Except as permitted by federal law, a person shall not sell a gene therapy kit in this state unless the seller includes a notice on the seller’s internet website in a conspicuous location that is displayed to the consumer prior to the point of sale, and on a label on the package containing the gene therapy kit, in plain view and readily legible, stating that the kit is not for self-administration.
Chapter 37Gene Therapy Kits: Notice
Section § 22949.50
This law says that gene therapy kits can’t be sold in California unless there's a clear notice both online before a customer buys it and on the physical packaging. The notice must state the kit is not meant for people to use on themselves.
gene therapy kit self-administration consumer notice internet website display package label seller's responsibility point of sale federal law exception purchase requirements California sales regulation
Section § 22949.51
This section defines key terms related to gene therapy. Gene therapy involves using genetic material to change how genes are expressed or to change living cells for therapeutic reasons. A gene therapy kit is a set of items designed to help perform gene therapy experiments, including tools like CRISPR systems, which are used to cut DNA at specific sites.
For purposes of this chapter, the following definitions apply:
(a)CA Business and Professions Code § 22949.51(a) “Gene therapy” refers to the administration of genetic material to modify or manipulate the expression of a gene product, or to alter the biological properties of living cells, for therapeutic use.
(b)CA Business and Professions Code § 22949.51(b) “Gene therapy kit” refers to a product that is sold as a collection of materials for the purpose of facilitating gene therapy experiments, including, but not limited to, a system for the targeted cutting of DNA molecules, such as type II clustered regularly interspaced short palindromic repeats (CRISPR), associated proteins (CRISPR-Cas) systems,
including CRISPR-Cas9, as described in Regents of University of California v. Broad Institute, Inc. (2018) 903 F.3d 1286.
gene therapy genetic material gene expression living cells therapeutic use gene therapy experiments gene therapy kit CRISPR DNA cutting CRISPR-Cas systems CRISPR-Cas9 targeted DNA editing Regents of University of California v. Broad Institute type II CRISPR associated proteins
