decree ordereddestruction. (F.D.C. No. 59309; S. No. 1-056 G; N.J. No. 57)

DRUGS/Human UseAfrodex methyltestosterone, yohimbine HOI, and nux vomica extract capsules,

at Covina, C. Dist. Calif.Charged 5-31-73: while held by ICN Pharmaceuticals, Inc. (Bentex Division), Covina, Calif., the labeling lacked adequate directions for use andwas not exempted therefrom, since the article was a new drug withoutan effective approved New Drug Application; 502(f)(1). Default decreeordered destruction. (F.D.C. No. 59254; S. No. 54-181 G; N.J. No. 58)

Afrodex methyltestosterone, yohimbine HCI, and nux vomica extract capsules,at Kansas City, W. Dist. Mo.Charged 5-23-73: when shipped by ICN Pharmaceuticals, Covina, Calif.,the article was a new drug without an effective approved New DrugApplication; 505(a). Default decree ordered destruction. (F.D.C. No.59225; S. No. 46-821 G; N.J. No. 59)

Basorex methyltestosterone, yohimbine HCI and nux vomica extract capsules,at St. Louis, E. Dist. Mo.Charged 8-3-73: while held for sale after manufacture by Private Formulae, Inc., St. Louis, Mo., from ingredients shipped in interstate commerce, the label ing lacked adequate di rect ions for use, and thearticle was not exempted therefrom, since it was a new drug for whichno approval of a New Drug Application was effective and no Noticeof Claimed Investigational Exemption was on file; 502(f)(1). Defaultdecree ordered destruction. (F.D.C. No. 59396; S. No. 47-717 G; N JNo. 60)

Choline chloride and methionine combination injection, at Anaheim, C. Dist.C a l i f .Charged 5-25-73: when shipped by Myers-Carter Laboratories, Inc., Glen-dale, Ariz., the article, labeled in part "Sterile Lipoject Fellows MedicalM f g . C o . I n c . A n a h e i m , C a l i f . . . . d l - M e t h i o n i n e . . . C h o l i n e C h l o r i d e. . . Inositol . . . Cyanocobalamin," was a new drug without aneffective approved New Drug Application; and the package insert statements "As a lipotropic agent" and "For use as a dietary supplement"were false and misleading, since the article was not adequate andeffective for such purposes; 505(a), 502(a). Default decree ordered destruction. (F.D.C. No. 59255; S. No. 52-650 G; N.J. No. 61)

Cyanocobalamin (vitamin B12) injection, U.S.P., and bulk cyanocobalamin, atBal t imore, Dist . Md.Charged 7-19-73: while held by John D. Copanos Co., who manufacturedthe injection from bulk cyanocobalamin shipped in interstate commerce,the circumstances of the article's manufacture, processing, packing,and holding, lacked conformity with current good manufacturing practice; and the strength of the injection differed from U.S.P. standards,since it contained approximately 92 percent of the declared cyanocob a l a m i n ; 5 0 1 ( a ) ( 2 ) ( B ) , 5 0 1 ( b ) . C o n s e n t d e c r e e a u t h o r i z e d r e l e a s e t o t h edealer for destruction of the injection and for salvaging of the bulkcyanocobalamin. (F.D.C. No. 59374; S. No. 12-849 G; N.J. No. 62)

Digi toxin tablets, U.S.P., at Dal las, N. Dist . Tex.

Charged 3-26-73: when shipped by Linden Laboratories, Inc., Los Angeles,Calif., the article's strength differed from and its quality fell befowthe United States Pharmacopeia standards, since the article failed theU.S.P. content uniformity requirements; 501(b). Default decree ordereddestruction. (F.D.C. No. 58900; S. No. 85-238 F; N.J. No. 63)

Hexachlorophene surgical skin cleaner, at Oak Ridge, N. Dist. III.Charged 4-10-73: whi le held for sale after manufacture by TuroffIndustries, Inc., using hexachlorophene shipped in interstate commerce,the labeling of the article, labeled in part "Surgi-Scrub AntibacterialSkin Cleaner . . . Made exclusively for Northern Laboratories Supply Co.,Chicago, III.," lacked adequate directions for use and was not exempted therefrom as a prescription drug, since it lacked adequate information for use by licensed practitioners for its intended purposes,and since the article was a new drug without an effective approvedNew Drug Application; 502(f)(1). Default decree ordered destruction.(F.D.C. No. 59103; S. No. 22-370 G; N.J. No. 64)

Magnesium sulfate injection, U.S.P., at Philadelphia, E. Dist. Pa.Charged 3-19-73: while held by Harvey Laboratories, Philadelphia, Pa.,who manufactured the article using magnesium sulfate shipped in interstate commerce, the circumstances of the manufacture, processing,packing, and holding of the article failed to conform to current goodmanufacturing practice; and the quality of the article fell below theUnited States Pharmacopeia standards, since the art icle fai led tocomply with the pH requirement of the U.S.P.; 501(a)(2)(B), 501(b).Default decree ordered destruction. (F.D.C. No. 58971; S. No. 84-082 G;N.J. No. 65)

