A Food and Drug Administration advisory committee narrowly voted in favor of loosening restrictions on peptides over strong objections from agency career scientists.Subscribe to read this story ad-freeGet unlimited access to ad-free articles and exclusive content.Throughout the daylong meeting, FDA scientists detailed a lack of evidence supporting the use of the peptides along with safety concerns.Over and over again, the FDA came back to a major sticking point: It’s unclear, chemically, what these peptides even are.
In other words, there was no universally accepted chemical formula for each peptide, making it extremely difficult for the FDA to evaluate its use.“We’ve never faced a problem of, ‘What is it?’” Russell Wesdyk, an FDA official, told the panel Thursday morning.
Peptides have surged in popularity in recent years, touted by the wellness industry as well as high-profile figures including Health Secretary Robert F.Kennedy Jr.
and podcaster Joe Rogan.The compounds are promoted for a variety of uses, from anti-aging benefits to better sleep and faster healing.
However, the peptides have largely existed in a “gray market” — they are not FDA-approved drugs but are often bought online from vendors who label them “for research use only,” a legal workaround to sell compounds they claim aren’t meant for humans.Allowing the peptides to be compounded, Kennedy has argued, would move people away from the gray market and toward safer products.On Thursday, the FDA’s Pharmacy Compounding Advisory Committee voted in favor of four peptides: BPC-157, KPV, TB-500 and MOTS-c.
On Friday, the committee will look at emideltide, epitalon and semax.The committee’s votes do not make the peptides FDA-approved drugs.
Instead, they are recommending that the peptides be added to a list of drugs that compounding pharmacies are allowed to make.The final decision will come from the FDA in the form of a rule proposal.Eight panel members were appointed under...