2019

HomeWashington Letter2019 ▶ Court Affirms FDA’s Authority to Regulate E-cigarette/Vape Products
Court Affirms FDA’s Authority to Regulate E-cigarette/Vape Products

This week, the DC District Court of Appeals upheld a lower court decision affirming the FDA’s authority to regulate e-cigarette and vape products. In the case Nicopure v. FDA, the e-cigarette industry sued the FDA on several grounds including, claiming the Agency violated federal law by not providing an easier pre-market authorization pathway for e-cigarettes, challenging the FDA’s premarket review of e-cigarette products as a violation of free speech, as well as its ban on the distribution of free e-cigarette free samples as a violation of free speech, and challenged the Agency’s review and regulation of modified risk claims.

The panel of three judges unanimously rejected all industry challenges and affirmed the FDA’s authority to regulate e-cigarette and vape products. The ATS was a party to this lawsuit and joined an amicus brief supporting the FDA’s authority to regulate e-cigarette and vape products. In responding to the court decision, Michelle Eakin, PhD, chair of the ATS Tobacco Action Committee said, “I am glad the court has affirmed the FDA’s authority to regulate e-cigarettes.  I am frustrated that the FDA has yet to use that authority to protect our nation’s kids from e-cigarettes.  It’s way past time for the FDA to act.”

Last Reviewed: December 2019