Category: Flavors

  • FDA Urged to Deny All Flavored E-Cigarettes

    FDA Urged to Deny All Flavored E-Cigarettes

    Photo: Boki

    Seven leading public health, medical and parent organizations are urging the U.S. Food and Drug Administration to expedite decisions on remaining marketing applications for e-cigarettes and promptly deny applications for all flavored e-cigarettes, including menthol-flavored products.

    The organizations say they are concerned about these products’ appeal to youth and the adverse impact on public health.

    In a letter to acting FDA Commissioner Janet Woodcock, the groups also urged the FDA to prioritize enforcement against unauthorized flavored e-cigarettes with the largest market shares and products with the highest prevalence of youth use.

    The groups sending the letter are the American Academy of Pediatrics, American Cancer Society Cancer Action Network, American Heart Association, American Lung Association, Campaign for Tobacco-Free Kids, Parents Against Vaping E-Cigarettes and Truth Initiative.

    Since Sept. 9, the FDA has denied marketing applications for more than 1,167,000 products, but it has yet to issue decisions on e-cigarette brands with the highest market shares, such as Juul, Vuse, NJOY and blu, which make up over 78 percent of the market, according to Nielsen data.

    The health groups expressed particular concern that the FDA is still considering whether to authorize any menthol-flavored e-cigarettes and urged the FDA not to do so given the clear evidence that menthol is a flavor that appeals to and is widely used by kids.

    “Contrary to the FDA’s Aug. 26 statement that menthol e-cigarette products raise ‘unique considerations’ for purposes of FDA review, we do not believe there is anything ‘unique’ about menthol flavoring that would justify issuance of a marketing order,” the groups wrote in their letter. “Indeed, there is no question that when FDA decided to prioritize enforcement against cartridge-based e-cigarettes in flavors other than menthol and tobacco, youth shifted to using menthol-flavored products.”

  • Bidi Vapor to Market Product Despite MDO

    Bidi Vapor to Market Product Despite MDO

    Bidi Vapor will continue to manufacture and market its Artic (menthol) Bidi Stick in the United States despite receiving a marketing denial order (MDO) for the product, according to a trading update issued by Kaival Brands Innovations Group, the exclusive distributor of Bidi Vapor products.

    As of Sept. 10, the U.S. Food and Drug Administration has issued MDOs for some 992,000 electronic nicotine-delivery system (ENDS) products from 168 companies. Bidi Vapor received an MDO for its nontobacco flavored Bidi Sticks, including its Artic (menthol) Bidi Stick.

    The company, however, insists the FDA mischaracterized the Artic (menthol) Bidi Stick as flavored. Because its Arctic Bidi Stick is menthol, Bidi Vapor believes that this product is not subject to the MDO.

    “This position is aligned with the FDA’s public statements and press releases stating that tobacco and menthol ENDS are not deemed flavored products subject to the MDOs,” the company wrote in a press note. “Accordingly, along with the Classic (tobacco) Bidi Stick, Bidi intends to continue to manufacture and market its Arctic (menthol) Bidi Stick for distribution by us.”

    The company, which has historically derived nearly all its revenues from sales of flavored Bidi Sticks, appears willing to accept the risk of enforcement.

    “If the FDA disagrees with Bidi Vapor’s position, issues a warning letter or takes other action against Bidi Vapor resulting in us not being able to distribute the menthol (Arctic) Bidi Stick in the United States, or consumers do not purchase the tobacco (Classic) or menthol (Arctic) Bidi Sticks, our revenues and, thereby our financial results and condition, would be materially adversely affected,” Kaival Innovations Group wrote in its news release.  

    For the three and nine months ended July 31, 2021, the Arctic (menthol) Bidi Stick constituted approximately 15.2 percent and 18.5 percent, respectively, of the company’s total Bidi Sticks sales.

  • Universal to Acquire Shank’s Extracts

    Universal to Acquire Shank’s Extracts

    Photo: Africa Studio

    Universal Corp. has entered into a definitive agreement to acquire Shank’s Extracts, a privately held specialty ingredient, flavoring and food company with bottling and packaging capabilities. Following the close of the transaction, Shank’s will operate as part of Universal’s plant-based ingredients platform, which includes the previously acquired companies Silva International and FruitSmart.

