It won't take action against compounding pharmacies that make popular wellness products like BPC-157 and TB-500
It's been illegal since 2023 for compounding pharmacies to make certain peptides that are commonly used for health and wellness reasons.
The Trump administration is allowing peptides like BPC-157 and TB-500 to be produced in the U.S. in a move that will widen access for Americans who want to take the controversial wellness products.
On Wednesday, regulators disclosed that the government won't penalize compounding pharmacies that produce the six peptides reviewed by the FDA's advisory committee in July: BPC-157, Epitalon, KPV, MOTS-c, Semax and TB-500.
These popular products are used for a variety of reasons, including to speed up muscle recovery and wound healing, improve sleep or help people lose weight.
The interim policy doesn't change the fact that peptides haven't been approved by the Food and Drug Administration. That's a key concern for critics, who say that the majority of Americans don't understand the difference between a change to an obscure compounding rule and the assurance of safety that comes with an FDA approval.
"Legally compounded arsenic is still arsenic," said Shabbir Safdar, executive director of the Partnership for Safe Medicines, which represents the interests of the pharmaceutical and pharmacy sectors.
The push to legalize production of 14 peptides was started by Robert F. Kennedy Jr., the top health official in the U.S. and de facto leader of the Make America Healthy Again movement. It's meant to reverse an FDA decision in 2023 that made it illegal to compound these products. At the time, the regulator had raised safety concerns.
Peptide-based drugs are common in medicine; insulin is a peptide, so are GLP-1 drugs like Novo Nordisk's (NVO) (DK:NOVO.B) Wegovy and retatrutide, Eli Lilly's (LLY) experimental weight-loss injection.
The peptides being discussed are different. Even though some were discovered in scientific labs and tested in animals, none have gone through rigorous clinical trials in the U.S. One of the six peptides is cleared for use in Russia. But they still remain popular among Americans, particularly those who are interested in fitness and wellness. Kennedy says he takes peptides, and so does the podcaster Joe Rogan. During a recent interview with the financial influencer Haley Sacks, who is known as Mrs. Dow Jones, the plastic surgeon Ryan Neinstein said he prescribes them to patients.
"These products have been used for years by consumers," said Jeff Cohen, co-founder of the American Peptide Association, this summer. "It only got into the public consciousness because of the GLP-1 issue, raising the bigger issue of peptides and exposing what had been going on for years, which is [when] consumers began to take responsibility for their own wellness."
Earlier this year, Kennedy announced that a group of advisers would assess 14 peptides and then make a recommendation to the FDA about whether they should be allowed to be compounded.
Before the first meeting of the advisers in July, the committee was restructured by Kennedy to include several experts with financial ties to the peptide business. The advisers ended up voting in favor of reclassifying six of seven peptides, even though the FDA's own staff recommended against doing so. That's something that's happened in the past, though it's rare.
The next FDA advisory meeting is scheduled for February. In the meantime, the Office of Management and Budget this month began reviewing the interim policy and took several meetings with organizations like the Center for Science in the Public Interest, which has described peptides as a "profound threat," and companies such as Hims & Hers Health, which plans to sell peptides.
Its stock (HIMS) was up 2.8% on Wednesday after the policy was issued. A broader review of whether the peptides should be formally reclassified is still underway.
-Jaimy Lee
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