MARCH 1974 NSUMER.

"mbatting ug "use e Government's mandate under the mprehensive Drug Abuse Preven , and Control Act of 1970 is to re se the frightening and expanding

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trend of recent years in the indiscrim inate, excessive, or illicit use of chem ical substances that alter the mind, behavior, or health of the abuser. It is a phenomenon that has touched all parts of our society. .. . C Co28 8 Z Z & Co4-coo a |||||| FLDOO3OOO90 This Month

an your kitchen pass the food storage test? We’ll ( bet most kitchens can’t. This month, FDA CON SUMER takes a tour through a kitchen to point out the main food storage problems. We hope you’ll use the information in the article to go over your own kitchen and correct the deficiencies you find. This month, FDA CONSUMER continues its effort to inform the public about vitamins. “Myths of Vitamins” describes some of the false or inaccurate qualities some people have claimed for vitamins, and what the scien tific evidence actually shows. In a few months, we’ll present “A Primer on Vitamins,” which will look at the same subject from another viewpoint. “Combatting Drug Abuse” describes FDA's con tribution to the Federal Government's fight against the abuse of legitimate and illicit drugs. FDA is not the en forcement arm of the Federal Government in this im

portant area, but its recommendations to the Drug En forcement Administration and its other activities are

important elements in the Government's program.

The word “recall” has become familiar to every con

sumer in the past decade. But many misconceptions

exist about them and FDA's role in food and drug re calls. “How Defective Products Are Recalled” tells you exactly what recalls are, when and why they’re made,

who makes them, the three kinds of recalls, and how the recall tool fits into overall consumer protection.

FDA Consumer-March 1974 / 1 t might be well for me to summarize the s consumerism has become a new and “I general philosophy with which I approach “A powerful force in the marketplace, my job as Commissioner of Food and Drugs. Government agencies have constructively re “First of all, I intend to be guided by the basic sponded to rightful demands by the new consumer premise that FDA is a scientific regulatory agency movement, and have often anticipated what some with a single responsibility—consumer health and of these demands and requirements might be. safety. We are a regulatory agency by law, a scien “The larger function of Government, however, tific agency by necessity, and a consumer protec should be to do more than react. It should be to tion agency by design. better understand the context within which the “I am convinced that for the FDA to serve the smaller situation has developed, and then to deal consumer most effectively, we must continue to with that larger context. This is especially true of broaden the base of expertise and advice upon the regulatory agencies, among them, the Food which our regulatory programs are erected. This and Drug Administration. expertise and this advice must be brought to bear “The FDA was once little more than an inspec across the boundaries of bureaucracy and across tion agency with certain police powers which it the barriers which separate the public and the exercised with varying effectiveness. It is now a private sectors. scientific, regulatory agency that draws on expert “As you may have heard, one way we are assur talent from throughout the country to assure the ing the close working of the private and public safety of the Nation's food and drug supplies. It worlds is to utilize more advisory committees, has had new authorities given it by the Congress

seeking their advice more often and earlier than which have greatly increased its responsibilities

heretofore. We will also seek out and use scien and the requirements made of it.

tific expertise, adding it to our own in order to “The FDA also operated in earlier times behind build the best scientific base we can for our actions. a screen that kept the public removed from the time, “At the same the consumer must be heard. Agency, whereas today it is open not only to pub

He must know why and how and if we in the FDA lic scrutiny but also to public participation in its

are acting in his best interest. And if he is to know, decision-making. Most of these changes have oc

the consumer must have the same opportunity as curred within the past 5 years.

industry to participate in regulatory decision “In the course of making these changes, many making. As you know, we are moving in a number bureaucratic traditions have been discarded. Such

of specific ways to ensure consumer access to our traditions tend to accumulate in a bureaucracy,

process of decision-making as well as our decision even as the outside world may be changing.

makers.” Bureaucracies, of course, exist in Government, in

dustry, and elsewhere, and all must, from time to Alexander M. Schmidt, M.D., Commissioner of Food and time, undergo fundamental revision. This the Drugs, group before the food of the American Frozen Food and Drug Administration has recently ac Food Institute, Washington, D.C., January 9, 1974.

complished, again in a process accelerated by the new consumerism. And the FDA which has

emerged is appropriate to the times, even as the

earlier style of the Agency may have been what those times required.”

Sherwin Gardner, deputy commissioner, Food and Drug Administration, before the New York State Bar As sociation annual meeting, New York City, January 23, 1974.

2 / March 1974 / FDA Consumer (FDA Caspar W. Weinberger Secretary, U.S. Department of ONSUMER. Health, Education, and Welfare VOL. 8, NO. 2-MARCH 1974

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

Alexander M. Schmidt, M.D. Commissioner of Food and Drugs

John T. Walden Acting Asst. Commissioner for Public Affairs

Wayne L. Pines-Editor

Harold C. Hopkins-Editorial Director

Jesse R. Nichols-Art Director

Joan M. Galloway-Managing Editor Myths of Vitamins 4

Frederick L. Townshend-Production Mgr.

FDA CONSUMER, the official magazine of the Combatting Drug Abuse 10 Food and Drug Administration, is published monthly, except for combined July-August and December-January issues. Subscriptions may be ordered from the Superintendent of Documents, Government Printing Office, Washington, D.C. How Defective Products Are Recalled 15 20402, at $5.30 a year ($1.35 additional for foreign mailing).

Address for editorial matters: FDA CONSUMER, HFI-20, Food and Drug Admin istration, 5600 Fishers Lane, Rockville, Md. Pass the Storage 20 20852. Can Your Kitchen Food Test?

Articles published in FDA CONSUMER are in the public domain and text may be repub lished without permission. Use of funds for printing publication approved by this the News Highlights 26 Office of Management and Budget November 1, 1972.

FDA CONSUMER was previously known as FDA PAPERS. Regional Reports 28 Section 705 [375] of the Food, Drug, and Cosmetic Act:

(a) The Secretary shall cause to be published from time to time reports summarizing all State Actions 32 judgments, decrees, and court orders which have been rendered under this Act, including the nature of charge and the disposition thereof.

(b) The Secretary may also cause to be regarding food, drugs, disseminated information Seizures and Postal Service Cases 33 devices, or cosmetics in situations involving, in the opinion of the Secretary, imminent danger to health, or gross deception of the consumer. Nothing in this section shall be construed to prohibit the Secretary from collecting, reporting, and illustrating the results of the Notices of Judgment 36 investigations of the Department.

FDA Consumer-March 1974 / 3 Myths Of Vitami

In today's health-conscious “Consumers should know that society, many Americans hold elaborate testimonials and myths about the proper role miraculous claims result of vitamins. While vitamins are from mere guesswork, essential for good health, confusion, and often excessive amounts are outright fraud.” unnecessary and can be harmful.

by Jane Heenan

nce a day, “just to be sure,” millions of Americans take a multivitamin pill. Then, when cold season comes around, some stock up on vitamin C. Others whose sex lives seem to be lagging may reach for vitamin E, with the added hope that it will stave off heart disease. And if all these vitamins don't prevent that “rundown feeling,” they might try a little—or a lot—of all the vitamins, with an added boost of vitamin B12. According to some of the latest “literature” appearing in books by nutrition “experts” and in magazine articles, this sort of therapy should do the trick. But as millions of Americans now know, it doesn’t necessarily mean you can even win a tennis match. And as a 4-year-old boy in Kansas will never forget, taking a whole bottle of 40 children’s vitamins at once won't help him grow stronger, faster. He spent the following 2 days in intensive care with vitamin A and iron poisoning. His experience was added to the statistics compiled by FDA's National Clearinghouse for Poison Control Centers which reveal that 4,000 cases of vitamin poisonings are reported each year,

4 / March 1974 / FDA Consumer with some 3,200 involving children. Sure,” takes a vitamin-mineral Other Americans, with rashes, supplement every day. “Some of the myths have been diarrhea, or headaches, may also This is the way we have come with us so long they’re difficult be unwary victims of the belief that to expect the marketing of dietary to distinguish from fact.” since vitamins are good for them, supplements. They are promoted as the more the better. an “insurance” policy to guarantee Of course, this is just one of the good health. The implication of many myths about vitamins that is such advertising has contributed accepted by many health-conscious to the myth that even a balanced Americans. Some of the myths diet cannot provide adequate have been with us so long they're nutrients. difficult to distinguish from fact. Some people have gone further For instance, many people will and maintain that modern farming tell you that vitamins provide extra methods have depleted the soil energy. False. Some of the B and that food itself no longer vitamins do aid in the conversion contains adequate nutrients. of food to usable energy, but in This is untrue. More is known amounts greater than the U.S. about the nutrient content of food Recommended Daily Allowance today than ever before. And more (U.S. RDA), they provide nothing is done, through modern farm of value. Only people with a practices, to protect and enrich the relatively rare medically diagnosed soil than was even known about A --> deficiency of a vitamin would in the good old days. Crop rotation," benefit from an amount greater Soil tests, and routine enrichment than the U.S. RDA levels. of crop soil were developed FDA has promulgated because the oft-revered “natural” regulations which are designed way of farming was quantitatively to prohibit false and misleading and qualitatively unreliable. promotional and labeling claims In addition, the protein, about vitamins and minerals, and carbohydrate, fat, fiber, and to distinguish between vitamins and vitamins are controlled primarily minerals that are dietary by the plant's genetic structure, supplements, and those that should not by the soil. Excess mineral be sold as drugs. (See “Vitamins, elements in soil beyond the plant's Minerals, and FDA,” requirements may be reflected in FDA CONSUMER, September the plants, but these differences are 1973.) Still, educational efforts usually small. Both desirable are required for the public to be (magnesium, zinc, iron, etc.) and able to know what vitamins can, undesirable (lead, cadmium, and cannot, accomplish. selenium, etc.) elements are similarly accumulated. The Daily Multi-Myth A balanced diet which generally An advertisement on television meets the U.S. RDA requirements shows a person explaining how he for vitamins A, B1, B2, C, and stays healthy and looking “great.” D will nearly always provide the He says he watches his diet, gets needed amounts of other vitamins, plenty of exercise, and, “just to be despite the claims of some people

FDA Consumer / March 1974 / 5 that these other vitamins are hard heart attacks, protect against air to find and therefore must be eaten pollution, and slow the aging “Many people will tell you that special by pill. process. virtually provide energy. in foods or taken But there is no vitamins extra proof majority False.” Even though eating is a personal scientific for the thing and the acceptability of foods of these claims. varies from person to person, it In fact, the new interest in E has is possible to obtain the U.S. been based on misinterpretations Recommended Daily Allowance of animal research studies: Male (U.S. RDA) in many different diet rats that deliberately had been patterns because of the wide variety deprived of dietary sources of of foods containing similar vitamin E became sterile, but the nutrients. But the simplest, surest use of large doses in treating human guide to follow for a good daily sterility or impotence has not balance of nutrients is still the been successful. Similarly, it is selection of foods from each of known that E is essential to four larger groups—milk, meat, maintain pregnancy, but it has not vegetable-fruit, and bread-cereal. been found to be a factor There are substances in food in fertility. which some “experts” glibly term One reason so little is known vitamins although they are of no about vitamin E is that E deficiency importance in the diet for human is almost impossible to produce in nutrition. Examples are inositol, human subjects. To withdraw all PABA (para-aminobenzoic acid), sources of vitamin E is almost to itself, citrus bioflavonoid complex, withdraw food since the hesperidin, and rutin. Many vitamin is present to some extent companies have marketed these in most foods and in large amounts substances individually or in in vegetable fats and oils. combination with essential vitamins. Discovered about 50 years ago, but consumers should not be the vitamin has also been described misled by claims for them that as a cure, preventive, or treatment ignore the fact that their absence of cancer, muscular dystrophy, from the diet does not cause a ulcers, burns, and skin disorders. disease or any form of illness. Again, science does not back this Foods can and do supply most up. In muscular dystrophy patients, Americans with adequate nutrients, for example, no deficiency of vitamin has been found and and consumers should not expect E any major physical benefits from large-dosage treatments have multivitamin pills, contrary been ineffective. to the myth. The vitamin has been used in some cosmetics for its antioxidant Much Ado About E properties, but one popular new Vitamin E supplements have been deodorant containing E was recalled found useful in only two conditions last year when widespread incidence —in premature babies who because of severe rashes were reported of poor placental transfer may after use. have received too little of the vitamin before birth, and in persons C for Colds? with intestinal disorders in which James Lind, surgeon's mate on the fats are poorly absorbed. H.M.S. Salisbury, and “the father This view by the National of nautical medicine,” conducted Academy of Sciences Committee the first properly controlled clinical on Nutritional Misinformation is therapeutic trial on record in 1747. vastly different from claims that Aboard ship, his experiment have more than doubled the sales determined the value of citrus fruit of vitamin E in the last 5 years. in the prevention and cure Among the latter claims are of scurvy. assertions that the vitamin can Forty-two years later, the Royal promote physical endurance, Navy adopted the administration enhance sexual potency, prevent of 1 ounce of lemon juice to

6-March 1973 / FDA Consumer each man each day. It wiped out studies, subjects who believed they B Vitamins

A common belief about B vitamins scurvy in the Royal Navy and were being given C but who were its to preserved numbers the extent actually receiving inert tablets is that the old “rundown feeling” C is that vitamin credited with reported fewer colds than they can easily be overcome by vitamin supplements. as as having done much Lord expected to have, and, in some B12 But unless there

to power is actually a deficiency—which is Nelson break the cases, those taking C reported

of Napoleon. no change. extremely rare—amounts beyond

So began the recorded and Some research has indicated the U.S. RDA will not be of any C,

gradual recognition of vitamin difficulties associated with large benefit to the body, and any

which was isolated and so named C, to doses of including kidney stones, apparent effect has been shown in 1933. severe diarrhea, and possible harm be psychological. In the case where is Today, these things are known to diabetics. Also, because the vitamin B12 treatment

C: It helps body a about hold cells body does pass off excesses of recommended, when person C, together and strengthens blood vitamin its presence in the urine actually cannot absorb the vitamin

vessels; it helps wounds; it testing heal makes accurate for diabetes properly, the treatment must be helps formation; tooth and bone impossible, since it gives a false carried out through injections, and

and it helps in resistance indication of sugar levels. At this it is relatively ineffective when to infection. point, unless a physician has administered orally.

It is also known that C does not diagnosed vitamin C deficiency, Another exotic claim for vitamins or is to cure prevent colds. The claims the safe, practical course get involves pantothenic acid and is

that C lessens the number and Daily the U.S. Recommended also based on misinterpretation of of severity colds remains Allowance of 60 milligrams per animal experiments. When a severe controversial, for in several clinical day (see table). deficiency was produced

“Foods can and do supply most Americans with adequate nutrients, and consumers should © not expect any major physical benefits from multivitamin pills, ",

contrary to the myth.” /

FDA Consumer-March 1974 / 7 deliberately in male rats, their any way between a vitamin from Vitamins A and D Toxicity hair turned grey, and when the a plant or animal and the same Vitamins A and D were the first process was reversed, the color was vitamin from a laboratory. Only the to explode the myth that vitamins restored. From this, some “experts” pocketbook “knows for sure.” are not toxic when administered have deduced that deficiencies of Perhaps even more revealing is in doses beyond body requirements. pantothenic acid are responsible for that some synthetic ingredients Excessive amounts of vitamin greying hair in humans. Although many persons are trying to avoid A taken over long periods can greying hair may occur because of today are also present in the increase pressure within the severe deficiency, grey hair per se “natural” products. In processing human skull and may mimic a does not mean a deficiency, since tablets and capsules, vitamin brain tumor. In fact, one teenager there are many other reasons manufacturers must use excipients actually was hospitalized and for the condition. Clinical and binders, such as ethyl cellulose, prepared for brain surgery only to deficiencies in man are truly rare. Polysorbate 80 (a synthetic find out the trouble was simply an There has been no discovery so far emulsifier), as well as gum overdose of vitamin A. Large doses to prevent grey hair. acacia, etc. of this vitamin taken over Skimping on protein and So it comes back down to some extended periods have also been overcooking vegetables in water basic rules about eating. Your known to retard growth in children will cut back on the amount of B body not only needs vitamins and cause dry and cracked skin, vitamins in a diet. But a rush for and other nutrients, it needs the headaches, bone pain, and other vitamin pills or expensive brewer's bulk and textures of real food. symptoms in fact, almost the yeast does more damage to the And it needs a balance of those budget and offers far fewer benefits foods, a balance that may not be to health than consuming a provided in fad dieting or in an proper selection of foods endless array of tablets carefully prepared. and capsules.

Natural vs. Synthetic “Getting back to nature” can sometimes be an expensive trip— “The implication of advertising especially when you wind up has contributed to the myth where you started. Such is the case that even a balanced diet - for persons paying close to $5 for cannot provide adequate 100 tablets of vitamin C “from nutrients.” pure rose hips,” from acerola cherries, or for a host of combinations with natural but ungermane ingredients, such as honey, when the same amount of pure ascorbic acid can be bought for under $1. Two major fallacies lie behind the rush for so-called “natural” vitamins: (1) Natural vitamins are superior to those synthesized by man; (2) vitamin products sold as “natural” don’t contain synthetic ingredients. In truth, each vitamin has a particular molecular structure that remains the same whether it’s synthesized in a laboratory or extracted from an animal or plant or consumed as part of an animal or plant. To be called “vitamin A,” for example, there has to be a specific molecular arrangement that is identical no matter where it is found or how it is derived. The body cannot distinguish in

8-March 1974 / FDA Consumer same symptoms as for a severe vitamins E, C, and folic acid, have strawberries, cantaloupe, cabbage, deficiency. also been reported recently. For broccoli, kale, potatoes. instance, Excessive doses of vitamin D there is evidence of Folic acid—Widespread in foods. has been known to retard mental a possible antagonistic effect of Liver, kidney, yeast, deep green as well as physical growth in high intake levels of vitamin C on leafy vegetables are children. It can also cause nausea, the nutritional status of A. highest sources. weakness, stiffness, constipation, As research continues, there will Thiamine—Pork, liver, and other hypertension, and even death. be more answers as to how much organs, brewer’s yeast, wheat germ, Because of this, FDA prohibits, is too much of a vitamin, what whole-grain cereals and breads, except by prescription, any daily the entire scope of usefulness of enriched cereals and breads, recommended intake of a tablet or each vitamin is, and which medical soybeans, peanuts, and other

capsule of more than 10,000 conditions may respond well to legumes, milk.

International Units (IU) of vitamin vitamin therapy. In the meantime, Riboflavin—Milk, powdered whey, A and 400 of vitamin D. While consumers should know that liver, kidney, heart, meats, eggs, this in no way prevents the elaborate testimonials, miraculous green leafy vegetables, dried yeast, consumer from taking as much claims, and vitamins supposedly enriched foods. as he chooses at any one time, derived from exotic sources result Niacin—Lean meat, fish, poultry, it does control the strength and from mere guesswork, confusion, liver, kidney, whole-grain and labeling for each package. and, often, outright fraud. enriched cereals and breads, (See “New Regulations on green vegetables, peanuts, Vitamins A and D,” Best Sources brewer's yeast. FDA CoNSUMER, October 1973.) Vitamin A–Fish-liver oils, liver, Vitamin Bo—Wheat germ, meat, From this regulatory action a butter, cream, whole milk, liver, kidney, whole-grain cereals, new myth may have arisen: That all whole-milk cheeses, egg yolk, soybeans, peanuts, corn. vitamins are nontoxic except for dark green leafy vegetables, yellow Vitamin B12—Amply provided by fact, A and D. In the correct vegetables, yellow fruits, small daily intakes of interpretation of this action is that fortified products. animal protein. the only conclusive, actionable Vitamin D—Fish-liver oils, fortified Biotin—Liver, sweetbreads, yeast, proof of toxicity so far is with milk, activated sterols, exposure eggs, legumes. excessive and D. Medical Pantothenic acid—Almost A to sunlight. libraries contain numerous Vitamin tissues—Wheat E—Plant universally present in plant and references to adverse side effects germ oil, vegetable oils (such as animal tissue. Liver, kidney, yeast, from ingestion of high levels of soybean, corn, and cottonseed), eggs, peanuts, whole-grain cereals, niacin or vitamin C. In addition, nuts, legumes. beef, tomatoes, broccoli, salmon. the interaction of nutrients within Vitamin K—Green leaves such as Choline—Egg yolk is best source. the body is affected by high intakes spinach, cabbage; cauliflower, Liver, heart, sweetbreads, milk, of certain vitamins and minerals. and liver. meats, nuts, cereals, Other problems, involving Vitamin C–Citrus fruits, tomatoes, vegetables, soybeans.

