(a)(1) Beginning October 1, 2025, or other date not more than 30 days following a premarket tobacco application submission deadline issued by the FDA, whichever is later, every e-liquid manufacturer and manufacturer of alternative nicotine products whose products are sold in this state, whether directly or through a distributor, retailer, or similar intermediary or intermediaries, shall execute and deliver on a form prescribed by the commissioner, a certification to the commissioner certifying, under penalty of perjury:
(i)whether the product contains any synthetic nicotine or nicotine derived from a source other than tobacco;
(ii)where the product was manufactured; and (iii) that any of the following apply:
a. The product:
(i)was on the market in the United States as of August 8, 2016,
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(a)(1) Beginning October 1, 2025, or other date not more than 30 days following a premarket tobacco application submission deadline issued by the FDA, whichever is later, every e-liquid manufacturer and manufacturer of alternative nicotine products whose products are sold in this state, whether directly or through a distributor, retailer, or similar intermediary or intermediaries, shall execute and deliver on a form prescribed by the commissioner, a certification to the commissioner certifying, under penalty of perjury: (i) whether the product contains any synthetic nicotine or nicotine derived from a source other than tobacco; (ii) where the product was manufactured; and (iii) that any of the following apply:
a. The product: (i) was on the market in the United States as of August 8, 2016, and the manufacturer has applied for a marketing order pursuant to 21 U.S.C. § 387j for the e-liquid, e-liquid in combination with an electronic nicotine delivery system, or alternative nicotine product, whichever is applicable, by submitting a premarket tobacco product application on or before September 9, 2020, to the FDA; or (ii) is an alternative nicotine product that was on the market in the United States as of April 14, 2022, and the manufacturer applied for a marketing order pursuant to 21 U.S.C. § 387j on or before May 14, 2022; and either of the following is true:
1. The premarket tobacco product application for the product remains under review by the FDA.
2. The FDA has issued a no marketing order for the e-liquid, e-liquid in combination with an electronic nicotine delivery system, or alternative nicotine product, whichever is applicable, from the FDA; however, the agency or a federal court has issued a stay order or injunction during the pendency of the manufacturer’s appeal of the no marketing order.
b. The manufacturer has received a marketing order or other authorization under 21 U.S.C. § 387j for the e-liquid, e-liquid in combination with an electronic nicotine delivery system, or alternative nicotine product, whichever is applicable, from the FDA.
c. For electronic nicotine delivery systems and e-liquid products containing nicotine derived from tobacco or any other source, the product was commercially marketed in the United States as of April 14, 2022, and the manufacturer applied for a marketing order pursuant to 21 U.S.C. § 387j on or before May 14, 2022.
(2) In addition to the requirements in subdivision (1), each manufacturer shall provide:
a. A copy of the cover page of the premarket tobacco application with evidence of receipt of the application by the FDA or a copy of the cover page of the marketing order or other authorization issued pursuant to 21 U.S.C. § 387j, whichever is applicable;
b. Information that clearly identifies each product, submission tracking number (STN), product name, product subcategory, characterizing flavor, and product SKU number.
(3) Notwithstanding subsection (h), if an alternative nicotine product manufacturer can demonstrate to the commissioner that an alternative nicotine product was on the U.S. market as of April 14, 2022, and the manufacturer applied for a premarket tobacco product application (PMTA) prior to May 14, 2022, pursuant to federal law, and the PMTA remains under review by the FDA, the alternative nicotine product shall be added to the directory upon request by the manufacturer if the manufacturer provides the Alabama Department of Revenue with the alternative nicotine product’s FDA submission tracking number (STN), as received by the manufacturer after proper PMTA filing.
(4) To the extent that 21 U.S.C. § 387j is amended or subsequent regulations or other official federal guidance is issued that changes compliance requirements or standards for an e-liquid, e-liquid in combination with an electronic nicotine delivery system, or alternative nicotine product to become federally compliant, each manufacturer of an e-liquid, e-liquid in combination with an electronic nicotine delivery system, or alternative nicotine product, as applicable, that is sold for retail sale in Alabama shall submit documentation to the commissioner substantiating compliance with the new federal requirements or standards within 30 days of when compliance with the requirement or standard is mandated. Failure to substantiate compliance with new federal requirements or standards shall be grounds for removal of the manufacturer and its e-liquid, e-liquid in combination with an electronic nicotine delivery system, or alternative nicotine product, as applicable, from the directory established pursuant to subsection (d).
(b) Any manufacturer submitting a certification pursuant to subsection (a) shall notify the commissioner within 30 days of any material change to the certification, including issuance by the FDA of any of the following:
(1) A market order or other authorization pursuant to 21 U.S.C. § 387j.
(2) An order requiring a manufacturer to remove a product from the market either temporarily or permanently.
(3) Any notice of action taken by the FDA affecting the ability of the new product to be introduced or delivered into interstate commerce for commercial distribution.
