Opinion ID: 322373
Heading Depth: 1
Heading Rank: 2

Heading: Standards of Identity

Text: 40 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 10 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. 41 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. 11 Confronted with a difficult problem, the agency developed an innovative solution. 12 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 Frankfurther. 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: 42 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. 43 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): 44 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. 45 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: 46 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. 47 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. 48 This argument finds support neither in the language of the statute nor in its legislative history. In sharp contrast to 403(i), 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 inter-relationship of subsections 403(g) and (i), and has no bearing on subsection 403(j). 49 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): 50 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. 51 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. 52 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. 53 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. 54 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: 55 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. 56 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 P1, 38 F.R. 20737 (1973), quoting 401, to promulgate the qualitative and quantitative standards of identity of new Part 80, see Conclusions of Law PP2, 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 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. 15 57 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. 58 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. 59 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 B(1), 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. 60 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 directly the barring of the product from sale as either enriched farina or farina. 16 The Court began by mentioning that 'the 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 'taking 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: 61 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. 62 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: 63 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 . . .. 64 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 . . .. 65 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. 17 The case turned on 403(c), which says that a food shall be deemed misbranded: 66 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. 67 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. 18 68 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, McNeil & 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 peanut butter. 69 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'; 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 72-73; United States v. 20 Cases . . . 'Buitoni 20% Protein Spaghetti,' 130 F.Supp. at 717-718; note 23 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. 70 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 'butter (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 dairy-farmers' 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 had 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. 71 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. 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. 20 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; to 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. 21 72 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 argue 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. 73 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. 22 To be sure, even this may give him a dosage somewhat exceeding precisely what he desires, 23 but again the FDA was entitled to weigh such disadvantages against what it considered the larger good. 74 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 decrease in unit sales by the manufacturers, is, however, a paradigmatic example of the kind of consideration the agency may find outweighed by public needs. 75 Finally, the fact that the agency chose not to extend the standard of identity requirements to the nonessential 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, 6959-61 (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. 24 76 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 to 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 or six pills of ninety milligrams each, at greatly enhanced cost. 77 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)(1); 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. 25 78 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. 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 and such particularized applications that did come in. Compare 38 F.R. 20710, P10 (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. 79 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 just those parts establishing the standard of identity, since, for example, a stay affecting only the standard of identity would force a Bcomplex manufacturer to change over to the new label imposed by the new regulations while knowing full well that if his 80.1(b)(4) application was denied his line would be off the shelves when the limited stay expired. We therefore order a stay of the regulations until six months after our judgment becomes final or June 30, 1975, whichever is later, a period which should be sufficient for the FDA to pass on at least the most meritorious applications both as to dosages and as to additional combinations. 