National Nutritional Foods Ass'n v. Kennedy

• Decision Date: 16 February 1978
• Docket Number: D,Nos. 604 and 605,s. 604 and 605
• Citation: 572 F.2d 377
• Parties: The NATIONAL NUTRITIONAL FOODS ASSOCIATION, the National Association of Pharmaceutical Manufacturers and Solgar Co., Inc., Petitioners, v. Donald KENNEDY, Commissioner of Food and Drugs, and United States Department of Health, Education & Welfare, Food and Drug Administration, Respondents. Miles H. ROBINSON, pro se, Petitioner, v. Donald KENNEDY, Commissioner of Food and Drugs, and United States Department of Health, Education & Welfare, Food and Drug Administration, Respondents. ockets 77-4097 and 77-4104.
• Court: U.S. Court of Appeals — Second Circuit

Page 377

572 F.2d 377

The NATIONAL NUTRITIONAL FOODS ASSOCIATION, the National

Association of Pharmaceutical Manufacturers and Solgar Co., Inc., Petitioners, v. Donald KENNEDY, Commissioner of Food and Drugs, and United

States Department of Health, Education & Welfare,

Food and Drug Administration, Respondents.

Miles H. ROBINSON, pro se, Petitioner, v. Donald KENNEDY, Commissioner of Food and Drugs, and United

States Department of Health, Education & Welfare,

Food and Drug Administration, Respondents.

Nos. 604 and 605, Dockets 77-4097 and 77-4104.

United States Court of Appeals, Second Circuit.

Argued Dec. 7, 1977.

Decided Feb. 16, 1978.

Milton A. Bass, New York City (Jacob Lauffer, and Bass, Ullman & Lustigman, New York City, of counsel), for petitioners, The National Nutritional Foods Association The National Association of Pharmaceutical Manufacturers and Solgar Co., Inc.

Miles H. Robinson, M. D., pro se.

Charles R. McConachie, Chief, Consumer Affairs Section, U. S. Dept. of Justice, Washington, D. C. and Jess H. Stribling, Food and Drug Administration, Rockville, Md. (John H. Shenefield, Asst. Atty. Gen., Antitrust Div., Dept. of Justice, Washington, D. C., and Stephen H. McNamara, Acting Chief Counsel, Food and Drug Administration, Rockville, Md., of counsel), for respondents.

Before FRIENDLY, SMITH and MESKILL, Circuit Judges.

FRIENDLY, Circuit Judge:

This is the latest but, unfortunately, probably not the last chapter in the bitter battle between the Food and Drug Administration (FDA) and manufacturers and vendors of pills and liquids containing vitamins and minerals and citizens allied with the latter. While the manufacturers and vendors have obvious private interests as well, the battle reflects what appears to be a sincere sentiment on the part of many citizens that daily ingestion of a substantial quantity and variety of vitamins and minerals in the form of pills or liquids, in addition to those furnished by ordinary diet, is needed for good health, especially because of the increasing consumption of "the modern food fads sweet drinks, junk foods, heavy sugar diets" and "wheat germ-free bread and nutritionally inadequate breakfast foods," 121 Cong.Rec. S. 21856 (daily ed. Dec. 11, 1975) (Sen. Proxmire), and the FDA's equally sincere belief that the promotion of what, on a previous review, this court called a "dazzling array" of recommended daily dosages and combinations, National Nutritional Foods Ass'n v. Food & Drug Administration, 504 F.2d 761, 776 (2 Cir. 1974), cert. denied, 420 U.S. 946, 95 S.Ct. 1326, 43 L.E.2d 424 (1975), is causing consumers to waste millions of dollars annually in the purchase of vitamin and mineral preparations which they either do not need at all or do not need in the potencies or combinations that are being bought. The battle began nearly a generation ago with the FDA's publication of a Proposal to Revise Regulations in the Federal Register of June 20, 1962, 27 F.R. 5815; the proposal included the establishment of standards of identity for "food for special dietary uses" and revised label standards for them. Because the FDA's establishment of a standard of identity under § 401 ¹ and its prescription of labels for foods for special dietary use under § 403(j) are among the few instances on the statute books where an evidentiary hearing is required for rulemaking, § 701(e), over twenty-two months were devoted to such a hearing, which developed a transcript of 32,405 pages and hundreds of exhibits. The Commissioner published final regulations on August 2, 1973, 38 F.R. 20708-18, 20730-40.

