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# Young Center Illegally Marketing Stem Cell Product: FDA
- URL: https://www.fdaweb.com/young-center-illegally-marketing-stem-cell-product-fda/
- Published: 2020-11-03T12:00:00.000Z
- Updated: 2026-09-14T16:35:01.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5148009

The CBER Office of Compliance and Biologics Quality says the Young Foundational Health Center, Largo, FL, is using a Web site, Facebook, and YouTube to market a cellular product administered intravenously for various diseases or conditions. A 10/30 [Warning Letter](ttps://www.fda.gov/media/143475/download) says the product is sometimes referred to in promotional materials as umbilical cord stem cells or stem cell therapy.

The letter says that a valid BLA or IND needs to be in effect for the lawful marketing of a drug that is also a biological product.

FDA says the Young Center’s marketing for unapproved uses “raises potential significant safety concerns. Moreover, because your product is administered by a higher risk route of administration, its use, if contaminated, could cause a range of adverse events.”

The Young Center was told to respond within 30 days.