Proposed Rule on Information Requirements for Tobacco Importers Follows Footsteps of Current USDA Rules
The Food and Drug Administration issued a proposed rule requiring domestic tobacco product importers and manufacturers to submit user fee calculation information. The information is currently collected by the Department of Agriculture, but in October 2014 they will cease collection, ceding the task to the FDA. The proposed rule is intended to ensure the agency collects information necessary to make allocations among tobacco product classes, and individual domestic importers and manufacturers within each class, FDA said.
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The proposed rule uses the Tobacco Transition Payment Program framework, the same USDA is currently using to collect data and distribute allocations among firms. “Because domestic manufacturers and importers are familiar with the TTPP, using this approach should help minimize confusion about the submission requirements and the methodology used to make the calculations of user fee assessments,” the rule said.
The proposed rule’s section on required information is also essentially the same one importers and manufacturers follow at USDA, the rule said. Monthly information importers and manufacturers would have to submit includes:
- Identifying information, including name, address, phone number
- Total amount of tobacco products removed into domestic commerce in the prior month, and the Federal excise taxes paid for those removals
- Certified copies of the returns or forms related to the removal of tobacco products into domestic commerce and the payment of excise taxes. Submission of the information would be in summary form along with supporting documents (copies of the relevant tax forms), the same requirement of USDA. Importers and manufacturers would be required to submit this information beginning with the October 2014 monthly report.
The proposed rule does vary from TTPP to reflect differences between the Fair and Equitable Tobacco Reform Act and the Federal Food Drug and Cosmetic Act, but the proposed changes will not affect the types of data importers and manufacturers would submit to FDA.
The proposed rule includes a scope section to explain how the regulation relates to collection and assessment of user fees, and how it would apply to domestic tobacco products manufacturers and importers. It also includes new definitions, including:
- Class of tobacco products would be defined as cigarettes, cigars, snuff, chewing tobacco, pipe tobacco, and roll-your-own tobacco.
- Importer would be defined as a person required to obtain a permit from the Tobacco Tax and Trade Bureau for the importation of tobacco products under title 27 of the federal code.
- Units of product would be defined as the number of sticks for cigarettes and cigars, or the weight measured in pounds for snuff, chewing tobacco, pipe tobacco, and roll-your-own tobacco.
Other sections of the proposed rule include:
- Yearly class allocations would be determined the same way USDA does now
- A requirement for FDA to make any annual adjustment to individual domestic manufacturer and importer assessments, if needed to account for any corrected assessments and to include those entities that were not assessed in previous quarterly assessments for that fiscal year.
- FDA would be required to notify domestic manufacturers and importers of the amount of the quarterly assessment imposed on them for each quarter of a fiscal year, no later than 30 days before the end of the quarter for which the assessment is made.
Comments on the proposed rule are due July 14 and can be submitted to www.regulations.gov.
(Federal Register 5/31/13)