Focus on Food Safety...Food Additives—Part I A primer on food additives, and the ﬁrst in a three-part se ries intended to tell consumers all about what is put into food and why

Joseph A. Califano, Jr.Secretary, U.S. Department ofHeal th , Educat ion, and Wel fare

Jul ius B. Richmond, M.D.Assistant Secretary for Health

Donald KennedyCommissioner of Food and Drugs

Wayne L. PinesA s s o c i a t e C o m m i s s i o n e r

f o r P u b l i c A f f a i r s

Harold C. Hopkins/Editorial Director

Jesse R. Nichols/Art Director

Frederick L. Townshend/Production Manager

FDA Consumer, the official magazine of theFood and Drug Administration, is publishedmonthly, except for combined July-August andDecember-January issues. Subscriptions maybe ordered from the Superintendent of Documents, Government Printing Office, Washington, D.C. 20402, at $10.00 a year ($2.50additional for foreign mailing).

Address fo r ed i to r ia l mat te rs : FDA Consumer,HFI-20, Food and Drug Administration, 5600Fishers Lane, Rockvi l le , Md. 20857.

Text of articles published in FDA Consumermay be republished without permission. Creditto FDA Consumer as the source is appreciated. Use of funds for printing this publicationapproved by the Office of Management andBudget November 1, 1972.

FDA Consumer was previously known as FDAP a p e r s .

Section 705 [375] of the Food, Drug, and Cosm e t i c A c t :

(a) The Secretary shall cause to be publishedfrom time to time reports summarizing alljudgments, decrees, and court orders whichhave been rendered under this Act, includingthe nature of charge and the disposition thereof.(b) The Secretary may also cause to be disseminated information regarding food, drugs,devices, or cosmetics in situations involving, inthe opinion of the Secretary, imminent dangerto health, or gross deception of the consumer.Nothing in this section shall be construed toprohibit the Secretary from collecting, reporting, and illustrating the results of the investigations of the Department.

Application to mail at second-class rates ispending at Rates & Classification Department,U.S. Postal Service, Washington. D.C. 20260.

Cover Art: Shel Kaplan

V O L . 1 3 N O . 3 A P R I L 1 9 7 9

Focus on Food SafetyThe debate has already begun on food safety. It has begunbecause answers are needed to tough questions: What to doabout saccharin and nitrites? How many parts per trillionare too many? And so forth. This lead article sums up thec u r r e n t s i t u a t i o n .

On Regulating Safety . . . and QualityAcute toxicity in our food is no longer a problem, says Dr.Sanford Miller, director of FDA's Bureau of Foods. Butthe quality of our food is a growing concern, he notes in ani n t e r v i e w a r t i c l e .

More Than You Ever Thought You Would Know AboutF o o d A d d i t i v e s — P a r t IA primer on food additives, and the first in a three-part series intended to tell consumers all about what is put intofood and why. An additive index is included.

Vitamins Over the Counter: Take Only When NeededA panel of experts tells FDA that nine vitamins and threeminerals are safe and effective as over-the-counter drugs butshould be used only for specified purposes.

F O I : H o w t o L e a r n F e d e r a l S e c r e t sAn article on the Freedom of Information Act and howFDA and other agencies respond to it. And respond FDAdoes .. .to more than 30,000 requests a year, mostly fromregulated industries.

State Actions and Regional ReportsThis regular department in the magazine is being expandedand this time includes a report on a deliberate PCB spilland its consequences.

News Highlights

Se izures and Pos ta l Serv ice Cases

Notices of Judgment

I n s i d e F r o n t C o v e r : T h e r e a r e v i t a m i n s — a n d t h e n t h e r e a r e v i t a m i n s .

Many people take quantities of these preparations in the real or imaginedbelief that they are needed to supplement the diet. Such vitamins are regulated under FDA 's food laws. But if vitamins are taken to prevent ortreat specific deficiencies they are considered drugs, and a panel of experts says they should be taken only on a physician's recommendation.What the panel had to say about vitamins and minerals is the subject ofVitamins Over the Counter: Take Only When Needed, beginning onpage 17.

FDA Consumer / April 1979 /1

J

focus on^Fbod&^Food safety is an issue whose time has come. Theproposed FDA limitation on saccharin, worryabout cancer risks associated with nitrites, advancesin scientific detection methods, continuing progressin food processing technology, and the constant re-evaluation of food additives have propelled the issue to the forefront. With its new-found ability todetect and measure chemicals in parts per trillion,science seems to have raised more questions thananswers. But answers must be provided, so the debate begins. Already it is recognized by the majornews media: "Playing God Over Food" is the titleof a recent New York Times editorial. "Cuttingthe Risk" is the headline on a Wall Street Journal opinion column. Washington Post editorialists expound on food safety under the caption "ADubious Remedy for FDA," and nationally syndicated columnist James J. Kilpatrick holds forthon the subject in a piece bannered "RegulatoryCommon Sense. " The Los Angeles Times headlined its editorial "Food Safety: It's Not Funny."To help bring the issue into focus, FDA Consumeroffers a series of articles on this issue. Leading offis an article bringing the issue up to date. It is followed by an interview with Dr. Sanford Miller,director of FDA's Bureau of Foods. Next is the firstof a three-part series on More Than You EverThought You Would Know About Food Additives.L e t t h e d e b a t e c o n t i n u e . — T h e E d i t o r s

Howls this for a scenario:• Put together America's sweet tooth and its fetish for wanting to look svelte. FDA Commissioner Donald Ken-Add to that the fact that most of the Nation is well-fed—even too well-fed. nedy said the committee's report ''pro

vides Congress, the Executive Branch,and the public with a useful starting

• Combine with a national fear of cancer—a well-founded dread of an insidi- point for consideration of a redesigno u s , s l o w - a c t i n g , o f t e n f a t a l d i s e a s e . o f t h e N a t i o n ' s f o o d s a f e t y p o l i c y . "

He noted that it called for a "sweeping transfer of policy-making authority

• Complicate matters further by having a small Federal agency (the Food and from the Congress to a regulatoryDrug Administration) declare that the sweetener most often used as an alter- agency." He added that this was clearlynative to sugar to satisfy the great American sweet tooth (and which people a policy issue of the greatest signifi-think helps them keep their waistlines trim) is carcinogenic—or cancer- cance and one certain to be contro-causing—and under present laws i ts use must be severely l imi ted. versial .

T h e F D A h e a d a l s o t e r m e d a s c r i ti c a l t h e r e c o m m e n d a t i o n t o a l l o w F D A

• Thicken the plot even more by having that declaration threaten a billion-dollar-plus industry.

• Have Congress step in and tell the agency to hold off on enforcement of thelaw pending further study.

• Bring some scientists and other prominent people into the picture, at therequest of Congress, to study the situation.

• Have the scientists and these people say that: yes indeed the sweetenercauses cancer but maybe the laws that require such decisions ought to bechanged.

That scenario approximates the cur- The committee said the current reg-rent situation on the saccharin is- ulatory system "has become compli-sue and, more important, on the issue cated, inflexible, and inconsistent inof food safety in general. implementation." It proposed a single

The scenario is really only for the standard for food safety to replace thefirst act, however. The final acts are current system, which distinguishesto be a national debate about safe food among deliberate additives, unavoid-and then a resolution of the issue. But able contaminants, and other cate-the scenario does set the stage for the gories. It suggested that risks be definedd e b a t e . a s l o w , m o d e r a t e , a n d h i g h , a n d i t s a i d

The call for changing the food safety the public should be allowed to makelaws came from a committee convened some of the decisions on whether itby the Institute of Medicine and the wants to use a risk product. A specialNational Research Council. Headed symbol similar to the ones used to warnby Frederick C. Bobbins of Case West- of poison and radiation was suggestedern University, the committee con- to help the public make those deci-sisted of scientists, lawyers, and public sions.policy experts. The committee made The committee further proposedits report in March under an FDA con- that both risks and benefits should be A symbol, such as these used to warntract called for by the Saccharin Study considered in regulatory action, and it of poison and radiation, has beenand Labeling Act of 1977, the law that called for supplying FDA with a vari- suggested to FDA for food productsput a moratorium on the restrictions ety of options for coping with food that contain some degree of danger top r o p o s e d f o r s a c c h a r i n b y F D A . s a f e t y i s s u e s . t h e c o n s u m e r .

FDA Consumer / April 1979 / 3

S A C C H A R I NN O T I C E

This store sells food including diet beverages anddietetic foods that contain saccharin. You will findsaccharin listed in the ingredient statement onmost foods which contain it. All foods which contain saccharin will soon bear the following warning:

USE OF THIS PRODUCT MAY BEHAZARDOUS TO YOUR HEALTH.THIS PRODUCT CONTAINS SACC H A R I N W H I C H H A S B E E N D ET E R M I N E D TO C A U S E C A N C E RIN LABORATORY ANIMALS .

THIS STORE IS REQUIRED BY LAW TO DISPLAY THIS NOTICE PROMINENTLY

During the moratorium on saccharin, this warning notice has been recjiiired inall retail establishments selling food that contains the artificial sweetener.

M o r e G r i s t f o r t h e M i l l

The food safety debate gets hotter. Adding fuel to the fire is the recentproposal on phasing out nitrites as a preservative. The joint proposal fromthe Departments of Agriculture and Health, Education, and Welfarewould ban nitrites after May 1, 1982, if the results of a study showingthat the additives cause cancer in animals are confirmed. The two departments have proposed legislation to carry out that phaseout. It's all moregrist for the congressional mill. FDA Consumer will keep its readersposted in detail as the nitrite portion of the debate develops.

to consider benefits—"particularlyeconomic ones"—in making health dec i s i o n s .

On saccharin, the committee calledit a "moderate to high" risk substance,,but sa id i t does not favor e i ther an imm e d i a t e b a n o r u n r e s t r i c t e d d i s t r i b ut i o n . I n l a t e r c o m m e n t s , t h eCommissioner made four points aboutthe saccharin/food safety situation. Theyw e r e t h a t :

1 . Saccha r in i s w i thou t doub t an animal carcinogen. "Any animal carcinogen must be regarded as a potentialcarcinogen in man," the Commiss i o n e r s a i d . " I t h i n k s a c c h a r i n ' s c o ntinued unrestricted bulk use poses apotential hazard to the public health;along with NAS (National Academyof Sciences) scientists, I am particularly concerned about its widespreadconsumption by children."

2. Under current law, food additivesmust be shown to be safe, and additivestha t cause cancer canno t be cons ide redsafe. Therefore, under present lawFDA mus t ban saccha r i n as a f ood additive. FDA's present intention is topropose a ban on saccharin as a foodadditive after Congress' moratoriumexpires in May.

3. FDA cannot take any final regulatory action on saccharin in less than1 2 t o 1 5 m o n t h s a f t e r t h e m o r a t o r i u mends. Administrative procedures, before any limitations can be imposed,include publishing a new proposal offering a comment period, issuing a final order, and possible judicial reviewof the proposal.

4. FDA's proposed action on sacchar in has been character ized as a tota lban. FDA, in fact originally proposeda ban on saccharin only as a food add i t i ve t o e l im ina te i t s bu l k use i n such

products as diet sodas. The proposalwould permit continued use of saccharin as a tabletop sweetener, withappropriate warning labels, so long asindustry can document scientificallyt h a t t h e r e a r e m e d i c a l b e n e fi t s f r o mt h i s u s e a s a n a r t i fi c i a l s w e e t e n e r.

The Commissioner said he hopedthe saccharin and food safety policyissues cou ld be reso lved in a ca lm andrational way. "FDA plans no precipitous action," he added.

4 ! April 1979 / FDA Consumer

On Regulating Safety.̂ And Quality

WJhen Dr. Sanford Miller came to FDA from the Massachusetts Institute of\y Technology last year to he director of the Bureau of Foods, he underwenta culture shock. In Washington, he discovered, you cant hedge your statements with "maybes" and "perhapses"; decisions must be made, and no matter what they are, someone will disagree. In this interview with Wayne L.Pines, associate commissioner for FDA's Office of Public Affairs, Dr.Miller presents his views on food safety, his new responsibilities, his perceptions of FDA when he was at MIT and now, and his plans for the Bureau. Dr.Miller, 47, a native of New York City, received his B.S. in chemistry and biology from the City College of New York and his M.S. and Ph.D. from Rutgersin physiology and biochemistry. He had been at MIT from 1957, and since1970 had been professor of nutritional biochemistry and director of the trainingprogram in oral science.

QDr. Miller, various polls indi-. cate the public is concernedabout the safety of the food supply.You've said you don't see any reasonfor this concern. Why do you hold thatv i e w ?

A The primary reason is that. health statistics just don't confirm that people are less healthy todaythan they were, say, 50 years ago.There's just no evidence that our foodis less safe than it was 50 years ago.What I am seeing is a shift in emphasis.Fifty years ago people didn't worryspecifically about food additives orcolor additives; what they worrieda b o u t w a s w h e t h e r t h e i r f o o d s w o u l dcause acute i l lness or whether the labelwas a correct description of what wasin the product or, for that matter, ifthey could get enough to eat. Whenthe first Federal Food and Drugs Actwas enacted in 1906 there were ser ious

questions about whether a significantportion of their food might be toxic.Today I see a different concern. We'vesolved the acute toxicity problems, ora t l e a s t h a v e t h e m u n d e r c o n t r o l s o

people don't perceive them as problems. Instead we have people who fearthis additive or that, or people whowant to know how they can eat better

foods to increase the quality of theirlives or live longer. But I just don'tthink these fears are val id; our foodsupply is safe by any conventionalmeasure. Nevertheless, we do need toaddress the more subtle problems ofbehavior, performance, and so on. Inthe case of health and safety, there isno "safe enough."

QDo you think there's a direct. a s s o c i a t i o n b e t w e e n d i e t a n dsuch diseases as heart d isease and canc e r ?

A The kicker in your question is. t h e w o r d " d i r e c t . " I b e l i e v ethat diet plays an important role in thec a u s e o f b o t h t h e s e d i s e a s e s . B u t Id o n ' t k n o w h o w d i r e c t o r i n d i r e c t t h a tcause may be. A lot more researchn e e d s t o b e d o n e .

QCan you assign a percentage or• other quantitative evaluation ofthe role diet plays in disease?

A No, and I wouldn't even want• to play that game. The fact iswe live in a complex environment, ina kind of cosmos, where everything interacts with everything else, and to assign a certain percentage of heartd isease o r cancer to env i ronmenta l fac

tors or to diet is ludicrous. The qualityof the air and the water and many otherfactors also play a role in the process.

QThe Secretary of HEW is em-. phasizing disease preventionand health promotion. If you could dothree things to change the diet of theAmerican public to reduce disease,what would they be?

A There are two ways to answer• that question. I could answerit in a general way or with specifics.Let me start by saying that the firstthing I would be concerned about isthe need for a more rat ional way ofcontrolling the number of calories people consume. . . .

QAre you talking about obesity?

A No. I'm talking about calorie. c o n t r o l . I n s o m e c a s e s t h i s

may mean increasing the number ofcalories. There is an optimum numberof calories people should consume—

FDA Consumer / April 1979 15

L .

r"I think it's terribly importan t t ha t we i n Gove rnmen trealize that the foods peopleeat are selected largely forstatus and peer acceptancer e a s o n s . "

n o t t o o m u c h a n d n o t t o o l i t t l e .The second thing is I would change

the pattern of the diet. I think there'sa need to increase the consumption ofcertain kinds of carbohydrates and toreduce the consumption of fats.

The third thing I would tell peopleis not to worry so much about it. Fundamentally, we are better off thanw e ' v e e v e r b e e n b e f o r e i n t e r m s o fhealth. I think people ought to thinkcarefully and choose a diet that will behealthy. But worrying about it isn'tdoing much good. If there are twophrases that sort of sum up how I feelabout this, they'd be: "eat everythingin moderation," and "before you eat,t h i n k . "

ODo you have some specific. guidance for people on howthey can improve their diets?

A Well, first, with regard to ca-• lorie control, I think the majorproblem is that we tend to eat foodsthat are high in fats. Our carbohydrateintake tends to be largely in the formof simple sugars, and I think it's betterto increase our intake of complex carbohydrates. I think we ought to consume greater amounts of vegetableprotein, in part to conserve limited resources and in part to reduce andchange the pattern of the fat we cons u m e . We s h o u l d c o n s u m e l e a n m e a t srather than meats with high fat content. We probably should consumegreater amounts of whole grain products, such as bread, and potatoes, forexample, instead of simple sugars.

OWhat is the role of the Govern-. ment, and specifically FDA, intrying to change the American diet ina disease-prevention sort of way?

A In nutrition and diet, I think. F D A h a s t w o r o l e s . T h e fi r s ti s t o m a k e i n f o r m a t i o n a v a i l a b l e t o

people; a rational public can makegood decisions. Second, we need toexplain to the public how to make useof this information; it's one thing toknow something and it's quite anothert o k n o w h o w t o m a k e u s e o f i t .

Essentially people have to maket h e i r o w n d e c i s i o n s a b o u t t h e f o o d s

they eat and their diets. There's no wayFDA or anyone else in Governmentcan o r shou ld make these dec is ions fo r

people. So, in terms of diet and nutri

tion, I see our role as basically educational, so that people can makeb e t t e r d e c i s i o n s f o r t h e m s e l v e s .

OSome people wonder whether. education can ever be successful, since people learn their eating habits from their parents, and eating habitsare so ingrained that education may be,to some extent, futile. What do yout h i n k a b o u t t h a t ?

A That's pure nonsense. We're• always changing our eatinghabits from one generation to the next.At the turn of the century people usedto eat much differently than they dotoday. Just compare how we eat todayw i t h h o w w e a t e b e f o r e W o r l d W a rII—we're eating pizza, a lot of Chinesefood, fast foods, and so on. So we don'teat like our parents did.

Underlying your question is anotherone, and that is, why do people eat theway they do? A lot of things contributeto our eating habits—what we're taughtand certain inborn psychological drivessuch as the drive for sweetness, for example. It also includes peer pressure.

In the end, the role of social statusin selecting a diet may be the most important of all. I'll give you just oneexample: most young people can't tolerate the taste of alcohol. They don'tlike it. Yet they drink, but they drinkin the form of very sweet drinks thatcover up the taste of alcohol. As theyget older they develop a taste for alcohol. Now, this is usually not something they learned from their parentsand it certainly isn't inborn. It's something they learn because in their peergroup drinking carries with it a certains t a t u s .

I think it's terribly important that wei n G o v e r n m e n t r e a l i z e t h a t t h e f o o d s

people eat are selected largely for status and peer acceptance reasons. TheAmerican food industry realizes thisand it plays a major role in how foodsa r e m a r k e t e d .

QAre you concerned about the• tendency of Americans todayto eat more fast foods?

A I am concerned, but not be-• c a u s e t h e s e f o o d s a r e i n h e r

ently evil or improper. I'm concernedbecause fast food represents an unthinking approach to what people eat.I think people must be continually cog-

6 I April 1979 / FDA Consumer

"... the fact is that we livei n an u rban c i v i l i za t i on andwithout processed food wecou ld no t ma in ta in t he

population that we have."

nizant of what they are eating. Theproblem with the fast food business isthat it makes things too easy to eat.We develop eating habits that do notnecessarily coincide with what peoplerequire. That's why I have some objections to the concept of fast food.

QDo you think the Federal Gov-. ernment should try to influencethe increased use of fast food? Shouldthere be more regulation?

A There's no reason for more. regulation except in one area,which is this: since people are eatingsuch a large proportion of their dietsfrom fast food, there ought to be somem o r e n u t r i t i o n a l i n f o r m a t i o n a b o u twhat people are really eating. I go backto my premise here that we need toeducate people more about the foodsthey eat.

O Are you talking about nutrition• labeling?

A Yes, and I'm also talking about. m o r e i n f o r m a t i o n o n t h e c o m

position of the foods. If we insist onfull ingredient statements on processedfoods, why not include similar types ofi n f o r m a t i o n f o r r e s t a u r a n t f o o d s , w h i c hnow represent 30 percent of the foodd o l l a r .

