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CFSAN on FDAAA Sec. 912

This article was originally published in The Tan Sheet

Executive Summary

FDA is reviewing comments that could shed light on the implementation of Sec. 912 of the Food and Drug Administration Amendments Act of 2007, but "we'll have to see what the new administration brings" before taking any action, says Louisa Nickerson, an attorney in the Department of Health and Human Services general counsel's office. At a Center for Food Safety and Applied Nutrition discussion of nutrition-related activities Dec. 12, Director Stephen Sundlof says the FDAAA provision "causes some problems for us" because it could make illegal any food substance originally evaluated, but not approved, as a drug. FDA's comment period has closed on how to implement Sec. 912 and a citizen petition that invoked the section in requesting FDA seize food products containing stevia-based sweeteners (1"The Tan Sheet" Nov. 3, 2008, p. 7)
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