A new study published this month in The Lancet’s eClinical Medicine – the largest electronic cigarette (e-cigarette) clinical trial in the U.S. to date – confirms the role of e-cigarettes in smoking cessation. Specifically, the new research supports that e-cigarettes can be a viable means of quitting or reducing more harmful combustible cigarette use for
FDA Receives Authorization to Regulate Synthetic Nicotine
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 to Participate in Panel on Tobacco Standards at FDLI Conference
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
Update on PMTA MDO Legal Challenges, Rescissions and PMTA Authorizations; CTP Leadership Presents at FDLI Conference
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
Will FDA Extend Its Proposed Ban on Menthol Cigarettes and Characterizing Flavors in Cigars to Flavored ENDS Products?
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
JUUL Enters Into Consent Judgment with North Carolina
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
Supplemental New Drug Application Submitted for FDA-Approved CBD Drug Epidiolex
Reposted from Keller and Heckman’s Blog, The Daily Intake
- As previously reported in this blog, the 2018 Farm Bill removed hemp – defined as Cannabis sativa L. with less than 0.3% THC on a dry weight basis – from the definition of “marijuana.” As a result, while marijuana remains a Schedule I