Opinion ID: 322373
Heading Depth: 1
Heading Rank: 5

Heading: Label and Labeling Requirements

Text: 114 We next consider the validity of portions of Part 125 not directly related to the problems heretofore discussed. 115 As earlier noted, several petitioners do not object to the basic requirement of 125.3(a), 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,' to which we have referred at the beginning of Part IV. In any event we see no infirmity in it. Whatever objections there may be to the U.S. RDA's when used as a basis for prohibiting the sale as dietary supplements of products exceeding the upper limits-- and we have sustained these only because of the blatantly erroneous restriction on the cross-examination of Dr. Sebrell, see Part V, supra-- they have no such force when the U.S. RDA's are used simply as measuring rods to inform the consumer what he is getting. 67 116 In contrast, there is a chorus of objections concerning the requirements of 125.2(b) with respect to labeling which we set forth in the margin. 68 117 The most general objection is that 403(j) authorizes the FDA only to prescribe contents for a 'label,' 69 whereas 'labeling' is defined by 201(m), 21 U.S.C. 321(m), to mean 'all labels and other written, printed, or graphic matter (1) upon any article or any of its containers or wrappers, or (2) accompanying such article.' It could be strongly argued that the power to prescribe the contents of a label must include the power to prevent labeling that would destroy the label's integrity. However, it is unnecessary to decide whether 125.2(b) could be supported on this ground since the FDA could and did draw on 403(a), which provides that a food shall be misbranded 'if its labeling is false or misleading in any particular.' We therefore turn to the specific provisions of 125.2(b). 118 (1) We shall not tarry long over 125.2(b)(1). The FDA marshalled evidence that past sales of dietary supplements have often involved highly questionable claims as to effectiveness in the prevention, cure, mitigation, and treatment of diseases and symptoms; that consumers of these products have been confused and misled by such claims; and that even more moderate claims of effectiveness have no scientific validity. 119 The FDA presented an impressive case, based largely on the records in seizure actions, of the exaggerated claims made on behalf of various vitamin and mineral products. 'Golden 50 Tablets' were said by their sellers to give pep to the post-50 generation, to assist them in constipation problems, and even to enable them to withstand the noise of children. 'Vitamins Concentrated Honey Alfa Tea' was said to be useful in connection with gout, ulcers, migraine, alcoholism, and bedwetting. 'Catalyn' was said to give one resistance to overweight, underweight, dropsy, prostate enlargement, and St. Vitus' Dance. 'Comfrey,' derived from a vigorous plant, was said thereby to increase virility. And another substance was claimed to be adequate in the treatment, inter alia, of mental disorders, cretinism, and poor teeth. 120 Evidence of consumer confusion about the efficacy of vitamins and minerals in the prevention, cure, mitigation, and treatment of diseases and symptoms was also clear. Ironically, some of the most effective evidence was provided in the form of about 50,000 letters received by the FDA in protest against the proposed regulations, apparently as a result of a campaign by NHF, which showed that many people were taking dietary supplements to remedy ailments which their physicians had been unable to diagnose or cure and that some had been urged to do so by claims of therapeutic value made in the promotion of such supplements. There was also evidence that even truthful claims, such as that vitamin C would prevent scurvy and that vitamin B(1) would prevent beriberi, were harmful and misleading. 70 It was difficult to imagine a person in the United States whose diet would give rise to scurvy, and beriberi, which has ordinarily resulted from a diet consisting almost exclusively of rice, is equally rare in the United States; yet the broadcasting of such claims might frighten consumers into purchasing dietary supplement products they did not need. Finally, there was ample expert testimony of lack of any scientific basis for promoting vitamins or minerals as useful in the prevention, cure, mitigation, or treatment of any 'diseases' or symptoms except nutritional deficiencies themselves and of gross exaggeration of the extent of the latter. 121 Against all this, petitioners relied upon evidence that many persons failed to ingest adequate amounts of vitamins and minerals; that vitamin and mineral deficiencies were associated with many diseases and symptoms; that physicians are often unable to identify some of the milder forms of vitamin deficiencies; and that it was therefore reasonable for consumers to purchase dietary supplements as 'insurance' against the dificiency maladies brought to their attention by past promotional efforts. Petitioners also take issue with the FDA's evidence of consumer confusion by attacking the competency of the witnesses presenting it. 122 Taking petitioner's evidence in the light most favorable to them, it merely posed an issue and did not dictate a decision. Petitioners may still make some rather broad types of statements about the importance of essential nutrients of health. 71 While the FDA might have presented more convincing witnesses on the subject of consumer confusion, still the witnesses who testified gave sufficient testimony on this score. We hold that there was substantial evidence to support 125.2(b)(1). 