- (a) A variant form may be completed and submitted in place of a product form if the Brand Style sought to be included on the UTL is a Variant of a Predicate Brand Style and meets one of the Variant types described in subdivision (c). A UTL submission for a Variant is not complete until the UTL submission for the associated Predicate Brand Style is complete.
- (b) Variant 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 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.
(c) A variant form may be used only for the following types of Variants:
- (1) Variants with packaging designed for a market outside of California, including exports;
- (2) Variants with different packaging or different Product count per package, unless the packaging itself imparts flavor;
- (3) Variants with promotional packaging or discount Brand Styles;
- (4) Language on packaging different from Predicate Brand Style, e.g., French or Spanish;
- (5) Variants with a different universal product code or stock keeping unit;
- (6) Multipacks; and,
- (7) Multipacks with electronic devices.
- (d) A variant form need not be submitted for a Brand Style that qualifies as a Variant, has the same external packaging as the Predicate Brand Style (or another Variant of the same Predicate Brand Style for which a variant form has already been submitted), but contains different internal packaging (for example, different phrases that are revealed once the package is opened), unless statements on the internal packaging implicitly or explicitly convey the presence of a characterizing flavor.
- (e) The Predicate Brand Style for all Variants other than a Multipack must be a Brand Style for which the Applicant submitted a product form. For Multipacks, the Predicate Brand Style may be any Brand Style that appears on the UTL (whether a product form or variant form was originally submitted) or a Brand Style for which the Applicant completed a product form or variant form.
- (f) Applicant must specify on the variant form whether the Variant is a Multipack, and, if so, whether the Multipack contains a device and the name of the Multipack. If the Variant is not a Multipack, all the applicable categories from subdivision (c)(1) -- (5) must be selected on the variant form.
(g) The following information must be provided to complete a variant form:
- (1) The applicable Variant type(s) from those listed in subdivision (c).
- (2) For Variants of the type described in subdivision (c)(1), a description of the market shall also be provided.
- (3) For Variants of the type described in subdivision (c)(2), if the packaging differs from the related Predicate Brand Style, a brief description of the Variant's packaging, the packaging's unique name (if any), and the difference in Product count per package (if any).
- (4) For Variants of the type described in subdivision (c)(3), a brief description of the promotion or discount.
- (5) For Variants of the type described in subdivision (c)(4), the language used.
- (6) For Variants of the type described in subdivision (c)(6), a brief description of the Variant's packaging.
- (7) For Variants of the type described in subdivision (c)(7), a brief description of the Variant's packaging, the device name, the device type, whether the device contains a lithium-ion battery, and the battery's capacity.
- (8) All Predicate Brand Style(s) the Variant relates to.
- (9) Whether the Variant has a Carton or Roll differing from the Carton or Roll for which information was provided in the product form for the Predicate Brand Style(s);
- (10) Universal product code for the Variant and any Carton or Roll of that Variant differing from the Carton or Roll for which information was provided in the product form for the Predicate Brand Style(s); and manufacturing stock keeping unit number for the Variant and any Carton or Roll of that Variant differing from the Carton or Roll for which information was provided in the product form, if there is no universal product code.
- (11) If the information provided for the Predicate Brand Style under subdivisions (c)(8) and (c)(9) of Section 945 does not apply to the Variant, subdivisions (c)(8) and (c)(9) of Section 945 must be completed in the variant form. If the Applicant affirms that the information for the Predicate Brand Style under subdivisions (c)(8) and (c)(9) of Section 945 does apply to the Variant, the Attorney General will consider the Variant's FDA information to be identical to that of the Predicate Brand Style, and therefore incorporated into the variant form.
- (12) A design file or photos of the Variant Product packaging as described in Section 945, subdivision (c)(7), except Carton or Roll design files and photos need not be provided if the Carton or Roll is identical to that of the Predicate Brand Style's Carton or Roll.
- (13) Any determinations regarding flavor as described in Section 945, subdivision (c)(10) if they are distinct from determination(s) included in the product form for the Predicate Brand Style.
- (14) A confirmation that the information submitted about the items listed in Section 945, subdivisions (c)(1), (c)(3)-(c)(5), (c)(6)(B)-(K), and (c)(6)(M)-(N), on the product form for the Predicate Brand Style accurately describes the Variant. If the Variant differs from the Predicate Brand Style with respect to any of the information submitted on the most recent product form for the Predicate Brand Style regarding the items listed in those subdivisions, a variant form may not be submitted for the Brand Style. Instead, a product form shall be completed and submitted.
- (15) 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.
Note: Authority cited: Section 104559.1, Health and Safety Code. Reference: Sections 104559.1 and 104559.5, 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 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).