Key facts
- An FDA advisory committee voted to recommend that compounding pharmacies be allowed to produce four peptides: BPC-157, KPV, TB-500, and MOTS-c.
- The vote occurred despite strong objections from FDA career scientists who cited a lack of supporting evidence and safety concerns.
- Committee members expressed confusion over the exact chemical formulas of the peptides, making evaluation difficult.
- The recommendations support Health Secretary Robert F. Kennedy Jr.'s efforts to increase access to wellness peptides.
- The committee's vote is a recommendation and does not constitute FDA approval; a public rulemaking process will follow.
- Peptides have been in a legal gray area, often sold online for research purposes, and the FDA had previously restricted their compounding.
A divided Food and Drug Administration advisory committee has voted to recommend that certain compounding pharmacies be allowed to produce four peptides, despite significant concerns raised by agency scientists regarding the lack of evidence and safety data. The committee's decision on July 23, 2026, supports Health and Human Services Secretary Robert F. Kennedy Jr.'s initiative to broaden access to these compounds, which are popular in the wellness industry.
The panel narrowly favored loosening restrictions on BPC-157, KPV, TB-500, and MOTS-c. FDA scientists had highlighted that the chemical identities of these peptides were not universally accepted, making them difficult to evaluate. They also noted a scarcity of data supporting their proposed uses, such as BPC-157 for ulcerative colitis and MOTS-c for obesity.
Several committee members, including some recently appointed and affiliated with clinics offering peptides, voted in favor, sometimes expressing disappointment with the data's incompleteness but still supporting broader access. Conversely, some members, like Josh Mailman, voted against the recommendations due to the "black box" nature of the compounds and insufficient evidence.
The committee's vote is a recommendation and not a final decision. The peptides will still need to go through a lengthy public rulemaking process. Experts note this pathway is unusual, as most drugs undergo a more rigorous FDA approval process rather than being dispensed through compounding pharmacies, which operate under less stringent oversight.
Previously, the FDA had restricted the compounding of these and other peptides in 2023, citing potential safety risks. Advocates argue that allowing compounding will move consumers away from unregulated online sources, particularly those in China, and toward safer, albeit unapproved, products.