FDA Committee Votes in Favor of Several Popular and Controversial Peptides
It’s still up to the FDA to decide whether to greenlight the substances for compounding pharmacies to make—and pave the way for a peptide gold rush
Biohackers, longevity enthusiasts and alternative medicine doctors want the peptide BPC-157. Now compounders may be one step closer to lawfully providing it.
At a series of hearings on Thursday and Friday, the Food and Drug Administration’s Pharmacy Compounding Advisory Committee voted in favor of easing restrictions on five out of six peptides up for consideration, with votes on one more peptide still to go. After the hearings conclude, it will be up to the FDA to decide whether to greenlight the substances for compounders to make—and pave the way for a peptide gold rush.
Today the term “peptides” often refers to a category of injectable substances that promise physical transformations and haven’t undergone regulatory approval. On social media, influencers, alternative medicine doctors and everyday people have promoted them for everything from muscle recovery to more youthful skin. These peptides are largely sold through an online gray market, where they’re labeled “for research use only” or “not for human consumption.” Health Secretary Robert F. Kennedy Jr. has advocated for loosening restrictions on the substances.
The rise of peptides has been controversial. Doctors have cited health risks, and the substances have not been studied extensively. Some compounders have already begun making the drugs despite FDA restrictions. Should the FDA decide to authorize the peptides for compounding, there would be more regulatory oversight. What remains unclear is whether that will make them safer.
At the hearing, committee members—including pharmacists, doctors, clinic owners, academics and regulatory experts—evaluated each peptide. Some of the committee members had ties to peptide businesses. The FDA generally follows advisory committee recommendations but has no obligation to do so.
The FDA’s career scientists recommended against greenlighting any of the peptides on the list, which come in formulations including injections, nasal sprays and topical creams. They cited the limited clinical studies and a lack of evidence indicating their effectiveness. Because of inconsistent chemical descriptions and names, they argued that it is impossible to know exactly which substances are being compounded. They also stated that there are FDA drugs approved for the same conditions being evaluated.
Last year, two women became critically ill at a longevity conference in Las Vegas after they received peptide injections at a booth. An investigation was unable to conclude exactly why the women became ill, but regulators in Nevada fined the doctor, who wasn’t licensed in their state, along with two other people in connection with the incident. A letter to the doctor from the Nevada State Board of Pharmacy said one of the “peptide cocktails” was believed to contain BPC-157 and MOTS-c, two peptides the FDA committee voted in favor of.
Along with voting in favor of the popular BPC-157, the committee also approved TB-500. BPC-157 was evaluated for use in ulcerative colitis and TB-500 for wound-healing. The two are often sold together online and called “the Wolverine Stack,” with claims it can help with everything from muscle and tissue repair to reduced inflammation. Joe Rogan called the combination of the two peptides “f—ing phenomenal” on his popular podcast. The committee also voted favorably for the peptides KPV, MOTS-c and Epitalon.
The committee voted against one peptide called Emideltide, evaluated for opioid withdrawal, chronic insomnia, and narcolepsy. David Pope, a pharmacist who voted affirmatively for other peptides, voted “no” on this one, citing a complex regimen and “potentially dangerous downstream consequences.”
Proponents argued that creating an accessible pathway for peptides would help doctors, patients and regulators gather more evidence about whether or not they work. Some patients said the gray-market products had helped them when the traditional medical system didn’t.
Under current regulations, compounders are not required to report serious negative side effects associated with compounded drug products to the FDA. FDA officials said the agency does not have the authority to require it in this case.
Scott Brunner, chief executive of compounding industry group the Alliance for Pharmacy Compounding, who spoke in support of peptides, said in an interview that adverse-event reporting should be required.
“There is not the sort of substantive safety data for these drugs that FDA would normally require,” he said. “The moment that we’re in is rather extraordinary, and it calls for a special approach.”