[co-author: Stephanie Kozol]*
On September 22, a group of 28 state AGs led by Iowa filed an amicus brief in Vapor Technology Association v. Wooten in support of North Carolina’s state directory law that prohibits the sale of electronic nicotine delivery system (ENDS) products or e-cigarettes that lack Food and Drug Administration (FDA) marketing authorization. According to the brief, 15 states have already enacted laws similar to North Carolina’s ENDS directory law, and another 25 states are considering such legislation.
As our team wrote in July, federal courts in recent months have split over whether states may condition the sale of ENDS products on FDA premarket authorization.
Now, three federal appeals courts — the Fourth Circuit in Vapor Technology Association v. Wooten, the Seventh Circuit in Wisconsinites for Alternatives to Smoking v. Casey, and the Eighth Circuit in Iowans for Alternatives v. Mosiman — are poised to determine whether such laws are preempted by the Federal Food, Drug, and Cosmetic Act (FDCA), as amended by the 2009 Family Smoking Prevention and Tobacco Control Act (TCA). The matters are fully briefed and awaiting oral argument.
Challengers have argued the FDCA preempts state ENDS directory laws because they effectively enforce FDA premarket review requirements for tobacco products — something the FDCA says only the federal government may do. Specifically, such laws typically require ENDS manufacturers certify their products have either: (1) received an FDA marketing granted order, or (2) timely submitted a premarket tobacco product application (PMTA) that either remains under FDA review or has received a marketing denial order that has been stayed, rescinded, or vacated by the FDA or a court. The laws then typically require a state agency, such as the Department of Revenue or state attorney general’s office, to publish a list of the products that satisfy these criteria, and only those products included on the directory can be sold in the state.
By conditioning the sale of ENDS products on whether the products have received FDA premarket review, challengers argue that the state directory laws usurp FDA’s exclusive authority to choose how and when to enforce the FDCA’s requirements.
Proponents of the state ENDS directory laws, including the 28 state AG amici, argue the directory laws are not preempted. Although the FDCA generally preempts state law enforcement of FDCA requirements and the TCA preempts state laws that impose additional or different premarket review requirements, they argue that the TCA’s inclusion of preservation and savings clauses recognized states’ longstanding authority to regulate tobacco sales. Accordingly, they argue the state directory laws are permissible salesrestrictions. In addition, proponents argue that challengers lack standing — a legal pre-requisite to bring the challenge — because they do not have a legally protected interest in selling unauthorized and unlawful ENDS products.
Why It Matters
The vast majority of ENDS products on the U.S. market lack FDA marketing authorization. The agency has only authorized the ENDS products of four companies to date. Although FDA has ramped up its enforcement efforts in recent months, states have sought to fill the gap by clearing market shelves through state ENDS directory laws.
The outcome of the three federal appeals decisions will help clarify whether the directory laws are permissible state sales restrictions or preempted attempts at enforcing FDCA premarket review requirements.
*Senior Government Relations Manager
