On Dec. 8, FDA issued a final guidance, "Tobacco Product User Fees: Responses to Frequently Asked Questions." This guidance provides details about what information is needed to assess user fees owed by each domestic manufacturer or importer of tobacco products and how FDA determines whether a company owes user fees in each quarterly assessment. This guidance also helps answer questions, such as: - How does FDA determine which companies are included in the quarterly tobacco user fee assessments?
- Is hookah or water pipe tobacco subject to user fee requirements?
- How should a company submit its monthly report to FDA?
The Federal Food, Drug and Cosmetic (FD&C) Act requires FDA to "assess user fees on, and collect such fees from, each manufacturer and importer of tobacco products subject to" the tobacco product provisions of the FD&C Act. The tobacco products that are subject to user fee assessments are cigarettes, snuff, chewing tobacco, roll-your-own tobacco, cigars, and pipe tobacco. ENDS products, such as e-cigarettes, are not subject to user fee assessments. The FD&C Act provides for the total quarterly assessment to be allocated among specified classes of tobacco products. The class allocation is based on each tobacco product class's volume of tobacco products removed into commerce. Within each class of tobacco products, an individual domestic manufacturer or importer is assessed a user fee based on its market share for that tobacco product class. This guidance document is intended only to provide clarity to the public regarding existing requirements under the law. FDA guidance documents, including this guidance, should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. |
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