The Peptide Gray Market Is Already Here. The FDA Is Just Catching Up.

A group of peptides could be a step closer to becoming available through certain pharmacies after key Food and Drug Administration (FDA) committee votes last week. 

On Thursday and Friday, the FDA’s Pharmacy Compounding Advisory Committee (PCAC) voted to recommend adding six peptides to the 503A bulks list for specific uses. The newly PCAC-recommended peptides include BPC-157, KPV, TB-500, MOTS-c, Epitalon, and Semax. If the FDA approves adding these peptides to the list, compounding pharmacies could use them to make customized medications for patients. The committee voted against recommending emideltide for opioid withdrawal, chronic insomnia, and narcolepsy uses. 

Most Americans are likely familiar with peptides like insulin and GLP-1s. But in recent years, the market for peptides has expanded to include substances—such as amino acid chains like BPC-157—that are promoted by wellness influencers and health gurus, and far beyond what is FDA-approved. As a result, a growing number of Americans are sourcing their peptides from China to skirt FDA oversight. As The New York Times has noted, “imports of hormone and peptide compounds from China roughly doubled to $328 million in the first three quarters of 2025, from $164 million in the same period of 2024,” according to U.S. customs data. 

Peptides are not illegal to use or own, but as the BBC notes, “they are not approved for human use, so are not subject to the quality controls that govern pharmaceutical manufacturing.” In 2023, under the Biden administration, the FDA classified a group of over a dozen peptides as Category 2 substances, which may “present significant safety risks,” effectively banning their use. 

In February, Health and Human Services Secretary Robert F. Kennedy Jr. told Joe Rogan he was a “big fan of peptides” and that he wanted to make several peptides legally accessible. 

“We created the black market. And it’s a very dangerous black market,” Kennedy said on The Joe Rogan Experience.  

In April, Kennedy announced that 12 of the peptides, including the seven voted on last week, would be removed from the Category 2 list and re-evaluated by “independent experts” for safety. 

Before last week’s PCAC vote, FDA scientists wrote in briefing materials that they would not recommend adding the seven peptides to the 503A bulks list. The FDA scientists concluded that “the peptides being considered lacked the necessary evidence to conclude that they were safe and effective for treating the conditions they were purported to help treat,” according to The Hill. 

Members of the PCAC, however, argued that they wanted pharmacies, not black markets, distributing peptides, reported TIME. According to the Associated Press, at least seven of the members had financial ties to the industry.

The FDA advisory committee’s vote is not a final approval, but a recommendation. Although the FDA typically agrees with the committee, the agency would still have to finalize new regulations, which could “take months or years to draft,” according to the A.P. The PCAC is also expected to vote on recommendations for the other five peptides before February, reports The Washington Post.  

Until the six PCAC-recommended peptides clear the FDA’s next regulatory hurdles, Americans will likely continue to seek out peptide dealers on Discord and online group chats, taking their health into their own hands. The gray market for peptides does not appear to be going away soon, and it will be up to the FDA whether to bring these substances into the mainstream.

The post The Peptide Gray Market Is Already Here. The FDA Is Just Catching Up. appeared first on Reason.com.