FDA Issues Final Guidance Related to Tobacco Product User Fees

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FDA Issues Final Guidance Related to Tobacco Product User Fees

The U.S. Food and Drug Administration has issued final guidance relating to tobacco product user fees. The recently released document, “Tobacco Product User Fees: Responses to Frequently Asked Questions,” provides responses to some frequently asked questions relating to tobacco product user fees that are assessed and collected under the Federal Food, Drug, and Cosmetic Act (FD&C Act).

“This guidance provides information regarding the submission of information 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,” the FDA stated on its Twitter account when announcing the release of this final guidance document.

This document provides companies with what information will be required for submissions to assess user fees owed by each domestic manufacturer or importer of tobacco products. The document also reveals how the FDA determines whether a company owes user fees in each quarterly assessment.