Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/cano-tobacco-inc-561674-10262018
Timestamp: 2019-08-24 12:40:52
Document Index: 614664903

Matched Legal Cases: ['§ 387', '§ 387', '§ 387', '§ 387', '§ 387', '§ 387', '§ 387']

Cano Tobacco Inc. - 561674 - 10/26/2018 | FDA
Cano Tobacco Inc. - 561674 - 10/26/2018
Cano Tobacco Inc. MARCS-CMS 561674 — Oct 26, 2018
Cano Tobacco Inc.
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) has reviewed our records and determined that Cano Tobacco Inc. is a domestic importer of cigars and roll-your-own tobacco products for the purposes of section 919 of the Federal Food Drug and Cosmetic Act (the FD&C Act) (21 U.S.C. § 387s) and subject to user fees in accordance with that provision. Section 919(b)(6) of the FD&C Act (21 U.S.C. § 387s(b)(6)) requires that each domestic importer of certain tobacco products, including cigars and roll-your-own tobacco, remit payment of its user fee assessment by the last day of the applicable quarter.
FDA has determined that all regulated tobacco products imported by Cano Tobacco Inc. are adulterated under section 902(4) of the FD&C Act (21 U.S.C. § 387b(4)) because you have failed to pay user fees assessed to you as required by section 919 of the FD&C Act (21 U.S.C. § 387s). Specifically, based on our records, you import tobacco products into the United States, you import products subject to section 919 user fees, and you were assessed user fees by FDA’s Office of Financial Management (OFM) on the dates indicated below. To date, FDA has not received payment from you for the assessment invoices enumerated in the table below.
2nd Quarter FY 17
3rd Quarter FY 17
4th Quarter FY 17
1st Quarter FY 18
2nd Quarter FY 18
Section 919(b)(6) of the FD&C Act (21 U.S.C. § 387s(b)(6)) requires that payments of all assessments must be made by the last day of the applicable quarter. Because you have failed to pay user fees assessed pursuant to section 919 of the FD&C Act by the last day of the applicable quarter, or by the 30th day after final agency action on a resolution of any dispute as to the amount of fees assessed, regulated tobacco products imported by Cano Tobacco Inc. are adulterated under section 902(4) of the FD&C Act (21 U.S.C. § 387b(4)).
In addition, compliance with the requirements of the FD&C Act under section 910(a)(2)(A)(i) of the FD&C Act (21 U.S.C. § 387j(a)(2)(A)(i)) includes payment of assessed user fees as set forth in section 919 of the FD&C Act. Accordingly, FDA is unable to issue an order finding a new tobacco product described in a pending or future substantial equivalence (SE) Report - other than for products marketed between February 15, 2007 and March 22, 2011, and for which an SE report was submitted by March 22, 2011— to be substantially equivalent to the predicate tobacco product until a firm has paid its assessed fees in their entirety.
Please note your reference number, ER1800008, in your response and direct your response to the following address: