SB299 Alabama 2025 Session

Summary

Primary Sponsor

Tim MelsonSenator

Republican

Session

2025 Regular Session

Title

Stem cell therapy; permitted in certain circumstances, notice and consent requirements provided, exceptions provided, State Board of Medical Examiners required to adopt rules

Summary

SB299 would let certain Alabama health care providers offer stem cell therapies not approved by the FDA if they give written notice and obtain informed consent, with required office postings and advertising disclosures, and it tasks the medical board with rules enforcement.

What This Bill Does

The bill defines stem cell therapy and who counts as a health care provider. It allows a provider to perform non-FDA-approved stem cell therapy if they provide written notice and obtain signed consent. It requires posting a notice in the office and including it in advertisements to say the therapy is not FDA-approved. It includes exemptions for FDA investigational therapies and for therapies done under certain employment or contractual arrangements, and it makes violations unprofessional conduct while requiring the Board of Medical Examiners to adopt implementing rules; the act becomes effective October 1, 2025.

Who It Affects

• Health care providers licensed in Alabama whose practice includes stem cell therapy, who may perform non-FDA-approved therapies if they meet notice and consent requirements.
• Patients receiving stem cell therapies not approved by the FDA, who must receive written notice and provide informed consent.
• Health care offices and advertisers offering stem cell therapy, which must display the required notice and include it in advertisements.
• The State Board of Medical Examiners, which would enforce the new rules and treat violations as unprofessional conduct.

Key Provisions

• Definition of stem cell therapy to include afterbirth placental perinatal cells or other human cells/tissues/products, excluding treatments using fetal or embryonic cells derived after abortion.
• A health care provider may perform non-FDA-approved stem cell therapy only if the patient receives written notice and the provider obtains a signed consent form before treatment.
• The consent form must explain the nature of the treatment, its FDA approval status, anticipated results, available alternatives, and the known risks/benefits in understandable language.
• Notice posting and advertisement requirements: display the notice in the office (large paper, readable font) and include it in advertising with legible text.
• Exemptions: the act does not apply to FDA-approved investigational therapies or to therapies performed under certain employment or contractual arrangements with specified accredited entities.
• Violations are deemed unprofessional conduct for licensure, and the Board of Medical Examiners must adopt rules to implement and enforce the act.
• Effective date: the act becomes effective on October 1, 2025.

AI-generated summary using openai/gpt-5-nano on Feb 22, 2026. May contain errors — refer to the official bill text for accuracy.

Subjects

Health