July 09, 2020

Fifth Circuit Finds Congress Appropriately Delegated Power to FDA to Regulate E-Cigarettes as Tobacco Products

On June 25, the Fifth Circuit Court of Appeals rejected a nondelegation challenge to FDA regulation of Electronic Nicotine Delivery Systems (“ENDS”) as tobacco products under the Family Smoking Prevention and Tobacco Control Act ("TCA"). Under the TCA, Congress may allow the HHS Secretary to determine which items, in addition to cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco, should be subject to TCA regulation. In 2016, the FDA promulgated a rule indicating that ENDS were an item that should be subject to TCA regulation. Big Time Vapes, a manufacturer and retailer of ENDS, challenged this regulatory action, arguing that Congress had unconstitutionally delegated this power to the FDA and that, as such, the resulting FDA regulation was invalid.

The Fifth Circuit disagreed with Big Time Vapes and affirmed the district court's dismissal of the case, noting that Congressional action is not often barred by the nondelegation doctrine. Congress must simply clearly delineate general policy, the agency to which power is delegated, and applicable boundaries of that delegation. The Fifth Circuit found that all of these requirements met in this case; first, the power was clearly delegated to the Secretary of Health and Human Services; second, the general policy of the TCA is to protect public health and prevent "young people from accessing (and becoming addicted to) tobacco products"; and third, Congress provided clear limitations on the delegated authority by defining four general products to which TCA applies and by constructing much of the regulatory landscape of the TCA within the language of the TCA itself.