FDA Reversal on Peptide Ban Under RFK Jr. Sparks Safety Concerns, Say Former Officials

The Food and Drug Administration (FDA) banned 19 peptide drugs from being dispensed by compounding pharmacies in 2023, citing safety risks. Compounding pharmacies mix components of approved drugs to create customized medications for patients who struggle with standard products.

Now, under Health and Human Services Secretary Robert F. Kennedy Jr., the FDA is considering reversing its decision. This potential reversal comes despite minimal clinical studies supporting the safety or effectiveness of these peptides, which are amino acid chains designed to regulate bodily functions. Peptides have gained popularity among fitness and longevity enthusiasts.

In February, Kennedy stated that the FDA’s 2023 decision to categorize the 19 peptides as unsafe was illegal. Speaking on The Joe Rogan Experience podcast, he argued that the FDA lacked a safety signal—evidence of adverse events—to justify the ban. Kennedy, a self-described “big fan” of peptides who has used them himself, said:

“It was illegal because they’re not supposed to do that unless there’s a safety signal. 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.”

However, three former FDA officials familiar with the agency’s 2023 decision strongly disagree. They assert that the ban was based on documented safety concerns and that Kennedy has mischaracterized their work. The officials emphasized that FDA regulations require the agency to assess both safety and effectiveness before approving a substance for compounding.

Janet Woodcock, former acting FDA commissioner, warned that reversing the ban without safety evidence would undermine a decades-old regulatory standard:

“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.”

If the FDA reverses its decision based on the claim that no safety concerns exist, it could falsely imply that more than a dozen unapproved and untested drugs are safe for public use, the officials said.

Since the 2023 ban, there has been little new scientific research on the 19 peptides. However, demand has surged, fueled by social media influencers promoting benefits such as improved physical appearance, accelerated healing, increased energy, and enhanced sexual performance. Ads on Meta platforms claim peptide users can achieve a range of health benefits.

This growing demand has led to a gray market, where wellness spas, multilevel marketers, and telehealth websites sell vials of “research grade” peptides labeled “not for human use.”

Lauren Colenso-Semple, a muscle physiology researcher and science communication specialist, noted the shift in public interest:

“More people want to use them. That’s what’s changed.”

While FDA-approved peptide drugs like insulin and oxytocin have been available for decades, newer peptides such as semaglutide and tirzepatide—used for weight loss and diabetes—have also entered the market.