The Seventh Circuit issued an opinion on Monday in a case filed by Gripum, LLC against the United States Food and Drug Administration (FDA). The opinion, written by Judges Wood, Hamilton, and Kirsch, ruled that the FDA has not arbitrarily denied the plaintiff’s premarket tobacco product application.
The plaintiff “manufactures and distributes hundreds of flavored liquids for use in e-cigarette devices.” In September of 2021, the plaintiff submitted a premarket tobacco product application to the defendant in which they sought to bring their products to market. The FDA denied their application, claiming that plaintiff Gripum had not adequately demonstrated the public health benefits that would accompany bringing their products to market as is require by the Family Smoking Prevention and Tobacco Control Act (the Act). Following the defendant’s denial, the plaintiff petitioned for a review of the FDA’s decision.
Under the Family Smoking Prevention and Tobacco Control Act, companies like the plaintiff that seek to market new tobacco products must obtain approval to do so. Applications may be denied if the Secretary of Health and Human Services determines that the product is not appropriate for the protection of public health (the appropriateness standard). The appropriateness standard is determined by the Secretary considering “the risks and benefits to the population as a whole, including users and nonusers of the tobacco product.”
The FDA explained in their denial of the plaintiff’s application that they needed to bring forth “robust and reliable evidence… regarding the magnitude of the potential benefit to adult smokers.” In their petition, the plaintiff claims that the FDA’s denial of their application was arbitrary because they failed to express attainable standards prior to denying the application, they allegedly shifted their evidentiary standard but express they would be relying on an easier-to-meet standard, and lastly that they failed to take an individualized approach to the application, instead applying generalized presumptions.
The Seventh Circuit ruled that the FDA’s acted in accordance with the Act when judging the plaintiff’s application. They ruled that the standards used by the defendant stem directly from the Act, meaning that no further elaboration was likely needed. Judges Wood, Hamilton, and Kirsch also determined that the FDA was consistent in the type of standards and evidence they required of companies like the plaintiff. They also denied their generalized presumptions reasoning, stating that the argument rested on “a questionable reading of both the agency’s marketing denial order and statutory burden.”
The Seventh Circuit made the determination that the application denial by the FDA was not arbitrary or unreasonable on Monday and subsequently denied Gripum’s petition for review.
Gripum was represented in the litigation by Troutman Law Office.
