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
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
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 today to join us for a two-day comprehensive seminar focused on legal and regulatory issues
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
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 importance to the quality management of e-cigarettes for export.
On July 18, 2023, STMA released
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 the decision of the Food and Drug Administration (FDA) to deem premium cigars subject
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 new device that has been on the market in the U.K. for several
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 FDA in its issuance of more than 570 warning letters to firms for the manufacture
Keller and Heckman Partner Azim Chowdhury was interviewed for the CSP Magazine article, “Regulations 2023: One Thing After Another.” The article discusses the many regulatory updates coming for tobacco products in 2023, including a likely ban on menthol cigarettes, an effective ban on non-tobacco flavored vapor products, new retail signage requirements, and even the likelihood
