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Pearson v. Shalala

This article was originally published in The Tan Sheet

Executive Summary

Five House members praise FDA for its progress in implementing the court decision in a Nov. 9 letter to Commissioner Jane Henney, MD. Reps. Ron Paul, MD, (R-Tex.), Helen Chenoweth-Hage (R-Idaho), Peter DeFazio (D-Ore.), John Hostettler (R-Ind.) and Bob Stump (R-Ariz.) note, "We are particularly pleased by the FDA's interest in allowing the use of disclaimers for statements that, while not approved by the FDA, are not inherently misleading." The congressmen also state they are "pleased that the FDA is committed to establishing clear scientific standards for reviewing health claims" for dietary supplements, adding they will "continue to closely monitor" the agency's "progress on this issue." In an Oct. 5 letter, FDA agreed it would reopen the comment period on the four relevant health claims after issuing its guidance on "significant scientific agreement" (1"The Tan Sheet" Oct. 18, In Brief)

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Pearson v. Shalala

FDA agrees to "extend or reopen" the 75-day comment period requesting scientific information on four proposed health claims after it releases its guidance on "significant scientific agreement." The decision comes in response to a Sept. 23 letter plaintiffs' attorney Jonathan Emord sent to the agency stating FDA's strategy for studying the health claims was "inconsistent with the Pearson mandate" (1"The Tan Sheet" Oct. 4, p. 11). The deadline for submissions in response to CFSAN's original request for scientific data on the claims was Nov. 22. FDA, in its Oct. 5 response to Emord, also affirms significant scientific agreement is not necessary for a claim to warrant approval, providing a disclaimer resolves any potential confusion. However, the agency declines to clarify this point in a Federal Register notice as requested by Emord

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