A Warning Letter Is Evidence: How Prior FDA Notice Turns an FDCA Violation Into a Felony for Stem Cell, Exosome, and Med Spa Operators

Buried on the fifth page of an FDA warning letter posted on August 25, 2026 is one sentence that matters more than everything above it. FDA tells the recipient that it had already written to him about the same legal problem in a letter dated May 28, 2019, and that his websites and social media accounts show the same products still being offered for the same conditions. That is not a compliance observation. That is the government building the knowledge element of a felony, in writing, and dating it seven years back.

A warning letter is not a charge. It is the document that fixes the date the government told you, and everything shipped afterward becomes knowing conduct.

Key Takeaways

• Most FDCA violations under 21 U.S.C. § 331 are strict liability misdemeanors. No proof of intent is required to convict.
• Under 21 U.S.C. § 333(a)(2) the same conduct becomes a three-year felony when committed with intent to defraud or mislead.
• A prior FDA warning letter is the cleanest evidence of knowledge a prosecutor can put in front of a jury.
• Unapproved biologics reach clinics through distributor partner programs, and the buying clinic has its own federal exposure.

What the Warning Letter Actually Says

The letter went to the chief executive of a group of co-located Arizona companies operating as a manufacturer, a private-label distributor, and affiliated clinics under common control. FDA inspected two of the facilities in late 2025.

The findings are stacked. The umbilical cord derived products are unapproved new drugs under 21 U.S.C. § 355(a), unlicensed biological products under 42 U.S.C. § 262(a)(1), and adulterated under 21 U.S.C. § 351(a)(2)(B) because manufacturing did not conform to current good manufacturing practice. Distributing them is a prohibited act under 21 U.S.C. § 331(a) and § 331(d).

The CGMP findings are worse than the paperwork language suggests. The firm never validated the aseptic process for products that purport to be sterile and are injected into patients. Samples were frozen before sterility testing, which can destroy the very contamination the test is supposed to find. A twenty-four month expiration date was assigned with no stability data behind it.

Freezing samples before sterility testing can destroy the very contamination the test is supposed to find. A twenty-four month expiration date was assigned with no stability data behind it.

FDA also questioned whether products sold as exosomes were exosomes at all, noting the process did not appear to isolate them. Selling a vial as something it is not is where the Food, Drug, and Cosmetic Act stops being a regulatory statute and starts looking like fraud.

Why the 2019 Letter Is the Whole Case

Criminal liability under the Food, Drug, and Cosmetic Act is built in two tiers, and the difference between them is everything.

The first tier, 21 U.S.C. § 333(a)(1), is a strict liability misdemeanor. The government does not have to prove the defendant knew anything. It proves the prohibited act and it is done. Under the responsible corporate officer doctrine from United States v. Dotterweich and United States v. Park, a corporate officer in a position to prevent the violation can be convicted without any showing of personal participation or awareness.

The second tier sends people to prison. If the violation is committed with intent to defraud or mislead, it becomes a felony carrying up to three years per count. Intent is the only thing standing between a probationary misdemeanor and a multi-count felony indictment.

Now put the 2019 letter next to that. FDA told this executive, in writing, that products promoted for conditions like ALS, diabetes, kidney failure, Lyme disease, Parkinson's, and stroke were not exempt under 21 CFR 1271.15, were not homologous use, and were therefore regulated as drugs and biologics requiring premarket approval. Seven years later FDA reviewed the same websites and found the same offerings. A prosecutor does not have to argue the defendant should have known.

"The government already told him, and kept the receipt. That is what a warning letter does that a Form 483 does not. It converts everything afterward into knowing conduct."— Aaron M. Cohen, AMC Defense Law

The HCT/P Exemption Almost Nobody Actually Qualifies For

Every clinic selling regenerative products believes it is operating under the tissue regulations rather than the drug regulations. Very few are. A human cell, tissue, or cellular and tissue-based product is regulated solely under section 361 of the PHS Act only if it satisfies every criterion in 21 CFR 1271.10(a). The one that fails most often is homologous use: the product must perform the same basic function in the recipient that it performed in the donor. Umbilical cord serves as a conduit. Cord blood replenishes the lymphohematopoietic system. Neither is treating arthritis or neuropathy.

