Summary#
This bill changes how the Food and Drug Administration (FDA) collects user fees from tobacco product manufacturers and importers. It raises the total fee amounts for fiscal year 2027 and ties future amounts to inflation. It also directs that, beginning in fiscal year 2029, user fees be assessed on all classes of tobacco products the FDA regulates, including classes the FDA deems subject to the law. The bill requires manufacturers and importers to send sales and product information to the FDA on a schedule that begins in 2028. It directs the FDA to make rules for how fees for newly covered product classes will be calculated and how fees are divided among makers. The bill also adds reporting rules so annual reports must show spending on e-cigarette (deemed) products versus combustible tobacco, explain how fee money for youth e-cigarette prevention is used, and report fees collected from different product categories.
What it means for you#
- Manufacturers and importers: The bill requires you to submit identification, product lists, and sales data by set dates (for 2027 data by March 1, 2028; for early 2028 data by April 1, 2028; and monthly thereafter). You may be assessed user fees for more product classes starting in fiscal year 2029. The FDA will set formulas and percentages to decide each class and each company’s share.
- General public and other groups: The bill requires more detailed annual reporting from the FDA about how fee money is spent, especially on education about youth e-cigarette use. No publicly available information about other direct effects on consumers or prices.
Expenses#
- The bill replaces prior fee amounts so that the total specified amounts are: $712,000,000 for each fiscal year 2019 through 2026, and $826,200,000 for fiscal year 2027.
- For fiscal year 2028 and each subsequent year, the total amount is adjusted by the Consumer Price Index (CPI) change for the 12-month period ending the June 30 before the fiscal year.
- Beginning in fiscal year 2029, fees will be assessed across all regulated tobacco product classes. The FDA must create a formula to allocate fees for classes not previously listed; that allocation will be based on the share of gross domestic sales for each class in the previous calendar year.
- The bill requires manufacturers and importers to submit sales data to support the fee allocation. It requires the FDA to report annually on how fee money is spent, including amounts for public education on youth e-cigarette use.
Proponents' View#
No publicly available information.
Opponents' View#
No publicly available information.