1. (a) A product form or variant form, as described in Section 946, must be completed and submitted to the Attorney General for a Brand Style in order to apply for placement of that Brand Style on the UTL. A Brand Style will not be considered for placement on the UTL unless and until a UTL application is submitted as outlined in Section 947; a product form or variant form alone is insufficient. A separate product form or variant form is required for each Brand Style, with two exceptions:

   1. (1) A separate product form or variant form need not be submitted for a Carton or Roll of the Brand Style if that Carton or Roll has been identified on the product form or variant form for the Brand Style and all information on the product or variant form is completed for the Carton or Roll, including submission of a design file or photographs as described in subdivision (c)(7).
   2. (2) A separate product or variant form is not required for variations in a Brand Style caused by changes in manufacturing materials or process that are not distinguishable by an ordinary consumer, where a product form or variant form for the Brand Style has already been submitted. Examples of such changes include replacement of a cigarette's tipping paper with substantially identical tipping paper from a new source, a minor adjustment in a cigarette's size (e.g., 84 mm to 83.8 mm) that is not marketed differently, and minor changes resulting from a Brand Style being manufactured by hand, such as minor inconsistencies in the dimensions of a hand wrapped cigar.
2. (b) Product forms shall be completed and submitted through the Attorney General's UTL web portal. Upon a showing of good cause that outweighs the operational needs of the Attorney General, the Attorney General shall permit exceptions from use of the web portal for product forms and/or variant forms. For example, good cause may be found when the Applicant demonstrates that they lack access to the web portal due to lack of necessary technology or internet connectivity. Examples of operational needs that combined or individually may outweigh an Applicant's good cause include strains on staff resources that divert resources from more critical responsibilities and difficulties integrating data from outside of the web portal.

3. (c) To complete a product form for a Brand Style, the following information must be provided:

   1. (1) Brand name; whether or not it has a Sub-Brand name, and if so, the Sub-Brand name; and any Marketing Descriptor;
   2. (2) Universal product code for the Brand Style and for any Carton or Roll of that Brand Style, and manufacturing stock keeping unit number for the Brand Style and for any Carton or Roll of that Brand Style if there is no universal product code;
   3. (3) Name of the holder of the trademark on the Sub-Brand name, or, if not applicable, then the holder of the trademark on the brand name, if applicable;

   4. (4) The Tobacco Product category (“Cigarettes”; “Heated Tobacco Products”; “Cigars” (including little cigars)); “E-Cigarettes, Vapes, and E-Liquids” (including electronic pipes and electronic hookahs); “Pipe Tobacco Filler” (exempting looseleaf tobacco, pursuant to Health and Safety Code, section 104559.1, subdivision (s)(3)); “Roll-your-own Tobacco Filler”; “Smokeless Tobacco Products” (including chewing tobacco and snuff); “Nicotine Pouch”; or “Other Tobacco Products”) and subcategory:

      1. (A) If the Tobacco Product category is “Cigarettes,” specification of whether the Product is combusted-filtered, combusted-non-filtered, or other.
      2. (B) If the Tobacco Product category is “Cigars,” specification of whether the Product is sheet- or leaf-wrapped, and whether the Brand Style is filtered or unfiltered.
      3. (C) If the Tobacco Product category is “E-Cigarettes, Vapes, and E-Liquids,” specification of whether the Product is E-Cigarette/Vape or E-Liquid. A Product is an E-Liquid if the e-liquid and the device are separable with ordinary use; otherwise, it is an E-Cigarette/Vape. If the Product is an E-Liquid, further specification of whether it is closed or open is required. The E-liquid is “closed” if the liquid is not accessed by the consumer under normal use (such as with a pod), and otherwise is “open.”
      4. (D) If the Tobacco Product category is “Smokeless Tobacco Products,” specification of whether the Product is loose moist snuff, portioned moist snuff, loose snus, portioned snus, loose dry snuff, dissolvable, loose chewing tobacco, or portioned chewing tobacco.
      5. (E) If the Tobacco Product category is “Other Tobacco Products,” a brief description of the Tobacco Product type.
   5. (5) The unit of the Product, as described on the package. The unit may be left blank if already captured by the Tobacco Product category or subcategory type.

