In U.S. Food and Drug Administration v. Wages and White Lion Investments, the U.S. Supreme Court will consider whether changes to FDA guidance on approval of new flavored e-cigarette flavors led to arbitrary and capricious denials of manufacturers’ applications.

The Family Smoking Prevention and Tobacco Control Act requires FDA approval for the production of new tobacco products. Since 2016, that has included e-cigarettes. Manufacturers of existing e-cigarette products were permitted to wait until September 2020 to apply for FDA approval to continue their production and sales. Applicants were required to establish that their product would appropriately protect public health by helping current tobacco users stop using tobacco products.