Category: Flavors

Court Rejects Challenge to California’s Flavor Ban

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A U.S. federal judge has thrown out a tobacco industry lawsuit against California’s statewide ban on the sale of flavored tobacco products, reports Law360.
On March 15, Judge Cathy Ann Bencivengo rejected the plaintiffs’ claim that the measure would unfairly discriminate against out-of-state businesses. Bencivengo argued that the contested law applies to sales only; manufacturers are still permitted to manufacture flavored tobacco products in California. Most manufacturers of flavored tobacco products are located outside California.
R.J. Reynolds and other tobacco companies sued California after voters approved the ban in a November referendum, claiming the law violates the federal Tobacco Control Act (TCA) as well as the U.S. Constitution’s commerce clause.
The law was originally passed by the state legislature but didn’t take effect after industry opponents gathered enough signatures to put the issue on the November ballot.
In rejecting the TCA claim, Bencivengo cited a 9th Circuit ruling in March 2022 that upheld a Los Angeles County ban on flavored tobacco products. The tobacco industry lawsuit also doesn’t meet the standards for arguing a state law discriminates against or unduly burdens interstate commerce, she argued.
The court also rejected the tobacco companies’ claim that out-of-state manufacturers of flavored tobacco products would be forced to change their operations to the tune of “tens of billions of dollars” to comply with the law’s new standards for tobacco products, an undue burden on interstate commerce.
California’s flavor ban doesn’t set new standards for the manufacture or marketing of tobacco products that depart from federal regulations, Bencivengo said. And financial losses for the tobacco industry alone are “not excessive enough for the court to find that the ban substantially burdens interstate commerce,” she added, citing the law’s aims to protect public health.
The TCA also gives states the authority to “opt out of the market for flavored tobacco products,” Bencivengo said in the ruling, which does not allow the tobacco companies to file an amended complaint.
March 16, 2023
Black Activists Split on Menthol Ban

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Black activists in New York are split on whether a menthol ban will be beneficial or harmful to the community, reports Gothamist.
One group, consisting of family members of those killed by police, including George Floyd’s brother and sister-in-law and Eric Garner’s mother, Gwen Carr. Garner was killed by police on Staten Island who were enforcing cigarette regulations.
“My son was a victim because allegedly he was selling ‘loosie’ cigarettes,” Carr said. “That’s what they’re going to do when they ban these cigarettes.”
“No more victims and no more violence,” she said, “and no ban on the menthol cigarettes.”
Another group gathered 30 minutes later and a block away supporting the ban. The group consisted of 40 clergy leaders and activists as well as Hazel Dukes, president of the NAACP New York State Conference and former president of the National NAACP.
“Our children are dying. Our kids think menthol is great. They think it’s bubblegum,” Dukes said. “Big Tobacco, you are getting out of our community.”
The proposed ban would expand current measures to include menthol-flavored products; a city council bill has been sponsored by 20 members and a state proposal from Governor Kathy Hochul is up for a vote.
According to New York public health officials, half of all adult smokers use menthol cigarettes, 86 percent of Black smokers smoke only menthol cigarettes, and 72 percent of Hispanic smokers smoke only menthol cigarettes. Black and Hispanic smokers make up a disproportionate number of smoking deaths in New York, according to state and federal data.
“Prohibition doesn’t work,” said Sylvia Miranda, executive director of the National Latino Officers Association. “The best way is through a medical model, not a criminal model.”
Supporters of the ban say it would specifically target retail sales and not personal consumption while critics fear the ban would ramp up policing in Black communities.
“Contrary to what the opposition is saying, read my lips: NYPD will not be involved,” said Council Member Rita Joseph, the main sponsor of the city council bill banning menthol-flavored tobacco products.
March 13, 2023
Health Advocates Urge FDA to Ban Flavors

