R3 Stem Cell Investigation | Consumer Fraud Lawsuits

The U.S. Food and Drug Administration issued a warning letter on August 14, 2026 to R3 Medical Companies and its chief executive, David L. Greene, MD. The Scottsdale, Arizona company is the parent of R3 Stem Cell, LLC, which promotes stem cell and exosome therapies through affiliated clinics.

The Lyon Firm is investigating consumer concerns about how those treatments were marketed. Contact our class action consumer fraud lawyers to learn more about deceptive marketing claims.

R3 Medical FDA Warning Letter: Consumer Fraud Investigation

According to the letter, Bello manufactured umbilical cord products that Regen distributed under private labels named ReBellaWJ, ReBellaXO, ReBellaXOL and ReBellaCB. The FDA wrote that these products are unapproved new drugs and unlicensed biological products. FDA investigators inspected two co-located Scottsdale facilities, Bello Bio, LLC and Regen Suppliers, LLC, in 2025.

The agency cited promotion on company websites, YouTube, TikTok, Instagram and Facebook for conditions that included arthritis, neurological disorders, autism and diabetes.

The FDA also described manufacturing concerns. It wrote that the firm had not validated its aseptic processes and had assigned 24-month expiration dates without supporting stability data. The letter added that products marketed as exosomes did not appear to come from a process that isolates exosomes. The agency warned that failure to resolve the issues may lead to action without further notice, including seizure or injunction.

A warning letter like this states the FDA’s position. It is not a court finding, and the company has the right to respond. As of writing, we have not yet located a public response to this letter. The FDA said that it found the corrective actions described in the company’s replies to inspection reports inadequate. It also noted that it sent R3 an untitled letter in May 2019 and wrote that umbilical and exosome therapies continue to be offered.

The Lyon Firm is not accusing R3 Medical Companies, R3 Stem Cell or any affiliated clinic of wrongdoing. We are investigating consumer concerns and the issues the FDA put in writing.

Stem Cell Procedures and Locations

The 2026 letter describes Wharton’s jelly, umbilical cord blood and exosome products promoted for joint and soft tissue pain, tendonitis, neuropathy and other uses, including intravenous treatment. The FDA letter places R3 operations in Scottsdale and names R3 Anti-Aging clinics in Brentwood, Tennessee and Beverly Hills, California. It also describes a partnership program called R3 Alliance Partner that supplies several other clinics throughout the country.

Because the structure includes affiliates, patients should confirm which business treated them, which procedure they provided and any other relevant information.

Concerns We Want to Hear About

Examples of concerns that may support a claim include:

• Marketing that linked umbilical cord or exosome treatment to serious conditions
• Products described as exosomes or stem cells that did not match what the FDA later wrote about them
• Missing or unclear disclosure of the product’s FDA regulatory status
• Payment for a treatment package with little or no documented improvement
• Infections, reactions or other complications after an injection or infusion

State consumer protection laws, including unfair and deceptive practices statutes, can apply when a business promotes health benefits it cannot support.

Because R3 sells through affiliated clinics, a claim may involve more than one business. Sorting out who advertised, who manufactured, who treated and who collected payment is a key part of our review. Whether any claim has merit depends on the facts, including what each patient paid and received.

Did You Receive Treatment From R3?

If you paid for an R3 treatment, or you were swayed by R3 marketing for a condition named in the FDA letters, you can call our attorneys to learn mroe about your legal options. Keep your receipts, consent forms, screenshots of ads and medical records. Call The Lyon Firm at (513) 381-2333 or request a free, confidential case review.

Why Choose The Lyon Firm

Over 23 years, Joseph Lyon has represented clients across all fifty states in consumer class actions, mass torts and complex individual claims involving deceptive business practices. Federal and state courts frequently appoint the firm to leadership positions in large class actions, and its work has helped secure relief for more than 50 million class members. We are proud to represent plaintiffs in stem cell fraud cases and other misleading advertising class actions.

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The Lyon Firm is investigating consumer concerns and has not concluded that R3 Medical Companies, R3 Stem Cell, LLC, Bello Bio, LLC, Regen Suppliers, LLC or any affiliated clinic violated any law. Statements attributed to the FDA come from public FDA documents, which state the agency’s position and are not court findings.