Health Secretary Robert F. Kennedy Jr. is temporarily allowing six unapproved peptides on the market, despite warnings from government scientists that there is not enough evidence to prove they are safe or effective.
In a policy released Wednesday, Kennedy said his department would no longer stop compounding pharmacies from distributing a handful of widely used peptides. The Food and Drug Administration is deciding whether to officially allow them to be compounded -- a decision that could take months or even longer. The new policy could make it more difficult for the FDA to restrict peptides in the future.
Many FDA staff aren't supportive of Kennedy's latest decision to lift restrictions on peptides, according to two sources familiar with the development.
Peptides are marketed for everything from muscle building to recovery and medically for conditions like ulcerative colitis and insomnia. They are widely promoted through social media and sold online and at med spas. None of the buzzy peptides have gone through the FDA approval process. Much of the evidence supporting their purported benefits in humans is anecdotal.
Before this new policy, the FDA didn't allow compounding of these peptides in part because of safety concerns.
Kennedy, who has used peptides himself, has been a proponent of the treatments, saying he wants to make peptides broadly accessible to Americans.
"There is significant interest in the use of these peptides," Kennedy said in a memo accompanying the new policy, which he said was designed to "expand and improve patient access."
An FDA spokesperson said the new policy is designed to help the health department confront the risks of black-market peptides by allowing legitimate compounders to produce these drugs with more oversight than had been the case previously.
Patient-safety and pharmaceutical industry groups criticized the agency for allowing peptides with limited data on the market.
"Safety and efficacy aren't a nice-to-have; they are required," wrote Fred Mills, the chief policy officer of Americans for Safe and Effective Medicines in a statement. "American consumers should not be treated like guinea pigs."
The six peptides are BPC-157, Epitalon, KPV, MOTS-c, Semax, and TB-500, which are marketed for antiaging, boosting metabolism and improving memory, among other things. Earlier this year, the FDA's Pharmacy Compounding Advisory Committee voted in favor of easing restrictions on the peptides, despite warnings from career scientists. Many of the committee members were selected on Kennedy's watch, and some had ties to peptide businesses.
The interim policy is expected to lead to a boom in peptide sales, with major telehealth companies including Hims & Hers and Noom considering or planning to expand the list of peptides they offer. Leerink analysts have estimated that with legalization, the peptide business for telehealth companies could reach $2 billion a year.
A person familiar with policymakers' thinking said millions more patients using the substances could make banning them much more difficult in later rule making. The FDA didn't immediately respond to a request for comment about that.
HHS pushed out the policy six days before the midterm elections and days after podcaster Joe Rogan criticized the Trump administration for moving too slowly on Make America Healthy Again efforts.
"Peptides was supposed to be done two years ago," Rogan said on his podcast last week. "All this stuff was supposed to happen a long time ago." FDA scientists have warned there isn't evidence that peptides actually do what their marketing promises. They said it is often difficult to tell even what is in the peptides because of inconsistent labeling and manufacturing. Regulators have previously raised concerns about potential immune reactions and impurities.
The proposed policy would require compounding pharmacies to follow certain testing and manufacturing standards, as well as report serious adverse events to the FDA, even when they don't believe the peptide caused them. Traditional compounders haven't generally been required to report side effects in the past, so this could help answer some questions about how safe peptides are. Peptide company executives and trade groups cheered the news Wednesday, publicly thanking Kennedy and President Trump for what they say is a win for patient control over their medical care.
"This is so much bigger than peptides. This is about medical freedom," said Brigham Buhler, the co-founder of a compounding pharmacy and telehealth company that sells peptides.
The policy isn't a final FDA rule or approval, and it could be revised or abandoned. A public comment period is expected to take place in November. A spokeswoman for the agency didn't clarify when the policy would go into effect.
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