FDA to Begin Requiring Monthly Tobacco Importer Reports in October
The Food and Drug Administration is amending its regulations to require monthly reports by tobacco importers and domestic manufacturers. The monthly reports are currently required by the U.S. Department of Agriculture under the Fair and Equitable Tobacco Reform Act’s Tobacco Transition Payment Program, but FDA is taking over because the USDA reporting program is ending in September and FDA still needs the information in order to calculate tobacco user fees. The information required in the monthly reports to FDA will be “essentially the same” as the elements currently required by USDA, as will the method by which FDA calculates user fees, it said. The first monthly reports will be due to FDA by Oct. 20.
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Reports Required for Cigarettes, Snuff, Chewing Tobacco, Roll-Your-Own
Under the final rule, domestic manufacturers and importers of tobacco -- defined as “a person who is required to obtain a permit from the Alcohol and Tobacco Tax and Trade Bureau of the Department of the Treasury with respect to the importation of tobacco products” -- will be required to file monthly reports on the amount of tobacco introduced into commerce no later than the 20th day each month. The reporting requirements will initially apply only to manufacturers and importers of cigarettes, snuff, chewing tobacco, and roll-your-own tobacco, although FDA says it may add cigars, pipe tobacco, and other types of tobacco at a later date if they are deemed subject to FDA’s tobacco regulations as FDA recently proposed (see 14042426).
Each covered tobacco importer or domestic manufacturer will have to submit (1) identification information, including name, address, a telephone number, an email address, the TTB permit number and the employer identification number; (2) the amount of product, by class, “removed” into commerce the prior month and not exempt from taxes; and (3) certified copies of forms related to the removal into commerce and payment of excise taxes on tobacco products. The reports will still be required even if the importer or manufacturer did not remove any tobacco products into commerce, said FDA.
Failure to Pay Quarterly Assessments Results in Products Deemed Adulterated
FDA will then calculate quarterly tobacco fee assessments using the same method currently used by USDA, it said. The agency will notify importers and manufacturers of the amount due no later than 30 days after the end of each quarter, it said. Payments will then be due by the end of the fiscal quarter. Importer and domestic manufacturers will be able to dispute any fee assessments by appealing to FDA within 45 days of the assessment notification, said the agency. If an importer or domestic manufacturer fails to pay any assessments within 30 days after the date payment is owed or the date a dispute is resolved, tobacco products produced or imported by that manufacturer or importer will be deemed adulterated by FDA, it said.
(Federal Register 07/10/14)