FDA Panel Makes 'Alarming' Move on Peptides

A panel of federal health advisers on Thursday narrowly recommended easing access to several peptides popular with wellness influencers and celebrities, despite warnings from government scientists that the chemicals haven't been shown to be safe or effective. In a series of votes, outside experts advised the Food and Drug Administration to drop current restrictions barring pharmacies from producing injectable peptides with names including BPC-157, TB-500 and KPV, the AP reports.

• RFK Jr. is a "big fan." The panel's vote is not binding but is likely to embolden Health Secretary Robert F. Kennedy Jr., who has described himself as a "big fan" of peptides and vowed to overturn FDA restrictions put in place under Joe Biden.

• The vote was close. Across several votes, the panelists voted 8-6, with one abstention, in favor of putting the peptides on the FDA's list of substances considered safe for pharmacy compounding. If the FDA follows that advice, telehealth companies are expected to ramp up marketing of the chemicals for wellness and cosmetic uses.
• Industry connections. Thursday's vote tally reflected the unusual makeup of the panel. Prior to the meeting, more than a half-dozen people with connections to the peptide industry were added to the group, including doctors, pharmacists, or consultants who work in the field. "I think we have seen an extraordinary abuse of the advisory committee process to secure ends that have no basis in science," said Dr. Peter Lurie, president of the Center for Science in the Public Interest, per the New York Times. Six of the eight new members have sold peptide products, according to the Times. The panel will vote Friday on three more peptides. The FDA isn't required to follow the group's advice, though it usually does.
• FDA scientists remain unconvinced of safety, benefits. The positive votes came despite highly critical reviews from FDA staff scientists, who said there was little data that BPC-157, TB-500 and the other chemicals can be safely used for medical purposes. Panel members with backgrounds in academia, rather than peptides, mostly voted against the substances, which are widely advertised on social media. "I'm concerned we're responding to a market-induced demand rather than a decision based in solid science," said Dr. Elizabeth Rebello of the University of Texas MD Anderson Center.

• Marketplace is a "Wild West." Peptide supporters include podcaster Joe Rogan and longevity influencers such as Gary Brecka, a supporter of Kennedy's "Make America Healthy Again" agenda who sells peptides through his website. But medical experts describe the marketplace as a "Wild West" of unproven, unregulated drugs that could cause serious harm, including infection, allergic reactions, or other problems. "This is really alarming," said Rita Jew, a pharmacist and president of the Institute for Safe Medication Practices, told the AP ahead of the meeting. "There aren't that many other substances people are injecting into themselves where you see that the clinical evidence is so lacking." In recent years, the FDA has warned Americans about the risks of injecting peptides like BPC-157 and TB-500. In 2023, both were placed on a list of substances considered to be too high-risk for pharmacy compounding. But Kennedy announced their removal from that list earlier this year.
• Most peptides are sold for unproven uses. Peptides are the building blocks of more complex proteins, triggering hormones inside the body needed for growth, metabolism, and healing. Drug companies have brought several to market as medications, including mainstay treatments for diabetes and weight loss. But most peptides sold online are promoted for unproven uses, often combined in "stacks," to purportedly heal injuries, build muscle, rejuvenate skin, or increase energy. FDA scientists said they could find little data on the effectiveness of peptides for proposed medical uses like ulcerative colitis, wound healing and opioid addiction. Five studies of BPC-157 reviewed by the agency "were of short duration, had small sample sizes and evaluated doses that were likely exploratory in nature," the staffers said. For TB-500, regulators said they could not find any human studies using the compound.
• Next steps. FDA-watchers say the most likely outcome may be a temporary policy reassuring pharmacies that they won't be targeted for compounding the peptides under review. Formally placing the substances on FDA's list of drugs that are safe for compounding would require new regulations, which can take months or years to draft. "We're still going through this process, but I think it's more than likely that the process will end up at the result that Secretary Kennedy wants," says Nathan Beaver, an attorney specializing in FDA issues.