Unapproved Commercial Interventions

If you have already had a bad reaction

If you have severe symptoms after a treatment, call 911 or your local emergency number first. Then tell the clinician who treats you which product you received. The FDA encourages anyone hurt or with a bad side effect after a regenerative medicine product to report it to its MedWatch program. [1] MedWatch is the FDA's safety reporting program for health professionals, patients and consumers. [2] A paper form can be requested by phone at 1-800-332-1088. [3]

Quick answer

Some clinics and companies sell treatments that no regulator has approved. This page covers what the U.S. FDA has said about them, mostly products marketed as "regenerative." Dates matter: the FDA pages read were posted in 2019 to 2021 and some were last updated in 2024, so check the FDA site for changes. This is information, not legal or medical advice. Other countries differ.

What the FDA has said (United States)

• Stem cell products. The FDA's consumer alert of July 22, 2020 says that, currently, the only FDA-approved stem cell products consist of blood-forming stem cells from umbilical cord blood, approved for disorders that affect production of blood but not for other uses. [4]
• Exosome products. The same alert says there are currently no FDA-approved exosome products. [4]
• Conditions. The FDA states regenerative medicine therapies have not been approved to treat any neurological disorder such as multiple sclerosis or ALS, or any orthopedic condition such as osteoarthritis, tendonitis or disc disease. [1]
• Clinics. The FDA says it has repeatedly notified manufacturers, clinics and health care practitioners of the need for Investigational New Drug applications. [1]
• Charging. It says that if you are charged for these products, or offered them outside a clinical trial, you are likely being deceived and offered a product illegally. [1]

Harms the FDA lists

For illegally marketed regenerative medicine products the FDA lists safety concerns including blindness, tumor formation, bacterial infections including life-threatening blood infections, unwanted inflammatory or immune responses, and cross-contamination with bacteria, viruses or mold related to processing. [1] In December 2019 it reported serious adverse events in patients in Nebraska treated with unapproved products marketed as containing exosomes. [5] Delays matter too: the FDA says such clinics put patients at risk by delaying treatment with legitimate, scientifically sound options. [5]

These are harms the FDA described for these product types, not a measure of how often they occur.

Claims that are not proof

• "It is registered." The FDA says listing in clinicaltrials.gov, or a firm registering with the FDA, does not mean the product is legally marketed. [1]
• "It is your own cells, so FDA does not matter." The FDA's page names products recovered from your own body or another person's body as covered by its warnings. [1]
• "We are a clinic, so it is approved." A clinic offering a treatment does not establish approval. See Claim Check: "FDA Registered" vs Product Approval.
• A disclaimer. A disclaimer does not make unsupported claims acceptable. See Overpromising and the Limits of Disclaimers.

General red flags from the FDA

The FDA says a health product is fraudulent if it is deceptively promoted as effective against a disease or condition but not scientifically proven safe and effective. [6] Its tip-offs include: [6]

• One product that claims to cure a wide range of diseases.
• Personal success stories, which are easy to make up and are not scientific evidence.
• Quick fixes: few conditions can be treated quickly, even with legitimate products.
• "All natural" wording, which does not necessarily equate to safety.
• "Miracle cure," "secret ingredient" or "guaranteed results" language.

If tempted by a questionable product, the FDA says to check first with your doctor or other health care professional. [6]

Questions to ask before any treatment

The FDA suggests asking whether it has reviewed the treatment and asking the clinical investigator for the FDA-issued IND number. [5] You can also get the consent form, which identifies the Institutional Review Board that protects participants' rights and welfare. [5] For regenerative products, the FDA invites questions at 800-835-4709 or ocod@fda.hhs.gov. [4] See How We Label Evidence for our evidence words.

Treatment abroad

The FDA says it does not have oversight of treatments done in other countries. [5] See Unapproved Clinics and Medical Tourism for Cell Therapies and Medical Tourism for Unproven Treatments.

Legitimate routes instead

For serious illness, ask your physician about registered clinical trials or about Expanded Access. See also Regulatory Status of Regenerative Products by Product and Indication and Financial Conflicts in Emerging Health Products.