{"ID":63707,"name":"Food and Drug Administration v. R.J. Reynolds Vapor Co.","href":"https:\/\/api.oyez.org\/cases\/2024\/23-1187","view_count":0,"docket_number":"23-1187","additional_docket_numbers":null,"manner_of_jurisdiction":"Writ of \u003Ci\u003Ecertiorari\u003C\/i\u003E","first_party":"Food and Drug Administration","second_party":"R.J. Reynolds Vapor Co.","timeline":[{"event":"Granted","dates":[1728018000],"href":"https:\/\/api.oyez.org\/case_timeline\/case_timeline\/55535"},{"event":"Argued","dates":[1737439200],"href":"https:\/\/api.oyez.org\/case_timeline\/case_timeline\/55558"},{"event":"Decided","dates":[1750395600],"href":"https:\/\/api.oyez.org\/case_timeline\/case_timeline\/55674"}],"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\u003ER.J. Reynolds Vapor Company manufactures e-cigarettes, including the popular menthol- and mixed-berry-flavored Vuse Alto products. When the FDA announced in 2016 that e-cigarettes would be regulated as \u201cnew tobacco products\u201d under the Tobacco Control Act, RJR Vapor timely applied for authorization to continue marketing its Vuse Alto products. Three years later, the FDA denied the applications, finding that RJR Vapor had failed to demonstrate that marketing these products would be \u201cappropriate for the protection of the public health.\u201d Rather than challenging the denial alone in either the D.C. Circuit or the Fourth Circuit (where it could properly file), RJR Vapor joined with retailers to file a joint petition in the Fifth Circuit: Avail Vapor Texas, L.L.C. (a Texas company operating a Vuse store in Houston), the Mississippi Petroleum Marketers and Convenience Stores Association, and another RJR corporate affiliate that sold Vuse products online.\u003C\/p\u003E\n\u003Cp\u003EThe FDA moved to dismiss the joint petition for lack of venue or alternatively to transfer it to the D.C. Circuit or Fourth Circuit, arguing that only disappointed applicants\u2014not retailers\u2014are \u201cadversely affected\u201d by denial orders under the Tobacco Control Act and thus have the right to seek judicial review. A divided panel of the U.S. Court of Appeals for the Fifth Circuit denied the FDA\u2019s motion, concluding that venue was proper because the retailers were \u201cadversely affected\u201d by the denial order and could properly petition for review.\u003C\/p\u003E\n","question":"\u003Cp\u003ECan retailers who would sell a new tobacco product seek judicial review of the FDA\u2019s denial of a manufacturer\u2019s marketing application under the Tobacco Control Act?\u003C\/p\u003E\n","conclusion":"\u003Cp\u003EThe Tobacco Control Act\u2019s provision that \u201cany person adversely affected\u201d by the FDA\u2019s denial of a marketing application may seek judicial review extends to retailers who would sell the new tobacco product, not just the manufacturers who applied for approval. Justice Amy Coney Barrett authored the 7-2 majority opinion of the Court.\u003C\/p\u003E\n\u003Cp\u003EThe phrase \u201cadversely affected\u201d is a term of art in administrative law that the Court has consistently interpreted broadly. When Congress uses variations of this phrase across different statutes, the Court presumes it carries the same meaning as in the Administrative Procedure Act\u2014covering anyone \u201carguably within the zone of interests to be protected or regulated by the statute.\u201d Congress reinforced this broad interpretation by using \u201cany person\u201d rather than limiting review to \u201cthe applicant.\u201d The Court\u2019s precedents from other contexts, including employment discrimination and fair housing cases, confirm that \u201cadversely affected\u201d encompasses more than just the direct recipient of agency action. Retailers face a direct, significant impact from denial orders because they lose the opportunity to profit from selling the product and face criminal penalties if they sell it without authorization.\u003C\/p\u003E\n\u003Cp\u003EThe statutory structure confirms Congress intended different scopes for different provisions. While the Act limits challenges to withdrawal of existing approvals to only \u201cthe holder of [the] application,\u201d it uses the broader \u201cany person adversely affected\u201d language for initial denials. This deliberate use of materially different terms creates a presumption that Congress intended different meanings. The FDA\u2019s arguments focusing on the application process and confidentiality provisions cannot override the plain language Congress chose for the judicial review provision.\u003C\/p\u003E\n\u003Cp\u003EJustice Ketanji Brown Jackson authored a dissenting opinion, joined by Justice Sonia Sotomayor, arguing that retailers fall outside the statute\u2019s zone of interests because the premarket approval scheme involves only manufacturers and the FDA, with no mechanism for retailer participation.\u003C\/p\u003E\n","advocates":[{"advocate":{"ID":63186,"name":"Vivek Suri","href":"https:\/\/api.oyez.org\/people\/vivek_suri","view_count":0,"last_name":"Suri","roles":null,"thumbnail":null,"length_of_service":0,"identifier":"vivek_suri"},"advocate_description":"for the Petitioners","href":"https:\/\/api.oyez.org\/case_advocate\/case_advocate\/23675"},{"advocate":{"ID":63753,"name":"Ryan J. 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