In what might be considered a major development in the cigar industry’s lawsuit against the U.S. Food and Drug Administration (FDA), the cigar trade associations have motioned the court for a preliminary injunction and partial summary judgment to prevent the FDA from moving forward with portions of the Deeming Regulations. The areas being targeted surround […]
Cigar News: Tom Price Resigns as Secretary of Health and Human Services
William Cooper Cigar News No Comments FDA, News
The Tom Price era as Secretary of Health and Human Services (HHS) has come to an end. Today, Price offered his resignation to President Donald Trump, who subsequently accepted it. The resignation comes on the heels of an investigation into his use of private charter and military jets which resulted in costs of $1,000,000 to […]
Cigar News: User Fees Increase for Tobacco Industry for FY 2018
William Cooper Cigar News 1 Comment FDA, News
In a move that was not unexpected, the U.S. Food and Drug Administration (FDA) will increase the user fees it is charging the U.S. tobacco industry. For Fiscal Year (FY) 2018, the industry will be charged $672 million dollars – an increase of $37 million dollars from FY 2017. From those numbers $64 million dollars […]
Cigar News: FDA Pushes Product and Establishment Registration Deadline to October 12th
William Cooper Cigar News 1 Comment FDA, News
The U.S. Food and Drug Administration (FDA) has announced the deadline for domestic cigar manufacturers to submit product and establishment registration information is being pushed out from September 30, 2017 to October 12, 2017. According to FDA Commissioner Dr. Scott Gottlieb, the delay is being implemented due to login and connectivity problems on the website […]
Feature Story: Understanding what the Passing of the Cigar Exemption in the House Appropriations Bill Means
William Cooper Feature Story 1 Comment FDA, Feature Story
On September 14, 2017, the U.S. House of Representatives passed a twelve-bill spending package for the 2018 Fiscal year that included the Agriculture Appropriations Bill that was crafted by a House Subcommittee earlier this summer. This bill includes language that calls for a premium cigar exemption and predicate date change to August 8, 2016. It marks the […]
Cigar News: House Appropriations Bill Passes with Premium Cigar Exemption and Predicate Date Change
William Cooper Cigar News 1 Comment FDA, News
Today the U.S. House of Representatives passed a twelve-bill spending package for the 2018 Fiscal year that includes the Agriculture Appropriations Bill that was approved by a subcommittee earlier this summer. This bill includes language that calls for a premium cigar exemption and predicate date change to August 8, 2016. The bill package now moves to […]
Cigar News: Court to Defer Decision on Motion by Health Organizations to Intervene as Defendants in FDA Lawsuit
William Cooper Cigar News 1 Comment FDA, News
The U.S. District Court for the District of Columbia has ruled that it will defer a ruling on a motion by six public health organizations to intervene as defendants in the cigar industry’s lawsuit against the U.S. Food and Drug Administration (FDA). The ruling was made by Judge Amit P. Mehta. This motion is of particular importance to the lawsuit […]
Cigar News: FDA and Trade Associations Respond to the Six Public Health Groups Motion to Intervene in Industry Lawsuit
William Cooper Cigar News No Comments FDA, News
Back on July 24, six public health organizations filed a motion to intervene as defendants in two lawsuits against the U.S. Food and Drug Administration (FDA), one of which is the lawsuit brought forward by the Cigar Association of America (CAA), Cigar Rights of America (CRA), and International Premium Cigar and Pipe Retailers (IPCPR). Over the past week, motions have […]
Prime Time Special Edition 8: The Gottlieb Doctrine
William Cooper Podcast No Comments FDA, Podcast, Prime Time Special Edition
For Special Edition #8, Bear and Coop discuss FDA Commissioner Dr. Scott Gottlieb’s announcements from 7/27/17. This included moving the date for pre-market approval for premium cigars to remain on the market that were not grandfathered, re-opening the discussion for how premium cigars should be regulated, and focusing around reducing nicotine in tobacco products. The guys also discuss […]
Cigar News: Industry Lawsuit Gets Another 30-Day Delay
William Cooper Cigar News No Comments FDA, News
There is another 30-day delay in the lawsuit involving the cigar industry trade associations against the U.S. Food and Drug Administration (FDA). A joint motion was filed by both parties to extend all of the briefing deadlines another 30 days in the lawsuit. This request was made following the announcement on July 28th that the FDA […]