NATIONAL NUTRITIONAL FOODS ASSOCIATION and Solgar Company, Inc., et al., Petitioners, v. FOOD AND DRUG ADMINISTRATION and United States Department of Health, Education and Welfare, et al., Respondents. Nos. 1189-1203, Dockets 73-2129, 73-2166, 73-2175, 73-2449, 73-2745, 73-2746, 732747, 73-2748, 73-2752, 73-2753, 73-2762, 73-2824, 73-2826, 73-2834 and 74-1055.

United States Court of Appeals, Second Circuit.

Argued June 19, 1974.

Decided Aug. 15, 1974.

Certiorari Denied Feb. 24, 1975.

See 95 S.Ct. 1326.

504

504

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, 111. (Dilling & Dilling and Dennis M. Gronek, Chicago, 111., 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.^{Footnote *}

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)^{Footnote 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."³ Both were published in the

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

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)(l) 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 "sup

V S. (.lutEKNMKNT RKrOUMEKtiED TfAtVf AliXWAHCZg (t'.S. IlDA's) ASK rERMISUIBW COMPOSITIONAL KANOES rOH DIETAUT 6UM-LKUBNT8 OF VITAMINS AND MINERALS plied 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."^{Footnote 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)(l) sets forth "the permissible qualitative and quantitative composition of dietary supplements of vitamins and/or minerals" in the form of a table, as follows:

Section 80.1 (c) requires that dietary supplements contain in the quantity specified in the label for consumption in one day by each population group listed in the table not less than the lower nor more than the upper limits there listed.

Rounding out the picture, §§ 80.1 (h) (1) and (2) prescribe: (h) Nomenclature. (1) The common name of a dietary supplement shall consist of a term descriptive of the vitamin and/or mineral composition of the product, as established in paragraph (h) (2) of this section, together with a phrase or phrases designating the group(s) for which the supplement is represented, as established in paragraph (h)(3) of this section (e. g., "multivitamin and multimineral supplement for children under 4 years of age"). The name of the dietary supplement shall appear prominently and conspicuously on the principal display panel(s) of the label. The letters of the phrase(s) designating the consumer group(s) for which the product is represented shall be no less than one-third the size of those used in the term descriptive of the composition of the product. In addition to the common name prescribed by this paragraph, a dietary supplement may be labeled with a proprietary name: Provided, That it is not false or misleading in any particular. (2) The terms used to describe the vitamin and/or mineral composition of dietary supplements listed in paragraphs (b)(l) and (2) of this section shall be as follows: (i) "Multivitamin and multimineral supplement" for a dietary supplement containing all vitamins and minerals, (ii) "multivitamin supplement" for a dietary supplement containing all vitamins, (iii) "multimineral supplement" for a dietary supplement containing all minerals, (iv) "multivitamin and iron supplement" or "multivitamin supplement with iron" for a dietary supplement containing all vitamins and the mineral iron, (v) " supplement" for a dietary supplement containing a single vitamin or mineral listed as a mandatory or optional ingredient in the table contained in paragraph (f)(l) of this section (the blank to be filled in with the name of the vitamin or mineral). Various exemptions are provided from the operation of Part 80, of which the most important are contained in § 80.1 (b)(5): The provisions of this section shall not apply to any food which contains or consists of any vitamin or mineral listed in § 125.1 (b) of this chapter [the same vitamins and minerals as those listed in the § 80.1 (f)(l) table, supra], or any combination thereof, provided that all of the following requirements are met: (i) No such nutrient is contained at a level of 50 percent or more of the adult U. S. RDA per serving for that nutrient, (ii) No direct or implied representation is made on the label, in labeling, or in advertising that the product is a dietary supplement or is adequate or appropriate for supplementing the daily diet with essential nutrients, and (iii) The product is labeled pursuant to the provisions of § 1.17 of this chapter [relating to nutrition labeling of foods]. and § 80.1(e)(5)-(7): (5) Raw agricultural commodities (including marine products) and fabricated and other conventional foods to which single or multiple vitamins and/or minerals are added to improve nutritional quality, unless the total level (including any naturally occurring amounts) of any added vitamin or mineral per single serving attains or exceeds 50 percent of the U. S. Recommended Daily Allowance (U. S. RDA) for adults and children 4 years or more of age as specified in § 125.1 (b) of this chapter, in which case the provisions of both this section and § 1.17 of this chapter shall apply. If the provisions of both this section and § 1.17 apply to a food, the labeling o± such food shall conform to the labeling established in this section except

that the labeling established in paragraph (c) of § 1.17 of this chapter, including the order for listing vitamins and minerals established in paragraph (c)(7)(iv) of that section, shall be used in lieu of the labeling established in paragraph (i)(l) of this section. (6) Raw agricultural commodities (including marine products) which by their nature are sources of a specific vitamin(s) and/or mineral(s) at a level that, if it had been added, would have brought them within the definition of a dietary supplement. Such shall meet all the requirements of this section if they are represented as dietary supplements. Such foods may also be used as a source of specific vitamins and/or minerals in dietary supplements meeting the requirements of this section. (7) A food with nutrients restored to pre-processing levels or added pursuant to § 1.8(e) of this chapter so that it is not nutritionally inferior to the food for which it substitutes and which it resembles. Finally, two provisions of § 125.1 are parts of this basic regulatory scheme.

