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Increased FDA Fees and Expansion to All Tobacco Products

This bill amends the Federal Food, Drug, and Cosmetic Act to increase user fees collected from tobacco manufacturers to fund FDA activities. Starting in fiscal year 2028, these fees will extend to all regulated tobacco products, including those containing nicotine from any source. The legislation sets new fee amounts, starting at $826.2 million in 2025, and establishes sales data reporting requirements for manufacturers.
Key points
Annual fees for the tobacco industry increase to $826.2 million in fiscal year 2025, with subsequent inflation adjustments.
Beginning in fiscal year 2028, user fees will apply to all classes of tobacco products, including products containing nicotine from any source.
Manufacturers and importers will be required to submit quarterly gross domestic sales data to calculate fee assessments.
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Additional Information
Print number: 118_HR_9425
Sponsor: Rep. McClellan, Jennifer L. [D-VA-4]
Process start date: 2024-08-30