US Health Secretary Robert F Kennedy Jr has unveiled plans to loosen restrictions on a group of controversial peptides that have become popular online despite lacking FDA approval, in a draft notice published in the Federal Register this week. The plan would allow compounding pharmacies to prepare six peptides — BPC-157, TB-500, KPV, MOTS-c, Semax and a sixth unnamed in the filing — that have not been cleared by the Food and Drug Administration for human use.
In an unusual move, the draft originated from the health secretary's own office rather than the FDA itself. An FDA advisory panel voted in July to loosen restrictions on the same six peptides, but FDA staff had recommended against the change, citing a lack of human clinical trials and unknown long-term effects. Kennedy has described himself as a "big fan" of the drugs and has previously pledged to ease restrictions imposed under the Biden administration, which had clamped down on the growing peptide industry. A two-week public comment period will open once the plan is formally published.
Peptides are short chains of amino acids that the body produces naturally to act as cellular messengers, playing roles in skin health, immune function and hormone regulation; insulin, used for more than a century to treat diabetes, is among the best-known examples. But unregulated peptides have surged in popularity on the wellness market since GLP-1 weight-loss drugs went mainstream, with online influencers marketing them in "stacks" for unproven uses — including, among teenagers on TikTok, as part of "biohacking" and "looksmaxxing" trends promising quicker muscle gain or younger-looking skin.
Health experts have repeatedly warned against the unsupervised use of the substances, pointing to the absence of clinical trials in humans and uncertainty about what happens with long-term use. Kennedy's plan would not make the peptides FDA-approved drugs, but would give them a legal pathway into pharmacies via compounding — a move critics argue effectively endorses substances the agency's own scientists had flagged as too risky to greenlight.