Starting with a reference to § 125.1 (b), which sets out the same vitamins and minerals as listed in the table reproduced above along with the U. S. RDA's for the three classes of consumers there listed and a fourth class of "infants," ^{Footnote 4} § 125.1 (c) states: (c) In addition to the vitamins and minerals listed in paragraph (b) of this section, vitamin K, choline, and the minerals chlorine, potassium, sodium, sulfur, fluorine, and manganese are recognized as essential in human nutrition, but no U. S. Recommended) Daily Allowance (U. S. RDA) has been established for these nutrients. These nutrients are not appropriate for addition to general purpose foods or dietary supplements of vitamins and minerals but may be added to such other foods for special dietary use as infant formulas, and foods represented for use solely under medical supervision to meet nutritional requirements in specific medical conditions. And§ 125.1 (h) states: (h) Any product containing more than the upper limit of the U. S. RDA per serving (or where appropriate, per daily recommended quantity) of a vitamin or mineral as specified in § 80.1 (f) (1) of this chapter is a drug, except for conventional foods which contain naturally-occurring amounts in excess of these limits or which contain added amounts in excess of these limits pursuant to § 1.8(e) of this chapter so that it is not nutritionally inferior to the food for which it substitutes and which it resembles, and except as provided for in a specific regulation for such special dietary foods as infant formulas or foods which are represented for use solely under medical supervision to meet nutritional requirements in specific medical conditions. It will be more convenient to defer description of other relevant provisions of the Regulations until subsequent discussion of them.

I. Jurisdiction

We must first deal with the claim of National Nutritional Foods Association, Solgar Co., Inc., and National Association of Pharmaceutical Manufacturers that we lack jurisdiction to review eight provisions which these very petitioners have challenged. These are (1) § 80.1 (b)(2), which has the effect of restricting the quantity of a single vitamin or mineral that may be sold in a dietary

supplement; (2) § 80.1(b)(5), which exempts certain foods from the operation of § 80.1 if those foods are sold in servings not exceeding 50% of the U. S. RDA's and satisfy special label and labeling requirements; (3) the definition of "special dietary use" in § 125.l(a); (4) § 125.1 (c), quoted above, which limits the inclusion of various nutrients for which RDA's have not been established; (5) § 125.2(a), which requires the principal display panel of the label of food for special dietary use to bear a statement of the usefulness of the food, a requirement which these petitioners consider, in light of one of the Commissioner's findings of fact (No. 3, 38 F.R. 20713 (1973)), to have the effect of prohibiting the listing and thus the inclusion of certain types and amounts of ingredients; (6) § 125.2(b), which prohibits six categories of statements in the labeling (as distinguished from the label) of foods for special dietary use, as well as § 80.1 (m), which incorporates by reference the label and labeling prohibitions contained in § 125.2(b); (7) § 125.2(b)(5), one of the six categories just mentioned, which prohibits the marketing of otherwise allowable foods for special dietary use if they contain ingredients the need for which in human nutrition has not been established; and (8) § 125.1(h), quoted above, which, with some exceptions, classifies as a drug any product containing in one serving or in the daily recommended quantity more than the upper limit of the U. S. RDA's specified in the table.

The basis for the challenge to our power to review the eight provisions is this: The jurisdiction of a court of appeals under § 701 (f) to review orders of the FDA is limited, so far as here pertinent, to orders promulgated under § 401, authorizing prescription of standards of identity, and § 403(j), authorizing the prescription of regulations concerning the labels of foods purporting to be or represented for special dietary uses. ^{Footnote 5}

A regulation issued under other sections, such as § 403(a), which deems a food "misbranded" if its labeling "is false or misleading in any particular," or § 701 (a), the FDA's general authority "to promulgate regulations for the efficient enforcement" of the statute, must be challenged by an action in a district court. Compare Gardner v. Toilet Goods Ass'n,  387 U.S. 167, 87 S.Ct. 1526, 18 L.Ed.2d 704 (1967), sustaining a suit in the district court attacking a general regulation promulgated under § 701 (a) concerning color additives despite the availability of review of a decision refusing to approve a particular additive in a court of appeals by a combination of § 706(d), 21 U.S.C. § 376(d), and § 701 (f). See also Abbott Laboratories v. Gardner,  387 U.S. 136, 87 S.Ct. 1507, 18 L.Ed.2d 681 (1967). Any authority to promulgate the eight provisions, say these petitioners, must have arisen from sections of the Act other than §§ 401 or 403(j).

Petitioners' argument in the main confuses the question of jurisdiction with the merits. If the Commissioner rested his action on an arguable interpretation of §§ 401 or 403(j), our jurisdiction is not defeated by the possibility, even the probability, that we may ultimately reject his interpretation. As Mr. Justice Black pointed out in Bell v. Hood,  327 U.S. 678, 682-683, 66 S.Ct. 773, 90 L.Ed. 939 (1946), such a decision would be an exercise of jurisdiction, not a refusal to exercise it. And the case would not stand differently if, having rejected the Commissioner's position under the cited sections, we should find his action sustainable under others. Having acquired jurisdiction on the basis of the Commissioner's arguable invocation of §§ 401 or 403(j), we would be bound to decide the case as required by law. The situation

is a fortiori to that where a federal court, having acquired jurisdiction of a suit challenging state action under 28 U.S.C. § 1343(3) because of a substantial constitutional claim, may decide pendent statutory claims over which it might not otherwise have jurisdiction because of lack of the required jurisdictional amount. See Rosado v. Wyman,  397 U.S. 397, 90 S.Ct. 1207, 25 L.Ed.2d 442 (1970); Hagans v. Lavine,  415 U.S. 528, 94 S.Ct. 1372, 39 L.Ed.2d 577 (1974) ; Almenares v. Wyman,  453 F.2d 1075 (2 Cir. 1971), cert, denied,  405 U.S. 944, 92 S.Ct. 962, 30 L.Ed.2d 815 (1972).

