S. 4257 — Resources To Prevent Youth Vaping Act

This section revises the tobacco product user fee program under section 919 of the Federal Food, Drug, and Cosmetic Act (i.e., annual fees assessed on manufacturers and importers to fund FDA's regulation of tobacco products, including premarket review, manufacturing standards, labeling, marketing restrictions, and enforcement). (1) Increases the total annual user fee amount by striking subparagraph (b)(1)(K) and inserting new subparagraphs setting it at $712 million for each of FY2019 through 2026, $826.2 million for FY2027, and for FY2028 and each subsequent fiscal year, the prior fiscal year's amount adjusted by the change in the Consumer Price Index for all urban consumers (all items; U.S. city average) for the 12-month period ending June 30 preceding the fiscal year. (2) Limits user fee assessments for FY2027 and FY2028 to the classes of tobacco products listed in current section 919(b)(2)(B)(i) (i.e., cigarettes, cigarette tobacco, roll-your-own tobacco, snus, and other smokeless tobacco), with each class's share equal to its applicable percentage of the total amount; for FY2029 and subsequent fiscal years, assesses and collects fees on all classes subject to the chapter (including any deemed subject by regulation), with— (A) listed classes receiving their applicable percentage of the total amount reduced by fees on other classes; and (B) other classes allocated fees pursuant to an FDA-developed formula based on each class's share of gross domestic sales (i.e., total dollar value of U.S. sales or distribution by all manufacturers and importers in the prior calendar year), with each manufacturer or importer's share within a class based on its sales percentage; if FDA fails to finalize the formula by FY2029, fees continue only on listed classes until finalized, with formula revisions made by regulation. (3) Requires each manufacturer or importer of tobacco products to submit specified information to FDA—by March 1, 2028, for CY2027; by April 1, 2028, for January 1 through March 31, 2028; and monthly thereafter—including firm identification, classes sold, full listing of finished products in other classes, and gross domestic sales data for each class. (Thus, beginning in FY2029, the fee program expands to previously excluded classes such as cigars and electronic nicotine delivery systems, increasing FDA's funding base contingent on data submission and formula implementation.)

This section amends the annual FDA report on tobacco product regulation activities required under 21 U.S.C. 387v(b) by adding three new reporting elements. Beginning with the FY2027 report, it requires (1) a breakdown of expenditures on activities related to deemed tobacco products (i.e., e-cigarettes and other products regulated under FDA authority post-2009) versus combustible tobacco products listed in 21 U.S.C. 387s(b)(2)(B)(i) (i.e., cigarettes, cigars, snuff, chewing tobacco, pipe tobacco, and roll-your-own tobacco); and (2) an explanation of how user fees allocated to public education campaigns on youth e-cigarette use and prevention (i.e., for Electronic Nicotine Delivery Systems or ENDS) are sufficient to educate teens and minors on their dangers. Beginning with the FY2029 report, it requires (3) a breakdown of user fees collected under this Act from manufacturers of deemed tobacco products versus those collected from manufacturers of the original pre-existing categories of tobacco products under 21 U.S.C. 387s(b)(2)(B)(i). (Thus, these requirements increase FDA transparency on the allocation of tobacco user fees—which fund product regulation, enforcement, and education—between traditional combustible products and newer deemed products such as e-cigarettes.)