QAre you thinking in terms of• specific regulations now?

A No, except that we have issued• regulations making it possiblefor fast food restaurants to providen u t r i t i o n i n f o r m a t i o n t o t h e i r c u stomers without fulfilling all the req u i r e m e n t s o f c u r r e n t l a b e l i n gregulations. I 'm disappointed thatthey're not doing more of that.

QWhat about processed foods?. More than half the food consumed in this country now is processed.Are you concerned about that?

A No, I'm not. I don't think. there is any food that's inherently evil; there are only evil uses offood, so to speak. Processed food isthe only way we have to build an urbancivilization. I don't want to get into adebate over whether that's good orbad, but the fact is that we live in anurban civilization and without proce s s e d f o o d w e c o u l d n o t m a i n t a i n t h e

population that we have.

OAre you concerned about an. excess consumption of sugar?

A Yes. I'm not concerned about• the consumption of sucroseper se, but I am about the consumptionof so much simple sugar in general—that includes things like glucose andf r u c t o s e . I ' m c o n c e r n e d a b o u t t h e m

irrespective of whether they're addedto food or whether they are inherentin the product.

Q Should the Government regu-• late the amount of sugar thatcan be added to food? Or is it sufficientto educate the public?

A I'm not concerned, as I just. said, about any particular sugaror its source. The body does not distinguish between a sugar that's addedto food and that which is naturallypresent. For that reason, I think itwould be extraordinarily difficult forus to regulate how much sugar can bea d d e d t o f o o d . T h e r e w o u l d b e s o m e

products—for example, honey—thatwe could not regulate and that containconsiderably more sugar than most ofthe foods to which sugar is added. Ithink the only regulatory approacht h a t m a k e s s e n s e i s t o m a k e s u r e t h a ti n f o r m a t i o n i s a v a i l a b l e .

OSome people say that foods. sold as "natural" are a rip-off,that consumers spend a lot extra for noadded benefit. How do you feel aboutt h a t ?

A That's a complicated question.. I much prefer a natural applegrown on a tree to a texturized soy-bean-based material flavored with apple. Yet, at the same time, I would behard put to demonstrate that the fabricated product is any worse nutritiona l l y t h a n t h e n a t u r a l p r o d u c t ,particularly when it represents only asmall portion of the diet.

This question of "natural" versus" u n n a t u r a l " i s a n o l d o n e . F o r e x a m

ple, sausage is a fabricated product,a n d a s s u c h i t i s " u n n a t u r a l . " S o i sb r e a d . T h i a m i n e i s a v i t a m i n t h a t c a nbe produced by a chemical synthesis.So it's not quite clear what is "natural"a n d w h a t i s n ' t .

I d o t h i n k t h e s a l e o f f o o d s l a b e l e das "natural" is a rip-off. They are soldon the premise that they provide somekind of metaphysical advantage that


"And I've found that whatever decision is made, therewill be people, inandout ofGovernment, who disagreew i t h i t . "

n o r m a l f o o d s d o n o t . T h e r e ' s n o b a s i sf o r t h a t .

OWhy doesn't FDA, then, pro-• hibit the use of the word "natural" on food labels?

A Because we run into the prob-• l e m o f h o w w e d e f i n e i t . I sbread a natural product because it contains natural ingredients or is it notbecause it does not appear in nature?There is no bread bush to my knowledge. We have no definition for thew o r d " n a t u r a l . "

O What about your own personal• diet? What do you eat, or noteat, because of your special knowledgeof foods?

A My guide here is moderation.. My family and I will eat practically any food we enjoy. My feelingis that I'm safe just so long as I don'teat an enormous amount of any food.M o d e r a t i o n .

O Let's turn to color additives.• The law now says color additives may be added to foods, but consumers are increasingly concerned aboutcolors and some want them eliminatedentirely. Flow do you feel about this?

A I begin here with the premise. that we are an urban societydependent on a processing industry toprovide for us the foods that our society needs. Processing itself results ina change in the product, includingsometimes a change in color. Sincecolor is an important component in theacceptability of a product—and no onecan argue that point—we need to havec o l o r s t h a t c a n r e s t o r e f o o d s t o w h a tconsumers expect. Let's face it, purpleeggs or chartreuse steaks just won't beeaten and enjoyed. Prehistoric manused to use co lo rs to make foods more

appealing, and we today must providesome way for food fabricators to makefood acceptable to people.

OIs there a difference between• natural and synthetic colors?

A A lot of consumer advocates• are tell ing me, "Well, whydon't you use only natural extracts,such as beet juice, to color foods?" Ther e a s o n i s t h a t I ' m s o m e t i m e s u n c o mf o r t a b l e w i t h t h e n a t u r a l e x t r a c t o f a

product whose chemical compositionis so complicated. I don't know of anytoxicity testing that's been done onsome of these natural products. I feelmore comfortable with synthetic products that represent a fairly well knownc h e m i c a l m i x t u r e a n d a b o u t w h i c h w eknow something in terms of toxicity.Everyone assumes that because Godput it there it must be safe. But God,to my limited knowledge, has neverbeen concerned about food safety, atleast in terms of the 1906 or 1938 Food,Drug, and Cosmetic Act.

O Let's look a bit to the future.• What changes do you anticipate in the way food is produced or theways people eat?

A I see a lot of changes, based• on new technology. We aregoing to have more fabricated foods.We are going to have to integrate foodproduction more into the lives of thecities—for example, we're going tohave to think about how to recyclew a s t e s f r o m o u r c i t i e s .

To be more specific, I think we'll seei n t h e f u t u r e s h e l f - s t a b l e m e a t s l i k e

hamburger that can be preserved without refrigeration. We're going to seepackaging that will provide protectionnot only from contamination but thatwill also provide ways to prepare thef o o d w i t h o u t t h e n e e d f o r a d d i t i o n a l

energy in the form of traditional cooking. We are going to have more imitations of old products and many newo n e s .

Your question reminds me of a marv e l o u s c a r t o o n i n T h e N e w Y o r k e ra few years back. A man is looking atthe menu in a restaurant and it saysthat today's specials are sandwiches inthe following soybean flavors: cornedbeef, ham, roast beef, etc.

QHow is the Bureau of Foods• preparing for the changes yousee coming?

A We're first trying to establish. a n a d m i n i s t r a t i v e s t r u c t u r e t h a twill allow us, on a continuing basis, toidentify what technology is developing, and what types of regulatory responses are going to be needed, torespond to the changes. This Agencyhas too often responded in the pastonly to crises; we now need to prepare


Ar k

y

"I'm concerned because fastfood represents an unthinking approach to whatpeople eat."

A .

for them. In particular, we need betterr e s e a r c h .

QYou just came to FDA from. academic life, and you've spentthe majority of your career in academia.Did you go through a culture shockwhen you came to Washington fromCambridge?

D i d I e v e r ! A c a d e m i c c o mmunities like Cambridge are

probably the last remaining humanprotected areas. They tend to be insu la ted f r om the rea l i t i e s o f t he wo r l d .

They deal with hypothetical and philosophical questions. And we need institutions like that to provide for thefuture of society.

But Washington is quite different,particularly in regulatory agencies. Inuniversities one could always point outthat all the facts weren't in, and youcould hedge your statements with"maybes" and "could bes" and a couple of "perhapses." Here, I have discovered tha t , whe ther we have thefac t s o r no t , t he dec i s i on mus t bem a d e . A n d I ' v e f o u n d t h a t w h a t e v e rdecision is made, there will be people,in and out of Government, who disagree with it. So you've got a constantego problem.

One other point is that in Washington, in contrast to the academic community, it is the perception of evil thatis more important than the reality. Thismay be a fairly recent phenomenon;I just don't know. Here in Washington,rather than argue the facts, peopleusually start off challenging the credibility of their opponents. In the academic community this happens butonly when you're losing the argument.

I s u f f e r e d a n o t h e r c u l t u r e s h o c kwhen I had to preside at hearings inLittle Rock on food labeling. I find thatpeople in Little Rock and elsewhereoutside of Washington view thingsquite differently than we do here. Little Rock's perception differs as muchfrom Washington's as Washington'sdoes from Cambridge's.

Q You've been here for a short• enough time to remember howyou perceived the Agency before yougot here. What was that perception?

A That it was an agency of bu-• reaucrats whose major func

tion was to restrict, inhibit, and delay.The standard of competence was low,although I knew a few individuals ofhigh competence. Since I've been inthe Agency I have discovered that thethings the bureaucrats do that are perceived in a negative way are often donethat way because of the laws writtenby Congress and interpreted by thec o u r t s . H e r e i n t h e B u r e a u o f F o o d sis perhaps the hardest working groupo f i n d i v i d u a l s I h a v e e v e r w o r k e d w i t h .It certainly is true of the Agency andthis bureau. These people are herelargely because they think they're serving an important social function.

Finally, I think the competence ofthe people in the Bureau of Foods iscertainly better than that of the industry we regulate and probably as goodas most of the academic departmentsI ' v e s e e n .

QWhy was your perception so. negative before you arrived?

A Because there is within the. Agency a concept of the publicservant, and good servants don't complain. They take the abuse becausethey think they're supposed to. I don'tbe l ieve in that . I don ' t th ink I 'm a servant. We are employees of the public.And it is my feeling that if we are unjustly challenged we should simplystand up and say it is unjust, and pointout exactly where the errors are. Wehave to do this to the Congress, to theinformation media, and to everyonewho challenges us unjustly.

QWhen you leave the Bureau,• what would you like your accomplishments to have been? What areyou trying to do?

A I would like the Bureau to. have the capacity to handle theproblems not only of today but of tom o r r o w a s w e l l . I w a n t i t t o h a v e t h e

ability to maintain the highest standards of credibility. I want to see regulatory policies tliat make some sensein terms of the real needs of people.I want a Bureau in which young recentuniversity graduates can come to makea contribution to society. I want thisto be a Bureau and an agency whosereal value to the American public isrecognized and whose reputation andstatus with the public is of the highest.


^orc Thanlbu £\er ThoughtT b u M b u l d K n o w A b o u tFood Addi tKes. . . Par t I

Additives are plentiful—and controversial. They are put into our foodsfor several reasons. Mostly they areproducts of modern technology. Because they are so common in today'sfoods and so controversial, FDAConsumer has planned a three-partseries designed to tell consumers morethan they ever thought they wouldknow about additives. This is the firstof the three articles.

by Phyllis Lehmann

Food additives are so much a part ofthe American way of eating todayt h a t m o s t o f u s w o u l d fi n d i t d i f fi c u l tto put together a meal that did not inc l u d e t h e m .

Take a typical lunch, for example:sandwich, instant soup, gelatin dessert, and a cola drink. The bread hasb e e n f o r t i fi e d w i t h v i t a m i n s a n d a l s ocontains an additive to keep it fresh.The margarine has been colored paleyellow—or, if you use salad dressing,i t h a s b e e n m a d e w i t h e m u l s i fi e r s t o

keep it from ''separating." The luncheon meat contains nitrite; the soup, anadditive to keep it from becoming rancid; the gelatin, red coloring to makeit pretty. Finally, the cola to wash it alldown: without coloring, flavoring,sweeteners, or ar t ific ia l carbonat ion,the pause that refreshes is, nothingmore than plain water!

No wonder many Americans haveb e c o m e c o n c e r n e d . A d d i t i v e s s e e m t obe in everything we eat. Are all thesesubstances good for us? Do they servea useful purpose, or do they just makemoney for the food industry?

To help you clarify your own thinking on these questions, let's explorehow our present situation came about,a n d w h a t c h o i c e s w e h a v e .

Food additives are not somethingnew. Humans probably have beentinkering with food since the first cavem a n k i l l e d h i s fi r s t w i l d b o a r. S a l t w a sused probably even before recordedhistory to preserve meat and fish.

Herbs and spices have been treasuredover the years solely for their capacityto add pizzazz to foods, not to mentiontheir function in a less technologicalage as a preservative.

Changing lifestyles in this centuryh a v e r e s u l t e d i n m o r e a d d i t i v e s t h a nformer generations could have imagi n e d . A s A m e r i c a n s m o v e d f r o m f a r m sto cities, there was a need for foodsthat could be mass produced, distributed over considerable distances, andstored for long periods. The exodus ofw o m e n f r o m t h e h o m e i n t o t h e o u t s i d e

workplace created a demand for morepre-prepared convenience foods.Greater sophistication increased demand for year-round supplies of seasonal products. Greater buying powergave industry a bigger market to please.So today we have a wider variety off o o d s a v a i l a b l e — a n d m o r e a d d i t i v e s i na l l f o o d s — t h a n h a d e v e r b e e n k n o w nin the past.

T h e f a c t t h a t a d d i t i v e s a r e i n f o o d sdoes not please everyone. Many contend tha t some add i t i ves a re o f ten dan-

gerous or at least "unnecessaryc h e m i c a l s . " T h e c r i t i c s n o t e t h a t s o m eadditives can cause allergic reactionsin some people.

Unnecessary Chemicals was the titleo f a n a r t i c l e i n t h e M a r c h 1 9 7 8 i s s u eof Environment magazine in whichthe author contended that "many hazardous chemicals (in food and otherproducts) provide consumers with trivi a l o r n o b e n e fi t s a t a l l . . . " . T h ewriter, Anita Johnson, an attorney fort h e E n v i r o n m e n t a l D e f e n s e F u n d , b elieves that women shoppers don't wantmany of the additives. She cited aMarch 1976 Gallup poll done for Red-book magazine, which "found that 59percent of the women surveyed saidthey favored banning food additivesused only to improve the appearanceof food even if there was no positivee v i d e n c e o f h a r m . "

However, food processors apparently think otherwise and their salesfigures would seem to back their think

ing. Moreover, the Nation's laws onthe subject are designed not to quest ion use o f add i t i ves bu t to assure tha t

they are as safe as possible.By broadest definition, a food ad

ditive is any substance that becomespart of a food product when addedeither directly or indirectly. Today,some 2,800 substances are intentionally added to foods to produce a desired effect. As many as 10,000 othercompounds or combinations of compounds find their way into variousfoods during processing, packaging, orstorage. Examples of these unintent i o n a l a d d i t i v e s i n c l u d e i n fi n i t e s i m a lresidues of pesticides used to treatcrops, minute amounts of drugs fed toanimals, and chemical substances thatmigrate from plastic packaging mater i a l s .

An additive is intentionally used inf o o d s f o r o n e o r m o r e o f t h e s e f o u r

p u r p o s e s :• To maintain or improve nutri

tional value. Many foods are fortifiedwith vitamins and minerals that mightotherwise be lacking in a person's dietor that have been destroyed or lost inprocessing. Common nutritional addit ives include vitamin D in milk, vitamin A in margarine, vitamin C infruit drinks, and iodine in table salt.B r e a d s a n d c e r e a l s a r e e n r i c h e d w i t hB vitamins lost or destroyed duringmilling and processing of grains. Suchfortification has helped eradicate once-prevalent deficiency diseases, such asrickets, scurvy, pellagra, and goiter.

• To maintain freshness. Foods lastas long as they do on the shelf or in therefrigerator because of additives thatretard spoilage, preserve natural colorand flavor, and keep fats and oils fromturning rancid. Preservatives such assodium ni t ra tes and n i t r i tes, for example, protect cured meats, fish, andpoultry from contamination by thebacterially produced toxin responsiblefor botulism, a food poisoning illness.Ascorbic acid (vitamin C) keeps uncooked peaches from turning brown.


Antioxidants, such as BHA (butylatedhydroxyanisoie) or BHT (butylatedhydroxytoluene), help prevent changesin color, flavor, or texture that occurwhen foods are exposed to air.

• To help in processing or preparation. A wide variety of compoundsare used to give body and texture tofoods, evenly distribute particles ofone liquid in another, affect cookingor baking results, control acidity oralkalinity, retain moisture, and prevent caking or lumping. Chemicalscalled emulsifiers give such productsas peanut butter and mayonnaise aconsistent texture and prevent themfrom separating into an oily layer atthe top of the jar and a dry layer at theb o t t o m . T h i c k e n e r s c r e a t e s m o o t h n e s sand prevent ice crystals from formingin f rozen foods such as ice cream. Hu-mectants are used to keep moisture inf o o d s l i k e s h r e d d e d c o c o n u t . L e a v e n

ing agents such as yeasts and bakingpowder are essential to make bakedgoods rise.

• To make food more appealing.The most widely used additives aret h o s e i n t e n d e d t o m a k e f o o d l o o k a n dtaste better. These include coloring

agents, natural and synthetic flavors,flavor enhancers such as MSG (mon-osodium glutamate), and sweeteners.The characteristic flavor of strawberryice cream, for example, may comefrom real strawberries, or it may comefrom a chemical flavoring. Becauseconsumers associate strawberries witha reddish color, strawberry ice creamis tinted pink. These uses are the mostcontroversial; industry says the publicprefers foods that are colored and flavored while many consumers and consumer advocates believe too manyc o l o r s a n d fl a v o r s a r e u s e d .

By far the most widely used additives are sugar, salt, and corn syrup.These three, plus such other substances as citric acid (found in orangesand lemons), baking soda, vegetablecolors, mustard, and pepper, accountfor more than 98 percent, by weight,o f a l l f ood add i t i ves used i n t h i s coun

t r y.Food additives also are more strictly

regulated now than at any other timein history. Despite our nostalgia for thegood old days, eating was not especially safe at the turn of the centurywhen it was difficult to protect foods

from spoiling and when manufacturersfreely used pigments containing suchtoxic metals as lead, copper, and arsenic to color candy, pickles, and otherfoods; created "strawberry" jam withonly coloring, flavoring, and grassseed; or stretched ground black pepperw i t h b i t s o f c h a r c o a l .

The 1906 Food and Drugs Act andthe more comprehensive Food, Drug,and Cosmetic Act of 1938 gave theGovernment authority to remove adulterated and obviously poisonous foodsfrom the market . But i t wasn ' t unt i lt h e F o o d A d d i t i v e s A m e n d m e n t w a senacted in 1958 and the Color AdditiveA m e n d m e n t s i n 1 9 6 0 t h a t t h e N a t i o nhad laws specifically regulating foodaddi t ives. In those amendments, thel a w m a k e r s s h i f t e d t h e b u r d e n f r o m t h eGovernment to prove a food additiveunsafe to the manufacturer to prove its a f e . T h e a m e n d m e n t s a u t h o r i z e d F D Ato regulate additives only on the basisof safety. The Agency has no powerto limit the number of additives approved or to judge whether a particularfood color, thickener, or sweetener isreally needed.

In an approval process that may take

FDA Consumer / April 1979 / II

up to several years, manufacturers firstmust subject a proposed new additiveto a battery of chemical tests to determ i n e w h e t h e r i t d o e s w h a t i s i n t e n d e dand to make sure it can be analyzeda n d m e a s u r e d i n t h e fi n i s h e d f o o d

product. Then the additive must be fedin large doses over an extended periodto at least two kinds of animals, usuallyrodents and dogs. These feeding studies are designed to determine whetherthe substance causes cancer, birth defects, or other injury to the animals.

M a n u f a c t u r e r s s u b m i t t h e r e s u l t s o fall these tests to FDA, and if they indicate the additive is safe, the Agencyestablishes regulations for how it canbe used in food. A basic ru le is a 100-fold margin of safety for anythinga d d e d t o f o o d . T h i s m e a n s t h a t t h emanufacturer may use only 1/lOOth them a x i m u m a m o u n t o f a n a d d i t i v e t h a thas been found not to produce anyharmful effects in test animals. A special provision of the 1958 and 1960amendments, the so-called DelaneyClause, states that a substance shownto cause cancer in man or animal maynot be added to food in any amount.

U n d e r t h e F o o d A d d i t i v e s A m e n dment two major categories of additivesare exempt from the testing and approval process. The first is a group ofsome 700 substances "generally recognized as safe" (GRAS) by qualifiedexperts. The idea behind what hasc o m e t o b e k n o w n a s t h e G R A S L i s tw a s t o f r e e F D A a n d m a n u f a c t u r e r sfrom being required to prove the safetyof substances already consideredharmless because of past extensive usew i t h n o k n o w n h a r m f u l e f f e c t . T h e i r

efforts, it was felt, would be betterspent on new additives and on thosecompounds about which less is known.

