With exosome companies rapidly populating in recent years, some of the companies have been working closely with the U.S. FDA to get a specific IND for each clinical condition. Other exosome companies have not and have been supplying their exosome products to consumers without regulatory oversight, despite the FDA being very clear that exosomes are now under their purview.
On January 16, 2020, yet another exosome company entered the public eye. The latest supplier of exosome products is Regen Suppliers, based in Scottsdale, Arizona.
In its recent press release, Regen Suppliers states that it offers ReBella and ReBellaXO, umbilical stem cell and exosome products used for regenerative aesthetic procedures involving hair, facial and sexual rejuvenation. According to the company, ReBellaXO is an “MSC Derived Exosome Biologic that is a minimally manipulated allograft derived from full term, post c-section umbilical cord tissue and Wharton’s Jelly.”
Currently, there are no FDA-approved exosome products and exosomes are clearly regulated by the U.S. FDA with products requiring a specific IND for each clinical condition.
In a ‘Public Safety Notification on Exosome Products’ released on Dec 6, 2019, the FDA states: “Exosomes used to treat diseases and conditions in humans are regulated as drugs and biological products under the Public Health Service Act and the Federal Food Drug and Cosmetic Act and are subject to premarket review and approval requirements.”