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National Nutritional Foods Association v. Kennedy

February 16, 1978


Petitions to review revised orders of the Food and Drug Administration establishing a standard of identity and labelling requirements for vitamins and minerals. Regulations vacated and cause remanded.

Author: Friendly

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 germfree 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, 504 F.2d at 776, 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*fn1 of its prescription of labels for foods for special dietary use under § 403(j) is 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 hundred 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*fn2 and six minerals,*fn3 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,*fn4 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 RDA's 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 to "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 (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.*fn5 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 vitamins or minerals. Section 501(b), which is of special importance to our decision, provided:

The Secretary of Health, Education, and Welfare shall amend any regulation promulgated under the Federal Food, Drug, and Cosmetic Act which is inconsistent with section 411 of such Act (as added by subsection (a)) and such amendments shall be promulgated in accordance with section 553 of title 5, United States Code.

Without engaging in any further proceeding, the Commissioner published final regulations in the Federal Register of October 19, 1976, 41 F.R. 46156-76. The Commissioner believed that almost all the applications for new formulations had been mooted by the 1976 amendment. He approved a new combination of vitamin A, D and C with provision for optional inclusion of vitamin E and/or iron, as a dietary supplement for infants and young children, denied an application for a preparation containing a higher level of vitamin B6 for pregnant and lactating women, and determined to treat as drugs multinutrient supplements for women taking oral contraceptives which contained estrogen. He overruled the exceptions to the ALJ's report concerning the examination of Dr. Harper, to other evidentiary rulings at the reopened hearing, and to FDA's continued reliance on the NAS-RDA's. He passed upon and largely rejected the exceptions to the amendments proposed in the notice of May 28, 1975, noting that many exceptions were mooted as a result of the 1976 legislation. The Commissioner's technique was essentially to readopt the 1973 regulations with reorganization "to improve clarity," modifications designed to meet our directions, addition of a section classifying dietary supplements not "generally recognized as safe" as "food additives," and a further modification, § 80.1(e), "which provides that products subject to the new vitamin/mineral legislation are not subject to the maximum potency limits and the limits on inclusion of ingredients otherwise imposed on dietary supplements by §§ 80.1 and 125.2(b)(5)." 41 F.R. 46170.

This action by the Commissioner evoked an "urgent petition" dated November 30, 1976 by the attorneys for National Nutritional Foods Association, National Association of Pharmaceutical Manufacturers and Solgar Co., Inc., who constitute one group of petitioners on this second round of review. While the petition advised that the details of the new regulations were being evaluated, its emphasis was directed at the FDA's procedure in promulgating the final regulations without having "requested from the public any input as to what changes would be necessary in the regulations in light of the newly enacted vitamin and mineral legislation." The petition asked the Commissioner to "withdraw the final order published in Federal Register of October 19, 1976 and substitute therefor a republished proposed order which gives the public the full right to submit comments and objections in accordance with the requirements of § 701(e) of the Federal Food, Drug and Cosmetic Act." A prompt ruling was requested.

The Commissioner made no answer for four and a half months.*fn6 In the Federal Register for April 19, 1977, 42 F.R. 20292-96, he published his response to the petition of November 30, 1976, as well as to a letter dated November 12, 1976, in which Dr. Robinson expressed disagreement with the FDA's ruling that the cross-examination of Dr. Harper had not impugned the U.S. RDA's. On the procedural issue, the Commissioner now took note of § 501(b) of the 1976 legislation, as he had not previously done. He concluded that he was nevertheless empowered to issue final regulations "without prior notice of proposed rulemaking and public procedure" because of the provision in 5 U.S.C. § 553(b) that "except when notice of hearing is required by statute," the requirement of publishing notice of proposed rulemaking does not apply

(B) when the agency for good cause finds (and incorporates the finding and a brief statement of reasons therefor in the rules issued) that notice and public procedure thereon are impracticable, unnecessary, or contrary to the public interest.

The Commissioner reviewed the provisions of the final regulation "that were prompted by the new legislation," and concluded in each case that public rulemaking procedures would be "impracticable" and "unnecessary" because he was simply bowing to the will of the legislature.*fn7 The Commissioner further rejected the contention that he should have followed the "hearing on the record" procedure described in § 701(e). These petitions for review followed.*fn8


(1) The procedural questions.