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Health advocates are urging the U.S. Food and Drug Administration to ban menthol cigarettes and flavored cigars, reports WGBO. The FDA issued draft measures to ban menthol in April 2022. Final regulations are expected later this year.
“Menthol is an analgesic; it numbs the throat, so it lets the poison go down easier,” said Carol McGruder, co-chair of the African American Tobacco Control Leadership Council. “It dilates the alveoli in the lungs, the little sacs in your lungs, and so it allows the toxins to stay longer and deeper in the lungs.”
Lincoln Mondy made a documentary called Black Lives/Black Lungs about the marketing of menthol cigarettes to Black communities, something many have pointed out as a trend in tobacco marketing.
“We say predatory because it was indeed predatory; they went in neighborhoods like Detroit and New York and majority Black neighborhoods and gave out free cigarettes. They just handed out free cigarettes; they drove up in Newport vans and Kool vans and handed out free cigarettes,” Mondy said.
As a result of this “predatory” marketing, 85 percent of Black smokers smoke menthol cigarettes. Some states like California passed laws banning flavors. However, McGruder says that the industry is still finding ways around such bans.
“They’ve already introduced new products that have some chemicals in there that mimic menthol, but they’re not menthol, and they’re actually on the market right now in California, and so now we have to deal with that, and so, the industry will never stop. They are going to continue to recruit their new smokers to replace the folks who are dying,” McGruder said.
February 22, 2023
New York Clergy Oppose Menthol Ban

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Several clergy members from New York State have signed a letter opposing Governor Kathy Hochul’s proposed ban on flavored tobacco products, reports Spectrum News 1. The clergy members cite civil rights and criminal justice concerns that banning menthol cigarettes in New York would implicate.
“It is unjust to expect communities of color to choose between greater public health protections and basic civil rights,” they wrote in the letter. “We do not accept the premise that we must choose between the two, that these interests are mutually exclusive or that this debate is zero-sum. A working group consisting of social justice advocates and law enforcement leaders, along with other organizations, is the best solution available to bridge the current divide.”
Hochul’s proposal would also raise the per-pack tax on cigarettes by $1 to $5.35.
Clergy believe banning flavored tobacco would lead to unfair outcomes for people of color.
“Our collective primary interest is protecting the public, specifically communities of color, from abuse at the hands of both corporate influences and law enforcement,” they wrote. “We share the same belief as others that we can have a robust and productive debate that prioritizes both public health and criminal justice concerns.”
“To that end, we are requesting that any proposed ban on menthol cigarettes be withdrawn at this time and a working group convened with the set mission to offer recommendations for new legislation,” they wrote. “That working group must take into account all of our collective concerns and address the need for greater public health protections that do not compromise our constitutional and civil rights.”
February 17, 2023
Trade Group: Cigar Flavor Ban Harmful

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Banning flavored cigars would do more harm than good, according to David Ozgo, president of the Cigar Association of America, reports The Center Square.
“The economic impact is one thing, but just as important is the fact that what you’re doing is taking away an adult’s right to choose,” Ozgo said. “When President [Barack] Obama passed legislation in 2009 regulating tobacco, he stressed the idea was not to take away an adult’s right to use tobacco if that’s what they choose.”
In 2021, flavored cigars made up 47 percent of the market, so banning them would have a huge economic impact, according to Ozgo. He projects losses of about $4 billion in retail sales, 16,000 jobs, $840 million in wages and an estimated $750 million in federal, state and local tax revenue.
“The proposed rules would help prevent children from becoming the next generation of smokers and help adult smokers quit,” Health and Human Services Secretary Xavier Becerra said in a statement on the U.S. Food and Drug Administration’s website. “Additionally, the proposed rules represent an important step to advance health equity by significantly reducing tobacco-related health disparities.”
Ozgo countered that it’s already illegal for a person under 21 to purchase tobacco. Government data shows less than 1 percent of youth use flavored cigars, he noted.
“This is a solution in search of a problem,” Ozgo said. “When you look at indicators of nicotine addiction, they’re not the same as, say, cigarettes. Really, people smoke cigars for different reasons. With cigars, it’s just something you do to relax and enjoy. We always say cigars are more of a hobby than a habit; you don’t even smoke one every day.”
February 1, 2023
Reynolds to Appeal Menthol MDOs

