Unproven Peptides Need More Regulation, AMA Delegates Say

The FDA must do a better job of regulating unproven peptides, members of the American Medical Association (AMA) House of Delegates said Monday.

At their annual meeting, the delegates passed a resolution directing the AMA to support “appropriate FDA oversight of synthetic peptides, recommending that unapproved synthetic peptide products undergo regulatory review, third-party testing, and demonstration of safety and efficacy through well-conducted clinical trials before marketing or clinical use.”

Millions of Americans are currently injecting the unapproved chemicals, promoted by wellness influencers and podcasters like Joe Rogan for everything from wound healing to longevity.

“We have seen clear benefit from peptide medications that have undergone rigorous scientific review, like insulin and GLP-1s,” said Christopher Wong, MD, MSc, of Houston, during debates about the resolution.

But a new generation of synthetic peptides — including BPC-157 and GHK-Cu — “have flooded the consumer market without any substantive clinical trials or safety oversight, promising such benefits as tissue repair and even treatment of ulcerative colitis,” said Wong, who represented the AMA’s Resident and Fellow Section that introduced the resolution.

The FDA appears to have shifted its stance on the unapproved chemicals under Health Secretary Robert F. Kennedy Jr., who has said that he wants to lift the current restrictions on the compounding of peptides. Kennedy has argued that the restrictions create a “very dangerous” black market for the substances, and FDA officials recently met with dietary supplement manufacturers seeking to include the chemicals in their products.

“People are injecting these things with impunity, allegedly for obesity, allegedly for wellness and ‘longevity’ — whatever the heck that means,” said Jennifer Hone, MD, of Santa Barbara, California. “I think unproved substances need to be stated as not studied and not effective or safe until they have in fact been studied, and shouldn’t be injected until that happens.”

Wong said the resolution would help “separate the science from the snake oil.”

The FDA’s Pharmacy Compounding Advisory Committee (PCAC) is scheduled to meet on July 23-24 to review several synthetic peptide products, with presentations expected to discuss their use for ulcerative colitis, wound healing and inflammatory conditions, osteoporosis, opioid withdrawal, insomnia, narcolepsy, cerebral ischemia, migraine, and trigeminal neuralgia.

“We have seen so many patients coming to us asking us about whether we should use these peptides, and a lot of them have started using them without physician oversight or safety supervision,” Wong said. “Pesticides have been found in some of these peptides advertised for weight loss … This is the time to uphold our commitment to patient safety, while supporting rigorous scientific review of these peptides.”

Some delegates called for further discussion of the topic.

“This is an incredibly complex topic, and it really needs some time to be studied,” said Jennifer Paisley, MD, of Lawrenceburg, Indiana, who spoke on behalf of the Obesity Medicine Association and disclosed being a paid speaker for Novo Nordisk and Eli Lilly.

Eugene Sherman, MD, a cardiologist in Englewood, Colorado, warned how that might look. “The podcasters will pick up on the fact that the American Medical Association discussed this topic and decided to study it rather than speak out against these unapproved peptides,” he said.

The resolution also calls for the AMA to submit a letter to the FDA’s PCAC “advocating for evidence-based regulatory oversight, third-party testing, and demonstration of safety and efficacy prior to marketing, compounding, or clinical use.”

But Seemal Desai, MD, of Frisco, Texas, who served on the PCAC for 8 years, told the delegates that the advisory committee was not the right place to send the letter and that the FDA commissioner would be more appropriate. As the committee only looks at individual peptides, “PCAC is not going to review a blanket letter on a topic,” he said.