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Structure/function guidance

This article was originally published in The Tan Sheet

Executive Summary

FDA seeking comments by May 23 on proposed guidance for implementing structure/function claims final reg, a Feb. 22 Federal Register notice says. Agency noted in final rule's preamble it would provide, through guidance, "examples of labeling claims that would and would not be considered disease claims under the rule, including examples of product names," notice says. FDA also invites comments on whether a guidance on citation of a publication or reference implying disease treatment or prevention is necessary. Agency notes it plans to issue a separate guidance on structure/function claims substantiation

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Structure/function reg

Proposed agency guidance providing examples of supplement labeling claims that would or would not be deemed disease claims is unnecessary, CHPA, CRN, AHPA, NNFA assert in separate comments. Trade associations say Jan. 6, 2000 final reg's lengthy preamble and numerous "courtesy" letters issued by FDA provide adequate industry guidance. Remarks respond to FDA's request for comments by May 23 on development of proposed guidance (1"The Tan Sheet" Feb. 26, p. 23)

Structure/function reg

Proposed agency guidance providing examples of supplement labeling claims that would or would not be deemed disease claims is unnecessary, CHPA, CRN, AHPA, NNFA assert in separate comments. Trade associations say Jan. 6, 2000 final reg's lengthy preamble and numerous "courtesy" letters issued by FDA provide adequate industry guidance. Remarks respond to FDA's request for comments by May 23 on development of proposed guidance (1"The Tan Sheet" Feb. 26, p. 23)

Structure/function reg

Proposed agency guidance providing examples of supplement labeling claims that would or would not be deemed disease claims is unnecessary, CHPA, CRN, AHPA, NNFA assert in separate comments. Trade associations say Jan. 6, 2000 final reg's lengthy preamble and numerous "courtesy" letters issued by FDA provide adequate industry guidance. Remarks respond to FDA's request for comments by May 23 on development of proposed guidance (1"The Tan Sheet" Feb. 26, p. 23)

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