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FDA’s AER Language Guidance Leaves Room For Interpretation – Consultants

This article was originally published in The Tan Sheet

Executive Summary

As dietary supplement firms revise their product labels to reflect FDA's adverse event reporting draft guidance, some industry experts say acceptable changes are not as onerous as many have feared

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NPA expects AER cost estimates

The Natural Products Association alerts dietary supplement firms to prepare to submit comments on expected estimates from FDA on manufacturers' costs to comply with adverse event report labeling requirements. The trade group says Oct. 7 a draft of a Federal Register notice the agency posted and withdrew the same day included cost estimates for compliance with FDA's December 2007 AER draft guidances. The guidances recommend that labels for supplements and OTC drugs include complete mailing addresses and statements informing consumers the information should be used for reporting AEs (1"The Tan Sheet" July 28, 2008, p. 12). NPA and other trade groups say neither requirement was in the law that made AERs mandatory and they should not be included in FDA's guidance

NPA expects AER cost estimates

The Natural Products Association alerts dietary supplement firms to prepare to submit comments on expected estimates from FDA on manufacturers' costs to comply with adverse event report labeling requirements. The trade group says Oct. 7 a draft of a Federal Register notice the agency posted and withdrew the same day included cost estimates for compliance with FDA's December 2007 AER draft guidances. The guidances recommend that labels for supplements and OTC drugs include complete mailing addresses and statements informing consumers the information should be used for reporting AEs (1"The Tan Sheet" July 28, 2008, p. 12). NPA and other trade groups say neither requirement was in the law that made AERs mandatory and they should not be included in FDA's guidance

NPA expects AER cost estimates

The Natural Products Association alerts dietary supplement firms to prepare to submit comments on expected estimates from FDA on manufacturers' costs to comply with adverse event report labeling requirements. The trade group says Oct. 7 a draft of a Federal Register notice the agency posted and withdrew the same day included cost estimates for compliance with FDA's December 2007 AER draft guidances. The guidances recommend that labels for supplements and OTC drugs include complete mailing addresses and statements informing consumers the information should be used for reporting AEs (1"The Tan Sheet" July 28, 2008, p. 12). NPA and other trade groups say neither requirement was in the law that made AERs mandatory and they should not be included in FDA's guidance

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