— U.S. RDA’s For Vitamins –

Adults and Pregnant or

Unit of Children under children 4 or lactating meaSurement Infants WOIT1CI1

4 years of age more years of age

Vitamin A International 1,500 2,500 5,000 8,000 units Vitamin D ** 400 400 400 400 2’ E Vitamin 5 10 30 30

Vitamin C Milligrams 35 40 60 60 2’ Folic acid 0.1 0.2 0.4 0.8 ” Thiamine 0.5 0.7 1.5 1.7 ” Riboflavin 0.6 0.8 1.7 2.0 3’

Niacin 8 9 20 20 2’ Vitamin Bo 0.4 0.7 2.0 2.5 3 6 Vitamin B12 Micrograms 2 8 Biotin Milligrams 0.15 0.15 0.30 0.30 ” 5 Pantothenic acid 3 10 10

FDA Consumer-March 1974/9 Combatting Drug Abuse

by Harold C. Hopkins and Edward C. Tocus, Ph.D. FDA plays an important role in the Federal Government's

effort to bring drug abuse under control.

increase in the misuse of mind-alter he widespread abuse of drugs, FDA is responsible for determining

which at times in the past dec acceptable methods for treatment of ing drugs among young people in ade reached epidemic proportions narcotic addiction, and authorizing the 1960's—has been laid to a num ber of causes. Much of the and brought tragedy to many indi researchers to protect the identity of Govern viduals and their families, is being research patients. FDA thus regu ment’s effort has been directed to

brought under control by a Federal lates methadone maintenance pro ward alleviating or eliminating them Government effort in which FDA grams for treatment of heroin addic through social, health, rehabilita or plays a major role. tion (see “Getting a Handle on tion, educational programs. The Agency’s knowledge of drugs, Methadone,” FDA CoNSUMER, Sep But two things have been com its storehouse of information about tember 1973). mon to all epidemics involving abuse of a its

its drug: availability existing and new drugs, and ex- Broadly defined, drug abuse is on the

market, it perience in drug regulation are vital the use of any drug in a way or to and the ease with which

in the Government’s methodical an extent that harms the health of could be obtained for nontherapeu by it or

person using tic A campaign to remove one of the most the threatens the purposes. 1970 report the Committee on Interstate and or of in House pernicious threats of modern times health welfare society. But to the health and welfare of our so the sense contemplated by the 1970 Foreign Commerce estimated, for

instance, as of ciety. law, the term is associated with drugs that late 1969 almost Government’s mandate The un that alter a person’s mood by acting half the amphetamines and barbitu

der the Comprehensive Drug Abuse on his central nervous system. rates produced legitimately in the and 1970 Prevention Control of to Act Most of these drug actions can country were being diverted illi cit use. be in of is to reverse the frightening and ex beneficial certain types ther

panding trend of recent years in the apeutic or experimental treatment, Congress had dealt with the abuse

indiscriminate, excessive, or illicit but they also can be harmful when of narcotics in the past, beginning use of chemical substances that with the Harrison Narcotic Act of al the drug is abused. These drug ac

mind, behavior, or of ter the health tions are narcotic, hypnotic, seda 1914. In subsequent legislation,

the abuser. It is a phenomenon that tive, depressant, antidepressant, cen notably the Drug Abuse Control

has touched all parts of our society tral stimulant, anorexigenic (appe Amendments of 1965, Congress to to and led such descriptive catch tite supressant), euphoriant, or hal turned its attention other drugs of abuse. words as “flower children,” “drug lucinogenic. Alcoholic beverages and subculture,” “turned-on genera tobacco are specifically excluded But the Comprehensive Drug tion.” from the legal definition. Abuse Prevention and Control Under the Controlled Substances Most drugs that have shown po Act of 1970—enacted in response

Act, II of law, recog Title the 1970 the tential for abuse also have to public concern about the alarm

or uses,

Secretary of Health, Education, and nized medical scientific and ing increase in use of “mind-bend by is charged providing many in Welfare with are considered essential ing” drugs young people—was a medical and scientific information Therefore, modern health care. declaration of war on abuse or po and recommendations to the Justice information and recommendations tential abuse of all existing or future Department’s Drug Enforce provided by FDA are particularly drugs. Its purposes, scope, and ef prevention ment Administration for significant, since legitimate medical fect are comprehensive in every needs and available sense of the word. of drug abuse and the control of all information

these drugs. Since November 1972, on abuse and dependency potential Significant sections relating to II, be at in FDA has been the DHEW agency must looked determining FDA's responsibilities in Title Act, responsible for collecting this data, just how far a drug should be con the Controlled Substances clas trolled. incorporating suggestions from other sify drugs for control or restrictions agencies. DHEW The rise of drug abuse over the on use according to the problems

part of law, Under another the years—and especially the dramatic they present as a result of abuse or

FDA Consumer-March 1974 / 11 “Two things have been common to all epidemics involving abuse of a drug: its availability on the market, and the ease with which it could be obtained.”

abuse potential; establish production ing in scientific and medical mat amobarbital, and secobarbital were ters. If FDA recommends that a quotas or import requirements for added to Schedule II. Drugs in

certain of these drugs to keep un drug not be controlled, its recom Schedule II are considerably more in needed supplies off the market; and mendation is binding on DEA. restricted manufacturing and dis provide authority qual tribution, prescription procedures, to determine If a company wishes to challenge ifications and establish standards for physical security requirements a DEA ruling in regard to sched and

any ongoing drugs in research with those uling a drug, it is entitled to an ad than the lower schedules.

drugs recog drugs a poten for which there is no ministrative hearing. After such a Schedule III have

therapeutic tial for abuse less than those in nized or scientific use. hearing, a hearing examiner then in these areas are FDA's functions may to renders a decision, which can be ap Schedule II. Abuse lead

advisory to the Justice Department's pealed. moderate or low physical or high Drug Administration, psychological dependence. Enforcement The five categories or schedules Exam

primary responsibility ples of drugs in which has for of drugs provided by the Controlled this class are nalor enforcing the 1970 legislation. But Substances Act: phine, phencyclidine, and methypry performs lon. Also included are limited FDA also several other ba Schedule I drugs have a high po

sic functions under the Food, Drug, tential for abuse and have no cur amounts of codeine, morphine, and and Cosmetic Act which are neces certain of their derivatives combined rently accepted medical use in treat

sary to the implementation of the ment in the United States. (A Sched with other medicaments. a newer legislation. ule I drug may be capable of leading Schedule IV drugs have low po Under the Controlled Substances to severe dependency or to little or tential for abuse compared to drugs

Act, FDA, upon request by DEA, no dependency.) However, these in Schedule III. Abuse may lead to makes a scientific and medical eval drugs can be used by qualified re limited physical or psychological

uation of a drug after gathering the searchers under protocols approved dependence compared to drugs in

necessary information, and recom by FDA, the Alcohol, Drug Abuse, Schedule III. Examples of Schedule mends to DEA whether it should be and Mental Health Administration, IV drugs are barbital, phenobarbi controlled, removed from control and their Joint Drug Abuse Re tal, chloral hydrate, paraldehyde,

entirely, or moved from one sched search Advisory Committee, a group and meprobamate. ule to another. of outside experts on drug abuse. Schedule V lists drugs with lower places drugs subject dependency potential DEA to Examples of Schedule I drugs are abuse and

abuse into five categories or “sched LSD, mescaline, peyote, marihuana, than those in Schedule IV. Under ules” for varying controls on distri tetrahydro cannabinols (active prin this schedule are small amounts of bution. This scheduled control is opium ciples of marihuana), and heroin. codeine and and their deriva

diphenoxylate, in based on the drug's potential for Most of the drugs in the remain tives and each abuse; known drug effects; history ing four schedules have established case when combined with nonnar

and current patterns of abuse; risk medical uses in the United States. cotic medicinal ingredients.

public abuse; is to the health from and Schedule II drugs have a high po FDA responsible for determin tential for abuse and have an psychic or physiological dependence ac ing medical and scientific needs to

liability. cepted medical use with severe re be considered by DEA in setting any drug DEA can add to a sched strictions. Abuse of these drugs may production quotas and importation

ule, move a drug from one schedule lead to severe psychological or phys requirements for drugs in Schedule another, any drug to or remove from ical dependence. Examples are opi I and II. DEA over many years has any gathering as of the schedules after um and opiates such morphine, developed a production-import quo

data, including as relevant a scientific synthetic narcotics such metha ta system for drugs with abuse po and medical evaluation by FDA and done and meperidine, other drugs tential, assessing legitimate medical

FDA's recommendation as to wheth such as cocaine, and stimulants and scientific needs through consul er be and the tation with has not it should controlled such as amphetamine, methamphet DHEW. FDA control, extent of or whether it amine, and methylphenidate. Re found it necessary to reassess these should be removed from control. cently methaqualone and the short needs except for drugs recently

FDA's recommendations are bind acting barbiturates pentobarbital, added to Schedules I or II.

12 / March 1974 / FDA Consumer “The Comprehensive Drug Abuse Prevention and Control

Act of 1970 . . . was a declaration

of war on abuse or potential

abuse. . . .” to FDA is charged with determining In 1970, FDA, concerned with moved from Schedule III II. This

the qualifications of researchers and the abuse and dependency potential was done by DEA in the same year. of evaluating the research protocols for amphetamines and methamphet These actions brought a sharp drop

amines, to registration in which Schedule I acted curtail label claims in prescribing of these drugs and en abled to make recommenda drugs are used. A Joint Drug Abuse for many questionable uses of these FDA

in sharp Research Advisory Committee, con drugs, such as for depression. At tions that resulted cutbacks

sisting of recognized experts in the DEA’s request, FDA recommended in amphetamine production quotas drug abuse area, reviews the proto the following year that these stim in 1972 and further cuts in 1973, so cols and recommends action to be ulants and two others with simi that current production of ampheta taken by FDA concerning studies lar abuse-dependency potential be mine has been reduced 92 percent with Schedule I drugs in humans and advises ADAMHA concerning supplies of Schedule I drugs main tained by that agency. As a part of FDA's responsibili ties under the Food, Drug, and Cos metic Act, the Agency:

• Assures that the labeling of all

drugs and the advertising of pre scription drugs accurately reflect abuse and dependency potential and do not encourage unwarranted use.

If information received by FDA

shows that an over-the-counter drug

presents an abuse problem, the

Agency can take action to reclassify

it as a prescription drug. If further

action is warranted and the drug fits

the legal description of a drug of abuse, the Agency can recommend

that DEA place it on one of the con trol schedules.

• Evaluates the safety and efficacy

of drugs used in the treatment of drug dependence before approving them for marketing.

• Requires that any new drug be tested for drug abuse potential when

there is reason to believe abuse may OCCUlf.

• Works with other Government

agencies, such as ADAMHA, DEA, the President's Special Action Of fice for Drug Abuse Prevention, and

the Veterans Administration, in var ious drug abuse programs. FDA has already worked closely

with DEA in seeking to control

many drugs of abuse.

FDA Consumer-March 1974 / 13 “In making its recommendations concerning the scheduling of drugs, FDA considers the extent and variety of legitimate medical and scientific uses. . . .”

or more from that in 1971. year. FDA also has ordered that in use in treatment of narcotic addic In 1973, after DEA had reported jectable amphetamine be taken off tion. These four drugs were devel

extensive diversion of several short the market as unsafe and that com oped by the pharmaceutical indus acting barbiturates to the illicit mar binations of amphetamine with seda try, but the Federal Government has ket, FDA recommended transfer to tives or other drugs be removed from assumed primary responsibility for Schedule II of certain short-acting the market because the ingredients the research. barbiturates and glutethimide, the in the various combinations do not The staff also reviews New Drug

latter a drug that drug abusers might contribute to weight reduction in the Applications in behalf of drugs af substitute for barbiturates. As a re user as claimed for these products. fecting the central nervous system recommendation, sult of this DEA In making its recommendations for abuse potential and recommends

has recently moved the three most concerning the scheduling of drugs, the necessary control measures. The abused barbiturates from Schedule FDA considers the extent and vari staff surveys drugs on the market for to Schedule abuse trends and recommends to III II. ety of legitimate medical and scien

In 1972, evidence began to ac tific uses, the possibility that less re DEA any necessary changes in

cumulate that methaqualone, a seda stricted drugs might be substituted scheduling. by drug tive-hypnotic that had not been listed abusers for those on which FDA also is seeking data from tightened, on any of the control schedules, was controls are the inhibi all available sources concerning the being widely country. tightened might abused in this tions that controls illicit use of drugs and the effects problem depend legitimate prescription No of abuse and have on on public health as well as methods ency potential had been indicated in needs, and the actual and potential for determining the abuse potential industry supplied dependency problems test data to FDA abuse and in of experimental drugs which may methaqualone approved volved. before was not be marketed. Thus FDA is hop

marketing Although Drug of for in 1965. an The Abuse Staff the Bu ing to obtain such data to head off

of Drugs of epidemic of methaqualone abuse reau Division Neuro problems such as that involving reported Japan pharmacological had been from in Products coordi methaqualone, in which abuse the 1960's, this drug was left off nates all FDA's activities related to reached serious proportions before the 1970 schedules by Congress drug abuse except for administration the drug was placed under control. largely because the World Health of the methadone maintenance regu Since 1970, FDA and DEA have

Organization's Expert Committee on lations, which is handled by a sepa imposed rigid controls on legitimate Drug Dependence Drug Staff, in had not recom rate unit. The Abuse use of amphetamines, pentobarbital, mended control. evaluating and monitoring clinical amobarbital, secobarbital, and meth

February 1973, qualifications of In FDA asked research and the aqualone. The abuse of these drugs

investigate researchers who use Schedule I DEA to the extent of has been a significant public health methaqualone. Upon being drugs, Alcohol, abuse of collaborates with the problem. In addition, FDA has lim by Drug Abuse, informed DEA that abuse was and Mental Health ited the number of approved thera indeed extensive, FDA recom Administration, which controls the peutic uses for the amphetamines, drug placed mended that the be in distribution of these drugs and sup markedly reducing their legitimate agreed and,

ports of Schedule II. DEA after some the research. uses as well as reducing production hearing a in which one of the manu FDA's Drug Abuse Staff is re quotas. Significant progress has facturers of the drug contested the sponsible for assuring that FDA been made since 1970, but further proposal, placed methaqualone in standards are met for all investiga work needs to be done to reduce Schedule in October 1973. II tive new drugs and for New Drug drug abuse—one of the country's During 1973, FDA asked that Applications involving drugs used in most pressing public health prob eight existing and new appetite-sup the treatment of narcotics addiction, lems. pressant drugs placed be on the con alcoholism, or any type of drug

trol schedule and that three abuse. interest is hallu Of current re Harold C. Hopkins is editorial di cinogens be added to Schedule I. search involving four drugs—one rector of FDA CONSUMER.

DEA has placed these under the opiate and three narcotic antagon Edward C. Tocus, Ph.D., is chief

recommended control in the past ists—which are being considered for of FDA's Drug Abuse Staff.

14-March 1974 / FDA Consumer HOW Defective Products Are Recalled by Margaret Morrison

Recalls of consumer products ducted by the company that made Use of recall procedures as a or distributed the defective or haz —from cars to foods—have means of protecting the public has product. grown steadily years. become a common occurrence. ardous over the There In the case of products which are were 1,549 recalls monitored by This is how recalls of regulated by FDA, the Agency may FDA during the last fiscal year. A products regulated by FDA are request a company to recall a larger number of actual recalls effected. product, and FDA monitors the re probably took place, since a com call to make sure it is accomplished. pany is not required to tell FDA t seems to crop up often in the However, in many instances firms when it is recalling a product. news. Another product recalled decide to recall products without a Companies may have a number from the market. The number of re request from FDA. of reasons for recalling a defective calls has increased to the point where FDA can remove hazardous or or hazardous product. If a company the very word “recall,” seldom used defective products from the market —or a consumer or the Government in relation to consumer products just by seizure, which is undertaken by —finds something wrong with a a short time ago, is now understood the courts at FDA's request. How product, the company may remove by virtually everyone. ever, seizures take time and do not it in the best interest of its customers. Even though the word is familiar, always result in optimum consumer Manufacturers and distributors to the actual way in which a recall is protection. Recall of a defective or day are very sensitive to consumer carried out may not be so well un hazardous product by the manu demands and their own responsibil derstood. For example, many people facturer or distributor has become ities for quality products. have the impression that a Govern the quickest and most practical In addition, a company that ment agency such as FDA conducts means of getting an unsafe or unac makes or distributes a defective or the recall. Actually, recalls are con ceptable product off the market. hazardous product faces a number

FDA Consumer-March 1974/15 “. . . many people have the

impression that a Government

agency such as FDA conducts the recall. Actually, recalls are conducted by the company that made or distributed the defective

or hazardous product.”

of less appealing alternatives. The the recall appears on the weekly re tions. Such information, formerly government product, list; complete could seize the call and effectiveness reported to the public only in FDA consumers could file private lawsuits checks are carried out to assure ade CONSUMER, has now been added to product someone, should the harm quate removal of the product from the weekly recall list, which can pub there is a chance that company the market. lish the information on a more cur rent basis. officials could be criminally prose Class II recalls involve products cuted, is and there could be adverse whose hazard is only potential. Ex- The fourth major change the of of is publicity due to public warnings by amples might be the recall of a drug modification FDA's policy

FDA when a company refuses to re not used in life-threatening situa suing a national press release for ev

call a product. tions, or an x-ray machine giving ery recall which presents a hazard All actions classed as recalls by off unnecessarily high but not acute to health. This does not mean that ly FDA appear on the weekly recall hazardous radiation. This also FDA will “withhold” or “keep se list, available from FDA's Office of includes recall of a product that is cret” any recall. the Assistant Commissioner for Pub adulterated, represents gross fraud All recalls will continue to be as as lic Affairs. The publication of this or deception to the consumer, or listed promptly possible on the

list was begun in 1967, as a further has a label that is misleading to the weekly recall list. The only change service in the interest of consumer is to provide in point where it might pose a danger that certain rare in protection. may of injury or damage to the consumer. stances the Commissioner de products regulated cide to limit the manner and the de The recalls of In Class II recalls, the product is to by FDA range widely in importance removed the retail level (removed gree of publicity the Agency will and in the amount of time and effort

in to weekly from retail store shelves); it is placed seek addition the list.

clarify its FDA devotes to them. To on FDA's weekly recall list; a press For example, a botulism recall in

role, published a policy FDA recall release may be issued; and FDA of volves a high degree of risk and

in year it

adequacy of 1971 and last reevaluated ficials check the the re wide distribution of the risk among procedures. and set forth some new moval in accordance with the degree the population. Obviously, the

changes in policy of par of consumer hazard associated with Four are broadest possible publicity is needed. ticular interest. the product. On the other hand, suppose that First, extended its definition Class recalls are those which FDA III a defective heart–lung machine is

of recalls to cover the activities of involve violation of the law but in distributed to 50 hospital operating the Agency's two newest bureaus, which a health hazard is remote or rooms. The manufacturer can iden Radiological Biologics. Health and nonexistent. An example might be tify all 50 of the hospitals. A per Before, routinely a neither Bureau re a product labeled to contain 10 sonal visit by FDA and telegram

ported of products to recalls the ounces which actually contains only or personal visit by the manufactu

public. 9. Removal is made to the wholesale rer to those hospitals would notify Second, divided recalls into FDA level, and the product is shown on the affected public promptly and Previously three classes. there had the weekly recall list, but there is adequately. been two. ordinarily no press release. Should a recall of this kind be

Class I recalls are those which Class II and Class III recalls, widely publicized before it is con

pose to the most serious threat since they deal with situations in ducted, it could cause unnecessary

health. Examples are confusion and concern in thousands botulism found which there is no imminent danger,

in food, a mix-up a of label on life-sav do not require a 100 percent check other hospitals where similar ma

ing drug, or a defective heart valve. of all known distributors of the chines, not involved in the recall,

Class I recalls receive top priority product. may be in use. and command the attention of the of The third major change in FDA Recalls life-saving products is top Agency officials. The product recall procedures is to make avail such as pacemakers or heart valves removed from the market down to a In able to the public more information create special problem. these

the consumer level (to the individ about regulatory actions, such as cases, FDA will, whenever possible,

ual user); a public warning is issued; seizures, injunctions, and prosecu identify the patients who have the

16-March 1974 / FDA Consumer JOHN DOE FIRST CLASS M LABORATORIES Somewhere, U.S.A. 12345

These are the model letter, envelope, and postcards which FDA has prepared to indicate how such A. B. C. Pharmacy communications should be handled. Anywhere, U. S. A.

