34. FEDERAL FOOD, DRUG, AND COSMETIC ACT The committee favors the omission of language that would exempt chemicals already in use. In the Priest bill (H. R. 5036, sec. 1) pertaining to chemicals in cosmetics, exemption would be afforded by the clause "but such a substance not so recognized shall not be deemed to be a 'new cosmetic ingredient' if at any time prior to the date of the enactment of this paragraph and subsequent to June 25, 1938, it has been used to a material extent as a component of a cosmetic." In the Priest (H. R. 4099, sec. 1) and O'Hara bills (H. R. 4100, sec. 1), which appear to be identical, the same effect would be achieved for chemicals in food by exempting substances "having been adequately shown through scientific procedures or through prolonged use in food to be a substance without hazard to man in its intended use." In the opinion of the committee, it is desirable to word the law so as to make all substances susceptible to control. Even though it would be impossible to evaluate within any reasonable period all substances now in use, the committee believes that the omission of a limiting clause would strengthen the Food and Drug Administration in its efforts to prevent injury resulting from chemical additives. With respect to the proposed requirement in your bill on chemical additives to food (H. R. 4475, sec. 5) that the application contain a statement demonstrating that employment of the chemical additive "will serve a purpose which will be useful to the consuming public," the committee's opinion is that although the intention is sound, the language should be more precise. Usefulness might lie in appearance, in packaging or in nutritive value. It is suggested that the directions for submission of applications might read: “A statement of the intended use of the chemical additive and justifying its addition on the basis of utility." All the bills except one propose that in controversial cases, an advisory committee of experts selected by the National Academy of Sciences be set up to review decisions and make recommendations. The committee is of the opinion that this provision for referral to a committee of technical experts is extremely valuable for the evaluation of chemicals to be added to either foods or cosmetics and that it should be retained in any legislation that is enacted. The committee urges the passage of the provision in your bill (H. R. 4476, sec. 4) which strengthens the wording of section 601 (a) by broadening the definition of coal-tar products used in hair dyes and making more emphatic the warning to be used on labels for such dyes. The committee further notes with approval your suggestion (H. R. 4476, sec. 6) that section 602 on misbranded cosmetics be amended to require the inclusion on the label of the common or usual name of the cosmetic chemical. This would appear to be an additional safeguard against the use of dangerous substances. Similarly, the committee approves the amendments to section 705 (b) which Mr. Priest has proposed (II. R. 5036, sec. 6): (1) That the dissemination of information regarding food, drugs, devices, or cosmetics in situations involving Imminent danger to health or gross deception of the consumer be made mandatory; and (2) that information on such situations be immediately publicized to the trade. It is suggested that these amendments be incorporated in the final form of the bill. The Committee on Public Health appreciates the opportunity to express opinions on this important legislation. It is hoped that these comments will be of value to the Committee on Interstate and Foreign Commerce in its consideration of the several bills. Very truly yours, H. D. KRUSE, M. D. THE ASSOCIATION OF STATE June 21, 1955. Hon. JAMES J. DELANEY, Member of Congress, House Office Building, Washington, D. C. DEAR MR. DELANEY: This is in further reference to your letter of April 6, 1955, concerning chemicals in food and cosmetics. I presented your letter to our executive committee at their meeting in Washington, D. C., on June 4, and the following resolution was reaffirmed by the committee: FEDERAL FOOD, DRUG, AND COSMETIC ACT RESOLUTION NO. VI-ADOPTED AT 1950 ANNUAL MEETING 35 Whereas there is an increasing use of chemical substances and other new ingredients in or on foods in production or processing; and Whereas many of these substances introduced purposely or accidentally may be harmful and may either directly or indirectly affect the nutritive value of the foods which contain them; and Whereas it is evident that additional research directed at the agricultural needs and public health implications of such chemicals should be encouraged and the results made available to Federal and State agencies responsible for protecting foods; and Whereas the Food and Drug Administration of the Federal Security Agency is qualified by experience and is authorized by the Congress to protect the interest of consumers in regulating the composition and labeling of many articles of food: Therefore be it Resolved, That the Association of State and Territorial Health Officers recommend to the Congress that it amend the existing Food, Drug, and Cosmetic Act to prevent the incorporaiton into or on foods of chemicals or other new ingredients before they have been reviewed and approved by the Food and Drug Administration. Your sincerely, FRANKLIN D. YODER, M. D., Mr. DELANEY. May I say that my office has notified many of the interested parties in this type of legislation, and in this particular legislation, and we have had responses from some of them. Some of them are unable to call together their groups and have a representative testify but there are some who wish to be heard, and I request that this committee give consideration to this. May I say further that Mr. Kleinfeld, our counsel, together with the members of the select committee, decided that