California, USA plans to introduce a draft "flavorless tobacco list" – only products identified on the list can be legally sold

Recently, the California Attorney General's Office released a draft regulation detailing how tobacco manufacturers and importers can apply to have their products included on the state's "Unflavored Tobacco List" (UTL). This is an important complementary measure to California's comprehensive ban on the sale of flavored tobacco, meaning only products officially recognized as not containing "characterizing flavors" can enter the market.

The draft requires applicants to submit individual online applications for each "Brand Style," proving that the product has no distinctive flavors, waiving possible sovereign immunity, agreeing to California court jurisdiction, and providing samples of maximum retail packaging. Each product must pay a $300 application fee, and the submitted information must be true and accurate, or else face penalties for perjury. Products submitted on time will be prioritized for inclusion on the initial list, which is planned to be released by December 31, 2025.

The main points of the proposed draft are as follows:

Scope and Objectives

The draft covers all categories of tobacco and nicotine products, including cigarettes, cigars, heat-not-burn products, e-cigarette devices and e-liquids, smokeless tobacco products, and nicotine pouches.

Flavorless Tobacco List" will be the only legal sales directory in the entire state, retailers can only sell products listed on the directory.

Identification of characteristic flavors

The bill does not list detailed classifications of characteristic flavors, but 2Firsts found that, according to California law (CA Health & Safety Code § 104559.5 (2024)), "characteristic flavor" refers to any flavor or aroma discernible by ordinary consumers before or during the consumption of tobacco products, other than the taste or aroma of tobacco itself. This includes, but is not limited to, flavors or aromas related to any fruit, chocolate, vanilla, honey, candy, cocoa, dessert, alcoholic beverage, mint, wintergreen, herb, or spice, or a cooling sensation discernible by ordinary consumers during the consumption of tobacco products.

Images, marketing phrases, etc. that have potential implications, such as fruit patterns, dessert names, etc., may be deemed as violations.

Application process and information requirements

Applications must be submitted through a dedicated website and a "Certifying User" must complete a legal declaration.

Detailed product data must be provided, including brand name, sub-brand, product category, packaging design files or high-resolution photos, ingredient information, nicotine source, and concentration.

E-cigarette products must disclose the type of device, whether it contains a lithium-ion battery and its capacity, and specify the separability of the e-liquid from the device (closed or open system).

All products must submit physical samples of their maximum retail packaging for on-site evaluation by regulatory agencies.

FDA approval status linked to state qualifications

Most new tobacco products (especially e-cigarettes) must comply with FDA's pre-market tobacco product applications (PMTA), substantial equivalence (SE), or exemption processes.

The draft includes transitional provisions: products that have been submitted for FDA review before the key dates and are still under review may be temporarily included in the list for listing before the market.

If the FDA approval is denied and not revoked, postponed, or overturned by the court, the product will be removed from the list.

Variant management refers to the process of managing different variations or versions of a product or system. This can include managing different configurations, features, or options to meet the needs of different customers or markets. Variant management is often used in industries such as software development, automotive manufacturing, and electronics to ensure that each variant is effectively controlled and released to the market.

Versions with the same formula but only differences in packaging, quantity, language, or promotional format can be applied for under a simplified "Variant Form.

For products containing electronic devices, the device model, type, and battery information must be provided to prevent regulatory evasion through packaging combinations.

Schedule and fees

Initial deadline: September 1, 2025 or 45 days after regulations come into effect, whichever is later.

The first list of items has been released: before December 31, 2025.

Application fee: $300 for each product; $150 for variants; yearly renewal fee $150.

Annual renewal must be completed from April 1 to April 15. Failure to renew on time may result in removal after June 30.

Enforcement and removal mechanism

Prosecutors may request additional materials at any stage, including consumer sensory tests, marketing materials, etc.

If a product is found to have a distinct flavor, FDA eligibility issues, or false information, a removal process will be initiated and public notice will be given.

Retail sales of products not listed on the UTL may face civil penalties or lawsuits.