On March 15, President Joe Biden signed a $1.5 trillion omnibus spending bill to fund the federal government through September. The bill, as passed, includes a provision amending the definition of “tobacco product” in Section 201(rr) of the Federal Food, Drug, and Cosmetic Act (“FDCA”) as “any product made or derived from tobacco, or containing
Keller and Heckman Associate Neelam Gill will be a panelist at the Food and Drug Law Institute’s (FDLI) Enforcement, Litigation, and Compliance Conference, to be held virtually on December 9 – 10, 2021. Neelam will be participating in the panel on “Preparing for Tobacco Product Standards and cGMPs,” which will focus on pending Tobacco Product
Two months after the September 9, 2021 PMTA enforcement discretion deadline, the US Food and Drug Administration (FDA) has taken action on well over 90% of timely submitted Premarket Tobacco Product Applications (PMTAs), and has issued over 323 marketing denial orders (MDOs) for more than
1.2 million non-tobacco and non-menthol flavored Electronic Nicotine Delivery Systems
Keller and Heckman Partner Azim Chowdhury and Associate Neelam Gill published an article for the Food and Drug Law Institute (FDLI) titled, “Will FDA Extend Its Proposed Ban on Menthol Cigarettes and Characterizing Flavors in Cigars to Flavored ENDS Products?” The article discusses FDA’s recent announcement to initiate a rulemaking to ban menthol cigarettes, as
On June 28, 2021, North Carolina Attorney General Joshua Stein announced entry of a final consent judgment between JUUL Labs, Inc. (JUUL) and North Carolina. This consent judgment ends a nearly two-year legal battle and marks the first time a state successfully settled a lawsuit against JUUL, the leading U.S. e-cigarette company. North Carolina’s original
Reposted from Keller and Heckman’s Blog, The Daily Intake
