Gripum, LLC v. United States Food and Drug Administration, No. 21-2840 (7th Cir. 2022)Annotate this Case
Gripum manufactures and distributes flavored liquids for use in e-cigarette devices. Gripum submitted a “premarket tobacco product application” to the federal Food and Drug Administration (FDA) in 2021. The agency denied the application, reasoning that Gripum had failed to demonstrate public-health benefits as required by the Family Smoking Prevention and Tobacco Control Act, 21 U.S.C. 387j. The 2016 “Deeming Rule,” promulgated under the Act requires denial of an application to market a new tobacco product if the manufacturer fails to show that the product would be “appropriate for the protection of public health,” considering the risks and benefits to the population as a whole, including users and non-users, the “increased or decreased likelihood that existing users of tobacco products will stop using such products and those who do not use tobacco products will start using such products.
The Seventh Circuit upheld the denial. The FDA required Gripum to show that its flavored e-cigarette products were relatively better at reducing rates of tobacco use than products already on the market. It properly applied the comparative standard mandated by the statute. Gripum failed to provide evidence specific to its products; its studies of other products did not even compare tobacco-flavored e-cigarette products to flavored products resembling Gripum’s products.