In April 2021, FDA published a new version of the FDA 3852 form “Report of Tobacco Product Removals Subject to Tax.” The updated form should be used immediately and can also be retrieved using the link at the bottom of this page.
On May 26, 2021, FDA announced the availability of a draft guidance for industry entitled “Tobacco Product User Fees: Responses to Frequently Asked Questions.” This draft guidance provides information in response to frequently asked questions related to tobacco product user fees assessed and collected under the Federal Food, Drug, and Cosmetic Act (FD&C Act).
Tobacco User Fee Guidance for COVID-19 National Emergency
FDA is aware that, on March 31, 2020, the Alcohol and Tobacco Tax and Trade Bureau (TTB) issued TTB Industry Circular 2020-2. Please see guidance below as it pertains to the reports and invoice payments for tobacco user fees.
FDA is unable to extend the deadlines for the monthly reporting of tobacco user fee information. For each monthly FDA tobacco user fee report where the associated TTB form(s) deadline has been postponed and a firm cannot timely provide all required information to FDA, FDA asks the firm to provide an approximation of such information (i.e. the removal volume and associated excise taxes) reported on the FDA 3852 form. Upon the firm’s submission of such information to TTB, it should submit a certified copy of the required relevant forms (TTB 5220.6, TTB 5210.5, and/or TTB 5000.24 forms) and, if necessary, an amendment of the approximation(s) reported on the FDA 3852 form.
FDA does not have the authority to suspend or delay the deadline for payment of tobacco product user fees. The FDCA and FDA regulations set a deadline for the payment of user fees. See 21 U.S.C. 387s(b)(6) (providing that “payments of all assessments shall be made by the last day of the quarter involved”); 21 C.F.R. 1150.13(a) (“Payment of [a tobacco product user fee] assessment must be received by FDA no later than the last day of each fiscal year quarter.”). FDA does not have discretion under the FDCA (or its regulations) to alter this deadline. FDA will be delivering the FY 2020 Quarter 3 tobacco user fee invoices electronically by email to be received no later than June 1, 2020, as the Agency’s operations have been impacted due to COVID-19.
FDA assess and collect user fees from manufacturers and importers of cigarettes, snuff, chewing tobacco, roll-your-own tobacco, cigar, and pipe tobacco, under Section 919 of the Food, Drug, and Cosmetic Act. You must submit information required for FDA to calculate assessments and you must pay these user fees. Failure to do either is a violation of Federal law.
Based upon the information provided, FDA assesses both annual and quarterly user fees. The Guidance contains detailed information on what you must submit and how FDA uses this information to assess both types of user fees.
FDA will notify you of the amount of the quarterly assessment no later than 30 calendar days before the end of each fiscal year quarter with the following information:
- Amount of the assessment;
- Due date;
- Class assessment information;
- Domestic manufacturer or importer assessment information;
- Any adjustments made by FDA;
- How to pay the fees;
- Interest information; and
- Dispute contact information.
FDA must receive your payment no later than the last day of each fiscal year quarter. You must submit payment to FDA in the manner specified in the notification. If you do not report or if you do not pay, your products may be deemed “misbranded” under federal law and, therefore, subject to regulatory action, including seizure and injunction. Submission of false information is also punishable by criminal and civil law.
In addition, compliance with the requirements of the FD&C Act under §910(a)(2)(A)(i) of the FD&C Act includes payment of assessed user fees as set forth in §919. Accordingly, FDA is unable to issue an order finding a new tobacco product described in a pending or future substantial equivalence (SE) Report -- other than for products marketed between February 15, 2007 and March 22, 2011, and for which an SE report was submitted by March 22, 2011— to be substantially equivalent to the predicate tobacco product until a firm has paid its assessed fees in their entirety.
Please note that entering a repayment plan for assessed user fees does not render a product compliant with the requirements of the FD&C Act. A firm in arrears but on a repayment plan “fails to pay a user fee assessed to such manufacturer or importer pursuant to section 919 by the date specified in section 919 or by the 30th day after final agency action on a resolution of any dispute as to the amount of such fee,” (§902(4) of the FD&C Act) and thus its products are adulterated.
FDA will start assessing and collecting user fees for cigars and pipe tobacco beginning in FY2017 (starting Oct 1, 2016).