P/G peptone injection and lodotein peptone and sodium iodide injection, atGlendale, Dist . Ar iz .Charged 5-25-73 and amended 8-13-73: while held by Myers-CarterLaboratories, Inc., Glendale, Ariz., who manufactured the articles usingbeef peptone shipped in interstate commerce, the package insert statements for lodotein injection, such as "Stimulation of leucocytosis andmobilization of immune bodies by systemic action of protein increasesresistance to infection, restrains bacterial invasion and hastens recovery. . . Indications and Uses Common cold, coryza, rhinitis, sinusitis,acute and chronic influenza, Tonsil i t is, Pharyngit is and Bronchit is."were false and misleading—502(a); and the package insert statementf o r P / G i n j e c t i o n , s u c h a s " I n d i c a t i o n s . . . R e l i e f o f P a i n s a s s o c i a t e dwith herpes zoster, relief of pain in neuritis (facial, sciatic, or intercostal) of inflammatory nature, not arising from traumatic or mechanicaletiology, were false and misleading—502(a); and the labeling of thearticles lacked adequate directions for use and were not exemptedtherefrom, since the articles were new drugs without effective approvedNew Drug Applications; 505(a). Consent decree ordered destruction.(F.D.C. No. 59210; S. Nos. 53-532/3 G; N.J. No. 66)

Sulfamethazole and phenylazG-diaminopyridine HCI capsules, at Kenosha, E.Dis t . Wis .Charged 5-25-73: while held for sale after manufacture by Park Laboratories, Inc., Fredonia, Wis., using phenylazo-diaminopyridine hydrochloride shipped in interstate commerce, the circumstances of the article's manufacture, processing, packing, and holding failed to conformto current good manufacturing practice; and the article's strength differedfrom its represented strength, since it contained approximately 62 percent of its declared phenylazo-diaminopyridine HCI; 501(a)(2)(B), 501(c).Default decree ordered destruction. (F.D.C. No. 59209; S. No. 59-221 G;N.J. No. 67)

DRUGS/VeterinaryC u s t o m B e e f d i e t h y l s t i l b e s t r o l p r e m i x e s f o r b e e f c a t t l e , 2 s e i z u r e a c t i o n s , a t

McCook, Dist. Nebr., and El Paso, W. Dist. Tex.C h a r g e d 11 - 2 8 - 7 2 a n d 11 - 2 2 - 7 2 : w h e n s h i p p e d b y F e e d P r o d u c t s , I n c . ,Denver, Colo., the articles were new animal drugs and no approved NewAnimal Drug Application was effective with respect to the articles' usesand in tended uses ; 501(a ) (5 ) . De fau l t dec rees o rde red des t ruc t i on . (F.D .C .Nos. 58521/2; S. Nos. 33-477/9 F; N.J. No. 68)

Russell Ru-Vi-Otic vitamin-streptomycin-penicillin powder and Russell procaine penicillin G, U.S.P., at Kansas City, W. Dist. Mo.Charged 7-10-73: while held by I. D. Russell Co. Laboratories, KansasCity, Mo., the circumstances of the articles' manufacture, processing,packing, and holding failed to conform to current good manufacturingpractice; and the articles were new animal drugs, and no approval ofN e w A n i m a l D r u g A p p l i c a t i o n s w e r e i n e f f e c t w i t h r e s p e c t t o t h e u s ea n d i n t e n d e d u s e o f t h e a r t i c l e s ; a n d t h e a r t i c l e s w e r e f r o m b a t c h e sw i t h r e s p e c t t o w h i c h n o c e r t i fi e d a n t i b i o t i c c e r t i fi c a t e o r r e l e a s e w a si n e f f e c t ; 5 0 1 ( a ) ( 2 ) ( B ) , 5 0 1 ( a ) ( 5 ) . 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 .(F.D.C. No. 59322; S. No. 48-925 G et al.; N.J. No. 69)

Sul famerazine tablets, at Sioux Fal ls , Dist . S. Dak.Charged 5-18-73: when shipped by Vet Products, Kansas City, Mo., thearticle's veterinary prescription legend was false and misleading, sincet h e a r t i c l e w a s n o t r e s t r i c t e d t o s u c h p r e s c r i p t i o n u s e ; a n d t h e l a b e l i n gl a c k e d a d e q u a t e d i r e c t i o n s f o r u s e f o r t h e p u r p o s e s a n d f o r e a c hspecies of animals for which the article was intended; 502(a), 502(f)(1).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 . ( F. D . C . N o . 5 9 1 9 7 ; S . N o . 4 3 - 9 8 8 G ;N.J. No. 70)

Tet ramyc in oxy te t racyc l ine HCI In jec tab le , a t Denver, D is t . Co lo .Cha rged 7 -11 -73 : wh i l e he ld by W i t t ney & Co . , Denve r, Co lo . , who manuf a c t u r e d t h e a r t i c l e f r o m i n g r e d i e n t s s h i p p e d i n i n t e r s t a t e c o m m e r c e , t h ea r t i c l e w a s a n e w a n i m a l d r u g , a n d n o a p p r o v a l o f a N e w A n i m a l D r u gA p p l i c a t i o n h a d b e e n fi l e d w i t h r e s p e c t t o t h e a r t i c l e ' s u s e a n d i n t e n d e duse; 501(a)(5). Consent decree authorized release to sliipper for salvaging. (F.D.C. No. 59354; S. No. 43-711 G; N.J. No. 71)

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

Apsee Ai r Charger e lect ron generator, a t Rosel le , Dis t . N.J.Charged 6-12-73: when shipped by Apsee, Inc., Reseda, Calif., the article'saccompanying brochures contained false and misleading claims for burns,surface infections, pepped-up feeling, blisters, diarrhea, virus and bact e r i a l i n f e c t i o n s ; 5 0 2 ( a ) . C o n s e n t d e c r e e a u t h o r i z e d r e l e a s e t o C l e w o r t hConditioning, Inc. (William J. Capo), Roselle, N.J., for relabeling. (F.D.C.No. 59282; S. No. 64-642 G; N.J. No. 72)

DIapulse electromagnetic energy generators (converted to P/EmP electromagnetic energy generators), at St. Petersburg, M. Dist. Fla.

