Tag: FDA Cigar Regulations

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

Posted on by bostonjimmie

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

Posted on by bostonjimmie

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: CRA Files Comment On FDA Proposed Rule Regarding Flavors

Posted on by bostonjimmie

WASHINGTON, D.C. – Yesterday, Cigar Rights of America (“CRA”) filed a comment on the U.S. Food and Drug Administration (“FDA”) proposal regarding flavored tobacco products. The CRA submission agrees with FDA that the Proposed Rule is inapplicable to premium cigars because premium cigars, by definition, do not have characterizing flavors. However, we remain concerned that certain Read more about Cigar News: CRA Files Comment On FDA Proposed Rule Regarding Flavors[…]

Breaking Cigar News: J.C. Newman Reports – FDA Regulation On Premium Cigars Put On-Hold

Posted on by bostonjimmie

In a press release this afternoon, J.C. Newman reported the results of the latest Federal Court hearing on Premium Cigar regulations. “This afternoon, Judge Amit P. Mehta of the U.S. District Court for the District of Columbia issued an opinion concluding that FDA acted “arbitrarily and capriciously” when it decided to regulate premium cigars in Read more about Breaking Cigar News: J.C. Newman Reports – FDA Regulation On Premium Cigars Put On-Hold[…]

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

Posted on by bostonjimmie

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: Premium Cigar Industry Town Hall Scheduled for Sept 29

Posted on by bostonjimmie

Last week, the PCA and CRA announced they would be holding an online Town Hall with leaders in the industry to discuss the recent legal victories, the current state of play in our advocacy, and some of the new ways we are working together moving forward. Due to the overwhelming amount of interest, registration for Read more about Cigar News: Premium Cigar Industry Town Hall Scheduled for Sept 29[…]

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

Posted on by bostonjimmie

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[…]