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
Federal Court Rules That FDA Was Arbitrary and Capricious in Deeming Premium Cigars Subject to the Tobacco Control Act
Since it became effective in 2016, the cigar industry has mounted several challenges to the U.S. Food and Drug Administration’s (FDA) “Deeming Rule,” which extended the Agency’s tobacco product authority beyond cigarettes, cigarette tobacco, smokeless tobacco, and roll-your-own tobacco, to all products that meet the “tobacco product” definition in the Food, Drug and Cosmetic Act,
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
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
FDA Authorizes NJOY ACE Tobacco-Flavored Electronic Nicotine Delivery System (ENDS) Products for Marketing
On April 26, 2022, the U.S. Food and Drug Administration (FDA) authorized an additional four tobacco-flavored electronic nicotine delivery system (ENDS) products for marketing under the Premarket Tobacco Product Application (PMTA) pathway. Marketing granted orders (MGOs)[1] were issued for the following NJOY tobacco-flavored ENDS products:
- NJOY Ace Device: Closed e-cigarette device
- NJOY Ace Pod
FDA Authorizes Tobacco-Flavored Logic Technology Electronic Nicotine Delivery System (ENDS) for Marketing & Issues Marketing Denial Orders for Fontem’s myblu ENDS Products
FDA Premarket Tobacco Product Application (PMTA) Pathway
Under FDA’s premarket tobacco product application (PMTA) pathway, manufacturers or importers of tobacco products must demonstrate to the U.S. Food and Drug Administration (FDA) that the marketing of a new tobacco product would be appropriate for the protection of the public health (APPH). See Section 910(c)(2)(A) of the
Breaking News – China Finalizes Management Rules for E-Cigarettes
We reported in December 2021 that China’s State Tobacco Monopoly Administration (STMA) published on its website the draft Management Rules for E-cigarettes and the updated national standard (GB) on e-cigarettes for public comment. Working with important industry members, including industry associations and manufacturers, Keller and Heckman filed comments to STMA to address and seek clarification
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
Two New State Laws Could Disrupt the Vapor Industry
On January 1, 2022, two new state laws will become effective in Illinois and Oregon and could cause significant disruption to the vapor industry. We provide background on the legislation and discuss the potential implications for the sales of vapor products in the respective states.
Illinois
On January 1, 2022, SB 0512, The Preventing Youth