186 FEDERAL FOOD, DRUG, AND COSMETIC ACT To Investigate the Use of Chemicals in Foods and Cosmetics, 82d Cong.:) Mr. WICKENDEN. My name is Leonard Wickenden. Throughout my adult life, I have been an industrial chemist. I received my scientific education at what is now known as the Imperial College of Science and Technology, of London, England. I graduated in 1906 and then took a postgraduate course in the chemistry of foods and drugs. From 1908 to 1911, I was assistant chemist to the world-famous biscuit manufacturers, Huntley & Palmers, Ltd., of Reading, England. I then emigrated to this country and obtained a position in the electrochemical department of the West Virginia Pulp & Paper Co. In 1913, I was placed in charge of the research division of the New York laboratories of that company, and in 1918, when the laboratories were enlarged, I was appointed chief chemist with a staff of 20 working under my direction. In 1924, I was elected a fellow of the American Institute of Chemists and in 1926 I became vice president of the Suchar Process Corp., a company formed to exploit some of my patents, of which 20 have been granted by the United States Patent Office and others are pending. In 1934 I started a consulting practice of my own with offices at 120 Wall Street, New York City. Since my early years I have been interested in the practice and theory of growing plants; at the end of 1949 I sold my laboratory and retired to my home at Westport, Conn., to devote whatever years remain to me to experimental agriculture and the study of the soil. I am the author of a book entitled Make Friends With Your Land, published by the Devin-Adair Co. The CHAIRMAN. Are there any further questions? If not, thank you very much, Mr. Jennings. May the Chair state that all of the bills before the committee seek to do, in effect, the same thing, and that is to protect the public and to provide pretesting procedures for additives. The chief difference that has developed largely, with one or two other exceptions, is largely a question of any appeal from a ruling by the Secretary. We appreciate your testimony and thank you for coming. Mr. JENNINGS. Thank you, Mr. Chairman. (The documents submitted by Mr. Jennings follow:) [Reprinted from the February 1954 issue of Food Drug Cosmetic Law Journal, published and copyrighted 1954 by Commerce Clearing House, Inc., Chicago, Ill. All rights reservedj CHEMICALS IN FOODS-A LEGAL VIEWPOINT By Vincent A. Kleinfeld Drafting a chemicals-in-foods bill satisfactory to industries, consumers' groups, and governmental establishments is an Augean, but not insuperable, task, says Mr. Kieinfeld, attorney, Washington, D. C. He addressed the food and nutrition section of the American Public Health Association on November 12, 1953. Before discussing some of the legal aspects of the chemicals-in-foods controversy, it would be well to set forth what I believe are some fundamentals. It seems clear that there is a real need for the use of so-called chemicals in connection with our food supply. I know of no qualified person who has taken the viewpoint that various staple foods should not be enrick:ed, and I doubt that the consumer would be satisfied with bread made solely from flour, water, and a little yeast. Additives such as sugar and vinegar have been employed in food for hundreds of years, and salt does not become dangerous when it is called sodium chloride. In other words, the term, “chemicals in foods" should not have an invidious connotation, for the utilization of pesticides and chemical fertilizers, as well. as of various additives in the processing of foods, has frequently served a valuable function as far as the consumer is concerned. As a matter of fuct, ultimately the rapid increase in population may compel the world to turn to chemicals for the purpose of increasing our food supply. The synthetic-fat program developed in Germany during the last world war was an attempt to replace a natural food with a synthetic. Recently it was announced that the chemical synthesis of sugar had been achieved. Our scientific Journals reveal that substances FEDERAL FOOD, DRUG, AND COSMETIC act 185 Delaney bill, or any of the other bills before us. Do you have in mind some amendment or is this just an example offered for some other purpose? Mr. JENNINGS. It is just an example thrown in. But incidentally, at that same time the Delaney committee was studying the emulsifiers, if you will recall, these bread standards were being worked on. Because of the evidence found in the. Delaney committee hearings against certain emulsifiers. those were banned in the bread standards. Mr. HESELTON. By the FDA! Mr. JENNINGS. That is right. Mr. HESELTON. And that was satisfactory to you? Mr. JENNINGS. That is right. The CHAIRMAN. Will the gentleman yield for one question? The McKay loaf, that you refer to, is on the market, is it not? Mr. JENNINGS. Oh, yes, and it has been for 4 or 5 years. The CHAIRMAN. Thank you. I just wanted to be sure of that. Mr. HESELTON. You quoted Mr. Wickenden, the author of the book Our Daily Poison. Could you give for the record something more about Mr. Wickenden. That is, is he an expert in this field, or is he a lawyer acquainted with