Unapproved, Untested, and Possibly Not Even Exosomes: The FDA's Warning to R3 Medical.

By Kate Dee, MD — Founder, MedSpa Board

On August 14, 2026, the FDA issued a warning letter to R3 Medical Companies of Scottsdale, Arizona, and its CEO, David L. Greene, MD. The letter covers two co-located companies: Bello Bio, LLC, which manufactures the products, and Regen Suppliers, LLC, which markets them. The products are derived from human umbilical cords: ReBellaWJ (Wharton’s jelly), ReBellaCB (cord blood), ReBellaXO and ReBellaXOL (sold as exosomes), and the matching Bello-branded versions.

The FDA’s conclusion was blunt. These are “unapproved new drugs” and “unlicensed biological products.” They were never approved for anything. Not for joints, not for hair, not for faces.

Then there is the detail every medspa owner should sit with. Regen sold ReBellaXO and ReBellaXOL as exosome products. According to the FDA, the exosome products were made from the same starting material, using the same manufacturing process, as the company’s other cord products, a process that the agency said “does not appear would isolate exosomes.” In other words, the label on the vial may not describe what is in the vial.

This is the regenerative aesthetics market in a single document. Exosomes, “stem cells,” and cord-derived “growth factor” products are being sold into medspas at a pace that has far outrun the science and the law. Clinics are buying on the strength of a sales rep, a brochure, and a certificate of analysis written by the seller. Patients are paying for something no one in the room can verify. And the legitimate practices who have stayed out of this get lumped in with the ones who didn’t.

A note on timing and sourcing. The FDA letter is dated August 14, 2026, and is one of the clearest, most concrete enforcement actions to date involving products marketed for aesthetic use. Everything below comes from the FDA’s letter and other public FDA and CDC documents, listed at the end. A warning letter records the FDA’s findings. It is not a court judgment, and the company has the opportunity to respond.

What the FDA found

FDA investigators inspected the Bello Bio and Regen Suppliers facilities between November 17 and December 16, 2025. Beyond the approval problem, the letter lists manufacturing failures that go directly to patient safety.

The aseptic process was never validated. These products are supposed to be sterile. The FDA found the company “has not validated the aseptic processes used to manufacture your umbilical cord derived products,” and had not validated how it cleaned and disinfected the biological safety cabinet where the work was done.

Sterility testing was done in a way that could hide contamination. The company froze samples before testing them. The FDA noted that “freezing samples has the potential to destroy or compromise any microbial content in the samples before testing.” A clean test result on a frozen sample tells you very little about what is in the vial.

The expiration date was not supported. The products carried a 24-month expiration date with no stability data behind it.

Donor screening documentation was incomplete. The FDA cited gaps in donor eligibility records for transmissible spongiform encephalopathy, the category of disease that includes Creutzfeldt-Jakob disease, which federal rules require donors to be screened for.

There was no functioning quality oversight. Written procedures describing the responsibilities of the quality unit had not been established.

And the marketing was exactly what you would expect. The FDA quoted promotional material describing the exosome products as a “safe option for fitting regenerative biologics into your patient care” for “IV’s, joints, soft tissue, hair, facial or sexual rejuvenation.” It also cited a March 2026 video in which an employee told viewers, “These are your stem cells. There’s 30 million in each vial.” The FDA also cited the R3 Stem Cell website, which promoted the Wharton's jelly product as a treatment for neurologic conditions, heart, kidney and lung failure, autism, cerebral palsy, diabetes, and Lyme disease. None of these uses has been approved.

This was not the company’s first notice. In May 2019, the FDA sent R3 Stem Cell, LLC and Dr. Greene an untitled letter over marketing unapproved stem cell products for serious diseases through what the agency described as more than 50 affiliated centers. Seven years later, the FDA is back, this time with a warning letter that raises the possibility of seizure and injunction. According to published reports, the company has said it will temporarily suspend manufacturing while it addresses the violations.

This is not one company. It is a pattern.

R3 is the latest in a long line. In January 2025, the FDA warned Chara Biologics of Chatsworth, California, over amniotic fluid and umbilical cord products, including one marketed for “skin repair and regeneration.” In May 2025, it warned Supreme Rejuvenation of Houston over umbilical cord stem cell-derived exosome products promoted for reducing wrinkles, improving skin texture, stimulating hair growth, and rejuvenating scars. In August 2025, it warned Platinum Biologics of Orlando over exosome and cord-derived products. The aesthetic claims are not incidental. They are part of the sales pitch.

The FDA told the public where it stands in December 2019, after patients in Nebraska suffered serious adverse events following exosome treatment: “There are currently no FDA-approved exosome products.” That remains the case. When exosomes are used to treat diseases and conditions in humans, the FDA regulates them as drugs and biological products, which means approval, or an investigational new drug application and a formal clinical trial, before they go into patients.

The infection risk is not hypothetical either. In December 2018, the CDC reported 12 patients in Texas, Florida, and Arizona who were hospitalized with bacterial infections after receiving umbilical cord blood-derived products marketed as stem cell therapy. The CDC found the contamination occurred before the products were ever distributed. The clinics injecting them had no way to know.

Experimental means experimental

Exosomes are small vesicles that cells release to signal other cells. The biology is real and the research questions are interesting. That is exactly why the products are still being studied rather than approved. The human data in aesthetics is early: small studies, short follow-up, few controlled trials, and wide variation in what each product actually contains. There is no standardized dose, no agreed-upon purity standard, and no reliable way for a clinic to confirm from the outside what is in a given vial. R3’s letter makes the point better than any review article could. The FDA did not just question whether the product worked. It questioned whether it contained exosomes at all.

