We will hear argument first this morning in case 23, 1038, Food and Drug Administration versus

wages and white-line investments. Mr. Gannon?

Mr. Chief Justice, and may it please the Court, 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. Respondent's nicotine solutions for e-cigarettes

are flavored to taste like fruit, candy, or various desserts. 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 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.

They now claimed 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.

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