Big Time Vapes, Inc. v. FDA, No. 19-60921 (5th Cir. June 25, 2020) (Smith, Higginson, Engelhardt)

The Family Smoking Prevention and Tobacco Control Act establishes a thorough framework for regulating tobacco products. 21 U.S.C. § 387, et seq. Four products—cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco—are automatically subject to the Act. But in section 901 of the TCA, Congress authorized the Secretary of Health and Human Services to determine which other products should be governed by the TCA’s regulatory scheme.

In May 2016, FDA promulgated a rule deeming Electronic Nicotine Delivery Systems (ENDS) “tobacco products” thus subjecting ENDS and e-liquid producers to FDA regulation under the TCA. Big Time Vapes, Inc., a small-business manufacturer and retailer of e-liquids, and the United States Vaping Association, an ENDS industry trade association, sued FDA, contending that the TCA unconstitutionally delegated to the Secretary the power to deem tobacco products subject to the Act’s mandates. The district court dismissed, and the Fifth Circuit affirmed.

Judge Smith’s opinion for the unanimous panel explains that the TCA’s delegation of authority to the Secretary to “deem” which tobacco products should be subject to the Act’s mandates was constitutional, see 21 U.S.C. § 387a(b), because Congress clearly delineated a general policy, the agency that should apply it, and the boundaries of that delegated authority. The Act’s “general policy,” he explained, was “[o]bvious": “(1) protecting public health and (2) preventing young people from accessing (and becoming addicted to) tobacco products.” Congress also limited its delegation by tethering the Secretary’s authority to the statutory definition of “tobacco product” and by making several key regulatory decisions itself.

After distinguishing this case from Panama Refining Co. v. Ryan, 293 U.S. 388, 433 (1935) and A.L.A. Schechter Poultry Corp. v. United States, 295 U.S. 495, 542 (1935), the Court concluded:

The Court might well decide—perhaps soon—to reexamine or revive the nondelegation doctrine. But “[w]e are not supposed to ... read tea leaves to predict where it might end up.” United States v. Mecham, 950 F.3d 257, 265 (5th Cir. 2020), cert. denied,––– U.S. ––––, 2020 WL 3405899 (U.S. June 22, 2020) (No. 19-7865). The judgment of dismissal is therefore AFFIRMED.
Big Time Vapes, Inc. v. FDA
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