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Tag: Premium Cigar Association

  • Cigar Group Wants Better Justification for U.S. Flavor Rule

    Cigar Group Wants Better Justification for U.S. Flavor Rule

    Image: razoomanetu

    The Premium Cigar Association (PCA) testified before the White House Office of Management and Budget’s Office of Information and Regulatory Affairs (OIRA) as part of the administration’s review of the U.S. Food and Drug Administration’s draft Final Rule “Tobacco Product Standard for Characterizing Flavors in Cigars.”

    PCA President Scott Regina provided several examples of the impact that the rule would have on specialty tobacco retail, emphasizing that the FDA had not conducted a proper small business impact analysis. The PCA also outlined how the rule would directly affect regulatory matters outside of the FDA’s jurisdiction, including law enforcement, international trade and foreign policy.

    “It’s questionable whether FDA has the authority to issue standards that result in a product ban, especially when they are acknowledging that the regulation does not address a specific risk,” said Regina in a statement.

    “Ultimately, we asked OIRA to consult with a host of affected federal agencies and to remit the draft Final Rule back to FDA for better justification of authority, cost-benefit analysis and small business impact,” said Scott Pearce, executive director of the PCA.

    The OIRA has scheduled meetings with additional stakeholders throughout the month as well as proponents of the characterizing flavor product standard for cigars.

    The PCA published a full list of recommendations on the draft Final Rule.

  • 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.  

  • Cigar Association Meets CTP Officials

    Cigar Association Meets CTP Officials

    Photo: Rawf8

    The Premium Cigar Association (PCA) briefed Brian King, the new director of the Center for Tobacco Products (CTP), on the industry’s issue set and the association’s priorities.

    The briefing, which was one of King’s first engagements with stakeholders, covered material facts about the uniqueness of the products, legislative history, current health data, economics and impact of regulatory efforts.

    King was joined by several other members of the U.S. Food and Drug Administration, including Michele Mital, deputy director of the CTP. The PCA was represented by Greg Zimmerman (The Tobacco Co.), Scott Regina (Emerson’s Cigars), Mike Condor (Crowned Heads), Scott Pearce (PCA), Joshua Habursky (PCA) and Patrick Anderson (PCA consultant).

    “Director King is a researcher, and we urged him to lean into that part of his background and shed the current mantel that CTP wears—‘tobacco-free’ ideology is not what the Tobacco Control Act authorized,” said Zimmerman, president of the PCA, in a statement.

    “A lot of time and money has been spent by the government to try and justify FDA’s efforts to regulate premium cigars. While PCA is proud of our wins in defense of the industry, what we really need them to understand is that they are not achieving their own goals when they take broad sweeping approaches to regulation,” said Pearce, executive director of the PCA.

    “As long as the FDA remains our regulator, there needs to be productive dialogue. The necessity for the FDA to be aggressive toward premium cigars is not prudent, and we are hopeful that this personnel change will represent a departure from the past actions that were based on a one-size-fits-all approach,” noted Habursky, deputy executive director and head of government affairs for the PCA.

  • FDA Ignored Evidence in ‘Deeming’ Premium Cigars

    FDA Ignored Evidence in ‘Deeming’ Premium Cigars

    Photo: Viacheslav Yakobchuk

    The U.S. Food and Drug Administration ignored evidence about health risks in considering premium cigars to be subject to same law as cigarettes, a federal judge ruled on July 5, reports Reuters.  

    The litigation focuses on the 2016 Deeming Rule, in which the agency identified a wide range of tobacco products, including premium cigars, to be subject to its regulatory authority along with cigarettes under the Family Smoking Prevention and Tobacco Control Act.

    The FDA rule requires cigar makers to register their products annually, provide ingredient lists for each product and submit products for laboratory testing—procedures the premium cigar industry considers impractical for its handmade, “artisan” products.

    The Premium Cigar Association and Cigar Rights of America challenged the Deeming Rule, arguing that, unlike cigarettes and e-cigarettes, premium cigars do not appeal to young people and are not associated with addiction. They cited studies showing that young people are unlikely to use premium cigars, that users of premium cigars are unlikely to smoke them frequently and that infrequent cigar use is not associated with increased mortality.

    U.S. District Judge Amit Mehta in Washington DC agreed that the FDA had not adequately considered the studies cited by the plaintiffs, instead asserting that there was “no evidence” that premium cigars were less harmful.

    “Where, as here, an agency speaks in absolute terms that there is no evidence, it acts arbitrarily and capriciously when there is in fact pertinent record evidence and the agency ignores or overlooks it,” the judge wrote.

    Judge Mehta asked the FDA and the industry groups to submit briefs on whether he should vacate the FDA’s decision or simply remand the matter back to the agency.