On this page:
- Requirements for Domestic Manufacturers and Importers of Certain Tobacco Products
- Guidance for Industry
Under Section 919 of the Food, Drug, and Cosmetic Act (FD&C Act), FDA assesses and collects tobacco user fees from domestic manufacturers and importers of cigarettes, snuff, chewing tobacco, roll-your-own tobacco, cigar, and pipe tobacco. These user fees provide funding for FDA’s tobacco regulatory activities.
Section 919 identifies the annual collection amount for tobacco user fees. FDA performs the Tobacco User Fee Yearly Allocation by Product Class to determine the percentage of the total annual collection amount for a given fiscal year that is attributed to each of the six tobacco classes (listed above). 21 CFR Part 1150 further elaborates on the requirements related to tobacco product user fees under Section 919. This is the final rule that explains the required information industry must submit; the process for calculating, assessing, paying, and disputing assessments; and how penalties are assessed.
Domestic manufacturers and importers of the six tobacco classes listed above must submit information on FDA’s Tobacco User Fee Reporting Form (FDA 3852) for FDA to calculate assessments. These reports are due no later than the 20th of each month for the removal and excise tax information for the prior month. Based on the information provided, FDA calculates individual market share percentages by tobacco class and issues quarterly tobacco user fee assessments. FDA provides notification of the amount of the quarterly assessment no later than 30 calendar days before the end of each fiscal year quarter.
A webinar, “Submission of Data Needed to Calculate User Fees for Domestic Manufacturers and Importers of Tobacco Products”, further discusses what information to submit, when to submit the required data, how to submit the data, and how the assessment is calculated for various tobacco products.
FDA must receive payment no later than the last day of each fiscal year quarter (due date is listed on the invoice), and payments must be submitted to FDA in one of the payment options specified on the assessment notification. To pay electronically via pay.gov, use the button below.
The Small Entity Compliance Guide contains detailed information on what domestic manufacturers and importers of certain tobacco products must submit to the FDA and how FDA uses this information to calculate and assess tobacco user fees as well as information on payment of user fee assessments.
On Dec. 8, 2021, FDA announced the availability of final guidance for industry entitled “Tobacco Product User Fees: Responses to Frequently Asked Questions.” This final guidance provides additional information for industry in response to frequently asked questions related to tobacco product user fees assessed and collected under the FD&C Act.