Troutman Sanders Tobacco Practice

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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).”…
In a March 2019 update to its guidance regarding “Extension of Certain Tobacco Product Compliance Deadlines Related to the Final Deeming Rule,” the FDA has extended the deadline for manufacturers of “Deemed Products” to report harmful and potentially harmful constituents (“HPHCs”) in their products.  “Deemed Products” are those that were first regulated by the FDA under the Deeming Regulations, and generally include e-cigarettes and other electronic nicotine delivery systems, cigars, pipe tobacco and hookah tobacco.…
A March 1 article on Axios indicates that the FDA is poised to formally implement a policy that would severely restrict the sale of flavored e-cigarettes in retail environments.  In a November 15, 2018 statement, FDA Commissioner Scott Gottlieb had announced a plan to prohibit flavored ENDS products (other than tobacco, mint and menthol or non-flavored products) that are not sold in an age-restricted, in-person location.  At the time, Commissioner Gottlieb indicated that the…
FDA recently revised its draft guidance on the “Use of Investigational Tobacco Products.” This draft guidance was originally issued in September 2015; however, after receiving numerous comments, FDA decided to revise the guidance to clarify certain information. FDA also regards the revision to be in furtherance of its commitments under the Agency’s comprehensive plan for tobacco and nicotine regulation.…