(red print), URGENT: DRUG RECALL

JOHN DOE CONTROL DIVISION LABORATORIES Date Somewhere, U.S.A. 12345

print). (red URGENT: DRUG RECALL – PLEASE FILL OUT AND RETURN We do not haveany stockof List 1234,Cyanocobalamin injection Lot No. 4321on hand. D Re: List 1234, Cyanocobalamin Injection, Lot No. 4321 We haverequestedour accountsto returntheirstocks of this merchandiseto us. D

We are returning____ bottlesof List 1234,Lot No. 4321

Recent tests show that the above lot number of this produ Name––––. -- is not Sterile. Consequently, we are recalling this lot Address—--- from the market. Other lot numbers are not involved. City –——State— Please examine your StockS immediately to determine if any so, dispensiY9–mm have of Lot 432l on hand. If discontinue the lot and promptly return via parcel post, to our New York City Plant ; ATTENTION: RETURNED GOODS. You will be reimbursed by check or credit memo for the returned goods and poStage. BUSINESS REPLY MAIL No PostageStampNecessaryif mailedin U.S.A.

Please return the enclosed card immediately providing the Postagewill be paid by requested information. JOHN DOE LABORATORIES Somewhere,U.S.A. 12345 This recall is being made with the knowledge of the Food HenryDoe and Drug Administration. Director,QualityControl

We appreciate your assistance.

Henry Doe Director of Quality Control “One important aspect of the recall of a product is that it may trigger the investigation of an entire category of products.”

ers be publicized. If the company agreed, it would issue a recall letter notifying its dis tributors that the product must be ". removed from consumer channels. FDA's consumer safety officers in the District or Field Office usually offer to assist the firm in arranging the text of telephone calls or com posing recall telegrams or letters, so the product can be promptly and effectively removed from the market in accordance with FDA require mentS. The appropriate FDA bureau, in this case the Bureau of Drugs, would issue an official recall number, de termine the classification of the re call (I, II, or III), and the District or Field Office would send out de tailed information (description of the product, dosage, potency, lot The most widely recalled product in recent months has been canned number or other identification, rea mushrooms. In this photo, Philadelphia District Consumer Safety Officers son for the recall, etc.) that would Kathy Mallon (left) and Joanne Hawkins check mushroom cans. facilitate removal of the product from the market. defective devices and notify the FDA, from a physician or someone In the case of an over-the-counter physicians who implanted them. The else in a health-related field, that a drug, a news release might go out patients will be notified by their consumer has suffered adverse re from FDA with full information physicians. Other patients, thou actions from an over-the-counter or about the name of the product, the sands of whom may be using simi nonprescription drug. Suppose fur name of the manufacturer, the po lar equipment which is functioning ther that a number of similar com tential hazard or problem, and a perfectly, will be spared the unnec plaints are received by FDA, from warning about using the product. At essary uncertainty and fear that various parts of the country. the same time, a message would go would occur if they heard of a re After reviewing information about out to FDA District and Regional call of the product on a TV newscast the adverse reactions suffered by Offices throughout the country, and or other public announcement. consumers, FDA would then inspect State and local health officials are In all decisions concerning pub the plant in which the product was also notified of the recall. The ac licity about recalls, the Commission manufactured and review all data tion would also be included in er of FDA will determine how much on the product, including ingredi FDA's weekly recall list. or what kind of publicity is consist ents, production procedures, and If the recall involved a potential ent with the nature of the hazard and containers. consumer hazard, it would be im with the numbers of people involved The conclusions might show the portant for the District Office moni in possible risk. drug to be a potential hazard to toring the recall to assure that stocks To illustrate how a product is ac health, and FDA would then rec of the product were found and re tually removed from the market, we ommend to the manufacturer that called as expeditiously as possible. might follow the course of a Class II the product be removed from the An agreed-upon time when the re recall. Suppose a report reaches market and that the risk to consum call might be expected to be con

18 / March 1974 / FDA Consumer “The fact that recalls are now happening more frequently than

in the past should be reassuring

to consumers. It means that both industry and Government are alert to consumers’ interests and more involved with consumer protection.”

cluded would be established with the

January 17, Schmidt, M.D., of firm. Later, the District Office would On Alexander M. Commissioner Food

and Drugs, addressed a national conference on product recall in follow through with the recalling

New York City. This is a short excerpt from Dr. Schmidt's speech: company, to confirm how much of the product had been recovered and “Not only do I believe recall will remain—I think it must! it, the ultimate disposition of and to “I see the technique as an administrative necessity for both of us. unsatisfactory prod ensure that the In this day of complex technology and massive distributions, the uct was indeed removed from the mandatory remedies of injunction, seizure, and criminal prosecution market and either reconditioned or are limited alternatives.

destroyed. “The need for such a recall system likely will endure as long as imperfect. Meanwhile, the FDA District staff man and his machines remain

“Speaking as a regulator, I can assure you that while voluntary and other agencies assisting in moni

recall cannot substitute for formal regulation, it undoubtedly redounds toring the recall would carry out

to the benefit of cooperative industry through lessened need for a Agency what the calls “effectiveness stringent regulatory posture.

checks” to make sure distributors, “But more than this, there are moral as well as legal imperatives subdistributors, and retail stores to prevent consumer injury. On the moral side it seems clear that complying were with the recall or modern industrial leadership—individual as well as corporate—must

der. This means making sure distrib embrace the concept of responsible citizenship, must accept that utors are holding up any further responsibility to the consumer goes beyond the mere limits of product

liability. If nothing else, public sophistication demands no less. shipments of the product to retail outlets and that retail stores are no “On the legal side the courts increasingly insist that responsibility for safe and useful products rests not alone with the inanimate cor longer selling the product.

poration; it extends as well to individual corporate leadership and

If the company has conducted

beyond that to all levels of production and distribution. If the product the recall properly, its distributors all causes injury, all concerned can be held liable.” know about the recall and have seg regated out the product. They have,

presumably, notified the stores that gory of products. When one medi manager, and by notifying FDA.

buy the product and they, too, have cated spray is found to be hazard However, it is important that you

put the merchandise aside, prepara ous, for instance, FDA may begin be sure of the facts—that you know

to it to name, tory sending back the distrib an investigation of other such spray the exact and the lot num utOr. products, and perhaps find that oth ber, of the product being recalled, However, ingredients—or ideal conditions don’t ers also contain are since recalls may be of one specific always may go exist. Recall letters packaged in containers—which pose product from a brand line, or one health hazards. an actual case of be in out late. They may delayed the In specific lot number of that product.

recall of a certain brand decon mails. They may be inadvertently of The fact that recalls are now hap

overlooked, in spite of bright gestant spray year, their last FDA later pening more frequently than in the

stamp reading “Urgent: requested of red Food (or the recall five other past should be reassuring to consum of Drug) Recall.” The distributor may aerosol spray products, all which ers. It means that both industry and 1, 1, put off telling his stores, or they may contained the solvent 1-trichlo Government are more alert to con

a sumers’ interests and more fail to respond. So the consumer roethane, substance that was pres involved

ent in substantial amounts in the safety officer or other official who with consumer protection. Whenever

product originally to a performs the effectiveness checks is found be haz recall takes place, consumers can ardous. a in serving vital function keeping know it is happening because FDA

potentially dangerous products from Whenever you hear or read about and the firm making the recall have

COITSUIII 1621’S. a action, recall and then see the de found evidence that the product is

One important aspect of the recall fective product on store shelves, you unacceptable and are using the fast est, of a product is that it may trigger can perform a public service by call most efficient method for remov

the investigation of an entire cate ing it to the attention of the store ing the product from the market.

FDA Consumer / March 1974 / 19 Can Your Kitchen PassThe Food Storage Test? The proper storage of foods in the home is essential for food safety. Can your kitchen pass this food storage test?

by Jane Heenan

t’ll never happen, but if the potent household chemicals. Bottles clean and dust-free. Any foreign

Food and Drug Administration of cleaning chemicals could matter on the tops of cans will

were to inspect every family kitchen easily be mistaken for bottles of be pressed into the food itself in the United States for proper soda or another food. Imagine a during opening. storage of foods—most of them salad dressing of vinegar and Pick up each can on the shelf. probably denatured alcohol! would flunk. Does it stick slightly? This could

It takes a concerted effort by Next, take a look at the open be a sign of leakage, and the homemakers and good planning in surfaces in your kitchen. Any food can should be returned to the store.

the kitchen to avoid many food sitting out? Meat thawing at Weak seams in the cans can allow

storage pitfalls. Proper storage room temperature? A carton of gases to build up and force is essential to assure the of food milk you’ll put away “in a minute”? fluid out. This can be a dangerous

products safety and quality. Foods that should be refrigerated situation, as toxins (poisons)

Prove it to yourself. Be your or frozen should be handled can be forming.

own inspector. Check out the always with special care. Bacteria If you have cans on your shelf

“family food firm” in your own in such foods can multiply rapidly that leak, bulge, or are otherwise

kitchen and see what needs to be under certain conditions—that is, unusual, be careful! Notify improved. changes very least, Make a list of outside the refrigerator or freezer. FDA. At the return that are needed, and then the can to the store and Always remember to keep cold make them. foods cold. notify the manufacturer. By alerting store, Take a look at your breadbox. the the Checkpoint One While bread normally keeps fresher manufacturer, and FDA, you could

be helping protect The first step is a check of cabinets longer at room temperatures than other consumers.

Necessary be underneath the kitchen sink, or in the refrigerator, in hot humid measures can taken to locate and remove other cans any cabinets through which water weather, bread is better protected with the same code number that pipes, drain pipes, or heating against mold in the refrigerator.

may be pipes pass. Any food stored there? Next, look at storage areas near also contaminated. as Sacks of onions or potatoes, or heat sources, such the stove. Resist any temptation to taste right. perhaps some liquids or canned Foods should not be kept in food that doesn’t seem You goods? cabinets above the stove. Even dry don’t even have to swallow the

to poisoned by If so, count yourself already in mixes, which may be held at food be the violation of good storage practices. room temperature, will not keep toxins produced by certain types

Foods should never be stored well in that area. of bacteria. In some cases, even the

in these cabinets, because they will food’s taste is no indicator

attract insects and possibly rodents Checking the Stock of safety.

through openings that are almost Now take a look at foods being While you're checking through at impossible to seal adequately. held room temperatures. the pantry, reread some of the

Also, possible leakage from the The first place to check is the labels to see if some of the goods pipes can damage the food canned goods. Reach all the way should have been refrigerated. products, causing cans, for to the back of the least accessible Don’t assume that all boxed or

example, to become overheated shelf. Any dust on the cans? canned goods may be held at

or rusty. If so, you’d better make some room temperature. For example, canned cheeses such as It is always a mistake to store adjustments in your kitchen. Brie anything you may eat alongside Cans should always be kept and Camembert should be kept

20-March 1974 / FDA Consumer Like most people, he's full of ideas—mostly bad ones. That “perfect” place under the sink is no place for food. Pipes passing through an area can not only leak, but also provide unsealable openings to draw bugs.

He's the one who pushed ahead of you at the bargain counter to buy a dented can. Little did either of you know it was no bargain. In buying dented cans, look for seam damage—which may mean the product is contaminated.

He never knew that dust on cans should be cleaned off. After all, it doesn’t reach the food. Right? Wrong. Harmful bacteria can easily be pushed into the food by a can opener. A neat pantry isn't always clean.

FDA Consumer / March 1974 / 21 The box reads “keep refrigerated.” But it's too late now to save the product. And like too many consumers, he's compounded the mistake by storing food near a heat source, in this case over a stove.

There's no food like an old food. Begging for medical bills, he uses the taste test to see if foods are still good. Foods that are “over the hill” don't necessarily have to be swallowed to poison you. And the assumption that mold is harmless is equally dangerous.

RatsQ-a - s under refrigeration even before nuts. Unshelled nuts held at room Refrigeration will retard the growth opening. temperature up to about 6 months of the bacteria found in food, And a double-check with every are no problem in your kitchen. and keep them from multiplying. purchase of grated Parmesan But other nuts, because of their Their ability to spread or produce cheese is necessary; some containers high fat content, should be a poison is greatly inhibited by call for refrigeration after opening stored in airtight containers in refrigeration, but bacteria or poison and others don't. If you’ve made a the refrigerator or freezer to delay present in a food may still be mistake and failed to refrigerate rancidity. If they have become there even after refrigeration. something that should be, moldy, throw them out. The same is true for freezing. throw the product away. You may also find in your pantry Freezing does not kill bacteria in You may also find honey and or perhaps atop the stove a can food, it simply stops their syrup that's been opened but of bacon drippings. This, along with spreading. The bacteria will become remains in your pantry. Syrups are margarine and butter of course, active and again continue to better protected from mold in belongs in the refrigerator— always! spread as the food is thawed. your refrigerator. If crystals Such foods should be prepared as form in refrigerated honey or Your Biggest Problem soon as possible after thawing. syrup, simply place the containers Now for the toughest part of your But with many foods you will in hot water before use. inspection—the refrigerator. You'll still have rapid deterioration even Peanut butter also belongs in probably find more problems in the refrigerator. Broths, gravies, the refrigerator after opening, and here than in any other area. Why? stuffings, chicken salad, potato it can stand at room temperature Because you’ve expected it to salad, poultry, fish, liver, kidneys, for a short while to soften do things it was never meant to do. brains, and giblets are some of before use. You may have thought the the foods that should be used Before your pantry inspection refrigerator would destroy most within 1 or 2 days of home storage. is complete, check on storage of harmful bacteria in food. Wrong. So your first check is to see

22 / March 1974 / FDA Consumer “warmer.” Good thermometers that foods aren't being held too missing an important part of long. Look inside covered dishes, made especially for refrigerator quality control for your kitchen,

sniff beverages, open bags and and freezer use may easily be and, in strictest terms, you don’t bins. Throw out questionable purchased and should be used. pass inspection. items as well as products you really In the normal home refrigerator, Next, check around the motor don’t plan to use. a temperature of 45 degrees and refrigerating unit. Lint and With the most obvious part of Fahrenheit may be adequate to dirt on these parts cut off the air your refrigerator survey out of hold food 3 or 4 days; but supply, overwork your refrigerator, the way, you still have several if items are to be kept longer, and reduce efficiency.

points to check before further they should be refrigerated at 40 Look at the gaskets (the rubber considerations about the stored degrees or lower. In the freezer insulation) around the doors. items themselves. compartment, foods to be held for They should be flexible. Stiff, Do you have an accurate long periods should be kept at cracked, and damaged insulation your refrigerator degrees, you’ll probably thermometer in zero but allows air seepage. Make a test with and freezer? Chances are there's no throughout find this not maintained a dollar bill. Hold it halfway in

thermometer at all—probably the compartment. A thermometer the door, shut the door, and see if only a regulator allowing for is really your safety map of the you can easily pull the bill out.

refrigerator. it, you're general setting of “colder” or Without If so, the gasket is allowing air to

It's a bad habit, and it means he'll probably wind up dribbling milk down his shirt. But the real problem is that bacteria from his mouth will contaminate the milk.

A study in how NOT to refrigerate food, our friend stacks, spills, crams, and tilts products and uses one criterion: just get the door shut. This makes for quick spoilage, forgotten items, and poor cooling patterns.

Carefully covering those last

treasured bites of dessert, he

doesn’t realize they'd keep in

moisture far better if transferred

to the smallest possible container, where wrapping could be almost airtight.

FDA Consumer-March 1974/23 Doing something right, for a change, he tests the refrigerator gaskets to see that the door shuts tightly. If the dollar bill can be slipped out easily, then it's time to replace the rubber insulation around the door.

He shows promise! He's finally bringing himself to throw away any old or leftover foods with “off” color, taste, or odor. Any food that has been around for awhile or set out at room temperature merits checking. escape and should be repaired. Next, check your freezer. Frost buildup of one-fourth inch or more actually serves as insulation AGAINST keeping foods frozen well. And one final, simple check for the refrigerator itself. Is it clean? Enough said!

Inspect for Good Management How you manage foods in cold storage—how you wrap them, where you place them, when you use them—is important for the safety and quality of every item. Your check list of things to change after this inspection could very well include management techniques. First, check for these procedures on wrapping: Fresh meat should be wrapped loosely, just enough to allow air to circulate but not enough to let the product dry out. The rule is reversed for leftovers: they should be covered tightly. Raw poultry should be unwrapped, placed on a dish, and covered. Giblets must be wrapped and stored separately. Also, stuffing must never remain in meat and poultry; warm dark cavities are ideal areas for growth of dangerous toxins. All containers should be closed or covered. Leftover egg yolks should be covered with cold water and refrigerated with a cover. (They should be used within 2 to 4 days.) Whites don’t need the water.

24 / March 1974 / FDA Consumer Storing Chart STORAGE PERIOD (To maintain its quality) PRODUCT Refrigerator Freezer 35 ° to 40° F. 0°F. DAY'S MONTHS FRESH MEATS Roasts (Beef and Lamb) .... 3 to 5 8 to 12 Roasts (Pork and Veal) .... 3 to 5 4 to 8 Steaks (Beef) ------3 to 5 8 to 12 Chops (Lamb and Pork) .... 3 to 5 3 to 4 Ground and Stew Meats ---- 1 to 2 2 to 3 Variety Meats ------1 to 2 3 to 4 Sausage (Pork) ------1 to 2 1 to 2 PROCESSED MEATS Bacon ------7 1 Frankfurters ------7 1/2 Inn CUase off EEmergency Ham (Whole) ------7 1 to 2 power fails or the freezer stops operating Ham (Half) ------3 to 5 1 to 2 If normally, try to determine how long before the Ham (Slices) ------. 3 1 to 2 operation. Luncheon Meats ------3 to 5 • freezer will be back in Freezing fully loaded freezer usually will stay cold (Smoked) ------7 A nCt recCm enough to keep foods frozen for 2 days if the cabinet is not opened. In a cabinet with less than £(Dry and Semi-Dry)------14 to 21-mended half a load, food may not stay frozen COOKED MEATS ImOre than 1 day. operation Cooked Meats and Meat If normal cannot be resumed before thaw, dry dry Dishes ------. 1 to 2 2 to 3 the food will start to use ice. If ice is placed in the freezer soon after the power Gravy and Meat Broth...... 1 to 2 2 to 3 is off, 25 pounds should keep the temperature FRESH POULTRY below freezing for 2 to 3 days in a 10-cubic-foot cabinet with half a load, 3 to Chicken and Turkey ------1 to 2 12 • • days Duck and Goose ------1 to 2 6 4 in a loaded cabinet. the dry ice small boards Giblets ------. 1 to 2 3 Place on cardboard or on top of packages, and do not open freezer COOKED POULTRY again except to put in more dry ice or to remove Pieces (Covered with Broth) 1 to 2 6 it when normal operation is resumed. Pieces (Not Covered) ------1 to 2 1 Or move food to a locker plant, using Cooked Poultry Dishes ------1 to 2 6 insulated boxes or thick layers of paper to Fried Chicken ------1 to 2 4 prevent thawing.

For freezing, all items should be meats, and most leftovers should How Did You Do? wrapped tightly in be in that area. You may have found several areas moisture-resistant materials, Foods should not be stacked, where you’ve used improper storage such as freezer paper or foil. and refrigerator shelves should methods. And you may say to Where you put the food is never be covered with foil or any yourself, “It can’t be so bad, important for three reasons: material that keeps down because what I’ve done hasn’t 1) Some should be kept colder air circulation. killed me yet!” than others; 2) Food placement Produce should be held in the But this response is a cop-out. affects air circulation and lower compartments to prevent How many times have you or efficiency of the refrigerator; crystalization. members of your family said, 3) Foods that should be used Food should also be arranged, “I don’t feel very good. It must quickly need to be in full view both in the freezer and the have been something I ate.”??? so they’re not easily forgotten. refrigerator, so that the oldest is The coldest part of the used first. This is important for Jane Heenan writes for FDA’s Con refrigerator is the area nearest safety as well as flavor, texture, Sumer Education and Information the freezing compartment. Milk, and nutrition. Staff.

FDA Consumer-March 1974/25 News Highlights

Legislation Suggested to Expand documents related to matters under investigation or FDA Authority in Many Areas review.

