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  • FDA Denies Marketing Applications for Vuse Menthol

    FDA Denies Marketing Applications for Vuse Menthol

    The U.S. Food and Drug Administration issued marketing denial orders (MDOs) for two menthol e-cigarette products currently marketed by R.J. Reynolds Vapor Company under the Vuse Solo brand.

    Reynolds is expected to challenge the order.

    The currently marketed products include the Vuse Replacement Cartridge Menthol 4.8% G1 and the Vuse Replacement Cartridge Menthol 4.8% G2, according to a statement. The company may resubmit applications or submit new applications to address the deficiencies for the products that are subject to these MDOs. 

    The FDA evaluates premarket tobacco product applications (PMTAs) based on a public health standard that considers the risks and benefits of the product on the population as a whole.

    After reviewing the company’s PMTAs, the FDA determined that the applications lacked sufficient evidence to demonstrate that permitting the marketing of the products would be appropriate for the protection of the public health, which is the applicable standard legally required by the 2009 Family Smoking Prevention and Tobacco Control Act.

    Specifically, the evidence submitted by the applicant did not demonstrate that its menthol-flavored e-cigarettes provide an added benefit for adult smokers relative to tobacco-flavored e-cigarettes.

    In October last year, the FDA issued MDOs for several menthol-flavored vaping products marketed by Logic Technology Development. It was the first time the FDA issued MDOs for menthol products after receiving a scientific review.

    A few days after the order was issued, Logic obtained a court order from the U.S. Circuit Court of Appeals for the 3rd Circuit that temporarily stayed the order.

    The case continues.

  • Black Activists Split on Menthol Ban

    Black Activists Split on Menthol Ban

    Photo: New Africa

    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.

  • Health Advocates Urge FDA to Ban Flavors

    Health Advocates Urge FDA to Ban Flavors

    Image: chocolatefather | Adobe Stock

    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.

  • New York Clergy Oppose Menthol Ban

    New York Clergy Oppose Menthol Ban

    Photo: New Africa

    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.”

  • Reynolds to Appeal Menthol MDOs

    Reynolds to Appeal Menthol MDOs

    Photo: BAT

    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.

  • 22nd Welcomes New Menthol Timeline

    22nd Welcomes New Menthol Timeline

    Image: nanzeeba

    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.

  • Menthol Ban Failed to Boost Illegal Sales

    Menthol Ban Failed to Boost Illegal Sales

    Photo: Rawf8

    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.”

  • Top Court Clears Way for California Flavor Ban

    Top Court Clears Way for California Flavor Ban

    Photo: Oleksii

    The U.S. Supreme Court on Dec. 12 refused to block California’s ban on flavored tobacco, clearing the way for the law to take effect next week, reports The New York Times. Consistent with its practice when ruling on emergency applications, the court gave no reason for its decision.

    Originally passed by lawmakers in 2020, California’s flavor ban was put on hold after opponents gathered enough signatures to force a referendum on the measure.

    After Californians voted to uphold the law on Nov. 8, tobacco companies challenged it in court, arguing that only the federal government can ban tobacco flavors, as the Family Smoking Prevention and Tobacco Control Act gives the U.S. Food and Drug Administration authority to regulate tobacco.

    State officials responded that the federal law was meant to preserve the longstanding power of state and local authorities to regulate tobacco products and to ban their sale.

    The tobacco companies also argued that they would suffer “irreparable harm” from being shut out of one of the country’s largest markets. Small retailers, they argued, would potentially have to lay off employees and close. The plaintiffs further noted that menthol cigarettes make up about a third of the cigarette market and are disproportionally smoked by people of color, suggesting that that group would suffer disproportionally from a flavor ban.

    In their Supreme Court brief, state officials urged the justices not to delay the law any longer. “The unsuccessful referendum campaign has already delayed the implementation” of the law for nearly two years, they wrote, “allowing children and teenagers across the state to be initiated into the deadly habit of tobacco use via flavored tobacco products throughout that period.”

    Previously, the 9th Circuit Court of Appeals denied the tobacco companies’ request to block the law pending appeal.

    Industry critics welcomed the Supreme Court ruling. “The tobacco companies’ battle against the California law shows once again that they haven’t changed and are lying when they claim to care about anything other than their bottom line,” said Matthew L. Myers, president of the Campaign for Tobacco-Free Kids, in a statement.

    The California flavor ban applies to flavored e-cigarettes, menthol cigarettes and flavored cigars but exempts loose-leaf tobacco, premium cigars and shisha tobacco.

    The state joins Massachusetts and the District of Columbia in ending the sale of flavored tobacco products, including flavored e-cigarettes, menthol cigarettes and flavored cigars. Three other states—New Jersey, New York and Rhode Island—prohibit the sale of flavored e-cigarettes. With local laws included, 25 percent of the U.S. population will now be covered by laws ending the sale of flavored e-cigarettes.

