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# Regenerative Cell Institute Illegally Marketing Cellular Products: FDA
- URL: https://www.fdaweb.com/regenerative-cell-institute-illegally-marketing-cellular-products-fda/
- Published: 2020-11-19T12:00:00.000Z
- Updated: 2026-09-14T16:37:03.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5148132

The CBER Office of Compliance and Biologics Quality says its review of a Web site maintained by the Regenerative Cell Institute, Las Vegas, NV, indicates the firm markets cellular products derived from either human adipose tissue or umbilical cord to consumers to treat various diseases or conditions. An 11/10 [Notice of Violation](https://www.fda.gov/media/143721/download?ref=fdaweb.com) says the products are regulated by FDA as drugs and/or biological products and are subject to the approval of an NDA or BLA.

The letter says the company’s use of the products to treat a variety of diseases or conditions including some that are serious or life-threatening, “raises potential significant safety concerns. Moreover, because these products appear to be administered by higher risk routes of administration, including intravenously and intranasally, their use, if contaminated, could cause a range of adverse events.”

The letter also notes that the Web site lists exosomes as one of its services and reminds the company that generally exosome products treating diseases or conditions in humans are regulated as drugs and biological products.

The company was told to respond within 30 days.