The State of Iowa has agreed to postpone the enforcement of a new law restricting the sale of electronic nicotine delivery systems (ENDS), also known as e-cigarettes and vaping products, following a lawsuit filed by several vape companies. The law, set to take effect next month, requires that all vaping products sold in Iowa have either received marketing authorization from the Food and Drug Administration (FDA) or have a pending application for authorization filed by September 2020.
In December, a group of six vape companies, including Alternatives to Smoking & Tobacco Inc. and Global Source Distribution, sued the state in the U.S District Court for the Southern District of Iowa. The companies allege that the new law violates the supremacy clause and equal protection clause of the U.S. Constitution, as well as the equal protection clause of the Iowa Constitution. They are seeking an injunction to block the enforcement of the law until a hearing on the matter is held.
While the state has yet to respond to the companies' allegations, the Iowa Attorney General's Office has agreed to stay the enforcement of the law, citing a need for more time to understand the new requirements and the absence of key personnel due to various personal obligations. A hearing on the matter is now scheduled for March 5.
FDA Authorization and Enforcement Discretion
Most vaping products currently on the market do not have FDA authorization. The plaintiffs argue that the FDA exercises its discretion to enforce federal requirements on a case-by-case basis, deliberately opting not to take enforcement action against some unauthorized products. They claim that the limited number of authorized products likely to appear on the state's registry will not be sufficient for retailers to maintain profitable businesses.
Alleged Pre-Emption and Unfair Treatment
The plaintiffs' lawsuit alleges that House File 2677 is pre-empted by federal law and regulation and that the state's plans to enforce the law on Feb. 3, 2025, would force many vape retailers to either shut down or incur significant civil penalties. They also argue that the law unfairly allows for the sale of some unauthorized vaping products containing tobacco-derived nicotine while failing to allow for the sale of any unauthorized products using non-tobacco-derived nicotine.
Potential Changes Under New Administration
The plaintiffs suggest that the incoming administration of President-elect Donald Trump may change the FDA's enforcement policies, potentially allowing more ENDS to be marketed while their pre-market applications are pending.
As the vaping industry navigates an evolving regulatory landscape, it is crucial for manufacturers, distributors, and retailers to stay informed about new laws and their potential impact on business operations. The outcome of this legal challenge in Iowa may have implications for similar laws and regulations in other states.
