“If allowed to stand, the FDA’s denial order will endanger the public’s health.”
—John Masslon, WLF Senior Litigation Counsel

Click here for WLF’s brief.

WASHINGTON, DC— Washington Legal Foundation (WLF) today urged the U.S. Court of Appeals for the Fifth Circuit to reject the Food and Drug Administration’s regulatory bait-and-switch. In an amicus brief, WLF argues that FDA’s actions violated NicQuid’s due-process rights and the Administrative Procedure Act.

The case arises from FDA’s approval process for electronic nicotine delivery systems (ENDS). After FDA decided that manufacturers needed premarket approval to sell ENDS in the United States, it gave guidance on what information the applications should include. NicQuid closely followed that guidance when submitting its applications. But FDA then yielded to political pressure and said that additional information, which it previously said was unnecessary, must also be included in the applications. It thus sent NicQuid a form denial letter.

In its brief supporting NicQuid, WLF argues that the Due Process Clause bars agencies from depriving regulated parties of fair notice of regulatory requirements. Fair notice is at the heart of due process. And as the brief explains, telling parties they need not include information in applications and then denying those applications for leaving out that information is the antithesis of fair notice.

WLF’s brief also describes why FDA’s denial order was arbitrary and capricious. NicQuid submitted data showing that its products do not appeal to youth and help current smokers quit or reduce their combustible tobacco use. FDA, however, ignored this evidence and instead cited generic studies that do not address NicQuid’s products.

Celebrating its 47th year, WLF is America’s premier public-interest law firm and policy center advocating for free-market principles, limited government, individual liberty, and the rule of law.