38 I June 1974 / FDA Consumer

Charged 7-5-72: when shipped after manufacture for Diapuise Corp. ofAmerica, New Hyde Park, N.Y., and while held for sale, the articles'accompanying treatment chart and booklet contained false and misleading claims that use of the article could cause sick, run-down cells ofthe body to perk up with new life and fresh vigor; cause human gammaglobulin to be four times more effective; restore good health; had beenproven successful in treating most all acute and chronic conditions; wasadequate and effective as a treatment for infections, fractures, bursitis,arthritis, low back pain, sinusitis, cystitis, colitis, diverticulosis, highblood pressure, phlebitis, neuritis, neuralgia, respiratory conditions suchas bronchitis, sore throat, and external otitis; and that there was nolimit to what radio waves might be able to do in maintaining health;502(a). Dr. Lee E. Arnold, St. Petersburg, Fla., answered the chargesstating that he had returned the seven devices to the distributor whohad originally sold him the articles, with specific instructions to convert the articles into "a diathermy machine, which is labeled as P/EmFDiathermy," that the articles had been "completely and totally convertedto a legally constituted diathermy machine and properly labeled asP/EmF Diathermy," and that the court was, upon hearing and proof,prayed to dismiss the action and order the release of the articles. TheGovernment moved for a postseizure sample of one of the seven devicesseized. The court granted the Government's motion. Subsequently, theclaimant moved for clarification and amendment of the postseizure orderand moved for a stay of such order. The claimant's motions sought theright to be present or have a representative present at the site ofexamination and testing, to be furnished prior to examination or testingby the Government, the procedures, instruments, and characteristics ofany patients that might be tested with the device, and that the executionof the postseizure sampling order be stayed. The claimant's motionswere denied. Thereafter, the claimant moved for summary judgment onthe grounds that the devices had been remanufactured into diathermy,labeled P/EmF, and given new serial numbers, that the devices were notheld by Dr. Lee E. Arnold for sale or resale but for his personal use,a n d t h a t D r . L e e E . A r n o l d w a s t h e u l t i m a t e c o n s u m e r o f t h e d e v i c e s .T h e G o v e r n m e n t s e r v e d w r i t t e n i n t e r r o g a t o r i e s o n t h e c l a i m a n t a n d fi l e da cross-motion for summary judgment. In finding for the Government, thec o u r t s a i d :

" C l a i m a n t c o n t e n d s t h a t t h e d e v i c e s s e i z e d w e r e c o n v e r t e d i n t o l e g a lapparatus prior to seizure; that when seized they were not in interstatecommerce nor being held for sale; and, as a consequence, that the converted devices were not subject to forfeiture under 21 U.S.C. §334(a).However, Claimant has not denied that the devices described in the warran t and mon i t i on were m isb randed w i th in t he mean ing o f 21 U .S .C . §352when placed in interstate commerce. As a result, such devices can beseized and condemned under 21 U.S.C. §334(a) at any time subsequentto such placing in interstate commerce despite any changes made inthem.

"Claimant has cited no authority which supports his position whereassummary judgment for the Government is warranted by the clear languageof 21 U.S.C. §334(a) and by such decisions as United States v. DeviceLabeled 'Cameron Spitler, etc.' 261 F.Supp. 243 (D. Neb. 1966), whichs t a t e d :

'Once an article is misbranded, it has violated the law and is subjectto seizure at any time thereafter and no subsequent action can purgei t f r o m t h e v i o l a t i o n . U n i t e d S t a t e s v. 1 8 0 0 0 . 2 6 2 5 W i n e G a l l o n s , 1 2 1F.Supp. 735 (W.D. Mo. 1954). '

Also see United States v. Allbrook Freezing and Cold Storage, 194 F.2d937 (5th Cir. 1952). It is, therefore,

" O R D E R E D a n d A D J U D G E D t h a t P l a i n t i f f ' s C r o s s - M o t i o n f o r S u m m a r yJudgment be, and the same is hereby, GRANTED."

Pursuant to the judgment in the Government's favor, a decree wase n t e r e d a u t h o r i z i n g H E W t o r e t u r n t h e s a m p l e d d e v i c e , c o n s i s t i n g o f o n edevice complete with all attachments and labeling, either to be destroyed or used only for exhibit purposes, and ordering the remainder ofthe devices destroyed. (F.D.C. No. 58105; S. No. 1-442 C; N.J. No. 73)

