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Structure/function reg

This article was originally published in The Tan Sheet

Executive Summary

Future FDA guidance should adopt "innocent construction rule" and allow use of disclaimers, Emord & Associates says in comments filed on behalf of Weider Nutrition, Pure Encapsulations, other supplement firms. "FDA must begin with the unbiased presumption that a structure/function claim that arguably implies disease cure, treatment, prevention or mitigation is convey a non-disease connotation," comments say. FDA should give firms "option of using a disclaimer that eliminates the disease connotation rather than a 'courtesy letter'" limited to explaining that claim may be used only if approved in a health claim petition or NDA. Several trade groups have said FDA guidance providing examples of supplement claims that would be deemed disease claims is not needed (1"The Tan Sheet" May 28, In Brief)

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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)

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