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# Exocel Bio Selling Unapproved Exosomes: FDA
- URL: https://www.fdaweb.com/exocel-bio-selling-unapproved-exosomes-fda/
- Published: 2024-05-09T12:00:00.000Z
- Updated: 2026-09-14T14:30:26.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5156952

FDA says Exocel Bio in San Diego, CA, is selling unapproved exosome products through a Facebook page and YouTube channel. A 5/7 CBER [letter](https://www.fda.gov/media/178528/download?attachment&ref=fdaweb.com) cites examples of promotional statements that demonstrate the firm intends the products for use in the diagnosis, cure, mitigation, treatment, or prevention of disease.

The exosome products are legally considered to be drugs and biological products, FDA says, and must have a valid BLA in effect. The letter says there are no BLAs or INDs in effect for any of the company’s products.