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FDA Revised Strategy Toward Health Claims Requested By Pearson Plaintiffs

This article was originally published in The Tan Sheet

Executive Summary

A revision of FDA's strategy for dealing with the four health claims the agency was ordered to reconsider under the Pearson v. Shalala decision is requested by plaintiffs' counsel Jonathan Emord (Washington, D.C.-based Emord & Associates) in a Sept. 23 letter to the agency. The letter asks FDA to notify the plaintiffs of such changes by Oct. 15.

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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

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

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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