Are Exosomes FDA Approved? 2026 Clinic Guide

Updated September 2026. Federal and state sources checked as of September 23, 2026.

Short answer: Are exosomes FDA approved? No. FDA has said since 2019 that "there are currently no FDA-approved exosome products," and it treats exosomes used to treat diseases or conditions as drugs and biological products that need premarket approval. Topical "cosmetic" exosome products are a gray area, but FDA has already acted against exosomes sold for topical use with treatment claims. Utah, Vermont and Florida add state duties on top, and none of them makes a product FDA-approved.

Are exosomes FDA approved? What FDA has said

FDA's position comes from two CBER notices:

December 6, 2019. FDA's public safety notification said exosomes used to treat diseases and conditions in humans are regulated as drugs and biological products and are subject to premarket review and approval. It reported serious adverse events in patients in Nebraska treated with unapproved products marketed as containing exosomes, and it called claims that such products fall outside the drug and biologic rules "simply untrue." It suggested patients ask for the IND number before treatment.
April 9, 2024. A consumer alert repeated that no exosome products are approved. It added that the only FDA-approved stem cell products are blood-forming stem cells derived from umbilical cord blood, and that products from adipose tissue, cord blood, Wharton's jelly or amniotic fluid are not approved for widely marketed uses such as orthopedic, neurologic or pain conditions.

HCT/P 361 vs 351: which framework applies

Human cells, tissues and cellular and tissue-based products (HCT/Ps) are regulated under 21 CFR Part 1271. The "361" and "351" labels refer to sections of the Public Health Service Act, and the difference decides whether a product needs FDA approval.

	361 HCT/P	351 biologic
Test	Meets every criterion in 21 CFR 1271.10	Misses any 1271.10 criterion, or is a drug or biologic by intended use
Key criteria	Minimally manipulated; homologous use; not combined with another article (limited exceptions); no systemic effect, or autologous, family-related or reproductive use	Fails one or more of these
Premarket approval	None; establishment registration and product listing	Approved biologics license (BLA), or an IND for clinical investigation

"Homologous use" means the tissue performs the same basic function in the recipient as in the donor. A supplier's statement that a product is "361" is a claim, not an FDA determination. FDA's exosome notice treats exosome products used to treat diseases or conditions as drugs and biological products needing premarket review, which is the 351 side of the table.

What FDA's letters to exosome sellers say

On May 7, 2024, CBER sent an untitled letter to Exocel Bio about its "Exovex" line, sold to health care providers across the U.S. FDA noted the products were used "for injection or topical use" and cited website, Facebook and YouTube statements about wound healing, alopecia, rosacea and inflammation. On that basis FDA called the products drugs and biological products, found no approved BLA and no IND in effect, and said shipping them in interstate commerce violated the FD&C Act and the PHS Act. Two details matter for clinics: the letter covered topical use, and it quoted a clinician customer's statements from the company's own YouTube channel as evidence of intended use.

Exosome skincare and FDA: the topical "cosmetic" question

Many exosome products for aesthetic practices are sold as topical serums or "cosmetics." Here is what FDA's rules do and don't settle:

Intended use decides the category. FDA establishes intended use from label and advertising claims, consumer perception and ingredients. Claims to restore hair growth, reduce cellulite or affect cell regeneration are drug claims, whatever the label says (FDA: cosmetic, drug or both).
"Cosmeceutical" is not a legal category. FDA says the FD&C Act doesn't recognize it. A product is a cosmetic, a drug, or both.
Microneedling is not an approved delivery route. FDA's microneedling device page says the devices are not approved for delivering cosmetics, topical medications, vitamin solutions, drugs or blood products into the skin.
Appearance-only exosome skincare is unsettled. We found no FDA statement that settles whether a human- or plant-derived "exosome" product making only appearance claims can be sold as a cosmetic. Until FDA speaks, treat that status as unconfirmed.

The words used by a supplier, on your website and in the treatment room feed into intended use, as the Exocel letter shows.

