US Supreme Court Hears Flavored Vape Case

The U.S. Supreme Court heard oral arguments on Monday in Wages and White Lion Investments. The Court heard arguments regarding the FDA’s defense of refusing to let two e-cigarette companies sell nicotine-containing flavored vape products deemed risky to youths. The FDA appealed a lower court’s decision, claiming it failed to follow proper legal procedures under the Administrative Procedure Act when rejecting the applications.

Background of the Case

Wages and White Lion Investments revolves around the FDA’s regulatory authority under the Family Smoking Prevention and Tobacco Control Act (TCA) of 2009. The TCA gave the FDA extensive powers to regulate the manufacturing, distribution, and marketing of tobacco products. In recent years, through the Deeming Regulation, the FDA has increasingly focused on vaping products.

White Lion Investments, d/b/a Triton, challenged the FDA’s regulations, arguing that they are overly burdensome and exceed the agency’s statutory authority. Specifically, the company contested the FDA’s requirement for premarket tobacco applications (PMTAs), which demand extensive scientific data to prove that a product is appropriate for the protection of public health. Triton secured a major victory in its case when the en banc Fifth Circuit Court of Appeals ruled in its favor.

Supreme Court Divided on Law, United on Remedy

It can be difficult to predict an outcome based on oral arguments. What was clear, and not necessarily unexpected, is the Court is divided. Justices Kagan, Soytomer, and Jackson repeatedly asked White Lion’s counsel where the surprise was (excerpts will be provided once the transcript is released), pointing both to the language in the statute and the apparent common knowledge about the dangers of flavored vapes. The conservative wing expressed a greater willingness to see how the FDA created a moving target. What may unify the Court is the remedy. The Justices grappled with what remedy the Court could provide, in particular, since both vape companies could simply re-submit the PMTA. White Lion’s counsel argued it was a question of enforcement, and absent the continued stay of the Marketing Denial Order (MDO), the two vape companies would go out of business.