Comments Presented at an FDA Listening Session Regarding FDA Enforcement of Regulations Applicable to Stem Cell and Regenerative Medicine Clinics that are Administering Unapproved Human Cells, Tissues, and Cellular and Tissue-Based Products

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In order to protect patients and public health, the Food and Drug Administration (FDA) after May 31, 2021, must take swift and aggressive enforcement actions against establishments — including self-identified stem cell and regenerative medicine clinics — engaged in the manufacturing or marketing of illegal, unapproved human cells, tissues, and cellular and tissue-based products. Such action to stop the manufacturing, marketing, and use of these unapproved, illegal products that have the potential to cause serious harm to patients but have not been proven to be effective and raise false hopes for patients is long overdue.