Section R384-415-7 - Product Quality(1) Consistent with 21 U.S.C 387j, no manufacturer or retailer shall sell, offer for sale, or distribute an electronic cigarette, an electronic cigarette product, or an electronic cigarette substance unless the product complies with each of the relevant electronic cigarette product standards established by the U.S. Food and Drug Administration under 21 U.S.C. 387g(3).(2) No manufacturer or retailer shall sell, offer for sale, or distribute an electronic cigarette, an electronic cigarette product, or an electronic cigarette substance unless the product has received marketing authorization from the U.S. Food and Drug Administration (FDA) under 21 U.S.C. 387j(c)(1)(A)(i), 21 U.S.C. 387j(a)(2)(A)(i), or 21 U.S.C. 387j(a)(2)(A)(ii) and related FDA regulations, policies, or actions.(3) A manufacturer or retailer will not be in violation of Subsection (2) and may continue to sell, offer for sale, or distribute an electronic cigarette, an electronic cigarette product, or an electronic cigarette substance if:(a) the manufacturer or retailer only sells, offers for sale, or distributes an electronic cigarette, an electronic cigarette product, or an electronic cigarette substance that is compliant with the requirements set forth in this rule;(b) the manufacturer submitted a timely Premarket Tobacco application or Substantial Equivalent application to the FDA by September 9, 2020, verified by being listed on the FDA's website as a deemed new tobacco product with timely application; and(c) the FDA has not issued a written marketing order and therefore the product's Premarket Tobacco application or Substantial Equivalent application is pending review by the FDA.(4) This section will take effect on the date that manufacturers are required to secure marketing orders from the FDA to continue marketing their products in the United States.Utah Admin. Code R384-415-7
Adopted by Utah State Bulletin Number 2016-2, effective 12/29/2015Amended by Utah State Bulletin Number 2016-9, effective 4/15/2016Amended by Utah State Bulletin Number 2016-20, effective 10/15/2016Amended by Utah State Bulletin Number 2016-24, effective 12/29/2016Amended by Utah State Bulletin Number 2019-24, effective 12/1/2019Amended by Utah State Bulletin Number 2021-12, effective 6/1/2021Amended by Utah State Bulletin Number 2021-17, effective 9/9/2021Amended by Utah State Bulletin Number 2023-18, effective 9/12/2023