Senate Majority Leader Mitch McConnell (R-KY) recently announced that he, along with Senator Tim Kaine (D-VA), have filed a new, bipartisan bill in Congress to raise the nationwide legal age to purchase tobacco and vaping products from 18 to 21. The bill, currently titled the “Tobacco-Free Youth Act,” would require all states to pass laws raising the minimum age to purchase cigarettes, electronic nicotine delivery systems (ENDS) and other tobacco products to 21. The bill…

House Energy and Commerce Chair Rep. Frank Pallone, Jr. (D-NJ) and Rep. Donna Shalala (D-FL) recently introduced H.R. 2339, a comprehensive bill seeking to amend the Federal Food, Drug, and Cosmetic Act with respect to the sale and marketing of tobacco products. The legislation, currently titled the Reversing the Youth Tobacco Epidemic Act of 2019, is a broad bill that covers many of the legislative movements and trends seen in recent years concerning the sale and marketing of tobacco products.…

The cigar industry has found some official support for its challenge to the Deeming Regulations. That official support has come from the State of Arizona, whose Attorney General has filed a brief as amicus curiae, supporting the cigar industry’s position in Cigar Association of America, et al. v. FDA, et al., No. 18-5195 (D.C. Cir.).…

Bryan Haynes of the Troutman Sanders Tobacco Team will attend the Next Generation Nicotine Delivery Conference in Miami on April 30 through May 1. Hosted by Arena International, the conference addresses regulations and trends in the electronic nicotine delivery systems (ENDS) industry.  The event brings together large and small ENDS companies, along with policy specialists and service providers to the industry.  The program will address the most pressing issues in the industry, including regulatory updates,…

Bryan Haynes of the Troutman Sanders Tobacco Team will attend the Food and Drug Law Institute Annual Conference on May 2-3, 2019.  The conference features an array of tobacco-related content, including a panel discussion with FDA’s Center for Tobacco Products Director Mitch Zeller, a discussion of strategies to prevent youth initiation of ENDS and updates on the modified risk tobacco application process and FDA’s policies regarding combusted products.  Bryan Haynes will host a discussion on…

The Family Smoking Prevention and Tobacco Control Act requires the FDA to issue regulations that require color graphics depicting the health consequences of smoking on cigarette packages and in cigarette advertisements. As we previously reported here, on September 5, 2018, the U.S. District Court for the District of Massachusetts found that the FDA “unlawfully withheld” and “unreasonably delayed” the promulgation of a rule mandating color graphic warnings for cigarettes.…

In an August 2017 Guidance, the FDA gave companies an extension to comply with certain deadlines for premarket review submissions, including “substantial equivalence exemption requests (SE EX requests), substantial equivalence reports (SE reports), and premarket tobacco product applications (PMTAs).”…