2021 Code of Alabama
Title 28 - Intoxicating Liquor, Malt Beverages and Wine.
Chapter 11 - Sale of Tobacco Products Regulated by the Alcoholic Beverage Control Board.
Section 28-11-17.1 - Certification Requirements for E-Liquid Manufacturers and Manufacturers of Alternative Nicotine Products; Directory; Fda Approval; Violations.
Certification requirements for e-liquid manufacturers and manufacturers of alternative nicotine products; directory; FDA approval; violations.
(a)(1) Beginning March 1, 2022, 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, either of the following:
a. The product 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; 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.
(2) In addition to the requirements in subdivision (1), each manufacturer shall provide 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) 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) 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.
(4) Information required to be listed in the directory shall not be subject to the confidentiality and disclosure provisions in Section 40-2A-10.
(e) 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 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.
(f) 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, two-thirds of the remaining funds shall be deposited into the General Fund, and the remaining one-third shall be distributed evenly to the Alabama State Law Enforcement Agency and to the board.
(g) 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 first obtaining approval from the FDA for sale as a drug under Section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act, a device under Section 201(h) of the Federal Food, Drug, and Cosmetic Act, a combination product described in Section 503(g) of the Federal Food, Drug, and Cosmetic Act, or some other medical purpose.
(h)(1) Beginning May 1, 2022, or on the date that the Department of Revenue first makes the directory available for public inspection on its website as provided in subsection (d), whichever is later, an e-liquid manufacturer or manufacturer of alternative nicotine products who offers for sale a product not listed on the directory is subject to a one thousand dollars ($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.
(2) Any other violation of this section shall result in a fine of five hundred dollars ($500) per offense.
(i) The commissioner shall adopt rules for the implementation and enforcement of this section.
(Act 2021-453, § 7.)