practices before the FDA, or what is he? Mr. JENNINGS. He is a recognized expert on his own. He also appeared before the Delaney committee back in 1950 or 1951. Mr. HESELTON. What is his occupation? Mr. JENNINGS. He is a noted chemist, and a fellow of the American Institute of Chemists. He was alarmed by our daily consumption of poisons and started research which resulted in his enthusiasm for organic culture, wherein no harmful sprays are needed in order to raise fine vegetables. He has discussed this method of growing food in two previous books. Mr. HESELTON. You have been reading, I take it, from the advertising on the book cover, is that right? Mr. JENNINGS. That is right. Mr. HESELTON. Of your own knowledge, do you know what background he has? Of your own knowledge, can you tell us by whom he is recognized and in what way? Mr. JENNINGS. I could probably find it in here, sir, but he is not a personal friend of mine. Mr. HESELTON. I did not mean that. I only wanted to know something more about him. I thought that the record might well show what his qualifications were. Mr. JENNINGS. As I understand it, he has been very helpful in this field over the years and he is a recognized chemist himself. Mr. HESELTON. A graduate of what university, if he is a graduate? Mr. JENNINGS. I do not know. It does not say on the cover. Mr. HESELTON. How long has he been a practicing chemist? Mr. JENNINGS. It does not say, but he looks to be a man of 60 years old, and it may mean he has been in it 30 years at least. Mr. HESELTON. Has he written other books in this field? Mr. JENNINGS. Yes. Mr. HESELTON. That is all, Mr. Chairman. (Mr. Jennings submitted the following, which is given in Mr. Leonard Wickenden's own words in testimony before the Delaney committee, p. 1077, pt. 3, hearings before the House Select Committee 186 FEDERAL FOOD, DRUG, AND COSMETIC ACT To Investigate the Use of Chemicals in Foods and Cosmetics, 82d Cong.:) Mr. WICKENDEN. My name is Leonard Wickendea. Throughout my adult life, I have been an industrial chemist. I received my scientific education at what is now known as the Imperial College of Science and Technology, of London, England. I graduated in 1906 and then took a postgraduate course in the chemistry of foods and drugs. From 1908 to 1911, I was assistant chemist to the world-famous biscuit manufacturers, Huntley & Palmers, Ltd., of Reading, England. I then emigrated to this country and obtained a position in the electrochemical department of the West Virginia Pulp & Paper Co. In 1913, I was placed in charge of the research division of the New York laboratories of that company, and in 1918, when the laboratories were enlarged, I was appointed chief chemist with a staff of 20 working under my direction. In 1924, I was elected a fellow of the American Institute of Chemists and in 1926 I became vice president of the Suchar Process Corp., a company formed to exploit some of my patents, of which 20 have been granted by the United States Patent Office and others are pending. In 1934 I started a consulting practice of my own with offices at 120 Wall Street, New York City. Since my early years I have been interested in the practice and theory of growing plants; at the end of 1943 I sold my laboratory and retired to my home at Westport, Conn., to devote whatever years remain to me to experimental agriculture and the study of the soil. I am the author of a book entitled Make Friends With Your Land, published by the Devin-Adair Co. The CHAIRMAN. Are there any further questions? If not, thank you very much, Mr. Jennings. May the Chair state that all of the bills before the committee seek to do, in effect, the same thing, and that is to protect the public and to provide pretesting procedures for additives. The chief difference that has developed largely, with one or two other exceptions, is largely a question of any appeal from a ruling by the Secretary. We appreciate your testimony and thank you for coming. Mr. JENNINGS. Thank you, Mr. Chairman. (The documents submitted by Mr. Jennings follow:) [Reprinted from the February 1954 issue of Food Drug Cosmetic Law Journal, published and copyrighted 1954 by Commerce Clearing House, Inc., Chicago, Ill. All rights reservedj CHEMICALS IN FOODS-A LEGAL VIEWPOINT By Vincent A. Kleinfeld Drafting a chemicals-in-foods bill satisfactory to industries, consumers' groups, and governmental establishments is an Augean, but not insuperable, task, says Mr. Kieinfeld, attorney, Washington, D. C. He addressed the food and nutrition section of the American Public Health Association on November 12, 1953. Before discussing some of the legal aspects of the chemicals-in-foods controversy, it would be well to set forth what I believe are some fundamentals. It seems clear that there is a real need for the use of so-called chemicals in connection with our food supply. I know of no qualified person who has taken the viewpoint that various staple foods should not be enricl:ed, and I doubt that the consumer would be satisfied with bread made solely from flour, water, and a little yeast. Additives such as sugar and vinegar have been employed in food for hundreds of years, and salt does not become dangerous when it is called