With the possible exception of § 125.1 (h), all the provisions, review of which is claimed to lie outside our jurisdiction, were rested at least in part on §§ 401 or 403(j). At this stage mere statement is practically sufficient to show that the FDA's position was fairly arguable, ^{Footnote 6} as our subsequent discussion will demonstrate in greater detail. If § 125.1 (h) stood alone, it would seem indeed that this was a regulation issued under the general rulemaking authority of § 701(a), interpreting the term "drug" in § 201(g)(l)(B), 21 U.S.C. § 321(g) -(1)(B), ^{Footnote 7} and that the petition to review should be dismissed as was done in an unreported order, Citizens for Truth in Nutrition v. Food and Drug Administration, No. 73-2826 (2 Cir., Mar. 4, 1974), where the court dismissed a petition to review an interpretive regulation issued under § 701 (a), 21 C.F.R. § 3.94 and 3.95, requiring that preparations of vitamins A and D in dosages in excess of 10,000 and 400 international units, respectively, should be restricted to sale as "prescription drugs" under § 503(b) (1)(B), 21 U.S.C. § 353(b)(l)(B), and labeled accordingly. See National Nutritional Foods Ass'n v. Weinberger, 366 F.Supp. 1341, 1343-1344 (S.D.N.Y.) [denial of temporary injunction], aff'd,  491 F.2d 845 (2 Cir. 1973), 376 F.Supp. 142 (S.D.N.Y.1974) [dismissal of complaint], appeal pending. But here the provision stands as an integral part of a regulation colorably alleged to rest on §§ 401 and 403 (j). The same important policy considerations of economy in judicial time which underlie the doctrine of "pendent jurisdiction" as viewed in other contexts apply a fortiori when the issue is whether a federal court of appeals with clear jurisdiction to review almost all provisions of a comprehensive set of regulations should finish the job or relegate a single provision to suit in a federal district court, possibly in another circuit, whose decision, of course, would be subject to appeal to a court of appeals. ^{Footnote 8}

4

We hold that we have jurisdiction to consider all issues tendered. ^{Footnote 9}

II. Standards of Identity The hardest issues in the case are (1) whether the FDA has power to set standards of identity for dietary supplements in such a way that vitamin and mineral products containing vitamins and/or minerals in nonstandardized combinations or whose daily dosage of any nutrient as specified in their labels exceeds the upper limit of the U. S. RDA's ^{Footnote 10} be deemed misbranded under § 403 (g), 21 U.S.C. § 343(g), see p. 775 infra, if they are offered for sale as foods; and, if so, (2) whether there was substantial evidence to support what the agency did. In this part of the opinion we shall deal with the issues generally, deferring to Part IV more detailed discussion of the evidentiary question with respect to the quantitative limits.

We should make clear at the outset that we do not at all join in the vituperation showered on the FDA by some of the petitioners. ^{Footnote 11}

Confronted with a difficult problem, the agency developed an innovative solution.

13

The questions for us are whether, giving the agency full credit for good intentions and according appropriate weight to its expertise, its action was within the powers that Congress has chosen to confer and is supported by substantial evidence. The conflicting considerations are neatly framed in two opinions of Mr. Justice Frankfurter. Writing of both the Food and Drugs Act of 1906 and the Food, Drug and Cosmetic Act of 1938 in United States v. Dotterweich,  320 U.S. 277, 280, 64 S.Ct. 134, 136, 88 L.Ed. 48 (1943), he said: The purposes of this legislation thus touch phases of the lives and health of people which, in the circumstances of will modern industrialism, are largely beyond self-protection. Regard for these purposes should infuse construction of the legislation if it is to be treated as a working instrument of government and not merely as a collection of English words.

But eight years later he warned in 62 Cases of Jam v. United States, 340 U.S.

593, 600, 71 S.Ct. 515, 520, 95 L.Ed. 566 (1951): In our anxiety to effectuate the congressional purpose of protecting the public, we must take care not to extend the scope of the statute beyond the point where Congress indicated it would stop.

We begin by rejecting the argument of some petitioners that the FDA could not proceed simultaneously under

§§ 401 and 403(j). Section 403(g) says that a food shall be deemed misbranded:

If it purports to be or is represented as a food for which a definition and standard of identity has been prescribed by regulations as provided by section 341 of this title, unless (1) it conforms to such definition and standard, and (2) its label bears the name of the food specified in the definition and standard, and, insofar as may be required by such regulations, the common names of optional ingredients (other than spices, flavoring, and coloring) present in such food.

