Happy Friday! 

Last week, an FDA committee voted to ease restrictions on six peptides—the experimental injections that are promoted online for everything from muscle recovery to mental clarity. No, peptides are not “legal” now, but proponents are applauding the outcome.

“I’ve been talking about these peptides for years while half the industry rolled their eyes,” said biohacker Gary Brecka. “This vote shows the momentum shifting,” said Will Cole, a podcaster and functional medicine practitioner. The two MAHA allies have publicly championed efforts led by Health Secretary Robert F. Kennedy Jr. On Brecka’s podcast last year, Kennedy reiterated his desire to “end the war at FDA” against peptides.

What, if anything, has actually changed?

Let me quickly break it down for you: The FDA Pharmacy Compounding Advisory Committee voted to recommend moving six peptides to a list of substances that can be compounded, or used in custom drugs made by special pharmacies. The peptides included the popular BPC-157 and TB-500, marketed together online as the “The Wolverine” stack. As noted during the hearing, these peptides have not been studied extensively and their possible health risks are unknown. 

The vote was a procedural step, not a formal agency decision. Should the FDA follow the committee’s guidance—which it often does but isn’t guaranteed to—doctors and patients would be able to lawfully obtain these peptides from regulated pharmacies. (Today, many are ordering them from gray-market sellers online.)

The vote went against the guidance of FDA’s career scientists, who expressed concerns about the lack of safety and efficacy data. Notably, the committee included eight newly added members: physicians, pharmacists and executives. Most of them have ties to the peptide industry. These new members largely voted as a bloc in support of compounding the peptides.

I wanted to hear from the people about the vote, and what it could mean for everyday consumers and businesses. Here’s what they had to say:

An FDA regulatory expert:

“I would caution [companies] to wait and see if this pathway is developed or not, because at this point, there would be a lot of liability involved in producing these drugs.”— Attorney Neil DiSpirito, who advises companies on FDA regulatory strategy

A compounding-pharmacy CEO:

“PCAC’s meeting confirms what we’ve said all along: Patients deserve a safe, regulated pathway for clinically needed therapies like these peptides through licensed compounding pharmacies. The alternative is access with no oversight at all.”— Shaun Noorian, founder and CEO of Empower Pharmacy

A gray-market peptide seller:

“If anything, it’s going to give a boost to the gray market. The approved peptides make up maybe 10% to 15% at most of the total market. The prices from the compounders will inevitably be higher. It will attract a lot of new customers who will try it. Then many of them will migrate over to the gray market because of prices. And the one thing about peptides is, it’s a slippery slope.”— Rory Hester, owner of Crush Research based in Idaho

A physician and concierge medicine founder:

“Just by having the hearings, it validates it. It’s a validation tool. ‘If they’re talking about it, it must be real.’ The truth is, if you peel the onion back a few layers: Show me the evidence. There’s a whole mindset of people that are like, ‘Hey, evidence and scientific method—that’s the old-school way. We’re just going to do things now and see if they work’ …Show me the evidence and I’m all in. But until such time, it is my job to be the advocate of someone else’s health. People tell me what they want, and I try to frame what they need and find the real solutions.”— Private Medical founder Dr. Jordan Shlain

A physician and researcher:

“If the FDA allows these peptides to be compounded, businesses will be free to promote them for any condition from brain fog to cancer. Not only are they likely to cause widespread harm, but it will be difficult to document that harm.”— Dr. Adriane Fugh-Berman, professor at Georgetown University Medical Center and director of research group PharmedOut

Read on for top stories of the week, from the Journal and elsewhere. I’d love to know your thoughts on peptides. Are you taking any? Would you? Which ones and why? And, send me your thoughts on this week’s newsletter and what you’d like to read about in future editions.

You can contact me at sara.obrien@wsj.com. If you’re reading this in your inbox, you can just hit reply!

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