1. (a) Information and documentation designated nonpublic and submitted under subdivisions (c)(8) and (c)(9) of Section 945, subdivision (g)(11) of Section 946, or subdivisions (b)(2) or (b)(3) of Section 952 shall be considered additional information and documentation regarding a Brand Style's status with the FDA that is confidential and proprietary under Health and Safety Code section 104559.1, subdivision (b)(3)(B), and not subject to disclosure under the California Public Records Act (Division 10 (commencing with section 7920.000) of Title 1 of the Government Code), with the exception of the following publicly disclosable FDA status designations:

   1. (1) “FDA authorization, approval, or order received,” if, under subdivision (c)(8) of Section 945, the Brand Style has received formal authorization, approval, or order from the FDA under 21 U.S.C. sections 387e(j) or 387j.
   2. (2) “Under Review by FDA,” if, under subdivision (c)(8)(B) of Section 945, formal authorization, approval, or order for the Brand Style has been sought under 21 U.S.C. sections 387e(j) or 387j, and, under subdivision (c)(8)(B)(i)(VII)(f) of Section 945, a request for authorization, approval, or order under 21 U.S.C. sections 387e(j) or 387j remains pending and under review by the FDA or, under subdivision (c)(8)(B)(i)(VII)(g) of Section 945, a provisional Substantial Equivalence report under 21 U.S.C. section 387j(a)(2)(B) remains under review by FDA.
   3. (3) “Negative action on application stayed or rescinded by FDA,” if, under subdivision (c)(8)(B) of Section 945, formal authorization, approval, or order for the Brand Style has been sought under 21 U.S.C. sections 387e(j) or 387j, and, under subdivision (c)(8)(B)(i)(VII)(b) or (c)(8)(B)(i)(VII)(c) of Section 945, a Marketing Denial Order (MDO), Not Substantially Equivalent (NSE), or Not Exempt Order for the Brand Style was stayed or rescinded by the FDA.
   4. (4) “Negative action on application stayed or vacated by court,” if, under subdivision (c)(8)(B) of Section 945, formal authorization, approval, or order for the Brand Style has been sought under 21 U.S.C. sections 387e(j) or 387j, and, under subdivision (c)(8)(B)(i)(VII)(e) of Section 945, a Marketing Denial Order (MDO), Not Substantially Equivalent (NSE), or Not Exempt Order for the Brand Style was stayed or vacated by a court of competent jurisdiction.
   5. (5) “Provisional Substantial Equivalence Product Removed From Review under 21 U.S.C. section 387j(a)(2)(B)”, if, under subdivision (c)(8)(B) of Section 945, formal authorization, approval, or order for the Brand Style has been sought under 21 U.S.C. sections 387e(j) or 387j, and, under subdivision (c)(8)(B)(i)(VII)(g) of Section 945, a provisional substantial equivalence report was submitted under 21 U.S.C. section 387j(a)(2)(B) and removed from review by the FDA.
   6. (6) “FDA authorization, approval, or order not sought,” if, under subdivision (c)(8)(B) of Section 945, authorization, approval, or order for the Brand Style has not been sought under 21 U.S.C. sections 387e(j) or 387j for one of the reasons identified under subdivision (c)(8)(B)(ii) of Section 945.
   7. (7) “FDA authorization, approval, or order denied,” if, under subdivision (c)(8)(B) of Section 945, formal authorization, approval, or order for the Brand Style has been sought under 21 U.S.C. sections 387e(j) or 387j, and, under subdivision (c)(8)(B)(i)(VII)(a), a Marketing Denial Order (MDO), Not Substantially Equivalent (NSE), or Not Exempt Order for the Brand Style was received and has not been rescinded or stayed by FDA under subdivisions (c)(8)(B)(i)(VII)(b) or (c)(8)(B)(i)(VII)(c) of Section 945 or stayed or vacated by a court of competent jurisdiction under subdivision (c)(8)(B)(i)(VII)(e) of Section 945.
   8. (8) “FDA issued 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,” if under subdivision (c)(8)(B) of Section 945, formal authorization, approval, or order for the Brand Style has been sought under 21 U.S.C. sections 387e(j) or 387j, and, under subdivision (c)(8)(B)(i)(VII)(h) of Section 945, the Applicant indicates that 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.
2. (b) Information and documentation submitted under subdivision (b) of Section 949 and design files submitted under subdivision (c)(7) of Section 945 or subdivision (g)(12) of Section 946 that are designated as nonpublic shall be considered additional information and documentation regarding a Brand Style's status with the FDA, packaging, and marketing that is confidential and proprietary under Health and Safety Code section 104559.1, subdivision (b)(3)(B), and not subject to disclosure under the California Public Records Act.
3. (c) Additional information and documentation submitted under subdivision (f) of Section 950 that relates to a removal decision based on Brand Style's characterizing flavor or FDA status is considered confidential and proprietary information under Health and Safety Code section 104559.1, subdivision (f)(2)(D), that is not subject to disclosure under the California Public Records Act.

4. (d) The Attorney General shall consider the following to be additional information and factual substantiation regarding a Brand Style's lack of Characterizing Flavor that is confidential and proprietary under Health and Safety Code section 104559.1, subdivision (b)(2)(B), and not subject to disclosure under the California Public Records Act:

   1. (1) Information and factual substantiation regarding a Brand Style's lack of Characterizing Flavor in a product form or variant form provided under subdivisions (c)(10) and (c)(11) of Section 945, subdivisions (g)(13) and (g)(15) of Section 946, or subdivision (b)(4) of Section 952 through the Attorney General's UTL web portal or by other means approved by the Attorney General; and
   2. (2) Information and factual substantiation regarding a Brand Style's lack of Characterizing Flavor provided in response to requests for additional information by the Attorney General under subdivisions (a) of Section 949.
5. (e) The Attorney General may disclose confidential and proprietary information received from UTL Applicants to third-party consultants designated by the Attorney General, provided the recipient agrees in writing to maintain the confidentiality of the information.

Note: Authority cited: Section 104559.1, Health and Safety Code. Reference: Section 104559.1, Health and Safety Code.

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)-(a)(7), (b) and (d)(1) and new subsection (a)(8), 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).