Also exempt from testing were "priorsanctioned substances," those that hadbeen approved before 1958 for use infood by either FDA or the U.S. Department of Agriculture. Some priors a n c t i o n e d s u b s t a n c e s a l s o w e r e i nc l u d e d o n t h e G R A S L i s t .

These lists of exemptions are not,however, engraved in stone. As testingmethods and scientific understandingof toxicology improve, new evidenceand questions may arise about thesafety of old standbys. To make surethese substances are judged by the latest scientific standards, FDA is review

ing all categories of food additives.A review of 450 natural and syn

t h e t i c s u b s t a n c e s o n t h e G R A S L i s twas begun in 1971 and continues. Itinc ludes a search o f wor ld med ica l andsc ien t i fic l i t e ra tu re back to 1920 fo r i nformation regarding the safety of eachcompound. When data turn up suggesting that an additive is unsafe, further testing by the Agency may takeit off the market or require manufact u r e r s t o c o n d u c t a d d i t i o n a l s t u d i e s .For example, FDA is proposing thatmanufacturers sponsor further study ofBHT, a preservative that was bothprior sanctioned and a member of theGRAS List, because of evidence thatit causes liver damage in rats.

FDA also is undertaking a similarreview of 2,100 flavoring agents, including those approved since 1958,prior sanctioned substances, and otheragents that for some reason failed tomake the original GRAS List.

T h e 1 9 6 0 C o l o r A d d i t i v e A m e n dments subject coloring agents used infoods, drugs, and cosmetics to rigorouspremarket testing. Colors in use whenthe amendment was passed were placedon a provisional approval list pendingfurther investigation or confirmationof their safety. Nearly 200 colors havebeen on the provisional approval lista t o n e t i m e o r a n o t h e r . B u t o v e r t h e

years about 80 have been droppedf r o m t h e l i s t b e c a u s e m a n u f a c t u r e r swere no longer interested in marketingthem or, in some cases, because they

were found to be unsafe. In 1976, forexample, FDA banned Red No. 2,then the most widely used red coloringagent, because tests in test animalsc o u l d n o t r e s o l v e w h e t h e r i t c a u s e dcancer or not. Currently 31 colors arefully approved for use in foods; threeothers are on the provisional list awaiting results of animal feeding studies.

Faced with a confusing tangle of regulations and reviews, consumers mayfeel that they are helpless in exertingany control over what goes into theirfood. In fact, the consumer wields thegreatest power of all—the power of themarketplace. Anyone concerned aboutf o o d a d d i t i v e s s h o u l d t a k e t h e f o l l o w

ing steps:• Become informed. Start by read

ing labels to find out what is in thefoods you buy. The names of additivesmust be included in the list of ingredients, although the law permits colorsand flavors to be described in generalterms l ike "artificially flavored" or"artificially colored." Learn what thev a r i o u s a d d i t i v e s d o a n d d e c i d e w h i c hones are of most concern to you. If youhave questions, contact the consumeraffairs officer at your nearest FDA office, listed in the telephone directoryunder U.S. Department of Health,Educat ion, and Wel fare. Or wr i te tot h e m a n u f a c t u r e r .

• Exercise your right to choose.Once you are informed, you can selectfoods on the basis of which characteristics—convenience, appeal, storagetime—mean the most to you. Youmight want to continue buying breadwith sodium propionate if you knowit prevents mold, but you may not wantto buy cookies that are artificially colored. It's your choice.

• Make your views known. Letmanufacturers and your representatives in Congress know what you wantand don't want in your food.

Food additives, like most things inlife, involve a trade-off. Scientists willnever be able to guarantee that anything added to food is absolutely safe.Ultimately, it is up to the consumer todecide what degree of risk is an acceptable price to pay for foods thatkeep well and are appealing, nutritious, convenient, and readily available year-round.

Phyllis Lehmann is a freelance writer.


A d d i t i y e s I n d e x :An alphabetical list of some substances commonly added to foods

K E Y D E F I N I T I O N S

Maintain/Improve Nutritional QualityNutrients: enrich (replace vitamins and mineralslost in processing) or fortify (add nutrients thatmay be lacking in the diet).

• Maintain Product QualityPreservatives (Antimicrobials): prevent foodspoilage from bacteria, molds, fungi, and yeast;extend shelf life; or protect natural color/flavor.

Antioxidants: delay/prevent rancidity or enzymatic browning.

• Aid in Processing or PreparationEmulsifiers: help to distribute evenly tiny particles of one liquid into another; improve homogeneity, consistency, stability, texture.

Stabilizers, Thickeners, Texturizers: impart body,improve consistency or texture; stabilize emulsions; affect "mouthfeel" of food.

Leavening Agents: affect cooking results—text u r e a n d v o l u m e .

pH Control Agents: change/maintain acidity oralkalinity.

Humectants: cause moisture retention.

Maturing and Bleaching Agents, Dough Conditioners: accelerate the aging process; improvebaking qualities.

Anti-Caking Agents: prevent caking, lumping, orclustering of a finely powdered or crystalline subs t a n c e .

# Affect Appeal CharacteristicsFlavor Enhancers: supplement, magnify, or modify the original taste and/or aroma of food without imparting a characteristic flavor of its own.

Flavors: heighten natural flavor; restore flavorslost in processing.

Colors: give desired, appetizing, or characteristicc o l o r t o f o o d .

Sweeteners: make the aroma or taste of foodmore agreeable or pleasurable.

FDA Consumer I April 1979 / 13

A c e t i c a c i d

Acetone peroxide

Adipic acidAmmonium alginateA n n a t t o e x t r a c t

ArabinogalactanA s c o r b i c a c i d

A z o d i c a r b o n a m i d e

pH controlm a t - b l e a c h - c o n d i t

pH controls t a b i l - t h i c k - t e x

c o l o r

s t a b i l - t h i c k - t e x

n u t r i e n t

preservativea n t i o x i d a n t

m a t - b l e a c h - c o n d i t

B

B e n z o i c a c i d # preservative

Benzoyl peroxide # mat -b leach-cond i t

Beta-apo-8' carotenal # c o l o r

B e t a c a r o t e n e # n u t r i e n t# c o l o r

BHA (butylated hydroxy- # an t i ox i dan tanisole)BHT (butylated hydroxy- # an t iox idan ttoluene)Butylparaben # preservative

C

Calcium alginate # s tab i l - th ick- tex

C a l c i u m b r o m a t e # mat -b leach-cond i t

C a l c i u m l a c t a t e # preservativeCalcium phosphate # leaveningCalcium propionate # preservativeC a l c i u m s i l i c a t e # anti-cakingC a l c i u m s o r b a t e # preservativeC a n t h a x a n t h i n • c o l o r

C a r a m e l # c o l o r

Carob bean gum # stab i l - th ick- tex

Carrageenan # e m u l s i fi e r# s tab i l - th ick- tex

C a r r o t o i l # c o l o r

C e l l u l o s e # s tab i l - th ick- tex

C i t r i c a c i d # preservative# an t iox idan t• pH control

C i t r u s R e d N o . 2 # c o l o r

C o c h i n e a l e x t r a c t • c o l o r

Corn endospermCorn syrup

c o l o r

s w e e t e n e r

D

Dehydrated beetsD e x t r o s e

DiglyceridesDioctyl sodium sulfosuccin-a t e

Disodium guanylate

D i s o d i u m i n o s i n a t e

Dried algae meal

c o l o r

s w e e t e n e r

e m u l s i fi e r

e m u l s i fi e r

flavor enhancer

fl a v o r e n h a n c e r

c o l o r

EDTA (ethylenediamine-tetraacetic acid)

a n t i o x i d a n t

F D & C C o l o r s :

B l u e N o . 1

R e d N o . 3

R e d N o . 4 0

Ye l l o w N o . 5

F r u c t o s e

' c o l o r

' co lo r

c o l o r

c o l o r

s w e e t e n e r

M I April 1979 / FDA Consumer

G e l a t i n

G l u c o s e

Glycerine

Glycerol monostearateGrape skin extractGuar gum

G u m a r a b i c

Gum ghatti


s w e e t e n e r

h u m e c t a n t

h u m e c t a n t

c o l o r




H

Heptylparaben

Hydrogen peroxideHydrolyzed vegetable prot e i n

preservativem a t - b l e a c h - c o n d i t


Invert sugar # sweetener

I o d i n e O nu t r i en t

I r o n n u t r i e n t

I r o n - a m m o n i u m c i t r a t e # anti-cakingI r o n o x i d e # c o l o r

K

Karaya gum # s tab i l - th ick - tex

L

L a c t i c a c i d # pH control# preservative

Larch gum # s tab i l - th ick - tex

L e c i t h i n # e m u l s i fi e r

Locust bean gum # s tab i l - th ick - tex

M

M a n n i t o l • s w e e t e n e r# anti-eaking# s tab i l - t h i ck - tex

Methylparaben # preservativeM o d i fi e d f o o d s t a r c h

MonoglyceridesMSG (monosodium gluta-mate)

S t a b i l - t h i c k - t e x

e m u l s i fi e r


N

N i a c i n a m i d e # n u t r i e n t

P

Paprika (and oleoresin) # fl a v o r• c o l o r

P e c t i n # s tab i l - th ick - tex

Phosphates • pH control

Phosphoric acid # pH control

Polysorhates # e m u l s i fi e r s

Potassium alginate • s t a b i l - t h i c k - t e x

P o t a s s i u m h r o m a t e • m a t - b l e a c h - c o n d i t

P o t a s s i u m i o d i d e • n u t r i e n t

Potassium propionate • preservativeP o t a s s i u m s o r h a t e • preservative

Propionic acid # preservative

Propyl gallate # a n t i o x i d a n t

Propylene glycol # s tab i l - t h i ck - tex# h u m e c t a n t

Propy lparaben # preservative

R

R i b o fl a v i n • n u t r i e n tc o l o r

FDA Consumer I April 1979 / 15

S o r b i t a n m o n o s t e a r a t e

S o r b i t o l

SpicesSucrose (table sugar)

• e m u l s i f i e r

# h u m e c t a n t# sweetener

9 fl a v o r

• s w e e t e n e r

Tagetes (Aztec Marigold)Ta r t a r i c a c i d

TBHQ (tertiary butyl hy-droquinone)T h i a m i n e

T i t a n i u m d i o x i d e

Toasted, partially defattedc o o k e d c o t t o n s e e d fl o u r

Tocopherols (vitamin E)

Tragacanth gumTumeric (oleoresin)

c o l o r

pH controla n t i o x i d a n t

n u t r i e n t

c o l o r

c o l o r

n u t r i e n ta n t i o x i d a n t


fl a v o rc o l o r

U

U l t r a m a r i n e b l u e 9 c o l o r

S a c c h a r i n 9 sweetener

S a f f r o n 9 c o l o r

S i l i c o n d i o x i d e 9 anti-cakingS o d i u m a c e t a t e 9 pH controlSodium alginate 9 s tab i l - th ick- tex

S o d i u m a l u m i n u m s u l f a t e 9 leaveningS o d i u m b e n z o a t e 9 preservativeS o d i u m b i c a r b o n a t e 9 leaveningSodium calcium alginate 9 s tab i l - th ick- tex

S o d i u m c i t r a t e 9 pH controlS o d i u m d i a c e t a t e 9 preservativeSodium erythorbate 9 preservativeS o d i u m n i t r a t e 9 preservativeS o d i u m n i t r i t e 9 preservativeSodium propionate 9 preservativeS o d i u m s o r b a t e 9 preservativeSodium stearyl fumarate 9 mat-b leach-condi t

S o r b i c a c i d 9 preservative

V

Vani l la , vani l l inV i t a m i n A

Vitamin C (ascorbic acid)

Vitamin D (Dj, D3)Vitamin E (tocopherols)

fl a v o r

n u t r i e n t

n u t r i e n t

preservativea n t i o x i d a n t

n u t r i e n t

n u t r i e n t

Yeast-malt sprout extract

Yellow prussiate of soda


anti-caking

Key to Abbreviations:s t a b i l - t h i c k - t e x = s t a b i l i z e r s - t h i c k e n e r s - t e x t u r i z e r s

leavening = leavening agentspH control = pH control agentsmat-bleach-condit = maturing and bleaching agents,

dough conditionersanti-caking = anti-caking agents


Yitaimns Over The Counter:Take Only >Oien Needed

N i n e v i t a m i n s a n d t h r e e m i n e r a l s a r e

safe and effective as over-the-counterdrugs, according to a panel of non-Government experts. But, the groupsaid in a report to FDA, such products should be used only to treat specific deficiencies and then only whena physician has determined that aneed for such therapy exists.

by Annabel Hecht

Vitamins are a billion dollar business in the United States. Anyonewho feels the need can get them indrugstores, supermarkets, and healthfood stores. They are also sold door-to-door or can be purchased by mail.

However, some vi tamins and minerals can be dangerous if taken by thewrong people or in excessive dosages,according to a panel of non-Government experts. Vitamin and mineralpreparations sold as nonprescription

drugs should be used only to preventor treat specific deficiencies, the panelsaid. Furthermore, the label shouldstate clearly that the preparations shouldbe used only "when the need for suchtherapy has been determined by a phys i c i a n . "

About three-quarters of the vitaminand mineral products Americans buyeach year are labeled as dietary supplements. A dietary supplement of av i t a m i n o r m i n e r a l i s a f o o d i n t e n d e dto supplement a diet by increasing thetotal dietary intake of one or more essential vitamins or minerals. However,if any therapeutic claims are made onthe bottle, FDA classifies the contentsas a nonprescription drug.

The expert panel, one of 17 createdby FDA to evaluate the safety and eff e c t i v e n e s s o f a l l o v e r - t h e - c o u n t e r

drugs, examined only those vitaminand mineral products sold as drugs,and not those sold as dietary supple

ments. Dietary supplements are regulated under FDA's food regulations.

Deficiencies that require drug treatm e n t w i t h v i t a m i n s a n d m i n e r a l s o c c u r

mainly among special groups such aspregnant and lactating women, peoplewho consume alcohol to excess, thosewith intestinal disease that impairs normal dietary intake or absorption, andthose taking drugs that interfere eitherwith the body's absorption or with itsu t i l i z a t i o n o f v i t a m i n s a n d m i n e r a l sf r o m f o o d .

The panel said nine vitamins couldbe sold as single ingredient, nonprescription drugs for prevention and/ortreatment of deficiencies. They are vitamin C, vitamin B,^, folic acid, niacin,vitamin B^, riboflavin, thiamine, vitamin A, and vi tamin D.

Biotin, choline, vitamin E, and pantothen ic ac id shou ld not be so ld as s in

gle ingredient, over-the-counter drugsb e c a u s e d e fi c i e n c i e s o f t h e s e v i t a m i n sare virtually nonexistent, the panel reported. Vitamin K should be takenonly when a physician has determinedthe need for therapy and should beavailable by prescription only. Thisvitamin is particularly dangerous forpeople taking anticoagulant (bloodthinning) drugs.

As for minerals, the panel said calcium, iron, and zinc are safe and effective for single ingredient use.However, the panel said the followings h o u l d n o t b e s o l d a s o v e r - t h e - c o u n t e r

drugs because deficiency is rare: copper, fluor ide, iodine, magnesium,manganese, phosphorous, and potassium. Copper, iodine, and manganesealso can be dangerous in high doses.

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

ingredients, including some that aren a t u r a l s o u r c e s o f v i t a m i n s a n d m i nerals, were considered inappropriatefor inclusion in vitamin-mineral preparations since they do not contributeto the effectiveness of these productsin treating or curing deficiencies. Included in the list are apricots, brewer'syeast, buckwheat, comfrey root, hes-peridin, kelp, lecithin, malt extract,molasses, rose hips powder, and wheatg e r m .

B e c a u s e c o n d i t i o n s t h a t c a u s e d e ficiencies usually involve more than onenutrient, the panel concluded thatcombination products are a rationalmeans of preventing or treating vitamin and minera l defic ienc ies . Thus,combinations that include all approvedvitamins alone or all vitamins plus approved minerals are safe and effectiveas over-the-counter drugs. Althoughpantothenic acid and vitamin E shouldnot be sold as single ingredients, theyc a n b e i n c l u d e d i n v i t a m i n - m i n e r a l

combinations, the panel said.Marketing of combinations that in

clude only the fat-soluble vitamins A,D, E, and K should not be permittedthe panel recommended. It would notbe safe or rat ional to t reat some of the

symptoms of a multiple deficiency andunwittingly neglect treatment of others. However, because the water-soluble vitamins, the B vitamins and vitamin C, are not stored in the body,a preparation containing all B vitamins, with or without vitamin C, is reco m m e n d e d .

Un l ike v i tamin defic ienc ies , mul t iple mineral deficiencies rarely occur asa resul t o f the same condi t ion, thepanel pointed out. Therefore, there isno need for any preparation containingonly multi-minerals. The panel, howe v e r, h a s r e c o m m e n d e d t h a t s o m emultiple vitamin combinations mayalso contain one, or all three, of them i n e r a l s d e t e r m i n e d t o b e s a f e a n de f f e c t i v e .

The panel also said that there is noneed for special vitamin-mineral combinations for the elderly since the rec

ommended doses are adequate forevery age. Any claims that such preparations are specially for geriatric useare false and misleading and should notbe allowed. Similarly the panel feltthere is no justification for special combina t ions fo r women who use o ra l con

traceptives. Further study is needed tosupport manufacturer's claims that folicacid deficiency in women taking oralcontraceptives can be prevented by adaily dose of 0.1-1.0 mg.

The panel recommended specificdoses of vitamin and mineral productsto prevent or treat deficiency diseases,warning that some vitamins and minerals can be dangerous at high doses.

For instance, high levels of vitaminA taken over a long period of time cancause liver and spleen enlargement,painful swelling under the skin, and,in its most serious form, permanentliver damage and stunted bone growth.High doses of vitamin C can cause kidney and bladder problems. Excessa m o u n t s o f t h i s v i t a m i n c a n i n t e r f e r ewith a common test for sugar in theu r i n e o f d i a b e t i c s . S o m e s t u d i e s i n d icate that doses of vitamin D greaterthan 1,000 to 1,2001.U. (InternationalUnits) may contribute to kidney stonesand heart attacks. Taking more than2,500 milligrams of calcium daily mayproduce excessive calcium in the bloodand rapid deterioration in kidney funct i o n .

Labels on vitamin and mineral preparations should state that the drug isfor use in prevention or treatment ofa deficiency "when the need for suchtherapy has been determined by a physician," the panel said. The group alsorecommended that FDA require a listing of all ingredients in these preparations. Claims of special effectiveness,such as "high" or "super" potencyshould not be allowed, the panel said,and neither should FDA permit the useon labels of terms listing symptomsthat may suggest the presence of a deficiency, except as specifically statedin the panel's recommendations.

Labels should not be permitted toclaim that a product is "natural" because there i s no ev idence tha t na tu ra lforms of v i tamins and minera ls are better than synthetic ones, the panel said.

In addition, the panel said manufact u r e r s s h o u l d n o t c l a i m t h a t v i t a m i n Cis useful for treating such conditions asthe common cold, atherosclerosis, allergy, mental illness, corneal ulcers,thrombosis, anemia, or pressure sores.Warnings on the labels of vitamin C

products should include the followingstatements: "Patients with gout and/ora tendency to form kidney stones maybe at increased risk when taking moret h a n t h e r e c o m m e n d e d d o s e , " a n d"Diabetics taking more than 500 mgof vitamin C daily may obtain falsereadings in their urinary glucose test."Labels for products containing vitaminBg should warn that patients who aretaking L-dopa for Parkinsonism shouldno t t ake t he v i t am in w i t hou t a doc to r ' s

supervision. There is no evidence thatB^ is useful for preventing kidneystones or controlling vomiting in pregnant women, the experts said.

