Maryland Federal Judge: FDA Abdicated Duty With 2017 Guidance

Mealey's (May 20, 2019, 9:58 AM EDT) -- BALTIMORE — A Maryland federal judge on May 15 agreed with various public health organizations that an August 2017 Guidance by the U.S. Food and Drug Administration — pursuant to which some newly deemed tobacco products can continue to be sold while awaiting their premarket review — runs afoul of the Administrative Procedure Act (APA), (American Academy of Pediatrics, et al. v. Food and Drug Administration, et al., No. 8:18-CV-883, D. Md., 2019 U.S. Dist. LEXIS 81652)....