    Founded in 1899, Shank’s has established a strong presence within the flavoring, extracts and bottling marketplace, with significant vanilla expertise. In addition to pure vanilla extract products, Shank’s offers a robust portfolio of over 2,400 other extracts, distillates, natural flavors and colors for industrial and private label customers worldwide. Headquartered in Lancaster, Pennsylvania, USA, Shank’s employs more than 200 people and has a 191,000-square-foot manufacturing campus.

    “This agreement with Shank’s marks another important step forward in Universal’s efforts to identify and execute on opportunities that broaden and enhance our plant-based ingredients platform,” said George C. Freeman III, chairman, president and CEO of Universal Corp, in a statement. “The Shank’s acquisition fits squarely in our new platform and our capital allocation strategy, bolstering our offerings for customers and expanding our value-added services by adding flavors, custom packaging and bottling, and product development capabilities.” 

    “Shank’s has been providing high-quality products and services for more than 120 years, earning a reputation for consistency, traceability and dependability. This has allowed us to build a strong portfolio of long-tenured, blue-chip customers. As part of Universal Corporation, Shank’s will benefit from the resources and scale of a global organization as we look to expand our offerings and enter new, lucrative end markets,” said Jeffrey Lehman, president-owner of Shank’s.

    Universal Corporation expects the transaction to close in the calendar-year fourth quarter, subject to customary closing conditions, and anticipates the acquisition will be accretive to earnings in fiscal year 2023. Following the close of the transaction, the existing management team will continue to run the business and report to J. Patrick O’Keefe, senior vice president of Universal Global Ventures.

  • ‘Menthol Ban Would Save 650,000 Lives’

    ‘Menthol Ban Would Save 650,000 Lives’

    David Levy

    Banning menthol flavors in cigarettes could reduce smoking by 15 percent by having smokers giving up tobacco products altogether or switching to e-cigarettes and other nicotine vaping products—avoiding 16,250 tobacco-related deaths per year by 2060, according to a new University of Michigan study.

    The report supports the April 2021 announcement by the U.S. Food and Drug Administration of its intention to ban menthol cigarettes and cigars nationwide. The menthol ban would not affect e-cigarettes or other flavored products. Published in Tobacco Control, the study notes that additional measures such as increasing taxes on cigarettes and cigars could further reduce smoking and related deaths.

    “This work is the culmination of a series of sequential projects aimed to assess the impact that a menthol ban could have on smoking, tobacco use and downstream health effects,” said Rafael Meza, one of the authors of the study and a professor of epidemiology at the University of Michigan’s School of Public Health. “Our findings show that a menthol ban could result in considerable health gains and highlight the urgency for final approval and implementation of the ban.”

    The study is based on the data analysis and computational modeling infrastructure that the researchers have assembled as part of the Center for the Assessment of Tobacco Regulations. Researchers used the Smoking and Vaping Model, a simulation model they had previously developed to reflect recent cigarette and vaping products and incorporated current trends in the use of menthol and nonmenthol cigarettes.

    Then, the researchers developed a scenario with a menthol ban starting in 2021, informed by expert assessment of the potential impacts, and estimated the public health impact as the difference between smoking and vaping attributable deaths and life-years lost in the current and the menthol ban scenarios, between 2021–2060.

    They found that with a menthol ban, combined menthol and nonmenthol cigarette smoking would decline by 15 percent by 2026. Deaths attributable to smoking and vaping were estimated to fall by about 5 percent and life-years lost by 8.8 percent—translating to 16,250 deaths per year averted and 11 million life-years gained (almost 300,000 per year) over a 40-year period.

    “Recent evidence finds that a menthol ban would likely increase smoking cessation, with more limited evidence of reducing smoking initiation and switching from smoking to other products like e-cigarettes,” said David Levy, professor of oncology at Georgetown University and lead author of the paper.

    The researchers said that the effects of a menthol ban will also depend on other tobacco control policies. In particular, higher cigarette taxes would reduce smoking initiation and increase cessation, and increased enforcement of age 21 purchase laws would likely reduce smoking initiation. However, a menthol ban is likely to be very effective as a standalone policy, they said.

    The work was conducted by the Center for the Assessment of Tobacco Regulations, one of nine Tobacco Centers for Regulatory Science funded by the FDA/NIH.

  • Filter: FDA Denies Additional 800 Products

    Filter: FDA Denies Additional 800 Products

    Photo: Boki

    The Food and Drug Administration on Aug. 31 denied the premarket tobacco product applications for 800 vaping products from three e-liquid manufacturers, according to Filter. The marketing denial orders have not been published on the agency’s website.