   6. (6) Product details identified below when they apply to the Product as specified by the product form in the UTL web portal. When Product details are left blank even though they apply to the Product, the form shall be deemed incomplete and will not be accepted.

      1. (A) Product count per package;
      2. (B) Volume of the Product (e.g., an e-cigarette may be measured in milliliters or puffs);
      3. (C) Weight of the Product;
      4. (D) Length;
      5. (E) Circumference, diameter, or ring gauge;
      6. (F) Fill type;
      7. (G) Whether the Product contains added nicotine; the type of added nicotine, including tobacco-derived nicotine, synthetic nicotine, nicotinic alkaloid or nicotine analog, or other type of nicotine; a description of the nicotine analog, nicotinic alkaloid or other type of nicotine; and the concentration or strength of nicotine in the Product;
      8. (H) Whether the Product contains added Cannabis;
      9. (I) Whether the Product contains a capsule;
      10. (J) Wrapper type;
      11. (K) Device type;
      12. (L) Package type;
      13. (M) If the Product is an e-cigarette or vape, the device name, whether the device contains a lithium-ion battery, and the battery's capacity;
      14. (N) If the Product is an e-liquid or heated tobacco product, the name of the device it is intended to be used in.
   7. (7) Design file for the Brand Style. The design file must contain all visual information needed to render or show every side of the packaging for the Brand Style that is not blank. If there is no design file available, photos may be provided of every side of the packaging for the Brand Style that is not blank. The design file or photos must include such file(s) or photo(s) for any Carton or Roll of the Brand Style.

   8. (8) Whether the Brand Style has received a formal authorization, approval, or order from the FDA under 21 U.S.C. sections 387e(j) or 387j. Additionally, the following information shall be provided:

      1. (A) If formal authorization, approval, or order under 21 U.S.C. sections 387e(j) or 387j has been received for the Brand Style:

         1. i. Identification of all pathways under 21 U.S.C. sections 387e(j) or 387j (Premarket Tobacco Product Form, Substantial Equivalence Report, Exemption from Substantial Equivalence Requests) for marketing the Brand Style for which the FDA provided authorization, approval, or order;
         2. ii. Identification of the date on which the FDA issued the authorization, approval, or order for the Brand Style under 21 U.S.C. sections 387e(j) or 387j; and
         3. iii. Documentation from the FDA establishing that the Brand Style received the required authorization, approval, or order under 21 U.S.C. sections 387e(j) or 387j, including any Marketing Granted Order, Substantial Equivalence Order, and Exempt from Substantial Equivalence Order.

      2. (B) If formal authorization, approval, or order has not been received under 21 U.S.C. sections 387e(j) or 387j for the Brand Style, whether any such authorization, approval, or order has been sought for the Brand Style.

         1. i. If formal authorization, approval, or order under 21 U.S.C. sections 387e(j) or 387j has been sought for the Brand Style, the following information about the submission to the FDA shall be provided:

            1. I. All pathways under 21 U.S.C. sections 387e(j) or 387j (Premarket Tobacco Product Form, Substantial Equivalence Report, Exemption from Substantial Equivalence Requests) for which authorization, approval, or order for the Brand Style has been sought.
            2. II. For Brand Styles containing nicotine that is not derived from tobacco, whether the Brand Style was commercially marketed in the United States as of April 14, 2022.
            3. III. For Brand Styles that contain nicotine derived from tobacco and that do not fall into the Product categories of Cigarettes, Roll-your-own Tobacco Filler, or Smokeless Tobacco Products under subdivision (c)(4) of this Section, whether the Brand Style was commercially marketed in the United States as of August 8, 2016.
            4. IV. The date of submission to the FDA of each request for authorization, approval, or order for the Brand Style under 21 U.S.C. sections 387e(j) or 387j.
            5. V. For each request submitted for authorization, approval, or order for the Brand Style under 21 U.S.C. sections 387e(j) or 387j, whether the FDA has accepted the request for filing or review.
            6. VI. The most recent FDA-assigned Submission Tracking Number for each request for FDA authorization, approval, or order associated with the Brand Style under 21 U.S.C. sections 387e(j) or 387j.

