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

WASHINGTON– WASHINGTON — The Food and Drug Administration will hold a meeting this summer to consider easing restrictions on more than a half-dozen peptide injections, a group of unapproved therapies that have become popular among wellness influencers, fitness gurus and celebrities.

The meeting announcement Wednesday follows Health Secretary Robert F. Kennedy Jr.’s repeated pledges to ease regulations on peptides, which are often touted as a quick way to build muscle, heal injuries or look younger. There is little research behind these claims and the safety of most peptides has not been reviewed by the FDA.

Kennedy discussed using peptides for his own injuries. And some major supporters of his Make America Healthy Again movement are big supporters, including Gary Brecka, a self-described “longevity expert” who sells various peptide formulas through his website.

The FDA said in a federal notice Wednesday that it will ask a group of outside pharmaceutical advisers to review seven peptides at a meeting in July, including whether they should be removed from a restrictive category reserved for high-risk personalized drugs.

The drugs contain some of the most popular peptides among influencers, such as BPC-157, which is marketed to heal wounds and reduce inflammation.

Under President Joe Biden, the FDA added more than a dozen of the most popular peptides to the federal list of substances that should not be produced by compounding pharmacies — companies that mix drugs that are not available from drug manufacturers.

At the time, the FDA’s pharmacy advisor panel voted overwhelmingly that peptides did not meet the criteria for a list of drugs that could be compounded safely. And FDA regulators agreed, later saying the substances “pose significant safety risks” because most have not been thoroughly tested on humans.

Many advisors and internal FDA staff who oversaw these decisions no longer work for the agency.

At the FDA’s July meeting, panelists will consider whether BPC-157, TB-500 and five other peptides should be added to a list of substances that can be routinely compounded by pharmacies. The FDA advisory cites several possible medical uses for these substances, such as the use of BPC-157 to treat ulcerative colitis.

Kennedy provided insight into the decision in an interview with podcast host Joe Rogan. Both men spoke about peptides several times and claimed to have benefited from their use.

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

Kennedy said the FDA, under Biden, had “illegally moved” drugs onto the list of banned substances.

Peptides are essentially the building blocks of more complex proteins. Inside the human body, peptides trigger hormones necessary for growth, metabolism and healing.

In recent years, peptides have become widely known thanks to the resounding success of GLP-1 drugs, which the FDA has approved for the treatment of obesity and diabetes. Other FDA-approved peptides include insulin for diabetics and hormone-based medications for several medical conditions.

But many of the peptides promoted online have never been approved, making them technically illegal to market as drugs. Several peptides, such as BPC-157 and TB-500, are banned as doping substances by international sports authorities.

But that hasn’t stopped them from gaining a foothold in the booming market for new wellness hacks and alternative remedies.

Wellness clinics sell in-office injections or IV drips, sometimes for monthly membership fees of several thousand dollars.

Along the same lines, some dietary supplement manufacturers have begun mixing peptides into capsules, protein powders, and gummies. At a recent FDA meeting, the industry advocated for expanding the federal definition of supplements to allow the use of new ingredients like peptides in their products.

When the FDA added a number of injectable peptides to its list of restricted substances in 2023, it cited safety risks including cancer and liver, kidney and heart problems. Pharmacies that violate this measure risk fines, prosecution or the potential loss of their state license.

This sparked a backlash from wellness entrepreneurs, compounding pharmacies and their allies in Washington.

Last year, several members of Congress, including Republican Sen. Tommy Tuberville of Alabama, sent letters to Kennedy asking him to lift limits on peptide production.

The compounding industry has claimed for years that FDA restrictions have given rise to an illicit market for chemicals imported from China and other countries that are not subject to U.S. pharmaceutical standards.

On platforms like TikTok, foreign suppliers offer dozens of varieties of peptides for just $5 a bottle. Products are almost always labeled with the phrase “for research use only.” Lawyers say the language is an attempt to circumvent FDA regulations since the agency does not oversee chemicals that are not intended for human use.

Kennedy echoed the drug industry’s concerns about unintended consequences of FDA regulations.

“With the gray market, you don’t know if you’re getting a good product,” Kennedy told Rogan. “And a lot of the things we looked at are just very, very substandard.”

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