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BAT will appeal the U.S. Food and Drug Administration’s marketing denial orders for its Vuse Vibe Tank Menthol 3.0 percent and Vuse Ciro Cartridge Menthol 1.5 percent, the company announced in a statement.
On Jan. 24, the FDA denied marketing applications for two menthol refills used in Vuse Vibe and Vuse Ciro vaporizers, which are sold in the U.S. by BAT subsidiary R.J. Reynolds. According to the agency, Reynolds’ applications presented insufficient evidence to show that the potential benefit to adult smokers outweighs the risks of youth initiation and use.
“Reynolds intends to seek a stay of enforcement immediately and will pursue other appropriate avenues to allow Vuse to continue offering its innovative products to adult nicotine consumers age 21-plus without interruption,” the company said.
“We believe that menthol vapor products are critical to helping adult smokers migrate away from combustible cigarettes. FDA’s decision, if allowed to go into effect, will harm, not benefit, public health.
“We remain confident in the quality of all of Reynolds’ applications, and we believe that there is ample evidence for FDA to determine that the marketing of these products is appropriate for the protection of public health.”
Anti-tobacco campaigners countered that menthol e-cigarettes appeal to underage consumers. “Existing evidence demonstrates that nontobacco-flavored e-cigarettes, including menthol flavored e-cigarettes, have a known and substantial risk with regard to youth appeal, uptake and use; in contrast, data indicate tobacco-flavored e-cigarettes do not have the same appeal to youth and therefore do not pose the same degree of risk,” said Matthew L. Myers, president of the Campaign for Tobacco-Free Kids, in a statement.
Morgan Stanley said it expected the rejected products to remain on the U.S. market for the duration of BAT’s appeal, with minimal impact on the company’s operations. “Longer term, should today’s denial order reflect a broader effort by the FDA to ban menthol e-cigarettes, BAT’s U.S. cigarette business could benefit given its menthol mix as it might discourage some smokers from quitting or switching to reduced-risk products,” the bank wrote in a note to investors. Reynolds’ Newport brand represents about 40 percent of BAT’s U.S. cigarette dollar sales, according to Morgan Stanley.
The Jan. 24 rejection of the Vuse refills underscores the FDA’s ongoing reluctance to approve menthol e-cigarette flavors. To date, the agency has approved only tobacco-flavored e-cigarettes.
However, the FDA has granted both a premarket tobacco product application and modified-risk tobacco product designation to IQOS’ menthol variant, which may eventually leave Philip Morris International’s heat-not-burn product as one of the few menthol reduced-risk alternatives on the market.
The FDA is targeting publishing a final rule to ban menthol cigarettes in August 2023, but considering expected industry litigation, final implementation could be five to six years away, according to Morgan Stanley.
January 25, 2023
FDA Denies Two Vuse Menthol Vapor Products

