A draft from the health secretary’s office would let pharmacies compound six peptides that have never been approved by the FDA.
Key points
- The health secretary’s draft would allow compounding pharmacies to prepare six unapproved peptides, pending a public comment period.
- Experts caution that the peptides have not undergone human clinical trials and may carry unknown health risks.
- An FDA advisory panel supported loosening restrictions, but FDA staff opposed the move, and the agency has not yet commented on the draft.
Robert F. Kennedy Jr., the US health secretary, has released a draft rule that would permit compounding pharmacies to prepare six popular peptides that are not approved by the Food and Drug Administration, according to a notice published in the Federal Register on Wednesday.
The proposal lists BPC‑157, TB‑500, KPV, MOTS‑c and Semax among the substances that could be mixed by pharmacies, with the draft indicating that a formal rule will be published later this week and will be open for a two‑week public comment period.
Proposed regulatory change
Peptides are short chains of amino acids that the body naturally produces and that have been used medically for more than a century – insulin being a well‑known example – but the unapproved variants have surged in the wellness market, promoted online as “stacks” for anti‑aging, muscle building and skin health, especially among teenage TikTok users.
Health experts have warned that these injectable peptides lack human clinical trials and that their long‑term effects remain unknown. An FDA advisory panel voted in July to ease restrictions on the six peptides, yet FDA staff members recommended against the change, and the agency has not yet issued an official response to the draft.
Expert concerns over safety
If the final rule proceeds, the public will have two weeks to submit comments, after which the health secretary’s office will decide whether to move forward. The BBC has reached out to the FDA for comment on the proposal.
Reader questions
What are peptides and why are they controversial?
Peptides are short chains of amino acids that act as cellular messengers. While some, like insulin, are approved medicines, the six peptides in the draft have never been cleared by the FDA and lack human safety data, leading to controversy.
How will the proposed rule change the current regulation of these substances?
The rule would let compounding pharmacies legally mix the six unapproved peptides for patient use, a shift from the current prohibition that requires FDA approval before such substances can be dispensed.
What is the public comment period and why does it matter?
After the draft is formally published, there will be a two‑week window for the public, experts and stakeholders to submit feedback. The comments can influence whether the health secretary finalises the rule.
Source: bbc.com
