Utah Admin. Code 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 Pre-Market 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 Pre-Market 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.
Notes
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