The label on vitamin (thiamine)preparations should not be permittedto claim this drug helps stimulate mental response or is useful in treating skindisease, multiple sclerosis, infections,cancer, or impotence. Vitamin A lab e l s s h o u l d w a r n t h a t e x c e s s i v e d o s e s

may be harmful. Claims that vitaminA is of value against warts on the bottom of the feet, acne or other skin diseases, dry and wrinkled skin, stressulcers, respiratory infections, or eyedisorders should not be permitted, according to the panel. Vitamin D labelsshould not be permitted to claim effectiveness in lowering blood cholesterol levels, or preventing or curingosteoporosis in the elderly.

The report of the vitamin-mineralpanel is the thirteenth received byFDA in its program to review all nonprescription or over-the-counter drugs.The panel's recommendations andproposed monograph or "recipe book"for vitamin-mineral preparations werepublished in the March 16th FederalRegister. Interested persons are allowed 90 days in which to comment.A f t e r t h e s e c o m m e n t s h a v e b e e n e v a luated FDA will publish a tentative final monograph and ask for furtherpublic comment. The last step in theprocess is publication of a final monograph, which specifies the ingredientsF D A c o n s i d e r s s a f e a n d e f f e c t i v e f o ruse in nonprescription vitamin andmineral drug products and the claimsthe Agency will permit on labels.

Six months after publication of thefinal monograph, manufacturers whosell vitamin and mineral preparationsas drugs, rather than food supplements, must reformulate and relabelto comply with the monograph or remove their products from the market.

Annabel Hecht is a staff writer withFDA's Office of Public Affairs.

18 / April 1979 / FDA Consumer

Panel Recommendations on Vitamin and Mineral Dosages to Prevent and/or Treat Deficiencies(mg - Milligram)

(I.U. = International Units)

VITAMINS

Vitamin C (Ascorbic acid)50-100 mg/day300-500 mg/day

Niacin (Niacinamide or Niacinamide ascorbate)10-20 mg/day prevention25-50 mg/day treatment

Vi tamin (Pyr idox ine)1.5-2.5 mg/day prevention7.5-25 mg/day treatment

Vitamin Bj (Riboflavin)1-2 mg/day prevention5-25 mg/day treatment

Infants 6 months to under 1 year—300-600 mg/day

Infants under 6 months—200-400 mg/day

For prevention only

Menstruating and lactating women—10-30 mg/day

Pregnant women—30-60 mg/day

Children 6 months to under 5 years—10-15 mg/day

In combination products other than for use in pregnancy: adults and children over 5—10-20 mg/day

Vitamin B, (Thiamine)1-2 mg/day prevention5-25 mg/day treatment

V i t a m i n A1,250-2,500 I.U./day prevention5,000-10,000 I.U./day treatment

Vitamin B,23-10 micrograms/day preventionnot to be used to treat deficiency

F o l i c A c i d0.1-1.4 mg/day prevention1.0 mg/day for pregnant and lactating womennot to be used to treat deficiency

V i t a m i n D400 I.U./day prevention, infants and growing chil

dren under 18 years of age.

200 I.U./day prevention, adultsnot to be used to treat deficiency

MINERALS

C a l c i u m

For prevention only

Adults, children 1-10, and 12 and over—400-800 mg/day

Children 10-12, and pregnant and lactating women—6(X)-1,200 mg/day

Adults over 51—500-1,000 mg/day

For prevention only

Adults, and children 1 year and over—10-25 mg/day

Pregnant and lactating women—25 mg/day

Some highlights of the panel report:

• Vitamin E should not be sold by itself as an over-the-counter drug because deficiencies of this vitaminare practically nonexistent.

• Vitamin K should be taken only when prescribedby a physician.

• S o m e m i n e r a l s s h o u l d n o t b e s o l d a s o v e r - t h e -counter drugs because deficiencies are rare. Includedare copper, fluoride, iodine, magnesium, manganese,phosphorus, and potassium.

• Multi-mineral preparations are not needed.

• The elderly do not need special dosages.

• Some vitamins and minerals can be dangerouswhen taken in excess. Examples include vitamins Aa n d C a n d c a l c i u m .

• Claims of "high" or "super" potency should notb e a l l o w e d o n l a b e l s o f v i t a m i n a n d m i n e r a l

products.

• T h e r e i s n o e v i d e n c e t h a t " n a t u r a l " f o r m s o fvitamins and minerals are better than synthetic ones.

• Labels of some preparations should contain warningnotices for certain users, and labels should beprohibited from stating unproven effectiveness claims.

FDA Consumer I April 1979 119

FOI: Hcm'ToLeamFederal Secrets

by James Greene

Big Brother is being watched!Yes, a full 5 years before itstime, 1984 is being repudiated. 1984was the title of George OrwelFs novelt h a t d e s c r i b e d a f u t u r e t i m e w h e n

every facet of a person's daily lifew o u l d b e c o n t r o l l e d a n d m o n i t o r e d .Citizens were warned that Big Brother(the government) was watching themat all times. And, through technology,it was true. Big Brother even lookedin (via two-way television set) on thecitizen's diligence in performing therequired morning exercises.

But this is 1979, and the oppositeappears to be coming true. For today,it is Government that is being watched—watched to the extent that every bur e a u c r a t s e n s e s t h a t s o m e o n e i s l o o k

ing over his shoulder on every memot h a t h e w r i t e s .

T h a n k s t o t h e F r e e d o m o f I n f o rmation Act, someone is watching asthat memo is wr i t ten—or, more correctly, someone other than the intended recipient may be reading thatm e m o . T h e F r e e d o m o f I n f o r m a t i o nAct was first passed in 1966 and greatlystrengthened in 1974. It has openedthousands of Government file cabinetsto public scrutiny.

This act set up FOI offices in allGovernment agencies, and was designed to make the release of recordsthe rule rather than the exception. Italso required the Federal Governmentto justify the denial of any record. Inaddition, it gave individuals the rightto go to court, if necessary, to obtainr e c o r d s .

The 1974 amendments requiredFederal agencies to publish rules stating how FOI requests would be serviced, established uniform fees for searchand reproduction of paperwork, andset a 10-day time period in which agenc ies mus t dec ide whe the r to re lease o r

deny the record. These amendmentsalso modified some of the original exemptions and encouraged agencies torelease portions of a record after non-

r e l e a s a b l e i n f o r m a t i o n w a s d e l e t e d .The exceptions or grounds for denial

include: internal operating rules ofagencies; information protected bystatutes, including trade secrets andfinancial data from private businessesobtained by FDA in carrying out itsstatutory obligations; trade secrets obtained under explicit or implicit pledgesof confidentiality; intra-Agency andinter-Agency memorandums and letters that precede adoption of an officialposition; personel and medical filesw h o s e d i s c l o s u r e w o u l d c o n s t i t u t e a ninvasion of privacy under law; and information that is part of an investigation for law enforcement purposes.

Agencies are required to submit anannual FOI Report to Congress underthe amendments. These reports list,among other details, the number ofrequests denied, the names of personsresponsible for those decisions, andhow many denials were appealed. FOIreports also cite any disciplinary actiontaken against agency officials whowi thheld re leasable in format ion, andcopies of fee schedules and agencyrules relating to FOI.

The public benefits as news mediapeople and public interest groups havegained access to previously denied materials. The law makes it possible forGovernment officials to be held morea c c o u n t a b l e f o r t h e i r a c t i o n s .

Individual citizens may benefit, too.All they have to know is what to askfor. In most cases, their requests willb e h o n o r e d .

However, a funny thing happenedon the way to unlocking the file cabinet. John Q. Public and his representatives found that in many cases theyare surrounded by other informationseekers. At some agencies—such asF D A — m o s t o f t h e i n f o r m a t i o n s e e kers are from businesses that are regulated by the agency. And, as might beexpected, much of the informationbeing sought is about rival companies.

F o r i n s t a n c e , F D A h a n d l e d m o r e

than 32,000 FOI requests in 1978. Just11 percent of those were from privateindividuals, the news media, and public interest groups. On the other hand78 percent—or some 26,000 requests—c a m e f r o m i n d u s t r i e s o r f r o m F O Iservice companies that specialize inproviding information to business andindustry. Another 8 percent of the requests were from lawyers, many representing businesses, while 2 percentcame from hospitals and health organ i z a t i o n s .

Most FOI requests to FDA seek information on drugs, foods, and medical devices, or administrative records,compliance manuals, and other guidelines used by the Agency to regulatemanufacturers. In addi t ion, manycompanies want to know how theircompetitors fared in FDA plant inspections. So, they request inspectionrecords, which detail violations of FDAGood Manufacturing Practice Regulations. These reports also list insanit a r y c o n d i t i o n s f o u n d b y F D Ainspectors and any seizure or recall ofdefective products.

In 1978, only one other Governmentorganization received more FOI requests than FDA. The Department ofDefense, which includes 14 separatecomponents, received nearly 56,500requests. The Department of HEWwas second in total requests with over51,000, which includes the 32,286 requests handled by FDA. The SocialSecurity Administration was a distants e c o n d w i t h i n H E W w i t h a t o t a l o fabout 7,000 FOI requests. Other agencies that regulate consumer productsreceived nowhere near the number ofFOI requests as those made to FDA.The Consumer Product Safety Commission, for example, received only6,800 requests, while the Environmental Protection Agency totaled about2,000.

FDA's workload under the Freedomof Information Act continues to groweach year. In 1974, before the Agencyissued final FOI regulations, therewere only about 13,000 requests. Thatnumber is expected to nearly triple thisyear. FDA also increased its FOIHeadquarters staff in Rockville, Md.,from 20 to 28 employees and placed anFOI officer in each of its six bureaus.In addition, the Agency has designatedan individual in each of its 33 regionaland distr ict offices to coordinate andanswer requests sent from headquart e r s .

FDA Consumer / April 1979 1 21

SAMPLE REQUEST LETTER

Dr. Donald KennedyC o m m i s s i o n e r

Food and Drug Administration5 6 0 0 F i s h e r s L a n e

Rockvi l le, Md. 20857

Re: Freedom of Information Act Request

Dear Dr. Kennedy:

Under the provisions of the Freedom of Information Act, 5 U.S.C.552, I am requesting access to (identify the records as clearly and specifically as possible).

If there are any fees for searching for, or copying, the records I haverequested, please inform me before you fill the request. (Or: . . . pleasesupply the records without informing me if the fees do not exceed$ )(Optional) I am requesting this information (state the reason for your request if you think it will assist you in obtaining the information.)(Optional) As you know, the act permits you to reduce or waive feeswhen the release of the information is considered as ''primarily benefitingthe publw\ I believe that this request fits that category and I thereforeask that you waive any fees.

If all or any part of this request is denied, please cite the specific ex-emption(s) which you think justifies your refusal to release the information, and inform me of the appeal procedures available to me under thel a w .

I would appreciate your handling this request as quickly as possible,and I look forward to hearing from you within 10 days, as the law stipulates.

Sincerely,

John Q. PublicAnytown, U.S.A. Zip Code

Consumers who want information from FDA under the FOI Act canuse this format to assure their requests are processed quickly and efficiently.

The additional personnel and equipment needed to process these requests,as well as day-to-day operating expenses, cost the Agency about $2.4million last year. The Agency, in turn,received and turned over to the U.S.Treasury about $158,000 in fees chargedto requesters as provided by the 74amendments, which established a system of nominal fees for search, reproduction of paperwork, and postage.All or part of these fees can be waivedby FOI if the information requested isconsidered primarily beneficial to thepublic. The Agency also is considering

raising the fees to more nearly reflectthe actual costs incurred in processingthe requests.

Despite its high volume of FOI requests, FDA has one of the lowest denial rates in Government. In 1978,FDA denied less than 2 percent of allrequests on the grounds that the information requested dealt with tradesecrets of companies and opened investigatory files. Denial rates for otherregulatory agencies such as the Environmental Protection Agency, the Department of Energy, the Federal TradeCommission, and the Occupational

Safety and Health Administrat ionranged from 7 to 15 percent.

The majority of FOI requests aremailed directly to FDA Headquartersin Rockville. Once an FOI request isreceived by FOI personnel it is enteredinto a daily log and given a controlnumber. This number and pertinentinformation about the request, including the date received, the type of information desired, and the action takenby the Agency, are fed into a computer. A daily printout of this inform a t i o n i s a l s o m a d e . T h e s e m e a s u r e sallow the Agency to keep track of thecurrent status of each request.

Of the requests received by FDAfrom or on behalf of businesses, nearlya quarter seek research data and otherscientific information on new drugst h a t h a v e b e e n s u b m i t t e d t o F D A f o revaluation. A drug company, for example, might want data on the safetyand effectiveness of a new drug whichhas been developed by another drugfirm and clinically tested.

The FOI office processes the requestand sends it to New Drug Evaluationin the Bureau of Drugs. From there itis sent to the proper division within theBureau for evaluation. A request forsafety and effectiveness data on a newdrug to treat certain infections, for example, would be forwarded to the Division of Anti-Infective Drug Products.

This type of information is availableto the public upon request to FDA,providing the drug has been approvedby the Agency. If it still is being evaluated for approval the data is not re-leasable. All denials are reviewed bythe FOI office and then by the FDAG e n e r a l C o u n s e l ' s o f fi c e .

If a denial is upheld then the Agencyofficially informs the requester in writing that the information is not releas-able and cites the reasons. All denialscan be appealed to the Department of Health, Education, and Welf a r e .

Despite extensive use of the FOI lawfor corporate prying and the addedexpense to Government agencies forprocessing requests, few people haveadvocated its repeal. The act hasachieved its primary goal of openingthe majority of Government files topublic scrutiny. It allows citizens theopportunity to double check—in mostcases—the "inner workings" of BigB r o t h e r .

James Greene is a staff writer withFDA 5 Office of Public Affairs.

22 / April 1979 I FDA Consumer

Deliberate PCB SpillBrings Arrests

State Actions

There was something in the hot,August air that got to people. Theycomplained of nausea, weakness, dizziness, and irritation of the eyes, nose,and throat. The complaints poured infrom the residents of rural areas ine a s t e r n N o r t h C a r o l i n a .

State and local health officials wereperplexed. Then someone mentionedthat the illness might be linked to astain that had recently appearedalongside roadways in the area. Vegeta t ion w i th in the s ta ined a reas was

dying, it was noticed. Someone elseremembered helping a driver with histruck that was stuck one night. It hadcontained a protruding pipe for discharging liquid.

Officials of the North Carolina Natural Resources and Community Development Department tested thestained areas and found that the oilysubs tance on t he r oads ides con ta i neda highly toxic PCB (polychlorinatedbiphenyl). White, crystalline PCS's arenot easily biodegradable. They havebeen used s ince 1929 but have been

tightly controlled by the Federal Government s ince the la te 1960 's when

laboratory tests linked them with livercancer, acne, dizziness, and cramps.

PCB's have been mixed in oil,mainly by utility companies, for useas an insulator for electrical transformers and capacitors. And that'swhat was killing the plant life alongthe Carolina roads. Specifically, it wasidentified as Arochlor 1260, an insulator manufactured by Monsanto Co.

It was found that some 210 miles ofroadways in 15 counties were contaminated by the substance. Spray thathad escaped into the air was causingthe human ailments. Once the problem was pinpointed, health officialsset out to inform residents about PCB's

and the consequences of the spill, whilepolice officials went to work to trackdown the polluters.

A u t h o r i t i e s k n e w t h a t t h e t r a n s

former fluid normally is disposed ofat three federally approved dumpingsites in the country, the closest onebeing a landfill operation at Livingston, Alabama. The cost of dumping a55-gallon drum there is $58, butdoesn't include the expense of gettingthe drum to the s i te.

With that knowledge, authoritiesbegan to suspect that someone wastrying to save money by spraying itaround the countryside to dispose ofit. Nine State Bureau of Investigationofficers were assigned to the case. Theybegan to check area transformer salvage firms—firms that buy up oldtransformers for scrap metal.

One is the Ward Transformer Co.of Raleigh. But Ward's records showedit had paid a New York State haulingfirm to take the PCB fluid off itsh a n d s .

T h e t r a d e n d e d w h e n a t t e n t i o nturned to the New York firm. Transformer Sales Co., owned by Robert J.Burns of Allegany, New York. Burnswas unable to explain to the satisfaction of the investigators what his firmhad done with the fluid. He and histwo sons were charged with dumpitigthe oil. They pleaded guilty in January in the Federal court at Raleigh.Sentencing is pending.

Also charged in the case is RobertEarl Ward III and his son, of theWard Transformer Co. Authorities saythe Wards conspired with the Burnsfirm to arrange for dumping some15,000 gallons of the PCB fluid alongthe rural roads. According to thecharges, the Burns hauling firm waspaid $1.70 a gallon to dispose of theoily substance, but 70 cents of thisw a s k i c k e d b a c k t o t h e Wa r d s . T h eWards have pleaded not guilty to thecharges, brought in Federal grand juryi n d i c t m e n t s .

To calm fears about the spills and


to educate residents on the extent ofthe problem, officials from the StateDepartment of Human Resources andAgriculture as well as county healthpersonnel hand delivered notices tothe affected areas. People were advised to avoid walking on the contaminated strips and to wash off theirfeet, shoes, and any clothing that camein contact with the oily substance.

The res idents were a lso to ld tha ttests would be made by request onany individuals who believed they hadbeen exposed to the PCB. Assuranceswere given that there was no immediate danger from the spill. It waspointed out that the chemical wastrapped in the soil and that it would

probably be 2 to 3 years before it migrates to any extent. However, theywere warned to keep livestock fromgrazing in the exposed areas. Somegardens were plowed under becauseof contamination.

The Food and Drug Protection Division of the State Department of Agriculture found contamination of upto 219,000 parts per million in grassat the stained sites. However, the exposure to vegetation dropped off dramatically just outside the contaminatedareas. Wells tested within a few feet ofsome sprayed areas showed no PCBconcentrations. State and FDA officials are watching closely to see iffarm crops have been affected. Of lin

gering concern was the possibility ofdust migrating from the affected areasin to o the r a reas .

Also of continued concern is whatto do with the contaminated soil. Atone point, officials proposed removing the soil from the sprayed areas-some 10,000 truckloads—and disposing of it at excavation sites in theState, but residents near all the proposed sites voiced strong opposition.Subsequent consideration was given tofinding a method of treating the soilto confine the PCB. If that isn't feasible, the 10,000 truckloads will probably have to be taken to the Alabamadisposal site. The cost could run intomillions of dollars.

M i l k D u m p e d C |The Puerto Rico Health Depart-

ment destroyed over 25,000 quarts ̂of milk at Compania Pasteurizadora,Trujiilo Alto, Puerto Rico, because (it was adulterated by antibiotics. TheHealth Department found evidenceof antibiotics in samples of milktaken during a routine inspection ofthe dairy plant and ordered the milkdestroyed. When the plant owner refused to destroy the product, the Department got a court order to carryout the destruction. Over $12,000worth of milk was destroyed by orderof Puerto Rico Superior Court JudgeP e t e r O r t i z .

Food Warehouse Closes

Polar Food Service, Inc., a foodwarehouse in Binghamton, NewYork, was ordered closed by theNew York Supreme Court afterseveral inspections by the New YorkDepartment of Agriculture andMarkets revealed that the warehousewas infested by and its food productsgnawed by rodents. When theCommissioner of Agriculture andM a r k e t s r e v o k e d t h e fi r m ' s l i c e n s ebecause of the insanitary conditions,the firm appealed the order. Theresultant inspection revealede x t e n s i v e r o d e n t i n f e s t a t i o n a n d l e dto seizure of 91,000 pounds of foodproducts stored at the warehouse.The firm then withdrew its appeal,paid almost $4,000 in penalties, andc l o s e d u n t i l i t c a n c o r r e c t t h e

insanitary conditions.

Food Destroyed

B & M Salvage Co., Inc., a foodstorage warehouse in Chandler,Indiana, destroyed approximately$2,000 worth of food productscontaminated by rodents. The Statehad embargoed the entire contents ofthe warehouse, including suchproducts as sugar, flour, andmacaroni, after a joint inspection byt h e I n d i a n a S t a t e B o a r d o f H e a l t ha n d F D A ' s D e t r o i t D i s t r i c t r e v e a l e dextensive rodent activity. In additionto destroying the food, the firmclosed down for 6 days to correct the

insanitary conditions and make itsfacilities rodent proof.

