BLACK CURRANT OIL DECISION: APPEAL TO U.S. SUPREME COURT

BLACK CURRANT OIL DECISION: APPEAL TO U.S. SUPREME COURT is being considered by FDA, Commissioner David Kessler indicated during a breakfast meeting with reporters on April 15. Asked whether FDA will take the Traco BCO case to the Supreme Court after losing in federal appeals court, Kessler replied that "it is under consideration." The Chicago federal appeals court ruled on Jan. 27 that Traco's black currant oil when marketed as a single ingredient in capsules is a "food." FDA had argued that single-ingredient BCO is a "food additive." Under the court's ruling in the case, U.S. v. Two Plastic Drums, the burden of proof is on FDA to show that the product is unsafe. For a "food additive," the burden is on the processor or vendor to show that the product is GRAS (generally recognized as safe). FDA's request for a rehearing of the case was rejected by the court on March 31 ("The Tan Sheet" April 12, In Brief). Kessler called the issue of dietary supplement regulation "the most misunderstood topic." If FDA does not have the authority to regulate supplements as food additives, Kessler asked, "what do I do with L-tryptophan?" He suggested that the L-tryptophan contamination several years ago was comparable to the deaths in the 1930s from a sulfanilamide elixir containing ethylene glycol that led Congress to pass the FD&C Act of 1938. "I think . . . the issue is: If you make a claim . . . then the issue is what is the basis for that claim, and that is either under the drug provisions [of the law] or under the NLEA provisions," Kessler stated. Kessler said that Congress asked FDA to set the scientific standard for dietary supplements making health claims in regulations for the Nutrition Labeling & Education Act and the agency decided that "it should be the same standard as foods." He indicated that FDA's concern goes beyond explicit health claims made for dietary supplements. Acknowledging that most manufacturers are not making claims in labeling, Kessler noted: "The problem is people . . . just don't wake up in the morning and just say, 'Well let me take some L-carnitine.'" He added that "one of the problems we have is manufacturers say, 'we're not going to put the claim on [the labeling] so you can't go after us under the claims provision.'" Echoing comments made by FDA Deputy Commissioner for Policy Michael Taylor in a recent speech at the annual meeting of the Federation of American Societies for Experimental Biology ("The Tan Sheet" April 5, p. 1), Kessler emphasized that FDA's concerns are not with "vitamins and minerals and one-a-day things . . . it is [with] the amino acids, it's [with] some of the herbal preparations . . . [where] there certainly may be chemical and pharmacological activity." He added that FDA has "seen harm in a number of these." FDA plans to publish an advanced notice of proposed rulemaking in an upcoming Federal Register that will discuss the conclusions of a recent FASEB report on the safety of amino acids as dietary supplements, and will seek information on the safety of amino acids and comments on a regulatory framework for these products. At a March 8 meeting with industry representatives, FDA said the intent of the notice would be "two-fold" -- "to obtain safety information necessary to address the concerns presented in the FASEB report and thereby determine the proper regulatory strategies for amino acids in supplement form; and to open the issue to public debate on all dietary supplements in order to assure that the proper regulatory framework is put into place for the future," according to an agency memorandum of the meeting. Speaking at a meeting of FDA's Food Advisory Committee on April 16, Center for Food Safety and Applied Nutrition's Office of Special Nutritionals Acting Director Elizabeth Yetley, PhD, said the notice "hopefully . . . will be out in the next couple of months."