504 F.2d 761 (2nd Cir. 1974), 73-2834, National Nutritional Foods Ass'n v. Food and Drug Administration

Docket Nº:73-2834 and74-1055.
Citation:504 F.2d 761
Party Name:NATIONAL NUTRITIONAL FOODS ASSOCIATION and Solgar Company, Inc., et al., Petitioners, v. FOOD AND DRUG ADMINISTRATION and United States Department of Health, Educationand Welfare, et al., Respondents. Nos. 1189-1203, Dockets 73-2129, 73-2166, 73-2175, 73-2449, 73-2745, 73-2746,73-2747, 73-2748, 73-2752, 73-2753, 73-2762, 73-2824, 73-2826,
Case Date:August 15, 1974
Court:United States Courts of Appeals, Court of Appeals for the Second Circuit
 
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504 F.2d 761 (2nd Cir. 1974)

NATIONAL NUTRITIONAL FOODS ASSOCIATION and Solgar Company,

Inc., et al., Petitioners,

v.

FOOD AND DRUG ADMINISTRATION and United States Department of

Health, Educationand Welfare, et al., Respondents.

Nos. 1189-1203, Dockets 73-2129, 73-2166, 73-2175, 73-2449,

73-2745, 73-2746,73-2747, 73-2748, 73-2752,

73-2753, 73-2762, 73-2824, 73-2826,

73-2834 and74-1055.

United States Court of Appeals, Second Circuit

August 15, 1974

Argued June 19, 1974.

Certiorari Denied Feb. 24, 1975, See

95 S.Ct. 1326.

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Milton A. Bass, New York City (Bass & Ullman, New York City, of counsel), for petitioners National Nutritional Foods Ass'n, Solgar Co., Inc., and National Ass'n of Pharmaceutical Manufacturers.

William R. Pendergast, Washington, D.C. (McMurray & Pendergast, Washington, D.C., of counsel), for petitioner Vitaminerals, Inc.

Kirkpatrick W. Dilling, Chicago, Ill. (Dilling & Dilling and Dennis M. Gronek, Chicago, Ill., of counsel), for petitioners National Health Federation and Mary Louise Martin.

Daniel Marcus, Washington, D.C. (Wilmer, Cutler & Pickering, Richard A. Allen, and Daniel D. Polsby, Washington, D.C., of counsel), for petitioners Archon Pure Products Corp., Plus Products, Wm. T. Thompson Co., and Council for Responsible Nutrition.

David S. King, Washington, D.C. (Williams & King, Washington, D.C., of counsel), for petitioners Karl B. Lutz, Ralph P. Glaser, Mary S. Hill, Dorothy Coffman, and Janie A. Meeter.

James S. Turner and Arthur D. Koch, Washington, D.C. (Swankin, Turner & Koch, Washington, D.C., of counsel), for petitioner Federation of Homemakers, Inc.

Edgar T. Bellinger, Washington, D.C. (Pope, Ballard & Loos and Dickson R. Loos, Washington, D.C., of counsel), for petitioner Sunkist Growers, Inc.

John Joseph Matonis, Washington, D.C., for petitioners Citizens for Truth in Nutrition, Catharyn Elwood, and East Coast Healthfood Organization.

Michael R. Sonnenreich, Washington, D.C. (Chayet & Sonnenreich, and Michael X. Morrell, Washington, D.C. of counsel), for petitioners Linus Pauling, Ph.D., and Roger J. Williams, Ph.D.

Howard S. Epstein, Antitrust Div. Dept. of Justice, Washington, D.C.; Stephen H. McNamara, and Howard M. Holstein, Dept. of Health, Education and Welfare, Washington, D.C.; Gregory B. Hovendon, Chief, Consumer Affairs Section, Dept. of Justice, Washington, D.C. (Thomas E. Kauper, Asst. Atty. Gen. Antitrust Div., Dept. of Justice, Washington, D.C., and Richard A. Shupack, Dept. of Health, Education and Welfare, Washington, D.C., of counsel), for respondents Food and Drug Administration, United States Department of Health, Education and Welfare, and others.

Before FRIENDLY and SMITH, Circuit Judges, and BARTELS, District judge. [*]

FRIENDLY, Circuit Judge:

We have here 15 petitions under 701(f) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. 371(f), to review two final regulations of the United States Food and Drug Administration (FDA) 1 relating to vitamin and mineral supplements sold as foods. One regulalation, entitled Part 125-- Label Statements Concerning Dietary Properties of Food Purporting To Be Or Represented For Special Dietary Uses, would replace corresponding parts of an existing regulation issued in 1955, 21 C.F.R. Pt. 125. The other, entitled Part 80-- Definitions And Standards Of Identity For Food For Special Dietary Uses, embodies a new concept in regard to this type of 'food.' 2 Both were published in the

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Federal Register of August 2, 1973, 38 F.R. 20708-18, 20730-40, to become fully effective January 1, 1975. The primary statutory authority invoked for the Regulations lies in the first sentence of 401:

Whenever in the judgment of the Secretary such action will promote honesty and fair dealing in the interest of consumers, he shall promulgate regulations fixing and establishing for any food, under its common or usual name so far as practicable, a reasonable definition and standard of identity, a reasonable standard of quality, and/or reasonable standards of fill of container.