State Actions reports on importantregulatory and administrative actionsconducted by State and local government agencies to provide health andeconomic protection to consumers offoods, drugs, cosmetics, and medicaldevices. Regional Reports, the sectionimmediately following State Actions,describes the operations of FDA's regional and district field offices acrossthe country in consumer protectionactivities, including inspections, product seizures, court proceedings, andconsumer education and informationp r o g r a m s .


Regicxial Rqxats

R E G I O N I

Connecticut, Maine, Massachusetts,New Hampshire, Rhode Island,V e r m o n t

T h e U . S . D i s t r i c t C o u r t f o r t h eDistrict of New Hampshire orderedt h e d e s t r u c t i o n o f 5 7 d r u m s o f a

product labeled as honey, importedfrom Mozambique by Charles E.Farris Co., Inc., New York City.FDA's Boston District sampled theshipment after a New Hampshirehoney producer reported that theproduct, sold to him by Farris, wasnot actually honey. When FDA laboratory analysis of a sample obtainedfrom the New Hampshire producerconfirmed that the product wassugar syrup and not honey, the Dist r i c t i n i t i a t e d s e i z u r e a c t i o n . T h e i m

porter asked that he be allowed toeither relabel the product or ship itback to the country of origin. Thisrequest was denied because the importer was unwilling to identify theingredients that provided the honeyl i k e fl a v o r a n d c o l o r a n d b e c a u s e t h e

importer had previously attempted toimport a similar product fromAfrica—also unsuccessfully—andt h e r e f o r e s h o u l d h a v e k n o w n t o t e s tthe product before marketing it. Approximately $15,000 worth of theproduct was ordered destroyed.

R E G I O N I I

New Jersey, New York, Puerto Rico,Virgin Islands

T h e A D C M e d i c a l I n s t r u m e n t

Corp., Farmingdale, New York, tookcorrective action after learning fromfour hospitals that its product, the"Scanna Cot Imaging Table," was

defective. The table is designed especially for use in scanning patients whohave received radioactive drugs aspart of the diagnostic process. Thetable's transparent acrylic top permitsscanning by camera or x-ray unit fromboth above and below. However,several hospitals told the firm thatthe tabletops had a tendency to benda n d c r a c k a n d t h a t i n o n e i n s t a n c e a

patient had fallen through the table-top onto the floor. FDA's New YorkDistrict inspected the firm as a resultof a trade complaint and learned thatthe firm knew of the problem andwas taking steps to remedy it. Thefirm told FDA that it had designed acorrective device—a narrow plywoodb o a r d t h a t c o u l d b e i n s e r t e d u n d e rthe tabletop—and was sending it toall purchasers of the product. Approximately 800 defective tables, eachvalued at about $500, had been dist r i b u t e d .

F D A ' s B u f f a l o D i s t r i c t i n i t i a t e d l e

gal action against Mark Medica, Inc.,Buffalo, because the firm, whichmanufactures surgical sponges, catheter trays, and other medical equipment, was not providing assurance ofproduct sterility. District investigators found insanitary manufacturingconditions at the firm, and examination of product samples revealed thatat least two lots of products, whichhad been recalled by the firm, weren o t s t e r i l e . U n d e r t h e t e r m s o f a c o ns e n t d e c r e e fi l e d i n t h e U . S . D i s t r i c tCourt for tl)e Western District of NewYork, the firm agreed to stop shipping medical devices in interstatecommerce until it could develop andimplement adequate sterilization proc e d u r e s a n d c o n t r o l s .

R E G I O N I I I

DelawarCy District of Columbia,Maryland, Pennsylvania, Virginia,West Virginia

An investigation by FDA's Philadelphia District led to the criminalprosecution of Raymond A. Bier-nacki, president of North Florida Research Center, for submitting falsedrug reports to Vick Chemical Co.Biernacki was employed by the company to test new drugs and submithis findings for use in preparing applications for FDA approval to market the drugs. FDA's GeneralCounsel, Peter Barton Hutt, was toldby attorneys representing the NewYork company that Biernacki hadsubmitted false reports on the drug,Nyquil. Hutt informed the Bureau ofDrugs, which assigned the Philadelphia District to investigate the case.FDA recommended criminal prosecution after District investigatorT h o m a s G r i m e s f o u n d t h a t B i e r n a c k ih a d i n d e e d s u b m i t t e d t e s t r e s u l t s o n

people who had never been tested.Biernacki pleaded guilty in the U.S.D i s t r i c t C o u r t f o r t h e S o u t h e r n D i strict of New York to charges of criminal fraud and was fined $10,000 andplaced on 3 years' probation with a2-year suspended jail sentence. SinceV i c k C h e m i c a l C o . n e v e r s u b m i t t e dBiernacki 's data to FDA, the factthat his reports were fraudulent doesnot change the marketing status ofthe drug.

Paul K. Keene, president of Walnut Acres, Inc., Penns Creek, Pennsylvania, was told by FDA that hewould have to obtain a temporaryemergency permit before continuing


t o m a r k e t l o w - a c i d c a n n e d f o o d

products in interstate commerce. ThePhiladelphia District recommendedthe requirement after an inspectiono f t h e fi r m r e v e a l e d n u m e r o u s v i o l ations of Good Manufacturing Practices (GMP's). Inspectors found thefirm was not using processing methods that would ensure that its products were safe to eat, was notadequately testing to see that canswere sealed properly, and hadn'tfiled its processing methods for someproducts with FDA. Other violationsincluded inadequate recordkeeping,failure to establish written recall procedures, and use of improper ventingmethods that might cause unevencooking of products. Low-acid GMPRegulations were developed andadopted by FDA to protect consumers from botulism, a deadly food-borne disease caused by themicroorganism Clostridium botu-linum, which can contaminate low-acid canned foods that are improperly processed. To obtain the emergency permit, the firm mustd e m o n s t r a t e t o F D A t h a t i t h a s c o rrected all the major violations. Afterobtaining the permit, the firm mayresume shipping products in interstate commerce, but if subsequent inspections reveal recurring violationsof GMP Regulations, FDA can suspend the permit immediately, thusshutting down the firm's shipping ope r a t i o n s .

R E G I O N I V

Alabama, Florida, Georgia,Kentucky, Mississippi, NorthCarolina, South Carolina, Tennessee

Greer Laborator ies, Inc. , Lenoir,North Carolina, agreed in the U.S.D i s t r i c t C o u r t f o r t h e W e s t e r n D i strict of North Carolina to bring its facilities into compliance with FDAregulations. The court action wasbrought after several inspections byF D A ' s A t l a n t a D i s t r i c t r e v e a l e d n um e r o u s v i o l a t i o n s o f G o o d M a n u f a c

turing Practice Regulations at thefirm, which manufactures a variety ofproducts including sterile vials, sterile diluent, and allergenic extracts.Investigators found that the air filtration, sterilizing, and water injectionsystems were not in good working

condition and were not being properly maintained by the firm, and thattesting for stability, sterility, and thepresence of pyrogens (fever-producing substances) was inadequate. In aconsent decree of permanent injunction, the firm agreed to stop manufacturing the sterile vials and diluent(sterile water used as a diluting agent)until it can comply with FDA regulat i o n s .

FDA's Bureau of Biologies suspended the license of Temple PlasmaCorp., a plasmapheresis center inLakeland, Florida, after investigatorsf r o m F D A ' s O r l a n d o D i s t r i c t d i s c o vered objectionable health protectivepractices. Investigators found thatd o n o r t e s t r e c o r d s w e r e n o t a d e

quately maintained, donors were allowed to give blood when their serumprotein levels were below the minimum limit set by FDA regulations,and donors were not properly advised of the hazards of plasmapheresis. Plasmapheresis is the methodused to obtain the plasma fractionf r o m w h o l e b l o o d . I t i n v o l v e s r e m o v

ing the whole blood from a donor,separating the plasma, and returningt h e r e d b l o o d c e l l s t o t h e d o n o r. T h efirm cannot receive plasma donationsor ship plasma in interstate commerce until it passes reinspection ofF D A a n d h a s i t s l i c e n s e r e n e w e d .

An inspection by the Orlando Dist r i c t a t C e d a r s N o r t h To w e r P h a r

macy, Inc., Miami, Florida, revealedthat the firm was manufacturing prescription acne medications in bulkand distributing these bulk drugs tod o c t o r s n a t i o n w i d e . F u r t h e r i n v e s t i

gation revealed that the firm was notregistered as a drug manufacturer,nor had it obtained any New DrugApplications for the drugs in quest i o n . W h e n O r l a n d o D i s t r i c t s e n t a

regulatory letter to the firm, the firmfiled an injunction in the U.S. Dist r i c t C o u r t f o r t h e S o u t h e r n D i s t r i c tof Florida to prevent FDA from interfering with what it considered tobe the practice of pharmacy. However, the court ruled that the firm'soperations clearly transcended theaccepted definition of the practice ofpharmacy, and the firm agreed tocease all bulk manufacturing and tofill prescriptions solely on an individua l bas i s .

R E G I O N V

Illinois, Indiana, Michigan,Minnesota, Ohio, Wisconsin

Canned Dairy Products, Inc.,Newcomerstown, Ohio, has temporarily stopped production of all low-acid canned milk products and is recalling all existing stocks distributedt o c u s t o m e r s n a t i o n w i d e . T h e fi r m ' sactions came after inspectors fromF D A ' s C i n c i n n a t i D i s t r i c t f o u n d v i ol a t i o n s o f c a n n e d f o o d l o w - a c i d G o o d

Manufacturing Practices (GMP's) att h e fi r m a n d e v i d e n c e o f b a c t e r i a i nthe products. Low-acid canned foodGMP Regulations were developed andadopted by FDA to protect consumers from botulism, a deadly food-borne disease caused by themicroorganism Clostridium botu-linum, which can contaminate low-acid canned foods that are improperly processed. FDA issued a regulatory letter to the parent firm inWaynesboro, Pennsylvania, whichthen ordered the recall of a varietyof products, including half and half,whipping cream, whole milk, low sodium milk, and chocolate-flavoredl o w f a t m i l k .

U.S. marshals seized 6,100 poundsof stone root (Collinsonia root) at


Standard Process Labs., Inc., in Milwaukee, after an inspection by FDA'sMinneapolis District revealed theproduct was stored in a rodent-inf e s t e d w a r e h o u s e . T h e fi r m u s e d t h eroot in the manufacture of capsuleswhose labels designated them as anh e r b a l f o o d a n d d i r e c t e d t h a t t w o

capsules be taken twice a day with aglass of water. Although stone root isl i s t e d i n t h e H o m e o p a t h i c P h a r m acopeia, no specific recommendationsfor use are included, and there is noknown nutritional need for this prepa r a t i o n i n t h e h u m a n d i e t .

R E G I O N V I

Arkansas, Louisiana, New Mexico,Oklahoma, Texas

The Bureau of Biologies suspendedGamma Dynamics' license to ship andreceive blood plasma because thefirm's practices were endangering theh e a l t h o f i t s d o n o r s . F D A ' s D a l l a sDistrict inspected the plasmapheresiscenter in Hurst, Texas, when a consumer reported she had been hospit a l i z e d f o r e x h a u s t i v e a n e m i a a f t e r

undergoing plasmapheresis at the facility. Plasmapheresis—the methodused to obtain the plasma fractionf r o m w h o l e b l o o d — i n v o l v e s r e m o v

ing whole blood from a donor, separating the plasma, and returning ther e d b l o o d c e l l s t o t h e d o n o r . F D A

regulations allow a person to contribute plasma up to twice within 7 days;however, donors whose red blood cellsare not reinjected must wait a minimum of 8 weeks before undergoingplasmapheresis again. The consumertold FDA she had given blood twicewithin 8 days without reinjection.During the inspection, FDA investigators learned that five other donorshad been similarly overbled. Thecompany's officials told FDA thattheir actions were justified becauset h e d o n o r s h a d b l o o d w i t h r a r e a n t ibodies and had been examined by aphysician. However, the investigatorsf o u n d t h a t t h e d o n o r s h a d n o t b e e nexamined by a physician, and recommended suspension of the firm's lic e n s e .

Approximately $7,000 worth of insect-infested candy was destroyed byUnited Wholesale Co., Inc., Dallas,

after a routine inspection by the Dallas District revealed insanitary conditions and laboratory analysisconfirmed that the candy containedi n s e c t s .

When China's Vice Premier TengHsiao-Ping arrived in Houston to visitthe oil field machinery plants andJohnson Space Center, FDA had already done its job. At the request ofthe Secret Service, FDA's HoustonSection inspected three food servicefacilities where the vice premier wass c h e d u l e d t o e a t w h i l e i n t h e a r e a .The banquet hall in Johnson SpaceCenter's recreation building passedinspection easily. So did Docier's Catering Kitchen, Fulshear, Texas, whichwas to provide a Texas-style barbecue during Teng's visit to the rodeoin Simonton, Texas. However, thestaff at the Hyatt Regency Hotel hadto work through the night to bring itsfacility up to FDA standards after inspectors found insanitary conditions,including dirty equipment and inadequate employee sanitation practices.

R E G I O N V I I

Iowa, Kansas, Missouri, NebraskaKing's Trading Inc., Kansas City,

Missouri, and the firm's president,Jar-Yu King, pleaded guilty in theU . S . D i s t r i c t C o u r t f o r t h e W e s t e r nDistrict of Missouri to charges of allowing food products to becomeadulterated. U.S. Magistrate CalvinK. Hamilton fined the firm $1,000and placed King on 1 year's probat i o n . T h e c o u r t a c t i o n o c c u r r e d a f t e r

investigation by FDA's Kansas CityD i s t r i c t r e v e a l e d t h e fi r m ' s w a r eh o u s e w a s a c c e s s i b l e t o r o d e n t s a n do r i e n t a l f o o d s s t o r e d t h e r e h a d b ec o m e c o n t a m i n a t e d .

R E G I O N V I I I

Colorado, Montana, North Dakota,South Dakota, Utah, Wyoming

A U . S . m a r s h a l m a d e a m a s s s e izure at Colorado Sutler Co., a foodprocessing facility and storage warehouse in Berthoud, Colorado, thats e l l s t o r e t a i l s t o r e s a n d o t h e r d i s t r i bu t o r s n a t i o n w i d e . T h e m a r s h a l s e i z e dt h e e n t i r e c o n t e n t s o f t h e w a r e h o u s e ,valued at about $25,000, after an in

spection by FDA's Denver Districtr e v e a l e d t h e f r u i t s a n d n u t s s t o r e dthere were contaminated by rodents.Investigators found evidence of widespread rodent infestation at the warehouse and defects in the building thatpermitted easy entry to rodents. TheColorado Health Department embargoed the products, pending Federalseizure. The seized products includedsoybeans, sunflower kernels, peanuts, almonds, and raisins.

R E G I O N I X

Arizona, California, Guam, Hawaii,N e v a d a

U . S . m a r s h a l s s e i z e d a n d d e

stroyed almost a hundred 50-millilitervials of adrenal cortex injection atPasadena Research Laboratories,Pasadena, California, because the firmdid not have an approved New DrugApplication (NDA) for the drug. Theproduct, intended to treat adrenalcortex deficiency, is considered byFDA medical experts to be ineffective and obsolete. FDA's Los AngelesDistrict investigated the firm's operations after receiving a request fromthe Bureau of Drugs to inspect allcompanies marketing this product.Inspectors found that the firm wasindeed marketing the drug withoutthe required approved NDA and init i a t e d s e i z u r e a c t i o n . F D A w i l l n o t

approve the drug until it is shown tob e b o t h s a f e a n d e f f e c t i v e .

After receiving complaints fromseveral surgeons that a device usedto open the skull during brain surgery could cause brain damage, thedevice 's manufacturer, Amco Hal lSurgical, Santa Barbara, California,recalled the product. Surgeons toldt h e fi r m t h a t t h e ' ' N e u r a i r t o m e " w a sh a z a r d o u s b e c a u s e t h e b l a d e o f t h edevice frequently came loose duringsurgery and could damage the outerlayers of the brain. A surgeon reported that during one surgical procedure when the blade came loose,the patient suffered a brain laceration. The firm told the Los AngelesDistrict that it was recalling over 200d e f e c t i v e d e v i c e s a n d h a d c o r r e c t e dthe product's design to prevent theblade from coming loose in futurem o d e l s .

FDA Consumer / April 1979 ! 27

Drug Expiration Dating DeferredIf you are looking for the expiration date on the label

of the drug you take, don't be surprised if you can't findt h i s i n f o r m a t i o n o n s o m e m e d i c i n e b o t t l e s . F D A h a s e xtended the effective date for this requirement in the recently revised Good Manufacturing Practice Regulations(GMP's) until September 28. All other provisions of theG M P ' s b e c a m e e f f e c t i v e M a r c h 2 8 .

The extension came as the result of a petition from theProprietary Association, trade organization for manufacturers of over-the-counter drug products. The associationrequested the extension because many drug manufacturers order preprinted labels 6 months to a year in advance. If the March date had been imposed labelingalready on order would have had to be destroyed. Manydrug companies were reluctant to adopt expiration datingvoluntarily pending publication of the final GMP's because of the risk of having to relabel if the final regulations contained provisions not in the original proposal.

The new effective date for expiration date requirements applies to drug products packaged after September29, 1979. The new ruling was reported in the FederalRegister of February 27.

F D A S e e k s C o m m e n t s o n U l t r a s o u n d

FDA is considering developing recommendations ormandatory performance standards for diagnostic ultrasound equipment, including that used to monitor the fetus during pregnancy and labor. To help in developingthis program, the Agency is asking for comments on suchquestions as: When should diagnostic ultrasound beused? How should users of this equipment be trained?What should be included in quality assurance programsto monitor equipment performance?

F D A a l s o w a n t s t o k n o w w h a t k i n d o f i n f o r m a t i o nshould be included in the manufacturers' specificationsprovided to users.

Diagnostic ultrasound has been used extensively inneurology, cardiology, obstetrics and gynecology, ophthalmology, and other areas of clinical medicine. Use hasbeen growing despite a lack of information on its biological effects. To date there have been no reports of adverse effects associated with the clinical use of diagnosticultrasound. Past epidemiological studies have yielded inconclusive evidence, and it will probably be several yearsbefore data will be available from ongoing studies.

Studies have been reported, however, which indicatethat ultrasound can affect the development of laboratoryanimals exposed in utero before birth. In light of thesestudies and a report of increased movement of the human fetus during examination with diagnostic ultrasound,FDA believes this equipment should be used only whenthere is a valid medical reason and that exposure shouldbe kept as low as possible, consistent with obtaining

needed diagnostic information.Persons wishing to comment on FDA's questions re

garding diagnostic ultrasound should write to the HearingClerk, HFA-460, Food and Drug Administration, 5600Fishers Lane, Rockville, Md. 20857. Cutoff date for comments is August 13, 1979. Details of the proposed actionappeared in the Federal Register on February 13.

FDA Sets Two 'Year of Child' Projects

The Food and Drug Administration will mark 1979 asthe International Year of the Child (lYC) with two projects intended to advance childhood health and wellbeing.

One project, operating in the Bureau of Foods, willm o n i t o r a n d d e t e r m i n e t h e l e v e l s o f c e r t a i n s e l e c t e d m i nerals in the diets of infants and toddlers in the UnitedStates. The other project, in the Bureau of Drugs, willlead to final regulations that require actual pediatric testing of drugs for use in children.

Samples were collected for the Bureau of Foods project during 1978, and analysis is being done at FDA's Total Diet Laboratory in Kansas City. Levels of iron,sodium, potassium, calcium, phosphorus, fluorine, andiodine are being determined in these samples, which represent the average intake of 100 frequently eaten foodsfor infants (age 6 months) and toddlers (age 2 years).

Levels of selected minerals will be determined for 2 or3 consecutive years, and the entire cycle will be repeatedperiodically. This will allow FDA to monitor imbalancesin the total diet and guide the Agency in setting policyon food fortification and enrichment. Such studies areneeded because foods now vary significantly from theircounterparts of only a few years ago, resulting fromchanges in food technology and manufacturing.

