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Wages and White Lion Investments, L.L.C.","href":"https:\/\/api.oyez.org\/cases\/2024\/23-1038","view_count":0,"docket_number":"23-1038","additional_docket_numbers":null,"manner_of_jurisdiction":"Writ of \u003Ci\u003Ecertiorari\u003C\/i\u003E","first_party":"Food and Drug Administration","second_party":"Wages and White Lion Investments, L.L.C.","timeline":[{"event":"Granted","dates":[1719896400],"href":"https:\/\/api.oyez.org\/case_timeline\/case_timeline\/55528"},{"event":"Argued","dates":[1733119200],"href":"https:\/\/api.oyez.org\/case_timeline\/case_timeline\/55553"},{"event":"Decided","dates":[1743570000],"href":"https:\/\/api.oyez.org\/case_timeline\/case_timeline\/55631"}],"lower_court":{"ID":10,"name":"United States Court of Appeals for the Fifth Circuit","href":"https:\/\/api.oyez.org\/taxonomy\/term\/10"},"facts_of_the_case":"\u003Cp\u003EIn 2009, Congress passed the Family Smoking Prevention and Tobacco Control Act, requiring FDA approval for new tobacco products, including e-cigarettes. FDA issued guidance on the application process, stating that long-term studies were not necessary and emphasizing the importance of marketing plans to prevent youth access. Manufacturers were encouraged to use existing data and observational studies. In January 2020, FDA announced it would prioritize enforcement against flavored, cartridge-based e-cigarette products due to their popularity among youth.\u003C\/p\u003E\n\u003Cp\u003EWages and White Lion Investments (Triton Distribution) and Vapetasia, manufacturers of flavored nicotine liquids for refillable e-cigarette systems, submitted applications in September 2020. Their applications included existing studies on e-cigarettes generally and detailed marketing plans to restrict youth access. However, in August 2021, FDA unexpectedly announced a new requirement for randomized controlled trials or longitudinal cohort studies specific to flavored products. Shortly after, FDA denied the applications of Triton and Vapetasia, citing a lack of evidence that their flavored products would benefit adult users enough to outweigh risks to youth. The manufacturers challenged this decision, arguing that FDA had changed its requirements without notice and refused to consider their marketing plans.\u003C\/p\u003E\n","question":"\u003Cp\u003EWas the Food and Drug Administration\u2019s orders denying respondents\u2019 applications for authorization to market new e-cigarette products arbitrary and capricious, in violation of the Administrative Procedure Act?\u003C\/p\u003E\n","conclusion":"\u003Cp\u003EThe FDA did not act arbitrarily and capriciously in denying the respondents\u2019 applications to market flavored e-cigarette products under the Family Smoking Prevention and Tobacco Control Act. Justice Samuel Alito authored the unanimous opinion of the Court.\u003C\/p\u003E\n\u003Cp\u003EThe FDA\u2019s rejection of the applications complied with its legal authority under the Tobacco Control Act and was consistent with its earlier guidance. The statute allows the FDA to require either \u201cwell-controlled investigations\u201d or other \u201cvalid scientific evidence\u201d showing a new tobacco product is \u201cappropriate for the protection of the public health.\u201d In its guidance, the FDA did not mandate randomized controlled trials or longitudinal studies but made clear that, in their absence, manufacturers must submit scientifically rigorous and product-specific evidence. The respondents failed to meet that standard.\u003C\/p\u003E\n\u003Cp\u003ELikewise, the FDA was justified in requiring proof that flavored products offered cessation benefits greater than tobacco-flavored products\u2014a requirement foreshadowed in prior statements emphasizing the unique appeal of non-tobacco flavors to youth. The FDA\u2019s approach to different e-cigarette device types also remained consistent, as its enforcement guidance never promised non-cartridge-based products immunity from review; the FDA reasonably inferred that youth demand would shift to any flavored product, regardless of format.\u003C\/p\u003E\n\u003Cp\u003EAlthough the FDA erred by disregarding the marketing plans that it had previously described as \u201ccritical,\u201d the Fifth Circuit incorrectly interpreted the relevant harmless-error standard too narrowly. The Administrative Procedure Act incorporates a civil litigation rule that courts must take \u201cdue account\u201d of whether an error caused actual prejudice.\u003C\/p\u003E\n\u003Cp\u003EJustice Sonia Sotomayor authored a concurring opinion.\u003C\/p\u003E\n","advocates":[{"advocate":{"ID":19038,"name":"Curtis E. Gannon","href":"https:\/\/api.oyez.org\/people\/curtis_e_gannon","view_count":0,"last_name":"Gannon","roles":null,"thumbnail":null,"length_of_service":0,"identifier":"curtis_e_gannon"},"advocate_description":"for the Petitioner","href":"https:\/\/api.oyez.org\/case_advocate\/case_advocate\/23639"},{"advocate":{"ID":63729,"name":"Eric N. 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