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# Optimal Health Selling Unapproved Cellular Products: FDA
- URL: https://www.fdaweb.com/optimal-health-selling-unapproved-cellular-products-fda/
- Published: 2020-10-13T12:00:00.000Z
- Updated: 2026-09-14T16:32:13.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5147856

FDA says its review of the Web site and YouTube channel maintained by Optimal Health Stem Cell and Wellness Institute, Appleton, WI, indicates that the firm markets cellular products derived from human umbilical cord, adipose tissue, and amniotic membrane. A 10/[1 Notice of Violation](https://www.fda.gov/media/142836/download?ref=fdaweb.com) says that to lawfully market such products, a company must have a valid BLA or IND in effect.

“Your products derived from human umbilical cord, adipose tissue, and amniotic membrane are intended to treat a variety of diseases or conditions, including some that are severe or life-threatening,” the letter says. “Such unapproved uses raise potential significant safety concerns. Moreover, because at least some of these products are administered by higher-risk routes of administration, including intravenously and intrathecally, their use, if contaminated, could cause a range of adverse events.”

FDA reminds the company it is responsible for meeting all statutory and regulatory requirements and asks for a response to the findings in the letter.