Get ready to hear a lot more buzz around peptides, thanks to Robert F. Kennedy Jr. Over the weekend, the health secretary stated that he would soon loosen restrictions on a certain number of these popular, albeit unapproved, drugs.
RFK Jr. announced his plan on the latest Joe Rogan Experience podcast, which aired on Friday. He specifically intends to reverse a previous decision from the Biden-era Food and Drug Administration that restricted nearly two dozen peptides from being produced by compounding pharmacies. The FDA will reportedly consider taking around 14 of these peptides off the banned list, with a formal decision expected in the next few weeks.
“My hope is that they’re going to get moved to a place where people have access from ethical suppliers,” RFK Jr. told Rogan, while also admitting the evidence supporting their use hasn’t been fully gathered.
The emerging era of peptides
Chemically, peptides are any compounds with two or more amino acids chained together by peptide bonds. Practically, though, peptides are considered simple compounds with 50 or fewer amino acids (proteins, meanwhile, are usually large and complex compounds with multiple peptide chains).
The human body produces thousands of peptides, some of which scientists have successfully adapted into medical treatments. These include approved medications like semaglutide (the active ingredient in Ozempic and Wegovy), which mimics the natural hormone glucagon-like peptide-1 (GLP-1). Many more peptides are being studied and even commercially developed as drugs.
In recent years, however, an emerging gray market of sorts has formed around peptides that are still early in development or haven’t been approved yet in countries like the U.S. Wellness influencers, celebrities, and supporters of the Make America Healthy Movement have touted peptides as treatments for anti-aging, better brain health, and weight loss, to name a few.
Some of these peptides can be created by compounding pharmacies, which are typically known for producing custom-made formulations of drugs to help patients with special needs (such as a rare allergy to common drug ingredients). Near the end of the Biden administration, however, the FDA tried to crack down on many of the most popular ones.
In September 2023, the agency made sweeping changes to its bulk drug substances list for compounding. The FDA placed 19 peptides on the Category 2 list, meaning pharmacies could no longer produce these compounds legally. Still other peptides not on the list were flagged for potential concerns.
The messy fight over peptides
In his interview with Rogan, RFK claimed the FDA banned these peptides because they’re not proven to be effective yet, not because they’re necessarily unsafe. This reversal, then, is supposed to put the FDA back on solid regulatory footing.
However, the FDA at the time did list (and still does list) possible safety risks of the peptides banned in 2023. The agency noted that it was aware of several adverse events, including deaths, linked to the use of growth hormone-releasing peptide-2 (GHRP-2), for instance. For others, the agency determined that there was little to no “data in humans to inform safety-related considerations.”
That said, there’s been a simmering fight over these peptides that began even before RFK Jr. took over HHS. Compounding pharmacy trade groups and others have accused the FDA of overreaching in its bans. In lawsuits these groups have filed against the FDA, the plaintiffs are arguing that some peptides have shown enough promise to merit distribution to people with certain medical conditions. They’ve also claimed the FDA was not transparent in making the safety data underlying the bans publicly available. At least some of these lawsuits have reached a settlement.
Kennedy provided another rationale for the reversal. By pulling these peptides away from compounding pharmacies, he argued, some users have instead turned to even less regulated sources on the black market, such as companies that produce them as “research chemicals.”
As is often the case, though, the Trump administration has offered mixed signals on peptide regulation. Earlier this year, for instance, the FDA threatened legal action against Hims for attempting to mass market compounded versions of Novo Nordisk’s Wegovy pill, made with semaglutide (Hims soon pulled back the product). It has also continued to steer the public away from compounded GLP-1s in general, even if, unlike most of the currently banned peptides, these are copycats of actually approved drugs.
Whatever you make of these individual decisions, there should at least be a level of consistency here. And while some of the peptides being unbanned could very well become mainstream medicines in the near future, they remain largely untested for their safety or effectiveness right now.
RFK Jr. looks set to throw open the floodgates for peptides, though he did not name the specific 14 drugs that the FDA will unban during his Rogan interview. But even if you’re buying them from compounded pharmacies, just know there’s a lot more inherent risk involved with these products than you’ll find on your typical drugstore shelves.
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