A Food and Drug Administration advisory panel has convened for a two-day meeting to determine whether compounding pharmacies should be permitted to fill prescriptions for certain unapproved peptide therapies that have gained considerable popularity in recent months.
The deliberations center on seven specific peptides that have attracted significant attention, particularly through online promotion by social media influencers. These substances are short chains of amino acids that serve as building blocks for proteins in the human body. While the FDA has approved more than 80 peptides for medical use in products ranging from insulin to skincare treatments and GLP-1 medications, the peptides under current review lack such approval.
The substances in question are typically marketed with disclaimers stating they are for “research use only” and have not undergone the rigorous clinical trials and human testing required for FDA approval. Nevertheless, proponents claim these peptides can slow the aging process, accelerate muscle growth, heal injuries, and reduce inflammation.
Health and Human Services Secretary Robert F. Kennedy Jr. has publicly stated his support for these therapies, describing himself as a “big fan” and noting his personal use of peptides to address injuries.
The panel’s task is to evaluate whether these seven peptides meet the criteria for safe production by compounding pharmacies, which specialize in creating medications not available through standard pharmaceutical manufacturers. Should the panel recommend their inclusion on the approved list, patients would still require a doctor’s prescription and would need to demonstrate a specific medical condition warranting treatment. It bears emphasizing that such a decision would not constitute formal FDA approval of the substances.
Among the peptides under consideration is BPC-157, which has garnered particular attention in online health circles for its purported injury-healing properties. However, medical experts have raised substantial concerns about the limited testing these substances have undergone. Dr. Rachel Pessah-Pollack of NYU Langone noted that BPC-157 has been tested in approximately 30 humans, a stark contrast to the hundreds of thousands of patients involved in GLP-1 drug trials.
Dr. Jessica Duncan, chief medical officer for IVIM Health, a company that prescribes FDA-approved peptides, argued that the FDA should acknowledge market realities. She contends that because public demand for these therapies exists and people are seeking them regardless of regulatory status, the agency should work to ensure access occurs through proper medical channels rather than unregulated sources.
The current regulatory gap has created what practitioners describe as a “gray market” where peptides can be purchased online without medical supervision. Medical professionals have expressed serious concerns about this unregulated space, warning of potential contamination and impurities in products obtained outside legitimate medical channels.
Dr. Pessah-Pollack issued a stark warning about the risks of unregulated peptide use, noting that injectable products obtained outside proper medical oversight could contain dangerous contaminants including arsenic or lead.
The meeting represents a shift in federal policy direction. During the previous administration, the FDA added nearly 20 peptides to the federal list of substances prohibited from production by compounding pharmacies, determining they did not meet safety criteria.
The panel’s recommendations will carry significant weight in determining how these increasingly popular therapies are regulated and whether Americans will have legitimate medical access to substances they are currently seeking through less secure channels.
Related: White House Confirms Trump Will Speak at July Correspondents’ Dinner
