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This article was originally published in The Tan Sheet

Executive Summary

DIETARY SUPPLEMENT SCIENTIFIC LITERATURE DISTRIBUTION TO CONSUMERS is protected free speech and should be allowed by FDA, the National Nutritional Foods Association asserted in an Oct. 18 "white paper" on third-party literature. Prepared for NNFA by the law firm Piper & Marbury, the white paper argues that "constitutional principles of protecting truthful, commercial speech dictate that manufacturers should be permitted to provide retail stores with reprints and summaries of third-party scientific literature that makes no reference to specific product brands." In arguing that the dissemination of scientific literature is protected under the free-speech provisions of the First Amendment, NNFA cited several cases in which the Supreme Court "unequivocally held that commercial speech is entitled to First Amendment protection." In general, NNFA complained that "FDA policies muzzle manufacturers and retailers from informing consumers of important advances in nutrition. When the FDA says that it does not want to take dietary supplements off the market -- that it simply wants to bar claims -- this muzzling is what it means." NNFA noted that "recent advances in our understanding of nutrition and health have been startling." However, the association cautioned, "new developments in nutrient-disease correlations will not address prevention and maintenance if only scientists and nutritionists can easily access the information." "FDA cuts off the flow of information about the beneficial effects of nutrients on health and disease by prohibiting manufacturers and retailers from providing the information to the consumer," NNFA maintained. While "the news media may write an article about such information," the association claimed that "if the local organic grocer were to put an article about the health benefits of broccoli next to the vegetable, the broccoli could be seized and the grocer incarcerated." "We are not talking about miraculous recoveries, testimonials, or other kinds of puffery or charlatanism," NNFA insisted. "The issue is the distribution of legitimate, non-product specific scientific information from well-respected, peer-reviewed scholarly journals." The white paper also criticizes FDA for its approach to regulating dietary supplement claims. NNFA asserted that "FDA rarely proceeds against dietary supplements for false or misleading labeling." Instead, NNFA argued, "FDA's practice is to proceed against dietary supplements as drugs (which they are not) based on "claims" and then find them misbranded because they do not have required drug labeling or now drug approval." FDA, NNFA maintained, is "blessed by" broad Supreme Court interpretations of "labeling" and "has the fuel necessary to challenge products by virtue of claims in literature sent independently from the products." A manufacturer may provide reprints of scientific literature to a retail store, NNFA clarified, but the literature must be "segregated from products." Store employees also "may not directly inform consumers about what the literature says about the health benefits of any dietary supplements or about particular literature on the supplements," according to NNFA. "Instead, all a consumer may be told in a retail store is that the store has a literature section if the consumer wants more information," the "white paper" states. NNFA also took aim at FDA's implementation of the Nutrition Labeling & Education Act. While the NLEA "appeared as a beacon of light, promising manufacturers the ability to provide expanded and meaningful health information to consumers," the white paper says, "it has instead been utilized by FDA as yet another means to maintain autocratic control over nutrition information and to deem itself the National Health Authority. Nothing may be said about nutrition and disease until FDA agrees with it." In a separate Oct. 26 "white paper" on dietary supplements and pharmaceutical innovation also prepared by Piper & Marbury, NNFA maintained that "dietary supplements and traditional medicines are not disincentives to pharmaceutical development." NNFA said that FDA's Dietary Supplements Task Force evaluated how "to ensure that the existence of dietary supplements on the market does not act as a disincentive to drug development." FDA's concern about innovation disincentives, NNFA asserted, results "from the agency's unbending compartmentalization of dietary supplement products which address health or physiological disease conditions into the drug category. By so classifying dietary supplements," the NNFA claimed, "FDA makes dietary supplements competitors with pharmaceuticals." The white paper also argues that "pharmaceutical innovation is most substantially impacted by marketing exclusivity," and not competition from existing product alternatives. Moreover, "the history of drug development shows that the pharmaceutical industry aggressively pursues opportunities even where there is already a low-cost product alternative," NNFA said. For instance, "aspirin has been available for well over 50 years," the white paper points out, but pharmaceutical firms have "nonetheless . . . spent millions developing non-steroidal anti- inflammatory drugs to compete with aspirin. The success of ibuprofen and others in this category is well established," NNFA concluded. NNFA said it plans to provide both white papers to congressional staffers working on compromise dietary supplement legislation, such as Senate Labor & Human Resources Counsel Mark Childress. Other staffers involved with the development of a compromise bill include Senate Labor & Human Resources minority staffer and Chief Health Advisor Patricia Knight, House Energy & Commerce/health subcommittee Counsel William Schultz, and John Lewis, a staffer of Rep. Bill Richardson (D-N.M.).

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