Diapuise electromagnetic energy generators, 12 seizure actions, at Herington,Dist. Kans.; Lyons, Dist. Kans.; Kansas City, W. Dist. Mo.; Woodstock,N. Dist. III.; Kansas City, Dist. Kans.; Napoleon, N. Dist. Ohio; Colfax, S.Dist, Iowa; Wichita, Dist. Kans.; Sedan, Dist. Kans.; Emporia, Dist.Kans.; Van Nuys, C. Dist. Calif.; Indianapolis, 3. Dist. Ind.Charged 1-30-73, 1-30-73, 2-15-73, 1-26-73, 1-30-73, 2-5-73, 2-20-73, 2-20-73, 2-20-73, 2-20-73, 2-22-73, 2-15-73: when shipped after manufacturefor Diapuise Corp. of America, New Hyde Park, N.Y., and while held forsale, the articles' labeling lacked adequate directions for lay use fortheir intended purposes, and adequate information for use by licensedpractitioners could not be prepared; 502(f)(1). Consent decree ordereddestruction of the article seized at Indianapolis, Ind. Default decreesauthorized donation to government institutions for educational purposesof the devices seized at Herington, Lyons, Kansas City, Wichita, andEmporia, Kansas. The other devices were the subject of default decreeswhich ordered the devices destroyed. (F.D.C. Nos. 58793/4, 58810,58815, 58833, 58844, 58850, 58852, 58854/5, 58858, 58903; S. Nos. 42-445 F; 42-451 F; 40-615 F; 21-072 F; 40-616 F; 30-782 G; 52-001 G;39-008 F; 48-402 G; 48-403 G; 52-122 G; 39-703 G; N.J. No. 74)

Dscilloclast electronic diagnostic unit with Reflexophone components, atSaginaw, E. Dist. Mich.Charged 6-29-73: when shipped by unknown shipper, the article's labelinglacked adequate directions for use for its intended purposes, since adequate directions could not be written for use by laymen for such purposes, and the article did not comply with the Rx device exemptionrequirements, since adequate information could not be furnished for useby licensed practitioners; 502(f)(1). Consent decree ordered destruction.(F.D.C. No. 59337; S. No. 41-241 G; N.J. No. 75)

NOTICES OF JUDGMENT on Criminal Actions

F O O D

American Bakeries Co., Robert H. McCaughey, plant manager, and Bobby L.Madon, assistant plant manager. North Kansas City, W. Dist. Mo.Charged 3-23-73: when shipped, bread labeled in part 'Taystee,' cont a i n e d i n s e c t fi l t h a n d h a d b e e n p r e p a r e d a n d p a c k e d u n d e r i n s a n i t a r yconditions; 402(a)(3), 402(a)(4). Nolo contendere pleas; fines. (F.D.C. No.58590; S. No. 42-777 F; N.J. No. 76)

Doyle W. Bell, t /a Bayou Crab Co., Pascagoula, S. Dist. Miss.C h a r g e d 1 - 2 3 - 7 3 : w h e n s h i p p e d , f r e s h c r a b m e a t c o n t a i n e d E . c o l i ,

coagulase positive staphylococci, and other bacterial filth and had beenprepared and packed under insanitary conditions; 402(a)(3), 402(a)(4).Nolo contendere plea; sentence suspended, fine and probation. (F.D.C.No. 57979; S. Nos. 2-394 E, 35-337 E; N.J. No. 77)

Flavour Candy Co., Inc., and Bernard J. Golan, president, Chicago, N. Dist.I I I .Charged 1-30-73: when shipped. Chicken Bones candy. Peanut ButterCrisps candy. Chocolate Malt Crisps candy, and Wisconsin Dairy Butterscandy contained insect and/or rodent filth and had been prepared,packed, and held under insanitary conditions—402(a)(3), 402(a)(4); andalmonds had been held in a building accessible to rodents and contaminated with rodent filth—402(a)(3), 402(a)(4). Guilty plea by corporation; fine. Guilty plea by individual; probation. (F.D.C. No. 58382; S. No.176 F et al.; N.J. No. 78)

Howard Food Companies, Inc., Frank F. Oddi, president & treasurer, andKarol Obremski, plant manager, Methuen, Dist. Mass.Charged 2-12-73: watermelon cubes (count 1) were prepared, packed,and held, and popcorn (count 2) was held, in a building accessible toinsects, and the articles were contaminated with insect filth; 402(a)(3),402(a)(4). Guilty plea by corporation to both counts; fine. Nolo contendere plea by individuals to count 1; fines. (F.D.C. No. 58193; S.Nos. 17-703 E, 17-705 E; N.J. No. 79)

Magnolia Grocery Co., and Robert E. Smith, Sr., and William E. Hook, partners, Carthage, E. Dist. Tex.Charged on or about 1-11-73: cornmeal, cornmeal mix, rice, and peanutswere held in a building accessible to insects and rodents and werecontaminated with rodent filth; 402(a)(3), 402(a)(4). Not guilty pleas. Thecase came on for trial by jury. The jury returned a verdict of guilty asto the corporation and verdicts of not guilty as to the individuals. Thereafter, the partnership was fined. (F.D.C. No. 58085; S. Nos. 31-503/9 F;N.J. No. 80)

Merchants Wholesale Grocery, Inc., Columbia, Dist. B.C.Charged 5-12-72: cornmeal was. held in a building accessible to insectsand was contaminated with insect filth; 402(a)(3), 402(a)(4). Guilty plea;fine. (F.D.C. No. 57729; S. No. 16-413 E; N.J. No. 81)

Safeway Stores, Inc., Robert L. Jaynes, vice president, Ernest L. Keily, distribution center manager, Arno A. Ford, warehouse manager. El Paso, W.D i s t . T e x .Charged 9-12-72: flour was held in a building accessible to rodentsand birds and was contaminated with rodent filth; 402(a)(3), 402(a)(4).Nolo contendere pleas; fines. (F.D.C. No. 58131; 8. Nos. 32-328/30 F;N.J. No. 82)

