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A bill to apply user fees with respect to tobacco products deemed subject to the requirements of chapter IX of the Federal Food, Drug, and Cosmetic Act.
1/25/2024, 5:15 AM
Summary of Bill S 3653
The bill specifies that the user fees would be calculated based on the volume of tobacco products sold by each manufacturer, importer, or distributor. These fees would be used to cover the costs associated with the FDA's regulation of tobacco products, including conducting inspections, enforcing compliance with regulations, and conducting research on the health effects of tobacco use.
Supporters of the bill argue that imposing user fees on tobacco products is a fair way to ensure that the industry contributes to the costs of regulation, rather than relying solely on taxpayer funding. They also believe that these fees will help to deter underage tobacco use and reduce the overall consumption of tobacco products. Opponents of the bill, however, argue that these user fees could disproportionately impact small businesses in the tobacco industry and ultimately lead to higher prices for consumers. They also raise concerns about the potential for these fees to be passed on to consumers in the form of higher prices for tobacco products. Overall, Bill 118 s 3653 represents an effort to hold the tobacco industry accountable for the costs of regulation and enforcement, while also aiming to reduce tobacco use and its associated health risks.
Congressional Summary of S 3653
Resources to Prevent Youth Vaping Act
This bill directs the Food and Drug Administration (FDA) to collect user fees on products that it deems by regulation to be tobacco products, including electronic nicotine delivery systems, and addresses related issues. Currently, the FDA is authorized to collect user fees only on specified classes of tobacco products.
The bill increases the total amount of such fees to be collected for FY2025. For each fiscal year after, the total amount of such fees shall be adjusted according to changes in a price index.
Starting in FY2027, the FDA must assess user fees on classes of products that it has deemed by regulation to be tobacco products, unless the FDA fails to finalize a formula for assessing such fees on time. Once it is finalized, the FDA may only revise this formula by regulation.
The bill also requires each tobacco manufacturer and importer to periodically submit certain information related to the tobacco products that it sells or distributes in the United States.
The FDA must annually report to Congress about its use of such tobacco product fees.




