Is Exosome Therapy FDA Approved? No, and Here Is What That Means

No. As of the FDA's public safety notification of December 6, 2019, there are no FDA-approved exosome products.

Some microneedling devices are cleared by the FDA for specific uses. That covers the device, not a product applied with it. Not approved does not mean banned, and it does not mean safe.

Last reviewed October 15, 2026

What the FDA has said about exosome products

On December 6, 2019 the FDA told the public that it had received multiple reports of serious adverse events in patients in Nebraska who were treated with unapproved products marketed as containing exosomes. It said the Centers for Disease Control and Prevention, among others, alerted the agency, and that it worked with the state health department.

The same notice says there are currently no FDA-approved exosome products. It adds that exosomes used to treat diseases and conditions in humans are regulated as drugs and biological products, and that they are subject to premarket review and approval requirements.

The FDA asks patients to ask whether it has reviewed the treatment, and to request the investigational new drug (IND) number and the FDA letter acknowledging it before treatment. Health care professionals and consumers should report adverse events to MedWatch.

We read the notice on October 15, 2026. The page is marked "content current as of" December 6, 2019, so we cannot tell you from that page whether the FDA has said more since. We keep a dated capture of it in our records.

Are exosomes legal in the US?

"Not approved" and "illegal to use" are different claims, and neither one means "safe". The law decides by what a product is intended to do and how it is sold.

Cosmetics. The FDA does not approve cosmetics before they go on sale. A cosmetic is defined by its intended use, such as cleansing or changing appearance. A product meant to treat or prevent disease, or to affect the structure or function of the body, is a drug or sometimes a device, even if it also changes appearance. Source: FDA overview of cosmetics law, current as of November 18, 2025.
Warning letters. The FDA has sent warning letters to companies that sell exosome products. In one dated December 30, 2024, it concluded that three products from one company were unapproved new drugs and unlicensed biological products, and cited its own 2019 notice on exosomes. Source: FDA warning letter, December 30, 2024.
Clinics. A clinic should be able to tell you in plain words under what framework it uses a product, and show documents. If the answer is vague, that is information too.

We are an information service and cannot say whether a given product or clinic is lawful. That question is for a lawyer or the licensing board.

What the FDA has cleared: microneedling devices, not exosomes

Microneedling devices for aesthetic use are a regulated device type, class II, under 21 CFR 878.4430. The FDA has cleared specific devices for specific uses. For example, its 510(k) letter K241400, dated August 29, 2024, lists two uses for one prescription-use device: improving the look of wrinkles of the neck for Fitzpatrick skin types II to IV, and improving the look of facial acne scars in adults aged 22 and older of all Fitzpatrick skin types. The device is meant for trained health care professionals.

The regulation also says the classification does not include devices intended for transdermal delivery of topical products such as cosmetics, drugs or biologics. We read this as meaning that a device's clearance does not speak to the product placed on the skin. If a clinic says otherwise, ask it to show you the FDA document.

Sources: 21 CFR 878.4430 and FDA 510(k) letter K241400.

Claims that should make you pause

A product or clinic described as "FDA approved" in connection with exosomes. The FDA said in 2019 that no exosome product has that status.
A device clearance used to imply the product is cleared too.
Promises that a product will fix a medical problem. The FDA's notice says some clinics make unsubstantiated claims of this kind.
Logos, seals or wording that suggest FDA review without a document to back it up.

This site covers cosmetic uses only. For any medical condition, talk to a doctor.

Common questions

Is exosome therapy FDA approved?

No. As of the FDA's December 6, 2019 notice, there are no FDA-approved exosome products. We read the notice again on October 15, 2026 and its page still carries the 2019 date.

Does FDA clearance for a microneedling device cover the exosome product?

No. A clearance applies to the device and the uses listed in its indications. The regulation that classifies microneedling devices says the classification does not include devices intended for delivering cosmetics, drugs or biologics through the skin.

Can a clinic say its exosomes are FDA registered?

Ask exactly what the clinic means, and ask to see the document. “Registered” and “approved” are different words, and the FDA's 2019 notice says no exosome product is approved.

Where can I report a problem?

The FDA asks patients and clinicians to report adverse events related to exosome products or other unapproved products through its MedWatch program. Call 911 for an emergency.

Sources

This page has not yet been reviewed by a licensed clinician. Sources are listed below. Last editorial check: October 15, 2026.