NOTICE OF JUDGMENT on Criminal Action

D R U G S

High Chemical Co., Div. Day & Frick Inc., and H. Winston Day, president,Phi ladelphia, E. Dist . Pa.Charged 3-1-73: when shipped, pink Hy-Po-Tone strychnine sulfate,thyroid and ferric pyrophosphate tablets (count 1), Sedatans pheno-barbital, hyoscyamus, and passiflora combination tablets (count 2),Tribarbs barbiturate capsules (count 3), Doverin aspirin, phenacetin, andDover's powder combination capsules (count 4), Ampha-Cap amphetamineand amobarbltal combination capsules (count 5), and yellow Hy-Po-Tonestrychnine sulfate, thyroid, and ferric pyrophosphate tablets (count 6),had been manufactured, processed, packed, and held under circumstancesthat fa i led to conform with current good manufactur ing pract ice—501(a)(2)(B); the pink Hy-Po-Tone tablets (count 1) had possessed lessthan the 1/10 grain of declared thyroid per tablet—501(c); groundpitcher plant (count 7) which had been shipped in interstate commercewas held in a building accessible to insects and rodents and was contaminated with rodent filth—501(a)(1), 501(a)(2)(A); and two lots of soyaflour (counts 8 & 9) were held under insanitary conditions in a buildingaccessible to rodents and insects and one lot (count 9) was contaminatedwith insects—402(a)(3), 402(a)(4). Guilty plea to all counts by corporation; fine. Nolo contendere plea by individual to counts 1, 6, and 7; fine.(F.D.C. No. 57612; S. No. 18-820 D et al.; N.J. No. 83)

NOTICE OF JUDGMENT on Injunction ActionB a r s o f L o u i s i a n a , I n c . , a n d G u l f S o a p C o r p . , G e o r g e F. T h e o b a l d , p r e s i d e n t ,

Fe l i x R . Sapp , v i ce p res iden t , and Arno ld Q. Ford , genera l manager. Ba tonR o u g e , E . D i s t , L a .C h a r g e d 1 - 1 3 - 7 1 i n c o m p l a i n t f o r i n j u n c t i o n : t h a t t h e d e f e n d a n t s w e r eengaged in preparing and holding dried meat scraps at their renderingp l a n t a t B a t o n R o u g e , L a . , a n d i n d i s t r i b u t i n g s u c h d r i e d m e a t s c r a p sf r o m s u c h r e n d e r i n g p l a n t ; t h a t , w h e n d i s t r i b u t e d , t h e d r i e d m e a t s c r a p scontained the added poisonous and deleterious substance Salmonellam i c r o - o r g a n i s m s ; t h a t t h e d r i e d m e a t s c r a p s w e r e p r e p a r e d a n d h e l da t t h e d e f e n d a n t s ' r e n d e r i n g p l a n t u n d e r i n s a n i t a r y c o n d i t i o n s w h e r e b yt h e f o o d m a y h a v e b e e n r e n d e r e d i n j u r i o u s t o h e a l t h ; t h a t t h e d efendants were introducing and causing to be introduced, and deliveringa n d c a u s i n g t o b e d e l i v e r e d , f o r i n t r o d u c t i o n i n t o i n t e r s t a t e c o m m e r c e ,such food; and that the defendants were well aware that their activitieswere in violation of the law; 402(a)(1), 402(a)(4). After a hearing beforethe court, the injunction was denied and the complaint was dismissed.In render ing such judgment , the cour t sa id :

" A t t h e t i m e t h i s c a s e w a s h e a r d o n F e b r u a r y 1 2 , 1 9 7 1 , t h e i n s p e ct o r s f o r t h e F o o d a n d D r u g A d m i n i s t r a t i o n d i d n o t k n o w w h e t h e r o r n o ta n y o f t h e i r r e c o m m e n d a t i o n s h a d b e e n c a r r i e d o u t s i n c e t h e i r i n s p e ct i o n i n A u g u s t o f 1 9 7 0 , a s n o f u r t h e r i n s p e c t i o n o f t h e p r e m i s e s h a db e e n m a d e s i n c e t h a t t i m e . B u t t h e e v i d e n c e i n t h e c a s e c l e a r l y s h o w e dthat all of the recommendations made by the inspectors have, in fact,been implemented by the defendants and indeed, additional precautionshave been taken by the defendants to insure the purity of their product.

"After hearing all of the evidence in this case, this Court finds as af a c t t h a t a s o f t h e t i m e o f t h i s t r i a l , a l l o f t h e r e c o m m e n d a t i o n s m a d eby the inspectors have indeed been carr ied out and that the def e n d a n t s h a v e , i n f a c t , g o n e b e y o n d t h e s c o p e o f t h e r e c o m m e n d a t i o n sof the inspectors and have made their plant a 'safe' plant for thep r o d u c t i o n o f u n c o n t a m i n a t e d f o o d p r o d u c t s . T h e r e w a s a b s o l u t e l y n oi n d i c a t i o n a t t h e t i m e o f t h i s t r i a l o f a n y p r e s e n t v i o l a t i o n s o f t h eF o o d a n d D r u g A c t . W h i l e t h e r e i s n o q u e s t i o n b u t t h a t v i o l a t i o n s w e r ep r e s e n t i n A u g u s t o f 1 9 7 0 , i t i s a l s o e v i d e n t t h a t t h e G o v e r n m e n t m a d e

FDA Consumer / June 1974 / 39

n o e f f o r t t o d e t e r m i n e w h e t h e r o r n o t t h e r e c o m m e n d a t i o n s o f t h e i rinspectors had been carried out since that time. This Court is convinced, from the evidence adduced at the trial in this case, that thedefendants have, in fact, cured all of the deficiencies that existed intheir plant in August of 1970, and the Court is further convinced thatthe defendants will, in the future, operate their plant in accordancewith law, and that they will continue to employ all of the safeguardspresently in use to assure the production of uncontaminated products.

