With the passage of the Tobacco Control Act User Fee Final Rule, 21 CFR Part 1150, domestic tobacco manufacturers as well as importers must now submit their required data for user fee assessment calculation, under the Federal Food, Drug, and Cosmetic Act, to the FDA beginning fiscal year 2015.
Required information includes the number of units removed into domestic commerce and Federal excise taxes paid for each class of product, which is to be submitted monthly, including months where not product is removed. FDA will assess user fees based on the company’s market share for that tobacco class and will follow the previous method of allocating user fees as used by USDA which previously collected the data.
These user fees go towards programs such as those which restrict the sale of tobacco products to minors, research on product regulation and risk and the administration of annual registration as well as potential biennial inspections under section 905 of the FD&C Act.
FDA has already begun enforcement of this new rule with the issuance of warning letters and import alerts against companies not in compliance with user fee payments.
Should your tobacco manufacturing or importing company have questions regarding this final rule or preparations for FDA’s biennial site inspection, EAS consultants with expertise in tobacco regulation can help.