FDA v. Wages and White Lion (23-1038)

argument 23-1038

FDA v. Wages and White Lion

Supreme Court of the United States 1h 20m 8 speakers 8 chapters transcribed 1 month ago official recording ↗

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What is the core issue being argued in FDA v. Wages and White Lion?

John G. Roberts 0:00

We will hear argument first this morning in case twenty three ten thirty eight, Food and Drug Administration versus versus wages and white line investments. Mr. Gannon.

Mr. Gannon 0:10

Mr Chief Justice, and may it please the Court.

How does the Family Smoking Prevention and Tobacco Control Act define the FDA’s approval criteria?

Mr. Gannon 0:12

Under the Family Smoking Prevention and Tobacco Control Act, a manufacturer may introduce a new tobacco product only with authorization from the Food and Drug Administration. An applicant must show that the marketing of its product would be appropriate for the protection of the public health, which requires FDA to take into account both the likelihood that existing users of tobacco products will stop using such products and the likelihood that those who do not use tobacco products will start using them if the product is marketed. Respondents' nicotine solutions for e-cigarettes are flavored to taste like fruit, candy, or various desserts.

Why did the FDA deny the flavored e‑cigarette applications?

Mr. Gannon 0:47

FDA denied their applications, concluding that respondents failed to show that their products have sufficient benefits for existing smokers to offset the serious risk that the flavors pose to attracting youth to the use of tobacco. Alone among the courts of appeals, the Fifth Circuit found FDA's reasoning to be arbitrary and

What was the Fifth Circuit’s reasoning for finding the FDA’s decision arbitrary and capricious?

Mr. Gannon 1:06

Capricious, but each of its five rationales was incorrect, and respondents barely defend any of them, instead, emphasizing other meritless objections that no court has countenanced. Respondents were not unfairly surprised by FDA's denials.

Does the lack of clear guidance constitute a due‑process or fair‑notice violation?

Mr. Gannon 1:20

They now claim that they had no idea they needed to compare their flavored products with tobacco-flavored e-cigarettes, but their applications drew such a comparison. They just did not have sufficient scientific evidence to bear out their claim that non-tobacco flavors are, quote, crucial to getting adult smokers to make the switch, end quote. Nor did respondents suffer any prejudice from FDA's failure to look at their marketing plans. They've identified no features that FDA has not already found are insufficient to mitigate the heightened risk of youth uptake that flavored e cigarettes pose, making the Fifth Circuit's remand to FDA a useless formality.

How is the harmless‑error doctrine being applied to the FDA’s denial orders?

Mr. Gannon 1:59

This Court should reverse the Fifth Circuit's outlier decision. I welcome the Court's questions.

Did the FDA’s change in guidance amount to misleading or mistaken advice to applicants?

Clarence Thomas 2:05

Well, in fairness to respondents, I think their argument is that uh the guidance were actually a moving target. that uh either they weren't clear or you changed the uh the guidance as time went on.

Mr. Gannon 2:21

That is their argument, Justice Thomas, but I think that

What role do menthol and other flavors play in the public‑health analysis?

Mr. Gannon 2:24

The key point is that they knew from the statute that they needed to be making this comparison about what the benefits were with respect to existing smokers and weighing that against the potential costs with respect to nonsmokers and attracting youth. They knew throughout that FDA was concerned about the fact that flavors are attractive to youth, and that is the second column that was going to be problematic. They knew then, therefore, that If that was a heightened risk on that side, that they needed to show a heightened benefit on the other side. And as I said in my introduction, their applications acknowledged that they were trying to make this claim. This is clear if you look at their application.

Mr. Gannon 3:02

They say when they are considering the question of evaluating the role of flavors with respect to population health incomes, this is their application. Relevant questions include the impact of flavors on the four. On adult smokers who transition or not to e-cigarettes. That is at page 355 of the joint appendix for Triton's application, the same thing as on page 448 for Vape Tasia's application. So they were trying to make this argument. And they said that the research is in its infancy, but their own review of the scientific literature said that no conclusions can be drawn about the association of e-cigarette flavors and smoking systems. And so the data just weren't there when they were filing their application in twenty twenty.

John G. Roberts 3:45

Do you recognise an obligation to tell people what they have to do to comply? uh with your regulation or do you think it is simply uh an obligation not to mislead?