The U.S. Food and Drug Administration (FDA) recently convened a committee to vote on whether seven different peptides could be compounded by pharmacies. Peptides are short chains of amino acids that play crucial roles in bodily functions, acting as hormones and chemical messengers.
While some peptides, such as GLP-1s and insulin, are FDA-approved and have undergone rigorous safety testing, much of the current public discussion centers on peptides that have not been. These unregulated peptides are often marketed on social media and online with claims of increased muscle growth, longevity, and anti-aging benefits, and are frequently sold with a "research use only" label, allowing sellers to bypass regulatory oversight.
Dr. Kelly Killeen of The Practice Healthcare noted that social media buzz often refers to peptides that are not thoroughly tested or FDA-approved. Examples include the "Wolverine" or "X-Men" protocol, a combination of two unapproved peptides aimed at faster healing, and "glow peptides," popular in medspas for purported anti-aging and scar improvement.
The FDA committee's vote on the seven peptides was largely in favor of allowing them to be compounded, with six receiving a "green light." Compounding pharmacies create customized medications not typically available in retail pharmacies. However, medical experts emphasize that this recommendation does not equate to FDA approval or an endorsement of their safety and efficacy.
Caitlin Dow, a nutrition scientist at the Center for Science in the Public Interest, explained that the meeting was specifically to recommend whether these peptides could be compounded, not whether they are safe for general use or FDA-approved. "This new decision does not mean that the peptides that were voted upon are proven safe or effective. It’s a regulatory classification, not a scientific endorsement," Dow stated.
Dr. Jacinta O. Anyaoku, a family medicine and obesity medicine physician, stressed that a long public rule-making process will follow, and the FDA is not bound by the committee's recommendations. She added that even if compounded, the safety and effectiveness of the molecules themselves remain unknown, as they have not undergone extensive study or clinical trials.
Dr. Abigail Waldman, a dermatologist at Mass General Brigham, indicated that allowing these peptides to be compounded by pharmacies could introduce some checks and balances compared to the current gray market where their contents are unverified. However, she noted that the FDA's stance is to prefer these substances be used under physician and pharmacist supervision rather than acquired online without regulation. This move, she explained, is not an assertion of the drugs' safety or efficacy but a preference for a controlled distribution method.
Despite potential improvements in oversight compared to the current unregulated market, concerns remain. Dow suggested that the FDA's decision might unintentionally expand the market for these peptides, increasing access without corresponding evidence and widening the gap between consumer enthusiasm and scientific certainty. She characterized the situation as "truly the wild west."
Doctors interviewed, including Anyaoku and Killeen, stated they would not recommend non-FDA-approved injectable peptides to patients due to the lack of objective study, unknown dosages, and uncertain side effects. Killeen expressed an inability to, in good conscience, recommend injecting something from dubious sources with insufficient evidence. Anyaoku noted that while she is not against peptides as building blocks for medications, patient safety must remain paramount.
Dr. Jonathan Long, an associate professor of pathology at Stanford University, voiced concerns about safety, highlighting that these peptides have not undergone in-depth safety testing. He predicted that the current situation might persist in a "gray space" where safety and effectiveness remain unclear, potentially leading to regulatory action only after serious adverse events or fatalities, a pattern he has seen historically with unproven medical treatments.
The FDA stated that it will consider the committee's recommendations, consult USP (Unified Submission Portal), and work to issue a proposed rule, with opportunities for public comment before a final rule is published. However, experts like Dow expressed disappointment, viewing the move as potentially prioritizing individualistic solutions over broader public health programs that could benefit more people.