FDA Panel Votes to Loosen Rules on Unapproved Peptides

The Food and Drug Administration moved closer to allowing the sale of unapproved experimental peptides on October 14 when a temporary access policy appeared on a White House docket. The proposal would permit licensed pharmacies to manufacture and sell specific compounds that have not yet received full regulatory clearance for safety or effectiveness. This development follows a vote by an advisory panel that recommended loosening current restrictions on these substances.

The FDA’s own scientists advised against the measure during a meeting in July. They warned that the drugs had not been adequately vetted in clinical trials. Despite this internal caution, the advisory panel voted to support greater accessibility. The panel included new appointees who hold financial interests in the peptide industry. Emily Hilliard, a spokesperson for the Department of Health and Human Services, stated in an email that every committee member satisfies the agency’s ethics requirements.

Haleem Mohammed, a new committee member, voted in favor of the change. He cited patient safety and medical freedom as his reasons. Mohammed serves as the chief medical officer for Gameday Men’s Health, a clinic that sells peptides to men. Another panel member, Kris Wusterhausen, is the founder of an antiaging company that markets BPC-157. He has claimed the peptide can reduce reflux disease and treat neurologic disorders.

Promoters of these compounds often argue that peptides are natural and therefore safe. Gary Brecka, co-chair of the MAHA Action committee, stated on a podcast that peptides help regulate cortisol and improve circulation. However, Jacob Sherkow, a biotechnology law professor at the University of Illinois Urbana-Champaign, noted that most drugs have antecedents in nature. He used heroin as an example of a natural substance that is still classified as a drug.

The most popular experimental peptide, BPC-157, was developed by Croatian scientists who isolated it from stomach lining juices. Katrin Svensson, a peptide scientist at Stanford University, pointed out that researchers have not found a trace of BPC in the human genome. This suggests the body does not naturally produce it. Svensson noted that natural things can be toxic, citing insulin as an example of a substance that can be fatal if taken in excess.

Clinical evidence for BPC-157 remains limited. A 2005 study on inflammatory bowel disease lacked critical methodological details, leading FDA scientists to call it inadequate. Another small study found that BPC-157 relieved knee pain in 14 of 16 patients, but it lacked a control group. Flynn McGuire, a rehabilitation doctor at the University of Utah, said he will not prescribe the peptide until quality studies are conducted. He noted that medicine and science do not work fast.

Robert F. Kennedy Jr., the health secretary, has pushed to make these peptides more accessible. He previously suggested on social media that the FDA hindered access to peptides because they cannot be patented. This claim conflicts with data from the U.S. Patent and Trademark Office, which lists hundreds of peptide patents. Sherkow explained that while the natural substance itself may not be patentable, modified formulations and delivery methods are.

Pharmaceutical companies have been slow to invest in large-scale trials for these peptides. 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 competed with GLP-1 weight loss drugs. The market for GLP-1 medications is projected to reach $190 billion within the next decade, according to Morgan Stanley. This high-value market may discourage companies from pursuing lower-potential peptide candidates.

The pharmaceutical trade organization PhRMA advised against easing restrictions on unapproved peptides in a letter to the FDA. The group warned that the move would erode incentives for manufacturers to undertake the time and cost required for FDA approval. The push for easier access aligns with a broader critique of healthcare costs. Six in ten U.S. adults said they worried about affording prescription drugs in a recent KFF poll, with four in ten saying they had skipped doses because of the price.

Leaders of the Make America Healthy Again movement correctly note that the U.S. spends more on healthcare per person than any other nation while ranking below other wealthy countries in life expectancy. However, researchers have outlined policies to lower costs that do not include skipping clinical trials. The current debate centers on whether to prioritize immediate access to unproven treatments or maintain strict standards for verifying safety and efficacy.