The Food and Drug Administration (FDA) has recently filed new injunction and civil money penalty proceedings against unauthorized, flavored e-liquids and electronic nicotine delivery systems (ENDS) manufacturers and...more
12/6/2023
/ Civil Monetary Penalty ,
Department of Justice (DOJ) ,
E-Cigarettes ,
FDA Warning Letters ,
Food and Drug Administration (FDA) ,
Injunctions ,
Life Sciences ,
Manufacturers ,
Retail Market ,
Tobacco ,
Tobacco Regulations ,
Vaping ,
Warning Letters
FDA recently announced the issuance of warnings letters to 189 retailers found to be selling unauthorized tobacco products, specifically Elf Bars and Esco Bars....more
Over the last several months, FDA and DOJ enforcement efforts have increasingly focused on manufacturers and distributors of vapor products covered by the Food, Drug, & Cosmetic Act and the PACT Act....more
On February 24, 2023, the Food and Drug Administration (“FDA”) issued a response to the report prepared by the Reagan-Udall Foundation in December 2022. The Foundation’s report was originally commissioned by FDA Commissioner...more
The Reagan-Udall Foundation, an independent nonprofit created by Congress “to advance the mission of the FDA to modernize medical, veterinary, food, food ingredient, and cosmetic product development, accelerate innovation,...more
California voters have approved Senate Bill 793, which prohibits tobacco retailers from selling flavored tobacco products or tobacco product flavor enhancers. A lawsuit has been filed in federal court claiming that it is...more
House Representatives Morgan Griffith (R-VA) and Brett Guthrie (R-KY) recently sent a letter to FDA Commissioner Robert Califf expressing “continued concerns involving systemic problems within the” Center for Tobacco Products...more
Litigation challenging FDA’s cursory denial of thousands of premarket tobacco product applications (PMTAs) continues. We have previously written about electronic nicotine delivery system (ENDS) manufacturers’ claims that the...more