(1) Beginning on August 1, 2024, every manufacturer of an electronic cigarette product that is sold in this state, whether directly or through a distributor, wholesaler, retailer, or similar intermediary or intermediaries, shall certify under penalty of perjury on a form and in the manner prescribed by the commission, that the manufacturer agrees to comply with this section and: (a) for an electronic cigarette product that contains nicotine, that the product is a premarket authorized or pending electronic cigarette product; (b) for an electronic cigarette product that is a non-nicotine inhalation product, that the product is approved for sale in interstate commerce by the United States Food and Drug Administration; or (c) for an electronic cigarette product that is a non-nicotine inhalation substance, that the product is a premarket authorized or pending electronic cigarette product. (2) When submitting the certification a manufacturer shall submit a form that separately lists each electronic cigarette product that is sold in this state. (3) (a) Each certification form shall include: (i) the name of the electronic cigarette product, nicotine content level by percentage, and any flavors contained in the product; (ii) for an electronic cigarette product that contains nicotine: (A) a copy of the order granting a premarket tobacco product application of the electronic cigarette product by the United States Food and Drug Administration under 21 U.S.C. Sec. 387j(c)(1)(A)(i); or (B) evidence that the premarket tobacco product application for the electronic cigarette product or nicotine product was submitted to the United States Food and Drug Administration before September 9, 2020, and a final authorization or order has not yet taken effect; (iii) for an electronic cigarette product that is a non-nicotine inhalation product, evidence that the product is approved for sale in interstate commerce by the United States Food and Drug Administration; (iv) for an electronic cigarette product that is a non-nicotine inhalation substance: (A) a copy of the order granting a premarket tobacco product application of the electronic cigarette product by the United States Food and Drug Administration under 21 U.S.C. Sec. 387j(c)(1)(A)(i); or (B) evidence that the premarket tobacco product application for the electronic cigarette product was submitted to the United States Food and Drug Administration before September 9, 2020, and a final authorization or order has not yet taken effect; (v) a nonrefundable $1,000 fee for an electronic cigarette product that is being added to the registry in the first instance; and (vi) information described in Subsection (10) if applicable. (b) The commission shall make the materials submitted under Subsection (3)(a) available to the Department of Health and Human Services for review and approval. (c) A manufacturer required to submit a certification form under this section shall notify the commission and the Department of Health and Human Services in a manner prescribed by the commission within 30 days of any material change making the certification form no longer accurate, including: (i) the issuance or denial of a marketing authorization or other order by the United States Food and Drug Administration under 21 U.S.C. Sec. 387j; or (ii) any other order or action by the United States Food and Drug Administration or any court that affects the ability of the electronic cigarette product to be introduced or delivered into interstate commerce for commercial distribution in the United States. (d) On or before January 31 of each year and in a manner prescribed by the commission, a manufacturer shall: (i) recertify that the information contained in the certification is correct and accurate; (ii) correct or amend information if necessary; and (iii) pay a $250 nonrefundable fee for each electronic cigarette product on the registry that is manufactured by the manufacturer. (e) A manufacturer may amend a certification, including to add additional electronic cigarette products to the registry, if all requirements of this section are met. (f) The commission shall: (i) provide an electronic notification to a manufacturer that has not submitted a recertification under Subsection (3)(d); and (ii) remove a manufacturer or an electronic cigarette product that is not recertified from the registry by March 15. (4) (a) The Department of Health and Human Services shall review materials described in Subsection (3)(a) and notify the commission regarding whether an electronic cigarette product should be included in the registry. (b) On or before October 1, 2024, the commission shall make publicly available on the commission's website a registry that lists each electronic cigarette product manufacturer and each electronic cigarette product for which certification forms have been approved by the Department of Health and Human Services. (c) An electronic cigarette product may not be listed on the registry unless the Department of Health and Human Services determines the requirements of Subsection (3)(a) are met. (d) An electronic cigarette product that contains a cannabinoid may not be listed on the registry. (5) (a) If the Department of Health and Human Services obtains information that an electronic cigarette product should not be listed in the registry, the Department of Health and Human Services shall provide the manufacturer notice and an opportunity to cure deficiencies before notifying the commission to remove the manufacturer or products from the registry. (b) Except as provided in Subsection (5)(c), the Department of Health and Human Services shall comply with Title 63G, Chapter 4, Administrative Procedures Act, before notifying the commission to remove an electronic cigarette product or manufacturer from the registry. (c) Subsection (5)(b) does not apply to a manufacturer failing: (i) to decertify an electronic cigarette product; (ii) to provide fees and documentation described in Subsection (3)(a) or (3)(d); or (iii) to comply with Subsection (10). (6) (a) If a product is removed from the registry, each retailer, distributor, and wholesaler shall have 30 days from the day on which the product is removed from the registry to remove the product from any inventory and return the product to the manufacturer for disposal. (b) After the period described in Subsection (6)(a), any electronic cigarette product of a manufacturer identified in the notice of removal are contraband and are subject to penalties under Subsection (8). (7) (a) Beginning on January 1, 2025, a person may not sell or offer for retail sale an electronic cigarette product in this state that is not included in the registry. (b) A manufacturer may not sell, either directly or through a distributor, wholesaler, retailer, or similar intermediary or intermediaries, an electronic cigarette product in this state that is not included in the registry. (8) (a) A wholesaler, distributor, or retailer who sells or offers for retail sale an electronic cigarette product in this state that is not included in the registry shall be subject to a civil penalty assessed by the tax commission of: (i) $1,000 for each unit of product offered for sale in violation of this section; and (ii) $100 per day until the offending product is removed from the market or until the offending product is properly listed on the registry. (b) The commission shall suspend the person's license issued under Sections 59-14-201, 59-14-301, and 59-14-803 for a violation of Subsection (8)(a) as follows: (i) for a second violation within a 12-month period, at least 14 days; (ii) for a third violation within a 12-month period, at least 60 days; or (iii) for a fourth violation within a 12-month period, at least one year. (c) A manufacturer whose electronic cigarette products are not listed in the registry and are sold in this state, whether directly or through a distributor, wholesaler, retailer, or similar intermediary or intermediaries, is subject to a civil penalty assessed by the tax commission of: (i) $1,000 for each unit of product offered for retail sale in violation of this section; and (ii) $100 per day until the offending product is removed from the market or until the offending product is properly listed on the registry. (d) A manufacturer that falsely represents any information required by a certification form described in this section shall be guilty of a class C misdemeanor for each false representation. (e) A repeated violation of this section shall constitute a deceptive act or practice as provided in Sections 13-11-4 and 13-11a-3 and shall be subject to any remedies or penalties available for a violation of those sections. (9) (a) To assist in ensuring compliance and enforcement of this section and Section 26A-1-131, the commission shall disclose to the following entities, upon request, any information obtained under this section: (i) the Department of Health and Human Services; (ii) a local health department; or (iii) the attorney general. (b) The commission and attorney general shall share with each other information received under this section, or corresponding laws of other states. (10) (a) The commission may not list a nonresident manufacturer of an electronic cigarette product in the registry unless: (i) the nonresident manufacturer has registered to do business in the state as a foreign corporation or business entity; or (ii) the nonresident manufacturer appoints and maintains without interruption the services of an agent in this state to receive any service of process on behalf of the manufacturer. (b) The nonresident manufacturer shall provide the name, address, and telephone number of the agent to the commission. (c) (i) A nonresident manufacturer shall provide notice to the commission 30 days before the termination of the authority of an agent and shall further provide proof to the satisfaction of the commission of the appointment of a new agent no less than five calendar days prior to the termination of an existing agent appointment. (ii) In the event an agent terminates an agency appointment, the manufacturer shall notify the commission of the termination within five calendar days and shall include proof to the satisfaction of the commission of the appointment of a new agent. (11) Before May 31 of each year, the commission and the Department of Health and Human Services shall provide a report to the Revenue and Taxation Interim Committee and the Health and Human Services Interim Committee regarding: (a) the status of the registry; (b) manufacturers and products included in the registry; (c) revenue and expenditures related to administration of this section; and (d) enforcement activities undertaken under this section and Section 26A-1-131. (12) All fees and penalties collected under this section shall be used for administration and enforcement of this section and Section 26A-1-131. (13) The commission, in consultation with the Department of Health and Human Services, may make rules in accordance with Title 63G, Chapter 3, Utah Administrative Rulemaking Act, to implement this section.
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