The Court need not sift through this evidence, however, because Congress entrusted the decision whether to supervise tobacco products, including e-cigarettes, to the expert judgment of the FDA. There can be no doubt that “the FDA has authority under the Tobacco [Control] Act to regulate e-cigarettes,” as the D.C. Circuit held in Sottera, Inc. v. FDA, 627 F.3d 891, 897 (D.C. Cir. 2010), and Plaintiffs cannot escape that conclusion simply because their “open-system” e-cigarettes are refillable. It is equally clear that the FDA’s exercise of the deeming authority is committed to agency discretion, given that Congress authorized it to subject “any” tobacco product (except certain raw tobacco leaf) to the Tobacco Control Act as it “deems” fit. 21 U.S.C. § 387a(b). In any event, the FDA rationally explained why it deemed e-cigarettes subject to the Tobacco Control Act, given their many known risks, as well as why it rejected the regulatory alternatives that Plaintiffs prefer. While Plaintiffs fault the FDA for adopting a “one-size-fits-all” approach, the Tobacco Control Act makes deeming a necessary precondition to any regulation of e-cigarettes—including the age restrictions that Plaintiffs profess to support, Stamler Decl. ¶ 41—and Plaintiffs offer no statutory support for their alternative, à-la-carte approach.

There is likewise no basis to review the FDA’s cost-benefit analysis, as the Tobacco Control Act requires no such analysis, and the Executive Orders under which the agency acted expressly preclude judicial review of its conclusions. Regardless, the FDA reasonably found that the costs of the deeming rule—an estimated $2 per beneficiary per year—were justified by its benefits, including more accurate labels, effective health warnings, and improved product consistency. Similarly misplaced are Plaintiffs’ criticisms of the FDA’s regulatory flexibility analysis, as the agency fully complied with the purely procedural requirements of the Regulatory Flexibility Act.



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