COLOR ADDITIVES Bio Ramo Drug Co., Inc., 325 West Baltimore Street, Baltimore, Md. Corn States Laboratories, 1124 Harney Street, Omaha, Nebr. Dorn & Mitchell, Post Office Box 999, Opelika, Ala. Dow Chemical Co., Midland, Mich. Drug Topics, 155 East 44th Street, New York, N.Y. E. I. du Pont de Nemours & Co., Inc., Wilmington, Del. Farm Journal, Inc., Washington Square, Philadelphia, Pa. The Fox Co., Inc., Newfield, N.J. The Gland-O-Lae Co., 19th and Leavenworth Streets, Omaha, Nebr. Hess & Clark, Inc., Ashland, Ohio. George H. Lee Co., 4175 Beck Avenue, St. Louis, Mo. Dr. LeGear, Inc.. 4161 Beck Avenue, St. Louis, Mo. Eli Lilly & Co., Indianapolis, Ind. Magnus, Mabee & Reynard, Inc., 16 Desbrosses Street, New York, N.T. 561 Mallinckrodt Chemical Works, Second and Mallinckrodt Streets, St. Louis, Mo. Merck & Co., Inc., Rahway, N.J. New York Quinine & Chemital Division, 100 Church Street, New York, N.Y. . Norwich Pharmacal Co., 17 Eaton Avenue, Norwich, N.Y. S. B. Penick & Co., 100 Church Street, New York, NY. Peters Serum Co., 1601 Genesee, Kansas City, Mo. Prentiss Prug & Chemical Co., Inc., 101 West 31st Street, New York, NY. I. D. Russell Co., 2463 Harrison, Kansas City, Mo. Sterwin Chonaicals, Ing., 1450 Broadway, New York, N.Y. Successful Farming, 1716 Loenst, Des Moines, Iowa. Vet Products Corp., 1522–24 Holmes Street, Kansas City, Mo. Vitamins, Inc., 800 West 58th Street, Chicago, Ill. Wallerstein Co., Wallerszéin Square Mariners Harbor, Staten Island, N.X. T. C. Wheaton Co., Millville, N.J. Whitmeyer Laboratories, Inc., Myerstown, l'a. Wilke Laboratories, Inc., Eox 244. Memphis, Tenn. KALAMAZOO SPICE EXTRACTION CO., Kalamazoo, lich., February 1, 1960. Hon. OREN HARRIS, Chairman, House Interstate and Foreign Commerce Committee, Washington, D.C. DEAR MR. HARRIS: We are engaged in grinding and extracting spices for the flavoring and/or coloring of food. We therefore have a substantial interest in the legislation which you are considering as H.R. 7624, commonly referred to as the color additives bill. It is our underetanding that the bill as originally presented to Congress was sultantially that recommended and drafted by the coal-tar color trade associa tion and that its key provisions reain unmodified. These provisions are desi 3 to make all colors equal, re: trdless of source, and regardless of the potekal le: rds to the public, by authorizing FDA to require certification for any side tance to color food. 1 Aming the sub-inners which we manufacture, and which might require FDA certification under the net, are paprika, red pepper, tumeric, saffron, and cinnamon. Similarly, chili, grapejuice, tomato puree, or beets might require certification if one of the purposes of its use was to impart a color-and VOL. 16 LEGISLATIVE HISTORY THE FOOD, DRUG & COSMETIC ACT certainly FDA could argue that these substances have, as one purpose, the Under the 1958 food additives amendment, colors derived from natural The subject legislation proposes to draw a distinction between colors, regardless of source, and all other food components, because of some unsavory association with food colors in the past. We submit that any unsavory association is with the coal-tar colors and the policies followed by their manufacturers, and not with natural colors per se, or grapejuice, or tomato puree, We do not see any advantage, except to coal-tar manufacturers, in imposing added and pointless burdens upon natural coloring materials and foods. If the experience of FDA shows that some coal-tar colors are sufficiently safe and that certification is not required, it would be better to lighten the burden on them, by modifying the coal-tar color law to make certification discretionary, than to make a new law penalizing all colors for the benefit of those which may be unsafe. Although the argument is presented that a color, because of its natural source, is not per se safe, any lack of safety is adequately handled by the food additives amendment. If this amendment does not protect against an unsafe natural color, it cannot protect against other unsafe natural or synthetic additives. We are unaware of any evidence that natural coloring materials commonly used in food have presented any hazard to health, either by themselves, or through their process of manufacture. Certainly, tomato puree appears no more hazardous and in need of certification than fresh tomatoes. Dried chili peppers or red peppers, when ground, do not appear more in need of batch certification than green peppers appearing in the market. Ground paprika does not appear to present a greater hazard than fresh pimientos; or paprika extract, made by essentially the same process as corn oil, any more in need of certification than corn oil. To apply certification procedures to any of the products mentioned in the above paragraph is a direct implication that any and all foods and food additives need batch certification to protect the public health. If such an assertion were made, it would be considered ridiculous. It is our opinion that certification provisions for any of the above substances are equally out of place. We cannot believe that your committee or the Congress believes that batch certification of certain spices or spice extracts, such as paprika, or any and all agricultural products, is necessary in the public health. We hope that you will not place a pointless burden on agriculture and agricultural processing industries for the sole purpose of aiding the coal-tar color manufacturers. If possible. I would appreciate your placing this letter in the record of your committee, and should be pleased to offer testimony at your convenience if anything might be gained by a fuller expression of the thoughts contained herein. Respectfully yours, KALAMAZOO SPICE EXTRACTION CO., KALAMAZOO SPICE EXTRACTION CO., Kalamazoo, Mich., March 