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# Innate Healthcare Illegally Marketing Stem Cells: FDA
- URL: https://www.fdaweb.com/innate-healthcare-illegally-marketing-stem-cells-fda/
- Published: 2025-08-27T12:00:00.000Z
- Updated: 2026-09-14T15:20:16.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5159765

An FDA review of the Web site maintained by Innate Healthcare Institute in Scottsdale, AZ, found that the company markets “umbilical cord mesenchymal stem cells” for allogenic use in the diagnosis, cure, mitigation, treatment, or prevention of disease or conditions in humans and/or are intended to affect the structure or function of the body. An 8/15 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/innate-healthcare-institute-695592-08152025?ref=fdaweb.com) lists some of the claims FDA found on Innate’s Web site to justify the finding that the stem cell product is regulated as both a drug and a biologic for which agency approval is required.

The letter also says the firm’s products are misbranded because they do not have adequate directions for their intended uses.

FDA says its review also found that the company markets exosomes. They are regulated as drugs and are subject to premarket review and approval requirements, it says.

Innate was told to respond with a list of steps it has taken to address the violations and prevent their recurrence, with documentation of the steps and a schedule for completing the corrections.