US Senators Introduce Bipartisan Legislation to Require Manufacturers of ENDS Products to Pay User Fees

Aug 11, 2021 | FDA, Law & Regulatory, Registration

On Friday, July 23rd, a bipartisan group of Senators introduced legislation that, if enacted, would require the manufacturers of e-cigarettes, vaping products, and other forms of electronic nicotine delivery systems (ENDS) to pay annual user fees to the Food and Drug Administration (FDA).  The Resources to Prevent Youth Vaping Act (S.3223), cosponsored by Senators Mitt Romney (R-UT), Jeanne Shaheen (D-NH), Lisa Murkowski (R-AK), Richard Durbin (D-IL), Susan Collins (R-ME), and Tammy Baldwin (D-WI), would extend to ENDS products the same statutory user fee requirements that currently apply to manufacturers and importers of cigarettes, snuff, chewing tobacco, roll-your-own tobacco, cigars, and pipe tobacco, under Section 919 of the Food, Drug, and Cosmetic Act (FD&C).  The proposed legislation would also apply to all other types of tobacco products that are not currently subject to user fee requirements

The Resources to Prevent Youth Vaping Act would increase user fees paid by tobacco product manufacturers by $100 million in 2022, to be allocated across manufacturers of ENDS and other tobacco products that are not yet subject to user fees. The amount paid by each manufacturer would be proportionate to their share of the market under a formula similar to that currently used to calculate user fees under Section 919.  

The increased revenue would be used by FDA’s Center for Tobacco Products to fund operations, health policy research, and enforcement – including enforcement of laws preventing youth access to tobacco.

If you have any questions regarding the above, please do not hesitate to contact us.

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