  • FDA Urged to Expand Menthol Ban

    FDA Urged to Expand Menthol Ban

    Image: Tobacco Reporter archive

    The U.S. Food and Drug Administration should extend the ban on menthol cigarettes to other products, like pipe tobacco and cigarette tubes, according to researchers at the Rutgers Center for Tobacco Studies and Ohio State University, reports EurekAlert!.

    “Tobacco companies have rebranded their roll-your-own cigarette tobacco as pipe tobacco to avoid taxes and rebranded flavored cigarettes as flavored cigars to skirt a federal ban,” said Andrea Villanti, deputy director of the Rutgers Center for Tobacco Studies and co-principal investigator of a study published in Tobacco Control discussing the addiction potential of menthol cigarette alternatives. “We have already seen companies advertising pipe tobacco and cigarette tubes alongside cigarettes and filtered cigars. The products we tested in our study are likely to be products that tobacco companies will promote following a ban on menthol cigarettes.”

    Research showed that mentholated pipe tobacco and tubes in a roll-your-own cigarette were the most appealing substitutes for menthol cigarettes and resulted in the highest number of indicators for future nicotine addiction. The proposed menthol ban does not include these products, however.

    “The present findings suggest that components of menthol roll-your-own products, including menthol rolling papers, cigarette tubes and pipe tobacco, should be included in the menthol cigarette and flavored cigar product standards,” said Theodore Wagener, director of the Center for Tobacco Research at the Ohio State University Comprehensive Cancer Center—Arthur G. James Cancer Hospital and Richard J. Solove Research Institute and corresponding author of the study. “Their absence from this restriction will result in a critical loophole that is already being exploited by the tobacco industry and has the potential to lessen the potential public health benefits of the proposed menthol ban.”

  • Menthol Use Up Among U.S. Adult Smokers

    Menthol Use Up Among U.S. Adult Smokers

    Photo: New Africa

    Menthol use has increased over the past decade among U.S. adult smokers, according to a study released by Columbia University Mailman School of Public Health and The City University of New York. Menthol use is much more common among adult smokers who are younger, from racial/ethnic minoritized groups and with mental health problems. The results are published in the journal Nicotine and Tobacco Research.

    According to the study, menthol use was common among approximately two out of five cigarette smokers overall. Over 80 percent of Black smokers preferred menthol in 2020, which is stable relative to prior reports. “That approximately 50 percent of smokers who were Hispanic, female, ages 18–25 and 26–34, lesbian/gay and adults with mental health problems, used menthol in 2020 is higher than previously reported and suggests use has expanded across all segments of the population of adults who smoke cigarettes,” noted said Renee D. Goodwin, who works in the department of epidemiology at Columbia Mailman School, in a statement.

    To estimate trends in menthol use among adults who smoke cigarettes by sociodemographic, mental health and substance use variables, the researchers analyzed nationally representative annual, data from 128,327 individuals ages 18 and older residing in the U.S. from the 2008–2019 and 2020 from the National Survey on Drug Use and Health (NSDUH). Depression was assessed using the DSM-IV criteria for a major depressive episode.

    There was a significant overall increase in menthol cigarette use among adults smoking cigarettes from 34 percent in 2008 to 41 percent in 2019. In 2020, 43 percent of adults who smoked cigarettes in the past month used menthol. Menthol use was most common among Black adults (80 percent). Over 50 percent of Hispanic, female, young (ages 18–34), lesbian/gay, with serious psychological distress, and with cigar use also used menthol. Menthol use grew more rapidly among adults, among Hispanics, light cigarette users (1–5 per day) and those who smoked cigars.

    A notable finding was the increase and majority menthol use among Hispanic adults over the study period (34 percent in 2008 to 48 percent in 2019) and 51 percent in 2020, with a more rapid increase among Hispanic compared with Non-Hispanic white smokers. “Until now, there was a lack of research in this area,” observes Goodwin, who offers a number of possible explanations for the increased popularity of menthol cigarettes among Hispanic smokers. “For one, there is evidence of greater marketing of menthol cigarettes to Hispanic adults.”

    “Our study shows persistent and unmitigated inequities in menthol use among tobacco use disparity group members in particular,” said Goodwin. “Data from 2020 demonstrate that the increase in menthol use among smokers over the past decade was broadly evident across subgroups.”

    The Food and Drug Administration’s Center for Tobacco Products intends to ban menthol as a characterizing flavor in cigarettes. However, given the regulatory process required to issue a product standard and the potential for tobacco industry litigation, menthol cigarettes will likely remain on the market for a considerable amount of time.