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# Scarsdale Integrative Marketing Unapproved Cell Products: FDA
- URL: https://www.fdaweb.com/scarsdale-integrative-marketing-unapproved-cell-products-fda/
- Published: 2021-07-14T12:00:00.000Z
- Updated: 2026-09-14T17:06:20.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5149703

The CBER Office of Compliance and Biologics Quality says its review of a Web site, Facebook page, and other materials relating to Scarsdale Integrative Family Medicine (doing business as See Beyond), Scarsdale, NY, has determined that the practice markets a cellular product that appears to be derived from human umbilical cord and/or human umbilical cord blood to consumers to treat pain and various diseases or conditions, including some that are serious or life-threatening. A 7/9 [Notice of Violation](https://www.fda.gov/media/150744/download?ref=fdaweb.com) says such products are regulated as drugs and biologics and require a valid biologics license or investigational new drug application, neither of which have been obtained by Scarsdale.

The letter also notes Web site and Facebook references to exosomes and says that generally exosome products intended to treat diseases or conditions in humans are also regulated as drug and biologic products that are subject to premarket review and approval requirements.

The letter reminds Scarsdale that it is responsible for ensuring that all its products comply with applicable laws and requests a response.