21 U.S.C. § 343(g). The claim is that this exhausts the FDA's power with respect to a label when a definition and standard of identity have been prescribed and that, conversely, label regulation under § 403(j) exhausts the agency's power with respect to foods purporting to be or represented for special dietary uses. It is argued that the two subsections represent two contrasting and mutually exclusive regulatory philosophies, each appropriate only within its limited sphere: With respect to "foods with long histories of use," the approach was to hold manufacturers to a " 'time-honored' standard" by use of the standard of identity power and the accompanying limited authority of § 403(g); but with respect to the less familiar foods for special dietary use, "where there are no time-honored recipes and where the knowledge of the importance of vitamins and minerals to health is changing rapidly," a requirement of full disclosure was thought better protection for the consumer.

This argument finds support neither in the language of the statute nor in its legislative history. In sharp contrast to § 403(i), ^{Footnote 13} nothing in § 403(j) restricts its applicability to cases where no standard of identity has been prescribed. The fair reading of the statute is rather that, in the case of foods for special dietary uses for which standards of identity have been prescribed, Congress wished to authorize the FDA to require label disclosure not only of optional properties, as in the case of other foods with standards of identity, but of mandatory ones as well. Nothing in the legislative history is persuasive to the contrary. The statement in Federal Security Administrator v. Quaker Oats Co.,  318 U.S. 218, 230, 63 S.Ct. 589, 596, 87 L.Ed. 724 (1943), that the purpose of Congress was "to require informative labeling only where no such standard [of identity] had been promulgated, where the food did not purport to comply with a standard, or where the regulations permitted optional ingredients and required their mention on the label," see also 318 U.S. at 232, 63 S.Ct. 589, was made with a view only to the interrelationship of subsections 403(g) and (i), and has no bearing on subsection 403(j).

The evidence supporting the need for both a qualitative and a quantitative standard of identity was impressive. We set out below the more important findings of fact (omitting references) : 3. The establishment of a standard of identity and quantitative limits for the nutrient ingredients in dietary supplements will reduce consumer confusion concerning choice of dietary supplements by insuring a basically rational formula for all products.

7. The sale and use of vitamin/mineral preparations in the United States are extensive, running into

hundreds of millions of dollars annually in wholesale bulk value, and involve three-fourths of American households. The majority of such preparations differ qualitatively and quantitatively from each other, presenting a bewildering variety to the consumer.

8.

Many dietary supplements are nutritionally irrational, in that they provide quantitative levels and qualitative combinations of nutrients for which no human individual need could possibly exist, if the products are used only as dietary supplements. Lay persons are incapable of determining, by themselves, whether they have or are likely to develop vitamin or mineral deficiencies.

9.

Although approximately 20 percent of the users of dietary supplements of vitamins and minerals actually use those articles to supplement or balance their diet, more than 40 percent of those persons admit they have no idea which vitamins or minerals, if any, are not sufficiently supplied by their diet.

10.

Certain basic vitamins and/or minerals should be included in all articles offered as multivitamin and/or multimineral supplements. The remaining group of appropriate vitamins and/or minerals are considered to be scientifically optional for inclusion. The mandatory group of vitamins and/or minerals found in multivitamin and/or multimineral supplements should include all those listed in the table entitled "Recommended Daily Dietary Allowances, Revised 1968" in publication 1694 of the National Academy of Sciences.

38 F.R. 20734-35 (1973). And again:

22. The establishment of qualitative and quantitative limits on the composition of dietary supplements will reduce consumer confusion concerning choice of dietary supplements by ensuring a basically rational formula for all products.

Id. at 20735. Although some petitioners have pointed up record references in these findings of fact which the FDA is mis-citing or misreading, and could have pointed up many more, nevertheless the agency had ample evidence to conclude that a consumer seeking a dietary supplement of a given vitamin or mineral, whether singly or in combination with others, is faced with a dazzling array of recommended daily dosages and that a consumer seeking a multiple supplement is faced with an equally dazzling array of combinations; that neither consumer is given any basis for intelligent selection ; and that it would "promote honesty and fair dealing in the interest of consumers," Conclusion of Law f[ 1, 38 F.R. 20737 (1973), quoting § 401, to promulgate the qualitative and quantitative standards of identity of new Part 80, see Conclusions of Law ffff 2, 3, 38 F.R. 20737 (1973). An FDA compliance officer submitted a chart, not purporting to be exhaustive, showing 59 multivitamin and/or multimineral products he had found on the market. The number of ingredients ranged from a low of 9 to a high of 57, with all kinds of intermediate variations. The dosage per tablet or capsule of vitamin C, for example, ranged from 30 to 500 mg., and the compliance officer referred to hundreds of instances of labels showing a daily dosage of a given mineral or vitamin in excess of the RDA. Offering a specially acute example of this. Dr. Herbert, an FDA witness, cited a particular B 12 supplement sold as a general dietary supplement which had 25 times the strength even a strict vegetarian would need. There was evidence from which the agency was entitled to conclude that consumers are ill-equipped to choose from this galaxy of offerings ^{Footnote 14}

'as if the point would be in doubt in any event. And if expert testimony on the precise question of the usefulness of the standards of identity in overcoming all this was necessary, the FDA took the precaution of getting some'albeit of a conclusory nature. ^{Footnote 15}

The FDA considers, with what seems to us, at least in general, cf. p. 783 infra, entirely sufficient reason, that neither the new label requirements nor additions that might be made to these will suffice to eliminate consumer confusion. The subject matter is simply too recondite and the offering of products too diverse for a label alone to be "clear enough so that, in the words of the prophet Isaiah, 'wayfaring men, though fools, shall not err therein' . . .," General Motors Corp. v. FTC, 114 F.2d 33, 36 (2 Cir. 1940) (A. N. Hand, J.), cert, denied, 312 U.S. 682, 61 S.Ct. 550, 85 L.Ed. 1120 (1941). Thus, again passing to Part IV of this opinion special problems with respect to the propriety of using the U. S. RDA's to set maximum daily dosages, and passing to Part V an important and related procedural objection, we hold the agency was justified, as a matter of good sense, in concluding that the stated purposes of § 401 would be furthered by promulgating qualitative and quantitative standards of identity in this area so as to allow for some 30-odd products (each with limited variability of daily dosages) rather than the hundreds now on the shelves of food and drug stores.