28, 1960. Subject: Color additives bill (referred to herein as the color bill). Hon. OREN HARRIS, Member of Congress, House Office Building, Washington, D.C. DEAR MR. HARRIS: Thank you your letter of March 17 and the subsequent correspondence with our counsel, Mr. Eric V. Brown. In accordance with the suggestion contained in your letter to Mr. Brown under date of March 18, we would appreciate the incorporation of this statement in the committee record: That the bill be rephrased to omit the part enclosed in black brackets. "Sec. 101 "(t) (1) The term 'color additive' means a material which (A) is a dye, pigment, or other substance made by a process of synthesis or similar artifice, Lor extracted, isolated, or otherwise derived, with or without intermediate or final change of identity,] from a vegetable, animal, mineral, or other source, and • • •* and after paragraph (B) of this section, add the phrase printed in italic: "except that such term does not include any material which the Secretary, by regulation, determines is used (or intended to be used) solely for a purpose or purposes other than coloring or any material which is directly derived from a vegetable or animal source." (a) Background 2. REASONS FOR PROPOSED CHANGE The 1958 Food Additives Amendment to the Federal Food, Drug and Cosmetic Act gives jurisdiction to FDA to control any substance which is a "food additive" within the meaning of that law. Among such substances are natural spices, extracts thereof, and other natural coloring materials such as extracts of carrots and beets. It appears that, as to such substances, the public health is adequately protected by the provisions of the food additives law, and that further restrictions are not required in the interest of public health. (b) Definition The color bill defines a “color additive" as any material capable of imparting a color to a food, except if the material is used solely for a purpose or purposes other than coloring. Under this definition, not only "food additives" such as spices, but foods themselves such as tomato puree and dried beets, would be considered "color additives." The 1958 Food Additives Amendment does not apply to foods, but only to "food. additives." We submit that the purpose of the color bill is similar and that food substances used to impart color to the products to which they are added are not intended to be covered. The color bill provides that a "color additive" shall be deemed to be suitable and safe if it is not a "food additive" as defined in section 201 (8). Since a food such as dried beets or carrots is not a "food additive" under section 201(s), it will not be deemed suitable and safe for listing unless the requirements proposed by section 706(b) are fulfilled; sucĥ requirements appear to be intended as safeguards against toxic substances in synthetic colors and not as applying to natural foods. 3. DISCUSSION In view of the above considerations, we believe that the scope of the color bill would be improved by modifying the definition of the term "color additive” in section 101 as above provided. This modification would remove agricultural products or derivatives thereof from the scope of the color bill and leave them under the food additives amendment or as foods; they would not be listed as a "color additive" and batch certification would not be a potential requirement for such natural foods, It appears to us that these modifications would have the following effects: 1. Condimental substances such as ground red pepper and paprika, and extracts thereof, could not be included in the definition of a "color additive" and would remain under the food additives amendment. 2. Colors derived from agricultural products classified as foods, like carrots and beets, would not be considered "color additives" but would come under the food additives amendment. The term “color additive" would not have to be a part of the label declaration of foods containing such substances, but the name of the food itself would be adequate to designate the source of the color. 3. It is not enough to say that under the color bill as proposed. FDA would have discretion to eliminate the requirement of batch certification from such natural foods. Whenever a Government agency has discretion to include or exclude a product from its scope, it tends to include rather than exclude such product. The interests of public health do not require this protection. The interests of the industry require that this possibility be eliminated. We greatly appreciate this opportunity of having our viewpoint considered by your committee. Very truly yours, KALAMAZOO SPICE EXTRAction Co., WALNUT GROVE PRODUCTS Co., Inc., Hon. BEN F. JENSEN, House of Representatives, Washington, D.C. DEAR BEN: The Interstate and Foreign Commerce Committee of your House is considering legislation aufending the Food and Drug Act with a bill known as the color additives amendment, H.R. 7624. Although you do not serve on this particular committee, Ben, we want to express our opinions to you in regard to this legislation and hope you will give them your due consideration and perhaps will pass them on to your fellow Congressmen. This bill is so worded that it can be applied to any substance added to animal feed regardless of whether or not it was so added to affect color. In the bill a "color additive" is defined as “a substance *** when added *** to a food * * * is capable *** of imparting color thereto." Color includes black, white, or intermediate grays. As virtually any substance when added to a feed imparts some degree of color to the final product, the scope of this amendment is extremely broad and, if passed as it is now worded, will be needlessly burdensome to the feed industry. It is suggested that the bill be amended to state that a color additive "does not