In August, the U.S. Food and Drug Administration (FDA) issued a new proposed rule that would require importers of electronic nicotine delivery system (ENDS) products to provide an FDA-issued submission tracking number (STN)...more
On April 2, three advocacy organizations filed a complaint in the U.S. District Court for the Northern District of California seeking an order directing the U.S. Food and Drug Administration (“FDA”) to promulgate its...more
The proposed rule, if finalized, would impose new manufacturing practice requirements on foreign and domestic manufacturers of finished and bulk tobacco products. On March 10, 2023, the Food and Drug Administration (FDA...more
On March 8, the Food and Drug Administration announced that it is proposing a long-awaited rule on so-called “tobacco product manufacturing practices.” Here are some preliminary thoughts on the proposed rule...more
On April 28, 2022, the U.S. Food and Drug Administration (FDA) released two proposed rules that would ban menthol as a characterizing flavor in cigarettes and prohibit all characterizing flavors such as strawberry and menthol...more
On January 23, 2017, the Food and Drug Administration (FDA) issued a proposed tobacco product standard that would establish a limit of N-nitrosonornicotine (NNN) in finished smokeless tobacco products not to exceed 1.0...more
On August 24, 2016, the US Food and Drug Administration (FDA) issued a Proposed Rule on Good Laboratory Practice for Nonclinical Laboratory Studies (Proposed Rule), which broadens the application and authority of Good...more