Opinion ID: 322373
Heading Depth: 1
Heading Rank: 6

Heading: Fresh Fruits and Vegetables

Text: 149 Sunkist Growers, Inc., petitioner in No. 73-2753, a cooperative of many citrus fruit growers in California and Arizona, complains in effect that any application of Part 80 to fresh fruits and vegetables, see 80.1(e)(5), (6), supra, would contravene the two provisos of 401 which we set out in the margin; 87 Sunkist also complains that the definition of 'special dietary use' in 125.1(a), which we likewise set out in the margin, 88 is so broad as to include fresh fruits and vegetables, which, it is argued, would also be unauthorized, or at least arbitrary or capricious and thus violative of 5 U.S.C. 706. On December 12, 1973, the Assistant General Counsel of the FDA wrote counsel for Sunkist, offering to stipulate that the regulations would not prevent advertising or labeling claims concerning vitamin or mineral content naturally occurring in fresh fruit or vegetables and would apply to such produce only in two eventualities. 150 One was that if vitamins or minerals were added to fresh fruits or vegetables so that the total level of any added vitamin or mineral per single serving (whatever that might be in the case of a vegetable) exceeded 50% Of the U.S. RDA, cf. 80.1(e)(5), supra, the product would be subject to Part 80. Since we cannot imagine natural produce, even as fortified, conforming to the standards of identity in that Part, the effect of this interpretation surely was to forbid such addition of vitamins or minerals to fresh fruits or vegetables offered for sale as foods. However, while the FDA could well have refrained from this refinement, we agree that such fabricated products are not within the intent of the provisos to 401. Moreover, petitioner's grievance seems theoretical since there is no evidence that any such practice has occurred or is intended. 151 The other set of qualifications was this: If fresh fruits or vegetables were represented as dietary supplements of vitamins and/or minerals, e.g., if oranges were sold as vitamin C supplements rather than with a simple statement that they are a source of vitamin C, Part 80 would apply, cf. 80.1(e)(6), supra; again, we take it that the consequence of this interpretation-- given that nature has not conformed oranges to the FDA's standard of identity-- is that no such representation may be made with respect to fresh produce sold as foods. Also, if a fruit or vegetable were offered for sale for a particular dietary use, e.g., if lemons were advertised as a source of flavoring for persons on low sodium diets, Part 125 (but apparently not Part 80) would apply. 152 We think all this goes too far. The first proviso to 401 rules out any standard of identity for most fruits and vegetables, and the second permits this for citrus and several other fruits only as to maturity and the effects of freezing. Nothing indicates that the making of promotional claims, e.g., that oranges are vitamin C supplements, should detract from the force of the provisos. And Part 125 simply does not fit fresh fruits and vegetables in their natural state. As petitioner says, the sheer variation in the content of oranges would seem to make compliance with Part 125 impossible. On March 14, 1973, the FDA promulgated a new provision, 1.17, cf. p. 783 supra, dealing with food labeling, 38 F.R. 6951, 6959; but, on November 28, 1973, in response to an attack on 1.17 in the United States District Court for the District of Columbia by Sunkist and another organization, Civ. No. 633-73 (complaint filed April 2, 1973), the agency exempted fresh fruits and vegetables pending further rulemaking, 38 F.R. 32786. We think that proceeding rather than this one is the proper place in which to deal with claims as to the value of fresh fruits or vegetables in their natural state as dietary supplements or to fulfill special dietary needs. We therefore enjoin enforcement of Part 80 and 125 against them.