include a food additive or any material which the Secretary, by regulation, determines is used (or intended to be used) solely for a purpose or purposes other than coloring." II.R. 7624 contains a cancer clause more restrictive than the Delaney clause in the Food Additives Amendment of 1958, and like the Delaney clause it prevents the exercise of scientific judgmeut by the Food and Drug Administration in the evaluation of all pertinent data. We believe the protection of the public health to be a paramount consideration; however, we do not believe that the interests of the public would be jeopardized by the exercise by the Food and Drug Administration of scientific judgment in evaluating all pertinent data. Therefore, we contend the cancer clause of the color additives bill should be amended to read in part as follows: "A color additive*** shall be deemed unsafe ・・・ if the additive is found in amounts and under conditions reasonably related to the intended use to induce cancer when ingested by man or animal." The italic portion is the only change we suggest in this clause. This would not take any power away from the Food and Drug Administration and would still require that the safety of the food additive be proven by the manufacturer. In addition, Ben, we urge this spine amendment be made to the Delaney amendment to the Food Additives Act of 1958. However, the point to be made at this moment is to not allow the same mistake made in the Delaney amendment to be made in regard to the color additives amendment. Finally, the bill provides that the color additives may be listed for use if they are "suitable and safe." If the bill is a public health measure, the determination of safety should be suficient, and questions of suitability should not be made matters of administrative determination but should be left up to the muofacturer. This color additives amendment is of great concern to us at Walnut Grove as it is, I am sure, to all well-informed feeders of livestock. New ideas in research and new theories of animal nutrition have been drastically thwarted because of the confusion existing after the adoption of the food additives amendmet. The broad scope of the color additive amendment will only multiply the existing confusion to the damage of not only the feed industry but farmers here in the Seventh Congressional District and elsewhere. Your efforts in bringing these facts to the consideration of your fellow Representatives will be sincerely appreciated. Sincerely yours, Hon. OREN HARRIS, WALNUT GROVE PRODUCTS CO., INC., THE KANSAS State Board of Health, Chairman, House Interstate and Foreign Commerce Committee, DEAR MR. HARRIS: Attached is a copy of a resolution adopted by the Kansas Board of Health relating to the subject of color additives for foods. We respectfully request that this resolution be made a part of the record of the hearings on color additive legislation now pending in the House. Yours very truly, EVAN WRIGHT, Director, Food and Drug Division. A RESOLUTION ON CARCINOGENS IN FOODS, ADOPTED BY THE KANSAS STATE BOARD OF HEALTH, MARCH 11, 1960 Whereas the problem of chemical additives in foods is one of the great public health issues of our times; and Whereas the interests of consumers were significantly compromised in 1959 when the Food, Drug, and Cosmetic Act was by amendment stripped of the so-called per se principle, which had since 1907 prohibited the setting of tolerance for toxic and deleterious substances in food unless they were actually necessary in processing or production ; and Whereas this loss was partially offset, at the 11th hour, by incorporation into the above amendment of an absolute prohibition on the setting of tolerance for substances known to produce cancer when ingested by man or animals, a prohibition which has come to: e known as the Delaney amendment; and Whereas the Department of Health, Education, and Welfare has declared and made evident its intention to enforce the prohibitions of the Delaney amendment, and to press for inclusion of its principle in future food, drug, and cosmetic legislation, particularly as related to the use of artificial colors; and Whereas the directness and vigor of the Department's present approach are in refreshing contrast to its attitudes of recent years, which have appeared to be unduly sensitive to the financial interests of the food industry and somewhat callous to the health interests of the consumer; and Whereas the present activity of the Department is of great assistance to the Kansas State Board of Health in the education of the public on matters dealing with the adulteration and contamination of foodstuffs, and in the enforcement of the Kansas pure food, drag, and costactic laws: Now, therefore, be it Resolved, That we, the Kansas State Board of Health, go on record as approving of an absolute prohibition of chemical additives known to be carcinogen in foods, drugs, or cosmeties, believing such a principle to be only common prudence in our present state of ignorance of the causative mechanism of cancer, and believing such a principle to be practical and enforcible within the existing struc ture of Federal and State controls; and be it further Resolved, That we warmly commend the Department of Health, Education, and Welfare, and the Food and Drug Administration for their courage and integrity as shown in 20 t actions with roard to cranberries and other foodstuffs adulterated or contaminated by carcinogenie substances. Senator THOMAS C. HENNINGS, Jr., Washington, D.C. UNIVERSITY of Missouri, DIVISION OF AGRICULTURAL SCIENCES, Columbia, March 15, 1960. DEAR SENATOR HENNINGS: Citizens of the United States are supplied regularly with the most abundant supply, the greatest variety, and most wholesome food of any nation, and as a e insequence are the best nourished people on earth. |