Yesterday’s decision by Judge Amit P Mehta delaying the implementation by the U.S Food and Drug Administration (FDA) of premarket authorization and substantial equivalence indefinitely, gave the premium cigar industry a much-needed win. Let’s face it – the premium cigar industry has taken a lot of lumps over the past decade. When it comes to […]
Judge Amit P. Mehta of the U.S. District Court for the District of Columbia has ruled that the U.S. Food and Drug Administration cannot move forward with the enforcement of premarket rule requirements until he comes up with a streamlined process for premium cigars. This means the September 9th, 2020 date has been thrown out […]
September 9th is the deadline premium cigar companies had been given to file for Substantial Equivalence to keep non-predicate (non-grandfathered) products on the market. This week the U.S. Food and Drug Administration (FDA) sent a letter to Judge Paul Grimm of the U.S. District Court of Maryland outlining a plan that includes an option for companies […]
The cigar industry got a victory as the United States Court of Appeals for the District of Columbia unanimously struck down warning labels for cigars and pipes ruling in favor of the industry trade associations (Cigar Association of America, Cigar Rights of America, and the Premium Cigar Association). The ruling was based on the fact […]
Over the past couple of weeks, a virtual event called “Cigar Enthusiasts for Trump” was being promoted as an opportunity to “sit down” with the Trump campaign and be part of a discussion with Donald Trump Jr, the son of President Donald Trump. One of the biggest questions asked by the cigar enthusiasts and industry-people […]
The United States Court of Appeals for the Fourth Circuit and the United States District Courts for the District of Columbia and Maryland have agreed to extend the deadline for submitting Substantial Equivalence (SE) applications for cigar products from May 12, 2020, to September 9, 2020. The 120-day delay is the result of the impacts […]
The Premium Cigar Association (PCA) and Cigar Rights of America (CRA) filed a Joint Petition with several independent premium cigar manufacturers requesting that both the Secretary of Health and Human Services (Alex Azar) as well as the Commissioner (Dr. Stephen Hahn) of the U.S. Food and Drug Administration (FDA) to enact a six month stay […]
Last month, HR 2339, a comprehensive anti-tobacco bill, passed the U.S. House of Representatives. It has now been referred to the Senate where a companion bill, S 3174 has been introduced to that chamber of Congress. While most of the same key provisions of S 3174 are the same as HR 2339, the one […]
United States President Donald Trump has unveiled his budget for Fiscal Year 2021. As a part of his proposed budget, it calls for moving the Center for Tobacco Products (CTP), the part of the U.S. Food and Drug Administration (FDA) that regulates tobacco products, into its own agency. The proposed idea would allow the new […]
Judge Amit P. Mehta of the U.S. District Court for the District of Columbia has ruled the U.S. Food and Drug Administration (FDA)’s requirements for warning labels are unlawful and has ordered those requirements to be vacated from the agency’s Deeming Rule on premium cigars. It essentially gives the premium cigar industry a major victory. […]
