Aesthetics & Wellness
Are Exosomes FDA-Approved for Aesthetic Use?
Published · Haute MD Editorial Team
No. FDA says "there are currently no FDA-approved exosome products." It first said so in a December 2019 public safety notification and repeated it in a July 2020 consumer alert, and FDA's list of approved cellular and gene therapy products, updated September 17, 2026, includes no exosome product. FDA says exosome products intended to treat diseases or conditions in humans generally require FDA approval, and its cosmetics guidance says a product marketed with claims such as restoring hair growth or regenerating cells is treated as a drug. FDA has also sent warning letters in 2025 and 2026 to companies selling exosome products. "Aesthetic" isn't a separate FDA approval category for exosomes. This is general information, not medical advice. Ask a board-certified physician about any treatment you are offered. For what the treatment itself involves and what studies show, see Exosome Therapy for Skin and Hair: Hype vs. Data.
At a glance
Is any exosome product FDA-approved? No. "There are currently no FDA-approved exosome products" (Public Safety Notification, Dec. 6, 2019; Consumer Alert, July 22, 2020).
Is there an exception for aesthetic use? FDA's pages don't create one. Its cosmetic-vs-drug rule turns on intended use, shown by claims, and lists claims to "restore hair growth" or "regenerate cells" as ones that make a product a drug.
Do cosmetics need FDA approval? Cosmetic products and ingredients (except color additives) do not need FDA approval before sale; drugs generally do.
Is a microneedling device the same as an approved exosome? No. FDA has cleared certain microneedling devices for specific uses, but says it hasn't cleared any for use with another product.
Does "FDA-registered" mean approved? No. FDA says a firm registering and listing a product does not mean the product is legally marketed.
What can I ask? FDA says to ask whether FDA has reviewed the treatment and to ask for the IND number.
What FDA has said, in order
December 6, 2019 — Public Safety Notification on Exosome Products. FDA reported "multiple recent reports of serious adverse events experienced by patients in Nebraska who were treated with unapproved products marketed as containing exosomes." It said there are no FDA-approved exosome products, and that "exosomes used to treat diseases and conditions in humans are regulated as drugs and biological products" subject to "premarket review and approval requirements."
July 22, 2020 — Consumer Alert on Regenerative Medicine Products Including Stem Cells and Exosomes (page content current as of April 9, 2024). FDA said "as a general matter, exosome products intended to treat diseases or conditions in humans require FDA approval" and "there are currently no FDA-approved exosome products." It also listed conditions for which "none of these products have been approved," including orthopedic, neurological, cardiovascular and pulmonary conditions, autism, macular degeneration, blindness, chronic pain and fatigue.
June 3, 2021 — Important Patient and Consumer Information About Regenerative Medicine Therapies (current as of April 8, 2024). FDA said there is "broad marketing of unapproved products," named exosomes among them, and said it had received reports of "blindness, tumor formation, infections, and more" tied to unapproved regenerative products as a group. It told anyone offered these products outside a clinical trial for which FDA has oversight to contact FDA at ocod@fda.hhs.gov.
May 5, 2025 — Warning letter to Supreme Rejuvenation, LLC (Houston, TX). FDA said the company's "stem cell exosome" products, including exosome gels and exosome preparations, were "unapproved new drugs" and "unlicensed biological products." FDA pointed to the company's website and Instagram claims, including statements about skin repair, reducing wrinkles, improving skin texture and stimulating hair growth, as evidence that the products were intended to affect the structure or function of the body.
May 26, 2026 — Warning letter to Blue Horizon International, LLC (Hackensack, NJ), which markets "exosome therapy" derived from Wharton's jelly. FDA said neither of the company's products was the subject of an approved biologics license application and that no investigational new drug application (IND) was in effect. That letter, like the 2025 one, is about those companies' products; it is not a ruling on every clinic.
Why "aesthetic use" doesn't change the answer
FDA's cosmetics page says "whether a product is a cosmetic or a drug under the law is determined by a product's intended use." Key points from that page (current as of September 11, 2024):
A cosmetic is intended for "cleansing, beautifying, promoting attractiveness, or altering the appearance." Cosmetic products and ingredients, with the exception of color additives, "do not require FDA approval before they go on the market."
A drug is a product intended to treat or prevent disease, or "to affect the structure or any function of the body." Drugs generally need premarket approval.
Intended use is shown by claims on labeling, advertising and the internet. FDA says "certain claims may cause a product to be considered a drug, even if the product is marketed as if it were a cosmetic," and gives as examples claims that products "will restore hair growth, reduce cellulite, treat varicose veins, increase or decrease the production of melanin (pigment) in the skin, or regenerate cells."
What we did not find: an FDA page that addresses skincare products that merely list "exosomes" as an ingredient. Those are a different question from exosome preparations used as treatments, and the claims on the label decide how FDA looks at them. Ask the manufacturer and your physician what the product is and what it claims.
Microneedling devices are not the same thing
Exosome preparations are often discussed alongside microneedling. FDA's microneedling pages (current as of October 15, 2025) say:
FDA has cleared microneedling devices "to improve the appearance of facial acne scars, facial wrinkles, and abdominal scars in patients aged 22 years or older."
"The FDA has not cleared any microneedling devices for use with another product," so FDA hasn't reviewed the safety or effectiveness of combining microneedling devices with creams, ointments, other drugs, cosmetics or platelet-rich plasma.
FDA has not cleared any microneedling devices for hair loss, although "clinical studies may be going on."
