FDA Panel Votes to Ease Rules on Unapproved Peptides Despite Safety Concerns

The FDA is moving to allow licensed pharmacies to sell six experimental peptides without full approval, a decision driven by new board members with financial stakes in the industry. On Oct. 14, a temporary access policy appeared on a White House docket, proposing this shift despite internal FDA scientists warning in July that the drugs had not been adequately vetted in clinical trials. The move aligns with the Make America Healthy Again movement, which has pushed for greater access to unproven longevity treatments.

The advisory panel that recommended loosening restrictions is composed largely of new appointees who hold positions in companies that sell these substances. Haleem Mohammed, the chief medical officer of Gameday Men’s Health, a men’s clinic that sells peptides, voted in favor of the change. At the meeting, he stated, “I voted ‘yes’ for patient safety, the greater good, and medical freedom.” Department of Health and Human Services spokesperson Emily Hilliard said in an email that every committee member satisfies the agency’s ethics requirements.

Promoters of these compounds often argue that peptides are not drugs because they are natural substances found in the human body. This framing is misleading. Gary Brecka, a co-chair of the MAHA Action committee, described using peptides on his podcast to “help regulate cortisol, improve circulation, all kinds of things.” However, when a substance is used to treat, prevent, or cure a condition, it functions as a drug by definition. Jacob Sherkow, a law professor at the University of Illinois Urbana-Champaign, noted that many established drugs have natural antecedents, comparing the logic to calling heroin not a drug simply because it is natural.

The claim that natural origin ensures safety is also contested. BPC-157, one of the most popular experimental peptides, was isolated from gastric juices by Croatian scientists. Yet researchers have found no trace of BPC-157 in the human genome. Katrin Svensson, a peptide scientist at Stanford University, explained that natural things can be toxic, citing insulin as an example of a natural substance that can cause death if taken in excess. Svensson emphasized that while she is excited about peptides, manufacturers must prove they are not harmful through placebo-controlled trials.

Clinical evidence for these treatments remains thin. Kris Wusterhausen, a new panel appointee who founded an antiaging company selling BPC-157, has claimed the peptide can reduce acid reflux and treat neurologic disorders. A 2005 study on BPC-157 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, making it difficult to distinguish the drug's effect from the passage of time. Flynn McGuire, a physical rehabilitation doctor at the University of Utah, said he will not prescribe BPC-157 until quality studies are completed, noting, “People want new things quickly, but medicine and science just don’t work fast.”

A persistent misconception is that pharmaceutical companies avoid peptides because they cannot patent them. In reality, hundreds of peptide patents exist in the U.S. database. Sherkow explained that while natural things themselves are hard to patent, modified formulations that improve stability or delivery are patentable. The market for GLP-1 peptides, used in weight loss drugs like Ozempic, is projected to reach $190 billion within the next decade. Companies may skip trials for other peptides if they believe the drugs cannot compete with these established blockbuster medications.

The pharmaceutical trade organization PhRMA advised against easing restrictions, warning it would erode incentives for manufacturers to undertake the substantial time and cost required for FDA approval. The push for easier access occurs amid legitimate concerns about U.S. health metrics. Americans spend 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, and four in 10 have skipped doses due to price. Researchers suggest policies like limiting drug monopolies and improving access to healthy food to address these issues, a list that does not include skipping clinical trials for unproven treatments.