HHS proposes rule allowing pharmacies to sell unapproved peptides

The Department of Health and Human Human Services proposed a temporary access policy on Oct. 14 that would allow licensed pharmacies to manufacture and sell specific unapproved peptides. The move follows a July meeting where FDA scientists warned against the measure, stating that the drugs had not been adequately vetted in clinical trials. Despite the internal scientific caution, an FDA advisory panel voted to loosen restrictions on the substances.

The panel includes several new appointees with financial ties to the peptide industry. Haleem Mohammed, a new committee member, voted in favor of the change, citing patient safety and medical freedom. He serves as the chief medical officer for Gameday Men’s Health, a men’s clinic that sells peptides. In an email, Emily Hilliard, a Department of Health and Human Human Services spokesperson, stated that all committee members satisfy FDA ethics requirements.

Promoters of these treatments frequently claim peptides are not drugs because they are natural. Gary Brecka, a co-chair of the MAHA Action committee, has said on his podcast that peptides help regulate cortisol and improve circulation. Jacob Sherkow, a law professor at the University of Illinois Urbana-Champaign, noted that when a substance treats or prevents a condition, it functions as a drug. He pointed to insulin, a natural peptide, as an example of a substance that is definitively a drug when injected to regulate blood sugar.

Proponents also argue that peptides are safe because they occur in nature. Katrin Svensson, a peptide scientist at Stanford University, countered that natural substances can be toxic. She noted that BPC-157, a popular experimental peptide, has not been found in the human genome. Researchers in Taiwan suggest it is produced by stomach microbes. Svensson emphasized that placebo-controlled trials are necessary to identify long-term issues such as liver damage.

Kris Wusterhausen, another new appointee to the advisory panel, has claimed BPC-157 can reduce acid reflux and treat neurologic disorders. He founded an antiaging company that sells the peptide. Clinical evidence for these claims remains limited. A 2005 study on BPC-157 for inflammatory bowel disease was deemed inadequate by FDA reviewers due to missing methodological details. Another study on knee pain lacked a control group, making it difficult to attribute relief to the peptide itself.

Flynn McGuire, a physical rehabilitation doctor at the University of Utah, said he will not prescribe BPC-157 until quality studies are conducted. He told patients that medicine does not work quickly. A 2025 review of musculoskeletal research warned that the peptide should be approached with caution due to a lack of evidence. Laboratory studies showing promise in animals do not guarantee safety or efficacy in humans.

Robert F. Kennedy Jr. suggested on social media that the FDA hinders peptide access because the compounds cannot be patented. That belief is contradicted by data from the U.S. Patent and Trademark Office, which lists hundreds of peptide patents. Sherkow explained that while the natural substance itself cannot be patented, modified formulations can be. Pharmaceutical companies are currently litigating over patents for GLP-1 peptides, a market projected to reach $190 billion within the next decade.

Pinchas Cohen, a gerontology scientist at the University of Southern California, said investors withdrew funding for trials on a peptide he helped discover because they feared competition from GLP-1 drugs. The pharmaceutical trade organization PhRMA advised against easing restrictions, warning that the policy would erode incentives for manufacturers to undertake the time and cost required for FDA approval. A recent KFF poll found that six in ten U.S. adults worry about affording prescription drugs, with four in ten reporting they have skipped doses due to price.