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Ex-FDA officials say RFK Jr. is mischaracterizing their work as he looks to reverse peptide ban

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04.04.2026

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Ex-FDA officials say RFK Jr. is mischaracterizing their work as he looks to reverse peptide ban

FDA's 2023 decision to place 19 peptides on “unsafe” list was supported by numerous documented safety concerns

Published April 4, 2026 6:00AM (EDT)

This article originally appeared on ProPublica.

Just under three years ago, the Food and Drug Administration deemed 19 peptide drugs too unsafe to be dispensed by compounding pharmacies, which mix components of approved drugs to create bespoke medication for people who have trouble taking commonly available products.

Now, under Health and Human Services Secretary Robert F. Kennedy Jr., the agency is poised to reverse itself. That’s despite few clinical studies supporting the effectiveness or safety of these peptides, which are amino acid chains meant to help regulate functions in the body and have become popular among fitness and longevity enthusiasts.

In February, Kennedy said the FDA acted illegally in 2023 when it categorized 19 peptides as too unsafe for compounders, whose final products aren’t tested or approved by the FDA. Kennedy, who described himself as a “big fan” of peptides, has used the therapies himself.

“It was illegal because they’re not supposed to do that unless there’s a safety signal,” Kennedy said on “The Joe Rogan Experience” podcast, referring to adverse events related to medications. “And they didn’t have a safety signal. They’re not allowed to look at efficacy. They’re not allowed to say, ‘Well, we don’t believe these are efficacious,’ or whatever. They can only look at safety.”

But three former FDA officials closely familiar with how the agency created the criteria to assess the peptides in the first place say Kennedy has mischaracterized their work. The agency’s 2023 decision to ban certain peptides was supported by numerous documented safety concerns, they said. FDA regulations also require the agency to assess both safety and effectiveness before approving a substance for compounding.

“It would be a disruption of the societal pact we have had since 1962 that drugs will be studied to see if they work before they are marketed in the U.S.,” said Janet Woodcock, a former FDA acting commissioner.

If Kennedy justifies reversal of the previous work by suggesting there were no safety concerns, it would give a false imprimatur of safety to more than a dozen unapproved, untested drugs, the officials said.

There’s been little new science on the 19 peptides since the FDA’s 2023 decision to categorize them as unsafe. But demand for the drugs has exploded as influencers have flooded social media with promises of sculpted physiques, glowing skin, luscious hair, rapidly healing injuries, youthful energy and blazing sex lives.

The demand has given rise to a burgeoning gray market, where wellness spas, multilevel marketers and telehealth websites ply the public with vials of “research grade” peptides labeled “not for human use.”

“More people want to use them,” said Lauren Colenso-Semple, a muscle physiology researcher and science communication specialist who........

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