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CRN on Davis bill

This article was originally published in The Tan Sheet

Executive Summary

New legislation authorizing FDA to consider a dietary supplement's "unreasonable risk" in light of the level of its benefit would reverse the basic tenets of DSHEA, according to the Council for Responsible Nutrition. HR 3156, introduced June 30 by Rep. Carolyn Davis (D-Calif.), also would "codify FDA's risk/benefit rationale for removing ephedra from the market that was invalidated by the court in Nutraceutical v. Crawford," CRN maintains. The bill contains a provision establishing that in the absence of a sufficient benefit, the presence of even a relatively small risk of serious adverse health effect to a user may be considered unreasonable (1"The Tan Sheet" July 1, 2005, In Brief)...

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“Unreasonable risk” bill

HHS Secretary would be granted greater authority to deem a dietary supplement's risk "unreasonable" under a bill introduced June 30 by Rep. Susan Davis (D-Calif.) and cosponsored by Reps. Henry Waxman (D-Calif.) and John Dingell (D-Mich.). The "Dietary Supplement Access & Awareness Act" (H.R. 3156) provides that in certain court procedures, the Secretary may consider a supplement's risk to be unreasonable by weighing its potential benefits against possible health risks. "In the absence of a sufficient benefit, the presence of even a relatively small risk of a serious adverse health effect to a user may be considered" unreasonable, the legislation states. The provision is new to the bill, which otherwise mirrors H.R. 3377, introduced by Davis in October 2003 (1"The Tan Sheet" Nov. 3, 2003, p. 13)...

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