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Adverse event compliance

This article was originally published in The Tan Sheet

Executive Summary

Firms have to comply with all aspects of the adverse event reporting law, the Dietary Supplement and Nonprescription Drug Consumer Protection Act, by Dec. 22, 2007. Based on language from the Senate HELP committee report and on comments by a member of Sen. Orrin Hatch's, R-Utah, staff who worked on the bill, "The Tan Sheet" previously reported firms had an additional year for labeling provisions. According to Senate Report 109-324 that accompanied the bill, "The general effective date of these amendments [to the FDCA] will be 1 year after enactment, although any labeling changes that may be required will take effect after another year." However, the law itself states that products are misbranded "unless the label ... includes a domestic address or domestic phone number through which the responsible person ... may receive a report of a serious adverse event." This misbranding "shall apply to any dietary supplement labeled on or after the date that is 1 year after the date of enactment of this Act." FDA also asserts that "any supplement labeled on or after Dec. 22, 2007 that does not have the required information is misbranded." It should be noted that the agency's draft guidance on AERs did not specifically recommend that labeling include street address information in addition to the city, state and zip code information already required by food labeling law...

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