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

The Food and Drug Administration plans to convene a meeting this summer to consider relaxing restrictions on several peptide injections, a class of unapproved treatments that have gained popularity among wellness influencers, fitness personalities, and celebrities.

Wednesday’s announcement follows consistent promises by Health Secretary Robert F. Kennedy Jr. to ease regulations on peptides, which are frequently marketed as solutions for muscle development, injury recovery, and anti-aging. Most of these claims lack substantial scientific backing, and the FDA has not reviewed the majority of these peptides for safety.

Kennedy himself has openly discussed using peptides to treat his own injuries. Several prominent supporters of his Make America Healthy Again movement actively promote these substances, including Gary Brecka, a self-proclaimed “longevity expert” who markets various peptide formulations through his website.

According to the federal notice issued Wednesday, the FDA will ask a panel of external advisers to evaluate seven specific peptides during a July meeting. The panel will consider whether these substances should be added to a list of compounds that pharmacies can safely produce. In the interim, the agency stated it would soon remove these chemicals from a restrictive list reserved for unapproved, high-risk drugs. Among the peptides under consideration is BPC-157, one of the most widely promoted peptides claimed to heal injuries and reduce inflammation.

“The Wild West is about to become wilder,” warned Dr. Peter Lurie, a former FDA official who now leads the Center for Science in the Public Interest. In an interview, he expressed concern that allowing peptides onto the market without clinical testing represents a “profound threat” to the FDA’s decades-old drug evaluation system. “I don’t see why one would take the path of a proper drug approval if there is now this less rigorous, alternative path to market,” he added.

Under President Biden’s administration, the FDA added nearly 20 peptides to the federal list of substances that should not be produced by compounding pharmacies – businesses that create custom medications not commercially available from pharmaceutical manufacturers. At that time, the FDA’s pharmacy advisory panel voted overwhelmingly that these peptides failed to meet the criteria for substances that could be safely compounded. FDA regulators concurred, later stating that the substances “present significant safety risks” because most lack extensive human testing.

Many of the FDA advisers and internal staff involved in those earlier decisions no longer work at the agency. The FDA’s pharmacy panel currently has several vacancies, which Kennedy could potentially fill before the July meeting.

Kennedy previewed Wednesday’s announcement during an interview with podcast host Joe Rogan. Both men have spoken extensively about peptides and claimed personal benefits from their use. “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.”

Given Kennedy’s public statements, Lurie expressed skepticism about whether these drugs would receive genuine scrutiny from the FDA. “Everybody knows the outcome that the secretary wants,” Lurie 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.”

Scott Brunner of the Alliance for Pharmacy Compounding described the upcoming meeting as the beginning of a “protracted process.” He noted that even if the panel votes to make the peptides available and the FDA agrees, the agency would still need to draft and publish rules implementing the change.

Peptides essentially function as building blocks for more complex proteins. Within the human body, they trigger hormones necessary for growth, metabolism, and healing. In recent years, peptides have gained widespread recognition through the extraordinary success of GLP-1 medications, which the FDA has approved for treating obesity and diabetes. Other FDA-approved peptides include insulin for diabetics and hormone-based drugs for various medical conditions.

However, many peptides promoted online have never received FDA approval, making them technically illegal to market as drugs. Several, including BPC-157 and TB-500, are prohibited by international sports authorities as doping substances.

This has not prevented them from establishing a foothold in the growing marketplace for wellness innovations and alternative remedies. “I think this is a disaster in the works,” said Dr. Eric Topol of Scripps Research Translational Institute, who has studied the issue. “These peptides have no data to support their safety and efficacy.”

Meanwhile, some dietary supplement manufacturers have begun incorporating peptides into capsules, protein powders, and gummies. At a recent FDA meeting, industry representatives advocated for expanding the federal definition of supplements to allow newer ingredients like peptides in their products.

When the FDA added numerous injectable peptides to its list of restricted substances in 2023, it cited safety concerns including cancer and liver, kidney, and heart problems. This decision prompted pushback from wellness entrepreneurs, compounding pharmacies, and their political allies in Washington.

Last year, several members of Congress, including Republican Senator Tommy Tuberville of Alabama, sent letters to Kennedy requesting that he lift restrictions on peptide production. Some in the compounding industry argue that FDA’s limitations have fostered an illicit market of imported chemicals from China and other countries not subject to U.S. drug standards.

Kennedy has expressed similar concerns about unregulated products. “With the gray market you have no idea if you’re getting a good product,” Kennedy told Rogan. “And a lot of this stuff that we’ve looked at is just very, very substandard.”