• Require the listing of the quantity of active ingredi The Administration has transmitted to the Congress ents on nonprescription drugs. Currently, such labels proposed legislation to strengthen and expand FDA

required to quantities only authority. are declare for certain ac tive ingredients. Titled The Food, Drug, and Cosmetic Amendments

• Make registration of foreign drug firms mandatory. of 1974, the proposed legislation is designed to im Registration and reporting requirements currently im prove FDA's ability to ensure the safety and quality of

posed on U.S. drug manufacturers would be extended food, drugs, cosmetics, and devices.

to foreign drug establishments. Enactment of the legislation would give FDA access

• Prohibit the exportation of uncertified antibiotics. to complaint files, processing records, quality control

This provision eliminates an ambiguity in present law records, and similar information. It would give the

which suggests that it may be lawful to export uncer Agency power to require recordkeeping and reporting tified human antibiotics. of industry data and actions, such as recalls. Addition The proposed bill would also repeal the Filled Milk ally, it would give the Agency detention and subpoena Act of 1923 and the restrictions on the sale of filled power, and would increase penalties for violating the cheese in the Internal Revenue Code. Food, Drug, and Cosmetic Act.

In addition, legislation presently before the Congress, Major provisions of the proposed legislation would: and supported by the Administration, would require • Broaden FDA's inspection authority. The legislation

food plant registration and mandatory labeling of would give FDA full access to formulas and complaint

ingredients in standardized foods. files, quality control and processing records. This au

thority would apply to all products under FDA's juris diction. FDA Outlines Procedures

• Require recordkeeping and reporting. FDA now has For Cyclamate Petition this authority only for new drugs. The legislation would it,

it to products regulated by extend other FDA. With FDA has outlined procedures it will follow in review

could, example, require to FDA for manufacturers ing a petition for reapproval of the use of cyclamate,

a sweetener, a report recalls of merchandise or submit existing safety nonnutritive as food additive.

or product experience data. As its initial action, FDA announced February 12

• authority to administratively prod Give FDA detain the formal filing of the petition, and the public avail Currently, authority ucts. FDA has no under the Fed ability of scientific data submitted in support of the by eral Food, Drug, and Cosmetic Act to hold a suspected food additive Abbott Laboratories, North Chicago,

product. In some cases, such products have been dis Illinois.

legal be legis tributed before action could taken. The In announcing the review procedures, Dr. Alexander to to lation would allow FDA hold the product for up M. Schmidt, Commissioner of Food and Drugs, said: days, appropriate legal 20 while action was initiated. “Use of nonnutritive sweeteners is of great interest • Increase fines for criminal violations. The maximum to both the public and scientific community. For this

fine for violation of the Federal Food, Drug, and Cos reason, we are charting, as precisely as we can, the

be $1,000 to $10,000 metic Act would increased from course we intend to follow during our review of cycla

$10,000 to $25,000 for the first offense and from for mate. These procedures are designed to allow the

subsequent or fraudulent violations. greatest public and scientific participation throughout

• Authorize issuance of subpoenas. This provision the decision-making process.”

give power to subpoena or would FDA the witnesses FDA has assigned a team of toxicologists, nutri

26-March 1974 / FDA Consumer tionists, and chemists to evaluate the data which has Objections by the physicians were based primarily

been submitted. It is anticipated that this preliminary on concerns that added dietary iron could create a evaluation will be completed in March. If required, health hazard for persons suffering from iron storage

FDA will request additional clarifying data from the disorders such as hemochromatosis, and that it could

petitioner. mask diagnosis of other disorders or contribute to the

When the data are complete, FDA will refer the development of other diseases.

petition to the Food Protection Committee of the Na FDA originally proposed to increase enrichment

tional Academy of Sciences for its evaluation also. This levels of iron and other nutrients in flour and bakery 3, committee is presently reviewing the safety of saccharin. products on December 1971. Although most com in Following FDA's evaluation of a recommendation ments supported the proposed increases the other

from the Academy, FDA will publish its intended ac essential nutrients, there was some opposition ex-

pressed to increasing tion as a proposal for public comment. the iron content.

“We realize these procedures will require time— At FDA's request, the Federation of American So probably into 1975,” said Dr. Schmidt. “But we will cieties for Experimental Biology (FASEB) and the Council on Foods and Nutrition of the American not act until all scientific issues and opinions are fully considered.” Medical Association reviewed the safety question Cyclamate has been available for some 30 years. thoroughly. They concluded that the increased iron

Because it was on the market before Congress passed consumption from enriched bread and flour would not of current premarketing requirements, it was not sub jeopardize the health normal individuals, nor would

it increase the incidence of hemochromatosis or other jected to the type of safety testing required of newer disorders. food additives. It was not, however, used extensively

Deficiency of in in food until the 1960's when the popularity of diet iron the American diet was noted foods and drinks increased greatly. Intensive testing by the White House Conference on Food, Nutrition

followed on the heels of increased usage. and Health (1969) and the Ten-State Nutrition Survey of In 1969, Abbott Laboratories, the major cyclamate (1968–70) conducted by the Department Health, of producer, submitted to FDA results of an animal feed Education, and Welfare. Both these projects pro

ing study which showed that animals fed cyclamate had duced recommendations urging that corrective steps be taken. developed bladder tumors. An FDA study resulted in

similar findings. The sole issue considered at the hearing is whether it is to in After evaluation of all available data, FDA con safe increase the levels of iron certain flour products. cluded that safety questions existed which could not be and bread

resolved on the basis of existing scientific evidence. The product was then banned. Chocolate Candy Balls Recalled;

“The earlier decision to ban cyclamate was made on Salmonella Contamination Suspected

the basis of the best scientific information of the time,

in provisions of and was made accord with clear FDA has announced the recall of foil-wrapped choco Food, Drug, Act,” the and Cosmetic said Dr. Schmidt. late balls labeled as Regent Solid Milk Chocolate, and

newer, convincing by “If more extensive data now offer distributed in this country Triumph Candy Corp.,

of safety of cyclamate, scientific evidence the we are Englewood Cliffs, New Jersey. The manufacturer is legally obligated to, and will approve its return to the Regent Chocolates Limited, St. Hyacinthe, Quebec, market.” Canada. The product has been associated with salmon

Abbott's petition consists of 440 papers bound into ella illness.

16 It is public in volumes. available for review the The recall was initiated as a result of investigations by of Hearing Clerk, 6-86, Office the Room 5600 Fishers public health agencies of 47 cases of Salmonella Lane, Rockville, Maryland. Eastbourne, a form of the infection which had been

rare in this country. Evaluation by the Center for Dis

Hearing Slated April 1 ease Control indicated that foil-wrapped chocolate balls On Iron in Bread Rule were the cause. In addition, the New Jersey Health

Department has identified this particular type of a 1 to FDA scheduled hearing for April resolve the salmonella in a sample of this brand of chocolate balls. issue of whether additional iron should be added to The solid chocolate round balls involved in the re products. some flour and bread call were individually wrapped in multicolored Christ

The action was in response to objections filed by mas-like foil and distributed nationally. individuals, including five physicians, to an FDA order FDA advises consumers who may have these prod

in prod which would have increased iron levels these ucts to return them to the store where purchased.

beginning April 15, by ucts 1974. The FDA order was Salmonella illness is characterized fever, nausea, 1, stayed until January 1975, pending the outcome of vomiting, and diarrhea. The illness generally disappears the hearing. within 24 to 48 hours.

FDA Consumer-March 1974/27 Regional Reports

REGION I lem had been corrected.

When Elkins-Sinn, a drug firm in Cherry Hill, New A U.S. marshal seized 1,840 unlabeled 100-pound bags

Jersey, was notified that a pharmacist in a Chicago of rice at Van Brode Milling Co., Clinton, Massachu

hospital had found a vial of the company's Procaine setts, where they became insect contaminated while HCL in a unit carton labeled “Sodium Chloride,” the held under insanitary conditions. The complaint,

company immediately initiated a recall of the two in brought by the Boston Field Office, further claimed that volved lots of Procaine HCL Solution U.S.P. 2% and because the bags were unlabeled, the name and place Sodium Chloride Injection U.S.P. Bacteriostatic 30 ml. of business of the manufacturer, packer, or distributor,

Newark District consumer safety officers in an in-depth an accurate statement of the quantity of contents, and

inspection at Elkins-Sinn found there had been a label

the common or usual name of the food, all required

mix-up in the company's printing shop. The Procaine by FDA, were not known. HCL carton labels were printed immediately after the Sodium Chloride carton labels, on the same day, and

REGION II

apparently the procedures used to protect the integrity

of the labels were not adequate.

New York District's Import Investigations Branch is Consumer Affairs Officer Gloria Martini, Newark Dis currently inspecting all imported canned mushrooms. office, recently presented Mushrooms fall into the category of low-acid canned trict two lectures for the

Living” at a high in Fairlawn, foods which—if improperly preserved or canned—are “Bachelor classes school

Jersey. is boys conducive to the growth of spores that can cause botu New The course offered for senior and parallels girls, lism, a rare but often fatal form of food poisoning. the Home Economics classes for cover

ing aspects of preparation, housekeeping, Thus far 337 lots of the imported mushrooms, valued various food to at over $114 million, have been checked by FDA in budgeting, and home safety. Mrs. Martini spoke by vestigators. The inspection was triggered the recent two assemblies of approximately 75 boys each on how

to prepare safely in FDA nationwide survey of all domestic mushroom food the home.

plants and warehouses after botulinum spores or toxin

Buffalo District detained a shipment of Black Diamond

was found in some canned mushrooms and products Canadian Farmer Cheese from Ontario, Canada, be

in which such mushrooms were used.

cause it was in violation of both the Fair Packaging Cooperation between the New York and Philadelphia and Labeling Act and the Food, Drug, and Cosmetic mandatory labeling missing. ship Districts helped to correct a problem found recently Act. The was The

on the Penn Central commuter train running into New ment of cheese was valued at over $400. York City. FDA's Interstate Travel Sanitation person

nel working out of the New York District have been REGION III concentrating on railcar sanitation inspections because

In Philadelphia District, Bogos, more people appear to be using the trains since the the Michael M. treas

cutback in automobile and travel. airline While check urer and manager of B. Bogoslafsky's Bakeries, Inc., in ing the drinking water supply in the bar car of the Philadelphia, was sentenced U.S. Court for the East

of Pennsylvania. commuter train, the inspectors found the sample of ern District The Government had

water collected to be quite dark in appearance. They charged both Mr. Bogos and the firm with shipping

commerce, it alerted the general foreman of the car department and adulterated food into interstate after had

recommended that the potable water tanks be flushed. been prepared and held under insanitary conditions,

Several days later when the inspectors rechecked, causing it to become insect and rodent contaminated.

nothing had been done. FDA's preliminary laboratory Judge A. Leon Higginbotham, Jr., sentenced Mr. Bogos tests had shown the water contained mold. New At to 3 years in jail, suspended the sentence, placed him

York District's request, FDA's Philadelphia District on a year's probation, and fined him $150. The court it its asked Penn Central's main office in Philadelphia to in did not sentence the bakery, for had closed doors

struct the railroad's New York personnel to flush and last October and gone bankrupt.

sanitize the water tanks as requested. When the New

York FDA inspectors made followup checks, the prob In FDA's Philadelphia District a Government-seized

28/March 1974 / FDA Consumer Diapulse device was destroyed following a motion of was taped during a tour in which Jerry L. Henderson, judgment of condemnation by default, granted by Judge District program manager and consumer affairs co R. Dixon Herman of the U.S. Court for the Middle ordinator, discussed the different laboratory analyses District of Pennsylvania. The Government asked for and answered questions about the work. the motion when the claimant, Donald McCabe, D.O., Harrisburg, Pennsylvania, failed to answer written in REGION VII terrogatories. The Government alleged that instruc adequate tions with the device did not contain direc A Nebraska warehouse corporation and two officials

by laymen. by tions for safe use were fined Judge Warren Urbom of the U.S. District Court for Nebraska, Lincoln, for permitting rodent in

REGION IV festation of stored foodstuffs. The Nash-Finch Co.,

Lincoln, pleaded guilty to all four counts of an indict by The first FDA mobile laboratory in Region IV’s eight ment brought on charges FDA's Kansas City District and was fined $50 on each count. Mower, State area has begun its tour of duty in Florida. The John T.

manager, Jay T. Phipps, super $20,000 traveling lab, equipped with its own electrical branch and warehouse

visor, pleaded to generator and water supply, is one of only 15 FDA nolo contendere one count each and were fined $25 each. labs of this type in the country. Coordinated by the Orlando Section office and manned by two FDA con fly by A complaint a consumer who found a in a bottle sumer safety officers, the lab will run tests to detect

of Pepsi Cola started an investigation by FDA's St. food filth and contamination of imported foods enter Louis Resident Post. Consumer safety officers visited ing Florida ports. About 72 percent of all imports the manufacturer, Union Bottling Works, doing busi arrive at Tampa, Miami, and Jacksonville. In the past,

ness as Pepsi Cola Co. of St. Louis, and found ex all lab work had to be sent to FDA's regional labora traneous matter in filled bottles of soft drinks at the

tory in Atlanta. Now the new van will save analysis

plant. FDA laboratory tests confirmed the presence of time and allow for increased examinations of imports.

mold and insect parts. The company was notified of

poor sanitary conditions found at the plant and promptly

REGION V

ceased operation, placed a hold on finished products at

the plant, and recalled all distributed products. The The Environmental Protection Agency (EPA) recently

plant voluntarily destroyed 8,000 cases of soft drinks informed FDA's Cincinnati District that several food

and carried out a thorough cleanup and repair of equip producing farms are located within a few hundred feet ment before resuming production.

of a Northwest Ohio industrial plant which has been

emitting fumes containing beryllium residues in excess

The Government seized 307 hundred-pound bags of

of EPA air quality standards. There was concern that

long grain rice, valued at $9,670, in the B & L Drayage the foods produced on the farms might be contami warehouse, St. Louis, after an inspection by consumer by nated residues of beryllium, a poisonous substance.

safety officers at Kansas City District's St. Louis Resi Cincinnati District sampled and analyzed the foods and dent Post revealed contamination by birds. The pres found the results negative for beryllium.

ence of bird excreta contamination was confirmed by laboratory analysis. already REGION VI FDA Seizure had been ordered when the warehouse received a new lot and this was seized also because the same conditions existed At Houston, FDA's Dallas District detained 163,699

in the warehouse—birds flying around the new lot and pounds of coffee, valued at $64,010 and imported from

bird droppings on the burlap bags of rice.

Indonesia, because of mold and insect contamination,

and 1,053,360 pounds, valued at $487,112 and im The Springfield Grocery Co., Springfield, Missouri, was ported from the Ivory Coast, because of insect con tamination. fined $200 on one count of a five-count information

charging adulteration of stored flour, cornmeal, beans,

Representatives of El College Centro and television and candy, after pleading guilty. Magistrate Dennis J.

station KERA-TV, both Dallas, were taken on a tour Stewart of the U.S. District Court for Western Missouri

of FDA's Dallas District laboratories by Juan A. Tije also fined Suzanne M. Tynes, president, and Joseph M.

Helfrecht, treasurer, of counts, rina, consumer affairs officer, to plan a half-hour pro $100 each on one five

gram for a TV course titled Man and Environment. and suspended these fines. The remaining four counts The program was shown eight times between November against the corporation and the individuals were dis 1 a 25 and December and will be shown over week missed. The charges were brought by FDA's Kansas

beginning April 14 this year. About half the program City District.

FDA Consumer / March 1974 / 29 Inspections by FDA's Kansas City District of two spections and sampling by FDA's Los Angeles District.

Missouri warehouses resulted in corrective actions. A Florence Manufacturing Co., Los Angeles, a maker St. warehouse converted over tons Louis 9 of insect of pasta products, pleaded guilty to three counts of

infested soy flour, grits, and proteins, valued at $4,279, maintaining an insect-infested plant, and was fined a by to animal feed. A Poplar Bluff warehouse voluntarily total of $600 Magistrate James J. Penne. Joseph R.

destroyed over 3 tons of flour and other cereal prod Esposito, vice president, pleaded guilty to one count ucts, valued at $467, found contaminated by rodents. and was fined $100.

Central Fish & Oyster Co., Los Angeles, and David E. REGION VIII Harvey, production manager and secretary, each pleaded

guilty to one of three counts charging that breaded fish A Denver company that makes salads found itself in by sticks held at the plant were contaminated rodents

two kinds of trouble from for processing its prod FDA and processing was done under insanitary conditions.

uct under insanitary conditions. After an inspection of Judge Robert J. Kelleher dismissed two counts against Co., Inc., plant by Shain, the Vincent Bar-None Al each defendant and fined the corporation $250 on the Denver District consumer safety officer, Mr. FDA remaining count. He suspended sentence against Mr.

Shain's list of insanitary conditions noted was given for Harvey and placed him on 2 years' probation.

review to W. G. Biggs, Region VIII interstate travel

consultant, as acting supervisory sanitation on detail A California company and one of its officials have been investigator. Mr. Biggs immediately recognized the enjoined from further manufacture, interstate distribu

company as a supplier to airline caterers and railroad tion of, and distribution after receipt of raw materials Whereupon immediately commissaries. FDA invoked for the drug Afrodex received in interstate commerce.

provisions of Regula the the Interstate Quarantine Afrodex is a new drug for which the company, ICN by

tions, prohibiting of company the use the interstate Pharmaceuticals, Inc., Covina, does not have an ap

as a supplier of carriers salads. proved New Drug Application. The drug is promoted

primarily for treatment of male impotence. REGION IX Bruce Delvin, group vice president of the company,

was also named in the permanent injunction restraint Among by 30 detentions San Francisco District by FDA's Judge Harry Pregerson of the U.S. Court for the

at port of a of beans, the San Francisco was lot cocoa Central District of California, Los Angeles. FDA's Los

totaling 770,627 pounds and valued at $462,376, Angeles District moved for the injunction because the

contaminated excessive residues of the pesti found with company was continuing to distribute Afrodex after

cide had originated in chemical DDT. The lot Ecuador seizure of the drug had been adjudicated in Texas by

but had been exported from The Netherlands. a Federal court.

The San Francisco District detained 34 lots of various

An Arizona farmer and a produce processing and dis patent medicines with a total value of $9,000 at the

tributing partnership and one of its partners have been

port of Honolulu on charges they were new drugs with

found guilty of violative shipment of lettuce containing out approved New Drug Applications. The drugs, from

excessive residues of the pesticide parathion as a result

the Peoples Republic of China, ranged from powdered

of investigations and sampling by FDA's Los Angeles

antelope horn to tablets containing known therapeutic

Singh, of Singh Farms, agents. District. Rala owner Rala Glen

dale, pleaded nolo contendere to one count; the partner

The Consumer Affairs Office at San Francisco District ship of Hamilton Farms, Eloy, and R. E. Schlittenhart,

is working with the California Federated Womens' a partner in Hamilton Farms, each pleaded guilty to

Clubs, with a membership of 60,000, in a public edu one count. Each was fined $250. Four other counts

cation program for prevention of Salmonella infection. against each defendant were dismissed by Magistrate programs by Individual conducted the federation's 740 Richard C. Gormley of the U.S. Court for the District

clubs include placement of printed information in pub of Arizona, Phoenix. The case involved five shipments libraries, lic work with Parent-Teacher Association of lettuce grown in 1970 by Mr. Singh and purchased,

groups, and arrangement of public meetings for dis packed, and shipped by Hamilton Farms.

seminating information to those attending. The District

The contested seizure of a Diapulse device was resolved

feels the combined Federal and volunteer effort is prov

in favor of the Government by Judge Malcolm M.

ing a success. Lucas of the U.S. Court for the Central District of

Guilty pleas were entered and sentencing imposed in California, Los Angeles. The seizure, resulting from

two prosecutions in the U.S. Court for the Central charges by FDA's Los Angeles District, was made be of District California, Los Angeles, resulting from in cause of inadequate directions on the label for safe use

30/March 1974 / FDA Consumer by laymen. Dr. Lawrence L. Cunningham, Los Angeles, REGION X claimant for the device, had held that a trial was re quired because there is a difference of medical opinion FDA's Seattle District has detained five lots of im concerning the use of the device, citing one case in ported frozen froglegs and shrimp, a total of over which the Government’s motion for summary judg 65,000 pounds valued at more than $120,000, because ment had been denied. of Salmonella contamination. The two shipments of froglegs, detained at Tacoma, were from Japan. Of A total of $60,000 worth of stored food products has three shipments of shrimp detained at Seattle, two were been seized by the Government from California Milling from Thailand and one from Hong Kong. Corp., Phoenix, Arizona, because of extensive evidence of rodent activity and rodent-defiled foods found during The Government has seized 14,102 pounds of frozen an inspection by FDA's Los Angeles District. At FDA's white halibut which FDA's Seattle District charges con request, the State of Arizona had placed the entire sists in part of decomposed fish. Seizure was made at warehouse under embargo pending Federal seizure of a cold storage warehouse in Bellingham, Washington. the food products involved. The halibut originated in Alaska.

