Tag: United States

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
U.S. Premium Cigar Imports Drop

Credit: Timothy S. Donahue
The Cigar Association of America (CAA) has released a report showing that U.S. imports of premium cigars from January-July 2023 are down 3.4 percent compared to the record pace that was set in 2022.
Through the end of July, CAA estimates the U.S. imported 252.81 million cigars, compared to 261.63 million in the same period during the year before.
While the numbers are down compared to last year, the trend line for the first seven months of the year is actually closer to 2022 than the Q1 numbers. More importantly, the numbers are still significantly above pre-Covid-19 levels, reports Halfwheel.
On a month-by-month basis, imports rose in four of the seven months, though March and April were down a combined 11.7 million cigars, or 14.41 percent compared to 2022. Addittionally, there were 6.5 million more cigars imported in May and July, or 8.33 percent over last year.
Nicaragua remains the dominant supplier of premium cigars to the U.S., accounting for roughly 55 percent of imports through the first seven months, according to CAA. However, those imports are down 4.2 percent compared to last year.
The CAA breaks down individual imports from seven countries and all were down except the Dominican Republic, which the group estimates has shipped 3.37 million more cigars compared to the same period last year, an increase of 4.8 percent.
September 28, 2023
White House Steps Up Fight Against Smoking
Photo: Alexander Ryabkov | The White House
The White House on Sept. 13 announced a $240 million investment to fight cancer, along with a slew of new health resources to further the administration’s “Cancer Moonshot” initiative.
The announcements from the Biden Cancer Moonshot include:
New investments to reduce the impact of menthol and other flavored commercial tobacco products in communities that experience health disparities
A new plan to decrease the impact of smoking on Americans’ health by expanding efforts to prevent smoking and to support everyone who wants to quit. To ensure Americans who want to quit have the support they need, the Department of Health and Human Services will finalize its Framework to Support and Accelerate Smoking Cessation this year.
New smoking cessation resources for underserved communities, including American Indian, Alaska Native and Black communities, to reduce cancer health disparities.
A new pilot program to increase veteran engagement in tobacco use treatment. The Department of Veterans Affairs, in collaboration with the National Cancer Institute, will conduct a clinical demonstration project to assess how to more effectively engage veterans in tobacco-use treatment programs.
New resources and actions to reduce exposures to environmental carcinogens. The Environmental Protection Agency (EPA) is launching gov/cancer, with new information and prominently featured resources from EPA and other federal agencies about secondhand smoke, smoking cessation and other cancer-related topics.
Tobacco harm reduction activist have been urging Biden administration to embrace less harmful alternatives in its Cancer Moonshot initiative. “If President Biden is serious about beating cancer, then embracing tobacco harm reduction is not just an option, it’s a necessity,” said Michael Landl, director of the World Vapers Alliance (WVA), in a statement.
Landl pointed to the examples of Sweden and the United Kingdom, which he said have proven the effectiveness of vaping and other less harmful products in reducing smoking rates. “Instead of fighting less harmful alternatives, the Biden Administration needs to embrace vaping as a smoking cessation aid,” he said.
The investments in programs aiming to reduce smoking among marginalized groups would be more impactful if they included harm-reducing alternatives, according to Landl.
“To achieve the desired outcomes in cutting cancer-related deaths, it’s imperative that the United States foster a comprehensive harm reduction strategy that acknowledges vaping’s potential to save lives. Many smokers fail to quit, so to beat cancer we need to get real about that and encourage the use of less harmful alternatives such as vaping,” he said.
The WVA urged the Biden administration to develop an inclusive strategy that incorporates a range of less harmful alternatives to smoking. “Flavor bans, high taxation on safer nicotine products and the overly bureaucratic FDA approval process must end immediately,” said Landl.
September 13, 2023
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.
August 9, 2023
Survey: Americans Support Harm Reduction

