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This article was originally published in The Tan Sheet

Executive Summary

FDAs DIETARY SUPPLEMENT POLICY RISKS VIOLATING PROXMIRE AMENDMENT, ROCHE maintained in recent comments on FDA'sproposed rule for dietary supplement health claims under the Nutrition Labeling & Education Act. "FDA is now interposing its judgment that one cannot have a health claim for something it views as excessively beyond what is 'nutritionally' needed; in effect, ignoring the clear intent of Congress in the NLEA by ignoring the restriction of Proxmire," Hoffmann-La Roche Associate VP Anthony Iannarone asserted. The Roche exec suggested that the 1976 Proxmire Amendment's prohibition of FDA's placing limits on vitamins and minerals also effectively prohibits FDA from restricting allowable health claims to vitamin and mineral products at certain specified levels. "Subject to certain conditions . . . the agency cannot limit the potency of vitamins and minerals under Proxmire," Iannarone explained. He added that vitamins and minerals "continue to be foods even at elevated levels when they are taken as dietary supplements." And under NLEA, he pointed out, "foods bearing approved health claims are not drugs." Iannarone argued that FDA is "bound to follow the statutory requirements and not rewrite them, as it attempts to do with strained interpretations of 'nutritive value.'" The Roche VP suggested that FDA "seems to be moving toward a drug-like, mode-of-action approach to determining whether or not something is a nutrient." That determination should not be based on the level of a nutrient, but rather on its use, Iannarone asserted. He claimed that FDA does not recognize "the difference between something given for a specific therapeutic use and something which is given as part of a nutritional approach to lower the risk of disease, usually over a long period." The FDA proposal, according to Iannarone, also has not resolved confusion "as to what will and will not be allowed" as health claims for supplements, even claims that "have been historically used on food labels and in various types of informational brochures," such as "vitamin C is essential for healthy gums" and "vitamin A is necessary to good eyesight." Iannarone maintained that it was not the intent of Congress "to interdict such well-established statements or require that they go through an agency petition procedure before being allowed." Roche also took exception to FDA's interpretation of the "significant scientific agreement" clause in NLEA. The act's language "does not require that there be 'significant scientific agreement' that the nutrient/disease relationship has been established," Iannarone argued, "but only 'that the claim is supported by such evidence.'" The standard of significant agreement, he maintained, "does not apply to efficacy, but rather the validity of what is said." FDA's position on health claims for dietary supplements, Iannarone argued, forces "the public [to] get their information from sources, however irresponsible they may be, that the agency simply cannot control," such as media reports. Instead, he suggested that the "education mandate" of the NLEA can best be carried out with "accurate, honest, well-balanced [statements which] included all of the limitations of the data and the need for further research." Iannarone recommended that FDA draw a distinction between health information in product labeling and promotional claims on a product's label. "A one or two line claim" on the product label is not a good way for supplement companies to communicate health information, Iannarone said, "because of the limited space which would make it very difficult to include any balancing information that might be necessary." "Responsible companies would like the opportunity to use brochures and the like to educate people on rational use with a well-balanced perspective," Iannarone said. "This can be done with the participation of the agency to assure propriety." However, Iannarone said that cooperation between FDA and "responsible industry . . . is not going to happen, if the agency's positions are too rigid or the rules are not clear, but are left to the judgment of compliance people on a selective case- by-case basis." Iannarone advised FDA to adopt health claim policies for supplements "which use essentially the same standards as for conventional foods," and abandon what Iannarone characterized as "this seemingly endless 'food versus the pill' argument." Addressing FDA concerns about the safety of supplement use, Iannarone maintained that "the safety of vitamins and minerals should be tested by reactions in normal populations." He said that "persons who have unusual conditions or sensitivities" are comparable to people with food allergies in that they must have "some responsibility for self-protection aided by sound education and clear label statements of contents so that they can avoid products which might cause them a problem." Shaklee U.S. also submitted comments on the NLEA regulations proposed by FDA. Company Vice President and General Counsel Marjorie Fine echoed Iannarone's comments that the FDA interpretation of "significant scientific agreement" was inconsistent with the statutory language and not "desirable as a matter of public policy." Fine maintained that FDA "impedes rather than advances the NLEA's objective of promoting good dietary practices." "A label statement accurately describing the results of a series of well-controlled clinical studies or quoting the recommendations of an authoritative government or public health body clearly can be 'scientifically valid,' as Congress intended, even if FDA has not endorsed a broader conclusory statement of the claim," Fine said. According to Shaklee, "the agency's approach takes the legitimate concern that consumers not be misled too far. Screening consumers from the receipt of truthful information "in their own best interests" is neither authorized by the statute nor warranted by good public policy."

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