FDA

WASHINGTON — The Food and Drug Administration will hold a meeting in the 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 that it will ask a panel of outside advisors to review seven peptides at a meeting in July, specifically whether they should be added to a list of substances that can be safely produced by pharmacies. In the meantime, the agency said it would soon remove the chemicals from a restrictive list reserved for unapproved, high-risk drugs. The peptides under discussion include some of the most popular among influencers, such as BPC-157, which is marketed to heal injuries and reduce inflammation.

“The Wild West is about to become wilder,” said Dr. Peter Lurie, a former FDA official who now leads the Center for Science in the Public Interest. In an interview, Lurie said allowing peptides on the market without clinical testing poses a “profound threat” to FDA’s decades-old system for vetting drugs.

“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 said.

Under President Biden, the FDA added nearly 20 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 advisors voted overwhelmingly that the peptides did not meet the criteria for substances 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 advisors and internal staff who oversaw those decisions no longer work for the agency. The FDA’s pharmacy panel currently has a number of vacancies, which Kennedy could fill before the July meeting.

Kennedy previewed Wednesday’s 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.”

Given Kennedy’s statements, Lurie said it was doubtful the drugs would receive real scrutiny from 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 said the coming meeting will be the start of a “protracted process.” Even if the panel votes to make the peptides available, and the FDA agrees, the agency will still have to draft and publish rules on the change, he noted.

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 wellness hacks 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 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 such as peptides in their products.

Safety risks were cited previously

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.

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.

Some in the compounding industry argue that FDA 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.

Kennedy has echoed those concerns.

“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.”

Perrone writes for the Associated Press.

U.S. abortion opponents are increasingly frustrated with the lack of action by President Trump’s administration to stem the flow of abortion pills prescribed online that they view as undermining state abortion bans.

A court ruling this week in a lawsuit the Louisiana attorney general brought against Trump’s Food and Drug Administration cast a spotlight on the simmering tension. The judge said the state has a strong case while declining to block telehealth prescriptions to the pill mifepristone for now.

Anti-abortion groups are pushing the FDA to move faster with a review that they hope will result in restrictions on the abortion pill, including blocking its prescribing via telehealth platforms. The administration says the work takes time.

The groups have focused mostly on the health agency and not the Republican president whose three U.S. Supreme Court appointees were instrumental in the 2022 ruling that overturned Roe v. Wade and allowed the state bans in the first place. But the administration’s requests in the Louisiana lawsuit and similar ones elsewhere to delay rulings until it finishes a review have sparked anger for some activists.

“The stall tactics are beyond frustrating,” Kristi Hamrick, a spokesperson for Students for Life of America, said in an interview. Hamrick said the administration could also block the pills from being mailed by changing its interpretation of a 19th century law and enforcing it.

A judge opened the door to pushing the administration

U.S. District Judge David Joseph, who was nominated to the bench by Trump, gave a mixed ruling Tuesday in a case brought by Louisiana Atty. Gen. Liz Murrill and a woman who says her boyfriend coerced her into taking mifepristone to end a pregnancy.

Their overall aim is to roll back FDA rules that have made the pills more accessible. Murrill, like officials in other states that have filed similar lawsuits, contends that the availability of the pills via online providers takes the teeth out of the bans in the 13 states that bar abortion at all stages of pregnancy, with limited exceptions.

Surveys of abortion providers have suggested that its availability through telehealth is a reason the number of abortions in the U.S. has not dropped since the overturn of Roe. While state abortion bans include prohibitions on abortion using the pills, some Democratic-controlled states have adopted laws that seek to protect medical providers who prescribe them over telehealth and mail the pills to states with bans. Those so-called shield laws are being tested through civil and criminal cases.

In the Louisiana case, Joseph declined to grant Murrill’s request to block telehealth prescriptions to the pills while the case moves through the courts. But he said he could do that eventually and the plaintiffs in the case are likely to succeed on the merits of their arguments because the state has demonstrated it’s suffered “irreparable harm.”

He also ordered the FDA to report to him within six months on the status of its review of the drug.

On Wednesday, Murrill filed a notice that she’s taking the case to the U.S. 5th Circuit Court of Appeals in hopes of forcing faster action.

The politics aren’t simple

Family Research Council President Tony Perkins, an influential conservative voice who is also a former Louisiana lawmaker, applauded Murrill’s step.

He said people he meets are often shocked to learn that the number of abortions has not dropped since the 2022 Supreme Court ruling.

“Bewilderment sets in,” he said. “We’re already seeing an enthusiasm gap between the parties. What the Republicans do not need is a dampening of enthusiasm in their base.”

He’s hoping the administration will restrict abortion pills rather than risk losing support from conservative, anti-abortion voters in November’s midterm elections.

Other groups are being more cautions.

Madison LaClare, director of federal government affairs at National Right to Life, said her group trusts the administration to review mifepristone. Marjorie Dannenfelser, president of Susan B. Anthony Pro-Life America, avoided harsh words for the president: “The Trump-Vance administration has an important opportunity right now to prioritize women’s safety,” she said in a statement.

Still, recent electoral results suggest that voters seeking to keep abortion available have the political momentum. Since Roe was overturned, abortion has been on the ballot directly in 17 states. Voters have sided with the abortion-rights side in 14 of those questions.

“There seems to be an emerging consensus in the country that people don’t want to ban abortion,” said Rachel Rebouche, a professor at the University of Texas School of Law who studies abortion.

The FDA says it’s working on it

In a statement Wednesday in response to questions from the Associated Press, the FDA said it’s reviewing the safety of mifepristone, “including the collection of robust and timely data, evaluation of data integrity, and implementation of the analyses, validation, and peer-review.”

After that, the agency said, it will decide whether to make changes to the rules about how the drug can be prescribed.

It said this kind of study can take a year or more to complete by academics but the agency is trying to move faster than that. A spokesperson did not answer questions about when the work began.

Mifepristone has been a political priority for anti-abortion activists and their allies in Congress since Trump returned to office last year. In his January 2025 confirmation hearing, Health and Human Services Secretary Robert F. Kennedy Jr. was repeatedly asked about the drug by Republican lawmakers and said the president had requested a safety review.

Frustration over signs that the FDA isn’t prioritizing curbing abortions flared last fall when the FDA approved an additional generic version of mifepristone.

The drug is most often used for abortion in combination with another drug, misoprostol.

Mifepristone was approved in 2000 as a safe and effective way to end early pregnancies.

Because of rare cases of excessive bleeding, the FDA initially imposed strict limits on who could prescribe and distribute the pill — only specially certified physicians and only after an in-person appointment where the person would receive the pill.

Both those requirements were dropped during the COVID years. At the time, FDA officials said that after more than 20 years of monitoring mifepristone use, and reviewing dozens of studies involving thousands of women, it was clear that women could safely use the pill without direct supervision.

Mulvihill and Perrone write for the Associated Press.