I've been getting a lot of questions about what's going on with peptides, the FDA, and where this is all heading.

So I'm going to lay it all out — what happened, what's happening now, and what it means for you. No speculation. Just documented facts with sources so you can verify everything yourself.

Let's get into it.

In September 2023, the FDA dropped a bomb on the peptide world. They added 17 peptides to the Category 2 Bulk Drug Substance list — which means compounding pharmacies can no longer legally produce them. This was effective immediately, with almost no warning.

The list includes most of the peptides you've probably used or heard about: BPC-157, TB-500 (Thymosin Beta-4), Thymosin Alpha-1, CJC-1295, Ipamorelin, AOD-9604, Epitalon, GHK-Cu (injectable), DIHEXA, Cerebrolysin, Selank, Semax, DSIP, Kisspeptin-10, MOTS-c, Humanin, and SS-31.

The FDA's reasoning? "Risk for immunogenicity, peptide-related impurities, and limited safety-related information." Essentially — not enough human trials, potential for immune reactions, and concerns about purity from compounding sources.

Then in February 2024, the FDA started issuing warning letters. US Chem Labs and Synthetix Inc. got hit for selling semaglutide and tirzepatide as "research use only" while making therapeutic claims on their websites. This was the first sign that enforcement was shifting from talk to action.

September 2024 brought an unexpected reversal. The FDA removed five peptides from Category 2 — Thymosin Alpha-1, CJC-1295, Ipamorelin, BPC-157, and Selank — and sent them to the Pharmacy Compounding Advisory Committee for review. Ipamorelin was evaluated in October. CJC-1295, AOD-9604, and Thymosin Alpha-1 were evaluated in December. These aren't fully cleared yet, but they're no longer in regulatory limbo.

October 2024 is when things got serious for GLP-1s. The FDA removed tirzepatide from the drug shortage list, which effectively killed legal compounding for it. The Outsourcing Facilities Association filed a lawsuit against the FDA within a week.

December 17, 2024 — the FDA posted four warning letters in a single day to companies selling semaglutide, tirzepatide, and retatrutide. Summit Research Peptides was one of them. The message was clear: enforcement is ramping up.

And then September 2025 — the FDA launched Import Alert 66-80, known as the "Green List." This authorizes border agents to detain GLP-1 APIs from any foreign manufacturer that isn't on the approved list. Commissioner Marty Makary put it bluntly: "We are taking aggressive action to protect consumers from poor-quality or dangerous GLP-1 drugs."

The enforcement around semaglutide, tirzepatide, and retatrutide is significantly more aggressive than what we've seen with other peptides. And there's a simple reason for that: money.

Ozempic and Wegovy generated over $21 billion for Novo Nordisk in 2023. Mounjaro and Zepbound are on track for similar numbers for Eli Lilly. Retatrutide is still in trials but projected to be even bigger. When that much revenue is at stake, pharmaceutical companies have the resources to push for enforcement — and they're using them.

The other factor is that the "Research Use Only" defense is officially dead.

The FDA has specifically called out the practice of selling peptides labeled "for research purposes only" or "not for human consumption" while simultaneously including dosing instructions, selling them with syringes and bacteriostatic water, and making therapeutic claims on websites or social media.

From the warning letter to Summit Research Peptides: "Although labeling indicates the products are 'for research use only and not for human consumption,' information and testimonials presented on websites and social media establishes that the products are intended for human use."

The FDA called this a "ruse to avoid FDA scrutiny." They're not buying it anymore.

Here's what's actually changed in 2025, and most people haven't caught on yet.

The FDA has shifted enforcement from websites to manufacturers. They're no longer just sending warning letters to storefronts making bad claims. They're going after the source — the facilities producing the APIs, the supply chains, the contract manufacturers.

The Florida Healthcare Law Firm published an analysis earlier this year that laid it out clearly: "The FDA has begun shifting its focus away from purely issuing warning letters to RUO platforms. The current wave of enforcement is now targeting manufacturers of peptides, particularly where the supply chain lacks transparency, and where quality control is not sufficiently demonstrable."