The Bureau of Drugs project for the Year of the Childis intended to make available to children prescriptiondrugs and medication that are not approved at presentfor pediatric use because they have never been tested inc h i l d r e n .

Almost 75 percent of the prescription drugs marketedtoday carry a statement on the label cautioning againstuse in infants and children—or omit mention of such useentirely—because they have not been studied in pediatricage groups to establish dosage and appropriate indications. Physicians who choose to use these drugs in children must rely on experience, and thereby riskprescribing an overdose, an underdose, or permittingother improper usage.

The Agency's new regulation will require pediatrictesting as a condition for approval of any new drug whichoffers a therapeutic advantage over currently availabledrugs for treating children. This will permit proper labeling that ensures safe and effective use of these drugs inchildren—generally considered as age 12 and under—andassure them the same drug safety protection provided toa d u l t s .


Seizures ard Postal Service QsesFILED SEIZURE ACTIONS charge violations of the Federal Food, Drug, and Cosmetic Act and are initiated based upon FDA

recommendations. A seizure action is commenced by the filing of a complaint in the U.S. district courtwhere the goods are located. A U.S. marshal is then directed by the court to take possession of the goods,removing the product from commerce, until the matter is resolved.

A total of 24 actions to remove from the consumer market products charged to be violative was reported in February. These actions included 14 offoods: 1 involved a charge concerning poisonous and deleterious substances. 12 involved charges concerning contamination, and 1 involved a chargeconcerning economic and labeling violations. Others included 1 of food additive, 7 of drugs, and 2 of medical devices.

P R O D U C T, D I S T R I C T & D A T EF I L E D

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

FOOD/Poisonous and Deleter ious Substances

Tuna chunks , canned. Breas t O 'Ch icken/U . S . D i s t r i c t C o u r t f o r t h e W e s t e r nD is t r i c t o f New York 11 /29 /78

Sun Flarbor Industries/San Diego, Calif. Contains the poisonous or deleterious substance histamine in a quantity which may render it injuriousto health; contains decomposed tunafish.

FOOD/Contamination, Spoilage, Insanitary Handling

A r t i c h o k e h e a r t s , c a n n e d / U . S . D i s t r i c tCourt for the Southern Distr ic t of NewYork 9 /22 /78

Beans, pink, canned/U.S. District Courtfor the Distr ic t of Puerto Rico 12/1/78

Chocolate flavor base powder for choco l a t e m i l k / U . S . D i s t r i c t C o u r t f o r t h eWestern Dis t r ic t o f Ok lahoma 11/21/78

C o c o n u t , d e s i c c a t e d / U . S . D i s t r i c t C o u r tf o r t h e S o u t h e r n D i s t r i c t o f F l o r i d a 1 2 /

2 0 / 7 8

F l o u r, r i c e , c a k e m i x , a n d o t h e r f o o d -stocks/U.S. Distr ict Court for the Eastern District of Virginia 12/8/78

Fruits, dried, assorted mix/U.S. DistrictCour t f o r t he Eas te rn D is t r i c t o f NewYo r k 1 0 / 2 7 / 7 8

Mushrooms, pieces & stems, canned/U.S.D is t r i c t Cour t fo r the Eas te rn D is t r i c to f Cal i forn ia 12/15/78

Oregano leaves/U.S. District Court forthe Southern Dis t r ic t o f F lor ida 11/14/7 8

Popcorn, yellow/U.S. District Court forthe Southern Distr ict of Texas 12/28/78

R ice /U .S . D is t r i c t Cour t f o r the Eas te rnDist r ic t of Missour i 12/18/78

Rice, enriched/U.S. District Court for theEas te rn D is t r i c t o f New York 11 /2 /78

Sugar, flour, rice, and other foodstocks/U . S . D i s t r i c t C o u r t f o r t h e S o u t h e r nDistrict of Mississippi 12/12/78

Imported from Spain.

Casera Foods , Inc . /Barce lone ta , P.R.

Shipped from Bridgeton, Mo.

Held in swol len cans.

Contains unidentified plastic objects.

Held under insanitary conditions.

Francois Jacquemoux, Inc./Miami, Fla. Held under insanitary conditions; contains rodent filth.

Mazo Lerch Co . , I nc . /Sands ton , Va .

Shipped from Passaic, N.J.

King Hong Canned Food Co./Taipei,C h i n a

Original Krispy Pizza of Miami, Inc./Hi-aleah, Fla.

David M. Slaughter & Sons, Inc./Laredo,T e x .

Crown Foods , Inc . /S t . Lou is , Mo .

Dubovsky & Sons, Inc./Glendale, N.Y.

The Merchants Co./Gulfport, Miss.

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

I n s e c t c o n t a m i n a t e d .

Prepared and packed under insanitary conditions.

Held under insanitary conditions; contains rodent filth.

Held under insanitary conditions; contains insect filth.

Held under insanitary conditions; rodent contaminated.

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

FOOD/Economic and Labeling Violations

"Honey," Wild Mountain/U.S. DistrictCourt for the Northern Distr ic t of Cali f o r n i a 1 2 / 1 9 / 7 8

H. W. Pilgrim/DeKalb, Miss.; Pond Products Co./Campbell, Calif.

Corn syrup substituted in whole or in part for honey.Shipper's unlabeled jars lacked common or usualname of food; lacked name and place of business ofmanufacturer, packer, or distributor; and lacked anaccurate quantity of contents statement. Dealer's labels have quantity of contents statements in too smalltype size, and without required parenthetical statem e n t s .

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

Odor suppressant for livestock & poultry/U .S . D is t r i c t Cour t f o r t he D is t r i c t o fK a n s a s 1 2 / 5 / 7 8

Haldiman Enterprises, Inc./McAllan, Tex. Product is a nonconforming food additive and labelingfails to bear the common or usual name of the food,i.e., ground shale rock.

FDA Consumer / April 1979 ! 29

PRODUCT, DISTRICT & DATEF I L E D

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

Amygdalin (Laetrile) tablets/U.S. DistrictCourt for the Eastern Distr ic t of Pennsylvania 11/22/78

Chlorpropamide tablets/U.S. DistrictCour t for the Eastern Dis t r ic t o f Mich

igan 12/14/78Chlorpropamide tablets, U.S.?., 250 mg/

U . S . D i s t r i c t C o u r t f o r t h e W e s t e r nDistrict of Kentucky 12/22/78

Chlorpropamide tablets/U.S. DistrictC o u r t f o r t h e N o r t h e r n D i s t r i c t o f I ll inois 12/14/78

Diazepam tablets/U.S. District Court forthe Eastern District of Michigan 12/14/78

Gerovital H3 procaine hydrochloride in-jectable/U.S. District Court for theDis t r ic t o f Ca l i fo rn ia 9 /27/78

Hydralazine hydrochloride tablets, U.S.?./U . S . D i s t r i c t C o u r t f o r t h e S o u t h e r nDis t r i c t o f F lo r ida 11 /13 /78

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

Chemisches Heinrich Kaden/Hamburg,W. G e r m a n y

Premo Pharmaceut ical Laborator ies, Inc.-South Hackensack, N.J .

C a m a l l C o . / D e t r o i t , M i c h .

F a r m a c i a D r. D . M a r i n o n i / M i l a n , I t a l y

Danbury Pharmacal, Inc./Danbury, Conn.

Labeling fails to bear name and place of business of themanufacturer, packer, or distributor; lacks an accurate quantity of contents statement; fails to bear established name of the drug; fails to bear adequatedirections for use; and fails to bear the legend.New drug without an effective approved New DrugApplication, and not exempted.

New drug without an effective approved New DrugApplication.

Inadequate directions for use and not exempted; newdrug without effective approved New Drug-Application; false and misleading claims as to an inadequately supported expiration date; and productioncircumstances lacked current good manufacturingpractice due to lack of stability testing.

New drug without an effective approved New DrugApplication.

Strength differs from that set forth in U.S. Pharmacopeia.

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

Hydrometer for testing specific gravity ofurine (Urinometer)/U.S. District Courtfor the Dis t r ic t o f Minnesota 10/30/78

Hydrometer for testing specific gravity ofurine (Urinometer)/U.S. District Courtfor the Eastern District of Michigan 11/17/78

B r o t h e r s S c i e n t i fi c P r o d u c t s , I n c . / C h icaeo. 111.

Labeling contains false and misleading claims to testdiabetic sugar levels, and of acceptance by FDA andapproval by medical profession; labeling lacks adequate directions for use to test diabetics' sugar levelsand such directions cannot be written; and the product is dangerous to health when used as directed.

U.S. POSTAL SERVICE actions taken in medical cases as authorized in the Mail Fraud Statute (18 U.S.C. 1341) and/or the FalseRepresentation Statute (39 U.S.C. 3{)()5) as reported by the Chief Postal Inspector.

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

December 18, 1978: Sure/Slim, P.O. Box 1507, Hollywood, Florida. Advertising and sale through the mail of the product "Sure/Slim ChewableDiet Tablets," representing the ability to cause weight loss.

December 19, 1978: Ansearch International Co., Inc., P.O. Box 4576,Charleston, South Carolina. Advertising and sale through the mail ofthe product 'The Face and Mouth Shaper Kit," representing theability to eliminate lines on your forehead, cheeks, eyes, upper andlower lips, and remove wrinkles and sags.

December 19, 1978: Wonder Products, 15 Clifton, Pittsburgh, Pennsyl

vania. Advertising and sale through the mail of the product "HealScars," representing the ability to dissolve ugly scars.

December 19, 1978: Movie Star Secret, P.O. Box 10417, Glendale, California. Advertising and sale through the mail of the product "SuperSkin Tightener," representing the ability as a face lift procedure.

December 28, 1978: European Specialties, 721 Acorn Street, Deer Park,New York. Advertising and sale through the mail of the product"Weight Reduction," representing the ability to cause weight loss.

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

December 16, 1978: Against Rev. Billy Sunday, 7911 S. State Street, Chicago, Illinois. Advertising and sale through the mail of informationon how to prevent arthritis.

December 16, 1978: Against Isola Products, P.O. Box 116, Parkville Station, Brooklyn, New York. Advertising and sale through the mail ofthe product "Weight Reduction," representing the ability to causeweight loss.

December 28, 1978: Against Super-E, 711 E. Walnut Street, Pasadena,

California. Advertising and sale through the mail of the product "E-Pill," representing the ability to rejuvenate sexual drive in men andw o m e n .

January 15, 1979: Against Cotner Distributors, 2316 Cotner Avenue, LosAngeles, California. Advertising and sale through the mail of theproduct "The Stay-Hard Guardian," representing the ability to maint a i n a n e r e c t i o n .


>btioes of Jui%rient

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

FOOD/Contamination, Spoilage, Insanitary HandlingAnnatto seeds, and chick peas, at Ponce, Dist. P.R.

Charged 4-11-78: while held by Monllor & Boscio Sucrs, Inc., Ponce,P.R., the articles contained insect filth and were held under insanitaryconditions; 402(a)(3), 402(a)(4). Consent decree authorized releaseto the dealer for salvaging. (F.D.C. No. 61692; S. Nos. 78-147-714/5, 78-147-717; N.J. No. 1)

Apples, sliced, canned, Shenandoah, at Dallas, N. Dist. Tex.Charged 1-13-78: when shipped by Shenandoah Apple Cooperative,Inc., Winchester, Va., the article contained decomposed apples andwas unfit for food due to being in swollen cans; 402(a)(3). Consentdecree authorized release to the shipper for salvaging. (F.D.C. No.61558; S. No. 78-114-415; N.J. No. 2)

Candy, Caroh Peanut Clusters, at Seattle, W. Dist. Wash.Charged 7-7-78: while held by Washington Chocolate Co., Seattle,Wash., one lot of the article contained insect filth, and all lots of thearticle had been prepared under insanitary conditions; 402(a)(3),402(a)(4). Default decree ordered destruction. (F.D.C. No. 61818;S. No. 78-148-727; N.J. No. 3)

Donut mix, pastry mix, and buttermilk-flavored donut mix, at Indianapolis,S. Dis t . Ind.Charged 6-14-78: while held by B. H. Gardner Co., Inc., Indianapolis, Ind., the articles contained rodent filth and had been heldunder insanitary conditions; 402(a)(3), 402(a)(4). Default decree ordered destruction. (F.D.C. No. 61791; S. Nos. 78-199-082/4; N.J. No.4)

Flour, at New Orleans, E. Dist. La.Charged 2-16-78: while held by Dalton Steamship Corp., New Orleans, La., at Poydras Street Wharf & Julia Street Wharf, the articlehad been held under insanitary conditions, and some lots of the articlecontained rodent filth; 402(a)(3), 402(a)(4). Consent decree authorized release to People's Moss Gin Co., Inc., Palmetto, La., for salvaging. (F.D.C. No. 61620; S. No. 78-136-155 et al.; N.J. No. 5)

Lentils, at Rio Piedras, Dist. P.R.Charged 2-3-78: while held for sale by M. Cuebas, Inc., Rio Piedras,P.R., the article contained insect filth and had been held under insanitary conditions; 402(a)(3), 402(a)(4). Consent decree authorizedrelease for salvaging. (F.D.C. No. 61600; S. No. 77-83-705; N.J. No.6)

Nonfat dry milk, at St. Paul Park, Dist. Minn.Charged 6-9-78: when shipped by Allen Eisenschenk, Albany, Minn.,from Alcester, S. Dak., (where part of the article had been repackagedinto new bags), the article in the original bags contained rodent filth,and all of the article had been held under insanitary conditions;402(a)(3), 402(a)(4). Default decree ordered destruction. (F.D.C. No.61796; S. Nos. 78-130-171/2; N.J. No. 7)

Peaches, canned, at Lubbock, N. Dist. Tex.Charged 5-23-78: while held for sale, the article was unfit for foodbecause of swollen cans and decomposition of the interior can lining;402(a)(3). Default decree ordered destruction. (F.D.C. No. 61739;S. No. 78-116-091; N.J. No. 8)

Peanuts, and other foodstocks, at Draper, Dist. Utah.Charged 5-5-78: while held by Oquirrh Distributors, Inc., Draper,Utah, the articles had been held under insanitary conditions; 402(a)(4).Default decree ordered destruction. (F.D.C. No. 61758; S. No. 78-119-010 et al.; N.J. No. 9)

Pigeon peas, dried, at San Juan, Dist. P.R.Charged 3-28-78: while held by Almacenes Maritimos, San Juan,P.R., the article contained insect filth and had been held under insanitary conditions; 402(a)(3), 402(a)(4). Consent decree authorizedrelease to Dietrich Buck Exportaciones, San Juan, P.R., for salvaging.(F.D.C. No. 61581; S. No. 78-147-842; N.J. No. 10)

Rice, at Norfolk, E. Dist. Va.Charged 4-26-78: while held by Julius Rothschild & Co., Inc., Norfolk, Va., the article contained rodent filth and was held under insanitary conditions; 402(a)(3), 402(a)(4). Consent decree authorizedrelease to the dealer for salvaging. (F.D.C. No. 61730; S. Nos. 78-103-381/2; N.J. No. 11)

Sha rk fins , a t Newark , D i s t . N . J .Charged 2-28-78: while held by Ocean Leather Corp., Newark, N.J.,the article contained insects and had been held under insanitary conditions; 402(a)(3), 402(a)(4). Consent decree authorized segregationof the article into the lots received from foreign sources and the lotsreceived from domestic sources, authorized export to original foreignsources of the foreign lots, and ordered destruction of the domesticlots. (F.D.C. No. 61612; S. No. 78-133-176; N.J. No. 12)

Spices, ground, and dried navy beans, at Houma, E. Dist. La.Charged 4-3-78: while held by Caro Produce Co., Inc., Houma, La.,the articles were held under insanitary conditions; 402(a)(4). Defaultdecree ordered destruction. (F.D.C. No. 61675; S. Nos. 78-136-216& 78-136-218; N.J. No. 13)

Tuna, frozen, at Long Beach, C. Dist. Calif.Charged 3-31-78: while held for sale, the article contained decomposed and rancid tuna; 402(a)(3). Default decree ordered destruction.(F.D.C. No. 61676; S. No. 78-125-715; N.J. No. 14)

Wa l n u t s , a t D e t r o i t , E . D i s t . M i c h .Charged 1-20-78: while held by Armen-Berry Co., Inc., Detroit,M i c h . , 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 rinsanitary conditions; 402(a)(3), 402(a)(4). Consent decree ordereddestruction. (F.D.C. No. 61548; S. No. 78-120-653 et al.; N.J. No.15)

V I T A M I N S / S P E C I A L D I E T A R Y F O O D S

B-vitamin capsules, at Carbondale, E. Dist. 111.Charged 1-30-78: when shipped by Bio-Dyne Industries, Harbor City,Calif., who manufactured the article using imported debitteredbrewer's yeast, the article had been prepared from yeast containingviable Salmonella microorganisms which might render the article injurious to health; 402(a)(4). Default decree ordered destruction.(F.D.C. No. 61590; S. No. 78-109-385; N.J. No. 16)

Protein supplement, at Westbury, E. Dist. N.Y.Charged 4-12-78: when returned to the manufacturer, Louis JordanLaboratories, Ltd., Westbury, N.Y., the article, labeled in part "Pre-digested Liquid Protein Supplement Cherry Flavor . . . Formula 688. . . Manufactured for : Foods Plus, Inc. Moonachie, N.J. , " was unfitfor food because it was contained in swollen [plastic] bottles;402(a)(3). Default decree ordered destruction. (F.D.C. No. 61686;S. No. 78-139-387; N.J. No. 17)

A N I M A L F E E D

Dog food chunks, and other stocks of animal food, at Bowdon, N. Dist.G a .Charged 5-17-78: while held by Roop Wholesale Co., Bowdon, Ga..the articles were held under insanitary conditions; 402(a)(4). Consentdecree authorized release to the dealer for salvaging. (F.D.C. No.61772; S. No. 78-190-269 et al.; N.J. No. 18)

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

Adrenal cortex injection, at Pasadena, C. Dist. Calif.Charged 5-5-78: while held for sale, three lots of the article (whichwere labeled in part ''Adrenex Adrenal Cortex Injection . . . Pasadena Research Laborator ies , Inc . , Pasadena, Ca l i f . , " and which hadbeen prepared by Pasadena Research Laboratories, Inc., Pasadena,Calif., using interstate components) failed to bear adequate directionsfor use and were not exempted, since the article was a new drugwithout an effective approved New Drug Application—502(f)( 1); andwhen shipped and while held for sale, all lots of the article (the lotslabeled in part as above; the lot shipped by Lypho-Med, Inc., Chicago,111., labeled in part "Adrenal Cortex Injection . . . Mfd. for PasadenaResearch Labs, . . . Mfd. by Lypho-Med, Inc. Chicago, IL"; and thelots shipped by Carter-Glogau Laboratories Division, ChromalloyPharmaceuticals, Inc., Melrose Park, 111., labeled in part "AdrenalCortex Injection . . . Manufactured For Pharmedical Melrose Park,Illinois" and "Lipo Adrenex (Adrenal Cortex 10 X NF) . . . Manufactured by C/G-Chromalloy—Melrose, Park, III., manufactured forPasadena Research Laboratories, Inc.") were new drugs without effective approved New Drug Applications—505(a). The article wasclaimed by Robert B. Vance, D.O., Salt Lake City, Utah, as soleowner of the art ic le. The claimant moved for removal of the case to

FDA Consumer ! April 1979 131

a district of reasonable proximity to his principal place of business.The Government opposed the motion on the grounds that the courtwas without jurisdiction to effect the transfer; and the Governmentserved written interrogatories and requests for admissions on theclaimant. Pursuant to stipulation of the parties, representative sampleswere ordered to be withdrawn and to be delivered to the parties.Subsequently, pursuant to stipulation, the claimant withdrew fromthe action; and a default decree ordered the article destroyed. (F.D.C.No. 61757; S. No. 78-127-640 et al.; N.J. No. 19)

Amygdalin powder, at Dallas, N. Dist. Tex.Charged on or about 7-28-78; when shipped by Hong Kong AlmondProducts Co., Kowloon, Hong Kong, the article was a new drugwithout an effective approved New Drug Application; 5()5(a). Defaultdecree ordered destruction. (F.D.C. No. 61831; S. No. 78-114-645;N.J. No. 20)

Benzocaine & ephedrine HCl ointment, at North Kansas City, W. Dist.M o .

