In July 2025, Brigham Buhler — founder of Ways2Well and ReviveRx Pharmacy — sat down on The Ultimate Human podcast and made a claim that stopped the peptide conversation cold: his practice had treated over 75,000 patients with peptides, with zero adverse events.
Not one. Across tens of thousands of patients.
That number matters because of what the FDA has been saying.
What Actually Happened
Beginning in late 2023, the FDA placed 17 peptides on Category 2 of its bulk drug substances list — effectively banning them from compounding pharmacies. The list reads like a who's who of the most popular peptides in functional medicine: BPC-157, ipamorelin, CJC-1295, AOD-9604, thymosin alpha-1, GHK-copper, MOTS-c, and more.
The stated justification? Three concerns:
- Immunogenicity risks — potential immune reactions
- Impurities and quality control — the FDA found that up to 40% of tested online peptides had incorrect dosages or undeclared ingredients
- Insufficient clinical safety data — most evidence comes from animal studies, not human trials
On the surface, these sound reasonable. Quality control matters. Safety data matters. But when you dig into the details, the picture gets more complicated.
The Safety Record Nobody Talks About
Buhler's 75,000-patient claim isn't happening in someone's garage. ReviveRx compounds in an ISO 5 cleanroom environment — that's cleaner than the legally required ISO 7 standard. They use FDA-approved ingredients with independent third-party verification. They hired a former Department of Justice prosecutor to build out their compliance program.
These aren't fringe operators. These are regulated compounding pharmacies operating under strict guidelines, producing peptides that physicians are prescribing to patients — and the adverse event rate is effectively zero.
The FDA's quality control argument — that 40% of tested peptides had issues — actually supports Buhler's point. The contamination problems come from unregulated online vendors selling "research chemicals," not from licensed 503A and 503B compounding pharmacies operating under USP 795/797 standards.
By restricting legitimate compounding pharmacies, the FDA arguably pushes more patients toward the exact unregulated gray market that creates the safety problems.
Follow the Money
Here's where Buhler's argument gets sharper.
Merck is actively investigating over 200 peptides for patent. Ibutamoren — one of the peptides the FDA has flagged — has entered Phase 2 FDA trials with another pharmaceutical company. As Buhler puts it: "It's on the ban list but in FDA trials so they can patent it and monetize it."
Thymalfasin, a Big Pharma drug made from synthetic thymosin alpha-1, remains on the market as an approved medication. Meanwhile, the exact same peptide is banned from compounding.
GLP-1 economics paint the starkest picture. Branded Ozempic costs over $1,300 per month without insurance. Compounded semaglutide from pharmacies like ReviveRx? $129 to $497 per month. When Buhler met with FDA officials at the White House in April 2025, he cited an OFA study showing GLP-1s were in stock only 5.8% of the time across 30,000 pharmacies nationwide. The FDA said pharma companies told them they could meet demand. The data said otherwise.
Eli Lilly and Novo Nordisk collected a combined $12.9 billion from GLP-1 products in 2024. Both companies subsequently launched lawsuits against compounding pharmacies and established their own direct-to-consumer online pharmacies.
The FDA received $1.1 billion in user fees from the pharmaceutical companies it regulates in 2021 alone. In Buhler's words: "A majority of the FDA's funding comes from private industry, and a majority of their discussion, influence, belief systems, and thought processes are being influenced by these companies."
The Legal Battle
The compounding industry didn't go quietly. The Alliance for Pharmacy Compounding wrote to the FDA that "'Trust us' is not a sufficient explanation for agency actions." Lawsuits from compounding pharmacies argued the FDA bypassed the legally required process — skipping Pharmacy Compounding Advisory Committee review and public comment periods — and effectively made new rules without proper notice.
The litigation forced the FDA to backtrack. They agreed to convene public PCAC meetings to review several flagged peptides. In September 2024, five peptides were actually removed from Category 2: AOD-9604, CJC-1295, ipamorelin acetate, thymosin alpha-1, and selank acetate.
But the fight isn't over. In December 2024, the PCAC reviewed additional peptides and the panel voted to uphold restrictions. Meanwhile, the Department of Justice prosecuted Tailor Made Compounding LLC for distributing unapproved peptides including BPC-157, forcing the company to forfeit $1.79 million.
What Needs to Happen
This isn't an argument against regulation. Nobody wants contaminated peptides. Nobody wants patients harmed by unqualified providers administering untested compounds.
But the data doesn't support the FDA's current approach. When 75,000 patients have been treated without adverse events through regulated compounding pharmacies, the "insufficient safety data" argument starts to ring hollow — especially when the same peptides are simultaneously being developed by pharmaceutical companies for patent protection.
What's needed:
- Human clinical trials for the most widely used peptides, funded independently of pharmaceutical companies
- Clear regulatory pathways that distinguish between regulated compounding pharmacies and unregulated online vendors
- Transparency about the FDA's decision-making process and the role of pharmaceutical industry user fees
- Patient access to affordable alternatives through legitimate compounding pharmacies while clinical data catches up
The FDA's job is to protect public health. But when the real-world safety record contradicts the regulatory action, and the primary beneficiaries of restrictions are the companies funding the regulator, it's worth asking: who is this really protecting?
This article is for educational and informational purposes only. It is not medical advice. Always consult with a qualified healthcare provider before starting any peptide therapy.
Key Sources:
- Brigham Buhler on The Ultimate Human Podcast, Episode 182
- Joe Rogan Experience #1873 and #2079 — Brigham Buhler
- FDA Category 2 Bulk Drug Substances List (2023-2024)
- Alliance for Pharmacy Compounding public letters to FDA
- Frier Levitt: Regulatory Status of Peptide Compounding in 2025