Is exosome therapy legal under state law? Utah, Vermont and Florida

MedGrid's state research found laws touching stem cell or regenerative therapies in 14 states. Some require disclosure, some permit certain non-FDA-approved uses under conditions, and some do both. Three matter most for exosome and birth-tissue products:

State	What the law requires	Exosomes covered?
Utah (Code 58-1-512, amended by SB 55, effective May 6, 2026)	Providers whose scope includes it may give non-FDA-approved placental or HCT/P stem cell therapy with a posted notice, a notice in all advertising and signed consent. New supplier duty: a person may supply HCT/Ps to a provider only after the provider confirms in writing that it will give patients the notice.	Not confirmed. The law uses the federal HCT/P definition, and secreted products such as exosomes may fall outside it.
Vermont (18 V.S.A. ch. 90, Act 61 of 2021)	Posted notices at the entrance and in patient areas, the notice in all advertising, and a patient-signed disclosure before each administration, kept in the chart.	Yes. "Stem cell-related products" include intracellular or extracellular components or vesicles. Source dated July 2022; check the current statute.
Florida (Fla. Stat. 458.3245 and the parallel DO section, since July 1, 2025)	MDs and DOs (not NPs or PAs) may perform non-FDA-approved stem cell therapy for orthopedics, wound care and pain management. Cells must come from an FDA-registered facility certified by a listed body such as AATB or AABB, with post-thaw viability testing, an advertising notice and signed consent. Willfully performing prohibited treatments is a third-degree felony.	Depends on the definition (afterbirth placental perinatal stem cells or HCT/Ps). Confirm with the Florida boards.

By contrast, Georgia's 2026 law (HB 1275) excludes secreted or extracted products, such as cell factors, from its definition. California, Washington, Tennessee, Wyoming and others have their own rules; see the sourced state stem cell law map.

Utah's supplier duty is new for 2026: a distributor or marketplace vendor shipping amniotic, placental or Wharton's jelly HCT/Ps to a Utah provider needs that written confirmation first.

Questions to ask an exosome or biologics supplier

Is the product licensed under a BLA, or distributed under an IND? If neither, what is the basis for selling it for your intended use?
For HCT/Ps: which 1271.10 criteria does the supplier say it meets, and is the establishment registered with FDA?
For topicals: what does the label and marketing claim? Any regeneration, hair-growth or condition claim is a drug claim.
For your state: does a notice or consent law apply, and does the supplier need a written confirmation from you?

MedGrid's exosome regulations page and cellular biologics page pull these rules together with live FDA lookups, and the regulatory lanes page explains how acellular and cellular biologics differ.

Sources

Frequently asked questions

Are exosomes FDA approved?

No. FDA has said since December 2019 that there are no FDA-approved exosome products, and it repeated that in an April 2024 consumer alert. FDA regulates exosomes used to treat diseases or conditions as drugs and biological products that need premarket approval, or an IND for clinical research.

Is exosome therapy legal?

Federally, an exosome product intended to treat a disease or condition needs an approved biologics license or an investigational new drug application in effect, and FDA has sent letters to firms selling exosomes without either. Some states add notice, consent or sourcing rules, but a state law cannot make an unapproved biologic FDA-approved.

Can exosome skincare be sold as a cosmetic?

It is unsettled. FDA decides by intended use, so claims about regeneration, hair growth or treating skin conditions make a product a drug. We found no FDA statement that settles whether an exosome product making only appearance claims can be marketed as a cosmetic, and FDA says microneedling devices are not approved for delivering topical products into the skin.

What is the difference between a 361 HCT/P and a 351 biologic?

A 361 HCT/P meets every criterion in 21 CFR 1271.10, including minimal manipulation and homologous use, and is regulated only under Part 1271, with registration and listing but no premarket approval. A product that misses any criterion is regulated as a drug, device or biological product and needs FDA approval or an IND.

Which states regulate exosome treatments?

Vermont's law expressly covers extracellular vesicles, so non-FDA-approved exosome use there comes with posted notices, advertising notices and signed disclosures. Utah and Florida regulate stem cell and HCT/P therapies, and Utah added a supplier duty on May 6, 2026. Georgia's 2026 law excludes secreted products such as cell factors from its definition.

This article is general information, not legal advice. Biologics rules and state stem cell laws change; confirm with FDA, your state boards and your counsel before ordering or administering these products.

Check the rules, then see what verified vendors list. Look up exosome and biologics rules for your state in the MedGrid regulations tool, and verify your NPI to see what diligence-cleared vendors list, with their licences and documents on each product page. Sign-up is free.

Are exosomes FDA approved? What aesthetic and regen clinics must know