From December 5-7, 2022, Keller and Heckman hosted a private conference with the China State Tobacco Monopoly Administration (STMA) on the topic of U.S. and global e-cigarette and tobacco product regulation. The event was approved by China’s Ministry of Science and Technology (MOST) and was attended by over 700 officials from STMA and its local
A Closer Look at China’s New E-Cigarette Regulations
With the implementation of the Management Rules of E-cigarettes and the forthcoming effective date for the GB Standard on E-cigarettes (October 1, 2022), China has been regularly updating its e-cigarette regulations. Following up on our recent articles on China’s GB Standard and manufacturer license requirements, below we summarize various e-cigarette regulations recently promulgated by the
FDA Denies Authorization to Market JUUL ENDS Products; Company Intends to Seek Stay of the Marketing Denial Orders
On June 23, 2022, the U.S. Food and Drug Administration (FDA) issued marketing denial orders (MDOs)[1] to Juul Labs Inc. for all of the company’s JUUL electronic nicotine delivery system (ENDS) products currently marketed in the United States. After review, FDA determined that Juul’s Premarket Tobacco Product Applications (PMTAs), submitted more than two years
Counsel Daniel McGee to Present at Next Generation Nicotine Delivery USA 2022 Conference
Keller and Heckman Counsel Daniel McGee will present, “Navigating Evolving Vaping Laws Around the Country – State Law Update,” at the Next Generation Nicotine Delivery USA 2022 event, June 22-23, 2022, in Miami, Florida. This event will bring together business leaders from the ENDS and tobacco industry together with other experts in the field for
Manufacturing E-Cigarettes in China: How to Obtain the Manufacturer License
Following China’s new GB standard on e-cigarettes that we summarized in early May 2022, the State Tobacco Monopoly Administration (STMA) has now published a rule outlining the process for Chinese e-cigarette manufacturers to obtain the required manufacturer license. This rule applies not only to manufacturers producing e-cigarettes for the domestic Chinese market, but also to
China Publishes Final GB Standard on E-Cigarettes: The Basis for Product Compliance
Since we reported in December 2021 on some significant developments in China’s regulation of e-cigarettes (including the draft national standard on e-cigarettes) as well as in March 2022 on the finalized Management Rules for E-Cigarettes, China’s State Tobacco Monopoly Administration (STMA), also referred to as China National Tobacco Corporation (CNTC), has not only released the
Ahead of Final Rule, U.S. Postal Service Publishes Guidance Regarding Non-Mailability of Electronic Nicotine Delivery Systems
As we have previously reported, on December 27, 2020, Congress amended the Prevent All Cigarette Trafficking (PACT) Act to apply to e-cigarettes and all vaping products (referred to in the legislation collectively as “Electronic Nicotine Delivery Systems” or “ENDS”). Under the amended PACT Act, these products are subject to the same federal and state
FDA Issues Warning Letters to Vape Companies that Did Not Submit Premarket Tobacco Product Applications (PMTAs)
Reposted from Keller and Heckman’s Blog, The Daily Intake
- On January 15, 2021, the U.S. Food and Drug Administration (FDA) issued warning lettersto ten companies that sell electronic nicotine delivery system (ENDS) products, including e-liquids. FDA’s letters warned that any new tobacco product not in compliance with the premarket authorization requirements of the Federal
FDA Won’t Enforce Pre-Market Review Requirement for E-Liquid Packaging Modified to Incorporate “Flow Restrictors”
In March of this year, the Consumer Product Safety Commission (CPSC) announced that it would interpret the Child Nicotine Poisoning Prevention Act of 2015 (CNPPA) as mandating specific flow-restrictor requirements for liquid nicotine containers that are sold, offered for sale, manufactured for sale, or distributed in commerce. CPSC soon began aggressive enforcement of its new
E-Vapor Industry Coalition Formally Opposes CPSC Novel Interpretation of CNPPA that Immediately Requires Flow-Restricted Packaging for E-Liquids
As previously reported on this blog, earlier this year, the U.S. Consumer Product Safety Commission (CPSC) announced that it was now reading the Child Nicotine Poisoning Prevention Act (CNPPA) to require nicotine e-liquid bottles to meet the “restricted flow requirement” in 16 C.F.R. § 1700.15(d), in addition to having child-resistant closures. A wave of enforcement