FDA to weigh easing limits on unproven peptides favored by RFK Jr.

WASHINGTON — The Food and Drug Administration announced Wednesday it will convene an outside advisory panel in July to consider whether seven unapproved peptide injections should be cleared for production by compounding pharmacies, and said it will soon remove the substances from its restricted list of high-risk, unapproved drugs. The announcement follows repeated pledges by Health Secretary Robert F. Kennedy Jr. to loosen regulations on peptides, a class of compounds popular among wellness influencers that have not been reviewed for safety by the FDA.

The regulatory shift reverses course from actions taken under the Biden administration, when the FDA added nearly 20 peptides to its restricted list after its own advisory panel voted overwhelmingly that the substances did not meet safety criteria for compounding — citing risks including cancer and organ damage. Critics said the July review lacks independence given Kennedy’s publicly stated personal enthusiasm for the compounds.

Kennedy previewed Wednesday’s announcement in an interview with podcast host Joe Rogan. Both men have repeatedly discussed peptides publicly.

“I’m a big fan of peptides,” Kennedy told Rogan. “I’ve used them myself and with really good effect on a couple of injuries.”

What the FDA announced

The agency said it will ask a panel of outside advisers to review seven peptides at a July meeting, specifically whether they should be added to a list of substances that can be safely produced by compounding pharmacies — businesses that mix medications not available from drugmakers. The FDA also said it will remove the peptides from its restricted list before that meeting takes place.

The peptides under review include BPC-157, which is marketed to heal injuries and reduce inflammation, and is among the most widely promoted by wellness influencers. BPC-157 and TB-500, another compound on the list, are banned by international sports authorities as doping substances.

Most peptides promoted online have never been approved by the FDA, making them technically illegal to market as drugs.

Prior regulatory findings reversed

Under President Biden, the FDA moved to restrict the compounds. When the agency added injectable peptides to its restricted list in 2023, it cited safety risks including cancer and liver, kidney, and heart problems. The FDA’s pharmacy advisory panel voted overwhelmingly at the time that the substances did not meet the criteria for safe compounding, and FDA regulators subsequently said the compounds “present significant safety risks” because most have not been extensively tested in humans.

Many of the FDA advisers and internal staff who oversaw those decisions no longer work for the agency. The FDA’s pharmacy panel currently has vacancies that Kennedy could fill before the July meeting.

Critics question independence of review

Dr. Peter Lurie, a former FDA official who now leads the Center for Science in the Public Interest, said the move threatened the agency’s core function.

“The Wild West is about to become wilder,” Lurie said. He described allowing peptides on the market without clinical testing as a “profound threat” to the FDA’s decades-old system for vetting drugs.

Lurie said he did not believe the advisory review would constitute an honest evaluation.

“Everybody knows the outcome that the secretary wants,” he said. “I don’t believe for one moment that what’s going on here is an honest investigation of whether these products should be compounded.”

Dr. Eric Topol of Scripps Research Translational Institute said the shift alarmed him.

“I think this is a disaster in the works,” Topol said. “These peptides have no data to support their safety and efficacy.”

Political and industry context

Republican Sen. Tommy Tuberville of Alabama was among members of Congress who sent letters to Kennedy last year asking him to lift limits on peptide production. Gary Brecka, a self-described longevity expert and prominent supporter of Kennedy’s Make America Healthy Again movement, sells various peptide formulas through his website.

Some in the compounding industry have argued that FDA restrictions fueled an illicit market of imported peptide chemicals from China and other countries not subject to U.S. drug standards. Kennedy echoed that argument in his Rogan interview.

“With the gray market you have no idea if you’re getting a good product,” Kennedy said. “And a lot of this stuff that we’ve looked at is just very, very substandard.”

Scott Brunner of the Alliance for Pharmacy Compounding said Wednesday’s announcement would mark the start of a “protracted process.” Even if the advisory panel recommends making the peptides available and the FDA agrees, the agency would still have to draft and publish rules to implement any change, Brunner noted.