Image: Maren Winter | Adobe Stock
Two out of three Americans support tobacco harm reduction over blanket prohibition as the better policy approach to tobacco regulation, according to a survey released by Altria.
The survey also shows that 82 percent think it is important for the U.S. Food and Drug Administration to focus on making smoke-free tobacco products available to adult smokers to help them switch from cigarettes.
“There is clear, overwhelming support for the FDA embracing harm reduction for the 30 million American adults who smoke. That means providing adult smokers who are unable or unwilling to quit with wider access to smoke-free alternatives and providing them the information and support to help them switch,” said Paige Magness, senior vice president of regulatory affairs at Altria Client Services. “Pursuing harm reduction is one of the most powerful steps the FDA can take to deliver on its mission to reduce tobacco-related death and disease in the U.S. It is our hope that the FDA will listen to these voices as it sets out its policy agenda for the coming years.”
The survey also shows that 90 percent agree that the FDA has a responsibility to accurately inform adult tobacco consumers about the risks associated with different tobacco products, and 88 percent agree that the FDA has a responsibility to address the widespread misperception that nicotine causes cancer.
Most adults also agree that policies that ban tobacco products will lead to illicit markets for tobacco products, endangering public health, youth and communities of color.
“Most Americans understand that prohibition-based policies don’t work and that it’s much better for public health to keep tobacco products legal and regulated,” said Magness. “Harm reduction is the better path forward. With harm reduction, regulators provide adult smokers with information, choice and support to expand the off-ramp from smoking—while also continuing to drive down underage use.”
The survey results also underscore the clear expectations that adults have for physicians to help adult smokers who want to switch, according to Altria. Seventy-nine percent agree that if certain tobacco products have been scientifically shown to be less risky than cigarettes, physicians have a responsibility to communicate this information to their patients who are adult tobacco consumers and have not successfully quit smoking by using traditional cessation therapies.
In addition to general population adults, the survey asked primary care physicians about their views on tobacco harm reduction. Of those surveyed, 89 percent support tobacco harm reduction as a public health concept and 85 percent believe it is important for the FDA to focus on making smoke-free tobacco products available to adult smokers to help them switch from cigarettes to less harmful alternatives.
Policy professionals were also surveyed and overwhelmingly believe that harm reduction is a better approach for the FDA to focus on than prohibition (78 percent), that tobacco products should remain legal so they can be properly regulated (77 percent) and that the FDA has a responsibility to accurately inform adult tobacco consumers about the different levels of risk associated with tobacco products (96 percent).
April 14, 2023
Cannabis, Caffeine Pouches Possible

Altria executives updated financial targets during its Investor Day event as well as highlighting several new product developments.
Company leaders touted Altria’s new SWIC heated-tobacco capsule product, which uses proprietary technology to heat tobacco-filled capsules to deliver a vapor similar to a combustible cigarette.
Altria executives also highlighted the company’s new On Plus! nicotine pouch product alongside broad statements on its long-term growth plans.
“We believe the international smoke-free and non-nicotine categories combined represent multi-billion-dollar opportunities for us,” Billy Gifford, CEO of Atria, said. “Our teams are evaluating these opportunities and expect to finalize strategies for these growth areas over the next 12 months. We intend to share specific goals for these areas once established.”
Altria said those non-nicotine offerings could include cannabis and caffeine.
Bonnie Herzog with Goldman Sachs said she came away optimistic about Altria’s future and ability to pivot its portfolio to a smoke-free business following presentations at the event.
“Overall, we feel there is more visibility on (Altria’s) transformation as management spent the bulk of the time discussing its smoke-free efforts, which is clearly the next important phase of growth for (Altria) as it accelerates plans to move beyond smoking and eventually beyond nicotine,” Herzog wrote in an email. “To give shape and structure to its smoke-free vision, management introduced 2028 enterprise goals, which included growing its U.S. smoke-free volume by at least 35 percent, doubling smoke-free revenue to $5 billion (including $2 billion from smoke-free) and maintaining leadership in U.S. tobacco.”
The company updated financial targets during the event; for example, guidance for full-year adjusted EPS in a range of $4.98 to $5.13 was reiterated.
Looking further ahead, the tobacco company set a goal to deliver mid-single-digits adjusted diluted EPS growth on a compounded annual basis through 2028.
March 26, 2023
Court Won’t Hear At-Home Smoking Ban Challenge

Photo: marjan4782
The U.S. Supreme Court on March 20 declined to hear a challenge to the federal government’s ban on smoking in public housing, reports Law360.
A New York group advocating for residents’ right to smoke in their apartments, sued the U.S. Department of Housing and Urban Development (HUD) for imposing the ban in 2016. The no-smoking rule applies within public housing apartments and in common areas, as well as within 25 feet outside apartment buildings.
NYC CLASH argued the ban violates tenants’ rights to due process and against unconstitutional seizures.
In August 2022, the D.C. circuit upheld the ban, arguing the 1937 Housing Act gave HUD the power to regulate smoking to improve air quality and maintain “safe and habitable” living quarters.
NYC CLASH’s founder Audrey Silk said his group’s legal challenge was about more than just tobacco smoking. “It is about the right to be left alone in your private home to use a legal product and by keeping government in check,” she said. “So the more ominous question now is ‘what’s next?’”
March 21, 2023
FDA Appeals Rejection of Graphic Warnings

