Opinion ID: 322373
Heading Depth: 1
Heading Rank: 3

Heading: The U.S. RDA's and the Prescription of Upper Limits

Text: 93 As has already appeared, the U.S. RDA's serve two different purposes in the FDA's regulatory scheme. One is the requirement, 125.3(a), see note 4 supra, that 'the label shall bear a statement of the percentage of the U.S. RDA of such vitamins and minerals, as set forth in 125.1(b), supplied by such food when consumed in a specified quantity during a period of 1 day.' The other consists of the substantive provision, 80.1(c)(1), that 'dietary supplements described in this section shall contain in the specified daily quantity no less than the lower limit nor more than the upper limit of any nutrient specified in paragraph (f) of this section for the group(s) for which the supplement is offered.'There is little controversy over the label requirement. 36 Counsel for petitioners in Nos. 73-2746 and -2747 say expressly in their brief, p. 30 n. 33, 'no one contests FDA's power to require such a (label) statement pursuant to Section 403(j).' And the reply brief of counsel in No. 73-2824, which, as we shall see, leads the attack on the RDA's in other contexts, states at pp. 2 and 12: 94 Petitioner, Federation of Homemakers, supports and commends the agency for the development of a informational device which, if properly regulated and clearly explained to consumers, can be a major tool in eliminating much of the confusion and misunderstanding which pervades the vitamin market . . .. It is the position of Petitioner, Federation of Homemakers, that when properly used as an information tool as indicated in in the NAS comment on the U.S. RDA the FDA has made a useful contribution to informing consumers and helping to provide clarifying information in the marketplace. 95 Similarly, as earlier mentioned, see note 10 supra, there is, and probably could be, no serious and separate objection, on an evidentiary basis or otherwise, to so much of 80.1(c)(1) as proscribes the sale of a dietary supplement containing less than the lower limits of the U.S. RDA's. In contrast there are violent objections to the use of the RDA's to prescribe upper limits. 96 As indicated by our discussion in Part II, supra, any attempt to prescribe an effective standard of identity had to deal in quantitative as well as in qualitative terms. The bewildering array of products confronting the consumer varied in terms of potency as much as in terms of specific nutrients contained. Although petitioners loudly criticize the U.S. RDA's they suggest nothing to take their place in a standard of identity; rather, as suggested most pointedly by petitioners' reply brief in numbers 73-2746, 73-2747, and 73-2748, they would relegate the whole matter to a label which would say, at most, something like this: 'The quantity of vitamin . . . contained in this product is five times what the FDA considers necessary for proper nutrition.' Yet, in light of experience with what amounted at least implicitly to a similar statement concerning the MDR's, the FDA might well have entertained doubt that, at least in general, cf. p. 783 supra, such a warning would turn purchasers off rather than turn them on. While it was for the FDA to justify the regulations, not for the petitioners to show the agency what to do, we must be aware that invalidation of the upper limits would seriously impair, if not destroy, the value of the standards of identity. 97 Perhaps the central evidentiary attack on the maxima, which are generally 150% Of the U.S. RDA's, 37 is that the FDA misapprehended the purpose of the National Academy of Sciences in promulgating the NAS RDA's on which the U.S. RDA's are based. This argument is most effectively presented in the reply brief in No. 73-2824, where counsel have reprinted a section entitled 'General Considerations' from the NAS 1974 edition of Recommended Dietary Allowances, which, of course, was not available to the agency when it promulgated the regulations. 38 Sample extracts from this are as follows: 98 RDA are estimates of 'acceptable daily nutrient intakes' in the sense that, although the needs of most individuals will be less than the RDA standard, there may be a small number who require more . . .. It is not possible to be more explicit about the relationship between RDA and the requirements of an individual; thus, it is only within the framework of statistical probability that RDA can be used legitimately and meaningfully. 99 This has important implications. It means that such general statements as 'RDA include a large safety factor; therefore a diet that meets two thirds of the RDA standard should be adequate' have no validity. It will be adequate for some, inadequate for others and-- without elaborate studies-- there is no way of knowing who falls into which category. 100 All the 'appropriate uses' of the RDA's envisioned by the NAS involve evaluation of adequacy of food supplies or consumption patterns over a large population, and not for individuals. Thus, the categories of uses listed are 'Planning and Procuring Food Supplies for Population Groups,' 'Interpretation of Food Consumption Records in Relation to Assessment of Nutritional Status,' 'Nutritional Allowances as Guidelines in Establishing Policy for Health and Welfare Programs,' 'Use of RDA in Nutritional Surveys and Their Relation to Government Policy,' and 'Nutrition Education.' Only in a final category, 'Product Development, Nutritional Labeling, and Regulation of Nutritional Quality,' does the possibility of any kind of individual application emerge. And that possibility is confined to informational labeling and to the establishment of minimal levels of fortification for foods which lose nutritional value in processing. 39 By way of demonstrating that the RDA's are objectively inappropriate for uses other than these envisioned by the NAS, petitioners also emphasize that, on the basis of the FDA's own findings, RDA's provide an adequate intake of essential nutrients only for 'essentially all of the normal healthy persons in the United States,' more specifically 95% To 99% Of the 'normal healthy' population; 40 that even this 95-99% Range is apparently derived by excluding certain needs which petitioners regard as nutritional but the FDA considers therapeutic (e.g., increased needs for vitamins and/or minerals on the part of women taking oral contraceptives and persons who do not absorb vitamins well), and is derived by partially ignoring what is now a fairly widespread if minority belief that the 'optimal' level of nutrition considerably exceeds that necessary to avoid clinical deficiencies; and that the experimental and other methods for developing the RDA's are admittedly far from perfect and the state of current knowledge far from complete. 101 If the FDA had sought to prohibit ingestion of more than the maxima insofar as it could, even with the considerable safety factor arising from increasing the limit to 150%, which is superimposed upon the vitamins and minerals contained in the consumer's basic food diet, see note 37 supra, we should indeed have found it impossible to sustain the regulations. 41 But the agency has done nothing of the sort. Beyond the possibility that some applications for relief from the upper limits will be granted pursuant to Part II of this opinion, anyone who is not satisfied with the quantity of a vitamin or mineral permitted in a combination or in a separate pill can take as many more tablets as he likes. He will doubtless find this more expensive, but, as previously suggested, see p. 782 supra, the additional payment required in such cases had to be weighed by the agency against the savings from useless expenditures by purchasers of supplements containing far higher potencies than they require. 42 The percentage of the population, whatever it be, who even under accepted scientific doctrine require dosages in excess of the upper limits have a similar recourse. Expert testimony on the advisability of adopting the maxima, in this limited way, was conflicting. Although the opinions of those experts who favored the maxima may seem to us somewhat the less thoroughly reasoned or at least the less thoroughly articulated, they were explicitly and not irrationally based on the fact that the RDA's are the best tool of their kind available and are subject to constant revision; resolution of the conflicting expert evidence was therefore for the agency. Indeed, since anyone who wishes is free to take dosages in excess of the maxima, these may readily be viewed as just a very pointed informational device-- and therefore as an application of the RDA's which is explicitly approved, rather than effectively disapproved, by the NAS' new edition, and which is by no means unreasonable, however imperfect the state of current nutritional knowledge. 102 In short, we cannot fault the agency, procedural issues apart, for adopting upper limits, generally 150% Of the U.S. RDA's, in its standard of identity. 43 103