FDA Panel Backs Loosening Rules On Peptides

The Food and Drug Administration is weighing a proposal that would let licensed pharmacies make and sell certain experimental peptides without agency approval. The temporary access policy appeared on a White House docket on Oct. 14. The move follows a July FDA panel vote in favor of loosening restrictions, a decision that ran against the advice of FDA scientists. Those scientists warned at the July meeting that the drugs had not been adequately vetted in clinical trials. Several members of the advisory committee are new appointees with financial ties to the peptide industry. Haleem Mohammed, who serves as chief medical officer at Gameday Men's Health, voted yes. "I voted 'yes' for patient safety, the greater good, and medical freedom," Mohammed said at the meeting. A Department of Health and Human Services spokesperson, Emily Hilliard, said in an email that every committee member satisfies FDA ethics requirements.

Peptides have become popular among some influencers, chiropractors, and doctors who focus on longevity or antiaging, even though the FDA has not approved them for safety or effectiveness. Health Secretary Robert F. Kennedy Jr. and other Make America Healthy Again leaders have pushed to widen access to these products. The FDA is considering lowering restrictions on BPC-157 and five other peptides that have not undergone high-quality clinical trials.

Claims surrounding these products often go beyond what the research supports. Gary Brecka, co-chair of the MAHA Action committee, has said on his podcast that peptides are not drugs. When a substance is used to treat, prevent, or cure a condition, federal law defines it as a drug. Insulin, a peptide humans produce, is regulated as a drug when injected to control blood sugar. "Most of the drugs we have had some antecedent in nature," said Jacob Sherkow, a biotechnology law professor at the University of Illinois Urbana-Champaign. "Heroin is natural. No one in their right mind would call it not a drug." A public relations representative for Brecka, Chris Woodward, said in an email that the health issues discussed on the podcast do not constitute medical advice.

Promoters also describe peptides as safe because they are natural. Katrin Svensson, a peptide scientist at Stanford University, said BPC-157 does not appear in the human genome, so the body does not make it. Researchers in Taiwan suggest the peptide comes from stomach microbes, according to Undark magazine. Even if a compound occurs in nature, Svensson said, "natural things can be toxic." People have died from too much insulin. Her lab studies several peptides, and she said, "you need to show they're not harmful." Evidence for treatment claims remains thin. A 2005 summary of a small BPC-157 trial for inflammatory bowel disease lacked critical details, and FDA scientists called it "inadequate." Another study of 16 patients had no control group. A 2025 review of BPC-157 research advised that it be "approached with caution." Flynn McGuire, a rehabilitation doctor at the University of Utah and an author of the review, said he will not prescribe the compound until quality studies exist. "People want new things quickly," McGuire said, "but medicine and science just don't work fast."

The claim that peptides cannot be patented is also inaccurate. Kennedy suggested on X last year that patent rules limit access to these therapies. The U.S. Patent and Trademark Office database lists hundreds of peptide patents, including one for an early BPC-157 formulation that is for sale. Sherkow said modified or formulated versions are patentable. Patents for GLP-1 peptides, which underlie Ozempic and similar medicines, are the subject of industry litigation. Morgan Stanley projects that market to reach $190 billion within a decade. Clinical trials cost millions of dollars, and Pinchas Cohen, a gerontology scientist at the University of Southern California, said investors pulled funding from trials on MOTS-c because they feared overlap with GLP-1 medicines. "Investutors felt we couldn't compete with that," Cohen said. In a letter to the FDA, the trade group PhRMA opposed easing restrictions, writing that the change would "erode incentives for manufacturers to undertake the substantial time and cost required for FDA approval."

Kennedy and other Make America Healthy Again figures point to real problems in U.S. health. The country spends more per person on healthcare than any other nation and ranks below all wealthy nations in life expectancy. A recent KFF poll found six in 10 U.S. adults worried about paying for prescription drugs, and four in 10 skipped doses or took other steps because of price.