Image: FDA
The U.S. Food and Drug Administration has appealed a court ruling that found the agency’s graphic health warning rule unconstitutional, reports CSP.
On Dec. 7, a federal judge in Texas blocked the FDA from enforcing a rule requiring tobacco companies to print graphic health warnings on their products, saying they violated free speech protections under the First Amendment.
The graphic cigarette health warning rule required manufacturers and retailers who sell cigarettes to rotate 11 health warnings on cigarette packs, which consisted of textual statements and color graphics depicting the negative health consequences of cigarette smoking.
The Texas court said the graphic cigarette health warnings would have compelled manufacturers and retailers to speak by displaying cigarette packages on store shelves and advertising cigarettes when, if given the choice, manufacturers and retailers would choose not to do so. The court also said the warnings were not purely factual and were open to interpretation by consumers and more extensive than necessary.
The FDA appealed that decision on Feb. 1 in the U.S. Court of Appeals for the Fifth Circuit, according to court documents.
The Family Smoking Prevention and Tobacco Control Act of 2009 instructs the FDA to create visual health warnings, but the D.C. Circuit in 2012 blocked the agency’s first attempt, saying that regulators had not convincingly demonstrated that the warnings would actually reduce smoking.
In March 2020, the FDA released the final rule requiring new graphic warnings for cigarettes that feature some of the lesser known but still serious health risks of smoking, such as diabetes, on the top half of the front and back of cigarette packages and at least 20 percent of the area on the top of cigarette advertisements.
Several tobacco companies, including R.J. Reynolds Tobacco Co., filed a First Amendment challenge in April 2020. The rule was set to take effect in November 2023 after the deadline was repeatedly pushed back by court.
According to health groups, the U.S. has fallen behind other countries with its tobacco control policies. Prior to 2009, when Congress passed the Tobacco Control Act, only 18 countries required graphic warnings for tobacco products, they pointed out. Today, more than 120 countries require them.
February 24, 2023
U.S. Court Orders Halt to Elfbar Sales

Photo: md3d
A U.S. federal judge on Feb. 23 ordered Shenzhen Weiboli Technology to stop marketing its Elfbar e-cigarettes in the U.S., finding that VPR Brands, which makes and sells Elf brand vapes, is likely to succeed on its claims that the Elfbar vapes infringe its trademark, reports Law360.
According to U.S. District Judge Aileen M. Cannon, VPR has shown there is a likelihood of confusion and the company stands to suffer harm if its Chinese competitor is allowed to keep selling the Elfbar vapes.
In November, VPR asked for an injunction blocking Shenzhen Weiboli from continuing to use the Elfbar mark, arguing the alleged infringement is costing VPR about $100 million because of the effect on future sales.
VPR claims Shenzhen Weiboli is not only infringing VPR’s Elf trademark but also its patent for its e-cigarette device.
While there is no direct evidence that Shenzhen Weiboli deliberately intended to adopt the Elf mark to take advantage of the existing trademark, Judge Cannon wrote that the company was well aware of the Elf mark and that there was potential for confusion, as the U.S. Patent and Trademark Office denied the registration of an Elfbar trademark specifically for those reasons.
VPR welcomed the judge’s decision. “VPR is pleased that the court found Elf is a strong trademark and granted the injunction,” said Joel B. Rothman of Sriplaw, which represented VPR in the case. “The injunction will allow VPR to move quickly against infringers and counterfeiters in the marketplace.”
An attorney for Shenzhen Weiboli said the company intends to appeal the order.
February 24, 2023
U.S. Cigarette Sales Down in 2020-2021

Photo: www.akolosov.art
The number of cigarettes that the largest cigarette companies in the United States sold to wholesalers and retailers nationwide decreased from 203.7 billion in 2020 to 190.2 billion in 2021, according to the Federal Trade Commission’s most recent Cigarette Report. The report also states that in 2021, menthol flavored cigarettes comprised 37 percent of the market among major manufacturers, more than double the 16 percent market share they held in 1963.
The amount spent on cigarette advertising and promotion increased from $7.84 billion in 2020 to $8.06 billion in 2021. Price discounts paid to cigarette retailers ($6.01 billion) and wholesalers ($917 million) were the two largest expenditure categories in 2021. Combined spending on price discounts accounted for 86 percent of industry spending.
According to the Smokeless Tobacco Report, smokeless tobacco sales decreased from 126.8 million pounds in 2020 to 122 million pounds in 2021. The revenue from those sales rose from $4.82 billion in 2020 to $4.96 billion in 2021. Menthol flavored smokeless tobacco products comprised more than half of all sales and fruit flavored smokeless tobacco products comprised 2.7 percent.
Spending on advertising and promotion by the major manufacturers of smokeless tobacco products in the U.S. increased from $567.3 million in 2020 to $575.5 million in 2021. As with cigarettes, price discounts made up the two largest spending categories, with $308.2 million paid to retailers and $81.3 million paid to wholesalers in 2021. Combined spending on price discounts represented 67.7 percent of all industry spending.
Smokeless tobacco manufacturers also reported selling $804.8 million of nicotine lozenges or nicotine pouches in 2021, not containing tobacco, up from $422.7 million in 2020.
The Commission has issued the Cigarette Report periodically since 1967 and the Smokeless Tobacco Report periodically since 1987.
February 1, 2023