27 80 The FDA should establish dates for the filing of such applications and, if these should prove to be numerous, procedures to screen out the most meritorious for early hearing and decision. In determining whether it is 'reasonable' to deny a particular application, the primary consideration must of course be the degree of increase in potential consumer confusion. Since the sheer variety of products is a central problem here, the applications will in a real sense be in competition with one another, and we do not expect a very large number to be granted. It would be reasonable in resolving this competition to favor products which, because of widespread prior publicity or even just because of simplicity of terminology, are unlikely to confuse many consumers when properly labeled. Indeed, we specifically direct that the FDA consider any such applications as to vitamin C in larger dosages and vitamin B complex supplements. Moreover, against any danger of slight increases in confusion should be weighed such factors as the following: (1) how large is the consumer demand for the product at present, and how widespread any expert belief that it is not an irrational product for a significant number of consumers; 28 (2) how effectively could any potential confusion with respect to the particular product be reduced or eliminated by requiring on the label (A) with respect to a high dosage product, a legend to the effect that the FDA has determined this product contains quantities of such-and-such nutrient not normally essential to human health, or (B) with respect to a combination, a legend to the effect that the FDA has determined this product does not contain all the nutrients essential to human health; 29 and (3) in the case of applications to exceed the upper limits, how dependable, if this can be determined, is the particular NSA RDA on which the upper limit is based relative to other RDA's, cf. Part IV infra. We wish to make clear that, while it would defeat the purposes of Part 80 for a very large number of such applications to be granted, either with respect to dosage limitations or with respect to combinations of less than all essential ingredients, we expect each application to receive the most serious consideration on its merits relative to the criteria just outlined. At the same time it should be obvious to the petitioners that we are broadly sustaining the regulations and that any attempt to convert the procedures we are here directing into something like a nearly complete reopening of the proceeding will be counter-productive. Indeed, if an avalanche of petitions for exceptions should occur, the agency would be justified in denying all applications (except those as to increased dosages of vitamin C and vitamin B complex supplements), without prejudice to subsequent renewal, on this ground alone. What we are doing is to provide the industry with another chance for individualized consideration of the most meritorious cases for exceptions. An exercise of responsibility on the part of the industry will be necessary if this is to confer the benefits we intend. 81 III. The Banning of Certain Essential Nutrients and the Classification As a Drug of Any Product Containing Quantities in Excess of the Upper Limits 82 Before examining the validity of the U.S. RDA's for the purposes for which the FDA has used them, we shall consider two other matters which, although more comfortably seen in our view as elements of the standard of identity scheme, appear in Part 125 relating to Label Statements. 83 Section 125.1(c) recognizes that, in addition to the 12 vitamins and 7 minerals approved as mandatory or optional ingredients, cf. table at p. 769 supra, two other vitamins and six other minerals are essential to human nutrition. Nevertheless, because no U.S. RDA's have yet been established for them, these are banned 'for addition to general purpose foods or dietary supplements of vitamins and minerals,' although they '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.' If this language left open any possibility that these vitamins and minerals could be separately sold as foods, this would be foreclosed by 80.1(b)(1) and (2), and 80.1(f)(1), which effectively ban the sale as dietary supplements of any vitamins or minerals not on the approved list. 84 We see no sufficient basis for such drastic treatment. At argument, government counsel sought to defend it both as a labeling requirement under 403(j) or (a), and as a 401 standard of identity. The regulation and the appurtenant findings of fact, however, contain no suggestion of implicit misrepresentation with respect to these nutrients comparable to the asserted basis of 125.2(b)(5), discussed at pp. 804-805 infra, so as to justify 125.1(c) under the labeling sections; and indeed, even where such a basis was asserted in 125.2(b)(5), it evidently was not thought sufficient to justify a ban on separate sale. Thus, the only satisfactory view of 125.1(c) is as part of the standard of identity scheme. As such, we hold the subsection is not 'reasonable' within the terms of 401. Assuming arguendo that bans on separate sale of nontoxic individual nutrients may at times be within the agency's statutory authority, see note 21 supra, the agency has articulated no basis for invoking such an extreme remedy here-- particularly when it is not invoked as to the 125.2(b)(5) elements, which the agency considers of far lower, indeed of negligible, nutritional rank. Moreover, even if 125.1(c) were viewed exclusively as a ban on certain combinations, like 125.2(b)(5), the evidence cited in support of the relevant finding of fact, P3 at 38 F.R. 20713 (1973), would not suffice to make the subsection reasonable. The relevant cited evidence concentrates almost exclusively on the lack of need for supplementation of the 125.2(b)(5) elements; indeed, the cited evidence would support 125.1(c) with regard to the vitamin choline at most-- although petitioners in number 73-2175 point to one piece of additional testimony which might conceivably have supported it with regard to potassium and sodium as well. Finally, the failure of the FDA, after twelve years of proceedings, to fix U.S. RDA's for the vitamins and minerals listed in 125.1(c) cannot in itself render the provision 'reasonable.' 