(4) Any change in policy that results in a product no longer being exempt from federal enforcement oversight.
(c) The commissioner shall develop and maintain a directory listing all e-liquid manufacturers and manufacturers of alternative nicotine products that have provided certifications that comply with subsection (a) and all products that are listed in those certifications.
(d) The commissioner shall do all of the following:
(1) Make the directory available for public inspection on its website by May 1, 2022.
(2) Update the directory as necessary in order to correct mistakes and to add or remove e-liquid manufacturers, manufacturers of alternative nicotine products, or products manufactured by those manufacturers consistent with the requirements of subsections (a) and (b) on a monthly basis.
(3) Remove from the directory any product that the board determines is a prohibited item pursuant to this section or Section 28-11-16(d).
(4) Send monthly notifications to each wholesaler, jobber, semijobber, retailer, importer, or distributor of tobacco products that have qualified or registered with the Department of Revenue, by electronic communication, containing a list of all changes that have been made to the directory in the previous month. In lieu of sending monthly notifications, the commissioner may make the information available in a prominent place on the Department of Revenue’s public website.
(e) Information required to be listed in the directory shall not be subject to the confidentiality and disclosure provisions in Section 40-2A-10.
(f) Notwithstanding subsection (a), if an e-liquid manufacturer or manufacturer of alternative nicotine products can demonstrate to the commissioner that the FDA has issued a rule, guidance, or any other formal statement that temporarily exempts a product from the federal premarket tobacco product application requirements, the product may be added to the directory upon request by the manufacturer if the manufacturer provides sufficient evidence that the product is compliant with the federal rule, guidance, or other formal statement, as applicable.
(g) Each certifying e-liquid manufacturer and manufacturer of alternative nicotine products shall pay an initial fee of two thousand dollars ($2,000) to offset the costs incurred by the department for processing the certifications and operating the directory. The commissioner shall collect an annual renewal fee of five hundred dollars ($500) to offset the costs associated with maintaining the directory and satisfying the requirements of this section. The fees received under this section by the department shall be used by the department exclusively for processing the certifications and operating and maintaining the directory. After the payment of these expenses, one-half of the remaining funds shall be deposited into the State General Fund, and the remaining one-half shall be distributed evenly to the Alabama State Law Enforcement Agency and to the Licensing and Compliance Division of the board to be used for the enforcement of this chapter.
(h) Beginning on September 1, 2021, no e-liquid, e-liquid in combination with an electronic nicotine delivery system, or alternative nicotine product that, in the case of any such product, contains synthetic nicotine or nicotine derived from a source other than tobacco may be sold or otherwise distributed in this state without either first: (i) certifying that a premarket tobacco product application was successfully submitted to the FDA and accepted for filing by May 14, 2022, in accordance with the applicable requirements under Section 201(rr) of the Federal Food, Drug, and Cosmetic Act; or (ii) obtaining approval from the FDA for sale as a drug under Section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act, as a device under Section 201(h) of the Federal Food, Drug, and Cosmetic Act, as a combination product described in Section 503(g) of the Federal Food, Drug, and Cosmetic Act, or for some other medical purpose.
(i)(1) An e-liquid manufacturer or manufacturer of alternative nicotine products or electronic nicotine delivery systems who sells, furnishes, or gives away a product not listed on the directory is subject to a one thousand dollar ($1,000) daily fine for each product offered for sale in violation of this section until the offending product is removed from the market or until the offending product is properly listed on the directory. For purposes of this subdivision, “sale” includes a delivery sale of e-liquids or electronic nicotine delivery systems or alternative nicotine products, as defined under this chapter.
(2) Any other violation of this section shall result in a fine of five hundred dollars ($500) per offense.
(j)(1) When any retail permit holder offers for sale a product not listed on the directory, the board shall assess the following administrative penalties:
a. For a first offense within a four-year period, an administrative penalty of one thousand dollars ($1,000).
b. For a second offense within a four-year period, an administrative penalty of two thousand five hundred dollars ($2,500).
c. For a third or subsequent offense within a four-year period, an administrative penalty of five thousand dollars ($5,000). In addition, the board shall revoke the permit of the permit holder and no permit may be issued at the location for a minimum of one year after the date of revocation.
(2) All products offered for sale and not listed on the directory shall be considered a prohibited item and declared to be contraband and may be seized and forfeited as provided in Section 28-11-14 by agents of the board or any law enforcement officer.
(k) Any fine collected for a violation of this section shall be deposited into the Vaping Licensing and Enforcement Fund under Section 28-11-10.
(l) Nothing in this section shall apply to any manufacturer of alternative nicotine products that were commercially marketed in the United States before February 15, 2007.
(m) The Alcoholic Beverage Control Board and the Commissioner of Revenue shall adopt rules for the implementation and enforcement of this section.