When a treatment is experimental, patients deserve to be told that in plain words. Not "cutting-edge." Not "next-generation regenerative." Experimental. Unapproved. Not proven to be safe or effective for this use. And the responsibility doesn't stop at the consent form. For a provider, it starts with the vial. Unless the FDA has approved the product, which confirms that it contains what the manufacturer claims, or you have tested it in a lab yourself, you do not know what you are putting into your patient. A supplier's brochure and a certificate of analysis the seller wrote don't count. Injecting or infusing an unverified biologic puts your patient's health, and possibly their life, at risk. It also falls below the standard of care, and that is exactly the kind of decision a malpractice claim is built on.

What legitimate legal compliance looks like

Every failure in this letter has a direct counterpart in how a properly run medspa operates.

Know what the product legally is. Before any regenerative product enters your practice, find out whether it is FDA-approved, FDA-cleared, sold as a cosmetic, or none of the above. If it is a human cell- or tissue-derived product intended to treat a condition, ask for the biologics license or the IND number. If the answer is a regulatory-sounding explanation instead of a number, you have your answer.

Know who made it, and check them. Search the FDA warning letter database for the manufacturer and the distributor before you buy. Ask for donor eligibility documentation, sterility testing methods, and stability data. R3’s products came with sterility testing on frozen samples and an expiration date no one had tested. A certificate of analysis from a seller is only as reliable as the seller.

Do not let the marketing become yours. If a supplier’s brochure promises hair regrowth or “facial rejuvenation,” and you repeat it to patients, those are now your claims. Your medical director (a physician, or an NP or PA where state law allows) is responsible for the products the practice uses and the claims it makes.

Tell patients the truth in the consent form. If you offer anything experimental, the consent has to say so, specifically, and name what is and is not known about it.

The MedSpa Board requires that the injectables and medical products a practice uses be FDA-approved. There is an important distinction worth drawing here. Platelet-rich plasma (PRP) and platelet-rich fibrin matrix (PRFM) are not FDA-approved products, but they are not purchased products either. They are prepared from the patient's own blood, at the point of care, using FDA-cleared devices, and returned to that same patient during the same visit. The provider knows exactly where the material came from. Donor-derived exosome, stem cell, and umbilical cord products are the opposite: manufactured from someone else's tissue, shipped, and sold with nothing but the seller's word as to what is inside. The FDA regulates those as drugs and biologics, and none has been approved.

If you are a patient

Before you agree to an exosome, “stem cell,” or “regenerative” treatment, ask. Is this product FDA-approved for what you are using it on? (For exosomes, the answer is no.) If it is experimental, what is the IND number? (Real clinical trials have one.) Who makes it? (Look the company up on the FDA’s warning letter page.) Is it going on my skin, under my skin, or into my vein? Who is your medical director? (Look them up.) A legitimate provider will answer every one of these without flinching. If the answers are vague, or the pitch is heavy on sales and not on science, walk away.

If you develop fever, chills, spreading redness, swelling, or pain after any regenerative treatment, seek medical care promptly and tell the treating clinician exactly what product you received. Adverse reactions can be reported to the FDA through MedWatch.

Where MedSpa Board certification fits

No certification can stop a manufacturer from mislabeling a vial. That is the FDA’s job, and in this case it did it. What certification does is make the practices that refuse to gamble with patients visible. For owners, it is a way to show that your products are approved, your sources are documented, and your consent forms say what they should. For patients, it is the difference between hoping and knowing. Trust, verified. Safety, certified.

If you run a medspa and your standards are ready to be verified, begin your application at medspaboard.com/certification-application. If you want to see where you stand first, download the free checklist at certification-checklist.

— Kate Dee, MD

Sources & further reading

• U.S. Food and Drug Administration, Warning Letter to R3 Medical Companies (CBER 26-726330), August 14, 2026. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/r3-medical-companies-726330-08142026
• U.S. Food and Drug Administration, “FDA puts company on notice for marketing unapproved stem cell products for treating serious conditions,” May 30, 2019. https://www.fda.gov/news-events/press-announcements/fda-puts-company-notice-marketing-unapproved-stem-cell-products-treating-serious-conditions
• U.S. Food and Drug Administration, “Public Safety Notification on Exosome Products,” December 6, 2019. https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/public-safety-notification-exosome-products
• U.S. Food and Drug Administration, “Public Safety Alert Due to Marketing of Unapproved Stem Cell and Exosome Products,” December 2019. https://www.fda.gov/safety/medical-product-safety-information/public-safety-alert-due-marketing-unapproved-stem-cell-and-exosome-products
• U.S. Food and Drug Administration, Warning Letter to Chara Biologics, Inc., January 17, 2025. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/chara-biologics-inc-698004-01172025
• U.S. Food and Drug Administration, Warning Letter to Supreme Rejuvenation, LLC, May 5, 2025. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/supreme-rejuvenation-llc-700749-05052025
• U.S. Food and Drug Administration, Warning Letter to Platinum Biologics LLC, August 15, 2025. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/platinum-biologics-llc-705090-08152025
• Centers for Disease Control and Prevention, “Notes from the Field: Infections After Receipt of Bacterially Contaminated Umbilical Cord Blood–Derived Stem Cell Products,” MMWR, December 20, 2018. https://www.cdc.gov/mmwr/volumes/67/wr/mm6750a5.htm
• Medical Daily, “Federal Regulators Cite an Arizona Stem Cell Company Over Sterility Failures and Claims Aimed at Desperate Patients,” September 2026. https://www.medicaldaily.com/fda-warning-letter-r3-medical-stem-cell-exosome-clinics-478193
• MedSpa Board, certification requirements. https://medspaboard.com/certificationrequirements/