FDA WAS ORDERED TO REGULATE E-CIGS AND VAPES BY FEDERAL JUDGE
In the latest challenge against vaping, the Food and Drug Administration (FDA) is being forced by a federal court to vacate previous industry guidance and begin expediting the process of regulating such products.
United States District Judge Paul W. Grimm of the District of Maryland ruled in the case of American Academy of Pediatrics et al v. FDA that due to a so-called lack of action taken on deemed tobacco products such as e-cigarettes under the FDA’s interpretation of the Tobacco Control Act, the public health regulator must act in expediting regulatory requirements.
Specifically, Grimm’s decision forces the FDA to vacate a 2017 guidance delaying premarket tobacco applications (PMTA) for e-cigarette and vape products to a later date.
In the 2017 compliance policy that was issued in August of that year, the FDA extended the compliance deadlines for filing PMTA submissions for Deemed Products to August 8, 2021, for combustible products and to August 8, 2022, for other noncombustible products.