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Plaintiffs acknowledge none of these risks. Their briefs give no inkling that nicotine is highly addictive, that e-liquids often contain toxic chemicals, or that e-cigarettes can explode. Instead, Plaintiffs contend that e-cigarettes should not be regulated at all, because they are generally “safer” than conventional cigarettes—one of the deadliest products ever brought to market. But that is rather like saying that cars should not be regulated because they are safer than motorcycles. And it is no answer to the many risks of e-cigarettes that are known now, and that could be mitigated through FDA oversight.
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 “onesize- 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.
Plaintiffs’ two First Amendment challenges—to the ban on the distribution of free samples, and to the premarket review of “modified risk” products—also lack merit. The free sample ban regulates conduct, not speech, and thus does not even implicate free speech concerns. And the premarket review of “modified risk” tobacco products is modeled after the premarket review of therapeutic drugs under the Federal Food, Drug, and Cosmetic Act (“FDCA”), which the D.C. Circuit has already upheld against First Amendment challenge. Moreover, both provisions would easily pass muster even if scrutinized as commercial speech, as they are narrowly tailored to prevent the harms that Congress foresaw.
Absent the deeming rule, the FDA cannot require e-cigarettes and e-liquids to have accurate labels. It cannot require warnings about their addictive potential. It cannot require that toxic and carcinogenic chemicals be reduced or eliminated. It cannot require that these products be made in accordance with good manufacturing practices. It cannot verify that purportedly “modified risk” products do, in fact, reduce risk. And it can do nothing to prevent risky products from falling into the hands of youth. The Court should reject Plaintiffs’ suggestion that e- cigarettes are somehow so unique among tobacco products that they should escape regulation of these known risks.
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Indeed, cigarette companies have long manipulated these components or parts to affect the performance of their products. See, e.g., United States v. Philip Morris USA Inc.,
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Even if the tobacco industry had no history of false and misleading statements about the relative health risk of their products, Congress’s determination that the government should ensure the accuracy and completeness of a manufacturer’s modified-risk claims through premarket FDA review when an addictive substance is at issue clearly advances the government’s substantial interest in protecting the public health. After-the-fact enforcement comes too late for the addicted consumer.