Gripum, LLC v. U.S. Food and Drug Administration

Record contained sufficient evidence to support respondent’s denial of petitioner’s (manufacturer of flavored liquids for use in e-cigarette devices) premarket tobacco product application. Applicable standards required respondent to weigh risk of hooking new users into world of tobacco through use of plaintiff’s product against its potential to help existing tobacco users wean themselves from tobacco’s unhealthier forms, and respondent could properly deny plaintiff’s application based on lack of evidence to demonstrate that marketing of plaintiff’s flavored products was appropriate for protection of public health. Ct. also noted that plaintiff had failed to provide bridge between data about other products and its own proposed offering. Ct. rejected plaintiff’s claim that: (1) respondent was required to set forth threshold levels of likelihood that existing users of tobacco products would stop using said products because of plaintiff’s new product; (2) guidance provided by FDA allowed plaintiff to forego product-specific testing in all cases; and (3) defendant based denial on general presumption that e-liquids increase youth tobacco use.