FDA Panel Votes to Ease Restrictions on Unapproved Peptides

A temporary policy posted to a White House docket on Oct. 14 proposes allowing licensed pharmacies to manufacture and sell certain unapproved peptides. The measure targets six experimental substances, including BPC-157, that have not undergone rigorous clinical trials or received FDA approval for safety and effectiveness. FDA scientists advised against the change in July, warning that the drugs had not been adequately vetted. Despite this internal counsel, an FDA advisory panel voted to loosen the restrictions.

The composition of that panel has drawn scrutiny. Many members are new appointees with financial ties to the peptide industry. Haleem Mohammed, a committee member and chief medical officer of Gameday Men’s Health, a men’s clinic that sells peptides, voted in favor of the measure. He cited patient safety and medical freedom as his reasons. Department of Health and Human Services spokesperson Emily Hilliard stated in an email that all committee members meet FDA ethics requirements. Kris Wusterhausen, another new appointee, is the founder of an antiaging company that advertises peptide treatments.

Proponents of the therapy often argue that peptides are not drugs because they are natural. Jacob Sherkow, a biotechnology law professor at the University of Illinois Urbana-Champaign, rejected that distinction. He noted that natural substances like heroin are classified as drugs. Katrin Svensson, a peptide scientist at Stanford University, pointed out that BPC-157 is not found in the human genome. While researchers in Taiwan suggest stomach microbes produce it, Svensson emphasized that natural origin does not guarantee safety. She noted that natural substances can be toxic and that humans can die from overdosing on natural peptides like insulin.

Claims about efficacy remain difficult to verify. A 2005 study on BPC-157 for inflammatory bowel disease was deemed inadequate by FDA reviewers due to missing details. A separate small study found relief for 14 of 16 knee pain patients but lacked a control group. Flynn McGuire, a physical rehabilitation doctor at the University of Utah, said he will not prescribe the peptide until quality studies are completed. He noted that medicine does not work fast, even though consumers often desire quick results. Laboratory studies showing promise in cells do not confirm safety or efficacy in humans.

The misconception that peptides cannot be patented has also fueled support for easier access. Hundreds of peptide patents exist in the U.S. Patent and Trademark Office database. Pharmaceutical companies are currently litigating over patents for GLP-1 peptides, the basis of weight loss drugs like Ozempic. Morgan Stanley projects the market for these medicines will 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 discovered because they feared it could not compete with GLP-1 drugs.

The push for accessibility coincides with valid concerns about healthcare costs. The U.S. spends more per person on healthcare than any other nation but ranks below other wealthy countries in life expectancy. In a recent KFF poll, six in 10 U.S. adults worried about affording prescription drugs, and four in 10 said they had skipped doses due to price. The pharmaceutical trade organization PhRMA advised the FDA against easing restrictions, arguing it would erode incentives for manufacturers to undertake the substantial time and cost required for formal approval.

The proposed policy remains on a temporary docket as the administration moves to make these unproven treatments more accessible to the public. The FDA continues to review the advisory panel’s recommendation while the public debate over natural versus pharmaceutical interventions intensifies.