FDA Releases Tobacco User Fee Draft Guidance

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FDA Releases Tobacco User Fee Draft Guidance

Confused by tobacco product user fees? There’s new draft guidance from the U.S. Food and Drug Administration (FDA) that may make things somewhat clearer for you.

“Tobacco Product User Fees: Responses to Frequently Asked Questions” provides information in regards to questions often asked about tobacco product user fees that are assessed and collected under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The draft guidance covers topics pertaining to the submission of information needed to assess user fees owed by domestic manufacturers and importers of tobacco products. It also addresses how the FDA determines whether a company owes user fees in each quarterly assessment.

When the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) was enacted in 2009, it amended the FD&C and gave the FDA the power to regulate tobacco products. Part of the Tobacco Control Act is the requirement that the FDA assess and collect user fees. Tobacco products that are subject to user fees include cigarettes, snuff, chewing tobacco, roll-your-own tobacco, cigars, and pipe tobacco. The total amount of user fees for each fiscal year is specified in section 919(b)(1) of the FD&C Act. According to this document, companies that are included in quarterly user fee assessments when “they meet the definition of a domestic manufacturer or importer of tobacco products during the fiscal quarter being assessed.” If a company does not meet the definition of domestic manufacturer or importer for the entirety of a fiscal quarter, then the FDA typically does not intend to include it in the user fee assessments for that fiscal quarter.