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# Chara Biologics Markets Unapproved Cell Product: CBER
- URL: https://www.fdaweb.com/chara-biologics-markets-unapproved-cell-product-cber/
- Published: 2019-12-05T12:00:00.000Z
- Updated: 2026-09-14T15:55:32.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5145663

The CBER Office of Compliance and Biologics Quality says Chara Biologics, Woodland Hills, CA, is marketing its unapproved CharaCore product to consumers, including parents of children with autism. According to an FDA [letter](https://www.fda.gov/media/133215/download?ref=fdaweb.com) to the company, the firm’s Web sites say that CharaCore contains “umbilical, cord tissue, and amniotic membrane” and is described as an “umbilical cord-derived cellular product” that is “suitable for all forms of injections, to assist the body’s ability to repair and regenerate.”

CharaCare is promoted for serious or life-threatening diseases or conditions, FDA says.

The letter says CBER regulates CharaCore as a drug and a biological product. To lawfully market a drug that is also a biological product, it says, a valid biologics license must be in effect. The letter says unapproved uses of the product for serious or life-threatening diseases or conditions “raise potential significant safety concerns.”