            7. VII. The status of each request for authorization, approval, or order under 21 U.S.C. sections 387e(j) or 387j for the Brand Style, including as applicable:

               1. a. The date of any FDA Marketing Denial Order (MDO), Not Substantially Equivalent (NSE), and Not Exempt Order for the Brand Style.
               2. b. The date of any rescission by FDA of any MDO, NSE, and Not Exempt Order for the Brand Style.
               3. c. The date of any stay by FDA of any MDO, NSE, and Not Exempt Order for the Brand Style.
               4. d. If review by a court of competent jurisdiction of any MDO, NSE, or Not Exempt Order applicable to the Brand Style has been sought, the name of the reviewing court, case number, and date of the initial case filing.
               5. e. If a reviewing court of competent jurisdiction has stayed or vacated any MDO, NSE, or Not Exempt Order applicable to the Brand Style, the name of the reviewing court, case number, and date of the stay or vacatur. A copy of any order staying or vacating an MDO, NSE, or Not Exempt Order applicable to the Brand Style must also be submitted.
               6. f. Whether the request for authorization, approval, or order for the Brand Style under 21 U.S.C. sections 387e(j) or 387j remains pending and under review by the FDA.
               7. g. Whether a provisional Substantial Equivalence report under 21 U.S.C. section 387j(a)(2)(B) remains under review by FDA or has been removed from review by FDA.
               8. h. Whether 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. If the applicant responds affirmatively, the applicant must identify and submit a copy of the rule, guidance, or other formal statement by the FDA.

         2. ii. If formal authorization, approval, or order for the Brand Style has not been sought under 21 U.S.C. sections 387e(j) or 387j, selection of one or more of the following for why such authorization, approval, or order has not been sought:

            1. I. The Brand Style does not contain nicotine from any source.

            2. II. The Brand Style is a pre-existing tobacco product that was commercially marketed in the United States as of February 15, 2007.

               1. a. If this is selected, specification of whether or not a Voluntary Pre-Existing Tobacco Product Status Determination Request has been submitted to the FDA.
               2. b. If a Voluntary Pre-Existing Tobacco Product Status Determination Request has been submitted to the FDA relating to the Brand Style, the following information shall be provided: the FDA-Assigned Submission Tracking Number(s) for the Brand Style and the status of the Request (under review, FDA determined the Brand Style is a pre-existing tobacco product and date of the decision, or “other” status). If the status is “other,” a brief description of the status.

            3. III. 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.

               1. a. If this is selected, a copy of the rule, guidance, or other formal statement by FDA must be submitted.
            4. IV. Formal authorization, approval, or order has not been sought for the Brand Style under 21 U.S.C. sections 387e(j) or 387j for another reason. If selected, the reason(s) why authorization, approval, or order has not been sought for the Brand Style under 21 U.S.C. sections 387e(j) or 387j must be provided.
   9. (9) Documents from the FDA sufficient to identify the Brand Style's current status under a pathway to market the Product, including the status of an application for formal authorization, approval, or order under 21 U.S.C. sections 387e(j) or 387j, and status of any Voluntary Pre-Existing Status Determinations Request.
   10. (10) Every determination regarding flavor in the Brand Style made by another government agency and received by Applicant.
   11. (11) Applicant may provide additional information or comments regarding the Brand Style that Applicant considers relevant to the Attorney General's determination as to whether the Brand Style is an unflavored Tobacco Product under Health & Safety Code section 104559.5.
4. (d) No product form or variant form will be accepted for any electronic device that is not sold with nicotine or liquid intended to be vaporized and inhaled from the device, or for any separately sold accessory, component, or part as those terms are defined in 21 Code of Federal Regulations, section 1100.3, unless that accessory, component, or part contains nicotine or liquid intended to be vaporized and inhaled.

Note: Authority cited: Section 104559.1, Health and Safety Code. Reference: Sections 104559.1 and 104559.5, Health and Safety Code; and 21 Code of Federal Regulations, Section 1100.3.

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 section, 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).