FDA to weigh easing limits on unproven peptides favored by RFK Jr. and other MAHA figures

WASHINGTON (AP) — 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 repeated pledges by Health Secretary Robert F. Kennedy Jr. to loosen regulations on peptides, which are often pitched as a quick way to build muscle, heal injuries or appear younger. There’s little research behind those claims and most peptides have not been reviewed for safety by the FDA.

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

The FDA said in a federal notice Wednesday it will ask a panel of outside pharmacy advisers to review seven peptides at a meeting in July, specifically whether they should be moved from a restrictive category reserved for risky, customized drugs.

The drugs include some of the most popular peptides among influencers, such as BPC-157, which is marketed to heal injuries 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 — businesses that mix medications that aren’t available from drugmakers.

At the time, the FDA’s panel of pharmacy advisers voted overwhelmingly that the peptides did not meet the criteria for a list of drugs that can be safely compounded. And FDA regulators agreed, saying later that the substances “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.

At the FDA meeting in July, 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 notice cites several possible medical uses for the substances, such as using BPC-157 to treat ulcerative colitis.

Kennedy previewed the move in an interview with podcast host Joe Rogan. Both men have repeatedly spoken about peptides and claimed to have benefited from their use.

RFK Jr. claims personal benefit from peptides

“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.”

Kennedy said the FDA under Biden had “illegally moved” the drugs onto the list of substances that are barred for compounding.

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

In recent years peptides have become widely known through the blockbuster 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 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 by international sports authorities as doping substances.

But that has not stopped them from gaining a foothold in the burgeoning marketplace for new wellness hacks and alternative remedies.

Wellness clinics sell in-office injections or IV infusions, sometimes with monthly membership fees of thousands of dollars.

In a related move, some dietary supplement makers have begun mixing peptides into capsules, protein powders and gummies. At a recent FDA meeting, the industry argued for expanding the federal definition of supplements to permit the use of newer 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 violating the measure risk fines, legal action or potential loss of their state licenses.

That triggered pushback 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 argued for years that FDA’s restrictions have given rise to an illicit market of imported chemicals from China and other countries, which are not subject to U.S. drug standards.

On platforms like TikTok, overseas suppliers offer dozens of peptide varieties for as little as $5 a vial. The products are nearly always labeled with the phrase “for research use only.” Lawyers say the wording is an attempt to skirt FDA regulations since the agency does not oversee chemicals that aren’t intended for human use.

Kennedy has echoed the compounding industry’s concerns about the unintended consequences of FDA regulation.

“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.”

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