21 U.S.C. 341, and in 403, which provides inter alia that a food shall be deemed to be misbranded

(j) If it purports to be or is represented for special dietary uses, unless its label bears such information concerning its vitamin, mineral, and other dietary properties as the Secretary determines to be, and by regulations prescribes as, necessary in order fully to inform purchasers as to its value for such uses.

21 U.S.C. 343(j).

The proceedings which culminated in these regulations began with a Notice of Proposal To Revise Regulations published in the Federal Register of June 20, 1962, 27 F.R. 5815. Extensive revisions were made in response to comments, but numerous parties filed objections to the proposed revised regulations and requests 'for a hearing pursuant to 701(e)(2), 21 U.S.C. 371(e)(2). The proposed regulations were accordingly stayed for an evidentiary hearing under 701(e)(3), 21 U.S.C. 371(e)(3). This lasted for more than 22 months and developed a transcript of 32,405 pages, together with hundreds of exhibits and other record materials. In the Federal Register of January 19, 1973, the FDA published proposed findings and conclusions and tentative versions of the regulations for a final round of exceptions and comments, 38 F.R. 2143 (1973). After considering these, the agency promulgated the final regulations.

As indicated, the novelty of the regulations lies in the FDA's invoking, with respect to the many vitamins and minerals and the myriad combinations thereof, its power to prescribe a standard of identity under 401. The new Part 80 begins, 80.1(a), by describing as its object 'dietary supplements of vitamins and/or minerals' which 'purport to be or are represented for special dietary use by man to supplement his diet by increasing the total dietary intake of one or more of the essential vitamins and/or minerals specified in paragraph (f) of this section.' The regulation then goes on as follows:

(b) Classifications of dietary supplements.

(1) A dietary supplement shall contain only those vitamins and/or minerals listed in paragraph (f) of this section and shall be offered for its vitamin and/or mineral content only in the following combinations, with the provision that any vitamin or mineral defined as optional in paragraph (f) of this section may be omitted:

(i) All vitamins and minerals.

(ii) All vitamins.

(iii) All minerals.

(iv) All vitamins and the mineral iron.

(v) Inclusion of the optional ingredients vitamin D and/or phosphorus in a multivitamin, multimineral, or multivitamin and multimineral supplement does not require inclusion of any additional optional ingredients. Inclusion of the optional ingredients biotin and pantothenic acid and/or copper and zinc in such products does not require inclusion of vitamin D and/or phosphorus when the latter two nutrients are optional. The inclusion of

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any of the other optional ingredients (biotin or pantothenic acid for vitamins and copper or zinc for minerals) requires the inclusion of both such optional ingredients if the product is a multivitamin or multimineral supplement, and requires the inclusion of all four such ingredients if the product is a multivitamin and multimineral supplement.

(2) A dietary supplement may also be composed of any single vitamin or mineral listed in paragraph (f) of this section.

Before going further it is necessary to refer to another major innovation in the regulations. The previous regulation had required, 21 C.F.R. 125.3(a)(1) and (2), 125.4(a)(1) and (2), that in the case of certain vitamins and minerals the label of a food represented for special dietary use should disclose the percentage of the designated 'minimum daily requirement' which would be 'supplied by such food when consumed in a specified quantity during a period of one day'; for other vitamins and minerals the requirement was merely that the label state the quantity of the nutrient contained in a specified quantity of such food. The regulations here under challenge substituted for 'minimum daily requirements' a new concept of 'U.S. Recommended Daily Allowances.' 3 These are stated, 80.1(f)(2), to have been derived by the FDA from the Recommended Dietary Allowances published by the Food and Nutrition Board, National Academy of Sciences-National Research Council, and to be 'subject to amendment from time to time as more information on human nutrition becomes available.'

Section 80.1(f)(1) sets forth 'the permissible qualitative and quantitative composition of dietary supplements of vitamins and/or minerals' in the form of a table, as follows:

U.S. GOVERNMENT RECOMMENDED DAILY ALLOWANCES (U.S. RDA's) AND PERMISSIBLE COMPOSITIONAL RANGES FOR DIETARY SUPPLEMENTS OF VITAMINS AND MINERALS ------------------------------------------------------------------------------- Children under [Fn4] years of age [FN1] Unit of Measurement U.S. RDA ---------------------------------- Lower Upper Limit Limit ------------------------------------------------------------------------------- Vitamins...

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