Draft issued from health secretary’s office, not the FDA
US Health Secretary Robert F. Kennedy Jr. released plans Wednesday that would allow compounding pharmacies to prepare six popular peptides that have not been approved by the Food and Drug Administration. The draft was announced in the US Federal Register and came from the health secretary’s office rather than the FDA, a route the BBC described as unusual. After the plan is officially published later this week, it will open a two-week public comment period.
The peptides named in the plan include BPC-157, TB-500, KPV, MOTS-c and Semax, and compounding pharmacies would be able to mix them to create medications. The BBC said it has contacted the FDA for comment.
The plan follows an FDA advisory panel vote in July to loosen restrictions on the six peptides. FDA staff members recommended against the move. Kennedy has described himself as a “big fan” of the drugs and has previously vowed to ease restrictions on them after the Biden administration stepped up enforcement against the growing industry.
Peptides are short chains of amino acids, or small proteins, that the body produces naturally. They act as messengers, telling cells what to do, and play vital roles in skin health, the immune system and hormone regulation. The substances have been used to treat medical conditions for more than a century; insulin, one of the first peptide hormones to be discovered, helps people with Type 1 diabetes and some with Type 2 manage their blood sugar levels.
Unregulated injectable peptides have exploded onto the wellness market since GLP-1 weight-loss drugs became mainstream. Online influencers market the substances in what they call “stacks” for unproven uses, claiming they offer a quick way to look younger, heal or improve their skin. The peptides have become popular among teenagers on TikTok, especially boys, over unproven claims that they help build muscle — part of online trends known as “biohacking” and “looksmaxxing.”
Health experts have cautioned against use of the drugs, citing a lack of clinical trials for humans and the unknown long-term effects of the substances.