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,
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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
2024 E-Vapor and Tobacco Law Symposium
We’re back! Keller and Heckman’s E-Vapor and Tobacco Law Symposium is returning in 2024 for our 8th annual conference. The symposium will be held Monday, January 29 – Tuesday, January 30, 2024, in Las Vegas, NV (right before TPE). Register
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
China Update: STMA Publishes Guidelines on Quality Assurance for E-Cigarettes for Export
Although e-cigarettes manufactured in China for export to overseas markets are not subject to pre-market approval in China, and are only required to comply with the regulations of the destination country, China’s State Tobacco Monopoly Administration (STMA) still attaches great
Federal Court Vacates FDA Deeming of Premium Cigars Subject to the Tobacco Control Act
On August 9, 2023, Judge Amit P. Mehta of the U.S. District Court of the District of Columbia issued a final Memorandum Opinion in Cigar Association of America et al. v. United States Food and Drug Administration et al., vacating
Azim Chowdhury Quoted in Law360 Article on Legislation to Watch at Midyear
Keller and Heckman Partner Azim Chowdhury was quoted in the Law360 article, “Product Liability Regulation & Legislation To Watch At Midyear.” The article discusses e-cigarette company Juul’s decision to file an application with the U.S. Food and Drug Administration (FDA) for a
Keller and Heckman Files Supreme Court Amicus Brief on Behalf of ENDS Industry in Support of Request to Overturn or Limit the Chevron Doctrine
On July 24, 2023, Keller and Heckman Partners Eric Gotting and Azim Chowdhury, along with co-counsel, on behalf of members of the Electronic Nicotine Delivery Systems (ENDS) industry[i], filed an amicus brief with the Supreme Court of the
FDA and FTC Issue Six Warning Letters for Delta-8 THC Copycat Snacks
Reposted from Keller and Heckman’s Blog, The Daily Intake
- Delta-8 Tetrahydrocannabinol (Delta-8 THC) is an isomer of Delta-9 THC, the intoxicating component of certain cannabis plants. It is naturally occurring at very low levels in hemp and can be synthetically
FDA Inspection Blitz Leads to Over 180 Warning Letters to Retailers for the Sale of Unauthorized E-Cigarettes
On June 22, 2023, FDA announced it had issued warning letters to 189 retailers for selling unauthorized flavored tobacco products manufactured by Elf Bar and Esco Bar brands. This enforcement action comes on the heels of earlier aggressive action by