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FDA supplement ombudsman

This article was originally published in The Tan Sheet

Executive Summary

Rep. Frank Pallone (D-N.J.) urges HHS Secretary Tommy Thompson to establish a dietary supplement ombudsman position at FDA, in Feb. 21 letter. Pallone states ombudsman "would be responsible for providing guidance on many of the questions the industry and the public have with regard to dietary supplements. [He] would help address the need for centralized authority and accountability within FDA." American Herbal Products Association called for a supplement ombudsman at FDA in a 2001 letter to the White House Commission for Complementary & Alternative Medicine (1"The Tan Sheet" July 30, 2001, In Brief). Pallone's letter also calls for the release of GMPs, noting they have been delayed numerous times...

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FDA should initiate a review process much like its ongoing OTC monograph review to evaluate botanicals and appoint a "dietary supplement ombudsman," American Herbal Products Association asserts in recent letter to White House Commission for Complementary & Alternative Medicine. AHPA maintains agency's August 2000 "Botanicals Drug Guidance" does not sufficiently address marketing botanicals with a long history of use as nonprescription drugs. WHCCAMP also should recommend FDA employ "responsible advocate" for supplement industry in its report to President. Interim report was scheduled for July 16, but has yet to be released (1"The Tan Sheet" July 9, p. 8)

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