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Medical food claims may need substantiation similar to drug claims -- FDA notice.

This article was originally published in The Tan Sheet

Executive Summary

MEDICAL FOOD CLAIMS MAY NEED DATA AKIN TO DRUG CLAIMS, FDA suggested in an Advance Notice of Proposed Rulemaking published in the Nov. 29 Federal Register. "The agency's preliminary view is that the scientific standard contained in the statutory medical food definition may require some of the same types of data for medical foods as are needed to support drug claims (e.g. data from clinical investigations)," the ANPR states. FDA is "soliciting comments to initiate a re-evaluation" of its approach to regulating medical foods; written comments are due Feb. 27.
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