In the case of Cigar Association of America et al, v. U.S. Food and Drug Administration et al. the United States District Court for the District of Columbia ruled to fully vacate the deeming rule as applied to premium cigars for being arbitrary and capricious.
Last night, the Food & Drug Administration (FDA) and the Center for Tobacco Products (CTP) released the Final Substantial Equivalence (SE) and Premarket Tobacco Product Application (PMTA) Rules to address deemed products. While the rules apply regulations to a wide variety of products, FDA stopped short of applying the new regulations to "premium cigars" acknowledging that the agency is evaluating industry comments and its own research on the category.
In court filings last night, the FDA announced a potential new program relating to the requirement that premium cigar manufacturers submit substantial equivalence reports for a decade’s worth of products. Therein, the FDA explained a potential program for premium cigar manufacturers to apply to the FDA for it to consider exercising its discretion to defer the submission of substantial equivalence reports.
Yesterday, J.C. Newman Cigar Co. filed detailed comments (download here) with FDA highlighting the numerous problems with the “substantial equivalency” process for premium cigars.
Last week, the FDA held a conference on tobacco regulation. The agency invited Drew Newman, J.C. Newman's general counsel, and a fourth-generation cigar maker, to address the conference on behalf of the premium cigar industry and respond to questions from the audience.
Earlier today, the US Food and Drug Administration (FDA) updated its roadmap for regulations, called the Unified Regulatory Agenda. This outlines the regulatory priorities and perspective timeline for the FDA and other federal agencies.
Now that I’ve had a day to sit down and properly review my original editorial statements, I hope that this follow up article provides better clarity.
I do believe that cigar industry organizations should continue to fight against all cigar regulation. To vilify companies who are trying to work within the framework of FDA legislation implemented that is done so in a logical, science based, and non-burdensome way, is ultimately self-defeating for the entire industry.
Anyone can submit comments during this process. IPCPR will be sure to submit comments and looks forward to communicating the content of those comments out to our retailers. Comments are due June, 25th.