FDA Offices

Phone numbers listed are those of the consumer affairs officers. District offices are indicated in large type. Cities that have both regional and district, section, or field offices are indicated by one asterisk. Two asterisks indicate other cities with consumer affairs officers.

*ATLANTA 880 W. Peachtree St., *DALLAS Suite 470-B, NEW ORLEANS U.S. N.W. 500 S. Ervay Customhouse Atlanta, Ga. 30309 Dallas, Tex. 75201 Rm. 222/423 Canal St. (404) 526-3162 (214) 749-2384 New Orleans, La. 70130 **Orlando, Fla. 32801 **419 S. Main, Rm. 301 (504) 527-2420 (904) 377-2282 San Antonio, Tex. 78.204 BALTIMORE 900 Madison Ave. *DENVER New Customhouse *NEW YORK 850 3rd Ave. Baltimore, Md. 21201 Bldg. Brooklyn, N.Y. 11232 (301) 962-3396 Rm. 500-20th & California Sts. (212) 788–1454 Church, 22046 **Falls Va. Denver, Colo. 80202 (703) 557-0389 (303) 837-4917 NEWARK Rm. 831/970 Broad ** Richmond, Va. 23240 St. DETROIT 1560 E. Jefferson Ave. (804) 782-2565 Newark, N.J. 07102 Detroit, *BOSTON 585 Commercial St. Mich. 48207 (201) 645-3265 Boston, Mass. 02109 (313) 226-6260 ** 110 Michigan, N.W. (617) 223-5857 *PHILADELPHIA U.S. Hartford, Grand Rapids, Mich. 49502 **E. Conn. 06108 Customhouse (203) 244-2529 (616) 456–2340 Rm. 1204-2nd & Chestnut Sts. **Indianapolis, Ind. 46204 BUFFALO 599 Delaware AVe. Philadelphia, (317) 633-8580 Pa. 19106 Buffalo, N.Y. 14202 (215) 597-4374 and 597-5857 (716) 842-6925 *KANSAS CITY 1009 Cherry St. **Albany, N.Y. 12207 City, Kansas Mo. 64106 *SAN FRANCISCO Federal (518) 472-6045 (816) 374-5623 Office Bldg. St., *CHICAGO (Regional) R.m. ** 1709 Jackson Rm. 108 Rm. 544/50 Fulton St. A-1945 Omaha, Nebr. 68102 San Francisco, Calif. 94102 175 W. Jackson Blvd. (402) 221-4676 (415) 556-2062 Chicago, Ill. 60604 **St. Louis, Mo. 63.101 (312)353-1046 (314) 622-5021 SAN P.O. BOX 4427 (District) Main Post Office Bldg. JUAN 1521 PicO Rm. 1222/433 W. Van Buren St. LOS ANGELES W. Old San Juan Station Blvd. Juan, Chicago, Ill. 60607 San P.R. 00905 Angeles, (312)353-7126 and 353-5244 Los Calif. 90015 (809) 622-0443 (213) 688-3771 CINCINNATI 1141 Central Pkwy. Cincinnati, Ohio 45202 MINNEAPOLIS 240 Hennepin *SEATTLE Federal Office Bldg. (513) 684-3500 Ave. Rm. 5003/909 First AVe. **Cleveland, Ohio 441 14 Minneapolis, Minn. 55401 Seattle, Wash. 98104 (216) 522-4844 (612) 725-2121 (206) 442-5258

FDA Consumer-March 1974/31 State Actions

Herbicide Contaminates have various medical ailments that Joint inspection by the Denver Department Blueberries would be adversely affected by the Health and FDA found sauna and wrap treatment. The vast infestation by rodents, includ 1973 blueberry crop was ruined A division said that although the prac ing gnawed bread, meat, and other on three farms in southwestern products. They tices have ceased, it is taking action also found that the Michigan by utility companies two to ensure that the defendants do not company's freezer had been operat applying the herbicide picloram to

ing improperly, resulting in return to Oregon to resume “their the rights-of-way adjoining their the fraudulent business practices” and thawing, refreezing, and rethawing farms, the Michigan Department of of much frozen food. The whole to recover money paid by Oregon Agriculture reports. The herbicide ians for “this useless body-wrap warehouse and its contents were was applied in spring 1972 and process.” judged to be in a deplorable state damaged some of the bushes along

of department In a letter to Raymond V. insanitation. The or the rights-of-way, but analysis at disposal of 100,000 pounds Mlecko, director of the Compliance dered that time revealed no herbicide resi at Branch FDA's Seattle District of unfit foods at the dump and per due on berries from undamaged of office, James L. Carney, division mitted salvaging only canned bushes. The department theorized chief counsel, expressed apprecia goods in sealed cases showing no that the high water table in the area evidence of rodent contamination, tion to FDA for cooperation and permitted later lateral movement of to in assistance the division evaluat the rest to be dumped unless the the herbicide within the fields to ing the Slender Wrap reducing company can come up with a satis cause the 1973 damage. claims. factory means of sanitizing.

Oregon Sues ‘Reducers’ Flour Embargo North Carolina Embargo Oregon Department The of Justice's The Puerto Rico Health Depart

Inspectors of Consumer Protection Division has the North Carolina

ment embargoed because of heavy Department of Agriculture have ob filed a complaint in Clackamas insect contamination two lots of all

embargoes of County charging tained flour and other Circuit Court six purpose flour manufactured by materials at two companies after persons and four corporations with Molinos de Puerto Rico, Cantano, joint inspection multiple misrepresentations one with FDA's in sell Puerto Rico. The flour was in inspection ing body-wrap weight Atlanta District and one treatments for possession of the Puerto Rico De performed under an FDA contract. reduction. The complaint seeks per partment of Social Services, Maya The State embargoed 14,000 manent injunction against all the guez. It will be held under embargo

pounds of and 31,000 pounds alleged misrepresentations, recision flour

pending analysis of samples taken of salt for rodent infestation and of all contracts with clients and re from the two lots by FDA's San 3,550 pounds of flour for insect con

all paid, nearly fund of monies and Juan District investigators. tamination after the joint inspection $900,000 in civil penalties. California Label Law of the Statesville Flour Distribution The charges involved the Slender The State of California has amended Warehouse, Charlotte. The State Wrap body reducing facility which

inspectors embargoed of its Food, Drug, and Cosmetic Act 1.5 tons operated at Lake Oswego for about dough to require ingredient declarations on flour and sweet mix infested 6 months in early 1973 and dis

inspection of all food items composed of two or with insects after an continued operations at the end of Warehouse, Raleigh. more ingredients. It goes into effect Colonial Stores July. The division, according to Lee

8, contaminated later was Johnson, attorney general, charges on July 1974. The regulation The flour processed converted to animal feed. that the defendants represented that affects most foods and their “magic formula” body wrap standardized products. Short-Weight Shrimp could remove fat from the body by Salvager Shut Down of a process of osmosis, but that the Two lots Sea Est brand glazed, so-called magic formula was nothing The Denver Health Department has peeled, cleaved shrimp have been embargoed by more than epsom salts, which can ordered the closing of Walk Broker the Florida State De

at only partment of Agriculture of best remove some water age, a local food salvage dealer, be because by from the body. The complaint cause of gross insanitation on the short weight. The lots, shipped charges the defendants misrepre company premises. The U.S. De the New England Shrimp Co., sented the treatment's effectiveness partment of Agriculture discovered Malden, Massachusetts, to Tampa

and the price and guarantee and the condition while tracing some and Jacksonville, were found to be

to may uninspected failed warn consumers who meat and notified FDA. 10 to 20 percent short in weight.

32 / March 1974 / FDA Consumer Seizures and Postal Service Cases

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

A total of 35 actions to remove from the consumer market charges concerning contamination, and 2 involved charges products charged to be violative was reported in December. concerning economic and labeling violations. Other seizures These included 26 seizures of foods: 1 involved charges con included 1 of food additive, 4 of drugs (including 2 of cerning poisonous and deleterious substance, 23 involved veterinary and medicated feed), and 5 of medical devices.

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

F00D/Poisonous and Deleterious Substance

Sprouter Kits, Biosnacky-Tulsa, Okla. 12/ Samen Mauser-Zurich, Switzerland (M) Contain the added poisonous and deleterious sub 12/73 stance Bacillus cereus; false and misleading label ing suggesting articles will supply one with health

and well-being. Labeling fails to bear statement of

the quantity of contents; common or usual name

of the food (some); and declaration of ingredients.

Contamination, Spoilage, Insanitary Handling & Basil leaves, Bulgarian/Countryside, Ill. Sokol Co./Countryside, III. (D) Rodent contaminated. 10/18/73 Beans, California blackeye/Barceloneta, Casera Foods, Inc./Barceloneta, P.R. (D) Held under insanitary conditions; insect contaminated. P.R. 11/29/73 Decomposed. Catsup, Shurfine tomato/Wichita, Kans. Fettig Canning Co./Elwood, Ind. (M, S) 12/7/73 insanitary conditions; insect contami Coriander, Morocan-Madison, Wis, 11/2/ Sokol & Co./Countryside, Ill. (S) Held under 73 nated. , *

Corn, whole, shelled, white/Phoenix, Ariz. R & S Mexican F000s, Inc./Phoenix, Ariz. 11/7/73 (D) insanitary conditions; Flour, cornmeal, salt/Caneyville, Ky. 11/13 Otis Bryant & Son Milling Co./Caneyville, Held under rodent contami /73 Ky. (D) nated. Garlic-Laredo, Tex. 12/6/73 David M. Slaughter & Sons, Inc./Laredo, Held under insanitary conditions; insect contami TeX. (D) nated. Nuts, mixed/Seattle, Wash. 10/29/73 The Commission Co./Seattle, Wash. (D) Held under insanitary conditions. ** 0ats, Triangle rolled/Fresno, Calif. 11/14/ Robb-Ross, Inc./Fresno, Calif. (D) ; rodent 73 Contaminated.

Peaches, Argo Yellow Cling Whole-Hopkins, Del Monte Corp./0akland, Calif. (S) Contain foreign material resembling paint chips. Minn. 12/21/73 Peanuts, Alexandria, La. 12/18/73 Noah's Potato Chip Co., Inc./Alexandria, Held under insanitary conditions; rodent contami La. (D) nated. shelled, Hartford, Ala. 11/21/73 Anderson's Peanuts-Hartford, Ala. (M, S) Held under insanitary conditions; insect and rodent COntaminated.

Pro-Nuts/Monroe, N.C. 11/16/73 Trophy Brands, Inc./Monroe, N.C. (D) Held under insanitary conditions; rodent contami nated.

FDA Consumer / March 1974 / 33 (M), (P), PRODUCT, PLACE & DATE SEIZED Manufacturer Packer CHARGES SHIPPER (S), DEALER (D)

Contamination, Spoilage, Insanitary Handling (cont'd)

Rice-Clinton, Mass. 12/3/73 Van Brode Milling Co., Inc./Clinton, Mass. Held under insanitary conditions; insect contaminated. (D) Fails to bear label containing name and place of

business of the manufacturer, packer, or distribu

tor; accurate statement of the quantity of con

tents; and common or usual name of the food. Mac's Finest Long Grain; Adolphus Long B & L Drayage Co., Inc./St. Louis, Mo. (D) Held under insanitary conditions; bird contaminated Grain-St. Louis, Mo. 11/27/73 (Adolphus). extra fancy long and medium grain/ Marbo Quality Foods, Inc./Fresno, Calif. Held under insanitary conditions; rodent contami Fresno, Calif. 11/26/73 (D) nated. Salt-Mosinee, Wis. 10/16/73 DuBay Finer Foods-Mosinee, Wis. (D) Held under insanitary conditions. Sardines, canned/Shreveport, La. 11/13/73 R.B. & C.G. Stevens Co./Jonesport, Maine Prepared and packed under insanitary conditions; de (M, S) composed; swollen cans. Shrimp, fresh, frozen/Dover, Fla. 11/9/73 Treasure Isle, Inc./Dover, Fla. (D) Prepared and packed under insanitary conditions. Spices, various, dates/Brooklyn, and N.Y. Action Warehouse, Inc./Brooklyn, N.Y. (D) Held under insanitary conditions; insect contami 12/10/73 nated (Spices); decomposed (dates). Sugar, brown, and flour/Des Moines, Iowa Acri Wholesale Grocery Co., Inc./Des Held under insanitary conditions; rodent Contami 11/23/73 Moines, lowa (D) nated. ** pure cane, granulated/Memphis, Tenn. Manufacturer and shipper unknown. 9/25/73 Tomatoes, canned/Cincinnati, Ohio 11/29/ Milroy Canning Co., Inc./Milroy, Ind. (M, S) Decomposed substance. 73

Economic and Labeling Violations

Popcorn-Lawrence, Kans, Products-Lawrence, 11/19/73 T-N-T F000 Kans. (D) Net quantity of contents statement on principal dis

play panel area not in conformity with the Fair Packaging and Labeling Act. Tea-Nashville, C0./Nashville, Tenn. 12/5/73 Colonial Coffee Tenn. (D) Net quantity of contents declaration not in conformity with the Fair Packaging and Labeling Act.

FOOD ADDITIVE

(special dietary food)/Detroit, Nuys, “Seventeen” General Research Laboratories-Wan Contains amygdalin, an unsafe food additive not in

Mich. 12/28/73 Calif. (M. S) conformity with regulations. False and misleading

vignette and statement suggesting amygdalin is a nutrient with special dietary properties; inadequate directions for use (the treatment and prevention

of Cancer). Inadequate Warnings; use may be

dangerous to health.

DRUGS/Human Use

Lipohep Injection-Gravette, Ark. 11/15/73 Medwick Labs-Melrose Park, III. (M.S) New drug without effective approved New Drug Ap plication. Medicated-Oxford, Sulfamethazine No. 100 Neese & Sons, Inc./Ankeny, Iowa (M. S) New drug without effective approved New Drug Ap Kans. 12/10/73 plication; contains less than labeled potency; label

fails to bear accurate statement of net quantity

of contents in terms of weight.

Veterinary-Medicated Feed

Veterinary Drugs, various/Ipswich, Pro, Inc./Ipswich, Rx Wet Mass. (D) Inadequate directions; sold to user without prescrip Mass. 10/10/73 tion. Stilbolsol-10 diethystilbestrol premix/ Kis Mid State Feed Mill-Kissimmee, Fla. (D) New animal drug without effective New Animal Drug simmee, Fla. 9/24/73 Application.

MEDICAL DEVICES

Diapulse-Lakeland,

Fla. 11/8/73 Diapulse Corp. of Hyde Park, America-New False and misleading claims to be effective as a N.Y. (M) treatment for infections, fractures, bursitis, ar.

thritis, etc.; inadequate directions for safe use by laymen. Brownwood, Tex. 10/15/73 Tarlton, D.C./Brownwood, A.L. Tex. (D) False and misleading claims to be effective as a treatment for tissue and bone healing, infections, bursitis, arthritis, etc.; inadequate directions for

safe use by laymen.

34-March 1974 / FDA Consumer (M), (P), PRODUCT, MANUFACTURER PACKER CHARGES PLACE & DATE SEIZED SHIPPER (S), DEALER (D)

MEDICAL DEVICES (cont'd) by Beaver, W. Manufactured for Diapulse Corp. of Amer Inadequate directions for use laymen.

Va. 10/1573 ica/New Hyde Park, N.Y. by Havre, Mont. 11/12/73 Diapulse Corp. of America-New Hyde Park, Inadequate directions for use laymen. N.Y. (M)

Specific Adjusting Machine-Albuquerque, Son of James W. Young, D.C./Menlo Park, Inadequate directions for use and inadequate warn

N. ings. Mex. 11/21/73 Calif. (M); James W. Young, D.C./Menlo Park, Calif. (S)

U.S. POSTAL SERVICE actions taken in medical cases as authorized in the Mail Fraud Statute (18 U.S.C. 1341)

and-or the False Representation Statute (39 U.S.C. 3005) as reported by the Chief Postal Inspector. by Complaints Filed Law Department Under 39 U.S.C. 3005 (False Representation)

October 2, 1973: Slim and Trim, Box 376, Encino, California 91316. October 31, 1973: Snowbird Products, Inc., P.0. Box 1988, Zephyr Cove, by by Advertising and sale mail of the Vitamin E Diet representing Nevada 89448. Advertising and sale mail of the U.S. Women's E is an of a that witamin integral part Weight loss plan. Ski Team Diet represented to be effective in causing a weight

of 20 pounds in 2 October 19, 1973: E-Diet, Box 376, Encino, California 91516. Advertis loss weeks. 5, by Myers Products, 9313, Lauderdale, ing and sale mail of the Vitamin E Diet representing that November 1973: P.0. Box Fort by

Advertising of a product Vitamin E is an integral part of a Weight loss plan. Florida 33310. and sale mail called

“get it up” represented to be effective as a sex stimulant. October 29, 1973: Shang-Ri-La Imports, 17430 South Drive Highway,

5, Myers Products, 9313, Lauderdale,

by November 1973: P.O. Box Fort Miami, Florida 33157. Advertising and sale mail of a product by Florida 33310. Advertising and sale mail of a product called called “Lose Weight Sensibly Program” represented to be an

“keep it up” represented to be effective as a sex stimulant. effective means of losing Weight. 7, November 1973. Frederick's of Hollywood, 6610 Hollywood Boule October 29, 1973: Shang-Ri-La Imports, 17430 South Drive Highway, ward, Los Angeles, California 90025. Advertising and sale by by Miami, Florida 33157. Advertising and sale mail of a product

mail of the Professional Swedish Thermal Massage Machine

called “Please” represented to be effective as a smoking de

represented to be an weight terrent. effective device for loss.

November 9, 1973: Vita-Slim, 1739 Country Club Dr., Cherry Hill, New October 31, 1973: New Hair Witamin E, Post Office Box 603, Delray by Jersey. Advertising and sale mail of Diet Plan in conjunction by Beach, Florida 33444. Advertising and sale mail of a product

With diet capsules that allegedly fills your stomach to curb

represented to be in preventing called “New Hair" effective your appetite. baldness.

November 15, 1973: Sibley Pharmacy, 280 E. 147th Street, Harvey, 31, Shang-Ri-La, Highway, Miami, October 1973: 17430 South Dixie by Illinois 60426. Advertising and sale mail of a product called by Florida 33157. Advertising and sale mail of a product called “Siblex diet tablet” represented to be effective in curbing the

“Genseng" represented to be effective as a sex stimulant. user's appetite.

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

October 16, 1973: Against Eve McElwain Methods, 1001 Glendale Boule of Report 43 and the Brentwood Method, instructions for making by ward, Los Angeles, California 90026. Advertising and sale mail a tonic represented to be effective as a weight loss program.

of White Magic and Blue Mystique, instructions for making a November 16, 1973. Against Cornell Research Corp., 797% North Main

tonic represented to be effective as a weight loss program. by Street, Akron, Ohio 44310. Advertising and sale mail of a 15, Against Products, November 1973: Gift House 4500 N.W. 135th product called “Metab-A Slim" represented to be an effective by by Street, Miami, Florida 33054. Advertising and sale mail of a diet pill turning fat into Water.

product called “Super-E Penetrating Cream” represented to be November 16, 1973: Against Lydia Feldman, 8228 Sunset Boulevard,

effective as a Wrinkle remover. by Los Angeles, California 90046. Advertising and sale mail of

November 16, 1973. Against Brentwood Research, 1800 North High My Secret, instructions for making a tonic represented to be by land, Los Angeles, California 90028. Advertising and sale mail effective as a weight loss program.

