On Monday, the Supreme Court denied the petition for review of a lawsuit alleging that new tobacco rules imposed by the Food and Drug Administration violate the Constitution.
The petition for writ of certiorari was filed in December 2020, and the initial lawsuit was filed by Big Time Vapes Inc. and the United States Vaping Association Inc. against the FDA in August 2019. The suit states that in 2009, Congress passed the Family Smoking Prevention and Tobacco Control Act, which imposed new regulatory rules on cigarettes and smokeless tobacco. Other types of tobacco products, such as cigars and hookah, were left unregulated. However, Congress purportedly gave the Secretary of Health and Human Services the authority to impose the act on “any other tobacco products that the Secretary by regulation deems to be subject to [the Act].” On May 10, 2016, the FDA published a final rule deeming all products meeting the statutory definition of “tobacco product” to be subject to the Act, including vaping products. The plaintiffs claimed that by allowing the FDA to do this, Congress violated Article 1 of the Constitution.
“The power to make policy is the legislative power, and that power has been vested exclusively in the ‘Congress of the United States,’” the suit states.
Furthermore, the plaintiffs claimed that vaping businesses are severely burdened by being subject to the requirements of the Act, including pre-market approval.
“The premarket approval requirement is prohibitively arduous, expensive, and complicated, and will force significant disruption and ‘market exit,’ just as FDA itself predicted. Many businesses will be extinguished completely, and any that survive will be forced to reduce product offerings simply because they cannot afford to submit the required premarket applications,” the suit states.
The case was initially dismissed by a southern Mississippi court in December 2019, and the dismissal was later affirmed by the Fifth Circuit Court of Appeals in June 2020 on the grounds that there was no nondelegation violation and that the FDA’s power was adequately constrained.
“Congress plainly limited the authority that it delegated. Far from giving the Secretary carte blanche, the TCA cabined its delegation in two important ways.
First, and critically, Congress enacted a controlling definition of ‘tobacco product,’ which necessarily restricts the Secretary’s power to only products meeting that definition…Congress also identified four products—‘cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco’—that were immediately subject to the TCA’ s mandates…Together, those features ‘ha[ve] the effect of constricting the [Secretary’s] discretion to a narrow and defined category,’” the court stated in its opinion.
Big Time Vapes was represented by the Navjar Law Firm.