5 Things to Know About the FDA’s Peptide Reversal

FDA advisers overrode their own scientists to back 6 peptides for compounding, even as safety data remains thin and gray-market risks persist.

When a reconstituted FDA advisory panel voted in late July to recommend 6 peptides for legal compounding, it was overriding the recommendation of the agency’s own career scientists, who recommended against it due to a lack of human safety data.1 The clash comes as HHS Secretary Robert F. Kennedy Jr is moving to reclassify 14 of the 19 restricted peptides back to legal status. However, almost none of these compounds have FDA-approved indications, and with little regulation in place, gray-market vials remain the default source for millions of Americans.

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