By Alvin Philipose, DC (Ret.), Clinic Director · Part of our guide to Stem Cells & Exosomes in Oklahoma
No. As of October 2026, the FDA has not approved any exosome product for any use. The FDA’s public safety notification states directly that there are currently no FDA-approved exosome products, and the FDA’s list of approved cellular and gene therapy products contains none.
Why the FDA treats exosomes as drugs
Exosomes intended to treat, prevent or mitigate a disease are regulated as drugs and biological products under the Federal Food, Drug, and Cosmetic Act and Section 351 of the Public Health Service Act. They do not fit the lower-risk “361” tissue category because they are not tissue at all: they are products secreted by cells grown in culture, and they are typically used for functions other than what they did in the donor. To be given to people lawfully, they need an Investigational New Drug application (IND); to be sold, they need a Biologics License Application (BLA).
What prompted the FDA’s warnings
In December 2019 the FDA issued a public safety notification after reports of serious adverse events in patients who received unapproved exosome products. Since then the agency has issued repeated warning letters to manufacturers and clinics. In 2026, warning letters continued to name exosome products alongside umbilical cord and Wharton’s jelly products, and cited both disease claims in marketing and manufacturing-quality failures such as unvalidated sterile processing.
What the FDA looks at
- Claims: websites, videos and social posts that say a product treats a named disease.
- Manufacturing: sterility, endotoxin testing, potency and stability data.
- Homologous use: whether a tissue-derived product is used for the same basic function it had in the donor.
Topical and cosmetic exosome products
Exosome-containing skincare is sold as a cosmetic. Cosmetics do not go through FDA approval before sale, and a cosmetic that claims to treat a disease or change the structure of the body becomes an unapproved drug.
Do state laws change this?
State laws cannot approve a drug or biologic; federal FDA law applies in every state. Oklahoma’s SB 933, effective November 1, 2026, creates a state pathway for individualized treatments produced for one patient from their own genetic profile. It is not an approval of off-the-shelf exosome products. Read what SB 933 does and doesn’t cover.
How patients can access exosomes lawfully
- Clinical trials registered on ClinicalTrials.gov.
- FDA expanded access (single-patient IND) when a sponsor agrees to provide the product and the FDA allows it.
- The federal Right to Try Act, for products that have completed a Phase 1 trial and remain in active development, for patients with a life-threatening condition.
See how each pathway works, or call (405) 848-7246 and our team can help you and your physician look for options.
FAQ
Is it illegal to receive exosomes?
FDA rules govern the companies and providers who manufacture, market and administer unapproved products; they are not aimed at patients. The concern for patients is safety: without FDA oversight there is no assurance about what is in the product or how it was made.
Are exosomes from my own blood different?
Your own platelet-rich plasma prepared at the point of care is regulated differently from a manufactured exosome product. Isolating and concentrating exosomes is a different process and may move a preparation into the drug category.
Educational information only, not medical or legal advice. Sources: FDA Public Safety Notification on Exosome Products (Dec. 6, 2019); FDA Approved Cellular and Gene Therapy Products list; 21 CFR 1271.10.