FDA holding judgment on anhydrous betaine status as dietary supplement.
This article was originally published in The Tan Sheet
Executive Summary
FDA HOLDING JUDGMENT ON ANHYDROUS BETAINE STATUS AS DIETARY SUPPLEMENT following approval of the ingredient as an orphan drug last fall. FDA Office of Special Nutritionals Director Elizabeth Yetley, PhD, told dietary supplement marketer Jarrow Formulas in a recent letter that "at the present time, the agency is not contemplating action that would affect the regulatory status of anhydrous betaine." The substance is marketed with homocysteine reduction claims.
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