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).