Health care practitioners: stem cell therapy.

Existing law provides for the licensure and regulation of various health care practitioners by boards within the Department of Consumer Affairs. Existing law requires licensed health care practitioners who perform stem cell therapies that are subject to regulation by the United States Food and Drug Administration (FDA) , and that are not FDA approved, to communicate to their patients specified information regarding the therapies in a notice and in writing prior to providing the initial stem cell therapy. Existing law exempts from these requirements a health care practitioner who has obtained clearance for an investigational new drug, or an investigational device exemption, from the FDA. Existing law authorizes the licensing board having jurisdiction over the health care practitioner to cite and fine the health care practitioner for violation of these provisions. This bill would additionally require a health care practitioner to include in all print and digital advertising materials, including internet websites, that the administration of stem cell therapies by the health care practitioner is not FDA approved. The bill would specify that it does not apply to research being conducted under the California Stem Cell Research and Cures Act.