Peptide peddlers cheer as RFK Jr. unilaterally grants access, overruling FDA

Anti-vaccine Health Secretary Robert F. Kennedy has unilaterally passed a rule that will allow specialty pharmacies to sell six specific peptide drugs, overruling scientists at the Food and Drug Administration.

The peptides are popular among members of Kennedy’s Make America Health Again movement and many prominent MAHA figures and Kennedy allies sell them. Kennedy said he uses some of the peptides and called himself a “big fan.” But FDA scientists continue to say there is insufficient evidence to show if they’re effective and they are potentially dangerous. In 2023, the safety concerns led the FDA to remove the six peptides from a list of drugs that can be made by specialty pharmacies called compounding pharmacies—which make customized formulations of drugs for patients, or, in cases such as this, specialty drugs in bulk.

Kennedy’s new rule sidesteps the need to formally undo that FDA action. The rule is titled “Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances” and was made available Wednesday on the Federal Register, with the final publication data set for October 30. The rule does not change the regulatory status of the peptide; instead, it states the Department of Health and Human Services (HHS) will no longer take enforcement action against compounding pharmacies for making the peptides, essentially giving them a green light to freely produce and sell them. Kennedy had quietly proposed this rule earlier this month.

Questionable rationale

Along with the notice in the Federal Register, HHS also posted a more detailed explanation of the policy today that includes more of Kennedy’s rationale for easing enforcement of the six select peptides, which are: BPC-157, Epitalon, KPV, MOTS-c, Semax, and TB-500.

One reason cited for all the peptides was that an FDA advisory panel voted in July to add these six peptides back to the list of drugs compound pharmacies can make. However, prior to the vote, Kennedy stacked that 12-member committee with eight new members. At least six of Kennedy’s additions have ties to peptide-related businesses and clinics, raising serious conflict-of-interest concerns.

Another explanation for allowing the peptides is that the safety concerns are mainly hypothetical or “inferential” and not based on observed harm in humans. But this is mainly because there are few to no studies involving humans that show either benefits or harms from the peptides.

Still, Kennedy argues in the policy that making the peptides more available through compounding pharmacies will improve safety because it will keep people from buying them on the gray or black market or buying formulas not intended for patient use.

“The Secretary of HHS has determined that this limited enforcement-discretion policy will discourage the continued, widespread use of certain research-use-only peptides supplied by foreign manufacturers that pose a safety risk to US patients,” the HHS policy document states.

Calling the compounded peptides “a more controlled alternative” to illegal versions of the peptides, the document says that “the Secretary has determined that the policy advances patient choice and freedom while appropriately protecting patient safety.”

Responses

Peptide sellers online were quick to celebrate the news. Brigham Buhler, who sells peptides in a wellness clinic he runs, cheered the news on X, thanking Kennedy, President Trump, Calley Means, and Joe Rogan. “Medical freedom just took a major step forward!” he wrote.

Zachary Shurtleff, a marketing executive for a wellness-focused compounding pharmacy, also celebrated, writing, ” Peptides are BACK like they never shoulda left!”

Lee Rosebush, chair of the American Academy of Peptide Medicine, a group formed last year, released a statement thanking Kennedy and the Trump administration for “taking a forward-thinking, evidence-based approach to the regulation of peptides.”

Critics have pushed back, noting that there are already reports of harms from peptides.

In a statement released Tuesday, before the new rule was released, the Center for Science in the Public Interest laid out several reasons why making unproven peptides more accessible is dangerous. For one, reports of harms will “continue to mount,” CSPI said. And if any of the peptides actually showed promise of efficacy, reputable pharmaceutical companies will have less incentive to follow up with thorough clinical trials if the peptide is already widely available. Further, allowing access to peptides based on marketing demand could open the doors for other unapproved products, creating an incentive for illegal sales.

Fred Mills, chief policy officer of Americans for Safe and Effective Medicines (ASEM), said in a statement Wednesday that the new rule “does not resolve problems with untested products, safety risks, questionable ingredients, or misleading claims. In fact, we believe this will worsen what we have already seen—the harms from mass compounding hitting communities hard due to a lack of oversight to rein in bad actors. We need to follow the science, and the reality is that FDA itself has continued to sound the alarm on lackluster data on these peptides. Safety and efficacy aren’t a nice-to-have; they are required.”

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