We conclude that the Commissioner committed procedural error and that this requires a further remand. We reach this conclusion with regret in light of the fifteen and a half years that have elapsed since the FDA began its efforts to achieve better control of the identity and labelling of vitamin and mineral preparations. However, we are convinced that in failing to give notice of proposed rulemaking and to accord an opportunity for public participation in the process, as provided in 5 U.S.C. § 553(b) and (c), the Commissioner violated the mandate of Congress.

We begin our discussion with Professor Kenneth Culp Davis' oft-quoted statement:

The procedure of administrative rule making is one of the greatest inventions of modern government.*fn9

In view of the important political interests served by public participation in rulemaking, it would be arguable that even in the absence of a specific direction, this unusual situation where Congress effected a profound alteration in an agency's powers while rulemaking was in progress*fn10 would have called for a new issuance of proposed rules and public participation in rulemaking, as the Commissioner had accorded on his own motion after he had redrafted the 1973 regulations in light of our remand. We need not address that question, however, since Congress did give explicit directions in § 501(b) quoted above.

It is true that, if read literally, § 501(b) applies only to regulations amending "any regulation promulgated" under the Act which is inconsistent with the new § 411 and the standard of identity regulations for vitamin and mineral food were not regulations amending a regulation that had been promulgated but rather regulations that were awaiting promulgatiion, since the previous opinion of this court stayed the regulations and remanded them to the FDA. However, the Commissioner properly did not attempt to read § 501(b) so literally;*fn11 clearly what Congress had in mind in enacting § 501(b) was the Commissioner's much debated proposed vitamin and mineral regulations, which Congress was aiming to restrict. Rather the Commissioner sought to justify his decision not to engage in public rulemaking on the basis, sound enough as an abstract proposition, that when Congress referred to 5 U.S.C. § 553(b), it included the exceptions therein contained. In effect the Commissioner reads § 501(b) as meaning only that if he decided that further procedures were needed, these could be of the notice and comment type prescribed by 5 U.S.C.§ 553(b) and (c) rather than the trial type procedure prescribed by § 701(e) of the Food, Drug and Cosmetic Act in cases where it applies.

One answer that might be made to the Commissioner's reliance on the exceptions in 5 U.S.C. § 553(b)(B) is that the Commissioner did not include in the October 19, 1976 rules the statement required in the parenthetical clause and that it was too late for him to do so on a petition for reconsideration.*fn12 While such a denial of a locus poenitentiae might seem unduly literalistic, cf. Nader v. Sawhill, 514 F.2d 1064, 1068 (TECA1975), we are not sure that is necessarily so. Congress could well have wished to require an agency to address its mind to whether a case fell within the exceptions before it committed itself to final regulations, not after it had done so without complying with 5 U.S.C. § 553(b) and (c) procedures and thereby created a need for self-justification.*fn13 At the very least, justifications after the event are somewhat suspect. See Burlington Truck Lines, Inc. v. United States, 371 U.S. 156, 168, 9 L. Ed. 2d 207, 83 S. Ct. 239 (1962); National Nutritional Foods Ass'n, supra, 504 F.2d at 789. However, we need not pass on this since the Commissioner would not have been warranted in dispensing with public rulemaking even if he had included in the October 19, 1976 regulations the findings of impracticability and lack of necessity which he made on April 19, 1977.

The legislative history of the Administrative Procedure Act demonstrates that Congress intended the exceptions in § 503(b)(B) to be narrow ones. The Senate Report, No. 752, 79th Cong. 1st Sess. (1945), reprinted in the Legislative History of the Act at 200, stated:

The exemption of situations of emergency or necessity is not an "escape clause" in the sense that any agency has discretion to disregard its terms or the facts. A true and supported or supportable finding of necessity or emergency must be made and published. "Impracticable" means a situation in which the due and required execution of the agency functions would be unavoidably prevented by its undertaking public rule-making proceedings. "Unnecessary" means unnecessary so far as the public is concerned, as would be the case if a minor or merely technical amendment in which the public is not particularly interested were involved. "Public interest" supplements the terms "impracticable" or "unnecessary"; it requires that public ...

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