There remain, however, the questions whether the standards promulgated are within the agency's general statutory power and, if so, whether they are "reasonable" within the meaning of § 401. Before considering these questions, it will be useful to review the authorities.

The Supreme Court has dealt with § 401 on only two occasions in the 36 years of the statute's history. The first was Federal Security Administrator v. Quaker Oats Co., supra,  318 U.S. 218, 63 S.Ct. 589, 87 L.Ed. 724. Quaker Oats had been marketing a concededly wholesome and accurately labeled product as "Quaker Farina Wheat Cereal Enriched with Vitamin D" or "Quaker Farina Enriched by the Sunshine Vitamin." The Administrator promulgated a standard of identity for farina which made no provision for the addition of any ingredient; he promulgated another standard for enriched farina which required the addition of prescribed minimum quantities of vitamin Bi, riboflavin, nicotinic acid and iron, ingredients of natural wheat lost in modern milling processes, and which allowed enrichment by vitamin D or certain minerals, see Quaker Oats Co. v. Federal Security Administrator, 129 F.2d 76, 78 (7 Cir. 1942), only as optional additional ingredients. The Quaker Oats product thus could not be sold either as "farina" since it contained the additional ingredient vitamin D, or as "enriched farina" since it did not contain the prescribed enrichment. The Court sustained the regulations.

The decision could perhaps have been rested on the basis that Quaker Oats had no real intention of marketing its product as farina simpliciter or as something clearly sui generis, and that its joinder of the words "farina" and "enriched" was misleading; the Administrator, this argument would run, was entitled to encourage and safeguard a belief on the part of consumers that "enrichment" would replace all the elements removed from natural wheat by the milling process, of which vitamin D is not one. But Chief Justice Stone preferred to uphold

504 directly the barring of the product from sale as either enriched farina or farina. ^{Footnote 16}

The Court began by mentioning that "[t]he composition of these enriched products [flours and farinas] varies widely," 318 U.S. at 225 & n. 5, 63 S.Ct. at 594, although the cited variants were eight rather than the hundreds at issue here. It referred, in language entirely applicable here, to testimony by nutritionists that "such products, because of the variety and combination of added ingredients, are widely variable in nutritional value; and that consumers generally lack knowledge of the relative value of such ingredients and combinations of them." Id. at 226, 63 S.Ct. at 594. As here, there was expert testimony tending to support a conclusion of consumer confusion and recommending the adoption of the definitions and standards. Id. at 226, 228-229, 63 S.Ct. 589. Thus, after referring to the statutory criterion of promoting "honesty and fair dealing in the interest of consumers," Chief Justice Stone said that "[tjaking into account the evidence of public demand for vitamin-enriched foods, their increasing sale, their variable vitamin composition and dietary value, and the general lack of consumer knowledge of such values," there was sufficient evidence "to support the Administrator's judgment that, in the absence of appropriate standards of identity, consumer confusion would ensue." Id. at 228-229, 63 S.Ct. at 595. In the most critical passage of the opinion, the Chief Justice summed up, id. at 230-231, 63 S.Ct. at 596 (footnote omitted): The provisions for standards of identity thus reflect a recognition by Congress of the inability of consumers in some cases to determine, solely on the basis of informative labeling, the relative merits of a variety of products superficially resembling each other.

We cannot say that such a standard of identity, designed to eliminate a source of confusion to purchasers' which otherwise would be likely to facilitate unfair dealing and make protection of the consumer difficult'will not "promote honesty and fair dealing" within the meaning of the statute.

Turning finally to the argument that "it is unreasonable to prohibit the addition to farina of vitamin D as an optional ingredient while permitting its addition as an optional ingredient to enriched farina," id. at 231, 63 S.Ct. at 597, the Court said, id. at 232-233, 63 S.Ct. at 597:

We must reject at the outset the argument earnestly pressed upon us that the statute does not contemplate a regulation excluding a wholesome and beneficial ingredient from the definition and standard of identity of a food. The statutory purpose to fix a definition of identity of an article of food sold under its common or usual name would be defeated if producers were free to add ingredients, however wholesome, which are not within the definition ....

Since the definition of identity of a vitamin-treated food, marketed under its common or usual name, involves the inclusion of some vitamin ingredients and the exclusion of others, the Administrator necessarily has a large range of choice in determining what may be included and what excluded. It is not necessarily a valid objection to his choice that another could reasonably have been made. The judicial is not to be substituted for the legislative judgment. It is enough that the Administrator has acted within the statutory bounds of his authority, and that his choice among possible alternative standards adapted to the statutory end is one which a rational person could have made ....