Charged 4-4-78: while held for sale after shipment by Neal Pharmaceutical Co., St. Louis, Mo., who manufactured the article usingin te rs ta te benzoca ine , the a r t i c le , wh ich was labe led "K l i ck a t theright time . . . Benzocaine . . . Ephedrine Hydrochloride, ... in abland ointment base. Manufactured expressly for Dean Rubber Mfg.Co.," had been manufactured, processed, packed, and held undercircumstances that failed to conform with current good manufacturingpractice; 501(a)(2)(B). Default decree ordered destruction. (F.D.C.No. 61656; S. No. 78-123-442; N.J. No. 21)

Chlordiazepoxide HCl & clidinium capsules, at Philadelphia, E. Dist. Pa.Charged 4-4-78: when shipped by Premo Pharmaceutical Laboratories, Inc., South Hackensack, N.J., the article, labeled in part "URL. . . C h l o r d i a z e p o x i d e H C l a n d C l i d i n i u m B r o m i d e . . .Capsules Manufactured For United Research Laboratories, Inc.,Philadelphia, Pa.," had been manufactured, processed, packed, andheld under circumstances not in conformity with current good manufacturing practice—501(a)(2)(B); and the article's purity or qualityfell below its purported purity or quality due to excessive levels of animpurity (i.e., 3-quinuclidinyl benzilate, a contaminant of the article'sraw material caused by a failure to recrystallize clidinium bromideproperly)—501(c). Default decree ordered destruction. (F.D.C. No61571; S. No. 78-143-870 et al.; N.J. No. 22)

Chlordinium Sealets chlordiazepoxide HCl & clidinium bromide capsules,at Newington, Dist. Conn.Charged 4-14-78: when shipped by Premo Pharmaceutical Laboratories, Inc., South Hackensack, N.J., the circumstances used for themanufacture, processing, packing, and holding of the article were notin conformity with current good manufacturing practice—501(a)(2)(B);and the article's parity or quality fell below its purported purity orquality, due to excessive levels of an impurity (i.e., 3-quinuclidinylbenzilate, a contaminant of the raw material caused by a failure torecrystallize clidinium bromide properly)—501(c). Default decree ordered destruction. (F.D.C. No. 61579; S. Nos. 78-106-276/7; N.J. No.23)

Diethylpropion HCl capsules, at Cincinnati, S. Dist. Ohio.Charged 8-11-78 and amended 8-16-78: when shipped by Calvin Scott& Co., Inc., Albuquerque, N. Mex., the article, labeled in part "Zenith . . . Diethylpropion Hydrochloride . . . Capsule . . . Zenith Laboratories, Inc., Northvale, New Jersey," was a new drug without aneffective approved New Drug Application; 505(a). Default decreeordered destruction. (F.D.C. No. 61847; S. No. 78-113-289; N J No2 4 )

Glycerin suppositories, at Landover, Dist. Md.Charged 5-17-78: when shipped by Dr. Rose, Inc., Rose LaboratoriesDivision, Madison, Conn., the article, labeled in part "Dart DrugGlycerin Suppositories Laxative . . . Distributed by Dart Drug Corp.,Landover, Md.," had been manufactured, processed, and packedunder circumstances not in conformity with current good manufacturing practice; 501(a)(2)(B). Default decree ordered destruction.(F.D.C. No. 61743; S. No. 78-104^190; N.J. No. 25)

Lidocaine ointment, at Flushing, E. Dist. N.Y.Charged 4-18-78: when shipped by Credo Co.. Fenton, Mo., thearticle, labeled in part "Lidocaine-5 . . . manufactured for HenrySchein Inc. Port Washington, N.Y.," had been manufactured, proc

essed, packed, and held under circumstances not in conformity withcurrent good manufacturing practice; 50i(a)(2)(B). Default decreeordered destruction. (F.D.C. No. 61690; S. No. 78-140-663; N.J. No.26)

Methylene blue urinary antiseptic tablets, and other drug stocks, at Mansfie ld , N . D i s t . Oh io .Charged 2-9-78: while held for sale, after manufacture by C. M.Bundy Co., Cincinnati, Ohio, from interstate active ingredients, thecircumstances used for the article's manufacture, processing, packing,and holding failed to conform with current good manufacturing practice—501(a)(2)(B); and the strength of the methylene blue urinaryantiseptic tablets differed from its represented strength—501(c). Consent decree ordered destruction of a number of specified lots of drugsand author ized re lease to Caldwel l & Bloor Co. , Mansfield, Ohio, ofseven lots of specified drugs for salvaging. (F.D.C. No. 61545; S. No.78-112-571 ; N .J . No . 27 )

Zinc undecylenate for manufacturing, at Buffalo, W. Dist. N.Y.Charged 9-9-77: while held for sale, after manufacture in part frominterstate undecylenic acid, the article's quality and purity icll belowthe U.S.P. standards, because of more than 1 percent residue ofalkalies and alkaline earths; 501 (b). The article was claimed by Penn-walt Corp., Buffalo, N.Y., who denied the charge. The court directeda joint postseizure assay of the article. Such assay showed that thearticle was not adulterated. Accordingly, the parties stipulated, thatthe action be dismissed with prejudice. (F.D.C. No. 61362; S. No.77-94-862; N.J. No. 28)

DRUGS/Veterinary UseMange preparations for topical use (Para-Mite, Otocide, & Demolene),

Para Dust topical preparation (against Heas, ticks, & lice), and injectable animal drugs (Vitamin B,̂ , Bal-Con, Syn-Aspra-Ject, Fer-Co,Poly litis, & Hydro C Ascorbic Acid), in in-process and finished form,at Baton Rouge, M. Dist. La.Charged 9-22-77: while held by Hart-Delta, Inc., Baton Rouge, La.,who was manufacturing the articles using interstate components, eacharticle was a new animal drug, and no approval of a New AnimalDrug Application was in effect with respect to its use or intendeduse—501(a)(2); and the vitamin B,̂ injection (lot # 7037/3-81) hadbeen manufactured, processed, packed, and held for sale under circumstances that failed to conform with current good manufacturingpractice—501(a)(2)(vB). Consent decree ordered the destruction ofsuch drugs as could not be brought into compliance, and authorizedrelease of the remaining drugs to the manufacturer for bringing intocompliance. (F.D.C. No. 61381; S. No. 77-38-737 et al.; N.J. No29)

McKay's Maxlin injection for horses, at Louisville, W. Dist. Ky.Charged 6-23-78: when shipped by Bickmorc, Inc., Hudson, Mass.,the article (all lots) was a new anim̂ al drug, and no approval of a NewAnimal Drug Application was in effect with respect to its use andintended use; and the circumstances used for the manufacture processing, packing, and holding of three lots of the article failed to conform with current good manufacturing practice; 501(a)(2)(B), 501 (a)(5).Default decree ordered destruction. (F.D.C. No. 61731; S No 78-130-540; N.J. No. 30)

Premix, medicated, at Sycamore, N. Dist. 111.Charged 8-15-77: when returned from Lake Mills, Wis., to DcKalbAgResearch, Inc., Sycamore, III., the article, labeled in part "Ak-lomix Medicated Premix An Aid In the Prevention of Coeeidiosis... In Chickens . . . Aklomide 2-Chloro-4-Nitrobenzamide . . . Salisbury Laboratories, Charles City, Iowa," was a new animal drug,and, at the time of removal from the distributor's establishment foruse in the manufacture of animal feed, the distributor did not havean unrevoked written statement from the drug's consignee, nor anHEW notice that the consignee held an approved New Animal DrugApplication, or (if the consignee was not a user of the article) wouldship only to one who held such an application; 5()l(a)(5). The articlewas claimed by DeKalb AgResearch, Inc., DeKalb, 111. The claimantmoved to dismiss for failure to state a claim upon which relief couldbe granted. The claimant admitted to lacking any application, statement, or notice for the article, and to being a distributor of a newanimal drug premix of Aklomide. and did not dispute that the article


was in tended tor use in the manutacture ot medicated animal feedbut argued that FDA had exempted the article under 21 C.F.R510.7(b)(2).

The court denied the claimant's motion to dismiss, saying;"The complaint in this case was filed to condemn 10 bags of ;

product named Akiomix Medicated Prcmix. The product was manufactured by Sal[i]sbury Laboratories pursuant to an approved NewAnimal Drug Application issued by the Secretary of Health, Education and Welfare. It was then shipped in interstate commerce to theIntervenor DeKalb AgResearch Inc. and thence to Creekwood Farms.Because DeKalb AgResearch Inc. did not have a|nl 'unrevoked written statement' or notice from H.E.W. that Creekwood held an approved New Animal Drug Application or that it would ship it onlyto a user which held such a document, the government seeks to seizeand condemn the product as unsafe within the meaning of 21 U.S.C.§ 360b(a)(l).

"The government relies on regulations promulgated pursuant to thestatute, particularly 21 C.F.R. § 558.3 which provides in pertinentpart as follows: (a) Regulations prescribing conditions under whichanimal drugs may be safely used in animal feed, animal feed supplements, concentrates, or prcmixcs or in animals intended for food useshall not be construed to relieve such druus from the provisions of[21 U.S.C. § 36()b.l

"The Intervenor calls attention to 21 C.F.R. § 510.7(b) which provides in pertinent part as follows: The requirements of paragraph (a)[that a drug manufacturer must obtain an unrevoked written statementor notice that the consignee has an approved feed NADA, or willonly ship to one who does, or the drug will be deemed unsafe at thetime it leaves the manufacturer or distributor] do not apply: ... (2)When the use of such drug in the manufacture of a finished feed hasbeen exempted from the requirements of [21 U.S.C. § 36()b(m)] underthe conditions specified by regulations in Part 558 of this chapter.

"The Secretary of Health, Education and Welfare is required byvirtue of 21 U.S.C. ^ 360b(i) to publish in the Federal Registerthe names, and conditions and specifications for use of drugs whichhave received approved New Animal Drug Applications. 21 C.F.R.§ 558, which codifies these publications, does not purport, by the merefact of publication, to exempt drugs from the statutory requirementthat a consignee must have an approved New Animal Drug Applicat ion for feed manufacture or an 'unrevoked wr i t ten statement ' thatthe drug will be shipped only to parties having such [an] approvedapplication. Some drugs, whose conditions and specifications for usehave been published in Reg. 558, have been specifically exemptedfrom the requirement (e.g., lincomycin, 21 C.F.R. § 558.325(a)), butwe find that the regulation covering Aklomide, 21 C.F.R. § 558.35,does not contain a specific exemption.

"DeKalb contends that feed premixes need not comply with thesafety requirements of 21 U.S.C. § 360b by virtue of the wording of21 C.F.R. § 558(a), supra, . . . which provides that the regulations'shall not be construed to relieve such drugs from the provisions of[21 U.S.C. § 360b.]' (emphasis added). DeKalb argues that the Actand regulations define 'drug' differently from 'feed premix,' and thattherefore Regulation 558(a) can be construed so as to relieve feedpremixes from having to comply with 21 U.S.C. § 360b, even thoughdrugs are not so relieved.

"According to the statute, the major classification division is between animal drugs, 21 U.S.C. § 321(w), and animal feeds, 21 U.S.C.§ 321(x), . . . 'Animal feed' is defined in § 321(x) ....

"Although it is true that 'feed premix' has its own definition, 21C.F.R. § 558.3(b)(4), we find and conclude that the safety requirements apply to premixes as well as to drugs. Such was the understanding of the Congressional Committee which reported on the AnimalDrug Amendments of 1968, stating as follows: 'On the other hand,a feed additive "premix" ... is, if it contains a new animal drug,itself classifiable as a "new animal drug" under the bill as distinguishedfrom an "animal feed." ' It is apparent that there was an obvious andrational distinction in the minds of the Committee between a premixand an animal feed. In Akiomix Premix, for example, the only 'nutrient' is Aklomide, which is used to prevent disease in chickens, notto nourish them. Furthermore, a premix contains drug concentrationsat extremely high levels, and must be diluted for safe ingestion, according to the definition in 21 C.F.R. § 558.3(b)(4), supra p. 5, n.l.Therefore, the subject matter is more like a drug than a feed. We

believe that Congress, in creating a comprehensive statutory schemeto insure animal drug safety, would not exclude the highly concentrated feed premixes from safety requirements.

"The Intervenor argues that the H.E.W. regulations are ambiguous,but this does not render them invalid if they can be applied rationally.Wisconsin Electric Power v. OSHARC, 567 F.2d 735 (7th Cir. 1977).In the case at bar, Akiomix Medicated Premix is obviously not ananimal feed but is a prophylactic drug for chickens. It should thereforebe treated as a drug and the Intervenor DeKalb AgResearch Inc.should not have shipped it to Creekwood Farms unless either partyhad an unrevoked written statement or notice from H.E.W. showingcompliance with § 360b(m).

"The Intervenor further contends that, if this regulation means whatwe believe it to mean, it should have been promulgated pursuant tothe rule-making requirements of the Administrative Procedure Act,5 U.S.C. § 553. However, the Secretary issued the regulation pursuantto § 36()b(i) of Title 21 which does not render the Secretary subjectto the Administrative Procedure Act but instead provides as follows:'. . . the Secretary shall by notice, which upon publication shall beeffective as a regulation, publish in the Federal Register the nameand address of the applicant and the conditions and indications of useof the new animal drug. . . .' (emphasis added).

"Since the Secretary of H.E.W. followed the procedure set forthin § 360b(i) and since 21 C.F.R. 558 was not issued under the Secretary's discretionary rule-making authority, we find and concludethat Regulation 558 was valid and within his authority as merely apublication of the specification of new drugs upon which New AnimalDrug Applications had been approved.

"It is therefore ordered, adjudged and decreed that the motion ofthe Intervenor DeKalb AgResearch Inc. to dismiss the complaint forfailure to state a claim upon which relief can be granted is denied."

Ultimately, a consent decree of condemnation authorized releaseof the article to the claimant for bringing into compliance under FDAsupervision by means of the return of the article to the manufacturerwho agreed to ship the article only to a consignee who had furnishedthe manu fac tu re r w i t h an un revoked w r i t t en s ta temen t o r HEW notice. (F.D.C. No. 61380; S. No. 77-04-208; N.J. No. 31)

Premixes, medicated, at Lewisburg, S. Dist. Ohio.Charged 2-3-78: while held by Carl S. Akey, Inc., Lewisburg, Ohio(who manufactured the articles using sulfamethazine shipped in interstate commerce), the articles, which were labeled in part "UnitedShoat Fortifier 850 Medicated . . . Chlortetracycline . . . sulfamethazine . . . penicillin . . . Manufactured For United Feeds, Inc., Sheridan, Indiana," and "Premium Sulfa 20 [or "100") Medicated . . .Sulfamethazine . . . Manufactured By Carl S. Akey, Inc., Lewisburg,Ohio," were new animal drugs, and no approval of a New AnimalDrug Application was in effect with respect to their uses or intendeduses; 501(a)(5). Consent decree authorized destruction. (F.D.C. No.61544; S. No. 77-80-841; N.J. No. 32)

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

Diapulse electromagnetic energy generator, at Balch Springs, N. Dist. Tex.Charged 6-30-77: the labeling of the article, which had been manufactured by Diapulse Corp. of America, New Hyde Park, N.Y., failedto bear adequate directions for its intended purposes, and neitheradequate directions for lay use nor adequate information for use bylicensed practitioners could be provided; 502(f)(1). Default decreeordered destruction. (F.D.C. No. 61179; S. No. 77-21-559; N.J. No.33)

Diapulse electromagnetic energy generator, at Columbia, M. Dist. Tenn.Charged 1-4-73 and amended 10-31-77: when shipped by DiapulseCorp. of America, New Hyde Park. N.Y., the article's labeling wasfalse and misleading, its labeling lacked adequate directions for useand was not exempted, its labeling lacked adequate directions for usefor its intended purposes, and neither adequate directions for use noradequate information for use could be provided—502(a), 502(f)(1).The article was claimed by Dr. Ralph Meecc, D. P. M., Columbia,Tenn., who denied the charges. The Government served written interrogatories on the claimant. The claimant moved to dismiss theaction on the ground that the court lacked jurisdiction over the article.The Government moved for summary judgment. In denying bothmot ions, the cour t sa id:

FDA Consumer / April 1979 I 33

"Claimant's motion may be disposed of with little discussion. Claimant asserts that the subject seizure is iinproper and that 21 U.S.C. §334 is inapplicable since he is the ultimate consumer and owner ofthe Diapulse device. This position is without merit. Numerous courtshave sanctioned the seizure of proscribed medical paraphernalia fromthe ultimate user thereof. . . .

"The government's motion must also be denied. The court cannotsay, as it must if it is to grant summary judgment, that no issue ofmaterial fact exists in this case. A dispute remains as to whetherDiapulse is useful in treating disease and concomitantly as to whetherthe machine depends on tissue heating to achieve results. Moreover,the parties disagree concerning what labeling accompanied the devicewhen it was shipped and what the content of that labeling was. Theconflicts must be resolved by a trial on the merits."

Subsequently, the case was heard by the court without a jurv. Thecourt found that the article was misbranded as alleged in the amendedcomplaint and ordered the article destroyed if no notice of appeal wasfiled. The time for appeal expired, and'the court ordered the articledestroyed. (F.D.C. No. 58671; S. No. 7-002 F; N.J. No. 34)

Electrosedation sleep therapy devices, in-process devices, and components,at Euless, N. Dist . Tex.Charged 10-28-76: while held by Tri-Tronics Laboratory, Inc.. Euless, Tex., who was manufacturing the completed devices, the article'saccompanying booklets and reprints contained fal.se and misleadingclaims for nervous tension and stress, harmful tension, psychosomaticillnesses and insomnia, relief from pressures of daily living, reactivedepression, acute physical discomforts of bursitis, severe musclecramps, tennis elbow, ankylosis, neurosis, depression, high bloodpressure, peptic ulcer, and anxiety—5()2(a); the article's labelinglacked adequate directions for its intended uses and the article wasnot exempted, since neither adequate directions for lay use nor adequate information for use by licensed practitioners could be furnished—502(f)(1); and the article's labeling lacked adequate warningsagainst unsafe uses—502(f)(2). The articles were claimed by the manufacturer who denied the charges. A consent decree authorized releaseunder bond to the manufacturer for the purpose of salvaging thecomponent parts. However, the claimant was unable to post the required bond, and the court ordered that the articles be destrovcd(F.D.C. No. 60957; S. No. 77-15-158; N.J. No. 35)

NOTICE OF JUDGMENT on Probation ViolationFrancis S. Faro, treasurer of a bakery, Methuen, Dist. Mass.

Charged 2-27-78 in a probation revocation proceeding: flour was heldunder insanitary conditions in equipment accessible to insects and wascontaminated with insect filth; 402 (a)(3), 402(a)(4). The court foundthat a violation of probation had been committed and sentenced thedefendant to an additional year of probation. In accordance with anagreement between the parties prior to the hearing, the defendantwas also obligated to pay the costs of a designated FDA inspection.(F.D.C. No. 60440; S. No. 77-105-801 et al.; N.J. No. 36)

NOTICES OF JUDGMENT on Criminal Actions

F O O D

Thea Pastry, Inc., and Otto Strauss, president, and Walter Bachenheimer,N e w Yo r k , S . D i s t . N . Y.Charged 8-2-77; poppyseeds were held under insanitary conditionsm a building accessible to rodents and were contaminated with rodentfilth; 402(a)(3), 402(a)(4). Guilty pleas; fines. (F.D.C. No. 62()22- SNo. 76-43-181; N.J. No. 37)

Tower Hill Bakery Corp., Howard A. Puglise, president & treasurer, andAndrew J. Puglise, clerk, Lawrence, Dist. Mass.Charged 1-11-78 by grand jury: flour was held in a building accessibleto insects, was exposed to insect contamination in an insect-infestedflour conveyor system, and was contaminated with insect filth—402(a)(3), 402(a)(4); when shipped to Salem, N.H.. Golden CrustItalian bread, twist rolls, and French enriched bread had been prepared under insanitary conditions—402(a)(4). Guilty plea by corpo

ration; fine suspended. Guilty pleas by individuals; probation withspecial conditions that individuals not be in any way involved in anyfood establishment. (F.D.C. No. 61170; S. No. 77-93-367 et al.; N.J.No. 38)

NOTICE OF JUDGMENT on Injunction ActionSanfair Bakeries, Inc., and Gerald O. Claus, president. Fairbanks. Dist.

