FDA Panel Votes 3-2 to Loosen Rules on Unapproved Peptides
The move contradicts advice from FDA scientists who warned the experimental drugs had not been adequately tested for safety.
By Kenji Yamamoto ·
14 out of 16 patients in a small study reported knee pain relief after taking BPC-157, an experimental peptide that has not received FDA approval. That study, however, lacked a control group, leaving open the possibility that the pain simply resolved on its own. Despite such gaps in evidence, a federal panel voted on Oct. 14 to recommend loosening restrictions that currently limit the sale of unapproved peptides.
The recommendation supports a temporary access policy that appeared on a White House docket earlier this month. The policy would allow licensed pharmacies to manufacture and sell specific unapproved peptides to consumers. This follows a push by Health and Human Services Secretary Robert F. Kennedy Jr. and other leaders in the Make America Healthy Again movement to make these substances more widely available.
FDA scientists advised against the measure at a meeting in July. They warned that the drugs had not been adequately vetted in clinical trials. The advisory panel, which includes several new appointees with financial ties to the industry, disagreed. In an email, Department of Health and Human Services spokesperson Emily Hilliard stated that every committee member satisfies the agency’s ethics requirements.
Haleem Mohammed, a new panel member and chief medical officer of Gameday Men’s Health, a clinic that sells peptides, voted in favor of the change. "I voted ‘yes’ for patient safety, the greater good, and medical freedom," Mohammed said at the FDA meeting.
Promoters of peptides often claim the substances are safe because they are natural. Gary Brecka, a co-chair of the MAHA Action committee, has said peptides are not drugs. Jacob Sherkow, a professor of law at the University of Illinois Urbana-Champaign, noted that many drugs have natural antecedents. "Heroin is natural. No one in their right mind would call it not a drug," Sherkow said.
Skeptics point to BPC-157, one of the most popular experimental peptides. Croatian scientists isolated the compound from gastric juices, but researchers have not found a trace of it in the human genome. Katrin Svensson, a peptide scientist at Stanford University, said that even if peptides exist in nature, natural things can be toxic. She added that researchers need to show the substances are not harmful through placebo-controlled trials.
Clinical evidence for these treatments remains limited. A 2005 study on BPC-157 for inflammatory bowel disease was deemed inadequate by FDA scientists due to missing details. A 2025 review of musculoskeletal injury research warned that the evidence should be approached with caution. Flynn McGuire, a physical rehabilitation doctor at the University of Utah, told patients he would not prescribe BPC-157 until quality studies were conducted. "People want new things quickly," McGuire said, "but medicine and science just don’t work fast."
Pharmaceutical trade organization PhRMA advised the FDA against easing restrictions in a letter. The group said the change would erode incentives for manufacturers to undertake the substantial time and cost required for FDA approval. Pinchas Cohen, a gerontology scientist at the University of Southern California, said investors backed out of funding trials for a peptide he helped discover because they worried it could not compete with existing weight loss drugs.
The issue of patentability also plays a role. Kennedy suggested on social media that the FDA hindered access to peptides because they could not be patented. However, hundreds of peptide patents are listed in the U.S. Patent and Trademark Office database. A patent on an early formulation of BPC-157 is currently for sale. Sherkow explained that while one cannot patent a natural thing itself, modifications that allow for injection or stability are patentable.
The MAHA movement correctly notes that the United States spends more on healthcare per person than any other nation while ranking below other wealthy countries in life expectancy. A recent KFF poll found that six in 10 U.S. adults worry about affording prescription drugs. Four in 10 said they have skipped doses or taken other measures because of the price. The next step is for the FDA to review the panel’s vote and determine whether to adopt the proposed access policy.
Source: Daily Breeze