FDA Consumer / March 1974 / 35 Notices of Judgment

NOTICES OF JUDGMENT 0n Seizure Actions Flatbreadand gingersnapcookies, at New York, S. Dist. N.Y. Charged 3-21-73, while held by Reliable Kirschbaum Warehouse Corp., F00D/P0is0nousand DeleteriousSubstances New York, N.Y., the articles were held under insanitary conditions; Lettuce, Chelsea, 402(a)(4). Consent decree authorized release to dealer for salvaging. at Dist. Mass. 58879; F, F; Charged 1-30-73:when shipped by Bruce Church, Inc., Yuma, Ariz., the (F.D.C. No. S. Nos. 57-325 58-400 N.J. No. 15) article contained the pesticide chemical 1-methoxycarbonyl-1-propen-2-yl Flour, at Casper, Dist. Wyo. dimethylphosphatein excess of the prescribed tolerance; 402(a)(2)(B). Charged 4-6-73 while held for sale after storage at Pioneer Markets, ordered destruction. (F.D.C. No. 58864; S. No. 14-864 Inc., Casper, Wyo., the article contained rodent filth and had been held #; N.J. #No. 1 under insanitary conditions: 402(a)(3),402(a)(4).Default decree ordered 59105; Salmon,frozen, at Seattle, W. Dist. Wash. destruction.(F.D.C. No. S. No. 45-182 G. N.J. No. 16) Charged 4-4-73: when shipped by Shoshoni, Inc., Grand Rapids, Mich., Flour, at Charlotte, W. Dist. N.C. the article contained the nonconformingfood additive DDT (a pesticide Chargedon or about 2-21-73; while in transit in a rodent-infested rail chemical) and its related degredation products; the article contained car, the article contained rodent filth and was held under insanitary decomposedfish; and the article's label statement “For Export Only" conditions: 402(a)(3), 402(a)(4). Consent decree authorized release to was false and misleading as being contrary to fact; 402(a)(2)(c),402(a) Southern Railway Co., Charlotte, N.C., for salvaging. (F.D.C. No. 58881; (3), 403(a). Default decree ordered destruction. (F.D.C. No. 58984; S. No. 1-503 F., N.J. No. 17) Nos. 74-863/6 D; N.J. No. 2)

Flour, at Des Moines, S. Dist. Iowa. F000-Contamination,Spoilage, Insanitary Handling Charged2-8-73: while held for sale, the article contained rodent filth:

402(a)(3).Default decree ordered destruction. (F.D.C. No. 58868; S. No.

Beans, dried, at Eaton, S. Dist. Ind. 50-203 G. N.J. No. 18) Charged 12-14-72:while held by Meridian Foods, Inc., Eaton, Ind., the Flour, at Detroit, E. Dist. Mich. article contained rodent filth and was held under insanitary conditions; Charged by Bakery, Detroit, Mich., 402(a)(3), 402(a)(4). Consent decree authorized release to dealer for 3-30-73: while held Tarnow the salvaging. 58683; article contained rodent filth and was held under insanitary conditions; (F.D.C. No. S. Nos. 38-789/92 F. N.J. No. 3) 402(a)(3), 402(a)(4). Default decree ordered destruction. (F.D.C. No. G; Breader, Star Chef & Colonial Farms frozen breaded mushrooms,and batter 59081; S. Nos. 40-365/6 N.J. No. 19) mix, at Oxford, E. Dist. Pa.

Flour, at Lansing, N. Dist. III. Charged 4-10-73 while held by The Oxford Corp., Oxford, Pa., the Charged by Co., Lansing, Ill., breader containedrodent filth, and the batter mix contained insect filth 2-8-73: while held Conrad Kern the article contained rodent filth and had been held under insanitary conditions; –402(a)(3); and the breader and batter mix were held under insanitary 402(a)(3), conditions, prepared packed 402(a)(4). Consent decree ordered destruction. (F.D.C. No.

and the breaded mushroomshad been and G, 58884; S. No. 22-381 N.J. No. 20) under insanitary conditions—402(a)(4).Default decree ordered destruc

tion. (F.D.C. No. 59079; S. Nos. 84-146/50G; N.J. No. 4) Flour, at Orlando,M. Dist. Fla. Charged by Bakeries, Inc., Orlando, Fla., powder, flour, milk, Honolulu, 1-9-73: while held Famous the Buttermilk and nonfat dried at Dist. Hawaii. article contained rodent filth and was held under insanitary conditions; Charged 3-2-73: while held by H & W Distributors, Inc., Honolulu, Hawaii, insanitary conditions; 402(a)(3): 402(a)(4). Consent decree ordered destruction. (F.D.C. No.

the articles were held under 402(a)(4). F., 58718, S. No. 84-523 N.J. No. 21) Consent decree authorized release to the dealer for reconditioning.

(F.D.C. No. 58869; S. No. 75-566F. N.J. No. 5) Flour, cornmeal,and donut mix, at Detroit, E. Dist. Mich. Charged by Co., Inc., Detroit, Mich., Candies, Phoenix, 12-6-72: while held Bedell Flour at Dist. Ariz. - the articles were held under insanitary conditions; 402(a)(3),402(a)(4). Charged 2-9-73; while held by Ponca Wholesale Mercantile Co., Phoenix, Consent decree authorized release to the dealer for salvaging. (F.D.C. Ariz., the articles were held under insanitary conditions; 402(a)(4).De No. 58609; S. No. 36-782 F et al., N.J. No. 22) decree destruction. (F.D.C. No. 58849; S. No. 47-014 F et £"al.; N.J. No. #dered Flour, donut mix, and donut dusting sugar, at Long Branch, Dist. N.J. Charged3-7-73: while held by Baldanza Bakery, Inc., Long Branch, N.J., Cashewkernels, blanched,at San Francisco, N. Dist. Calif. the articles contained insect and-or rodent filth and Were held under Charged sale, insects; 3-6-73: while held for the article contained insanitary conditions; 402(a)(3), 402(a)(4). Default decree ordered de 402(a)(3).Consent decree authorized release to Hirschfelder Co., San struction. (F.D.C.No. 58912; S. No. 63-470 F et al.; N.J. No. 23) Francisco, Calif., for salvaging. (F.D.C. No. 58959; S. No. 91-285 G;

N.J. No. 7) Flour and flour mix, at Union City, N. Dist. Calif. Charged by Cheney Products, Inc., Catsup, actions, Muskegon, 11-27-72: while held Bros. Food 3 seizure at W. Dist. Mich. Union City, Calif., the flour contained rodent filth, and the articles Charged 12-14-72,1-8-73, and 1-11-73:when shipped by Fettig Canning insanitary conditions; 402(a)(3), Corp., Elwood, Ind., article, part Catsup were held under 402(a)(4).Default decree

the labeled in “Shurfine Tomato F, ordered destruction. (F.D.C. No. 58573; S. Nos. 75-070/2 N.J. No. 24) . Distributed by Shurfine Central Corp., Northlake, III.," contained

decomposedtomato material; 402(a)(3). Consent decrees ordered de Flour and rice, at South Boston, Dist. Mass. struction.(F.D.C.Nos. 58685, 58766, 58808; S. Nos. 98-421 F, 98-423 F, Charged 3-6-73; while held by Abbey Warehouse Corp., South Boston, 98-422 F. N.J. No. 8) Mass., the articles contained rodent filth and were held under insani tary conditions; 402(a)(3), Catsup, Ripe, Dam, 402(a)(4).Default decree ordered destruction.

Wine at Beaver E. Dist. Wis. G, (F.D.C. No. 58883; S. No. 14-541 N.J. No. 25) Charged 3-27-73: when shipped by Fettig Canning Corp., Elwood, Ind., the article contained decomposed tomato material; 402(a)(3). Default FIOur and Sunflower Seedsat South Boston, Dist. Mass. ordered destruction. (F.D.C. No. 590.42;S. No. 60-047 G. N.J. Charged 3-15-73, while held by Abbey's WarehouseCorp., South Boston, O. 9) Mass., the flour containedrodent filth, and the articles were held under '' insanitary conditions; 402(a)(3), 402(a)(4). Default decree ordered de sweepings, Philadelphia, Cocoa bean at E. Dist. Pa. G; struction. (F.D.C.No. 58983; S. No. 15-909 N.J. No. 2 Charged3-2-73:while held by Ben Rosenberg,Inc., Philadelphia, Pa., the article was held under insanitary conditions; 402(a)(4).Consent decree Lentils, dried, split peas, rolled oats, shelled peanuts, millet, and soybeans,

ordered destruction. (F.D.C. No. 58946; S. No. 83-001 G, N.J. No. 10) at Culver City, C. Dist. Calif. Charged 4-2-73, by Trading Co., Inc., City, Cornmeal,flour, pinto beans, Paintsville, Ky. while held Erewhon Culver and dried at E. Dist. Calif., the articles were held under insanitary conditions; 402(a)(4). Charged6-26-73: while held by Paintsville Grocery Co., Inc., Paintsville, Consent decree authorized release to Erewhon, Inc., of Boston, Mass., Ky., the articles contained rodent filth and were held under insanitary for salvaging.(F.D.C. No. 59096; S. Nos. 52-366/7 G et al.; N.J. No. 27) conditions; 402(a)(3), 402(a)(4). Consent decree authorized release to

(F.D.C. No. 59333; S. Nos. 3-574/80 G, 3-703/4 G; Milk, nonfat, dried, at Thomaston,M. Dist. Ga. .J. No. ) Charged 3-30-73: while held for sale, the article was held under in

'' sanitary conditions whereby it may have become contaminated with Cornmealmix, hominy grits, and flour, at South Milwaukee, E. Dist. Wis. mold, 59094; Charged by Sucharski, Inc., Milwaukee, 402(a)(4).Default decree ordered destruction. (F.D.C. No. 11-18-71:while held W. South G, * S. Nos. 5-124/5 N.J. No. 28) Wis., the articles contained insect filth and were held under insanitary

conditions; 402(a)(3), 402(a)(4). Default decree ordered destruction. Mung beans, at Chicago, N. Dist. III. (F.D.C. No. 57646; S. Nos. 35-193/5 E, 35-198/9 E. N.J. No. 12) Charged 8-21-73,while held by Great China Food Products Co., Chicago, Ill., insanitary lupini beans, Denver, the article contained rodent filth and was held under

Fennel seed and at Dist. Colo. G; conditions; 402(a)(3),402(a)(4).(F.D.C. No. 59428; S. Nos. 24-951/2 Charged 10-15-71:while held for sale, the fennel seed contained rodent N.J. No. 29) filth, and both articles contained insects; 402(a)(3). Default decree

ordered destruction.(F.D.C. No. 57562; S. Nos. 63-569/70 E. N.J. No. 13) Mustard bran, at Nashville, M. Dist. Tenn. Charged 3-27-73; by Foods, Nashville, Tenn., Filberts, shelled, Trenton, while held Dale's the at Dist. N.J. article contained rodent filth and was held under insanitary conditions; Charged 2-13-73: while held by Mrs. Erzak's Foods, Inc., Trenton, N.J., 402(a)(3), 402(a)(4). Default decree ordered destruction. (F.D.C. No. insanitary the article contained rodent fifth and was held under condi 59083; S. No. 3-426 G; N.J. No. 30) tions: 402(a)(3),402(a)(4).Default decree ordered destruction. (F.D.C. No. 58859; S. No. 63-981 G. N.J. No. 14) Orangejuice, at Detroit, E. Dist. Mich.

36-March 1974 / FDA Consumer Charged 1-8-73: While held for sale, the article contained a decom 1453(a)(2).Consent decree authorized release to the dealer for relabel G; posed substanceand was in rusty, swollen, and leaking cans; 402(a)(3). ing. (F.D.C. No. 59129; S. No. 47-703 N.J. No. 47) Evans, Consent decree authorized release to Kenneth C. t/a Ken Evans beverages,HappySparkle Food Distributor, Detroit, Mich., for salvaging.(F.D.C. No. 58738; S. No. Carbonated LemonSour and Black Jack Tom Collins

Sour, at Ellsworth, 37-991 F; N.J. No. 31) Mixer East W. Dist. Wis. by Charged4-12-73 when shipped Jacob Ries. Bottling Works, Inc., . Sha Peanuts, shelled, Charlotte, at W. Dist. N.C. kopee, Minn., the articles failed to declare the optional ingredient so

Charged 2-26-73: while held for sale, the article contained insects; dium benzoate as prescribed by the definition and standard of identity

402(a)(3). Consent decree authorized release to D0than Oil Mill CO., for such beverages; 403(g)(2). Default decree authorized donation to F., G; Ala., for salvaging. (F.D.C. No. 58911; S. No. 6-435 N.J. No. charitable institution. (F.D.C. No. 59133; S. No. 60-587 N.J. No. 48)

#" C00kies, gingerbread, at St. Louis, E. Dist. M0. by Peanuts, unshelled, at Greenville, E. Dist. N.C. Charged 6-1-73, when shipped Crystal Cookie Corp., San Fernando,

Charged 11-7-72:when shipped by Gold Kist Peanut Co., Ashburn, Ga., Calif., the article was in violation of the Fair Packaging and Labeling in a the articles, which had been involved fire, were unfit for food by Act, since the principal display panel of the individual cookie packages a of of a reason of a strong odor of smoke, blackened shells, scorched nuts, lacked statement the identity the commodity and lacked

empty shells, and miscellaneous debris; 402(a)(3).Consent decree au quantity of contents statement; 15 U.S.C. 1453(a)(1),1453(a)(2).Consent A; G; S. thorized release to Keel Peanut Co., Inc., Greenville, N.C., for salvaging. destruction. (F.D.C. No. 58257 No. 47-709 N.J. F., (F.D.C. No. 58484; S. No. 5-467 N.J. No. 33) £rdered0. at C. Pecan pieces, at Miami, S. Dist. Fla. Corn kernels, Los Angeles, Dist. Calif. Charged 3-5-73: when shipped by Dasher Pecan Co., Waldosta,Ga., the Charged2-28-73: when shipped by Crispy Corn Co., Bellingham, Wash.,

article contained E. coli; 402(a)(3).Consent decree authorized release the article, labeled in part “Clover Club Jumbo Corn . . . Distributed G; . . . in of for reconditioning.(F.D.C. No. 58956; S. No. 584 N.J. No. by Clover Club Foods Co. Kaysville, Utah,” was violation

£ese the Fair Packaging and Labeling Act, since the quantity of contents declaration was not separated from other printed label information ap

Pecans, shelled, Mansura, at Memphis,W. Dist. Tenn.

pearing declaration, quantity of statement,

by below the and the contents Charged on or about 3-26-73: when shipped Central Pecan Shelling

appearing on the principal display panel area of more than 25 square Co., Mansura, La., the article contained E. COli; 402(a)(3). Consent

inches, was in a type size less than 3/16 inch high; 15 U.S.C. 1453(a)(2), G; destruction. (F.D.C. No. 59093; S. Nos. 2-090/1 N.J. 58933; #,"0. 1453(a)(3)(C)(i).Default decree ordered destruction. (F.D.C. No. G; S. No. 53-141 N.J. No. 50)

Rice, at Colma, N. Dist. Calif. Salmon, smoked, at Minneapolis, Dist. Minn. Charged by Quality Foods, Inc., Colma, Calif., 4-10-73: while held the Charged 2-26-73: when shipped by Specialty Seafood Co., Anacortes, articles, insanitary contained rodent filth and were held under condi Wash., the article, labeled in part “Specialty Brand Smoked Barbecued tions; 402(a)(3), 402(a)(4). Default decree ordered destruction. (F.D.C. Salmon. . . . . Packed for International Packing Co., ...... Minneapolis, G, No. 59120; S. Nos. 90-647/51 N.J. No. 36) Minn.,” was in violation of the Fair Packaging and Labeling Act, since

Sage, coriander seed, and dried chilis, at Los Angeles, C. Dist. Calif. the quantity of contents declaration was not in the bottom 30 percent

Charged 2-23-73: while held by Tampico Foods (Jesus Martinez), Los of the principal display panel area, and the quantity of contents state

Angeles, Calif., the articles were held under insanitary conditions; 402 ment, appearing on the principal display panel area of more than 5 to (a)(4). Consent decree authorized release the dealer for recondition Square inches, was in a type size less than 1/8 inch high; 15 U.S.C. F; ing. (F.D.C. No. 58910; S. Nos. 49-365/7 N.J. No. 37) 1453(a)(2),1453(a)(3)(C)(i).Consent decree authorized release to Inter national Packing Co., Minneapolis, Minn., for relabeling. (F.D.C. No.

slices, Smoked,canned, at Paul, Salmon St. Dist. Minn. G; 58932; S. No. 60-361 N.J. No. 51) Charged8-10-73; while held for sale, the article contained decomposed

Spaghetti, Chef-a-Roni, at Attleboro, Salmon;402(a)(3).Consent decree authorized release to GourmetF00ds, Sauces for Dist. Mass. Charged shipped by Industries, Inc., Inc., St. Paul, Minn., for export to the original foreign supplier. (F.D.C. 3-6-73: when Eastern Food East G, G, No. 59421; S. Nos. 59-837 60-435 N.J. No. 38) Greenwich,R.I., the ingredient statementwas not prominentlyplaced on

the , articles', labels with conspicuousness, since the statement was

Salt and flourmill food component, at Henderson, E. Dist. N.C.

printed in gold ink on a gold-coloredbackground—403(f);and the arti Charged 10-25-72:while held by Sanford Milling Co., Henderson,N.C., cles were in violation of the Fair Packaging and Labeling Act, since the articles were held under insanitary conditions; 402(a)(4). Consent the quantity of contents statement, appearing on the principal display

decree authorizedrelease to dealer for reconditioning.(F.D.C. No. 58424; panel area of more than 5 square inches, was in a type size less than F; S. Nos. 6-673/4 N.J. No. 39) 1/8,inch high; and the quantity of contents declaration was not sepa printed appearing Soups of various kinds, at Bridgeport, Dist. Conn. rated from other label information above the declara

by 1453(a)(3)(C)(i), Charged 9-28-71: when shipped Bon Vivant Soups, Inc., . Newark, tion-15 U.S.C. 1453(a)(2). Default decree authorized

58872; S. N.J., the articles, labeled in part “Bon Vivant Cream Vichyssoise Soup institutions. (F.D.C. No. Nos. 14-621/2 ;

(or other kind of soup) . . . Packed by Bon Vivant Soups, Inc., Newark, N.J. N0.£rtable

N.J.,” Soup of soup) . . . £ “Ancora Clear Green Turtle (or other kind Shrimp, raw, breaded, frozen, at Biloxi, S. Dist. Miss.

