HHS Proposes Allowing Unapproved Peptides to Be Sold in Pharmacies

The Department of Health and Human Services placed a temporary access policy on a White House docket on October 14, proposing that licensed pharmacies be permitted to manufacture and sell specific unapproved peptides to consumers. This action follows a July meeting where FDA scientists recommended against loosening restrictions, citing insufficient clinical trial data to verify safety and effectiveness.

An FDA advisory panel voted to support the relaxation of these rules, despite internal scientific concerns. The panel includes several new appointees with financial interests in the peptide industry. Emily Hilliard, an HHS spokesperson, stated in an email that all committee members meet the agency’s ethics requirements. Haleem Mohammed, a panel member and chief medical officer of Gameday Men’s Health, a clinic that sells peptides, said he voted yes for patient safety and medical freedom.

Proponents of these substances often claim they are not drugs, a distinction that experts say is misleading. Gary Brecka, co-chair of the MAHA Action committee, has stated 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 any substance used to treat, prevent, or cure a condition is defined as a drug, just as insulin is a drug when injected to manage blood sugar.

Marketing materials frequently describe peptides as safe because they are natural. Brigham Buhler, a compounding pharmacy owner and co-author of The Peptide Revolution, has promoted this view alongside Brecka. However, Katrin Svensson, a peptide scientist at Stanford University, pointed out that BPC-157, one of the most popular experimental peptides, has not been found in the human genome. Svensson argued that natural substances can be toxic and that placebo-controlled trials are necessary to identify potential side effects like liver damage.

Promoters also assert that these peptides treat various illnesses and heal injuries. Kris Wusterhausen, a new FDA panel appointee and founder of an antiaging company, has claimed BPC-157 can treat acid reflux and neurologic disorders. Clinical evidence remains limited. A 2005 summary of a BPC-157 trial for inflammatory bowel disease was deemed inadequate by FDA reviewers due to missing methodological details. Another small study found the peptide relieved knee pain in 14 of 16 patients, but it lacked a control group to account for natural recovery.

Flynn McGuire, a rehabilitation doctor at the University of Utah, authored a 2025 review warning that BPC-157 should be approached with caution due to a lack of evidence. He has told patients he will not prescribe the peptide until higher quality studies are completed. He noted that while laboratory studies may show promise, they do not confirm safety or efficacy in humans, where complex biological interactions can lead to unexpected outcomes such as cancerous growths.

Robert F. Kennedy Jr. previously suggested on social media that the FDA hindered peptide access because the substances could not be patented. Sherkow clarified that while natural compounds themselves cannot be patented, modified formulations can and do hold patents. The GLP-1 peptide market, which includes weight loss drugs like Ozempic, is projected to reach $190 billion within the next decade according to Morgan Stanley. PhRMA, a pharmaceutical trade group, advised the FDA against easing restrictions, warning that the change would erode incentives for manufacturers to undertake the substantial costs and time required for standard approval.

Leaders of the Make America Healthy Again movement correctly point out that the United States spends more on healthcare per person than any other nation while ranking lower in life expectancy among wealthy countries. A recent KFF poll found that six in 10 U.S. adults worry about affording prescription drugs, with four in 10 reporting they have skipped doses due to cost. Researchers have proposed policies to lower these costs, but none suggest skipping clinical trials to sell unproven treatments that might cause harm.