FDA "FULLY INTENDS" TO PUBLISH DIETARY SUPPLEMENT LABELING FINAL RULES

FDA "FULLY INTENDS" TO PUBLISH DIETARY SUPPLEMENT LABELING FINAL RULES by the Dec. 31 deadline set by Sen. Orrin Hatch's (R- Utah) Dietary Supplement Act of 1992, FDA Special Assistant for Policy Mitchell Zeller told the Food & Drug Law Institute's Annual Educational Conference in Washington, D.C. on Dec. 15. The publication of the final rules would follow the Dec. 15 expiration of the dietary supplement moratorium provided by the Hatch bill. Zeller noted that the "hammer provision" of Hatch's supplement act established that if FDA fails to publish the final rules by Dec. 31, the agency's June 18 proposed regulations would become final. However, Zeller said "there are people at FDA feverishly working on getting the documents [for the final rules] completed and cleared." He added that FDA is "open to any and all suggestions . . . about how to get a better handle on the safety of dietary supplements." Zeller emphasized that the final rules "will not affect or alter in any way consumer access to dietary supplements . . . There's nothing in these regulations that will restrict a company's ability to sell dietary supplements," he said. In a keynote address to FDLI on Dec. 14, FDA Commissioner David Kessler emphasized that "FDA's position should be clear: we support access." He noted that the forthcoming dietary supplement regulations will "hold the labels of dietary supplements to the same standards as food," as indicated in the June 18 proposed rules. In addition, Kessler said FDA "[believes] that disease claims should be scientifically supported" and that the agency "[looks] forward to working with Congress to be sure that there is an appropriate basis for achieving these goals." The first session of the 103rd Congress closed with the House failing to pass a moratorium extension for dietary supplements after the Senate voiced unanimous consent for a four-month addendum. Currently, a number of bills concerning FDA regulation of supplements are pending, including: S 784 and HR 1709 introduced by Hatch and Rep. Bill Richardson (D-N.M.), respectively, and favored by industry; HR 2923 introduced by Rep. Cardiss Collins (D-III.), which would bring dietary supplement regulation under the NLEA rubric; and House Energy & Commerce/health subcommittee Chair Henry Waxman's (D-Calif.) bill (HR 3650) introduced Nov. 22. The expiration of the dietary supplement moratorium on Dec. 15 set the stage for increased media attention to the debate. FDA officials, including Kessler and Deputy Commissioner for Policy Michael Taylor, appeared on television news and radio talk shows to assure consumers that the end of the moratorium would not affect access to vitamins. In addition, FDA released a Dec. 15 statement on the end of the moratorium. The agency also notified Congress of the upcoming moratorium expiration in a letter sent to all congressional offices on Dec. 2. In a Dec. 13 press release, the Nutritional Health Alliance claimed that "once these regulations go into effect, dietary supplement consumers will be put in the dark about the benefits of dietary supplements." In addition, NHA asserted that "FDA will continue on its agenda" to restrict the sale of certain amino acids and single-ingredient oils. NHA also predicted that, under FDA regulation, "no other claims [than calcium and folic acid benefits] would be permitted on labels, labeling, or advertising, including nutritional statements of fact on how nutrients affect the structure and function of the human body, which are currently permitted by law." On Dec. 14, the Center for Science in the Public Interest held a press conference in Washington, D.C. where CSPI Director of Legal Affairs Bruce Silverglade heralded the expiration of the NLEA supplement moratorium and voiced support for Waxman's HR 3650 legislation. Silverglade pointed to Waxman's eleventh-hour legislation as an example of Congress "exerting some leadership on the issue" of dietary supplement regulation. Silverglade also suggested that contrary to grassroots rhetoric, the current debate centers on "label law" rather than questions of access. Silverglade asserted that Waxman's bill "guaranteed consumers' access to dietary supplements." In addition, he maintained that HR 3650 "prohibited FDA from providing prescriptions for vitamins [and] it removed any possible question about consumers" rights to purchase dietary supplements." Joining CSPI at the press conference were the American Association of Retired Persons (AARP), the American Heart Association (AHA), the American Dietetic Association (ADA) and the Consumers Union. These groups all oppose the Hatch and Richardson bills, favoring instead Collins" legislation ("The Tan Sheet" Aug. 16, p. 4). To date, the Collins bill has fewer than 10 cosponsors, according to Silverglade. But, he said, the groups are advising their members "not to judge a bill on the basis of the number of cosponsors."