Here is the part that catches people. Intended use is established by the manufacturer's own objective intent, and FDA reads that off your marketing. In this letter the agency quoted a blog post, product pages, a treatments tab, a YouTube video, and TikTok and Instagram accounts. The website that generates the leads is the same document that establishes the violation.

Mistakes That Turn a Regulatory File Into a Criminal One

Keeping product moving after the letter arrives. FDA noted the responses did not address continued distribution or the disposition of inventory made under violative conditions. Every unit shipped after receipt is a separate prohibited act, and now a knowing one.

Answering the fifteen-day response letter without counsel. That is a written submission to a federal agency about conduct that is already potentially criminal. FDA's Office of Criminal Investigations reads it if the file moves, and anything inaccurate creates independent exposure.

Quietly deleting the marketing. The agency noted that a distributor website returned a 404 as of the date of the letter and that certain product claims appeared only until recently. FDA captured the pages before they came down. Taking material offline after notice does not erase it, and it can support a consciousness-of-guilt argument.

Assuming a warning letter is the ceiling. Injunction and seizure are the stated next steps, and criminal referral runs on a parallel track the recipient does not see. The same dynamic drives unannounced med spa inspections, where a routine visit is the front end of a federal file.

Injunction and seizure are the stated next steps. Criminal referral runs on a parallel track the recipient does not see, and the fifteen-day response becomes the first filing in it.

Exposure Beyond the Food, Drug, and Cosmetic Act

FDCA counts are rarely charged alone. When the marketing makes therapeutic claims the sponsor cannot support and money moves by card or wire, the government reaches for 18 U.S.C. § 1343. When any of it touches a federal health care program or a private insurer, 18 U.S.C. § 1347 comes in with a twenty-year maximum. A conspiracy count under 18 U.S.C. § 371 sweeps in the people who ran distribution and marketing without ever touching a vial.

Then there are the buyers. A distributor partner program placing unapproved biologics with unaffiliated clinics means physicians, nurse practitioners, and med spa owners across multiple states are holding product FDA has now publicly declared unapproved, unlicensed, adulterated, and possibly not what the label says. That is a state licensure problem, a civil liability problem, and a federal criminal problem at the same time. The Scalpa plea shows what the sentencing end of that looks like.

Florida matters here in a way that is not abstract. The state has one of the densest concentrations of med spas, IV hydration clinics, and regenerative medicine practices in the country, and the Southern and Middle Districts of Florida are among the most active federal health care enforcement venues anywhere. A supplier case in Arizona becomes clinic cases in Miami, Fort Lauderdale, Boca Raton, and Tampa.

What to Do If You Bought or Sold This Category of Product

Stop distributing and stop administering today, and document when and why. The date you halted is the date the knowing conduct ends.

Preserve everything. Purchase records, invoices, certificates of analysis, the partner agreement, marketing materials, and the website and social media as they existed. Issue a litigation hold. Deleting anything now is worse than whatever it says.

Do not talk to FDA investigators or agents without a federal criminal defense attorney in the room.

Have counsel draft the fifteen-day response and treat it as the first filing in a case, not a compliance form.

Common Questions

Received an FDA Warning Letter, or Bought Products Named in One?

AMC Defense Law represents manufacturers, distributors, clinics, physicians, and med spa owners in FDA and Department of Justice investigations involving unapproved drugs, unlicensed biologics, compounded and regenerative products, and health care fraud, in Florida and nationwide. If a warning letter, Form 483, grand jury subpoena, or agent visit has landed, the fifteen-day clock is not the only deadline running. Consultations are confidential.

Aaron M. Cohen represents manufacturers, distributors, clinics, and med spa owners in FDA and DOJ investigations in Florida and nationwide.

If you or your loved ones have been arrested, received an FDA warning letter, or been contacted by federal agents, call Aaron M. Cohen, 24 hours a day to get help.