FDA Files Permanent Injunctions Against Six Small Vape Shops for Alleged Premarket Review Violations
On October 18, 2022, the U.S. Department of Justice (DOJ), on behalf of the U.S. Food and Drug Administrat
ion (FDA), filed complaints for permanent injunctions against six domestic e-liquid manufacturers across different federal district courts, all of which appear to be small vape shops that were producing nicotine-containing e-liquids used in open-system e-cigarette devices.
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
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 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
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 Extends HPHC Reporting Deadline for Deemed Tobacco Products
Section 904(a)(3) of the Food, Drug and Cosmetic Act, as amended by the Tobacco Control Act, (FDCA) requires manufacturers and importers to report the quantities of Harmful and Potentially Harmful Constituents (HPHCs) found in their tobacco products, or in the smoke produced by their products, by brand and sub-brand. 21 U.S.C. § 387d(a)(3). This
FDA Releases Second Draft Guidance to Support Development of Novel Nicotine Replacement Therapies
On February 21, 2019, FDA released the second of two draft guidance documents related to the development of novel nicotine replacement therapies (NRT). The first draft guidance document, Nonclinical Testing of Orally Inhaled Nicotine-Containing Drug Products Guidance for Industry is available here, and the second draft guidance document, Smoking Cessation and Related Indications: Developing
FDA Announces Additional Steps to Protect Youth: Limiting Access to Flavored ENDS, Enhancing Online Age-Verification and Banning Menthol in Cigarettes and Flavored Cigars
Following a series of actions over the last several months, on November 15, 2018, the U.S. Food and Drug Administration (“FDA”) announced new steps aimed at protecting youth from tobacco, including, among other things, preventing access to flavored electronic nicotine delivery system (“ENDS”) sold in certain retail locations, and potentially banning menthol in combustible tobacco
FDA Commissioner Dr. Scott Gottlieb’s Recent Remarks on Vapor Products and the Continuum of Risk; Update on Deeming Rule Appeal
On June 18, 2018, U.S. Food and Drug Administration (FDA) Commissioner Dr. Scott Gottlieb delivered remarks on “FDA’s Nicotine and Tobacco Regulation and the Key Role of Regulatory Science” at the Tobacco Regulatory Science Program Meeting.[1] While addressing the importance of regulatory science to inform FDA’s Center for Tobacco Products (CTP) regulatory efforts, Commissioner