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# Vitacell Biologics Illegally Selling Cellular Products: FDA
- URL: https://www.fdaweb.com/vitacell-biologics-illegally-selling-cellular-products-fda/
- Published: 2024-01-25T12:00:00.000Z
- Updated: 2026-09-14T14:21:12.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5156220

The CBER Office of Compliance and Biologics Quality says its review of a Web site maintained by Vitacell Biologics in Lewisburg, TN, found the company is illegally selling cellular products derived from human umbilical cords and an exosome product. A 1/16 [untitled letter](https://www.fda.gov/media/175643/download?attachment&ref=fdaweb.com) lists Web site testimonials for the products that demonstrate the products are regulated as drugs, devices, and/or biologics.

The company does not have the required approvals for its products, the letter says.

Vitacell was advised to comprehensively review its Web site, product labels, and other labeling and marketing materials to ensure that it is lawfully marketing its products in full compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations. The agency asked for a written response from the company.