HHS grants enforcement discretion for six unproven peptides

The Department of Health and Human Services announced a new policy on Tuesday that allows small compounding pharmacies to produce six popular peptides that have not been approved by the Food and Drug Administration. The agency will exercise enforcement discretion for these substances, effectively permitting their manufacture while they remain technically outside the standard regulatory framework.

The six compounds include BPC-157, Epitalon, KPV, MOTS-c, Semax, and TB-500. Proponents often cite uses such as ulcerative colitis, insomnia, wound healing, metabolic health, and migraine relief. The FDA’s advisory panel voted in July to expand access to these drugs through compounding pharmacies, though the agency’s own scientists recommended against lifting existing restrictions during the same meeting.

Health Secretary Robert F. Kennedy Jr. has publicly supported the use of peptides, stating that he has used some himself. His administration argues that compounding provides a safer alternative to the current gray market, where “research-use-only” peptides are often sourced from overseas suppliers with variable quality standards.

Joshua Fritzler, president of Olympia and Wesley Pharmaceuticals in central Florida, said his company has received years of customer inquiries for these products. Because they were illegal to compound, his firm did not produce them. Under the new rules, only his 503A facility can manufacture the peptides, and it will likely start with just one of the six.

Fritzler warned that supply will remain tight. He stated that his company needs to prepare its facility first and believes that all 503A pharmacies in the country combined will struggle to meet consumer demand. The policy applies specifically to smaller 503A compounders and does not extend to larger 503B outsourcing facilities that produce higher volumes of medicines.

Scott Brunner, CEO of the Alliance for Pharmacy Compounding, said the decision offers a more accountable alternative for patients. He noted that the move brings these patients into a system with pharmacy standards and adverse event reporting. However, he cautioned that it may take time before products reach shelves, as ingredient suppliers must verify that active components meet the policy’s requirements.

Consumer advocacy groups criticized the move. Dr. Robert Steinbrook of Public Citizen wrote that Kennedy acted unilaterally rather than through typical rulemaking. He argued that allowing unproven peptides to be marketed without concern for federal enforcement undermines the FDA and threatens public health. Steinbrook advised clinicians to discuss contamination risks with their patients.

Shabbir Safda, executive director of the Partnership for Safe Medicines, said the decision leaves Americans in a gray area regarding safety. His organization filed a citizen petition last week urging the FDA to ignore its advisory committee’s July recommendation. Safda pointed to the FDA scientists’ earlier vote against expanding access due to concerns about the evidence base.