123 ( 2) Much of the attack on 125.2(b)(2) is bottomed on reading it to say more than it does. This is notably true of petitioner's evidence that many Americans-- careless eaters, the elderly, the poor, and persons enrolled in many weight-reducing programs-- who do not eat a balanced diet are dificient in various nutrients. Nothing in the challenged regulation prevents a manufacturer from saying so. 72 The regulation was aimed rather at scare advertising typified by a drug store counter sign which proclaimed, 'The physician is faced, more and more, with the problem of restoring proper combinations of vitamins and minerals to the devitalized foods of the nation.' Such promotional techniques have been commonplace, as testimony and exhibits offered by the FDA amply demonstrated. 124 On the other hand, the portions of the record that have been presented to us 73 do not contain much evidence either to support or to controvert the FDA's conclusion that a balanced diet of ordinary foods can supply adequate amounts of nutrients. 74 Perhaps the strongest support for this conclusion is that it is a tautology; since nature admittedly furnishes all the needed nutrients, a diet of 'ordinary foods' that does not provide them is not 'balanced.' Beyond that is the known fact that millions of Americans get along quite nicely without 'dietary supplements.' 125 Nevertheless we are obliged to fault 125.2(b)(2) with respect to iron, for there was strong and uncontradicted evidence that it was very difficult for women of child-bearing age and for children to obtain an adequate supply of this even from a balanced diet. 75 On the remand we are directing, the FDA may either adduce further evidence on this point, or, as might be preferable, insert a proper qualification in 125.2(b)(2). 126 ( 3) This provision was likewise aimed at scare advertising, of which the record contains several examples. However, in view of the paucity of evidence that consumers have thereby been induced to purchase unnecessary dietary supplements, we shall examine whether the prohibited statement would be false. 127 The relevant findings of fact are as follows: 128 37. Scientifically it is inaccurate to state that the quality of soil in the United States causes abnormally low concentrations of vitamins or minerals in the food supply produced in this country. 38. There is no relationship between the vitamin content of foods and the chemical composition of the soil in which they are grown. 129 38 F.R. 20715 (1973). Our review of the record makes clear that there was substantial evidence to support finding 38 and so much of finding 37 as relates to vitamins. The case with respect to minerals is closer since one of the FDA's two witnesses cited in support of the validity of the statement contained in finding 37, 76 Dr. William Allaway, later conceded that iodine and selenium contents in crops vary with soil composition, 77 although iron content does not, and agreed that the following statement on dietary supplement labeling would be reasonable: 'Plants grown on boron deficient soil may be deficient in Carotene or pro-Vitamin A.' However, such recondite exceptions, even if important in the context of the regulatory scheme proposed by the FDA, 78 would not seem to require us to invalidate 125.2(b)(3) in view of the FDA's interpretation that the regulation would not prohibit 'any truthful claims, supported by adequate scientific data, relating to the specific nutrient value of a product,' but would only proscribe 'unsupported generalization that there is a general deficiency in the daily diet because of soil in which the food was grown.' 38 F.R. 20711 (1973). 79 We therefore uphold 125.2(b)(3) on the understanding that the FDA will apply it in that light. 130 (4) This provision was supported by findings which read as follows: 131 39. Mineral nutrients in foods are not significantly affected by storage, transportation, cooking, and other processing. 40. While some vitamins are susceptible to partial destruction through the effects of heat, light, oxidation, and other physical and chemical reactions . . ., loss of nutrients from the ordinary effects of cooking, processing, transportation, and storage have not significantly impaired the nutritional quality of food in the United States. There is no need or scientific justification for recommending, for example, the routine use of dietary supplements of vitamins and minerals to offset losses that occur as a result of these processes. 41. It is reasonable to prohibit representation or suggestions in labeling, promotional material, or advertising of foods offered for special dietary use based on vitamin and mineral qualities, that imply that a dietary deficiency of vitamins or minerals exists or is threatened in the United States by virtue of loss of nutrients which occur from processing, transportation, storage, and cooking. 132 38 F.R. 20715 (1973). 133 The evidence that minerals in food are not affected by transportation, cooking, processing, and storage was clear and substantial. The case with respect to vitamins, however, was otherwise. FDA witness, Dr. Bernard Schweigert, testified that, while some vitamins are stable (vitamins D and K), others may be destroyed by oxidation during storage (vitamins A, C, and E), light (riboflavin), and heat (many B vitamins). 80 Consequently, if the regulation prohibited any statement that vitamins are lost during the storage, transportation, processing, or cooking of a food, we could not sustain it. 134 Once again, however, petitioners read the regulatory proscription too broadly. The FDA has said that it is not the intent of this provision to 'preclude factually supportable statements that certain losses (in nutrient content) may be due to improper handling;' the target is rather the 'unsupported generalization that there is a general deficiency in the daily diet because of . . . transportation, or processing methods used in preparing food.' 38 F.R. 20711 (1973). 