This is a major escalation. When they go after manufacturers, the entire downstream supply dries up. Storefronts can't sell what doesn't exist.

This is the part that frustrates me — but I have to be honest about it.

FDA testing of online and compounded peptides revealed that up to 40% contained incorrect dosages or undeclared ingredients. That's not a small number. That's a systemic problem.

The peptide space grew too fast with too many suppliers cutting corners. Fake COAs. No third-party testing. APIs from unverified foreign sources with zero traceability. The bad actors gave regulators the ammunition they needed to justify broader enforcement.

From Import Alert 66-80: "The Agency has identified specific areas of concern for drugs compounded from GLP-1 APIs that appear to be adulterated... there is a heightened risk that any quality concerns associated with the bulk drug substance would not be adequately controlled for or monitored."

Whether you agree with the FDA's approach or not, this is the reality they're pointing to.

Let me break down where things actually stand right now.

The five peptides removed from Category 2 — Thymosin Alpha-1, CJC-1295, Ipamorelin, BPC-157, and Selank — are currently under review by the Pharmacy Compounding Advisory Committee. They're not fully cleared. The outcome of those reviews will determine whether they move to Category 1 (approved for compounding) or get restricted again. We're waiting on final decisions.

Semaglutide can still be compounded because it remains on the FDA drug shortage list. But the API has to come from an FDA-registered manufacturer on the Green List, and the compounding pharmacy has to be operating under proper 503A or 503B regulations. The window is narrower than it used to be.

Tirzepatide is a different story. It's no longer on the shortage list, which means compounding is significantly restricted. Finding a legitimate source is much harder now.

Retatrutide cannot be compounded at all. It's not FDA-approved for anything, doesn't appear on any approved bulks list, and the FDA has specifically issued warning letters targeting companies selling it.

Oral peptides and bioregulators appear to be in a different enforcement category. The focus has been on injectable, non-sterile vials. Oral formulations, capsules, and tablets haven't faced the same level of action. That said, I'd still recommend working with suppliers you trust and staying informed as things evolve.

If you're currently using peptides from research suppliers, access is going to become more difficult. Some suppliers will shut down — voluntarily or otherwise. Prices will likely increase as supply tightens. And quality verification becomes even more critical than before.

If you're working with a telemedicine provider or compounding pharmacy, ask questions. Verify they're sourcing from FDA-registered facilities. Ask about their API sourcing, especially for GLP-1s. Understand that some peptides may become unavailable even through legitimate channels.

If you're an athlete or military, be especially careful. BPC-157 is prohibited by WADA under the S0 category with no therapeutic use exemption available. The U.S. Department of Defense explicitly prohibits it for service members through Operation Supplement Safety. Standard drug tests don't screen for it, but specialized anti-doping tests can detect it.

Here's what I think is actually happening.

The research peptide model — buy a vial online, reconstitute it yourself, inject at home — is being systematically shut down. Whether you agree with the FDA's reasoning or not, that's the direction this is heading.

What's replacing it? Telemedicine platforms with licensed prescribers and pharmacy partnerships. 503A and 503B compounding pharmacies operating under strict regulations. Direct pharmaceutical products that are FDA-approved but significantly more expensive.

The peptides themselves aren't going away. The science is too strong. The demand is too high. The results are too real. But the gray-market access that made them accessible and affordable? That window is closing.

My advice: Stay informed — this is evolving monthly. Build relationships with legitimate providers now. Don't panic-buy from sketchy suppliers trying to offload inventory before they shut down. Focus on what you can control: training, nutrition, sleep, stress management.

The people who adapt will still have access to everything they need. The people who don't will be scrambling when their usual sources disappear.

I'll keep you updated as things develop.

Talk soon,

Lee

FYI, Biolongevity Labs is running their End of Year Sale right now. 40% off all peptide and bioregulator vials, plus an additional 15% off when you use code LEE15 (55% off total) at checkout.

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