85 Perhaps in the year that has elapsed since the regulations were promulgated the FDA has now arrived at these figures and the list of optional ingredients with U.S. RDA's established can be readily expanded on remand. But in the meantime we shall enjoin enforcement of so much of the regulations as prohibits the inclusion of the vitamins and minerals listed in 125.1(c) in general purpose foods, 30 or as optional ingredients in dietary supplements, including dietary supplements for separate sale under 80.1(b)(2). We leave it to the agency on remand to integrate these nutrients into 80.1(b)(1)(v), by determining whether addition of one of them shall require addition of all, or shall require addition of the other 80.1(b)(1)(v) nutrients, and so forth. 31 86 Petitioners also object, both as a matter of statutory authority and as a question of substantial evidence, 32 to 125.1(h), providing, with certain exceptions intended to conform to the standard of identity exemptions in 80.1(e), supra, that preparations containing more than the upper limits of the U.S. RDA per serving are drugs. This would implicate the many provisions of subchapter V of the Food, Drug and Cosmetic Act, including the more elaborate label requirements of 502, 21 U.S.C. 352, and, potentially, the burdensome provisions of 505, 21 U.S.C. 355, for approval of 'new drugs'; would involve petitioners in an elaborate investigation now being conducted by the FDA into the composition, labeling and sale of over-the-counter drugs, including 'vitamin-mineral products,' 21 C.F.R. 130.301(b)(8), with the possible result that their products could be sold only on prescription or under other limiting conditions, id. 130.301(a)(5)(i); and might, we were informed at argument by counsel in numbers 73-2826 and -2834, result in various restrictions on sale in some states which automatically impose limitations on any product deemed a 'drug' under federal law. In addition to defending on the merits, 33 the FDA says that this provision was inserted ex gratia, since, without it, preparations exceeding the upper limits could not be sold at all. Whatever the purpose, petitioners attack the provision and are entitled to our judgment about it. Section 201(g)(1) of the Act says: 87 The term 'drug' means (A) articles recognized in the official United States Pharmacopoeia, official Homeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and (D) articles intended for use as a component of any article specified in clauses (A), (B), or (C) of this paragraph; but does not include devices or their components, parts, or accessories. 88 21 U.S.C. 321(g)(1). Although the findings on which the FDA apparently sought to rest 125.1(h) were evidently based on subdivision (B) of 201(g)(1), see 38 F.R. 20170, P12 (1973); cf. id. at 20715, P44; id. at 20735, P11, government counsel now suggest that they could properly have been based on subdivision (A), since all the vitamins and presumably all the minerals with which we are here concerned are recognized in the official United States Pharmacopoeia or the official National Formulary. If this argument be seriously advanced, a sufficient answer is the statement in Burlington Truck Lines, Inc. v. United States, 371 U.S. 156, 168, 83 S.Ct. 239, 246, 9 L.Ed.2d 207 (1962), that 'the courts may not accept appellate counsel's post hoc rationalizations for agency action.' Moreover, the argument would prove too much, for it would lead to the conclusion that all vitamin and mineral preparations even within the limits are drugs-- a position which would run counter to the regulations. 89 The FDA's decision to handled as drugs all vitamin and mineral products in excess of the upper limits of the U.S. RDA's rested essentially on the thought expressed in paragraph 12 of the preamble to Part 125, 38 F.R. 20710 (1973): 'The hearing record discloses no known food or nutrition use of nutrients at such high levels, and no such uses were shown in the exceptions.' We believe that this mischaracterizes the record. As will emerge more fully in the next section of the opinion, dealing with the RDA's as a basis for the upper limits in the standards of identity, a significant number of persons have indisputable nutritional need for potencies exceeding the upper limits; in particular, and by no means exclusively, this includes the large number of women taking oral contraceptives. 34 In light of this, it cannot be said even as an objective matter that a given bottle of pills, each containing more than the upper limit of one or more nutrients, is not being used for nutritional purposes. 90 A fortiori it follows that the vendor of such a product can in good faith intend it for nontherapeutic use. Section 201(g)(1)(B) makes the vendor's intent the crucial element in the definition of 'drug' here at issue, see also S.Rep.No.361, supra, in Dunn at 240, and the cases consistently have read that language for its plain meaning. While we agree that a factfinder should be free to pierce all of a manufacturer's subjective claims of intent and even his misleadingly 'nutritional' labels to find actual therapeutic intent on the basis of objective evidence in a proper case, such objective evidence would need to consist of something more than demonstrated uselessness as a food for most people. We therefore hold that 125.1(h) is invalid. 35 91 Our invalidation of this subsection in no way prevents high-dosage products properly labeled from being marketed as over-the-counter drugs. But under our ruling 125.1(h) will cease to have any independent restrictive force. 92