All posts tagged: FDA

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: J.C. Newman Files Further Comments With FDA

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.

Cigar News: Drew Newman Addresses FDA at Conference on Tobacco Regulation

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.

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: The Altria Fallout – 2 Days Later

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.

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.

Cigar News: FDA Releases ANPRM on Premium Cigar Regulations

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.

Cigar News: Premium Cigar Regulation Discussed at 2019 Budget House Committee Hearing

Cigar News: Southern Draw Cigars Discusses IPCPR 2016

As the premium cigar industries’ BIGGEST week rapidly approaches, Southern Draw Cigars would like to share a few thoughts with partners, consumers and friends along with media members and industry associations.