On Wednesday, the U.S. Federal Register published a draft rule from the Office of the Health Secretary that would loosen restrictions on six peptides that have not received Food and Drug Administration approval. The plan would allow compounding pharmacies to prepare and dispense BPC‑157, TB‑500, KPV, MOTS‑c and Semax, among others, for patients who request them.
Unlike typical FDA guidance, the draft emerged from the health secretary’s office rather than the agency itself. After the rule is officially published later this week, a two‑week public comment period will open.
Experts warn that unregulated injectable peptides lack clinical trials and their long‑term effects remain unknown. The FDA advisory panel voted in July to relax restrictions on the six peptides, but staff members advised against it.
RFK Jr. has called himself a “big fan” of the drugs and has previously pledged to ease restrictions after the Biden administration tightened the industry’s oversight. The move comes amid a surge in online marketing of peptides as “biohacking” or “looksmaxxing” products, especially among teens on TikTok.
Health professionals caution that while peptides such as insulin have a long history of medical use, the unregulated variants marketed for weight loss, skin health or muscle gain have not been proven safe or effective.
The FDA has been contacted for comment, and the public will soon have the opportunity to weigh in on the proposed changes.
