All posts tagged: FDA

Cigar News: FDA Deeming Rule Fully Vacated for Premium Cigars

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.

Cigar News: FDA Releases Final SE and PMTA Rules

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.

Cigar News: FDA Announces Potential Program for Premium Cigar Manufacturers to Request Deferral of Filing Substantial Equivalence Reports

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.

Cigar News: FDA Updates Unified Regulatory Agenda

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.

Cigar Editorial: Analyzing Altria’s Comments to the FDA

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.