Microneedling devices "are not approved for delivery of cosmetics, topical medications.. vitamin solutions, drugs, or blood products."
These FDA pages don't mention exosomes. The point is narrower: a cleared device doesn't make a product used with it FDA-approved. FDA also lists an October 15, 2025 safety communication on radiofrequency (RF) microneedling on its device page; this page doesn't summarize it.
"FDA-registered," "clinical trial" and other phrases
FDA's 2021 page warns that patients are sometimes referred to clinicaltrials.gov, or told a product is registered with FDA, "as a way to suggest that the products being offered are in compliance with FDA laws and regulations. This is often false." It says that a product listed in the clinicaltrials.gov database, or a firm that has registered with FDA and listed its product, "does not mean the product is legally marketed."
Questions to ask before any exosome treatment
From FDA's 2019 notification:
1. Has FDA reviewed this treatment? FDA says to ask, and to ask the clinical investigator for the FDA-issued Investigational New Drug (IND) application number and the chance to review FDA's communication acknowledging it. 2. Is this part of a clinical trial? FDA says a trial that requires an IND involves a consent form that explains the experimental procedure and names the Institutional Review Board (IRB) protecting participants. 3. Is any part of it done abroad? FDA says it doesn't have oversight of treatments done in other countries.
Other questions to ask (ours, not FDA's): What is the product's exact name and maker? What is it being used for, and what does the practice claim it will do? What happens if there is a reaction, and who do I contact?
If something goes wrong
FDA asks patients and health care professionals to report adverse events related to exosome products to its MedWatch program. For questions about how a product is regulated or whether it is FDA-approved, FDA's consumer alert lists 800-835-4709 and ocod@fda.hhs.gov.
Find a physician
Dr. Dhaval Bhanusali — board-certified dermatologist
Dr. Lisa Airan — board-certified dermatologist
Neither profile lists exosome treatments. They are linked as board-certified dermatologists you can ask about regulated options for skin and hair. Ask any physician what they use, and ask the questions above.
Related Haute MD pages
Exosome Therapy for Skin and Hair: Hype vs. Data
Questions to Ask an Aesthetic Physician
Sources
Public Safety Notification on Exosome Products, U.S. Food and Drug Administration, December 6, 2019
Consumer Alert on Regenerative Medicine Products Including Stem Cells and Exosomes, FDA, July 22, 2020 (content current as of April 9, 2024)
Important Patient and Consumer Information About Regenerative Medicine Therapies, FDA, June 3, 2021 (content current as of April 8, 2024)
Approved Cellular and Gene Therapy Products, FDA (content current as of September 17, 2026)
Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?), FDA (content current as of September 11, 2024)
Warning letter: Supreme Rejuvenation, LLC, FDA, May 5, 2025
Warning letter: Blue Horizon International, LLC, FDA, May 26, 2026
Microneedling Devices and Microneedling Devices: Getting to the Point on Benefits, Risks and Safety, FDA (content current as of October 15, 2025)
All accessed October 11, 2026. FDA pages can change.
Frequently Asked Questions
Are exosomes FDA-approved?
No. FDA says there are currently no FDA-approved exosome products (Public Safety Notification, December 6, 2019; Consumer Alert, July 22, 2020). FDA's list of approved cellular and gene therapy products, current as of September 17, 2026, includes no exosome product.
Are exosomes FDA-approved for skin?
No exosome product is FDA-approved, for skin or any other use. FDA says a product's intended use, shown by its claims, decides whether it is a cosmetic or a drug. A claim to regenerate cells or restore hair growth is, in FDA's words, the kind of claim that makes a product a drug.
Are exosomes FDA-approved for hair loss?
No. FDA has not approved any exosome product, and its cosmetics page names restoring hair growth as a drug claim. FDA has also said it has not cleared any microneedling device for hair loss.
Is exosome therapy legal?
FDA says exosome products intended to treat diseases or conditions generally need FDA approval, and that a product still in development may be used clinically in humans only if there is an IND in effect (stated in its 2025 and 2026 warning letters). Whether a particular practice is compliant is a question for that practice and for FDA. Ask for the IND number if you are told a treatment is part of a study.
Can a topical exosome serum be sold without FDA approval?
Cosmetics generally don't need FDA approval before sale, but a product marketed with drug claims is treated as a drug. We found no FDA page that addresses exosome skincare products by name, so the claims on the label and what the product actually is matter. Ask your physician.
Are exosomes used after microneedling approved?
No exosome product is approved. FDA also says it has not cleared any microneedling device for use with another product, so it hasn't reviewed the safety or effectiveness of those combinations.
Does "FDA-registered facility" mean the treatment is approved?
No. FDA says a firm registering with FDA and listing its product does not mean the product is legally marketed, and that being listed on clinicaltrials.gov doesn't either.
What are the risks?
FDA's 2019 notification reported serious adverse events in Nebraska patients treated with unapproved exosome products. FDA's 2021 page lists concerns for illegally marketed regenerative medicine products as a group, including blindness, tumor formation, infections and reactions at the injection site. It does not give risk rates for exosomes specifically.
Where do I report a bad reaction?
To FDA's MedWatch Adverse Event Reporting program. FDA's consumer alert says health care professionals and consumers should report adverse events related to exosomes, and gives 800-835-4709 and ocod@fda.hhs.gov for regulatory questions.
Does "not FDA-approved" mean exosomes don't work?
No. Approval status and effectiveness are separate questions. This page covers what FDA has said about approval, not what studies show. See Exosome Therapy for Skin and Hair: Hype vs. Data and What Is Exosome Therapy?.
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