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# The Body Building Selling Unapproved Cellular Products: FDA
- URL: https://www.fdaweb.com/the-body-building-selling-unapproved-cellular-products-fda/
- Published: 2021-01-27T12:00:00.000Z
- Updated: 2026-09-14T16:44:26.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5148532

CBER says its review of a Web site and Facebook page indicate that The Body Building, Clovis, CA, is marketing cellular products derived from human umbilical cord or human umbilical cord blood for many diseases and conditions. A 1/25 [Notice of Violation](ttps://www.fda.gov/media/145459/download) says that FDA regulates such products as drugs and biological products that require approval through a BLA or IND.

The letter also notes that the company lists an exosome product as one of its treatments and reminds the company that, as a general matter, exosome products intended to treat diseases or conditions in humans are also regulated as drugs and biological products and are subject to premarket review and approval requirements.

The Body Building was told to respond within 30 days.