An advisory committee to the Food and Drug Administration (FDA) voted on Thursday to recommend easing restrictions on several popular peptides. The Pharmacy Compounding Advisory Committee voted in favor of allowing specialized pharmacies to produce BPC-157, KPV, MOTS-c, and TB-500. While the FDA is not legally bound to follow the recommendations of its advisory panels, it generally adopts their findings.
The votes occurred during a two-day meeting to review whether these compounds, which are not currently approved as drugs, should be reclassified for production by compounding pharmacies. Proponents, including industry representatives and clinicians, told the panel that thousands of Americans currently purchase these substances on the unregulated "gray market" through online vendors. They argued that easing restrictions would allow for oversight by licensed pharmacies and medical professionals.
FDA scientists presented analyses opposing the change, citing a lack of clinical trial data regarding the safety and efficacy of the peptides in humans. Agency officials noted that much of the existing research for substances like BPC-157 is limited to animal studies. Health and Human Services Secretary Robert F. Kennedy Jr. has previously expressed support for expanding access to these compounds.
The advisory panel recently underwent membership changes, including the addition of new members this week. Critics of the process have raised concerns regarding potential conflicts of interest among panel members with ties to the peptide industry. Peptides are amino acid chains used by some consumers for purposes including injury recovery, muscle growth, and weight loss.