On June 11, the FDA finalized its guidance for manufacturers submitting new tobacco product applications through the premarket tobacco application (PMTA) process for electronic nicotine systems (ENDS), including e-cigarettes, vaping devices and nicotine-containing e-liquids.  By way of background, when the FDA issued the Deeming Regulations asserting jurisdiction over ENDS in May 2016, it also issued a draft guidance for ENDS PMTAs.  The Agency had been promising to finalize that guidance as it proposes to move forward the deadline for these submissions. Continue Reading FDA Finalizes ENDS PMTA Guidance

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 would compel each state to pass individual laws or risk losing substance abuse prevention and treatment funding. Continue Reading Bill Introduced to Raise the Nationwide Minimum Legal Age for Tobacco Product Sales

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. This bill reflects an attempt to combine the various issues into one comprehensive piece of legislation ostensibly intended to limit youth tobacco access. Continue Reading “Reversing the Youth Tobacco Epidemic Act of 2019” Introduced in Congress

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.). Continue Reading Deeming Regulations Litigation Update – Arizona AG Supports Cigar Challengers in Appellate Court

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, consumer trends and international opportunities. 

We look forward to seeing our clients and friends in Miami.


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 tobacco products premarket review submissions.

We look forward to seeing our clients and friends at the conference. 


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. Continue Reading Court Orders FDA to Issue Proposed Graphic Cigarette Warnings Rule This Year

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).” Continue Reading Deeming Regulations Litigation Update–Challenge to Premarket Review Submission Deadlines in Limbo After FDA Issues Draft Guidance