A panel of advisers partially appointed by Health Secretary Robert F. Kennedy Jr. is recommending the government expand access to six peptides not approved by the Food and Drug Administration.
If the FDA accepts the Pharmacy Compounding Advisory Committee’s recommendations — which is at odds with recommendations by its own scientists — select pharmacies could start using these typically gray-market substances in the specialized medications they create for customers, something that is currently illegal.
An FDA spokesperson said Friday that the agency “appreciates” the panel’s recommendations and will propose a rule the public can comment on, but didn’t provide a timeline. The FDA doesn’t have to accept the panel’s recommendations but it usually does.
Peptides, which are typically injected, are chains of amino acids that serve as the building blocks of protein. Some peptides, including insulin and GLP-1 weight-loss drugs, have been heavily studied and approved by the FDA for years.
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The peptides the panel recommended are currently marketed for ulcerative colitis, migraines, pain, wound healing, anti-aging, memory and stroke recovery.
Kennedy, who is a fan of the injections touted by online wellness influencers for a range of health benefits, appointed eight of the panel’s 19 members, all of whom voted to expand access to peptides. Six of those members run clinics that sell peptides.
The meeting over Thursday and Friday attracted unusual attention as the latest illustration of tension between the ballooning wellness industry — which largely views Kennedy as an ally — and government scientists and mainstream medical experts who tend to be more wary of products not approved by the FDA.
“The committee weighed the evidence, followed the science and stood up for medical freedom,” said Lee Rosebush, chair of the American Academy of Peptide Medicine.
The panel did vote 7-6 against recommending one peptide, emideltide, which is believed to promote sleep.
An FDA official said the agency was recommending against the peptide due to “a lack of data to support safety in these substances when used in humans.” FDA officials also recommended against approving the other peptides, stressing they haven’t been studied enough.
That concern was echoed by panel members who voted against recommending the peptides. One member, Todd Durham, cited “low-quality evidence around efficacy and the fact there are approved medical therapies for all the proposed uses.”
But Kennedy appointees who sell peptides stressed anecdotal evidence that they’re beneficial.
“There’s been a mismatch in real-world data versus evidence,” said Gabriel Alizaidy, who works for a telehealth company that sells growth-hormone peptides.
A broad array of other peptides without FDA approval are booming in the United States, promoted by social media influencers touting a broad range of health benefits including speeding healing, improving skin or boosting athletic performance.
Kennedy told podcaster Joe Rogan in February that he was “very anxious” to make peptides more accessible to people from ethical suppliers.
“I’ve used peptides myself and used them to really good effect on a couple of injuries,” Kennedy said.
Access to the six peptides would dramatically expand if the FDA approves them for use by compounding pharmacies, which create customized medications on-site by mixing raw ingredients to fit a specific patient’s health needs.
People often buy unapproved peptides from vendors who label them “for research use only” or websites that source from China, creating safety concerns peptide advocates say could be alleviated by adding them to the list of substances U.S. compounding pharmacies can use.
The American Medical Association has said unapproved peptides should undergo regulatory review by the FDA and third-party testing “to demonstrate their safety and efficacy before marketing or clinical use.”
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