AS THE CURIOSITY around peptides grows, the FDA has made efforts in removing a portion of the 19 synthetic peptides from the Category 2 Bulk Substances List. This is kind of a huge deal because when the FDA classifies a substance as Category 2 they believe that it carries significant safety risks, and prohibit compounding pharmacies from making it. In July 2026, an FDA advisory committee met to evaluate evidence for seven popular synthetic peptides on the Category 2 list and recommend whether the FDA should move them onto the Category 1 list, which allows them to be made.
Another five will be under review in 2027.The FDA is not bound to the advisory committee’s recommendations. The panel voted to loosen the restrictions on BPC-157 and TB-500 (those make up the infamous “Wolverine Stack”), as well as KPV, MOTS-C, Epitalon and Semax. It voted no for Emedeltide; that’s the one people reach for to help their sleep.
None of the compounds scored a unanimous vote. This October, US Health Secretary Robert F. Kennedy Jr. pushed forward a policy to temporarily increase access to these six unapproved peptides.
The government will not penalize licensed pharmacists in compounding pharmacies for creating and distributing these substances for people with a prescription. The nudge from RFK Jr. to allow the temporary sale of peptides has received mixed reactions. ”The American Peptide Association applauds the efforts of the Trump Administration and HHS to green light certain peptides into production by compound pharmacies,” Jeff Cohen, cofounder of the American Peptide Association wrote in an email to MH. While she focuses on providing personalized care to her patients, she doesn’t agree with expanding access to unapproved peptides before having adequate evidence of their safety and effectiveness.
My concern is that the enthusiasm around peptides has moved much faster than the clinical evidence.” For Dr. Lewis, several questions are still missing that the FDA has not answered: do these peptides actually work and for whom, peptide quality especially from third-party suppliers, and who is in charge of oversight. That doesn’t mean she is unwilling to discuss peptides, which is happening more than ever.
Sritha Rajupet, MD, MPH, chair of the department of family, population, and preventive medicine at Stony Brook Medicine, also has concerns. Meaning that even if the FDA removes the Category 2 label, there’s still not a lot of research around if and how they work—along with any side effects. In the document outlining RFK Jr’s new policy, compounding pharmacists must report “serious adverse events, and product quality issues to FDA and to the States where the products are compounded.” Still, Dr.
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