The U.S. Supreme Court is considering the case of two companies whose applications to sell e-cigarettes that taste like sweet treats were rejected by the FDA.
The justices heard arguments in the case of Food and Drug Administration v. Wages and White Lion Investments LLC. The FDA appealed to the high court after the 5th U.S. Circuit Court of Appeals agreed with the companies’ argument that the rejection of their applications was unwarranted.
The FDA’s action stems from the federal Family Smoking Prevention and Tobacco Control Act of 2009 , which gives the agency regulatory authority over tobacco products. Under this law, the FDA can approve the sale of a tobacco product if the applicant shows the product would be “appropriate for the protection of the public health.” To meet this standard, the FDA weighs the likelihood that the new product will help existing tobacco users stop using tobacco or switch to a less dangerous alternative against the possibility that the product will attract nontobacco users, specifically children. The Tobacco Control Act also preserves state and local authority to regulate tobacco products more strictly than the federal requirements.
The two companies sought FDA approval to sell flavored e-cigarette liquids called “Rainbow Road,” “Crème Brulee” and “Jimmy the Juice Man Peachy Strawberry.” The FDA says it rejected their applications because fruit- and candy-flavored e-cigarettes are more attractive to children, and the companies presented no evidence that flavored e-cigarettes benefitted current adult smokers by enticing them to switch to the less toxic e-cigarettes. The companies allege the FDA’s denial was arbitrary and capricious because the agency changed the requirements the companies had to meet, resulting in the denial of their applications.
During oral arguments, a majority of the justices were skeptical of the companies’ position. They pointed out that the Tobacco Control Act gives the FDA clear authority to regulate tobacco products; if the companies disagree with the FDA’s decision, they have the option to reapply and provide more evidence for the FDA to consider.
Nineteen states and Washington, D.C., filed as amici supporting the FDA’s regulatory authority. They argue that protecting children from tobacco use is an important public health interest. They noted that “states also have a particular interest in the continued strength of the federal government’s nationwide system of oversight over such products. Regulation and control of these harmful products at the national level is critical to address the ease with which such products can be transported across state borders, whether purchased at brick-and-mortar stores or online.”
A decision in this case is expected by June next year.
Susan Frederick is NCSL’s senior federal affairs counsel.