Soups, Inc., Newark, N.J.,” S. . . . . Bon Vivant and “S. Pierce Red Label Charged4-2-73: when shipped by Hudson Mercantile Corp., Hattiesburg,

Vichyssoise Cream Soup (or other kind of soup) . . . Packed for S. S. Miss., the article lacked the name and place of business of the manu

Pierce Co., Boston, Mass.,” were unfit for food in that some cans

facturer, packer, or distributor, and lacked an accurate statement of had been found to be defective and abnormal, and in that the manu the quantity Of Contents; and the article's label lacked the name of

facturing procedures used did not assure proper sealing of the cans the food as specified by the definition and standard of identity for

or adequate of to prevent heat treatment the sealed can contamina frozen, raw, breadedShrimp;403(e)(1&2),403(g)(2).Consentdecreeauthor tion and Spoilage; and the articles had been prepared, packed, and

to & Henry Guiterrez, tya of Biloxi, insanitary whereby they may ized release Ramon United Seafoods held under conditions have become con G, Miss., for relabeling. (F.D.C. No. 59089; S. No. 1-145 N.J. No. 53)

taminatedwith filth or wherebythey may have been rendered injurious

Shrimp, raw, breaded,frozen, at Scranton, to health; 402(a)(3),402(a)(4).Default decree ordered destruction. (F.D.C. M. Dist. Pa. E, E; by No. 57505; S. Nos. 29-016 5-318 N.J. No. 40) Charged 4-26-73 when shipped National Shrimp Processors, Inc.,

Brownsville,Tex., the article, labeled in part “Chicken of the Sea Shrimp Soybean cakes, at New York, S. Dist. N.Y. - Miniatures . . . Dist. by Ralston Purina Company,St. Louis, Mo., Ingre by Charged 2-27-73 when shipped Quong Hop & Co., San Francisco, dients . . . Sodium Tripolyphosphate,”failed to conform to the defi Calif., the article had been prepared,packed, and held under insanitary

of identity frozen, raw, shrimp, conditions; nition and standard for breaded because 402(a)(4). Default decree ordered destruction. (F.D.C. No. percent shrimp

G; the article tested less than 50 material and because 58905; S. No. 71-222 N.J. No. 41) the shrimp material contained sodium tripolyphosphate, a food additive at E. Sugar, jelly, ketchup,mustard,and relish, Norfolk, Dist. Va. not permitted as an ingredient; and the article's label lacked the name by by

Charged Norfolk, Baltimore, & lines, 2-16-73 while held Carolina of the food, as specified the definition and standard of identity;

Inc., Norfolk, Va., the articles were held under insanitary conditions; 403(g)(1), 403(g)(2). Default decree authorized donation to charitable G; to 402(a)(4).Consent decree authorizedrelease the dealer for salvaging. institution. (F.D.C. No. 59146; S. No. 85-513 N.J. No. 54) G; (F.D.C. No. 58927; S. Nos. 10-343/54 N.J. No. 42)

cane molasses sirup with added citric acid, at Waxahachie, N. *: Tomatojuice, at Fort Wayne, N. Dist. Ind. - sors:iSt. TeX.

by Charged shipped by Brothers, Monroe, La., Charged3-6-73 when shipped Beckman & Gast CanningCo., St. Henry, 1-18-73: when Norris West

article, in part Mary Sorghum-MolassesIngredients: Ohio, the article, labeled in part “Hillcrest Tomato Juice . . . Dis the labeled “Little by T. tributed Wesco Foods Company, Cincinnati, Ohio,” contained de Sorghum, Cane Molasses and Citric Acid . Distributed by W. composed tomato material; 402(a)(3). Default decree ordered destruc Burleson and Son, Inc., Waxahachie,Texas,” had been substituted for G; S. tion. (F.D.C. No. 58954; No. 39-706 N.J. No. 43) sorghum molasses, the article was offered for sale under the name of

another food, i.e., sorghum molasses, and the name of the article was Tomato juice, Naas, at St. Louis, E. Dist. Mo.

misleading—402(b)(2),403(a), 403(b); in Charged2-22-73: when shipped by NAAS Foods, Inc., Geneva, Ind., the false and and the article was

of Packaging Labeling Act, quantity of article containeddecomposedtomato material; 402(a)(3).Default decree violation the Fair and since the

placed in percent of

G; contents declaration was not the bottom 30 the ordered destruction. (F.D.C. No. 58930; S. No. 47-809 N.J. No. 44)

principal display area, the quantity of contents declaration was not

Wafers, wheat, Venus, and cheese sticks, Venus, at Des Plaines, N. Dist. Ill. separated from other printed label information appearing above and by Charged 2-7-73 when shipped Venus Wafers, Inc., Quincy, Mass., below the declaration, and the quantity of Contentsdeclaration was ex

the articles had been prepared, packed, and held under insanitary Con pressed as “Net Wt. 1 Lb. 14 Oz.” instead of “Net Wt. 30 Oz. (1 Lb. ditions; 58877; 402(a)(4).Default decree ordered destruction. (F.D.C. No. 14 Oz.)”; and the quantity of contents statement, appearing on the F; S. Nos. 21-843/5 N.J. No. 45) principal display panel area of more than 5 Square inches, was in a type high–15 1453(a)(2),1453(a)(3)(A)(i), Wheat, at Julesburg, Dist. Colo. size less than 1/8 inch U.S.C.

to organi Charged2-9-73: while held by Farmer's Grain Co., Julesburg, Colo., the 1453(a)(3)(C)(i).Consent decree authorized donation charitable F;

58759; S. article contained rodent filth and was held under insanitary conditions; zation. (F.D.C. No. No. 32-078 N.J. No. 55) to 402(a)(3), 402(a)(4). Consent decree authorized release dealer for Taco shells, Pancho Villa, at St. Paul, Dist. Minn. F; reconditioning.(F.D.C. No. 58874; S. No. 34-091 N.J. No. 46) Charged2-7-73: when shipped by RaymondDistributing Co., Inc., Supe rior, Wis., the article was short weight (approx. 5.5 percent); 403(e)(2). Labeling F00D/Economicand Violations Consent decree authorized release to Gourmet Foods, Inc., St. Paul, G; Minn., for relabeling. (F.D.C. No. 58885; S. No. 59-922 N.J. No. 56) Candy, Chocolate Peanut Clusters, at St. Louis, E. Dist. Mo. Charged by CO., Louis, Mo., 4-6-73: while held St. Louis Peco Flake St. Turnip greens, frozen, and other frozen vegetables, at Memphis, W. Dist. the article, which had been packagedby the dealer from bulk, was Tenn.

in violation of the Fair Packagingand Labeling Act, since the principal Charged 4-26-72: when shipped by Morrison Grain Co., Salina, Kans.,

display panel a quantity of declaration; lacked contents 15 U.S.C. the articles, labeled in part “Fresh Delight Brand . . . ChoppedTurnip

FDA Consumer / March 1974 / 37 Greens[or “Chopped Turnip GreensWith Diced Turnips" or “Whole Leaf DRUGS/HumanUse Spinach"] Processing Corpo . . . Packers and Distributors Delta Food Aminophyllinetablets, Mansfield, ration, Moorhead, Miss.,” “Stilwell Brand Stilwell Frozen Foods, Inc., U.S.P. at N. Dist. Ohio. Stilwell, Chopped Charged3-1-73: while held for sale after manufactureby C. M. Bundy Oklahoma . . Packers and Distributors Mustard Co., Cincinnati, Ohio, ingredients Greens,” and “Capitol Foods Sliced Squash . . . Capitol Foods Company who manufacturedthe article from Atlanta, Ga.,” weight (approx. per shipped in interstate commerce, the article's strength differed from Distributor . . . were short 2.54-4.98 quality standards, cent)–403(e)(2); and the articles were in violation of the Fair Pack and its fell below U.S.P. since the article failed the U.S.P. test for ethylene diamine; 501(b). Default decree ordered destruc aging and Labeling Act, since the quantity of contents of the spinach 58908; F; and both kinds of turnip greens was not placed within the bottom 30 tion. (F.D.C. No. S. No. 26-711 N.J. No. 64) percent of the principal display panel area; all the articles except the Beef peptone combinationinjection, at Brooklyn Park, Dist. Md. mustard greens were labeled as “Net Weight: 3 Lbs” or “Net Weight Charged on or about 3-30-73: when returned to D-M Pharmaceuticals, 2% Lb" instead of “Net Wt. 48 Oz. (3 Lbs.)” or “Net Wt. 40 Oz. (2 Inc., Rockville, Md., from Albuquerque, N. Mex., the article, labeled Lbs. 8 Oz.)”; and the quantity of contents statements of all the arti in part “Prosan Injection . . . manufacturedfor Sandia Pharmaceuticals, cles except the mustard greens, appearing on principal display panel Inc., Albuquerque,N.M. . . . Beef Peptones,” was a new drug without areas of more than 25 square inches, were in a type size less than an effective approved New Drug Application, and the package insert 3/16 inch high–15 U.S.C. 1453(a)(2), 1453(a)(3)(A)(i),1453(a)(3)(C)(i). contained false and misleading claims to the effect that because of Consent decree authorized release to the dealer for bringing into com the Beef Peptone constituent, the article was generally recognized as pliance with the law. (F.D.C. No. 57960; S. Nos. 1-770/4 F, N.J. No. 57) a rational, safe, and effective treatment for stimulating the antibody forming and detoxifying mechanismsof the body, and that the article Turnips with potatoes and carrots, mashed,frozen, Horn & Hardart, at Phila pain inflammatoryneuritis, delphia, E. Dist. Pa. was safe and effective for the relief of in Charged by Services, Inc., relief of pain and healing of lesions in herpes zoster opthalmicus, relief 11-29-72:while held Blue Grass Food Phila of pain associated with tabes dorsalis, when, in fact, the article was delphia, Pa., who had manufacturedthe article in part from turnips generally recognizedby experts qualified by training Shippedin interstatecommerce,the nameof the article, “Frozen Mashed not scientific and Turnips,” setting presented experienceto evaluatethe safety and effectivenessof drugs as rational, in the in which it was was false and mis safe, and effective treatmentfor such purposes; 502(a), 505(a). Default leading, since the article also containedsubstantial amountsof potatoes, 58940; C; carrots, “Vegetable stock,” destruction. (F.D.C. No. S. No. 10-823 N.J. and and the label lacked the common or #,"0. usual name of each ingredient, since the declared “vegetable stock" was not the commonor usual name of any ingredient, 403(a), 403(i)(2). Dig0xin tablets, U.S.P., at Danbury,Dist. Conn. Consent decree authorized release to the dealer for relabeling. (F.D.C. Chargedon or about 12-17-71;when returned to Davis-EdwardsPharma No. 58507; S. No. 69-024 F, N.J. No. 58) cal Corp., Danbury,Conn., from Philadelphia, Pa., circumstances of the Vanilia flavoring, imitation, Como, and other flavorings and spices, at Nash article's manufacture,processing, and the packing and holding failed Ville, Dist. Tenn. to conform to current good manufacturingpractice, and the article's Charged 3-13-73: while held by Cumberland Manufacturing Co., Nash strength and quality differed from and fell below U.S.P. standards, since ville, Tenn., who had manufacturedthe flavorings and had repacked the article failed the U.S.P. test for content uniformity; 501(a)(2)(B), the spices, the articles were short weight; 403(e)(2). Default decree 501(b). Default decree ordered destruction. (F.D.C. No. 57329; S. No. authorized donation to charitable organizations. (F.D.C. No. 58949; S. 5-014 E; N.J. No. 66) No. 7-374 F., N.J. NO. 59) Heptron,heparin sodium, choline, and vitamin combination, at St. Louis, E. WITAMINS-SPECIALDIETARY FO0DS Dist. Charged 2-22-73: when shipped by Myers-Carter Laboratories, Glendale,

corn, at Kisco, S. Caramel Mount Dist. N.Y. Ariz., the article was a new drug withoutan effective approvedNew Drug

Charged or shipped by Companies, on about 5-3-72: when Howard Food Application, and the labeling of the article contained false and mis

Inc., Methuen, Mass., labeling of article, in part the the labeled leading claims in that the listing in the labeling of the article of heparin

. . . is Sugar “Sweet'N Low Caramel Corn "Sweet'N Low America's #1 sodium, choline chloride, cyanocobalamin,folic acid, and niacinamide as . . . Substitute No Salt Added–No Butter Fats Eat All You Want-As ingredients of the article and the statement “Indications: Wherever

. . . Ingredients Syrup Solids, Often As You Want! Corn Pure Unsalted impaired lipid metabolism exists or is suspected as in hypertension,

Vegetable Margarine . . . Distributed by Sweet'N Low Confections Inc., diabetes mellitus, xanthomatosis,hypothyroidism,angina pectoris, myo York,” misleading being New contained false and claims about Sweet cardial infarction, and certain diseases of the liver and kidney asso

ened with “Sweet'N Low” sugar substitute in place of ordinary Sweet ciated with atherosclerosis” representedand suggested that each Such

eners, being of in weight being and about value control diets and about ingredient of the article was of value for the article's intended use

consumed in any amount desired by dieting individuals-502-a); the and that there was substantial scientific evidence that the article Was labeling required represented special lacked information for food for safe and effective under the specified conditions of use; 502(a), 505(a). F;

dietary use–403(j); in of and the article was violation the Fair Pack ordered destruction. (F.D.C. No. 58919; S. No. 43-688

aging and Labeling Act, since the quantity of contents declaration, ap .J. No.#"

pearing principal display panel of square £ on the area more than 25 Lidocaine hydrochloridewith epinephrineinjection for dental block and infil inches, was in a type size less than 3/16 inch high–15 U.S.C. 58000; tration, at Bellwood, N. Dist. Ill. 1453(a)(3)(C)(i).Consent decree ordered destruction. (F.D.C. No. Charged shipped by Co., Toledo,

F; 4-10-73 when Litton Dental Products S. No. 67-375 N.J. No. 60)

Ohio, the strength of the article, labeled in part “Lidocaton 2% with

E candy bars, at Phoenix, Power Dist. Ariz. EpinephrineLidocaine HC1 . . . Manufactured in Switzerland by: Phar Charged shipped by Carolyn's Candies, Inc., Angeles, 12-5-72:when Los matonLtd. . . . ExclusiveDistributors for USA: MPL, Inc., Chicago, Ill.,”

Calif., the article's name and the label Statement“Vitamin E 400 Intl. differed from, and its quality and purity fell below, the U.S.P. standards; falsely misleadinglyrepresented suggested Units” and and that vitamin 501(b). Default decree ordered destruction. (F.D.C. No. 59.077; S. No. F., E provided energy and stamina, and that such a candy bar was neces 23-050 N.J. No. 68)

sary and useful in supplementingthe diet with vitamin E-403(a); and

Lidocaine hydrochloridefor dilution with Add-A-Jet injector, 6 seizure actions, the article was in violation of the Fair Packaging and Labeling Act,

at Venice, M. Dist. Fla.; Columbia, W. Dist. Mo.; Fort Lauderdale, S. since the quantity of contents declaration was not located on the prin cipal display panel–15 Lynchburg,W. Dist. Va.; Philadelphia, E. Dist. Pa.; and Exeter, U.S.C. 1453(a)(2).Default decree ordered de 1st. N.H. F; # # struction.(F.D.C.No. 58594; S. No. 46-941 N.J. No. 61) Charged3-26-73,3-27-73,3-30-73,3-19-73,4-4-73, 3-19-73: when shipped tablets, powder, Neo-Life Pro-Nibs Neo-Life Minute Meal and Neo-Life 90 Plus by International Medication Systems, Ltd., South El Monte, Calif., the

High food, at Fremont, Instantized Protein Dist. Nebr. article was a new drug without an effective approved New Drug Appli

Charged 6-14-68: when shipped by Neo-Life of America, San Lorenzo, cation and without notice of claimed investigational exemption; 505(a). Calif., powder the Minute Meal had had the valuable constituents vita Default decrees ordered delivery to FDA and-or destruction. (F.D.C. Nos. G, G,

B1, B2, C in part or abstracted; min vitamin and vitamin omitted and the 59014, 59037, 59055, 59059, 59061/2; S. Nos. 3-189 48-922/3 G, G, G, G; labeling of the Minute Meal was false and misleading as to the declared 531 12-72.5 82-186 15-193 N.J. No. 69) vitamin content and contained false and misleading claims that the

Mykocert medicatedvaginal tampons, at Chicago, N. Dist. Ill. article was a significant source of protein for the diet when used in Charged1-26-71;while held by Beutlich, Inc., Chicago, Ill., after manu

place of ordinary meal–402(b)(1), 403(a); labeling of an the the Pro locally hydrochloride Nibs tablets containedfalse and misleadingclaims for promoting health facture for the dealer from 9-aminoacridine which

had been shipped in interstate commerce,the article's box label Con and energy in people of all ages and conditions and of being a signifi

tained false and misleadingclaims as a treatment of most vaginal infec cant source of protein for the diet; and the article failed to bear the tions caused by gram-positive and gram-negativeorganisms; and the required special dietary use information,such as the number of available article's labeling lacked adequate directions for use and was not ex calories, the percent of the nonnutritive constituent calcium cyclamate,

empted therefrom, since the article was a new drug without an effec and the word “nonnutritive" in juxtaposition with the name calcium

tive approvedNew Drug Application, and no notice of claimed investi cyclamate-403-a), 403(j); and the labeling of all the articles contained gational exemption was on file, 502(a), 502(f)(1). The article was false and misleading claims to promote proper glandular function, as claimed by the dealer who denied the charges. The parties served writ

food, rebuilding processes of body; similation of and the that the interrogatories subsequently articles containedall known Vitamins,minerals, and trace elements from ten on each other which were answered

by party. a summaryjudgment. natural and organic sources; that they were truly nutritive food supple each The Governmentfiled motion for ments; that, directed, significant Thereafter, the case came on before the court on the motion for sum and when used as the articles were mary judgment stipulation by parties sources of protein containing all essential amino acids for the diet; and with the all that should the

court decide that it could not or did not wish to dispose of the case within that the article Minute Meal was a balanced meal, low in Calories; and

the limitations of the summaryjudgmentrule, that the court might decide

to or of ingre the articles failed bear the common usual name each merits, taking affidavits, deposi dient, since calcium cyclamatewas not declared and since other ingre the case on the into considerationthe tions, interrogatories, and other information on file, as refined and dients were not declared by their common or usual name–403(a), by Smith, Fremont, Nebr., by oral argument. In finding for the Government,the court 403(i)(2).The articles were claimed Clara who said: denied the charges. The parties served written interrogatorieson each £ed

“The seeming complexity of this action diminishes, once the critical other and litigated the answers thereto. Subsequently, a consent decree

issue around which the entire case revolves is isolated. The drug here of condemnationordered destruction. (F.D.C. No. 55465; S. No. 30-415

in question consists of a tampon impregnated with 14 mgs. of the C et al.; N.J. No. 62)

chemical ingredient 9-aminoacridine hydrochloride and a binder of

F000 ADDITIVE 14 mgs of polyvinylpyrrolidonewhich Beutlich markets as a prescrip

tion drug for the alleviation of various vaginal infections. The tampon

Cherries, Maraschino, Baer, at Omaha, Blanke Dist. Nebr. is inserted in the conventionalmanner and its intended purpose is to

Charged 4-19-73, when shipped by Blanke Baer Fruit & Flavor Co., St. slowly release the medication onto the infected area. The Government Louis, Mo., nonconforming the article contained the color additive Pon in its 21 U.S.C. § 352(a) argument contends that purpose falls short

SX, in in of ppm of ceau that the article contained excess 150 such of accomplishmentand that the labeling statements in regard to its color; 591.39; red 402(c). Default decree ordered destruction. (F.D.C. No. adequacyand effectiveness are therefore false and misleading in vio S. G. No. 50-144 N.J. No. 63) lation of the statute. Though not in any way conceding any part of

38-March 1974 / FDA Consumer these allegations the Government'sbriefs concentratedon the second Charged 2-5-73: while held for sale, the strength of the article fell

part of its argument in regard to the 21 U.S.C. § 352(f)(1)violations. below its purported strength, since it contained approximately71 per “There are five conceivabledefenses that claimant could have raised cent of the declared phenobarbital;501(c). Default decree ordered de

to the Government's $ 352(f)(1)grounds for struction. (F.D.C. No. 58873; S. No. 6-654 F; N.J. No. 71) * * * forfeiture. *

“The fifth and final avenue and the one chosen by claimant is that DRUGS-Veterinary

Mykocert is not a ‘new’ drug as defined in 21 U.S.C. § 321 and 21 Dr. Brittner's calcium gluconate tablets and Dr. Brittner's Cough Suppress

§ though § is inapplicable CFR 130.1 and that even 352(f)(1) because dextromethorphancombinationtablets, at Pennsauken,Dist. N.J.

of the drug's prescriptive nature the non-newness of the drug exempts Charged 8-23-73: while held by Animal Specialties, Inc., Pennsauken,

it any of requirements of previously from the the mentionedalternatives N.J., who had repackedthe article from bulk tablets, the articles were

Such as application or filing with the Federal [Food and] Drug Adminis new animal drugs, and no approval of a New Animal Drug Application

of is dependent tration. Thus the entire crux the case on the one was in effect with respect to the use and intended use of Such drugs;

as Mykocert is or is a drug. critical decisive issue whether not new 501(a)(5). Consent decree ordered destruction. (F.D.C. No. 58206; Nos. 54-976 F, 54-979/80 F; N.J. No. 72) “In applying the statutes, regulations and cases to our set of facts

we find the Government'sposition to be the correct one. 0xytetracyclinepowderaccompaniedby bottles of a diluent base for injection, Rushville, “Claimant's contention that Mykocert is not a new drug can only at S. Dist. III.

