FDA panel votes to loosen rules on unapproved peptides

A temporary access policy appeared on a White House docket on Oct. 14.

The proposal would allow licensed pharmacies to manufacture and sell certain unapproved peptides. The FDA had not approved these substances for safety or effectiveness. Scientists at the agency advised against the measure during a July meeting. They warned that the drugs had not been adequately vetted in clinical trials.

A panel advising the FDA voted to loosen the restrictions. Many of the new appointees hold financial stakes in the peptide industry. Emily Hilliard, a spokesperson for the Department of Health and Human Services, said in an email that every committee member satisfies the FDA’s ethics requirements. Haleem Mohammed, chief medical officer of Gameday Men’s Health, voted in favor of the change. His clinic sells peptides to men. "I voted ‘yes’ for patient safety, the greater good, and medical freedom," he said at the meeting.

Promoters of these treatments often rely on specific arguments that may not hold up under scientific scrutiny. Gary Brecka, co-chair of the MAHA Action committee, claimed on his podcast that peptides are not drugs. He suggested they help regulate cortisol and improve circulation. When substances treat, prevent, or cure conditions, or affect body function, they are legally defined as drugs. Jacob Sherkow, a law professor at the University of Illinois Urbana-Champaign, compared the argument to calling heroin not a drug because it is natural.

Supporters also argue that peptides are safe because they are natural. BPC-157, a popular experimental peptide, was isolated from stomach juices by Croatian scientists. Researchers have not found a trace of BPC in the human genome. Katrin Svensson, a peptide scientist at Stanford University, noted that natural things can be toxic. She pointed to insulin, a human-made peptide that can kill people if taken in excess. The FDA is considering lowering restrictions on BPC-157 and five other experimental peptides that lack high-quality clinical trials.

Kris Wusterhausen, founder of an antiaging company, has claimed that BPC-157 can reduce acid reflux and treat neurologic disorders. Few clinical trials support such claims. A 2005 study on inflammatory bowel disease was called inadequate by FDA scientists. Another 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, told patients he will not prescribe BPC-157 until quality studies are conducted. "People want new things quickly," he said, "but medicine and science just don’t work fast."

Robert F. Kennedy Jr. suggested on social media that the FDA hindered access to peptides because they cannot be patented. Hundreds of peptide patents are listed in the U.S. Patent and Trademark Office database. The market for GLP-1 weight loss drugs is projected to reach $190 billion within the next decade. PhRMA, a pharmaceutical trade organization, advised against easing restrictions in a letter to the FDA. It argued that the move would erode incentives for manufacturers to undertake the time and cost required for approval. Six in 10 U.S. adults said they worried about affording prescription drugs in a recent KFF poll.