FDA's JULY DIETARY SUPPLEMENT REPORT: 34% OF "MISLEADING" CLAIMS

FDA's JULY DIETARY SUPPLEMENT REPORT: 34% OF "MISLEADING" CLAIMS were attributed to one firm that did not make or sell 80% of the products cited by the agency in a report to Congress on unsubstantiated health claims, according to an Oct. 21 report prepared by staffers of Sen. Orrin Hatch (R-Utah). Calling the FDA report "riddled with inaccuracies," the Hatch staff report says that 178 of the 528 "misleading" products listed in the FDA report were attributed to a small, California-based company named Crystal Star. According to the Hatch report, Crystal Star "does not make, manufacture or sell 141 of the 178 products attributed to it." The Hatch staff report, which was released at a same-day hearing of the Senate Labor & Human Resources Committee, argues that "the agency went to great extremes to attribute certain nonexisting products to Crystal Star Herbal Nutrition." The Hatch report maintains that "statements of nutritional fact" were "taken out of context or were used by the agency to justify listing a product and a claim, even where no product exists." At the hearing, Hatch declared that he is "asking the Clinton Administration today to withdraw the report" and "to take the necessary steps to make sure that in the future," information "provided by the FDA to Congress and the American people is both accurate and unbiased and gathered pursuant to federal law." The FDA report, entitled "Unsubstantiated Claims and Documented Health Hazards in the Dietary Supplement Market," was released by the agency at a July 29 hearing of the House Energy & Commerce/health subcommittee. The -report listed 528 products including herbals, amino acids, vitamins and minerals that made claims for a variety of conditions, such as AIDS, cancer, herpes, hypertension and diabetes ("The Tan Sheet" Aug. 2, p. 8). Sen. Hatch's staff alleged other "key inaccuracies" in the FDA report, including: 34 of the 528 products mentioned by FDA "simply do not exist"; 25 products are listed more than once; "one of the alleged dietary supplements is not a product but a paperback book"; three products are listed more than once for the same claim; and "17 of the products on the list were removed from the marketplace prior to release of the report," the Hatch staffers found. Overall, "more than half of the 528 products are attributed to only three companies." In an executive summary, the Hatch staffers recommended that the "Clinton Administration take immediate steps to discipline those who have participated in the preparation and submission of this misleading document." The FDA report, Hatch staffers asserted, "conclusively proves FDA's animosity to dietary supplements" and was "hastily thrown together for a dramatic unveiling" at the House hearing. FDA Commissioner David Kessler said at the hearing that he continued to "stand by that report." Asked by Hatch to explain the inaccuracies in the report, Kessler said "there is substantiation" for every statement made in the agency document. Kessler also told Hatch that FDA was providing for the record a list of an additional 300 misleading product claims that have been collected since the first report was issued in July. Kessler said the aim of the report was to illustrate that "there's a problem out there" with unsubstantiated claims. Mitchell Zeller, special assistant to Deputy Commissioner for Policy Michael Taylor, explained to Hatch that FDAers collected catalogs, books and other written material but did not purchase every product listed in each catalog. Thus, "if an individual company at the time that we were able to take a brochure off the shelf happened not to be manufacturing that product at that time, we couldn't have known." The claims made in the materials, he continued, "were claims that any consumer could have been exposed to in these stores in early- to mid-July." Zeller emphasized that the FDA report as well as the additional listing of 300 unsubstantiated claims were intended to be "snapshots in time." "We didn't intend them to be an exhaustive survey of every single health claim being made either on the label or in the catalogs for the universe of dietary supplements," Zeller noted. Moreover, FDA believed that the report "would be of value to Congress and to the public for the kinds of things you could be exposed to if you walked into a store, either through oral representation, label claims or catalog and brochure claims," Zeller concluded. Both Kessler and Zeller said the project initially was undertaken in response to congressional inquiries about what kinds of dietary supplement products are currently available and the spectrum of claims they carry. At an Oct. 14 Food & Drug Law Institute workshop, however, Zeller said that due to high public demand for the agency's report, FDA would publish an additional 1,000 copies of the document for distribution.