Although some petitioners contend that 62 Cases of Jam v. United States, supra,  340 U.S. 593, 71 S.Ct. 515, 95 L.Ed. 566, sounded a retreat from Quaker Oats, we

do not consider it to be such. ^{Footnote 17}

The case turned on § 403(c), which says that a food shall be deemed misbranded: If it is an imitation of another food, unless its label bears, in type of uniform size and prominence, the word "imitation" and, immediately thereafter, the name of the food imitated. 21 U.S.C. § 343 (c). The Court held that a product labeled as an imitation jam was not misbranded simply because it contained less fruit than would have been dictated by the standard of identity for a fruit jam. We need not determine whether this would permit a manufacturer to market a product containing less than the prescribed minimum limits for vitamins and/or minerals'or containing more than the maxima or a nonstandard combination'as an imitation; none of the manufacturer petitioners has expressed any desire to do this and none of the consumer petitioners has intimated any interest in having such products available. ^{Footnote 18}

The cases in the courts of appeals certainly do not detract from Quaker Oats, as they hardly could, and may even go a bit beyond it in one particular hereinafter discussed, see note 20 infra. The leading ones are Libby, McNeill & Libby v. United States, 148 F.2d 71 (2 Cir. 1945), upholding the seizure as misbranded of a product, sold as "tomato catsup with preservative," which contained sodium benzoate in addition to the prescribed ingredients for catsup; United States v. 20 Cases . . . "Buitoni 20% Protein Spaghetti," 130 F.Supp. 715 (D.Del. 1954), aff'd on the opinion below,  228 F.2d 912 (3 Cir. 1956), upholding the seizure of spaghetti containing 20% protein as against a permitted maximum of 13% ; and, finally, a case which did not seriously test the limits of the agency's statutory authority, Corn Products Co. v. HEW,  427 F.2d 511 (3 Cir.), cert, denied, 400 U.S. 957, 91 S.Ct. 354, 27 L.Ed.2d 265 (1970), upholding a regulation which required a 90% peanut content in peajiut butter.

So far as concerns the statutory text, petitioners' main argument is that, in fixing a standard of identity for "dietary supplements" of vitamins and/or minerals, the FDA has gone beyond its authority since this is not a "common or usual name" of a particular food but rather an imposed functionally oriented denotation of a class of foods. The statute says, however, that a reasonable definition and standard of identity shall be prescribed for a food "under its common or usual name so far as practicable" (emphasis supplied); Congress thus seems to have envisioned the possible need to prescribe a reasonable definition and standard of identity for a food or a class of foods under something other than "its common or usual name." Moreover, our examination of the record discloses that, despite the enormous variations of content within the class of dietary supplements, vitamin and/or mineral preparations and multivitamin and/or multimineral preparations are commonly sold under the shared rubric "dietary supplement." While this may initially have been due to a desire of the producers to make clear that they were operating under the label requirements of Part 125 rather than of § 502, 21 U.S.C. § 352, relating to drugs, nevertheless the name has become "common and usual" for the full range of such products. Indeed in light of this, given a product of the kind here at issue and giving the manufacturer credit for not harboring a therapeutic intent so that his product is not thereby classifiable as a drug, see Part III infra, the agency had every reason to conclude that such a product by its

very existence "purports to be" what most people now know as a "dietary supplement." Cf. Libby, McNeill & Libby v. .United states, supra, 148 F.2d at 7273; United States v. 20 Cases . . . "Buitoni 20% Protein Spaghetti," 130 F.Supp. at 717-718; note 20 infra. The conclusion is in no way rebutted by a claim that "dietary supplement" describes a class of foods rather than a single food, since it is in the very nature of a standard of identity that it standardizes to a single formula (or here a selected group of formulae) what used to be a varied class of products. Any remaining objection must rather be to the purposes and consequences of delineating the class in a particular way, which brings us to petitioners' second line of attack.

This is based on legislative history. As petitioners correctly point out, Congress' dominant concern in enacting §§ 401 and 403(g) was to combat "economic adulteration." One of the Senate Reports, S.Rep.No.361, 74th Cong. 1st Sess. (1935), in Dunn, Federal Food, Drug, and Cosmetic Act 237, 245-46 (1938) [hereinafter cited as Dunn], noted, for example, that "[b] utter [before enactment of the earlier Butter Standards Act] was found on the market with a fat content varying from about 66 to 85 percent or more. Some manufacturers deliberately worked water into their product, thus obtaining butter prices for water and at the same time curtailing the market for the dairyfarmers' butterfat . . . Conditions similar to those which prevailed with respect to butter exist today with many other food commodities and can be corrected only by the action here authorized." A later House Report on the same bill, H.R.Rep.No.2139, 75th Cong. 3d Sess. (1938), in Dunn at 815, 819, said, "One great weakness in the present food and drugs law is the absence of authoritative definitions and standards of identity except in the case of butter and some canned foods. The Government repeatedly has had difficulty in holding such articles as commercial jams and preserves and many other foods to the time-honored standards employed by housewives and reputable manufacturers. The housewife makes preserves by using equal parts of fruit and sugar. The fruit is the expensive ingredient, and there has been a tendency on the part of some manufacturers to use less and less fruit and more and more sugar. . . . By authorizing the establishment of definitions and standards of identity this bill meets the demands of legitimate industry and will effectively prevent the chiseling operations of the small minority of manufacturers . . . ." Petitioners also place great reliance on a passage where the Senate Report went on to say that § 401 sought to prevent products with nonstandard'and generally cheapened'recipes from being marketed under standard-product names, but was not intended to bar the marketing as a food of any recipe not proved harmful: "It should be noted that the operation of this provision will in no way interfere with the marketing of any food which is wholesome but which does not meet the definition and standard, or for which no definition and standard has been provided; but if an article is sold under a name for which a definition and standard has been provided, it must conform to the regulation." S.Rep.No.361, supra, in Dunn at 246. The same thought appears in the House Report: "Under this a single reasonable standard of quality can be prescribed for any food and if the product falls below this standard it must be labeled as substandard [but can still be marketed]." H.R.Rep.No.2139, supra, in Dunn at 819.

