FDA advisory panel expected to recommend legal production of up to seven peptides

When the FDA panel that is considering whether to recommend legal production of seven peptides meets starting Thursday, Shaun Noorian will be at its Maryland campus in person.

"I wouldn't miss it for the world," Noorian, the founder and CEO of Houston-based Empower Pharmacy, one of the nation's largest compounding pharmacies, told Forbes. "The who's who of the peptide space will be there."

Hundreds of others are expected to fill the room as well, including compounders, telehealth founders and longevity influencers, who are flying in for the event.

"It will be a circus," said Scott Brunner, CEO of the Alliance for Pharmacy Compounding, the industry's trade group. "Everybody and their brother is coming."

The Gray Market

While these peptides are currently not legal to produce for anything other than "research purposes," that has not stopped a booming gray market from exploiting that loophole. There is little scientific data on their safety and efficacy, and the many sketchy sellers who distribute them operate with no oversight.

Still, the illicit peptide market could be worth an estimated $3 billion. Silicon Valley bros, longevity medics and MAHA believers take them, while wellness influencers promote their "peptide stacks" online to speed recovery or improve sleep. Health and Human Services Secretary Robert F. Kennedy Jr. is a self-described "big fan of peptides," as he told podcaster Joe Rogan in February.

The Peptides in Question

While peptides are a broad category of amino acid-based drugs that include well-known legal ones (like insulin and the GLP-1 weight loss drugs), the buzz—and the FDA panel—is focused on a group known by strings of letters and numbers. These are injectables such as:

• BPC-157 – extremely popular online for its reputed ability to heal tendons, ligaments and muscles
• TB-500 – believed to reduce inflammation and improve wound healing

"This is akin to the supplement industry," said Michelle Davey, founder and CEO of telehealth company Wheel. "I feel like it will be the Wild West for the first six months at least."

"It will be a circus. Everybody and their brother is coming."

The Safety Debate

Kennedy has argued that legalizing these substances would make them safer by moving Americans away from the existing gray market. There is some truth to that. When people buy peptides directly from China or other countries, there is a risk of contamination, incorrect dosing or other problems—and buyers cannot easily tell if they have actually received the peptide they purchased.

However, legalization would also make these substances whose efficacy has not been proven more readily available and give them a stamp of approval. That is why the FDA's own technical staff has recommended against expanded access, and the public health group Partnership for Safe Medicines calls them "popular, unproven, dangerous."

As Peter Kolchinsky, managing partner of biotech investor RA Capital Management, put it: "Is the FDA going to stand on science or is it going to permit all kinds of snake oil to be readily available?"

The FDA Meeting and Timeline

The FDA meeting will last two days. The panel is widely expected to recommend allowing compounders to make at least some of the seven peptides under review in what some online commentators are calling "Peptide Liberation Day." Another five peptides are slated for consideration in 2027.

The panel makes its recommendations to the FDA, which will then determine whether to begin the process of approving these peptides. That approval could take as little as a few months or longer than a year.

Market Implications

For compounding pharmacies like Empower, telehealth giant Hims & Hers and a slew of others—which can concoct drugs specifically for individual patients—that puts a potential multi-billion-dollar market within reach.

"We'd love to make them, and we're getting ready to do it," said Mike Walker, cofounder and president of Strive Pharmacy, another major compounder. "We are just waiting for the green light from the FDA."

The Rise of Compounding Pharmacies

Compounding pharmacies are in some ways a throwback. A century ago, three-quarters of prescriptions required some sort of in-pharmacy compounding—mixing up drug formulations in the shop rather than giving a patient a standard off-the-shelf medication—but that number dropped to 1% by the 1970s. In the last two decades, compounding found new life with the boom...