"While improvement is always to be sought, the law simply requiresthat the defendants operate their plant in such a manner as to produceu n c o n t a m i n a t e d p r o d u c t s . * * *

" S h o u l d t h i s C o u r t b e p r e s e n t e d w i t h e v i d e n c e i n t h e f u t u r e o f a n yr e l a x a t i o n i n t h e u s e o f t h e s e c o n t r o l s , i t w o u l d , o f c o u r s e , t a k e a nentirely different view of this matter. There is, of course, no doubtthat the power exists in the Court to issue an injunction if it is reasonable to expect that the defendants will commit violative acts in thefuture, despite the discontinuance of such legal conduct at the timet h e i n j u n c t i o n i s s o u g h t . * * *

"Thus, the critical determination in this case is whether or not iti s r e a s o n a b l e t o e x p e c t t h a t t h e d e f e n d a n t s w i l l c o m m i t v i o l a t i v e a c t si n t h e f u t u r e . I t i s t h e c o n c l u s i o n o f t h i s C o u r t , f r o m t h e e v i d e n c ea d d u c e d a t t h e t r i a l , t h a t t h e r e i s s i m p l y n o s h o w i n g t h a t s u c h v i o l at i o n s a r e l i k e l y t o r e o c c u r . T h e r e f o r e , s i n c e t h e r e a s o n a n d t h enecessity for the issuance of an injunction are not clearly established,injunctive relief will be denied. Judgment will be entered accordingly."(Inj. No. 603; S. No. 7-533 D; N.J. No. 84)

NOTICE OF JUDGMENT on Miscellaneous Action

Drug effectiveness evidenced by controlled investigations, Wilmington, Dist.D e l .Charged 11-4-69 by Pharmaceutical Manufacturers Association, a Delaware corporation, against H.E.W. Secretary Robert H. Finch and FDACommissioner Herbert L. Ley, Jr., in a complaint for declaratory judgment and injunctive relief; that the September 19, 1969, FDA regulations(34 Fed. Reg. 14596) prescribed the kinds of evidence to establish theeffectiveness of drug products and set the standard of whether anevidentiary hearing was needed to remove a drug from the market forl a c k o f s u b s t a n t i a l e v i d e n c e o f e f f e c t i v e n e s s ; t h a t t h e P h a r m a c e u t i c a lManufacturers Association ("PMA") included, as members, the manuf a c t u r e r s a n d d i s t r i b u t o r s o f m o r e t h a n 9 0 p e r c e n t o f t h e N a t i o n ' sprescription drugs, and that PMA filed the action on behalf of itsmember companies affected by the regulations; that various officialstatements, prior to the issuance of the contested FDA regulations, hadindicated official recognition of clinical experience as an element ofsubstantial evidence supporting the effectiveness of drugs; that theFDA regulations made it clear that clinical experience would not beconsidered relevant in determining whether a drug was effective; thatthe defendants acted wrongfully, as follows: (a) exceeded statutoryauthority in promulgating a definition of "substantial evidence" thatgave no weight to clinical studies and experience other than the clinicalinvestigations specified in the regulations, (b) promulgated the regulat ions arbitrari ly and capriciously in fai l ing to specify which drugsdefendants believed were questionably effective and in failing to providea reasonable period of time in which the specified clinical investigationscould be conducted, (c) exceeded statutory authority, denied due process,and were arbitrary and capricious in the arrogation to the Commissionerof the power, unilaterally and in camera, to resolve factual issues,(d) exceeded statutory authority under Sections 505(d) and (e) of theAct, in permitting the withdrawal and denial of New Drug Applicationswithout a hearing, and (e) violated the Administrative Procedure Actin promulgating substantive regulations without notice or opportunityfor comment; that the plaintiff and its member companies were irreparably injured by the regulations; that all available administrative remedieshad been exhausted; and that the plaintiff sought a judgment holding theregulations were null and void and an injunction enjoining the defendants from acting in reliance upon the regulations.

