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# More FDA Stem Cell Steps Needed: Pew
- URL: https://www.fdaweb.com/more-fda-stem-cell-steps-needed-pew/
- Published: 2019-08-22T12:00:00.000Z
- Updated: 2026-09-15T01:45:37.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5144837

The Pew Charitable Trusts says that while FDA and members of Congress have taken important steps in recent months to protect consumers from unproven and risky stem cell products offered by hundreds of clinics nationwide, “the agency needs to take broader action to deter businesses from selling interventions whose safety and effectiveness have not been proven to regulators.”

A Pew online [report](https://www.google.com/amp/www.pewtrusts.org/en/research-and-analysis/articles/2019/08/22/fda-and-congress-move-to-stop-unproven-stem-cell-interventions%3famp=1?ref=fdaweb.com) outlines actions FDA has taken in recent years to remove high-risk treatments from the marketplace. “Although FDA recognizes the therapeutic promise of stem cells,” it says, “it has long warned of the public health threat posed by unapproved products.” It references four 2017 guidances that provide the agency’s regulatory framework for regenerative medicine, a growing field that includes therapies derived from living human tissue.

CBER director **Peter Marks** told Pew that FDA “will continue to take steps in this area to prevent the use of unproven and potentially dangerous products through whatever enforceable legal means are necessary to protect the public.”