Get ready to hear a lot more buzz around peptides, thanks to Robert F. Kennedy Jr. At the end of the week, the secretary of health declared that soon he will remove the restrictions on a certain number of these popular, although not approved, drugs.

RFK Jr. Office has partnered his plan on the latest Joe Rogan Experience podcast, which aired last Friday. He specifically intended to reverse a previous decision from the Biden-era Food and Drug Administration that prevented nearly two dozen peptides from being developed into prescription drugs. The FDA will reportedly consider removing 14 of these peptides from the banned list, with a formal decision expected in the next few weeks.

“My hope is that they will be moved to a place where people have access to ethical suppliers,” RFK Jr. said.

The emerging era of peptides

Chemically, peptides are any compounds that contain two or more amino acids joined by peptide bonds. In practice, however, peptides are considered simple compounds with 50 or fewer amino acids (proteins, meanwhile, are usually large and complex compounds with many peptide chains).

The human body produces thousands of peptides, some of which have been successfully adapted by scientists in medical treatments. These include approved drugs such as 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 produced as drugs.

In recent years, however, there has been a growing trend towards a gray market. turned around peptides that are still in development or not yet approved in countries like the US Wellness influencers, celebrities, and supporters of the Make America Healthy Movement honored 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 generally known for creating 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 dismantle many of the most prominent ones.

In September 2023, the agency made several changes to the list of drug substances for compounding. The FDA has placed 19 peptides in the List of category 2, meaning that pharmacies can no longer make these compounds legally. Some peptides are not listed libel suit for possible concerns.

The chaotic battle of peptides

In his interview with Rogan, RFK admitted that the FDA banned these peptides because they had not been proven effective, not because they were necessarily unsafe. This change, then, should put the FDA back on solid regulatory footing.

However, the FDA at that time listed (and still lists) the potential safety risks of peptides that will be banned in 2023. The agency noted that it knew of many adverse events, including deaths, linked to the use of growth hormone-releasing peptide-2 (GHRP-2), for example. For others, the agency determined that there was little or no “population data to inform safety-related considerations.”

That said, there was a simmering fight over these peptides that started even before RFK Jr. Compounding pharmacy trade groups and others have accused the FDA overreaches its restrictions. In the lawsuits filed by these groups against the FDA, the plaintiffs argued that certain peptides showed enough promise to warrant distribution to people with certain medical conditions. They also claim that the FDA is not transparent in making safety data subject to restrictions available to the public. At least some of these cases have reached a SETTLEMENT.

Kennedy gave another reason for the change. By pulling these peptides from compounding pharmacies, he argues, some users are instead turning to less regulated sources on the black market, such as companies that make them “research chemicals.”

As is often the case, however, the Trump administration has offered mixed signals on peptide regulation. Earlier this year, for example, the FDA threatened legal action against Hims for testing mass market compounded versions of Novo Nordisk’s Wegovy pill, made with semaglutide (Hims later withdrew the product). It also continues to distance the public from GLP-1 compounds in general, even though, unlike most of the currently banned peptides, they are copies of actual approved drugs.

Whatever you do with these individual decisions, there should be at least some level of consistency here. And while some of the off-label peptides may become mainstream drugs in the near future, they remain untested for their safety or effectiveness at present.

RFK Jr. looks to open the floodgates for peptides, though he didn’t name the specific 14 drugs the FDA will remove in his interview with Rogan. But even if you buy them from compounding pharmacies, know that there are more inherent risks associated with these products than you’ll find on your usual drugstore shelves.