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 intended...to 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
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