By Timothy S. Donahue

Top Takeaways:

• Company cites NYTS data: Drip More argued FDA overlooked evidence showing youth were not using its products.
• FDA says flavors drive risk: The agency maintained youth follow flavors, not individual brands.
• Court explores limits of comparative-efficacy standard: Judges questioned whether FDA’s requirement can be applied uniformly.

The United States Court of Appeals for the Ninth Circuit  on June 11 heard challenge from Drip More LLC, with the company arguing that the U.S. Food and Drug Administration improperly denied its premarket tobacco product applications (PMTA) without considering evidence specific to its products.

Unlike the MH Global v. FDA case, which was also submitted by the same Ninth Circuit panel, Drip More focused heavily on what it described as product-specific evidence demonstrating limited youth interest.

The company’s attorney, Eric Gotting of Keller and Heckman LLP, told the court that National Youth Tobacco Survey data from 2019 to 2021 showed no youth respondents reported using Drip More products. “Not a single minor in 2019, 2020, 2021 identified this product,” Gotting argued.

Drip More maintained that the FDA should have considered that evidence before applying its comparative-efficacy framework. The panel repeatedly questioned how that argument aligned with existing precedent, including the Ninth Circuit’s decision in Lotus Vaping and the Supreme Court’s rulings in Wages and White Lion.

FDA attorney Ben Lewis responded that youth-risk evidence does not depend on whether a specific brand appears in survey data. “Young people follow the flavors,” Lewis told the court, arguing the scientific evidence supporting youth appeal of fruit, candy and dessert flavors remains strong regardless of brand-specific data.

Lewis also used the recently authorized Glas products to explain FDA’s position that the comparative-efficacy inquiry is tied to youth risk rather than functioning as a de facto flavor ban.

“FDA has not told manufacturers that flavors are banned,” Lewis said. “What it said is that you can make your product with any flavor you want, but you still have to demonstrate that it’s appropriate for the protection of the public health.”

The case was submitted without a decision.