135 The important point in this connection is not whether certain foods may suffer important nutrient losses by whether the overall daily diet, consisting of a number of foods each with its own nutrient levels, is inadequate. The expert opinion of Dr. Olaf Mickelsen was that, while diets consisting solely of a food seriously deficient in nutrients can lead to nutritional disorders, the inclusion of the wide variety of foods normally found in the daily diet eliminated any significant danger. It is thus immaterial that, as one of the petitioners' witnesses testified, 60% Of the vitamin C in snap beans is lost in transportation and refrigeration. No one lives on a diet of snap beans, and citrus fruits are rich in vitamin C. 136 (5) This prohibition presents a special problem in that, while the first and fourth sentences and the proviso, like all the other provisions in 125.2(b), deal only with labeling, the second and third sentences are substantive in effect. 137 Basic to the validity of all parts of 125.2(b)(5) is the question whether there is substantial evidence that the four named ingredients or products 'are of no significant value or need in human nutriction.' 81 Stated as such, the proposition is questionable as to some of the substances. 82 However, the FDA's real meaning is made clearer in finding 3: 138 Many dietary supplements include named ingredients which are of no value as supplements to the human diet. 139 38 F.R. 20713 (1973). With respect to the four substances named in this provision, this proposition was supported by testimony that, even when such substances do play some role in nutrition, there was no known evidence of need for supplementation. 83 As to many others that have been included in dietary supplements there was no evidence of nutritional value at all. If subsequent research should show the need for such supplementation, the case would be appropriate for action under 80.1(b)(4); if the standard of identity were modified to allow these as optional ingredients, 125.2(b)(5) could not prohibit references to them in labeling. 140 With this much established, the validity of the first sentence of 125.2(b)(5) requires little further discussion. There was ample evidence that labeling of dietary supplements making reference to included nonessential substances was misleading. The FDA found: 141 3. . . . Many consumers will purchase such products with long lists of ingredients, believing them to be of better value than products with a lesser number of ingredients . . .. Such consumers believe that if an ingredient is listed, it must significantly contribute to the value of the product as a dietary supplement. 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. 142 38 F.R. 20713 (1973). The record contains substantial evidence to support this part of the provision. 143 While one would have predicted loud protest against the proviso in the third sentence, apparently there is no direct challenge. In any event, as evidenced by United States v. An Article of Food . . . Labeled . . . Nuclomin,482 F.2d 581 (8 Cir. 1973) (where the product included inositol and para-amino-benzoic acid, two of the nonessential substances specifically mentioned in this provision), the FDA's experience had shown that disclaimers of value did not solve the problem of the misleading effect of including such ingredients in combinations. Thus the FDA could well conclude that in the sale of products consisting solely of such nonessential ingredients a disclaimer could have the effect of calling attention to the potential nutritional value of the product, and it could therefore proscribe such disclaimers as misleading. 144 This leaves the substantive provisions of the second and third sentences. Since the named substances are reasonably deemed nonessential and since the first sentence is valid, the second and third sentences are easily sustained, for the power to establish a reasonable standard of identity for dietary supplements necessarily includes the power to exclude from combinations ingredients that have not been shown to be useful for the purpose for which they are offered, even though they are harmless. 84 145 (6) Most of the argument over this prohibition stems from petitioners' reading into it language that is not there; they fear that the regulation would prohibit labeling that would merely disclose that the vitamin was natural and what its source was. 85 However, the Government's brief construes the regulation as prohibiting only 'representations that a natural vitamin in superior to an added or synthetic vitamin, or that there is a difference between vitamins naturally present and those that have been added,' Brief for Respondent at 44-45, and calls attention to a passage in the preamble to the regulations, 38 F.R. 20711 (1973), where the agency stated: 'A factual and true statement of the origin of a nutrient is permitted, and only a claim of superiority is prohibited. This prohibition was included because of widespread claims that nutrients of natural origins are superior to synthetic nutrients.' This is surely a permissible, indeed we think the only permissible, reading of the regulation. Since there was abundant evidence to sustain finding 26: 146 There is no nutritional difference between a vitamin produced by a synthetic source and the same vitamin provided by a natural source, but the natural source may contain other ingredients which may limit the absorbability of the vitamin provided by the natural source. 147 20714 (1973), 86 we unhold this regulation. 148 The upshot is that we sustain 125.2(b) in its entirety save for so much of 125.2(b)(2) as prohibits appropriate statements about the adequacy of a balanced diet of ordinary foods to provide needed amounts of iron for women and children. On this the FDA on remand must either adduce additional probative evidence or include an appropriate qualification.