Fifteen petitions to review were filed; their disposition by this court required a 47-page opinion, 504 F.2d 761 (1974), cert. denied, 420 U.S. 946, 95 S.Ct. 1326, 43 L.Ed.2d 424 (1975), familiarity with which is assumed. Although "broadly sustaining the regulations," 504 F.2d at 786, we stayed them and remanded the case for the FDA to carry out a number of directives. One was that it should modify § 80.1(b)(4) of the Standard of Identity regulations to include increases in upper limits of potency as well as new combinations of vitamins and minerals and to entertain applications thereunder before the new regulations became effective, 504 F.2d at 783-86. We invalidated § 125.1(c) of the Label Regulations, which forbade the inclusion in "general purpose foods or dietary supplements of vitamins and minerals" of two vitamins ² and six minerals, ³ which the FDA had recognized to be essential to human nutrition but for which no U.S. RDA's (recommended daily allowances) had been established, 504 F.2d at 786-787, ⁴ and § 125.1(h) of the Label Regulations declaring that preparations containing more than the upper limits of the U.S. RDA per serving were "drugs." 504 F.2d at 788-89. Finding that the cross-examination of Dr. William Sebrell, the most knowledgeable witness testifying on the preparation of the 1968 National Academy of Science Recommended Dietary Allowances whence the U.S. RDA's were drawn, by Dr. Miles Robinson, then representing the National Health Federation and now a pro se petitioner here, had been improperly restricted by the hearing examiner, we instructed the FDA "to reopen the record for the limited purpose of permitting reasonable cross-examination of Dr. Sebrell (or, if he is not available, some other qualified member of the (Food and Nutrition) Board (of the National Academy of Sciences-National Research Council) by Dr. Robinson or counsel of some other similarly interested Participants," 504 F.2d at 792-99. We faulted § 125.2(b)(2) of the Label Regulations as unsupported by substantial evidence insofar as it prohibited claims that a balanced diet of ordinary foods would not supply an amount of iron adequate for women of childbearing age and for children; as to this we directed that the FDA either supply further evidence to justify this prohibition or "insert a proper qualification" in the regulation, 504 F.2d at 802. Finally, we directed that fresh fruits and vegetables be exempted from the regulations, 504 F.2d at 806-07.

After the Supreme Court had denied petitions for certiorari by those who had been petitioners here, 420 U.S. 946, 95 S.Ct. 1326, 43 L.Ed.2d 424 (1975), the Commissioner published in the Federal Register of May 28, 1975, 40 F.R. 23244-50, a paper bearing the three-headed title "Opportunity for Filing Applications for Additional Formulations of Dietary Supplements of Vitamins and Minerals; Preliminary Notice of Reopening of Hearing; Tentative Amendments to Final Orders." Under the first heading the FDA prescribed how and where applications for additional approved formulations should be made; it also advised that it would not be necessary to seek approval of products having a higher potency than the U.S. RDA's so long as the products consisted of a single vitamin or mineral since the Commissioner intended to amend the regulations to permit this. Under the second heading the Commissioner proposed to tender on the reopened hearing, in lieu of Dr. Sebrell who was no longer a member of the Food and Nutrition Board, his successor as Chairman, Dr. Alfred E. Harper. The cross-examination was to include (1) the methodology employed in development of the recommended dietary allowances by the Board and the scientific foundation upon which these allowances are based, (2) the scientific appropriateness of the Food and Drug Administration's use of the Board's recommended dietary allowances, and (3) possible biases or conflicts of interests on the part of the Board, as well as other relevant subjects, and the FDA intended to open cross-examination not only to Dr. Robinson but "to as many participants reflecting as many points of view as is reasonably possible." 40 F.R. 23245. Under the third heading the Commissioner proposed a number of amendments to the regulations, most of which were intended to implement this court's order.

The reopened hearing before an Administrative Law Judge (ALJ) occurred in November, 1975, lasted six days and produced an additional 1119 pages of transcript. On February 20, 1976, the ALJ entered a report and recommended order finding that:

(1) Alleged biases and/or conflicts of interest of the witness or other members of the Food and Nutrition Board have not been established in any degree which might reasonably be interpreted as affecting the judgment of the witness or other members of the Board in determining the RDA's.

(2) Although the Board determined the RDA's as a guide to sound nutrition for a healthy population, and not as standards for regulatory purposes, there is nothing inconsistent or unsound in using the RDA's as a basis for regulatory determinations as to labeling and nutritional content requirements, and

(3) Information adduced through detailed cross-examination into the scientific basis and methodology utilized by the Board in determining the RDA's does not require adoption of regulations differing from those published.

Exceptions to this were filed.

Meanwhile the scene of action had shifted. On April 22, 1976, the President signed Public Law 94-278, extensively amending the Food, Drug and Cosmetic Act. Section 501(a) added to the Act § 411, which we reproduce in the margin. ⁵ Broadly speaking subsection (a) put an end to the FDA's efforts to limit the potency of any vitamin or mineral included in "a food for special dietary use," as defined in subsection (c), or the number or combination of vitamins, minerals or other food ingredients included therein except when the vitamin, mineral, other ingredient of food, or food, . . . is represented for use by (1) individuals in the treatment or management of specific diseases or disorders, (2) children under the age of twelve, or (3) pregnant or lactating women. The limitation of the FDA's authority with respect to labelling was much less severe; the main thrust was to forbid FDA regulations that would wholly prohibit inclusion in labels of ingredients which were not...