Cigar News: CRA Reports the DOJ Filed Initial Brief in CAA et al v. FDA

The Cigar Rights of America reported that the United States Department of Justice (DOJ) filed its initial brief on behalf of the United States Food & Drug Administration (FDA) in the U.S. Court of Appeals for the District of Columbia in Cigar Association of America (CAA), Cigar Rights of America (CRA), and Premium Cigar Association (PCA) v FDA.  Read more about Cigar News: CRA Reports the DOJ Filed Initial Brief in CAA et al v. FDA[…]

Cigar News: FDA Ombudsman Asked to Review Regulatory Actions Against Premium Cigars

The Premium Cigar Association (PCA) has filed a formal request for a meeting with the Ombudsman of the U.S. Food and Drug Administration’s (FDA’s) Center for Tobacco Products to discuss PCA’s significant concerns related to FDA’s March 10, 2023, Proposed Rule seeking to establish so-called tobacco product manufacturing practice (TPMP) requirements. The request references the Read more about Cigar News: FDA Ombudsman Asked to Review Regulatory Actions Against Premium Cigars[…]

Cigar News: PCA Joins European Cigar Manufacturers Association in Commenting on the European Commission’s Legislative Framework for Tobacco Control

Today the Premium Cigar Association submitted a comment to the European Commission in reference to its “Framework for Tobacco Control” related to the 2040 Tobacco Free agenda. This agenda would ultimately lead to the ban of sale and use of any tobacco or nicotine derived device from the European Union market by 2040. The first step Read more about Cigar News: PCA Joins European Cigar Manufacturers Association in Commenting on the European Commission’s Legislative Framework for Tobacco Control[…]

Cigar News: FDA Marks Historic Public Health Milestone with Finalization of Two Key Rules for Companies Seeking to Market New Tobacco Products

Yesterday, the U.S. Food and Drug Administration finalized two foundational rules for the premarket review of new tobacco products. These final rules provide additional information on the minimum requirements for the content, format and review of premarket tobacco product applications (PMTAs) and substantial equivalence (SE) reports. PMTA and SE are two of the pathways through which a manufacturer can Read more about Cigar News: FDA Marks Historic Public Health Milestone with Finalization of Two Key Rules for Companies Seeking to Market New Tobacco Products[…]

Cigar News: FDA Acknowledges their Huge Workload for Substantial Equivalence Reports and Offers Possible Deferment

On August 5th 2020, just 4 years after the FDA’s deeming regulations on the the cigar industry took effect, the U.S. Food and Drug Administration submitted a court filing which essentially proposed a program that will allow manufacturers to request a deferral on submitting substantial equivalence reports. Essentially it allows premium cigar manufacturers to apply Read more about Cigar News: FDA Acknowledges their Huge Workload for Substantial Equivalence Reports and Offers Possible Deferment[…]

Cigar News: Words A Premium Cigar Manufacturer/Brand Owner Never Want To See

“We completed our review of your Substantially Equivalent (SE) Report submitted under section 905(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and determined that the new tobacco product is not substantially equivalent to the predicate tobacco products listed in Appendix A…..“ These are the words that start the letter from the FDA Read more about Cigar News: Words A Premium Cigar Manufacturer/Brand Owner Never Want To See[…]

Cigar News: DC Court of Appeals Rules Against FDA Warning Labels on Cigars

The United States Court of Appeals for the District of Columbia Circuit unanimously ruled in favor of the Premium Cigar industry today, by striking down a former ruling that warning labels are required on cigar products. The court ruled that the FDA warning labels are “arbitrary and capricious.” The complete opinion of the court can Read more about Cigar News: DC Court of Appeals Rules Against FDA Warning Labels on Cigars[…]

Cigar News: Premium Cigar Industry Scores a Court Win

The premium cigar industry scored a big win in court today. The Premium Cigar Association sent out a press release that reads as follows:   ”Today, United States District Court Judge, Amit Mehta, threw out the warning requirements for premium cigars contending that the FDA did not properly analyze the different usage patterns between premium Read more about Cigar News: Premium Cigar Industry Scores a Court Win[…]

Drew Newman

Cigar News: Drew Newman testified alongside Premium Cigar Association President John Anderson.

This morning, the U.S. Small Business Administration held a public roundtable on the regulation of premium cigars at its headquarters in Washington, D.C.  Fourth generation cigar maker Drew Newman testified alongside Premium Cigar Association President John Anderson.  Drew described his family’s 124-year history of rolling premium cigars.   Using The American as an example, he explained how Read more about Cigar News: Drew Newman testified alongside Premium Cigar Association President John Anderson.[…]

Cigar News: Largest Premium Cigar Manufacturers Challenge Improper FDA Regulation

Wednesday, July 17, 2019 — Washington, DC — The largest manufacturers in the premium cigar industry today filed a joint comment with the Food & Drug Administration (“FDA”) opposing the agency’s Proposed Substantial Equivalence (“SE”) Rule, which would require manufacturers to submit to an extensive application and testing regime to keep any “non-grandfathered” cigars on the market. Read more about Cigar News: Largest Premium Cigar Manufacturers Challenge Improper FDA Regulation[…]

Save the Leaf

Cigar News: FDA ALERT!!

It seems the Government just can’t get things right. Even with the the current set of regulations that the FDA is trying to slap on the premium cigar industry, lawmakers this week have drafted a comprehensive bill that would extend cigarette regulations to all other tobacco products like premium cigars. The bill is the work Read more about Cigar News: FDA ALERT!![…]

Save the Leaf

Cigar News: Senator Rubio Takes Another Shot for the Cigar Industry

Another year and a new congress takes hold as we once again take the fight to exempt premium cigars from FDA regulations. Back in July of 2018, Senator Marco Rubio, R-Fl  took to the Senate floor to fight for the premium cigar industry and co-sponored a bill, with then Senator Bill Nelson, D-Fla, to free Read more about Cigar News: Senator Rubio Takes Another Shot for the Cigar Industry[…]

Cigar Industry Scores Another Victory

The premium cigar industry can chalk up another victory in their ongoing battle to win exemption from the US FDA’s deeming regulations on tobacco. Yesterday, D.C. District Court Judge Amit Mehta issued an injunction prohibiting the U.S. Food & Drug Administration from enforcing its warning label requirements on cigars and pipe tobacco. The injunction order Read more about Cigar Industry Scores Another Victory[…]

Senators Send Letter to FDA on Premium Cigar Exemption

The International Premium Cigar and Pipe Retailers (IPCPR) Association reports that 17 US Senators sent a letter to FDA Commissioner Scott Gottlieb outlining the need for the quick adoption of a premium cigar definition by the agency and the ultimate exemption of that product category from current FDA regulations.  The letter was a bi-partisan effort led Read more about Senators Send Letter to FDA on Premium Cigar Exemption[…]