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National Nutritional Foods Association and Solgar Co. v. Food and Drug Administration

decided: August 15, 1974.


Petitions to review final regulations of the Food and Drug Administration fixing standards of identity for and prescribing label statements concerning food for special dietary uses.

Friendly and Smith, Circuit Judges, and Bartels, District Judge.*fn*

Author: Friendly

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)*fn1 relating to vitamin and mineral supplements sold as foods. One regulation, 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."*fn2 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 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)(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."*fn3 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."*fn3

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,


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) (1) 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)(1) 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)(1) 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 of 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)(1) 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,"*fn4 § 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" labeling requirements; (3) the definition of "special dietary use" in § 125.1(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.*fn5 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 Assn, 387 U.S. 167, 18 L. Ed. 2d 704, 87 S. Ct. 1526 (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, 18 L. Ed. 2d 681, 87 S. Ct. 1507 (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, 682-83, 90 L. Ed. 939, 66 S. Ct. 773 (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, 25 L. Ed. 2d 442, 90 S. Ct. 1207 (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, 30 L. Ed. 2d 815, 92 S. Ct. 962 (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,*fn6 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)(1)(B), 21 U.S.C. § 321(g)(1)(B),*fn7 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)(1)(B), and labeled accordingly. See National Nutritional Foods Ass'n v. Weinberger, 366 F. Supp. 1341, 1343-44 (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.*fn8

We hold that we have jurisdiction to consider all issues tendered.*fn9

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*fn10 will 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.*fn11 Confronted with a difficult problem, the agency developed an innovative solution.*fn12 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, 88 L. Ed. 48, 64 S. Ct. 134 (1943), he said:

The purposes of this legislation thus touch phases of the lives and health of people which, in the circumstances of 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, 95 L. Ed. 566, 71 S. Ct. 515 (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),*fn13 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, 87 L. Ed. 724, 63 S. Ct. 589 (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 ...

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