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In Brief: Structure/function claims reg

This article was originally published in The Tan Sheet

Executive Summary

Structure/function claims reg: FDA plans to issue a "procedural" regulation on how to formally notify the agency when making a statement of nutritional support for a dietary supplement product. The reg will address what information should be included in a structure/function claim notification and will spell out FDA's policy on reviewing notifications. FDA has been telling companies to submit notifications to Elizabeth Yetley, head of the agency's Office of Special Nutritionals, and that the notifications should not be accompanied by substantiating data. The agency said it is considering establishing a database to organize the notices...
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