FDA Warning Letters to Stem Cell Clinics

What these letters mean

The FDA's biologics center (CBER) regulates stem cell, exosome, and other cell and tissue products. Most of these products need FDA approval before they can be sold to treat a disease, and none is approved for orthopedic use. See our guide to what the FDA has and hasn't approved.

• Warning letter. The FDA's formal notice that it found significant violations. It asks the company to respond within 15 working days and warns that failing to fix the problems may lead to enforcement action, such as seizure or an injunction.
• Untitled letter. An earlier-stage letter. The FDA describes it as citing violations that don't meet the threshold of regulatory significance for a warning letter. For clinics it usually follows a review of the clinic's website or social media.

A letter records the FDA's findings at the time it was sent. It is not a court ruling. Companies often respond, change their marketing, or dispute the findings, and some later receive a close-out letter. The FDA page for each warning letter shows any response or close-out the agency has posted.

How to use this before choosing a clinic

1. Search the clinic's name and the brand name of the product it offers. Some letters go to the lab or distributor that supplies many clinics rather than to a clinic itself.
2. Ask the clinic what exactly it would inject, who makes it, and whether it is FDA-approved for your condition. For orthopedic pain, the honest answer is that it isn't.
3. Be wary of the claims these letters cite: one treatment for many unrelated diseases, guaranteed results, or "FDA-registered" presented as if it meant "FDA-approved."

Not finding a clinic here doesn't mean it's in good standing. This list only includes letters the FDA has published. Check your state medical board as well; our state guides link to each board's license lookup.

Methodology

• Sources. Warning letters come from the FDA warning letter database, searched for 14 terms: stem cell(s), exosome(s), umbilical, amniotic, Wharton's jelly, placental, cord blood, HCT/P, stromal vascular, regenerative medicine, mesenchymal, and perinatal. Untitled letters come from CBER's list of untitled letters.
• Inclusion. We read every letter and kept those about a stem cell, exosome, umbilical cord, cord blood, amniotic or placental, or fat-derived (SVF) product intended for people. We excluded letters about fertility clinics and sperm banks, eye and bone tissue banks, bone grafts, fecal transplants, veterinary products, and cosmetics or supplements that only mention "stem cells" in marketing.
• Coverage. The FDA's searchable warning letter database covers roughly the last five years, so warning letters here start in 2021. Untitled letters start in 2019; older ones are only on the FDA's web archive. Major earlier cases are not included.
• Fields. Product type comes from the FDA's own description of what the company makes or markets. "How FDA found it" records whether the letter followed an inspection or a review of the company's website or social media. We don't summarize the conditions each company marketed. Read the letter for that.
• Updates. We re-check both FDA sources monthly. Spot an error or a missing letter? Email [email protected].

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