Succeed if it is recognizedby experts in the field as safe and effective. Charged 2-20-73: while held by Schuyler Laboratories, Rushville, Ill., There are two possible alternatives that would substantiate claimant's whose printed flyers promotedthe sale of the powder and diluent, the

assertions. Either a Mykocert type drug in its exact form, dosage, and article consisting of the powderand the diluent was a new animal drug, application must be recognizedby experts (even though that drug may and no approval of a New Animal Drug Application was in effect with

be marketedunder a different name) or each of the componentparts respect to the use and intended use of the article, and the labeling adequate mixing of Mykocert must be recognizedwith the critical caveat that the com lacked directions for and use in each condition and

bination of these parts does not in any way create a new drug under in each species of animal for which the article was intended; 501(a)(5),

21 CFR § 130(h). 502(f)(1). Consent decree authorized release to dealer for destruction

“It is clear from the affidavits, documents and all other evidence of labels and accompanyinglabeling and bringing into compliance.(F.D.C.

that though there are other dosages and forms of application for the No. 58907; S. No. 22-121 G, N.J. No. 73)

type of drug is no general recognition here involvedthere however under Waspmedicatedpremix, at Fort Dodge, N. Dist. Iowa. any construction of that test for Mykocert in its exact form. Charged3-15-73: while held by Quality Plus Products, Fort Dodge, Iowa,

Mykocert in is virtually nonexistent, “Literature on its exact form Who manufacturedthe article using drug componentsreceived in inter

no a body of literature, is expert opinion less and there no available State commerce,the article was a new animal drug, and no approval

as to general recognition of a mg. dosage of the 14 9-aminoacridine of a New Animal Drug Application was in effect with respect to the applied in a tampon form and claimant therefore cannot succeed with use and intended use of the article; 501(a)(5).Default decree ordered

a Mykocert type,drug is recognized. the contention that itself Without destruction. (F.D.C. No. 58924; S. Nos. 50-201/2 G; N.J. No. 74) going into great detail the few affidavits that address themselves to

Mykocert itself rather than to its componentparts are inadequate,since MEDICAL DEVICES

they focus on safety and effectiveness rather than general recognition

and furthermore are by practitioners prescribing the drug for patients Aire N-Aquabath device, at Colorado Springs, Dist. Colo. Charged shipped by Anaco, Inc., Brainard, Minn., experts in the field. (See 294 F. Supp. 1307 Supra at 2-23-73: when the ac Companyingleaflets contained false and misleading claims for arthritis,

£" it is to acknowledge general bursitis, rheumatism,neuritis, Soreness, veins, backache, “In addition difficult for this Court the muscle varicose tension, hemorrhoids, sprains, strains, contusions, recognition of Mykocert when the chairmen of the Obstetrics and Gyne nervous traumatic

cology Departments at Chicago Medical School: State University of New Synovitis, bone injuries, post fractures, circulatory disturbances, inflam York, DownstateMedical Center; NorthwesternUniversity.Medical School; mation, edema, ulcers, arteriosclerosis, peripheral vascular diseases,

and Loyola University Medical Center all swear that Mykocert is not painful joints, scar tissue, adhesions, peripheral nerve injuries, post

generally recognized. While we do not express an opinion as to poliomyelitis Spasm,and for toning and conditioning muscles, controlling

whether a ‘mere conflict in expert opinion constitutes lack of general weight, and providing better mental and physical health; 502(a). Default F., recognition, it cannot be denied that the affidavits of five of the lead destruction. (F.D.C. No. 58886; S. No. 33-639 N.J.

ing in deny general recognition #,"0. doctors the field which creates more than

a “mere' conflict. It is inconceivablethat a drug Such as this could Diapulse electromagneticenergygenerators,12 seizure actions, at Lancaster,

be considered generally recognized in the face of Such learned non

Calif.; Oakland, N. Calif.; Beach, C. Calif.; recognition. Dist. Dist. Redondo Dist.

Cambridge, S. Dist. Ohio; Larned, Dist. Kans.; Unionville, E. Dist. Mich.;

“Yet even if these experts claim that Mykocert is not generally recog . Harrisburg,M. Dist. Pa.; Stockton, Dist. Kans.; Smith Center, Dist. Kans.;

nized in its present state, claimants might still attempt to salvage Cimarron,Dist. Kans.; Hays, Dist. Kans.; and Glendale, C. Dist. Calif. Mykocert by using the other avenueavailable by asserting that absence Charged on or about 12-14-72, 12-13-72, 12-6-72, 11-22-72, 12-7-72,

of recognition, Mykocert as is given for such irrelevant the fact that 12-11-72, 11-20-72, 11-30-72, 11-28-72, 11-30-72, 11-28-72, 12-14-72:

its componentparts, generally, recognized. in are Claimant does fact when shipped after manufacture for Diapulse Corp. of America, New

place great in by directing a of faith this contention vast amount litera Hyde Park, N.Y., and while held for sale, the articles' labeling lacked

to recognition of tampons ture the effectivenessand and aminoacridines adequatedirections for lay use for their intended purposes, and ade

generally In argument to for use on infections. order for this succeed quate information for use by licensed practitioners could not be pre

Mykocert in its present state must be similar enough in form, dosage, pared; 502(f)(1).Default decrees ordereddestruction or, in the Kansas

purpose, and application to the general usage of aminoacridinesso as Seizure actions, rendering inoperableand donation to an educational in

to be within the genre aminoacridine’and the general recognition at stitution. (F.D.C. Nos. 58517, 58531/2, 58538, 58549/55, 58560; S. Nos.

to genre. If Mykocert in any degree tributed that deviates substantial 47-683 F, 74-243 F, 47-686 F, 25-959 F, 40-397/8 F, 38-173 F, 66-464 F,

previous of usage it rely from forms aminoacridine then cannot on the 42-343 F, 42-342 F, 42-349 F, 42-354 F, 45-819 F; N.J. No. 76)

general recognition of its component parts. The regulations in fact E Z

cabinet, at Winchester, indicate that combinations of ‘old’ drugs may be a ‘new’ drug as is Breathe electrostaticair filter W. Dist. Va.

Charged or shipped by Industries, stated in 21 CFR 130.1(h)(1)through (5). See Supra, pages 6 and 7. on about 12-31-70:when M-Tron Yank

ton, S. Dak., labeling a of “Simply stated under the drug laws the whole of a drug may be the article's contained number false and

misleading including Z rep greater or ‘newer' than all of its parts. statements the statement“E Breathe” which

“How Critical this factor becomes to our case is evidenced in the resent and suggest that the article was adequateand effective to filter

fact that the Vast majority Of claimants’ affidavits and documentsare the air in a 15 x 15 foot room in 14-18 minutes; to totally remove

particles air, viruses; to a directed at the recognition of the componentparts of Mykocert rather all from the even bacteria and make room

healthier; to Smoke, pollen, dust, than to the exact form and dosage of Mykocert.There is a vast amount make the air free from and household

Spray; to breathing easier, especially people breathing of literature on aminoacridines,affidavits on the efficacy of and rec make for with

problems,pollen irritation, or general congestion; to ognition of aminoacridinesand literature on tampon usage and claimant reduce the discom of adds up the general recognition of tampon usage and 9-aminoacridine fort asthma, hay fever, and other respiratory diseases, and by re of to of usage and COmesup with a total of non-newness.Thus if we determine moval Smoke,dust, and householdsprays reduce the cause Suf fering patients asthma, emphysema, allergies; that Mykocert is more than just the componentparts of tampons and for with and 502(a). The by shipper charges. aminoacridines,claimant is practically foreclosed from succeedingbased article was claimed the who denied the The Govern

interrogatories Thereafter, a on its almost total reliance on affidavits directed at the component ment served written on the claimant.

parts rather than the Whole. consent decree authorizedrelease to the claimant for relabeling. (F.D.C. D; “In adding up the tampon and aminoacridineusage we do not come No. 56879; S. No. 12-957 N.J. No. 77)

up with a total of Mykocert. In view of the fact that the 14 mg. Firm 0 Matique battery-poweredvibrator pads for face, throat, and breasts,

dosage of Mykocert is a much larger dosage than used in other amino and pink “firming” cream, at Beaumont, E. Dist. Tex.

vaginal infections; given tampon of acridine medications for the form Charged5-31-72: when shipped by Peel-0-MatiqueCorp., Inc., Los Ange

application is gell of application which unlike tablet and cream form les, Calif., the articles' labeling contained false and misleading claims

of vaginal infection medication;that the element of polyvinylpyrrolidone to firm the body; provide a firmer, healthier, more attractive appear

is as a chemical,binder, Mykocert is a drug added we hold that new ance; renew the firmness of youth in a woman'sface, chin, and breasts;

as in § of a dosage or defined 21 CFR 130.1(h)(5)i.e. ‘The newness restore and build muscles and muscle elasticity; create better circula

or of or application method duration administration [constitutes newness] tion; tighten and firm soft and sagging skin tissues, saggy breasts,

. . . though in dosage, or of even when used other method duration double chins, and flabby jaws; tone the muscle fibers that support the

or administrationon application . . . is not a new drug.” breasts, and develop and strengthenthese muscles to return them to

dosage of application “We believe that the new and form creates their natural shape and firmness—502(a); the pink cream lacked an

greater risks and questions of safety and effectiveness than previously accurate statement of the quantity of contents, lacked the name of

recognized of vaginal given forms medication for infections and the each active ingredient, lacked adequatedirections for use, lacked warn

area of its application—warrants a finding of ‘newness.” delicate ings against unsafe use, and was a new drug without an approvedNew Drug Application—502(b)(2),502(e)(1)(A)(ii),502(f)(1), 502(f)(2), Summarize,then, 505(a). “T0 we are satisfied that based on all the docu The articles were claimed by the shipper, who denied the charges. The

is general recognition among ments and evidence submitted there no Governmentserved written interrogatories on the claimant. After the

qualified experts Mykocert as is that such safe and effective and that claimant answeredthe interrogatories,the Governmentmoved for sum

claimant cannot rely on the recognition of its componentparts since mary judgment.Thereafter, a consent decree ordered destruction. (F.D.C.

is a drug meaning of regulations. the combination new within the the F; No. 58048; S. Nos. 31-710/12 N.J. No. 78)

Mykocert is therefore a new drug and not exemptfrom the statutes un by der which forfeiture the Governmentwas accomplished. Massage-A-Bathbath device, at Davenport, S. Dist. Iowa. “Judgment will be entered for the United States.” (F.D.C. No. 56959; Charged 2-27-73:when shipped by Anaco, Inc., Brainard, Minn., the ac

D; Companying misleading arthritis, S. No. 26-459 N.J. No. 70) leaflets contained false and claims for bursitis, rheumatism, neuritis, muscle soreness, varicose veins, back

Phenobarbitalcombinationliquid, at Florala, M. Dist. Ala. ache, nervous tension, hemorrhoids, traumatic sprains, strains, contu

FDA Consumer-March 1974/39 sions, synovitis, bone injuries, post fractures, circulatory disturbances, July 7, 1970, wherein the distinction between an administrativesearch

inflammation, edema, ulcers, arteriosclerosis, peripheral vascular dis and a criminal search is made. Here, of course, there was an ad

eases, painful joints, tissue, adhesions, peripheral injuries, ministrative Search Similar to that in Thriftimart. scar nerve muscles, and postpoliomyelitis spasm, and for toning and conditioning “We reverse the order suppressing evidence and remand for further

controlling weight, and providing better mental and physical health; proceedings in the trial court.” 502(a). Default decree ordered destruction. (F.D.C. No. 58887; S. No. The case came on for trial before the district court, and the corpora 38-92.7F, N.J. No. 79) tion was found guilty and was fined $5,000, plus costs. The Govern

ment submitted charges based on the actual costs to the Government. Tights, body suits, shirts, and stretch garment for neck and chin, at Colum The corporationmoved to retax costs on the grounds that there was no bus, S. Dist. Ohio. authority to assess costs of inspecting the warehouse, costs for Charged2-13-73 when shipped by True Form Foundations, Inc., Darby, analysis of food samples, costs for more than one round-trip airline Pa., the labeling of the articles, labeled in part “Skin Gym by Sub fare from Los Angeles to Las Vegas for one witness who testified on tract . . . New York, N.Y." and “Chin Gym by Subtract . . . .New York, May 5 and May 11, 1971, costs for attendanceand services in a rep N.Y.,'" contained false and misleading claims,for the tights, body suits, resentative capacity (rather than a witness), costs for witnesses for and shirts for toning and beautifying the body with gentle massage-like days other than days of actual testimony, etc. The court sustained the action, in shaping the body, in working isometrically to tone, firm, and costs of inspection and cost for analysis, sustained the two round-trip beautify the body, in improvingthe posture, in shaping the body when airline fares, retaxed a number of the other contested costs, and one sleeps, and for the Chin Gym garment for firming- the chin and - - of $702 costs. (F.D.C. No. 54252; S. Nos. neckline, in providing gentle mas:"" '

" 0. wrinkles, working - ":83) and in isometri “: destructionof Chin Gym garments: * E OF JUDGMENTon Injunction Action of other articles for relabeling. (I.D.C fig. 533 . 7= AY_*=* * fas, 2, al.; N.J. No. 80) *> L0., Raymond F. Underwood,president, and Richard J. Prasser,

productionvice president, Skokie, N. Dist. III. Saf T Labs portable oxygenkits, at Bloomfield, Dist. N.J. Charged6-1-71 in complaint for injunction: that the defendantsoperated Charged on or about 12-21-72; when shipped by Safety Laboratories, a candy-makingplant at Skokie, Ill., for the production of soft jelly Inc., Miami, Fla., the article's labeling lacked adequatedirections for candies, candy lozenges, and hard candy, that FDA analysis revealed a use for its intended purposes by untrained laity, and Such directions

fragments 1 8 in in written, labeling adequate warnings number of wood between mm and mm size the could not be and the lacked defendants' soft jelly candy, that the soft jelly candy was unfit for against unsafe use; 502(f)(1), 502(f)(2). Default decree ordered de food because of the wood chips, that the soft jelly candy and the rest struction.(F.D.C.No. 58537;S. No. 55-942 F; N.J. No. 81) of the candy from the plant was prepared, packed, and held under in

sanitary conditions whereby they may have been rendered injurious to NOTICES OF JUDGMENTon Criminal Actions health, and that the defendants were well aware that their activities

F000 were in violation of the law; 402(a)(3),402(a)(4). A consent decree of permanent injunction permanently enjoined the violations complained Parnell Green, tya Green Livestock Co., Layton, Dist. Utah.

of enjoined of any Charged 5-22-72; when shipped, beef steers contained the new animal and the introduction into interstate commerce soft jelly candy until a number of specified conditions concerning the drug diethylstilbestrol, and the use of the drug did not conform to any production of candy had been met and until all soft jelly candy on effective approved New Animal Drug Application, since the drug had hand had been segregatedunder FDA supervision. (Inj. No. 609; S. Nos. not been withdrawnfrom use in the beef steers 7 days before slaughter; 1-092/3 D et al.; N.J. No. 84) 402(a)(2)(D).Guilty plea, impositionof sentencesuspendedand probation.

57978; F., (F.D.C. No. S. No. 33-985 N.J. No. 82) NOTICE OF JUDMENT 0n Miscellane0us Action Lewis, Inc., Vegas, Alfred M. Las Dist. Nev. IMS 4% lidocaine hydrochloridefor dilution (Add-A-Jet & Flex-0-Jet systems), Charged alphabet macaroni, macaroni, macaroni, 10-2-67: elbow Salad South El Monte, C. Dist. Calif. -- -

yellow flour, yellow in a building corn and cornmeal were held ac Charged 2-21-73 in complaint for declaratory judgment and injunction,

to insects; 402(a)(3), cessible insects and were contaminatedwith 402 by IMS Limited, tya International Medication SystemsLtd., against HEW

corporation pleaded guilty to suppress (a)(4). The not and moved all Secretary Caspar W. Weinberger and FDA CommissionerCharles C. Ed

stuffs, of any contamination, during food evidences and records taken wards: that the plaintiff had since 1969 been engaged in manufacturing

the FDA inspection of the corporation's warehouse. The district court and distributing 4% lidocaine hydrochloride;that the drug was packaged ruled as follows: in the delivery systemsknown as Add-A-Jet and Flex-0-Jet, which systems

to suppress is granted. “Motion The search could not be conducted comprised a vial and a vial injector; that FDA had requested the

a warrant, to given. without unless consent search was The Court finds plaintiff to halt distribution and recall the articles; that FDA's allega given." consent to search was not tion that the design of the articles and their labeling representedand

The Governmentappealedthe granting of the motion to suppress. In suggested that the medication was intended for intravenous use was

reversing the district court and denying the motion to suppress, the wholly incorrect; that FDA's allegation that the only acceptedintravenous

of Appeals

for the 9th Circuit said: of hydrochloride of arrythmias Court - - - - use lidocaine was the treatment cardiac

was irrelevant to the articles' labeling in that there was no mention of

“Inspection of is a necessary to food warehouses incident such hold “intravenous,” “cardiac,” or “arrythmias” in the labeling; that lido

ing of Inspections § 374(a), food. are authorized under 21 U.S.C. (d) caine hydrochloridewas first synthesized in 1943, had been continuously

specified It is undisputed inspection under certain conditions. this was used and sold with the same label claims since prior to October10, 1962,

in spirit of it carried out accord with the letter and the statute. Thus and was not a new drug; that the drug constituted a very substantialpart

a a time, a was ‘reasonable and both ‘credentials' and ‘written notice' of the plaintiff's business; that, if the plaintiff was forced to discontinue

presentedby to Riddle, manager. were Mr. Chin Mr. the warehouse Per the sale of the drug by FDA seizure or injunction, the plaintiff would be

to inspect granted by Riddle, only mission was Mr. not without limita irreparablyharmed;and that, accordingly,the plaintiff was entitled to an condition, whole-heartedly tion or but and with Mr. Riddle's full and injunction restraining FDA. The defendantsmoved to dismiss the actions, cooperation, by employer, by active as authorized his and as instructed or in the alternative for summaryjudgment, on the grounds that the

employer. at a that ‘It was reasonable time and within reasonable complaint failed to state a claim upon which relief could be granted;

limits and in a reasonablemanner.' that the case was inappropriate for declaratory judgment; that, as to

imagine a giving of a “We cannot clearer factual case of the consent seeking to enjoin multiple seizure of the article, the action was m00t,

to an inspection which reflected an understanding (uncoerced and since multiple seizures had already been instituted across the United unequivocal)that the warehouse owners knew their rights and gladly States; and that the plaintiff's pleadings, affidavits, and exhibits estab

in inspection. cooperated such - - - lished that the drug was an unapprovednew drug and a misbrandeddrug.

Pursuant to stipulation betweenthe parties, the defendantswere granted

“The ‘search,' or more properly 'inspection, in this case occurred an extension of time to answer or otherwise plead, because of a hearing

on September13, 1966. The See and Camaracases, . . . were decided in a companioncase. Thereafter,the plaintiff having adoptednew labeling June 5, 1967. The trial judge held them retroactive. Both cases relate for its lidocaine hydrochloridewhich renderedthe issues moot, the case the exclusion evidence. was dismissed.(Misc. No. 219; N.J. No. 85) to of *

“Assuming that See and Camara accomplish a change in the law as

to the right to search in FDA cases, and if we assume arguendo that

the search in this case was rendered unreasonableunder the new rule,

at place. still that was not the rule the time the search took The search Notices of Judgment are given pursuant to section 705 of the Federal Food, . . .

at that time was therefore not unreasonable. Drug, of Judgment report involving * - - - - and Cosmetic Act. Notices cases seizure proceedings, criminal proceedings, and injunction proceedings. Seizure pro .

“Finally, in v. Milling Co., Consent to United States Hammond ceedingsare civil actions taken against goods alleged to be in violation, and

inspection to validly an such as here occurred was held have been criminal and injunction proceedingsare against firms or individuals charged

given, though not actually expressed. In Hammond,the corporate of. to be responsible for violations. The cases generally involve foods, drugs,

objection to ficers made no and intimated no reluctance toward such devices, or cosmetics which were alleged to be adulterated or misbranded or

an inspection. There the Fifth Circuit panel distinguished United States OtherwiseViolative of the law when introduced into and While in interstate

v. Blalock, . . . intelligently a which held that one cannot surrender commerce, or while held for sale after shipment in interstate Commerce.

right Agreeing of which he does not know he has. with the soundness Notices of Judgmentare preparedby Food and Drug Division, Office of the

that principle, the Hammondopinion points out that in the Blalock bank GeneralCounsel,DHEW.

robbery a investigation case the search was at time that the had Publishedby direction of the Secretary of Health, Education,and Welfare.

the accusatory stage. . . . In summation,the Hammondpanel AlexanderM. Schmidt,M.D., Commissioner of Food and Drugs

said:£ed Washington,D.C., March 1, 1974

“In the case at bar, the defendants had not been charged with a

crime at the time of their voluntary consent to the inspection nor had the investigation attained the accusatory stage. Accordingly, we conclude that the defendants need not have been aWare of their # in order to consent to a survey of the premises. (413 F.2d at “This circuit has approved the same rule, where there had been

Voluntary presentation of evidence to revenue agents, with no stealth,

trickery, fraud or misrepresentation involved on their part, where defendantwas without counsel, and where the defendanthad not been

warned of his rights. . . .

“In this connectionwe note with approvalUnited States v. Thriftimart,

et al., 9 Cir., 429 F.2d 1006, decided by a panel of this court on

40-March 1974 / FDA Consumer *U.s. Gover NMENT PRINTING OFFICE: 1974_544-189/39 PLAN TO STOP PREPARE FOR THE POISONINGS UNEXPECTED

Many commonly used household products and medicines found in your home maintain health and ease household chores . . . BUT they are also swallowed by thousands of young children each year with harmful and sometimes fatal results. These accidents occur suddenly, catching parents off guard. Use child-resistant packaging and close it properly after use. In addition, lock up hazardous household substances out of sight and reach of children. REMEMBER! Poisonings Don't Happen Only to Other People's Children. United States Government Printing Office POSTAGE AND FEES PAID DIVISION OF PUBLIC DOCUMENTS U.S. DEPARTMENT OF HEW 1 Washington, -+ D.C. 20402 HEW 393

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