Again we find several answers. The most obvious is that Congress was not focusing on any such problem as is presented here. Even if Congress' paramount concern in enacting § 401 was with cases of economic adulteration, any limitation of the section's scope to such instances would run afoul of the portion of Quaker Oats which sustained the banning of the vitamin D enriched product

from sale even as farina. ^{Footnote 19}

A rule that a standard of identity may never totally ban the sale of a product, provided only that it be labeled as substandard, may also have gone by the board with Quaker Oats; in 62 Cases of Jam, supra, 340 U.S. at 598, 71 S.Ct. 515, Mr. Justice Frankfurter seems to have read that case as holding that the product "could not be sold" in any form.

80

Moreover, even if a prohibition of total bans might make sense in some situations, the present case is precisely the type of case where, under the logic of Quaker Oats, it would not apply. For while that decision establishes beyond question that Congress wanted § 401 to be read to cover some nonadulteration cases such as that here in issue, so much of the legislative history earlier quoted as suggests a rule against total bans by use of the § 401 power was directed narrowly to adulteration and similar problems. The remarks in the Senate and House Reports to the effect that there will be no total bans thus say nothing more than that cheapened products may still be marketed, provided they are properly marked. But here, as in the "farina" branch of Quaker Oats, not cheapening but the variety of available products is the problem; \o allow the total array to continue to be marketed under some other name'for example, by avoiding use of the term "dietary supplement" or any equivalent'would, in such a special situation, render useless the § 401 power which we believe Congress intended to have available to the agency in a variety of unanticipated circumstances such as that now presented. The remarks in the legislative history regarding total bans simply do not speak therefore to cases such as that before us. ^{Footnote 21}

The petitioners also argue that the standard of identity is not "reasonable" as required by the language of § 401 or, for similar reasons, is "arbitrary" or "capricious" within the terms of the Administrative Procedure Act, 5 U.S.C. § 706. Much of their fire here is directed at the upper limits; they say essentially that there can be nothing wrong in giving a consumer more of a good thing when there is no claim of toxic effect. But the argument ignores that the purpose of a standard of identity is not simply to protect against unwholesomeness or adulteration but to "promote honesty and fair dealing in the interest of consumers." Advertising a potency in excess of the upper limits is bound to make consumers think they are getting a superior product when, in the FDA's view, they are not; furthermore, particularly in light of experience to date with the minimum daily requirements and passing still the appropriateness of the use of the RDA's for this purpose, the agency was far from irrational in concluding that, at least in general, see p. 783 infra, the problem would not be fully obviated by prescribing a label statement that the potencies exceeded the RDA's by particular amounts. Petitioners arg-ue also that it is unreasonable to prevent a purchaser from obtaining any combination he may desire by restricting him to the FDA's list of all vitamins and minerals, all vitamins, all minerals, or all vitamins and iron. So far as concerns the sophisticated purchaser this may well be so. But the FDA was entitled to give thought to the ordinary consumer, who may be harmed, for example, by purchasing a less inclusive combination while believing that he is getting everything he needs. Again it was far from irrational, at least as a general matter, for the agency to conclude that no label statement could fully meet this problem. Striking a proper balance among the interests of sophisticated and unsophisticated consumers is for the agency, not for a reviewing court. Some petitioners urge that if a purchaser of a combination wishes more than the upper limit of some particular vitamin or mineral, he will be condemned to more than he wants of many others. But this ignores that such a purchaser, who by very statement is one of some sophistication, can avoid the problem by taking both the combination and the single vitamin.

28

To be sure, even this may give him a dosage somewhat exceeding precisely what he desires, 83 but again the FDA was entitled to weigh such disadvantages against what it considered the larger good.

Concededly, in each of the situations we have just discussed, the consumer who is disappointed by not being able to obtain precisely the dosage or combination he seeks in the standardized products is likely to find his costs somewhat increased if he sets about achieving the same result by purchasing larger numbers of a particular type of pill, or even by purchasing a little of this and a little of that. Such an increase in effective price, and the likely consequential de-

crease in unit sales by the manufacturers, is, however, a paradigmatic example of the kind of consideration the agency may find outweighed by public needs.

