Key facts
- Most FDA scientific staff opposed a plan to ease access to unproven peptide drugs.
- The policy directs the FDA not to take action against specialty pharmacies selling certain wellness peptides.
- HHS officials initially wanted the FDA to add peptides to a list of drug substances deemed safe for use by compounding pharmacies.
- FDA officials warned that scientific staffers had major safety concerns and would not support such a regulation.
- In 2023, the FDA added more than a dozen peptides, including BPC-157 and TB-500, to its list of substances that should not be compounded due to safety risks.
Most Food and Drug Administration scientific staff members opposed a plan to give people in the United States easier access to unproven peptide drugs, according to six people familiar with its development. The policy, driven almost entirely by the Department of Health and Human Services (HHS), faced pushback among FDA drug staffers who warned it could undermine the agency’s mission of keeping unproven health products off the US market. The document posted online Wednesday by HHS directs the FDA not to take action against specialty pharmacies that sell a half-dozen wellness peptides, including BPC-157, TB-500 and KPV, which would otherwise be considered illegal drugs. HHS officials initially wanted the FDA to add these peptides to a list of drug substances deemed safe for use by compounding pharmacies, but FDA officials warned that scientific staffers had major safety concerns. In 2023, the FDA added more than a dozen peptides, including BPC-157 and TB-500, to its list of substances that should not be compounded due to safety risks.