we would not call anyone before our select committee during these hearings in 1950 and 1951 and 1952 unless they were qualified. Every man that testified there, I think, with the exception of Louis Bromfield, who had received world recognition because of his experimental organic farms, every man or woman that testified was recognized in his own field. We had the most eminent list of nutritionists and health officers that could be found anywhere. We were very careful not to let unqualified people that just wanted to make a statement come in, and we tried to get only recognized authorities whose qualifications were well accepted by all of these associations. The CHAIRMAN. May I compliment you on the adoption and the carrying out of that policy, Mr. Delaney. Are there any further questions? Mr. O'HARA. Mr. Chairman, I should like to sincerely compliment my friend from New York on his statement. I recall distinctly the great interest the late Frank Keefe had in this subject. As a result of that, I believe the gentleman from New York, the witness before us, brought about the formation of this special committee which made an exhaustive study into the subject. There was a great deal of interest on my part. I do want to say as a member of the Committee on Interstate and Foreign Commerce that I have greatly appreciated the gentleman's interest. I assure him that my individual wish is that we accomplish something in the public interest. To be the author of a bill is of small moment to me personally. Mr. DELANEY. I can very well say the same. As long as the public receives the protection, I am not interested in whose name is on any 36 FEDERAL FOOD, DRUG, AND COSMETIC ACT of the bills, and I must say at this time that if it had not been for the crusading efforts of Frank Keefe, that committee would never have been formed. As a member of the Rust committee in those days, Frank Keefe was up there time after time bringing to the attention of that committee the importance of this. It was recognized, as I say, by the late Adolph Sabbath, who sat in on the first pure food law legislation in 1908. Mr. O'HARA. Let me ask the gentleman one question. The appeal provisions contained in H. R. 4475, your bill, provides only for the appeal, as I understand it, to the circuit court of appeals upon the record made before the Food and Drug Administration at a hearing, is that correct? Mr. DELANEY. It provides for an appeal from their decision; yes. Mr. O'HARA. But it would be to the circuit court of appeals rather than some of the bills which provide for declaratory judgment proceedings, which would be in the nature. I presume, of proceedings de novo. I think the provisions in your bill refer only to the appeal provisions of the circuit court of appeals. Mr. DELANEY. Well, that is a very unimportant thing, as to where the appeal is made. As long as they have adequate relief in their appeal, that is the important thing. I have no objection to any amendment on that, but this was thought out principally, as to the appeal section, by various members of industry, and various members of the Food and Drug Administration, and they thought this was the best approach. I believe Mr. Kleinfeld, the counsel, is in the room and may I say for him that for many many years he was in charge of the food and drug prosecutions in the Attorney General's Office. It took a great deal of inducement to get a man of his type to come and act as counsel to the committee. We were able to borrow him from the Department of Justice at that particular time and it was through his years of experience that we were able to cover the great program that we have. Mr. O'HARA. The gentleman does agree, does he not, that an appeal provision which does provide a review of the important questions involved in some of these matters should be in any legislation that is passed, so that a speedy determination by the courts of the problems involved should be had, whether it is in the district court or whether it is in the circuit court of appeals? Mr. DELANEY. As long as it is prompt, and affords them adequate relief. Mr. DIES. I have always been under the impression that the very purpose of the Administrative Procedures Act is to provide a uniform system of appeals. It would seem to me that there ought to be some clarification by our counsel as to the need and advisability of inserting special appeal clauses in a bill. If we do it in this bill, we will do it in another one, and we should have a uniform system. It was supposed to obviate or eliminate the necessity of this sort of clause. Mr. O'HARA. There is quite a difference of opinion as to the effectiveness of the administrative appeal provisions. Let me say to the gentleman, some people feel where you appeal to the circuit court of appeals, that sometimes it is unsatisfactory on a question of fact. There is not so much trouble on the question of law. I have been one of those who have advocated that the circuit court of appeals is not FEDERAL FOOD, DRUG, AND COSMETIC ACT RESOLUTION NO. VI-ADOPTED AT 1950 ANNUAL MEETING 35 Whereas there is an increasing use of chemical substances and other new ingredients in or on foods in production or processing; and Whereas many of these substances introduced purposely or accidentally may be harmful and may either directly or indirectly affect the nutritive value of the foods which contain them; and Whereas it is evident that additional research directed at the agricultural needs and public health implications of such chemicals should be encouraged and the results made available to Federal and State agencies responsible for protecting foods; and Whereas the Food and Drug Administration of the Federal Security Agency is qualified by experience and is authorized by the Congress to protect the interest of consumers in regulating the composition and labeling of many articles