TOBACCO INDUSTRY USER FEES IN THE UNITED STATES Mitch Zeller, J.D.

Microsoft PowerPoint - US user fees on tobacco TOBACCO INDUSTRY USER FEES IN THE UNITED STATES Mitch Zeller, J. [...] Food and Drug Administration 9 November 2023 REGULATORY/LITIGATION HISTORY • FDA’s initial effort • 2+ year investigation of the industry and role of nicotine • Assertion of jurisdiction over tobacco products in 1996 • Tobacco industry immediately sued • Industry litigation resulted in Supreme Court ruling in 2000 • Supreme Court decision in the Brown & Williamson case • FDA assertion of jurisdict. [...] 3 RATIONALE FOR SECTION 919 • Bipartisan support for making the tobacco industry pay to be regulated rather than out of taxpayer dollars or by raising federal taxes • Avoid making FDA’s tobacco regulatory budget subject to the annual appropriations process in Congress • One-year budget cycle where Congress decides each year how much money each agency gets and what it should be spent on • Can be ex. [...] user fee system is proof of principle • Mandates to raise money from the tobacco industry can work • The U. [...] 'polluter pays' proposal adds value by going further • Capping tobacco manufacturers' profits will: • Support delivery of the U.