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The U.S. Food and Drug Administration issued marketing denial orders (MDOs) for R.J. Reynolds Vapor Co.’s Vuse Vibe Tank Menthol 3.0 percent and the Vuse Ciro Cartridge Menthol 1.5 percent.
“Consistent with the authorities granted by Congress, the FDA remains committed to evaluating new tobacco product applications based on a public health standard that considers the risks and benefits of the tobacco product to the population as a whole,” said Brian King, director of the FDA’s Center for Tobacco Products. “The applications for these products did not present sufficient scientific evidence to show that the potential benefit to adult smokers outweighs the risks of youth initiation and use.”
“Existing evidence demonstrates that nontobacco-flavored e-cigarettes, including menthol-flavored e-cigarettes, have a known and substantial risk with regard to youth appeal, uptake and use; in contrast, data indicate tobacco-flavored e-cigarettes do not have the same appeal to youth and therefore do not pose the same degree of risk,” the FDA wrote in a statement.
“Given these existing differences in youth risk, applicants need to provide robust evidence to demonstrate that using their menthol-flavored e-cigarette products are likely to promote a complete switch or are likely to significantly reduce combustible cigarette use in adult smokers beyond that facilitated by tobacco-flavored e-cigarette products. Data from the 2022 National Youth Tobacco Survey found that Vuse was the second most common brand youth e-cigarette users reported ‘usually’ using.”
“Today’s decision pertains to the specific application submitted for review by FDA,” said King. “It is the responsibility of the applicant to provide sufficiently robust scientific evidence to demonstrate that the necessary public health standard has been met. In this case, the presented evidence did not meet that standard.”
In assessing the implications of the most recent MDOs for RJRV’s parent company, BAT, Morgan Stanley noted that Vuse Vibe and Vuse Ciro represent only a small portion of BAT’s overall e-cigarette sales in the U.S.
“Should it choose to appeal, we would expect its products to remain on the market as the appeal is ongoing, resulting in minimal/no operating impact,” the investment bank wrote in a note to investors.
Morgan Stanley said the MDO provides another example of the FDA’s ongoing reluctance to approve menthol e-cigarette flavors. To date, the agency has approved only tobacco-flavored e-cigarettes.
The financial institution also noted that the FDA has granted both a premarket tobacco product application and modified-risk tobacco product designation to IQOS’ menthol variant, which may make it one of the few menthol reduced-risk alternatives on the market.
The FDA is targeting publishing a final rule to ban menthol cigarettes in August 2023, but considering expected industry litigation, final implementation could be five to six years away, according to Morgan Stanley.
January 24, 2023
22nd Welcomes New Menthol Timeline
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22nd Century Group is poised to greatly benefit from the recent advancement of the U.S. Food and Drug Administration’s proposed ban on menthol as a flavoring agent in combustible cigarettes to final rule status, the company wrote in statement published on its website today.
“The most recent updates to the Biden administration’s Unified Agenda on Regulatory and Deregulatory Actions include major advancements in the FDA’s proposed tobacco harm reduction policies in 2023,” said John Miller, president of tobacco products for 22nd Century Group. “Advancement of FDA’s proposed menthol ban could position VLN Menthol King as the only combustible menthol tobacco cigarette on the market, providing a critical off-ramp to the estimated more than 15 million menthol smokers in the U.S.”
Menthol cigarettes account for an estimated $26 billion in retail sales. Menthol is also known to enhance nicotine’s addictive effects, making it more difficult to quit, and a disproportionate amount of menthol smokers are members of minority groups, particularly African Americans, 22nd Century wrote on its website.
“FDA’s proposed menthol policy specifically contemplates exempting certain products from the ban, such as our MRTP authorized VLN cigarettes, providing a critical off-ramp opportunity for adult menthol smokers,” stated John Pritchard, vice president of regulatory science for 22nd Century Group. “Without an off-ramp product, both research and real-world experience show the vast majority of menthol smokers would simply transition to traditional combusted cigarettes. 22nd Century’s MRTP authorization documents how VLN products can help people to smoke less, leading to a true reduction in smoking in line with FDA’s important public health goals.”

