Tag: Premium Cigar Association

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

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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.
November 7, 2023
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.
September 30, 2023
Court Tosses Premium Cigar Regulations
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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.
August 9, 2023
Cigar Association Meets CTP Officials

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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.
September 12, 2022
FDA Ignored Evidence in ‘Deeming’ Premium Cigars

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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.
July 6, 2022
Cigar/Pipe Rules and Fees Upheld in Court

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The U.S. Food and Drug Administration properly implemented federal law when it extended certain cigarette rules to other tobacco products and when it assessed fees on cigars and pipe tobacco, the U.S. Court of Appeals for the District of Columbia Circuit ruled on June 20, according to Reuters.
The court unanimously rejected a challenge by the Cigar Association of America, Cigar Rights of America and Premium Cigar Association to aspects of the FDA’s Deeming Rule subjecting cigars and pipe tobacco to the same regulatory framework as cigarettes.
The FDA adopted the Deeming Rule in 2016, identifying a wide range of tobacco products, including cigars and pipe tobacco to be subject to its regulatory authority under the Family Smoking Prevention and Tobacco Control Act of 2009.
The industry groups challenged the rule in the District of Columbia. Some aspects of that challenge have been successful, as when the D.C. Circuit last year overturned a warning label requirement for cigar and pipe tobacco products.
In its recent ruling, however, the appeals court upheld the FDA’s authority to require cigar and pipe tobacco products to undergo premarket review or for manufacturers to provide “substantial equivalence reports” (SE) showing that a product is equivalent to one already on the market before 2007.
The cigar groups had challenged that rule on the grounds that the FDA failed to provide product-specific instructions on how to prepare SE reports and did not consider the cost and benefits of premarket review specifically for each industry or product. They also challenged the user fees on the grounds that the agency did not impose similar fees on other newly deemed products such as e-cigarettes.
Circuit Judge Judith Rogers wrote that it was unnecessary to address whether the law required the FDA to provide the instructions because the agency had said it would give companies 18 months to submit SE reports. She argued that even if the FDA were required to provide instructions, it did not have to do so as part of the rule but could do so later.
Rogers also upheld the agency’s user fees on cigar and pipe tobacco manufacturers and importers, arguing that the Tobacco Control Act specifically gave the FDA authority to impose fees on cigarettes, cigars, snuff, chewing tobacco, pipe tobacco and roll-your-own tobacco.
Anti-smoking activists described the court ruling as “a win for kids, their families and the public health.”
“The D.C. Court of Appeals’ unanimous decision upholding the premarket review provisions of the FDA’s Deeming Rule for cigars will finally force cigar makers to show that their products are substantially equivalent to products that were already on the market before the passage of the landmark Tobacco Control Act,” said Matthew L. Myers, president of the Campaign for Tobacco-Free Kids, in a statement.
“Cigarettes have been subject to FDA regulation since the enactment of the Tobacco Control Act in 2009, but cigar makers were entirely unregulated for seven years until the Deeming Rule subjected them to minimal regulations.”
July 23, 2021
Tobacconists Donate $50,000 For Advocacy

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The Tobacconist Association of America (TAA) will donate $50,000 to the Premium Cigar Association (PCA) to aid in the industry’s growing work in local and state legislation impacting the premium cigar and pipe industries.
“The PCA would like to thank the TAA for this outstanding show of support as our industry is facing some of the most egregious tax grabs and potential smoking bans in recent history,” said PCA Executive Director Scott Pearce. “The PCA is hard at work in over two dozen states already fighting tax increases that, at the best of times, are harmful to our small business retailers. Especially during the pandemic that could potentially put our members out of business.”
PCA President John Anderson echoed Pearce’s gratitude, urging retailers everywhere to engage in the fight. “We are at our best when we are all participating in this fight, and we need all of our retailer voices to join in to ensure we will not be steamrolled by misguided public policy,” Anderson said. “TAA’s support will help ensure that we can continue to be active and put all of our resources towards defending our retailers across the country.”
“The TAA is happy that it can support the brick-and-mortar community in these most challenging times,” said Joe Arundel, TAA president. “The TAA recognizes and appreciates the outreach that PCA gives to our retail members in their respective communities across this country. We are confident that PCA can effectively help defend our stores and businesses in the coming months.”
Founded in 1933, the PCA represents and assists retailers, manufacturers and suppliers of premium tobacco products. Established in 1968, the TAA supports its members with tools and relationship building opportunities to optimize their success in the brick-and -mortar business.

January 27, 2021