On June 21, 2024, FDA issued marketing granted orders (MGOs) to NJOY LLC for two non-tobacco flavored electronic nicotine delivery system (ENDS) products, the DAILY 4.5% and DAILY EXTRA 6% disposable devices, along with two ACE 2.4% and 5% pre-filled pods. All four of these NJOY ENDS products are menthol flavored. This FDA action, the
5th Circuit Issues Blistering Critique of FDA’s Handling of PMTAs for E-Cigarettes
In a long-anticipated decision, the U.S. Court of Appeals for the Fifth Circuit ruled against FDA on January 3, 2024, criticizing the Agency for its handling of Wages and White Lion Investments, LLC, d/b/a Triton Distribution and Vapetasia LLC (“Vapetasia”) (collectively, “Triton”) premarket tobacco product applications (“PMTAs”) for its non-tobacco flavored, open-system e-liquid products.
DC Circuit Vacates MDO for Tobacco-Flavored myblu ENDS Products; Potential Impact on Pending Juul PMTA
On August 29, 2023, a three-judge panel on the U.S. Court of Appeals for the District of Columbia Circuit unanimously ruled against FDA on the Agency’s review of Fontem LLC’s “unflavored” (i.e., tobacco-flavored) myblu electronic nicotine delivery system (ENDS) products, vacating FDA’s marketing denial orders (MDOs) for these products. For Fontem’s non-tobacco flavored myblu ENDS
2023 National Youth Tobacco Survey Shows Significant Decline in High School Vaping
On November 2, 2023, the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) released data from the 2023 National Youth Tobacco Survey (“NYTS”), a cross-sectional, school-based, self-administered, web-based survey of U.S. middle school (grades 6-8) and high school (grades 9-12) students. The NYTS has been conducted periodically during
Largest U.S. E-Cigarette Clinical Trial Confirms Role in Smoking Cessation
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