Advancement of FDA’s proposed menthol ban could position VLN Menthol King as the only combustible menthol tobacco cigarette on the market.
John Miller, president of tobacco products, 22nd Century Group
The Unified Agenda also indicates that the FDA intends to advance its transformative reduced nicotine content standards later in 2023, which seeks to limit the nicotine levels in all cigarettes to a level considered “minimally or non-addictive.” Both of these standards are considered game changers for public health and could be extremely favorable for 22nd Century Group due to VLN’s 95 percent reduced nicotine content.
22nd Century has been expanding sales of VLN cigarettes across five states with anchor partners including Circle K and Smoker Friendly. Following the company’s stated growth strategy to expand to 12-15 states during 2023, 22nd Century is actively engaged with multiple industry leading distribution partners and retail store chains wanting to introduce VLN products to adult smokers in both existing and new markets.
“The proactive and forward-thinking policies of the FDA have the power to reduce the harms of smoking and save millions of lives,” said Miller. “22nd Century Group continues to fully support these policies, and VLN^® reduced nicotine content products demonstrate that these programs are 100 percent achievable.”
22nd Century Group’s VLN brand cigarettes are the only combustible cigarettes that the FDA has authorized as modified risk tobacco products. The company’s VLN King and VLN Menthol King brands contain 95 percent less nicotine than traditional addictive cigarettes.
A final decision on the menthol ban is expected in August 2023.
January 17, 2023
Green Light for EU Flavor Ban Challenge

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Ireland’s High Court has granted two tobacco companies permission to challenge the EU ban on flavored tobacco-heating products, reports The Irish Times.
The ban, which covers all flavors except tobacco, took effect Nov. 23, 2022. EU member states have until July 23, 2023, to transpose the rule into national legislation.
BAT subsidiaries PJ Carroll and Co. and Nicoventures Trading claim the EU directive is invalid. Their challenge targets the minister for health, Ireland and the attorney general.
PJ Carroll contends the EU ban undermines its “ability to capitalize fully on the unique opportunity of being the first company to launch heated-tobacco products on the Irish market for adult smokers who would otherwise continue to smoke.”
The company, which holds 10 percent of the Irish market for e-cigarettes, started commercializing heated-tobacco products in Ireland in 2021.
In an affidavit, PJ Carroll Director and Head of Trade Simon Carroll said the ban will also undermine BAT’s significant investment in the development of “products with reduced-risk profile (relative to cigarettes) to cater to the preferences of adult smokers in Ireland who would otherwise continue to smoke.”
In addition, the ban has significant implications for the implementation of public health policy and anti-smoking campaigns where there are acceptable alternatives to traditional cigarettes, he said.
PJ Carroll and Nicoventures have also challenged the directive at the EU General Court, which is part of the EU Court of Justice.
January 12, 2023
Menthol Ban Failed to Boost Illegal Sales

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Banning menthol cigarettes does not lead more smokers to purchase menthols from illicit sources, according to a new research study published in Tobacco Control.
Researchers at the International Tobacco Control (ITC) Policy Evaluation Project at the University of Waterloo evaluated the impact of federal and provincial menthol cigarette bans in Canada by surveying smokers of menthol and nonmenthol cigarettes before and after Canada’s menthol ban.
Smokers were asked whether their usual cigarette brand was menthol-flavored and to report their last brand purchased. Those who were still smoking after the menthol ban were also asked where they last purchased their cigarettes.
Results showed that after the ban, there was no significant change in the purchase of cigarettes from First Nations reserves, the main source of illicit cigarettes in Canada.
“The tobacco industry has a long history of claiming that policies to reduce smoking will lead to substantial increases in illicit trade,” said Janet Chung-Hall, a research scientist for ITC and lead author of the new study, in a statement. “We can add the Canadian menthol ban to the long list of effective policies, such as graphic warnings and plain packaging, whose evaluation disproved the scare tactics by industry—showing that illicit trade did not, in fact, increase.”
A 2022 study that combined the ITC project data with data from a comparable Ontario evaluation study showed that the Canadian menthol ban led to an increase of 7.3 percent in quitting among menthol smokers above that of nonmenthol smokers. Projecting this effect to the U.S., whose Food and Drug Administration has proposed its own menthol ban, the ITC researchers estimate that a U.S. menthol ban would lead 1.33 million smokers to quit.
“Our previous research from Canada and the Netherlands showed that a menthol cigarette ban leads to significant reductions in smoking,” said Geoffrey Fong, principal investigator of the ITC project and professor of psychology and public health sciences at Waterloo. “These findings combine to provide powerful evidence in support of FDA’s proposed menthol ban.”
January 12, 2023