The FDA expects this directive to facilitate the provision of additional health information to consumers, who receive scientific support. The FDA expects that, given the scientific study on the role of dietary factors in health life, some qualified health claims will be substantiated, while for other qualified health claims, the “weight of scientific evidence” will be shifted from “more for” to “more counter.” It is therefore possible that information provided to consumers through qualified health claims regarding food labelling may change over time. However, the FDA believes that the dissemination of up-to-date scientific information on the health benefits of traditional foods and dietary supplements should be encouraged to enable consumers to make informed nutritional decisions that can bring significant health benefits. JHCI`s Code of Conduct defined the source and nature of the scientific evidence that required a systematic verification of all available scientific evidence regarding the validity of the claim (Article 8.4.1). After evaluation by the JHCI`s expert committee, the proposed application was submitted for approval by the JHCI Council. In 2007, JHCI`s directors and the Council agreed that the new EU regulation on “health claims” for food should supplant this area of activity (JHCI press release 22.3.2007). JHCI has not approved probiotic claims. The FDA`s general legal authority to regulate food labelling derives from Section 403 (a) (a) (1) of the Federal Food, Drug, and Cosmetic Act (21 USC 343 (a) (1)) which considers a food to be false or misleading if its labelling is “in no way” false or misleading. 1 The FDCA contains similar provisions for drugs and medical devices (21 USC 352 (a)) and cosmetics (21 USC 362 (a)). In some cases, the courts have interpreted the FDCA to “protect the ignorant, thoughtless and gullible consumer.” See z.B. United States v. El-O-Pathic Pharmacy, 192 F.2d 62, 75 (9.

Cir. 1951); United States Against An Article on Food . . . . “Manischewitz . . . Diet Thins,” 377 F. Supp. 746, 749 (E.D.N.Y. 1974).

In other cases, the courts have interpreted the law as imposing an assessment of claims from the perspective of the ordinary man or reasonable consumer. See z.B. United States v. 88 Cases, Bireley`s Orange Beverage, 187 F.2d 967, 971 (3d Cir.), cert.

Andrew Verboncouer • (920) 562-9601 •