Finally, the fact that the agency chose not to extend the standard of identity requirements to the nonessentia] nutrients listed in § 125.2(b)(5), see n. 68 infra, when individually marketed in the limited manner permitted by that subsection, or, § 80.1(b)(5), supra, to vitamins and minerals in daily dosages less than 50% of the adult U. S. RDA not represented as dietary supplements and labeled in accordance with 21 C.F.R. § 1.17, cf. 38 F.R. 6951, 695961 (1973), in no way renders the regulation unreasonable or arbitrary within its selected sphere. The Agency might well have believed that the preclusion from marketing the exempted products as dietary supplements, together with the present and possible future provisions of § 1.17 specifically invoked by § 80.1(b) (5), would prevent these products from causing the same problems of consumer confusion presented by those products to which the Part 80 standards do apply; it might at the same time have believed that no such limitations on marketing technique could obviate the problem of confusion with respect, for example, to products which could honestly be said to contain very large dosages of essential nutrients, or even that it was precisely because of the drastic simplification of product displays sought by Part 80 as a whole that the limited § 125.2(b)(5) and § 80.1(b)(5) exemptions would be tolerable. In any event, it was for the agency to decide how far to reach with this particular remedial effort. ^{Footnote 24}

Despite all this we are concerned that the all-or-nothing attitude adopted by both sides in this long and bitter controversy may have led the FDA into proscribing some combinations whose sale should be permitted under the standards of § 401 and into prescribing some maxima where a good case can be made for allowing an excess. Cf. Staley Mfg. Co. v. Secretary of Agriculture, 120 F.2d 258, 260-261 (7 Cir. 1941). Without intending either to prejudge or to be exclusive, vitamin B complex may represent an example of the former and vitamin C, sold as a single vitamin, of the latter. It is hard for us to see how a bottle plainly and simply labeled vitamin B complex contributes sufficient confusion that the goal of honesty and fair dealing should require a consumer who desires the various types of vitamin B to purchase several bottles rather than one; similarly, and in light of the testimony as to particularly wide variations in philosophy concerning the optimal intake of vitamin C, we are not convinced as things stand that a consumer who believes a 500 milligram pill of vitamin C, a quantity now frequently sold, will maintain his optimal body stores should be required to purchase five dr six pills of ninety milligrams each, at greatly enhanced cost.

Although the FDA has evinced some small concern for the need for such differentiation'and it was not particularly encouraged in this regard by petitioners 'we do not believe that it has gone far enough. In regard to the maxima, the agency did attempt, largely on the testimony of Dr. Sebrell, see pp. 797 infra, to update in scientific terms what was then the latest edition of the RDA's with respect to particular nutrients, and there was also other sporadic testimony pro and con with regard to the upper limits for particular ingredients. But

the agency made no effort to draw the parties into a comprehensive study of the possibility of raising some upper limits, and particularly of raising them even if scientific considerations were somewhat against it simply because such moves in selected cases might meet real and not altogether irrational market demands without contributing appreciably to consumer confusion, nor any particular effort to deal in its findings with such testimony on particular upper limits as did happen to arise. Neither has provision been made for ready flexibility along these lines in the future: The upper limits are to be responsive to RDA changes based on new nutritional knowledge, §§ 80.1(f)(2), 125.1 (b)(l); but there is no provision that they be responsive, for example, to a demonstration that (1) vast multitudes of consumers and significant numbers of nutritionists reject, e. g., the FDA's view that 500 mg. per day of vitamin C is without nutritional value, and that (2) the availability of such dosages as foods, clearly marked and flagged with necessary warnings, may not confuse anyone. On the present record it seems to us distinctly possible that such a demonstration could be made. ^{Footnote 25}

With respect to combinations of less than all essential ingredients, the agency itself apparently recognized that it had given at most sporadic consideration to the possibility that some exceptions might be in order. Hence greater and procedurally more particularized future flexibility is presumably provided by § 80.1 (b) (4), which we set out in the margin. ^{Footnote 26}

It has long been settled that an agency may adopt a rule shown to be appropriate for the generality of instances and leave the correction of injustices to applications by those concerned, see The New England Divisions Case,  261 U.S. 184, 204, 43 S.Ct. 270, 67 L.Ed. 605 (1923), and we would, of course, expect the FDA to apply this subsection in good faith and with dispatch. However, while paragraph 3 of the preamble to the final regulation, 38 F.R. 20731 (1973), implicitly suggests that some petitions seeking such particularized amendments may have been received with the exceptions to the proposed regulations, the agency has not provided us with the relevant exceptions, nor with a listing of those (if any) which included § 80.1(b)(4) petitions, nor does the preamble contain any real assurance that the agency separately considered any such particularized applications that did come in. Compare 38 F.R. 20710, U 10 (1973). Moreover, even apart from the important point that the escape clause relates only to combinations and not to the maxima, it is not sufficiently clear to us on the wording of § 80.1 (b) (4), and certainly not on the cryptic wording of paragraph 3 of the preamble, that the agency intends to evaluate § 80.1 (b) (4)

petitions in light of a balancing of freedoms infringed against the increased dangers of consumer confusion which would be triggered by allowance of each additional product'as we believe the reasonableness requirement of § 401 requires it to do, in a manner set forth in greater detail below. Rather § 80.1 (b) (4) may suggest an absolute insistence on new scientific data similar to what would be required to modify the RDA's. Finally, even if the FDA would apply the appropriate criteria in this area should § 80.1(b)(4) petitions now begin to flow, it would be commercially disruptive for a product to have to be withdrawn from sale in January 1975 only to be returned to the market in July.

In light of all these considerations, we direct that § 80.1(b)(4) be modified to permit upward revisions in the maxima for particular vitamins or minerals and that the criteria be broadened to conform to the standards of § 401. We also believe the agency should receive and deal explicitly with applications for increases in particular upper limits and applications under the present § 80.1 (b)(4) before the regulations become effective. To this end we think it necessary to stay the regulations in their entirety, and not