The cour t found in favor o f the p la in t i f f say ing:"*** The September regulations (34 Fed.Reg. 14596) promulgated newstandards of evidence necessary to demonstrate the effectiveness ofdrug products and applied those standards retroactively so as to placein jeopardy the continued marketing of thousands of drug products introduced before 1962 with Food and Drug Administration ('FDA') approvaland the effectiveness of which FDA has not yet challenged. Specifically,the regulations detail criteria for 'adequate and well-controlled clinicalinvestigations' that will be deemed by the Commissioner to constitute' s u b s t a n t i a l e v i d e n c e ' o f e f f e c t i v e n e s s a n d e x c l u d e s a s i r r e l e v a n t o t h e rclinical tests and documented clinical experience. The regulations furtherprovide that when the Commissioner seeks to remove a product fromthe market for lack of substantial evidence of effectiveness, the affecteddrug company will be entitled to a hearing only if it demonstratesto the Commissioner an ability to produce substantial evidence before ahearing is held, and convinces the Commissioner that the efficacy ofthe drug in question is, in fact, supported by adequate and well controlled clinical investigation of the kind described in the regulations.***

"The September regulations, which prescribe in specific detail, for thefirst time, the kinds of clinical investigations that will be deemed necessary to establish the effectiveness of existing and future drug productsand which require that such evidence be submitted as a condition toa v o i d i n g s u m m a r y r e m o v a l f r o m t h e m a r k e t , a r e p e r v a s i v e i n t h e i r s c o p eand have an immedia te and substant ia l impact on the way PMA's memberssubject to FDA regulation, conduct their everyday business. The regulations apply to more than 2000 drug products first marketed between1938 and 1962 with FDA approval and place all of them in jeopardy,s u b j e c t t o s u m m a r y r e m o v a l b y o r d e r o f F D A .

"The all pervasive and substantial impact which the September regulat ions have upon the drug indus t ry and in tu rn upon prescr ib ing phys ic iansand their patients, makes it imperative that the Commissioner complyw i t h t h e n o t i c e a n d c o m m e n t p r o v i s i o n s o f S e c t i o n 4 b e f o r e s u c hr e g u l a t i o n s b e c o m e e f f e c t i v e .

" I n c o n t e n d i n g t h a t h e w a s n o t o b l i g a t e d t o g i v e n o t i c e a n d o p p o rtunity for comment, the Commissioner does not deny that compliancew i t h t h e t e s t i n g r e q u i r e m e n t s o f t h e S e p t e m b e r r e g u l a t i o n s w i l l h a v e as u b s t a n t i a l a n d p e r v a s i v e e f f e c t o n t h e d r u g i n d u s t r y. R a t h e r, t h e C o mmiss ione r a rgues t ha t t he t es t i ng s tanda rds o f t he Sep tember r egu la t i onsa r e n o t n e w a n d t h a t a n y b u r d e n i m p o s e d b y t h e m i s t h e d i r e c t r e s u l to f t h e ' s u b s t a n t i a l e v i d e n c e ' o f e f f e c t i v e n e s s r e q u i r e m e n t s e m b o d i e d i n

the 1962 amendments to the Act. Thus, the Commissioner concludesthat the only effect of the September regulations was to 'particularize't h e s t a t u t o r y s t a n d a r d .

" D e s p i t e t h i s a r g u m e n t , t h e r e c o r d i s c l e a r t h a t t h e a d m i n i s t r a t i v epractice applying the statutory standard to drugs marketed before 1962has not uniformly insisted on evidence produced in accordance with thecarefully controlled testing requirements of the September regulations.For example, in promulgating 'prescription drug advertising regulations,'the Commissioner has recognized explicitly the relevance of well-documented clinical experience in establishing the effectiveness of drugstha t have been approved fo r marke t ing be tween 1938 and 1962 . * * *

" I n l i gh t o f t he adm in i s t r a t i ve p rac t i ce ou t l i ned above [ i . e . , 1 . p resc r i ption drug advertising regulations, 2. FDA and industry conferences between 1963 and 1964, 3. NAS-NRC guidelines, 4. Federal Register requestfor drug efficacy information, 5. NAS-NRC Panel final reports], theCommissioner is incorrect in asserting that before September 1969 therewas a uniform understanding concerning the range of evidence whichcould be offered to support a claim of drug effectiveness for a drugmarketed before 1962. The above discussion indicates that the September regulations did effect a material narrowing of the range ofevidence which previously had been considered relevant in evaluating adrug's efficacy. Because of the important clarification of acceptabletesting standards effected by the September regulations and becauseof the substantial impact of these regulations on the drug industry,the Commissioner should have issued these important regulations onlyafter providing notice and opportunity for comment.

"The considerable confusion and controversy in this proceeding inregard to the feasibility, impact, and basic validity of the Septemberr e g u l a t i o n s i n d i c a t e t h a t a f f o r d i n g n o t i c e a n d o p p o r t u n i t y f o r c o m m e n tw o u l d h a v e b e e n e s p e c i a l l y a p p r o p r i a t e . M a n y o f t h e i m p o r t a n t i s s u e sn o w r a i s e d b y P M A i n t h i s C o u r t a r e m a t t e r s w h i c h r e q u i r e t h o r o u g hand expert consideration by the Commissioner. For example, PMA assertsthat it would be difficult, if not impossible, to employ sufficient researchinvestigators to perform the extensive testing required by the Septemberr e g u l a t i o n s f o r a l l d r u g p r o d u c t s c u r r e n t l y m a r k e t e d , e s p e c i a l l y b e c a u s emany trained clinicians are not interested in testing drugs which havebeen marketed for a long period of time and accepted by the medicalp r o f e s s i o n a s e f f e c t i v e . * * *

" T h e r e l a t i o n s h i p o f t h e N A S - N R C P a n e l s t u d i e s t o t h e s t a n d a r d s a n dp r o c e d u r e s o f t h e F D A f o r j u d g i n g t h e e f fi c a c y o f d r u g p r o d u c t s h a s ,unfortunately, never been fully clarified. As pointed out in the aboved i s c u s s i o n o f p r i o r a d m i n i s t r a t i v e p r a c t i c e , t h e g u i d e l i n e s e s t a b l i s h e df o r t h e N A S - N R C P a n e l s a n d s u b m i s s i o n s a c c e p t e d f r o m t h e p h a r m a c e ut i c a l i n d u s t r y w e r e n o t l i m i t e d t o e v i d e n c e p r o d u c e d b y s t r i c t l y c o nt r o l l e d t e s t s a s n o w r e q u i r e d b y t h e S e p t e m b e r r e g u l a t i o n s .

