Health and Human Services secretary Robert F. Kennedy, Jr. has announced an interim enforcement discretion policy allowing broader compounding of six previously restricted peptides, against the advice of the FDA. Allure reports that FDA scientific staffers had little input on the decision and opposed the changes, according to six people familiar with its development.

The six are BPC-157, KPV, TB-500, MOTS-c, Epitalon and Semax. An advisory panel, the Pharmacy Compounding Advisory Committee, voted in July to move them toward the 503A Bulks List, the roster of ingredients compounding pharmacies may legally prepare. That vote was advice, not action, and the peptides have still not been added to the list.

What the policy actually does

Enforcement discretion means HHS will not act against pharmacies that compound these six, provided they meet every condition. Attorney Dustin Robinson of LumaLex Law told Allure those conditions include raw ingredients from FDA-registered manufacturers, a certificate of analysis covering identity, purity, endotoxins and contaminants, one peptide per product, and specified routes such as intranasal for Semax.

Nothing here is over the counter, and nothing here is approved. A prescription from a licensed physician is required, and the HHS document itself frames the policy as a way to discourage use of research-use-only peptides from foreign manufacturers.

Access is not validation

The most useful line in the piece comes from dermatologist Ava Shamban, MD, who has served as an investigator in FDA trials: "Access should never be confused with scientific or clinical validation." She says the policy creates a pathway to greater access without establishing a new standard for approval, which still requires rigorous evaluation of safety, efficacy, dosing and manufacturing quality.

Steve Kates, PhD, of Dicerna Pharmaceuticals, puts the gap in scale terms: Ozempic was tested in thousands of people before wide availability, generating a massive body of safety data. The same safety data does not exist for these six.

Where this goes next

Robinson expects the same panel to weigh in on a further batch of peptides in February, and notes a future administration could reverse the policy overnight. Jay Campbell of the American Peptide Association expects prices to climb substantially as the overseas supply chain is cut out, which he thinks will keep the gray market in business.

Campbell also warns that clinics will start calling these peptides FDA approved. They are not, and Robinson is blunt about why: "HHS made a policy call, not a scientific finding that they're safe or that they work."