LPR Tobacco Importers, Inc. – FDA Warning Letter, Jul 30, 2019

The FDA issued a Warning Letter to LPR Tobacco Importers, Inc. on June 19, 2019, for failure to pay assessed user fees. As a domestic importer of cigars, LPR Tobacco Importers, Inc. is subject to user fees under section 919 of the FD&C Act (21 U.S.C. § 387s), which requires payment by the last day of the applicable quarter.

The FDA's records indicate that LPR Tobacco Importers, Inc. has not paid user fees for the 2nd, 3rd, and 4th Quarters of 2018, and the 1st and 2nd Quarters of 2019. This failure to pay renders all regulated tobacco products imported by the company adulterated under section 902(4) of the FD&C Act (21 U.S.C. § 387b(4)).

The introduction or delivery into interstate commerce of adulterated tobacco products is a prohibited act under section 301(a) of the FD&C Act (21 U.S.C. § 331(a)). Furthermore, the FDA will be unable to issue substantial equivalence (SE) orders for new tobacco products until all assessed fees are paid in full. Entering a repayment plan does not negate the adulterated status of the products.

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