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Tag: Cigar Rights of America

  • FDA Appeals Premium Cigar Ruling

    FDA Appeals Premium Cigar Ruling

    Photo: poco_bw

    The U.S. Food and Drug Administration on Jan. 31 appealed an August 2023 court ruling vacating the agency’s decision to regulate premium cigars, reports Halfwheel.

    The court ruling stemmed from a lawsuit filed by the Cigar Association of America, the Cigar Rights of America and the Premium Cigar Association (PCA).

    In 2022, Judge Amit Mehta issued an opinion examining the rulemaking record and detailing the FDA’s failure to address evidence in the record showing that premium cigars have different usage patterns, with different resulting health effects, than other cigars. Mehta later ruled that the FDA’s mishandling of significant questions that the FDA itself asked in its proposed rule merited vacating it, as the FDA never made a nonarbitrary decision to regulate premium cigars.

    In its appeal, the FDA urges the court to elevate deference to the agency’s “scientific judgment” over its duty of explanation under the Administrative Procedure Act. The FDA also argues that Mehta should have sent the flawed rule back to the agency to fix it while allowing the FDA to continue regulating premium cigar retailers and manufacturers under the arbitrary rule in the meantime.

    In a statement, the PCA said it would be responding to the FDA’s arguments and defending Mehta’s opinion in a forthcoming filing with the D.C. Circuit Court. A hearing before three judges of the appellate court is likely to follow.

  • Copperman to Lead Cigar Rights of America

    Copperman to Lead Cigar Rights of America

    Credit: Thapana Studio

    The Cigar Rights of America (CRA), a cigar industry trade group, announced the promotion of Mike Copperman to executive director.

    Copperman, who serves as director of legislative and regulatory affairs, has been with the organization since 2011. Before that, he owned Bethesda Tobacco in Bethesda, MD, and once served on the board of the IPCPR, the organization now known as the Premium Cigar Association.

    He will continue to serve as director of legislative and regulatory affairs while also serving as executive director.

    “We are thrilled to welcome Mike as the new executive director of CRA. His wealth of experience and dedication to our cause make him the ideal leader to advance our mission and navigate the evolving landscape of premium cigar advocacy,” said Robert Levin, president of CRA and owner of Holt’s/Ashton, in a press release.

    The CRA’s executive director role has remained vacant for three years following the departure of Glynn Loope in late 2020.

  • Resolution to Exempt Premium Cigars

    Resolution to Exempt Premium Cigars

    Image: conzorb

    A resolution introduced in the U.S. House of Representatives would remove the Food and Drug Administration’s authority to regulate premium cigars, according to Halfwheel.

    Cigar Rights of America (CRA) worked with Representative Byron Donalds to introduce the joint resolution, which would provide a definition of premium cigars and specify that the term “tobacco product” does not mean premium cigar.

    To be considered a premium cigar, a product must meet these requirements: is wrapped in whole tobacco leaf; contains a 100 percent leaf tobacco binder; contains at least 50 percent (of the filler by weight) long filler tobacco (i.e., whole tobacco leaves that run the length of the cigar); is handmade or hand-rolled (i.e., no machinery was used apart from simple tools, such as scissors to cut the tobacco prior to rolling); has no filter, nontobacco tip or nontobacco mouthpiece; does not have a characterizing flavor other than tobacco; contains only tobacco, water and vegetable gum with no other ingredients or additives; and weighs more than 6 pounds per 1,000 units.

    The resolution has gained 10 co-sponsors from both political parties. It has been referred to the House Committee on Energy and Commerce and is awaiting further action.

    If the resolution is passed, premium cigars would be exempt from all aspects of the Family Smoking Prevention and Tobacco Control Act. Congress would take back authority over cigar regulation.

  • DOJ Appeals FDA Premium Cigar Decision

    DOJ Appeals FDA Premium Cigar Decision

    The premium cigar industry recently declared victory in the fight against oversight by the U.S. Food and Drug Administration. Celebrations may have been premature.

    The U.S. Department of Justice has filed an appeal on behalf of the FDA for a decision handed down from the United States District Court for the District of Columbia that fully vacated the Deeming Rule as it applied to premium cigars, according to media reports.

    The lawsuit was filed by the Cigar Association of America, the Cigar Rights of America (CRA) and the Premium Cigar Association. The case focused in part on the rulemaking process, which requires the FDA to inform the public about upcoming regulations and solicit feedback on those proposed rules.

    In last month’s decision in Cigar Association of America et al. v. United States Food and Drug Administration, Judge Amit P. Mehta made a sweeping, albeit expected, ruling that granted relief to the three cigar industry trade groups that sued the regulatory agency in 2016 on behalf of the premium cigar industry.

    The news confirms industry fears that warning labels, premarket tobacco product application (PMTA) review of cigars and other limitations that have impeded the ability of cigarmakers are still a possibility.

    Recently, the FDA acknowledged the decision and one of its impacts, telling cigar companies that it did not plan to assess user fees for “premium cigars” sold during Q4 FY23.

    The Department of Justice, which represents FDA on legal matters, had 60 days to appeal the ruling. It’s unclear whether the agency will ask a court for a stay, which could reenact the deeming regulations for “premium cigars” as the appeal process works itself out.

  • Court Tosses Premium Cigar Regulations

    Court Tosses Premium Cigar Regulations

    Photo: Olena

    The U.S. District Court for the District of Columbia has vacated the Food and Drug Administration’s deeming regulations for premium cigars, reports Halfwheel.

    As a result, the deeming regulations introduced by the agency in 2016 do not apply to cigars that meets all of the following criteria:

    • It is wrapped in whole tobacco leaf
    • It contains 100 percent leaf tobacco binder
    • It contains at least 50 percent long filler tobacco
    • It is handmade or hand rolled
    • It has no filter, nontobacco tip or nontobacco mouthpiece
    • It does not have a characterizing flavor other than tobacco
    • It contains only tobacco, water and vegetable gum with no other ingredients or additives
    • It weighs less than 6 pounds per 1,000 units.

    The lawsuit was filed by the Cigar Association of America, the Cigar Rights of America (CRA) and the Premium Cigar Association.

    The case focused in part on the rulemaking process, which requires the FDA to inform the public about upcoming regulation and solicit feedback on those proposed rules.

    Contrary to the FDA’s assertion when it announced its finalized rules in 2016, the agency received feedback, according to Judge Amit P. Mehta. Specifically, the CRA in a comment to the proposed rules cited a finding from an FDA-funded study indicating that cigar smokers do not have higher “all-cause” mortality rates than nonsmokers.

    According to Halfwheel, the cigar industry is likely to ask the FDA to reimburse the user fees it has paid the agency, which the publication estimates at about $100 million per year for both premium and non-premium cigars.

    The FDA still has the option to deem premium cigars as regulated tobacco products, but it must complete the process that it failed to complete properly from 2014 to 2016.