UT SB0055

Suppliers of human cells, tissues, or cellular/tissue-based products for stem cell therapy must obtain written confirmation from health care providers that patients will receive the required FDA non-approval disclosure notice before supplying the products.

Health care providers performing non-FDA-approved stem cell therapies must provide written notice (at least 8.5"x11" paper, 40-point type) informing patients the therapy lacks FDA approval and encouraging consultation with their primary care provider.

Providers must obtain signed consent forms detailing the treatment's nature, FDA approval status, anticipated results, alternative treatments, and possible risks before performing stem cell therapy.

All advertisements for stem cell therapy must include the FDA non-approval notice in font size no smaller than the largest font in the advertisement, or clearly spoken in audio/video ads.

Effective date: May 6, 2026.