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# Peace Wellness Marketing Tissue Products: FDA
- URL: https://www.fdaweb.com/peace-wellness-marketing-tissue-products-fda/
- Published: 2023-09-27T12:00:00.000Z
- Updated: 2026-09-14T18:58:42.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5155432

A CBER review of the Web site maintained by the Peace Wellness Center in Phoenix, AZ, established that the company markets “stem cell therapy” products to consumers to treat various diseases or conditions. Implying potential violations, a 9/21 [unlabeled letter](https://www.fda.gov/media/172438/download?attachment&ref=fdaweb.com) says the company represents that the products are derived from sources including umbilical cord or placental tissue. They are administered by nebulizer, intranasally, and/or injection, including intravenous injection, the letter says.

The CBER letter says such products are regulated as drugs and biologics and require a BLA or IND to be in place.

CBER says its review of company materials also appears to show that Peace Wellness markets exosome products. “As a general matter,” it says, “exosome products intended to treat diseases or conditions in humans are also regulated as drugs and biological products and are subject to premarket review and approval requirements.”

Peace Wellness was told to respond to the letter within 30 days and to provide its reasoning if it believes there is no basis for the regulatory concerns cited in the letter.