Final Guidance on Tobacco User Fees

The U.S. Food and Drug Administration has issued a final guidance relating to tobacco product user fees.

Titled, “Tobacco Product User Fees: Responses to Frequently Asked Questions,” this document 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.

Among other topics, this guidance explains how the FDA determines which companies are included in the quarterly tobacco user fee assessments; whether water pipe tobacco is subject to user fee requirements; and how companies should submit their monthly report to the agency.

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.