of food: Therefore be it Resolved, That the Association of State and Territorial Health Officers recommend to the Congress that it amend the existing Food, Drug, and Cosmetic Act to prevent the incorporaiton into or on foods of chemicals or other new ingredients before they have been reviewed and approved by the Food and Drug Administration. Your sincerely, FRANKLIN D. YODER, M. D., Mr. DELANEY. May I say that my office has notified many of the interested parties in this type of legislation, and in this particular legislation, and we have had responses from some of them. Some of them are unable to call together their groups and have a representative testify but there are some who wish to be heard, and I request that this committee give consideration to this. May I say further that Mr. Kleinfeld, our counsel, together with the members of the select committee, decided that we would not call anyone before our select committee during these hearings in 1950 and 1951 and 1952 unless they were qualified. Every man that testified there, I think, with the exception of Louis Bromfield, who had received world recognition because of his experimental organic farms, every man or woman that testified was recognized in his own field. We had the most eminent list of nutritionists and health officers that could be found anywhere. We were very careful not to let unqualified people that just wanted to make a statement come in, and we tried to get only recognized authorities whose qualifications were well accepted by all of these associations. The CHAIRMAN. May I compliment you on the adoption and the carrying out of that policy, Mr. Delaney. Are there any further questions? Mr. O'HARA. Mr. Chairman, I should like to sincerely compliment my friend from New York on his statement. I recall distinctly the great interest the late Frank Keefe had in this subject. As a result of that, I believe the gentleman from New York, the witness before us, brought about the formation of this special committee which made an exhaustive study into the subject. There was a great deal of interest on my part. I do want to say as a member of the Committee on Interstate and Foreign Commerce that I have greatly appreciated the gentleman's interest. I assure him that my individual wish is that we accomplish something in the public interest. To be the author of a bill is of small moment to me personally. Mr. DELANEY. I can very well say the same. As long as the public receives the protection, I am not interested in whose name is on any 36 FEDERAL FOOD, DRUG, AND COSMETIC ACT of the bills, and I must say at this time that if it had not been for the crusading efforts of Frank Keefe, that committee would never have been formed. As a member of the Rust committee in those days, Frank Keefe was up there time after time bringing to the attention of that committee the importance of this. It was recognized, as I say, by the late Adolph Sabbath, who sat in on the first pure food law legislation in 1908. Mr. O'HARA. Let me ask the gentleman one question. The appeal provisions contained in H. R. 4475, your bill, provides only for the appeal, as I understand it, to the circuit court of appeals upon the record made before the Food and Drug Administration at a hearing, is that correct? Mr. DELANEY. It provides for an appeal from their decision; yes Mr. O'HARA. But it would be to the circuit court of appeals rather than some of the bills which provide for declaratory judgment proceedings, which would be in the nature. I presume, of proceedings de novo. I think the provisions in your bill refer only to the appeal provisions of the circuit court of appeals. Mr. DELANEY. Well, that is a very unimportant thing, as to where the appeal is made. As long as they have adequate relief in their appeal, that is the important thing. I have no objection to any amendment on that, but this was thought out principally, as to the appeal section. by various members of industry, and various members of the Food and Drug Administration, and they thought this was the best approach. I believe Mr. Kleinfeld, the counsel, is in the room and may I say for him that for many many years he was in charge of the food and drug prosecutions in the Attorney General's Office. It took a great deal of inducement to get a man of his type to come and act as counsel to the committee. We were able to borrow him from the Department of Justice at that particular time and it was through his years of experience that we were able to cover the great program that we have. Mr. O'HARA. The gentleman does agree, does he not, that an appeal provision which does provide a review of the important questions involved in some of these matters should be in any legislation that is passed, so that a speedy determination by the courts of the problems involved should be had, whether it is in the district court or whether it is in the circuit court of appeals? Mr. DELANEY. As long as it is prompt, and affords them adequate relief. Mr. DIES. I have always been under the impression that the very purpose of the Administrative Procedures Act is to provide a uniform system of appeals. It would seem to me that there ought to be some clarification by our counsel as to the need and advisability of inserting special appeal clauses in a bill. If we do it in this bill, we will do it in another one, and we should have a uniform system. It was supposed to obviate or eliminate the necessity of this sort of clause. Mr. O'HARA. There is quite a difference of opinion as to the effectiveness of the administrative appeal provisions. Let me say to the gentleman, some people feel where you appeal to the circuit court of appeals, that sometimes it is unsatisfactory on a question of fact. There is not so much trouble on the question of law. I have been one of those who have advocated that the circuit court of appeals is not |