A U.S. advisory panel has recommended easing restrictions on six out of seven peptides under review for potential inclusion on the list of substances permitted for pharmaceutical compounding, despite concerns from medical professionals about safety and lack of solid scientific evidence. The panel’s guidance, issued Friday after a two-day meeting, urges the Food and Drug Administration (FDA) to allow compounding pharmacies to use these peptides in custom drug formulations, although the recommendations are not binding.

The advisory committee endorsed semax and epitalon, two synthetic peptides often promoted in wellness circles. Semax is marketed for conditions such as depression and anxiety, while epitalon is claimed to have anti-aging effects and benefits for insomnia. Conversely, the panel narrowly voted against approving emideltide, a peptide pitched for insomnia, narcolepsy, opioid withdrawal, and various other conditions, citing potential risks. David Pope, chief pharmacy officer of Xifin Pharmacy Solutions, cast the pivotal negative vote on emideltide, expressing concern over “potentially dangerous downstream consequences,” despite having previously supported other peptides.

This decision followed Thursday’s session, where the panel voted to add four additional peptides—BPC-157, KPV, TB-500, and MOTS-c—to the compounding list. These substances have gained popularity for purported benefits including tissue repair, reducing inflammation, and metabolic enhancement. However, many physicians and public health advocates warned the panel about the inadequate evidence supporting safety and efficacy, stressing that widespread availability could expose patients to unproven therapies.

FDA staff acknowledged the public commentary expressing worries about quality control and identification challenges related to these peptides, citing problems with their nomenclature that complicate regulation. Russell Wesdyk, an FDA official, described it as both “shocking” and “encouraging” that the committee and public raised concerns over the variable quality of these substances. He also highlighted the agency’s limited authority to impose stricter quality measures specific to the compounding bulks list.

Peptides, short chains of amino acids derived from proteins, naturally occur in the human body. Synthetic versions have surged in popularity within the wellness industry, often accompanied by broad claims, including enhanced skin appearance, muscle growth, improved cognitive function, and accelerated wound healing. Despite these marketed benefits, clinical data substantiating their use remain minimal or absent.

Experts caution that expanding compounding access to these compounds might divert patients from established, evidence-based treatments, potentially exposing them to unknown risks. The FDA’s final decision will weigh the panel’s recommendations alongside expert scientific input and regulatory considerations.