sodium chloride. In other words, the term, “chemicals in foods" should not have an invidious connotation, for the utilization of pesticides and chemical fertilizers, as well. as of various additives in the processing of foods, has frequently served a valuable function as far as the consumer is concerned. As a matter of fuct, ultimately the rapid increase in population may compel the world to turn to chemicals for the purpose of increasing our food supply. The synthetic-fat program developed in Germany during the last world war was an attempt to replace a natural food with a synthetic. Recently it was announced that the chemical synthesis of sugar had been achieved. Our scientific Journals reveal that substances FEDERAL FOOD, DRUG, AND COSMETIC ACT 187 never before found in food products are being employed in ever-increasing numbers to stimulate the growth of and cause other changes in livestock and poultry, cure vegetable and fruit blights, act as preservatives, and produce cheaper fertilizers. These substances are also finding their way into food wrappers, where they are used to retard mould and decomposition. The fact remains that serious problems have arisen with the increasing use of food additives. There has been considerable testimony in hearings before Congressional committees, and from qualified persons. that a definite health lazard may be created by the ingestion over long periods of time of many substances which may not present any acute danger when consumed in minute quantities. Insecticidal-spray contamination is occurring not only in our fruits and vegetables, but also in such staples as milk and meat. The recent parenteral use of some of the new and highly toxic insecticides for the elimination of various external parasitic infestations of livestock raises the possibility of the accumulation of the insecticides in the edible tissues of the animals at the time of slaughter. The residues of antibiotics and other potent drugs in the tissues of animals treated with high-level therapeutic dosages of medicinals to combat various animal diseases, and the addition of such products to feeds in order to stimulate animal growth, are causing increasing concern to health officials. There is considerable evidence, moreover, that some of the newer substances presently in use have not undergone comprehensive testing. LONG-CONTINUED USAGE NO PROOF OF FREEDOM FROM HAZARD It is not entirely safe to assume that a substance which has been employed for many years is free from hazard because of this long-continued usage. It is possible that toxic effects caused by such a substance may not have been recognized or may have been ascribed to some other substance or cause. Take, for example, coumarin, which was used for 75 years as an ingredient of some imitation vanilla flavors, and as a fixative and base for other synthetic food flavors. These flavors were consumed in ice cream, baked goods, soft drinks, prepared desserts, and chocolate. Nevertheless, pharmacological studies recently revealed impressive evidence of the capacity of coumarin to produce serious damage to the liver of experimental animals. It may be noted, in passing, that the results of these studies were called to the attention of the Government by the manufacturers of coumarin, who have stopped its sale to the food industry. In other words, "safety by assumption," based entirely on long usage or on studies of vital statistics, would not appear to be sound from a scientific viewpoint. The subtle, insidious effects of a substance upon a limited number of persons, particularly when consumed over long periods of time, may not be readily recognized. This may be the situation even where great precautions are taken, as with new drugs under the new-drug section of the Federal Food, Drug, and Cosmetic Act, and notwithstanding that the drug may be consumed only under medical supervision. I am sure that we are all familiar with the fact that it was discovered that certain cases of serious blood disorders were associated with the administration of chloramphenicol. It is pertinent to note, also, that very recent studies by the Division of Pharmacology of the Food and Drug Administration of certain certified coal-tar dyes used in coloring foods have revealed evidence of serious chronic toxicity. It is true that it is possible to go to fanatical extremes in attempting to require that a substance be proved entirely and completely safe from a chronic-toxicity viewpoint. My point is that comprehensive experimental evidence is always needed, and that we cannot rely on assumptions or probabilities. Thus, the increasing employment of food additives has caused a growing appre hension that the Federal Food, Drug, and Cosmetic Act does not adequately protect the consumer, who is necessarily an amateur with respect to both the foods and drugs which he purchases. The statute requires that, before a new drug is marketed, evidence as to its safety must first he submitted to the Food and Drug Administration. The burden is on the manufacturer to demonstrate the freedom of the drug from bazard when used as directed. However, the law does not make a similar requirement with respect to substances employed in food