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
On March 13, the FDA proposed a new enforcement policy that could have a significant impact on sales of flavored electronic nicotine delivery systems (“ENDS”) and flavored cigars in the United States. Continue Reading New Proposed FDA Enforcement Policy Could Curtail Sales of Flavored ENDS and Cigars
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. Continue Reading FDA Extends HPHC Reporting Deadline for Deemed Products
Bryan Haynes of the Troutman Sanders Tobacco Team participated in a panel discussion entitled “How Innovation is Changing the Vape Category” at the Tobacco Plus Expo on February 12. A video of the panel discussion can be found here. Continue Reading Troutman Sanders Tobacco Team Participates in Panel Discussion – “How Innovation is Changing the Vape Category”
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 would provide additional details “soon,” and suggested that in the interim manufacturers voluntarily remove flavored ENDS from convenience stores. Some manufacturers did just that. Continue Reading FDA Appears Poised to Restrict the Sale of Flavored E-Cigarettes
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. Continue Reading FDA Revises Draft Guidance on Investigational Tobacco Products