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# CBER Raps RichSource for Cell Therapy Claims
- URL: https://www.fdaweb.com/cber-raps-richsource-for-cell-therapy-claims/
- Published: 2019-11-22T12:00:00.000Z
- Updated: 2026-09-14T15:54:07.000Z
- Author: David McFarland
- Tags: Biologics, FDA Policy/General, #legacy-id-D5145571

CBER Office of Compliance and Biologics Quality has issued RichSource Stem Cells an [untitled letter](https://www.fda.gov/media/132931/download?ref=fdaweb.com) over promotional statements on its Web site ([https://richsourcestemcells.com](https://richsourcestemcells.com/?ref=fdaweb.com)) for cell therapy and “regenerative therapy” RichGen. The letter says that the product also does not have an approved BLA.

“We note that your product is intended to treat a variety of diseases or conditions, including some that are serious or life-threatening,” CBER says. “Such unapproved uses raise potential significant safety concerns. Additionally, because the product is administered by various higher risk routes of administration, including via spinal injections, their use, if contaminated could cause a range of adverse events.”

The letter also directs the firm to review FDA’s regenerative medicine policy framework for tissue and cell-therapy products at [https://www.fda.gov/BiologicsBloodVaccines/CellularGeneTherapyProducts/ucm585218.htm](https://www.fda.gov/BiologicsBloodVaccines/CellularGeneTherapyProducts/ucm585218.htm?ref=fdaweb.com).