Are Exosome Serums Regulated?
Exosome serums, popular in skincare and hair treatments for their promises of healing and regeneration, face strict oversight in places like the United States, but they lack full approval for cosmetic use. These tiny sacs from cells carry proteins and signals that can boost skin repair or hair growth, yet regulators treat them more like medicines than simple beauty products.
In the US, the Food and Drug Administration views exosomes as both drugs and biologics, meaning companies need special licenses to sell them legally. For example, in May 2024, the FDA issued a warning letter to ExoCelBio for marketing exosome products without a biologics license. This reflects tougher guidelines that kicked in recently, cracking down on unapproved claims. Topical exosome serums for hair loss or anti-aging fall under this scrutiny because they act at a cellular level, not just on the skin’s surface.
Cosmetic serums with exosomes are not FDA-approved for beauty purposes, so they remain unregulated as everyday skincare. The FDA demands extensive safety tests and clinical trials for drugs, which most exosome products have not completed. Products like Plated Skin Science, packed with platelet-derived exosomes, highlight this gap: they are sold but without the green light that ensures proven safety and effectiveness.
Some clinics claim their exosomes come from FDA-regulated labs, using sources like umbilical cord stem cells screened for purity. These steps help avoid contaminants, but they do not equal full product approval. In Europe, rules are even tighter, banning human-derived exosomes for hair loss treatments.
The Modernization of Cosmetics Regulation Act of 2022 boosted FDA powers over cosmetics, adding rules for manufacturing and safety records. Still, it carves out exemptions for items like injectables or those meant for internal use, which some exosome applications might touch. Experts urge sticking to medical-grade versions from compliant sources to minimize risks.
Without regulation, quality varies widely. Serum-free production avoids animal contaminants like those in fetal bovine serum, but many products skip rigorous checks. Buyers should watch for purity claims backed by lab standards, as untested serums could spark reactions or fail to deliver.
Sources
https://www.hairlosscure2020.com/topical-exosomes-for-hair-growth/
https://pmc.ncbi.nlm.nih.gov/articles/PMC12729007/
https://empireondemand.com/blogs/posts/what-are-exosomes-science-benefits-clinical-uses
https://www.aol.com/shopping/beauty/review/exosomes-are-the-newest-anti-aging-skincare-trend-but-do-they-work-we-put-them-to-the-test-150025330.html
https://stemcellmia.com/microneedling-exosomes-side-effects/
https://www.fda.gov/cosmetics/cosmetics-laws-regulations/modernization-cosmetics-regulation-act-2022-mocra
https://www.droracle.ai/articles/651390/can-exosomes-improve-erectile-dysfunction-ed