A l a s k a .

Charged 10-28-76 in complaint for injunction: that the defendantswere engaged at their bakery at Fairbanks, Alaska, in holding interstate flour for use in the manufacture of bakery products and in pre-Daring, packing, and holding bakery products, including bread, rolls,3uns, and sweet bakery products after interstate shipment of one ormore of their components; that the flour and bread contained insectfragments or insect larval cast skins; that the flour and bakery productshad been prepared, packed, and held under insanitary conditions;that FDA inspections of defendants' bakery disclosed a number ofspecified insanitary conditions and practices; that FDA laboratoryexamination confirmed insect filth in and around bakery processingequipment and in flour and bread samples; and that the defendantshad been warned on numerous occasions; 4()2(a)(3). 4()2(a)(4).

A consent decree of permanent injunction enjoined the complainedof violations and enjoined certain bakery operations unless and untilmeasures were taken to assure freedom from contamination and unlessand until the food on hand was deemed in compliance. (Inj. No. 748;S. No. 76-52-551 et al.; N.J. No. 39)

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

Regulations establishing warning statements for cosmetic products marketed in self-pressurized containers, Washington. Dist. Columbia.Charged 10-17-75 by Cosmetic. Toiletry and Fragrance Association.Inc. ("CTFA"), Washington, D.C.. against FDA (Commissioner Alexander Schmidt and the Food & Drug Administration: that CTFA wasa nonprofit membership association which included nearly 200 manufacturers and distributors of cosmetic products, many of which products were marketed in self-pressurizcd "aerosol" containers and weresubject to the regulations in issue; that, in view of the regulations'deadlines, many of plaintiff's members needed to begin shortiv toredesign their labels and product containers, necessitabng considerable monetary outlay as well as dramatic modifications in^he designand structure of many product containers; that only a prompt adjudication could spare many CTFA members from undergoing suchburdens unnecessarily; that the Commissioner's regulations requiredtwo sets of warnings on the labels of aerosol cosmetics; that the regulations had been promulgated despite the objections of CTFA andothers and despite CTFA's petition for reconsideration; that the Commissioner had not adduced, and the administrative record did notcontain, evidence which suggested that aerosolized fragrance productshad ever caused injury from deliberate misuse, did not contain evidence that, under normal conditions of household use. aerosolizedfragrances in packages not exceeding 4 ounces could present a hazarddue to spraying in the eyes, puncturing, breaking, incineration, storageat over 120°, or exposure to children; that the Commissioner hiRlacted arbitrarily and capriciously, and abused his di.scretion. in requiring such warnings and in requiring such warnings on the labels;that the language, structure, and legislative history of the FDC Actdistinguished between information which must appear on the labeland information which may be included in product labeling, and theCommissioner could not restrict the manufacturers' choice.

The Government moved for summary judgment. The plaintiff similarly moved for summary judgment in its own favor. The district courtruled in favor of the Government, saying:

"This case comes before the Court on the parties' cross motionsfor summary judgment. Plaintiff, a non-profit association whose members include nearly two hundred manufacturers and distributors ofcosmetic products, asks this Court to declare invalid certain regulations promulgated by the defendant Food and Drug Administrationon the ground that the regulations are arbitrary and capricious, d'heCourt has jurisdiction over the present matter pursuant to the jurisdictional provisions of the Administrative Procedure Act (APA). 5

34 /April 1979 i FDA Consumer

U.S.C. M 702-706, which provide a right of review to persons aggrieved by final agency action. Both parties agree that all availableadministrative remedies with respect to the Food and Drug Administration's final regulations have been exhausted.

'The regulations in question require that the following warningappear on the labels of all aerosolized food, drug, and cosmetic products: 21 C.F.R. § 740.11(a) Warning—Avoid spraying in eyes. Contents under pressure. Do not puncture or incinerate. Do not store attemperatures above 120° F. Keep out of reach of children.

"In addition, the regulations require that the following warningappear on the labels of all aerosolized food, drug, and cosmetic products which contain halocarbon or hydrocarbon propellants: 21 C.F.R.§ 740.11(b) Warning—Use only as directed. Intentional misuse bydeliberately concentrating and inhaling the contents can be harmfulor fatal. The regulations will become effective May 31, 1976.

"The administrative history of this case spans nearly three years.On March 7, 1973, the Commissioner of Food and Drugs publishednotice of proposed rulemaking in the Fhdhral Register (38 Fed.Reg. 6191) and invited public comment thereon, pursuant to 5 U.S.C.§ 553. On May 7, 1973, Cosmetic, Toiletry and Fragrance Association,Inc. (CTFA), the plaintiff herein, filed a letter of comment on theproposed rules. CTTA maintained, essentially, that the defendants*regulations were arbitrary and capricious in that the regulations failedto reflect a consideration of the specific nature of aerosol fragranceswhich, CTFA alleged, had no history of abuse. Final regulations werepromulgated on March 3, 1975, and published at 40 Fed. Reg. 8912-8917. On June 23, 1975, representatives of CTFA met with representatives of the Food and Drug Administration to discuss further objections to the final reguladons. Defendants recommended thatplaintiff file a petition for reconsideration. On June 27, 1975, defendants received CTFA's petition for reconsideration, or in the alternative, to amend the regulation. In a three-page letter dated August4, 1975, defendants denied CTFA's petition for reconsideration.

"The issues presented for review concern whether, in promulgatingthe regulations, the agency acted in an 'arbitrary and capricious' manner, 5 U.S.C. § 706(2)(A). Plaintiffs also contend that the Commissioner's requirement that all warning statements appear on the product'label' as opposed to anywhere on the product 'labeling', see 21 C.F.R.§§ 740.2, 740.11, is (a) beyond the statutory authority of the Commissioner, and (b) represents a clear error of judgment on the parto f t h e C o m m i s s i o n e r. F o r t h e r e a s o n s d i s c u s s e d b e l o w, t h e C o u r tfinds that the defendants' regulations were not promulgated in anarbitrary and capricious manner in that there is ample evidence in theadministrative record to support the Commissioner's assertion as tothe need for the warning requirements of 21 C.F.R. § 740.11(a) and(b). In addition, the Court finds that the Commissioner had the statutory authority to require that the warnings appear on the productlabel, and that the record reveals that said requirement was not aclear error of judgment. Plaintiff's motion for summary judgment isdenied and defendant's motion for summary judgment is herebygranted.

I. In Reviewing Informal Rulemaking, this Court Must Apply the'Arbitrary and Capricious' Standard.

"As an initial matter, the Court notes that while the parties agreethat the 'arbitrary and capricious' standard should be applied in reviewing the defendants' informal rulemaking in the instant case, see5 U.S.C. § 702(2)(A), they differ as to [the] meaning of that standard.In the case of Citizens to Preserve Overton Park v. Volpe, 401 U.S.402 (1971), Mr. Justice Marshall, for the Court, addressed this veryissue. . . . The court of appeals for this circuit has also addressed themeaning of 'arbitrary and capricious.' For example, in AutomotiveParts and Accessories As.sociation v. Boyd, 407 F.2d 330 (D.C. Cir.1968), Judge McGowan, for the court, held that the 'paramount objective [in judicial review of the informal rulemaking procedure] is tosee whether the agency, given an essentially legislative task to perform, has carried it out in a manner calculated to negate the dangersof arbitrariness and irrationality in the formulation of rules for generalapplication in the future.' 407 F.2d at 338. In this connection, according to Judge McGowan, 'Our function is to see only that the resultis reasonable and within the range of authority conveyed, that it hasbeen formulated in the manner prescribed, and that the disappointedhave had the opportunity provided by Congress to try to make their

views prevail.' 407 F.2d at 343. . . .II. Defendants' Regulations were not Promulgated in an Arbitrary

or Capricious Manner."Section 704(a) of the Food, Drug, and Cosmetic Act, 21 U.S.C.

§ 371(a), authorizes the Secretary of Health, Education, and Welfareto promulgate regulations for the efficient enforcement of the Act.This power has been delegated to the Commissioner of Food andDrugs. 21 C.F.R. § 2.120(a)(1). Section 201(n) of the Act, 21 U.S.C.§ 321(n), provides that the Commissioner may promulgate regulationswhen an article is alleged to be misbranded because the labeling isfalse or misleading. The regulations at issue in the instant case werepromulgated pursuant to section 201(n).

"CTFA alleges that under section 201(n), defendants can only require warnings to cure misbranded products if they show that: (1)those products present the hazards toward which the warnings aredirected; and (2) such hazards exist under the customary and usualconditions of use of those products. With respect to the 'intentionalmisuse' warning, 21 C.F.R. § 740.11(b), plaintiff's major contentionis that the Commissioner did not, as required, make a determinationthat the hazards presented by the customary and usual use of aerosolfood, drugs, and cosmetics in general existed for fragrances as well.With respect to the 'general' warning, 21 C.F.R. § 740.11(a), plaintiff'smajor contention is that there is not sufficient evidence in the administrative record to identify the alleged hazards and thereby justifythe warning. The Court disagrees with both of plaintiff's contentions.A. The 'intentional misuse' warning:

"As a threshold matter, the Court notes that it was not necessary,in the context of this case, for the Commissioner to make an individualized determination that the general hazard—intentional misuseof aerosol products—existed as to plaintiff's sub-category, aerosolfragrances. The Commissioner's authority to promulgate regulationsin the public interest for an entire category of products rather thanon a case-by-case basis is unquestioned. . . . Thus, at the outset, theCommissioner was responsible only for justifying the need for administrative action taken as to the general category of products. Inthe instant case, the administrative record is replete with findingswhich substantiate the dangers inherent in aerosolized products andthereby bear out the need for the warning in question.

"Once the Commissioner established a general justification for thewarning affecting the category of aerosol products, the burden fellupon plaintiff or other complaining parties to demonstrate that thesub-category of aerosol fragrances should not have been subject tothe intentional misuse warning. * * * The 'evidence' which wasbrought to the Commissioner's attention to justify the assertion thataerosol fragrances should not be included within the scope of thewarning consisted, essentially, of: a) an informal poll of CTFA's members showing that there is no history of abuse of aerosol fragranceproducts; and b) claims that aerosol fragrances are inherently notsubject to abuse because of their penetrating odor, customary use inthe facial area, high cost, and low propellant content. The Commissioner found, and this Court agrees, that 'inadequate data and information were presented to justify a conclusion that products should beexcluded from the warning statement requirement. . . .' 40 Fed. Reg.8914 (1975). The evidence presented by the plaintiff was not of theweighty and substantial sort as to justify consideration of the plaintiff'sproduct on an individual basis. ...

"Accordingly, the Court concludes that plaintiff did not sustain itsburden on the administrative level to present substantial evidencewhich would call for an individual determination of whether its productshould be excluded from the scope of the regulations.

"But, even assuming arguendo that the interests represented byplaintiff were entitled to an individualized determination, the recordreveals that the Commissioner spoke directly to most ot the contentions raised by plaintiff and other complaining parties. After concluding, as pointed out above, that 'inadequate data and informationwere presented to justify a conclusion that products should be excluded from the warning statement requirement solely for reasons ofpenetrating odor, low pressure, purchase price, or because the productis intended for use on or about the face, or is actually intended forinhalation,' the Commissioner went on to note that, in any case: 'Aproduct with a penetrating odor, for example, may be misused byactuating the container in an upside down position, which would allow

FDA Consumer / April 1979 i 35

only the propellant to escape and hence remove or greatly reduce theobjectionable odor. There is no reason why products intended for useon or around the face, or those intended for inhalation, may not bemisused intentionally and should therefore not be labeled accordingly.The warning statement does not speak against incidental inhalationor deliberate inhalation as directed. Its purpose is to warn againstintentional misuse and to inform the consumer of the possible consequences resulting from such misuse.' . . . Moreover, in response toa variety of comments to the effect that certain sub-category productsshould be excluded from the warning requirement because of lowpropellant content and/or no substantial likelihood that the productcontainer would allow for sufficient access to release harmful quantities of propellant, the Commissioner excluded a number of subcategory products with the requisite characteristics. . . . Thus, theassertion that the Commissioner ignored substantive comments is, inthe context of this case, 'belied by . . . the fact that the Commissioner. . . incorporated in the final regulations suggestions of . . . otherswho submitted comments.' Finally, while there must be a 'reasonedbasis for agency action,' informal rulemaking does not require 'a formal opinion specifically covering all rejected alternatives.' . . .The Court concludes that there was more than a reasoned basis forapplying the intentional misuse warning to all aerosol food, drug, andcosmetic products in the instant case, and that the Commissioner'saction was not 'arbitrary and capricious' within the meaning of thatterm as discussed in part 1, infra.B. The 'general' warning:

"CTFA objected to the general warning statement for self-pressurized containers .... However, this Court finds that the administrative record as well as the Commissioner's 'purpose and basis'clause set forth a rational basis for the Commissioner's findings.

"The gist of plaintiff's comments are addressed to the Commissioner's failure to demonstrate the hazards inherent in cosmetic fragrances. However, once defendant demonstrated a general justificationfor the warning to prevent the hazards of customary or usual use ofaerosolized food, drugs, and cosmetics, it was unnecessary for theCommissioner to make an individualized determination as' to aerosolized fragrances. And, it is clear from the administrative record thatthe general hazards were identified by the Commissioner. For example, in the 'Report of the Committee on Aerosol Toxicity,' a partof the record in this case, it was pointed out that 'one obvious hazardof a pressurized container is explosion. This hazard is compoundedby heat. Thus the basic warning is directed against puncturing thecontainer, storing in excessive heat and disposal by burning.' Withreference to the clause 'Avoid spraying in eyes,' the Committee reported that 'eyes and mucous membranes iriav be damaged if thespray is directed towards them at close range.' The administrativerecord also contains various other references to the hazards againstwhich the warning is directed.

"In fact, the contention that aerosol food, drugs, and cosmetics dopresent a hazard seems to have been a 'given' in the context of theadministrative record. Thus, even plaintiff's objections focused noton the need for the general warning, but rather on how the warningshould be applied. In this vein, the plaintiff submitted extensive comments in a letter dated May 7, 1973, indicating its preferences for thewording of the warning. In response, the Commissioner proved amenable to amending the proposed regulations. Specifically, plaintiffsuggested that the warning against spraying in the eves would not beappropriate for products not expelled'in spray form; 21 C.F.R. §740.11 (a)(4) allows manufacturers to delete the clause 'Avoid sprayingin eyes' if the product is not expelled as a spray. Plaintiff also commented that the clause 'Keep out of reach of children' was inappropriate for cosmetics intended for use by children. 21 C.F.R.§ 740.11(a)(2) was amended in response to plaintiff's comment toinclude the phrase 'except under adult supervision.' Finally, pursuantto yet another of plaintiff's suggestions, the Commissioner ruled thatin the case of products manufactured in glass containers, the word'break' can be substituted for the word 'puncture.'

"It is the opinion of this Court that the foregoing more than adequately illustrates both the Commissioner's good faith considerationof plaintiff's comments and the reasonable and non-arbitrary mannerin which the regulations, supported by the administrative record, werepromulgated.

111. The Commissioner had the Statutory Authoritv to Require thatthe Warnings in Question Appear on the Product Label, andhis Decision to so Require was not a Clear Error of Judgment.

"Sections 602(a) and 201(n) of the Food, Drug, and Cosmetic Act,21 U.S.C. § 362(a) and 21 U.S.C. § 321(n) provide that a productshall be deemed misbranded if its 'labeling' appears false or misleadingin any particular. Pursuant to his broad statutory powers to promulgateregulations for the efficient enforcement of the Act, 21 U.S.C. ^371(a), the Commissioner, in promulgating the regulations at issue,has required that the warning statements appear on the immediatelabel 01 the product rather than anywhere on the product's packaging.Plaintiff contends that the Commissioner's authority extends only tocorrecting misbranded 'labeling' (i.e. packaging) and, therefore, thatthe requirement that warnings appear on the immediate label is notwithin the scope of the Commissioner's statutory powers.

"Plaintiff's interpretation of the word 'labeling' within the contextof 21 U.S.C. §§ 321(k) and (m) is too restrictive. ... it is clear to thisCourt that the term 'labeling' includes 'labels' and, to correct anymisbranding, the Commissioner has the authority to require that thewarnings appear on the immediate label of the product. Such aninterpretation is consistent with the Commissioner's statutory mandateto promulgate regulations for the efficient enforcement of the Act.The Supreme Court has indicated that 'when faced with a problemof statutory construction, this Court shows great deference to theinterpretation given the statute by the officers or agency charged withits administration.' Udall v. Tallum, 380 U.S. I, 16 (1965).

"P la in t i f f s a l so con tend tha t , even i f t he Commiss ione r had t hestatutory authority to require that the warnings appear on the productlabel, his decision to that effect was a clear error of judgment andtherefore arbitrary and capricious. This Court finds, however, thatthe Commissioner's decision was supported by the record.

"Plaintiff's major contentions in this area, as'expressed to the Commissioner in a letter dated June 27, 1975, which is a part of theadministrative record, are that the Commissioner's decision to requirewarnings to appear on the labels, as opposed to a decision requiringa 'hangtag' on the packaging, will cause the fragrance industrv severeeconomic burden and will lead to the destruction of the aesthetic valueof the industry's product packaging (which consumers have come torecognize). In responding to the plaintiff's contentions, the Commissioner wrote that 'the reasonableness of this requirement is apparentfrom the nature of the warning. Part of the required warning relatesto the proper storage of these products; it is obviouslv appropriatethat such storage warnings be available throughout the'full period ofuse of the product.' As to the aesthetics of the container, the Com-rnissioner's response was that such concerns were outweighed by considerations of public health.

I V. C o n c l u s i o n"The Court finds that defendants' regulations were properly pro

mulgated under the Commissioner's authority pursuant to 21 U.S.C.§ 371(a). The Court further finds that the regulations are neitherarbitrary nor capricious. Therefore, the plaintiff's motion for summaryjudgment is denied and defendants' motion for summary judgmentis hereby granted in accordance with the findings of fact 'and conclusions of law set forth herein and the order entered of even dateh e r e w i t h . "

The plaintiff appealed. Upon appeal, the Court of Appeals for theDistrict of Columbia heard the action on the record on appeal andconsidered the issues presented. The judgment of the District Courtwas affirmed without an opinion. (Misc. No. 315; N.J. No. 40)

Notices of Judgment are given pursuant to section 705 of the FederalFood, Drug, and Cosmetic Act. Notices of Judgment report casesinvolving seizure proceedings, criminal proceedings, and injunctionproceedings. Seizure proceedings are civil actions taken against goodsalleged to be in violation, and criminal and injunction proceedings areagainst .//>wA' or individuals charged to be responsible for violations.The cases generally involve foods, drugs, devices, or cosmetics whichwere alleged to be adulterated or misbranded or otherwise violative ofthe law when introduced into and while in interstate commerce, orwhile held for sale after shipment in interstate commerce.

Notices of Judgment are prepared by Food and Drug Division, Officeof the General Counsel, HEW.

Published by direction of the Secretary of Health, Education, andW e l f a r e .

Donald Kennedy, Commissioner of Food and DrugsWashington, D.C., April I, 1979

36 i April 1979 / FDA Consumer ☆ U.S. GOVERNMENT PRINTING OFFICE: 1979-281-272/24

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