SkinSelf Renewal Blog
Are Exosomes FDA Approved? What the FDA Says About Exosome Products
No. As of September 2026, the FDA states that there are currently no FDA-approved exosome products in the United States. The FDA regulates exosome products intended to treat diseases or medical conditions, and such products generally require FDA review and approval before they can be legally marketed for those uses. This distinction is particularly important for patients considering exosome-based skin treatments, exosome injections, exosome facials or microneedling with exosome-containing products. At Azani Medical Spa in Bethlehem, PA, patients considering emerging exosome-based aesthetic treatments should understand the difference between scientific research, commercial marketing, FDA authorization, FDA approval and investigational use. The fact that exosomes are an active area of scientific research does not mean that a particular commercial exosome product has been approved by the FDA. At a Glance: Are Exosomes FDA Approved? Question Evidence-Based Answer Are exosomes FDA approved? No. FDA states that there are currently no FDA-approved exosome products.… Read More
