Cal. Code Regs. tit. 11, § 948 – Impact of FDA Status on Listing and Removal.

(a) A Brand Style that requires formal premarket authorization, approval, or order under 21 U.S.C. sections 387e(j) or 387j, but has not received such authorization, approval, or order is ineligible for listing on the UTL unless:
1. (1) The Brand Style contains nicotine derived from tobacco; the Brand Style was brought within the regulatory authority of the FDA under the May 10, 2016 Deeming Rule, 81 Federal Register 28973 through 29104; the Brand Style was marketed in the United States as of August 8, 2016; and the Brand Style has an application for formal authorization, approval, or order that was submitted to the FDA on or before September 9, 2020, was accepted for filing or review, and remains pending;
2. (2) The Brand Style contains nicotine derived from a source other than tobacco; the Brand Style was marketed in the United States as of April 14, 2022; and the Brand Style has an application for formal authorization, approval, or order that was submitted to the FDA on or before May 14, 2022, was accepted for filing or review, and remains pending; or,
3. (3) The Brand Style meets the criteria of subdivisions (a)(1) or (a)(2) of this Section, except the Brand Style no longer has a pending application with the FDA for formal authorization, approval, or order under 21 U.S.C. sections 387e(j) or 387j because a negative action on that application is stayed, rescinded by the FDA, or vacated by a court of competent jurisdiction.
(b) The Attorney General shall not exclude a Brand Style from the UTL under subdivision (a) of this Section for lacking formal premarket authorization, approval, or order under 21 U.S.C. sections 387e(j) or 387j if the Applicant demonstrates:
1. (1) The FDA has issued a rule, guidance, or other formal statement that the Brand Style does not require authorization, approval, or order under 21 U.S.C. sections 387e(j) or 387j, or,
2. (2) The Brand Style has been deemed to be within the FDA's regulatory authority under 21 U.S.C. section 387a or otherwise brought within the FDA's authority by statute or court order; the Brand Style was marketed in the United States as of the date it was deemed or otherwise brought within FDA's regulatory authority; and the Manufacturer or Importer of the Brand Style has submitted an application for formal authorization, approval, or order under 21 U.S.C. sections 387e(j) or 387j by the deadline established by the FDA that was accepted by the FDA for filing or review and remains pending, or has received a negative action that is stayed, rescinded by the FDA, or vacated by a court of competent jurisdiction.
(c) The Attorney General shall not exclude a Brand Style from the UTL under subdivision (a) for lacking formal premarket authorization, approval, or order under 21 U.S.C. sections 387e(j) or 387j if the Brand Style is a Variant of a Predicate Brand Style that has been placed on the UTL and a variant form for the Brand Style has been submitted under Section 947.

Note: Authority cited: Section 104559.1, Health and Safety Code. Reference: 21 U.S.C. Sections 387a, 387e and 387j; and Deeming Tobacco Products to Be Subject to the Federal Food, Drug and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; and Restrictions on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products, 81 Fed. Reg. 28973-29104 (May 10, 2016), Docket No. FDA-2014-N-0189.

History

1. New section filed 8-25-2025 as an emergency; operative 8-25-2025 (Register 2025, No. 35). A Certificate of Compliance must be transmitted to OAL by 2-23-2026 or emergency language will be repealed by operation of law on the following day.

2. New section refiled 2-18-2026 as an emergency; operative 2-24-2026 (Register 2026, No. 8). A Certificate of Compliance must be transmitted to OAL by 5-26-2026 or emergency language will be repealed by operation of law on the following day.

3. New section refiled 5-21-2026 as an emergency; operative 5-27-2026 (Register 2026, No. 21). A Certificate of Compliance must be transmitted to OAL by 8-19-2026 or emergency language will be repealed by operation of law on the following day.

4. Certificate of Compliance as to 5-21-2026 order, including amendment of subsections (a)(1)-(2) and (c), transmitted to OAL 5-7-2026 and filed 6-19-2026; amendments effective 6-19-2026 pursuant to Government Code section 11343.4(b)(3) (Register 2026, No. 25).