products.. Additives whose safety is not firmly established may be excluded from foods which are standardized by the Food and Drug Administration, and this exclusionary power has been sustained by the courts. But the establishDent of standards is frequently a laborious and expensive process, and most foods are not, and may never be, standardized. Consequently, a substance whose safety has not been demoustrated may be utilized in many foods because the Government, although suspicious of the possible long-range adverse effects of 188 FEDERAL FOOD, DRUG, AND COSMETIC ACT the additive, cannot prove to the satisfaction of a court and jury that it way he poisonous or deleterious. The problem is highlighted by the polyoxyethelene stearate emulsifiers, which were employed in many food products, including bread. After extremely protracted hearings, the Food and Drug Administration refused to permit the use of these "softeners" in bread, and this decision was ultimately sustained by the courts. Recently, the food protection committee of the National Research Council's food and nutrition board issued a report that presently available data "fail to demonstrate" that these substances are safe for use in foods "under all patterns of dietary consumption and for all segments of the population." The committee stated, in part: "No new food additive should be introduced for human consumption or continued in use in the diet as long as a reasonable doubt remains concerning its safety. *** "The introduction into a foodstuff of a new additive which does not positively contribute to the nutritional quality of the food presents a situation demanding a particularly conservative judgment. The use of such an additive in a variety of basic foods which are unavoidably consumed by all groups within the population in both health and disease, requires that sufficient evidence be obtained to provide a positive proof of harmlessness." IN THE INTEREST OF SAFETY Yet these emulsifiers were used in a variety of foods for a considerable period of time. This is of little concern to some. A recent editorial in a publication devoted to food technology criticized the report of the food-protection committee on the surprising ground that the committee had "leaned a bit backward in the interest of safety." On the other hand, large segments of the food industry believe that we should bend quite considerably in that direction. These groups hold the view that existing law is inadequate to cope with the problem, and that remedial legislation is required. For example, the American Bakers Association, the American Meat Institute, the Institute of Shortening and Edible Oils and the Millers' National Federation have adopted a "Statement of Principles on Chemical Additives in Foods" which declares, in part: "We believe it to be a proper function of Government to control those factors which may affect adversely public health. Therefore, we believe the results of animal experimentation in pretesting new substances proposed for use in food. should be reviewed and approved by the Food and Drug Administration before the substance is allowed to be used in food sold to the public." In view of the serious nature of the problem and the alarm evinced by those qualified to render expert opinions, is it asking too much of the manufacturer of a substance which is to be used in a wide variety of foods, and by people in all walks of life and in various degrees of health, to submit evidence that the product does not present a hazard? If this is not done, is not the consumer au unwitting guinea pig, upon whom experimental work is being conducted? If this premise is accepted, there is little doubt that some time in the not-too-distant future the State will enter the picture by means of the creation of an additional control, an amendment to the Federal Food, Drug, and Cosmetic Act requiring the pretesting of chemicals proposed for use in or on foods. APPROVAL OF CHEMICAL ADDITIVES H. R. 2245, the food-additives bill which has been introduced by the former chairman of the Select Committee To Investigate the Use of Chemicals in Foods and Cosmetics, defines a "chemical additive" as a substance intended for use in or on food, which is not generally recognized by experts as having been adequately tested to show that it is not poisonous or deleterious or, if it is poisonous or deleterious, it is not generally recognized as having been adequately tested to show that it is safe. The bill provides that no person shall introduce into interstate commerce any chemical additive, as so defined, unless its use has been approved by the Secretary of Health, Education, and Welfare. A person desiring to obtain approval of a chemical additive must submit to the Secretary reports of investigations which have been made to determine the toxicity and other potentiality for harm of the substance; a statement of its composition; and a description of methods of analysis for its quantitative determination in or on food. If the substance is poisonous or deleterious, a statement must be submitted showing that it is required in the production of food, together with reports of investigations which have been made to show the quantities remain |