" F u r t h e r c o n f u s i o n e x i s t s b e c a u s e t h e fi n d i n g s o f t h e N A S - N R C P a n e l sregarding the effectiveness of more than 2800 drug products have notbeen fully released to the drug manufacturers, even though all panelr e p o r t s w e r e s u b m i t t e d t o t h e C o m m i s s i o n e r o v e r s i x m o n t h s a g o . W h i l et h e C o m m i s s i o n e r a s s e r t s t h a t i t w o u l d c r e a t e s e r i o u s c o n f u s i o n t o r el e a s e a l l t h e s e p a n e l r e p o r t s i m m e d i a t e l y , t h e d r u g c o m p a n i e s h a v ei n d i c a t e d s u b s t a n t i a l c o n c e r n a b o u t t h e p o s s i b l e f u t u r e a c t i o n w h i c h m a yb e t a k e n a g a i n s t t h e i r d r u g p r o d u c t s b a s e d o n t h e s e u n r e l e a s e d p a n e lreports. This concern has become magnified in regard to the possibleneed to begin further testing in order to comply with the standards prom u l g a t e d i n t h e S e p t e m b e r r e g u l a t i o n s . I n d i v i d u a l d r u g m a n u f a c t u r e r sw i s h t o k n o w t h e P a n e l ' s d e c i s i o n a t t h i s p o i n t i n o r d e r t o m a k e s o m ej u d g m e n t a s t o t h e f e a s i b i l i t y a n d v a l u e o f c o n d u c t i n g s u c h t e s t i n g i norder to protect the marketability of a drug product.

"In regard to the question whether further time would be allowed fortesting after the issuance of particular NAS-NRC Panel reports, counselfor the Commissioner stated at oral argument that 'we have establisheda p o l i c y o f a l l o w i n g a s i x m o n t h s t i m e f o r t h e " p o s s i b l y e f f e c t i v e " a n d at w e l v e m o n t h s t i m e f o r t h e " p r o b a b l y e f f e c t i v e " a n d t h a t p e o p l e h a v easked fo r and ob ta ined ex tens ions o f some o f those t imes . ' * * *

"The program for evaluating the findings of the NAS-NRC Panelsa n d r e l a t i n g t h o s e fi n d i n g s t o t h e r e q u i r e m e n t f o r f u r t h e r t e s t i n g o jd r u g p r o d u c t s i s o f c o u r s e f o r t h e r e s p o n s i b l e d e t e r m i n a t i o n o f t h eC o m m i s s i o n e r . B e c a u s e o f t h e e v i d e n t c o m p l e x i t y o f t h e s c h e m e i nwhich the Commissioner is now engaged, this Court believes that thea d m i n i s t r a t i v e p r o c e d u r e s r e q u i r e d b y S e c t i o n 4 o f t h e A d m i n i s t r a t i v eProcedure Act would at the very least provide an opportunity for clarifying some of the difficult matters and problems which, if unresolved, mayimpede effective enforcement of the Food and Drug Act.

" T h e C o u r t i s n o t s u g g e s t i n g t h a t t h e C o m m i s s i o n e r m u s t , o r e v e nshould consider the particular problems stated above, and the Courtcertainly does not presume to tell the Commissioner the kind of balancehe shou ld s t r i ke i n cons ide r i ng t hese va r i ous , compe t i ng i n t e res t s . Theseproblems are pointed out simply to illustrate the necessity of givingno t i ce and oppo r tun i t y f o r commen t be fo re a regu la t i on o f such pe rvas i veimpact as here involved is finally issued. Because the minimal proceduralr i g h t s o f n o t i c e a n d o p p o r t u n i t y f o r c o m m e n t w e r e n o t a f f o r d e d i n t h ep r e s e n t c a s e , t h e p r o m u l g a t i o n o f t h e S e p t e m b e r r e g u l a t i o n s w a s i n v a l i dand a preliminary injunction will be granted."

Subsequently, the regulations revising 21 CFR 130.12(a)(5), 130.14(b)and 146.1 were republished with due notice and opportunity for commen t . (M i sc . No . 134 ; N . J . No . 85 )

Notices of Judgment are given pursuant to section 705 of the Federal Food,Drug, and Cosmetic Act. Notices of Judgment report cases involving seizurep 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 d i n g s . S e i z u r e p r oceed ings a re c i v i l ac t i ons t aken aga ins t goods a l l eged t o be i n v i o l a t i on , andc r i m i n a l a n d i n j u n c t i o n p r o c e e d i n g s a r e a g a i n s t fi r m s o r i n d i v i d u a l s c h a r g e dt 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 s g 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 , o r c o s m e t i c 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 n i n t e r s t a t ec 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 r s t a t e c o m m e r c e .

No t i ces o f Judgmen t a re p repa red by Food and D rug D i v i s i on , O ffice o f t heGeneral Counsel, DHEW.

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