AUDIENCE: Health Professional, Patient, Consumer, Risk Manager
ISSUE: FDA is informing the public, especially patients, health care practitioners, and clinics, of multiple recent reports of serious adverse events experienced by patients in Nebraska who were treated with unapproved products marketed as containing exosomes. FDA is carefully assessing this situation along with our federal and state partners. Certain clinics across the country, including some that manufacture or market illegal “stem cell” products, are now also offering exosome products to patients. They deceive patients with unsubstantiated claims about the potential for these products to prevent, treat or cure various diseases or conditions.
BACKGROUND: As a general matter, exosomes used to treat diseases and conditions in humans are regulated as drugs and biological products under the Public Health Service Act and the Federal Food Drug and Cosmetic Act and are subject to premarket review and approval requirements. Clinics may claim that they these products do not fall under the regulatory provisions for drugs and biological products – that is simply untrue. There are currently no FDA-approved exosome products.
The clinics currently offering these products outside of FDA’s review process are taking advantage of patients and ultimately puts patients at risk by either delaying treatment with legitimate and scientifically sound treatment options, or worse, posing harm to patients, as evidenced by these recent reports of adverse events.
RECOMMENDATION: Patients considering treatment with exosome products in the United States should:
- Ask if the FDA has reviewed the treatment.
- Ask the clinical investigator to give you the FDA-issued Investigational New Drug Application (IND) number and the chance to review the FDA communication acknowledging the IND. Ask for this information before getting treatment and follow up with your personal health care provider to confirm this information.
- Sign a consent form. Because there are no approved products, patients must sign a consent form to participate in a clinical trial that requires an IND application. The consent form also identifies the Institutional Review Board (IRB) that assures the protection of the rights and welfare of human subjects. Make sure you understand the entire process and known risks before you sign. You also can ask the study sponsor for the clinical investigator’s brochure, which includes a short description of the product and information about its safety and effectiveness.
If you are considering treatment using an exosome product in another country you should:
- Learn about regulations that cover products in that country.
- Know that FDA does not have oversight of treatments done in other countries. FDA typically has little information about foreign establishments or their products.
- Be cautious. If you’re considering an exosome product in a country that may not require regulatory review of clinical studies, it may be hard to know if the experimental treatment is reasonably safe.
FDA remains committed to protecting patients. Our work to ensure compliance with the law does not take away from our firm commitment to advance an efficient path for the safe and effective development of novel regenerative medicine therapies and to help foster beneficial new innovations.
Health care professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report online.
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
[12/06/2019 – Public Safety Notification - FDA]