    Earlier in August, the FDA announced its first outright denial of 55,000 flavored vaping products from three other companies. Prior to that, the FDA refused to file 4.5 million of the 6.5 million applications sent to the agency because the company that put them together did not include appropriate environmental assessments for each product.

    All of the products rejected on Aug. 31 were flavored, and consumer advocates and manufacturers are worried that the FDA is moving toward an effective flavor ban.

    According to industry consultant Dimitris Agrafiotis, the applications he helped the three companies file were unfinished. The companies had intended to send more data piecemeal to the agency as substantial product stability testing wrapped up. Just last week, his clients drafted a letter to the FDA, stating that they would be sending further information.

    Agrafiotis said that each company he represents is now moving into the synthetic nicotine space, a legal gray area. The FDA defines a “tobacco product” as anything “made or derived from tobacco that is intended for human consumption, including any component, part or accessory of a tobacco product.”

    The FDA has until Sept. 9 to determine the legality of other vaping products, though the agency has signaled it will rule on the major players but not complete the process for everybody else by then.

  • FDA Urged to Deny All Flavored Vapes

    FDA Urged to Deny All Flavored Vapes

    Photo: Brian Jackson

    The Campaign for Tobacco-Free Kids (CTFK) reiterated its call for banning all flavored vapor products following the U.S. Food and Drug Administration’s denial of marketing applications for about 55,000 flavored e-cigarette products.

    While welcoming the FDA decision, the CTFK noted the denial involved only a small percentage of the flavor products under review by the FDA. 

    “The FDA’s action covers just a fraction of the more than 6.5 million tobacco products for which the FDA has received marketing applications, and it does not include any e-cigarette brands with a significant market share or that are most popular with kids, such as Juul, the number one youth brand,” CTFK President Matthew L. Myers wrote in a statement.

    “Today’s action will be effective in reversing the youth e-cigarette epidemic only if FDA also denies the applications for all flavored e-cigarettes (those with flavors other than tobacco) as well as high-nicotine products like Juul that put kids at risk of addiction.”

    According to the 2020 National Youth Tobacco Survey, 3.6 million kids use e-cigarettes, including nearly one in five high school students. The CTFK blames flavored e-cigarettes for this situation. Eighty-three percent of youth e-cigarette users report using flavored products, and 70 percent of youth users say they use e-cigarettes because of the flavors, according to the organization.

    “To protect our kids and end the youth e-cigarette epidemic, the FDA should not authorize the sale of any flavored or high-nicotine e-cigarettes,” wrote Myers.

    The FDA must decide whether to grant marketing applications for e-cigarettes by Sept. 9.

  • ‘FDA Unlikely to Include ENDS in Menthol Ban’

    ‘FDA Unlikely to Include ENDS in Menthol Ban’

    Photo: makcoud

    The U.S. Food and Drug Administration is unlikely to incorporate electronic nicotine-delivery devices (ENDS) into its proposed rulemaking to ban menthol cigarettes and flavored cigars, according to Azim Chowdhury and Neelam Gill.

    Azim Chowdhury

    Writing on the Food and Drug Law Institute’s website, the Keller and Heckman attorneys say that doing so would only further complicate a rulemaking that is already poised to receive hundreds of thousands of comments and will likely be litigated once final.

    On April 29, 2021, the FDA announced that it will initiate a notice and comment rulemaking process to ban menthol-flavored cigarettes and all characterizing flavors in cigars and cigarillos within the next year.

    In its announcement, the FDA did not mention ENDs, which come in a wide variety of nontobacco flavors and have been the subject of much debate.

    Chowdhury and Gill believe Congress is more likely to defer to the premarket tobacco product application (PMTA) process rather than intervene and legislate a flavored ENDS ban. All ENDS products require FDA marketing authorization through that process.

    But while a federal ban on flavored ENDS seems unlikely while FDA reviews the science and the manufacturers’ arguments, these products continue to face the threat of prohibition at the local level, according to the attorneys.

    Many state and local authorities and attorneys general are pushing for bans or have requested the FDA to deny PMTAs for flavored ENDS. New York, New Jersey, Rhode Island and Massachusetts have already banned the sale of flavored ENDS while Maryland, California and Connecticut are considering similar measures.

  • Study: Vapor Flavor Ban Would Boost Smoking

    Study: Vapor Flavor Ban Would Boost Smoking

    Photo: kurgu128

    If vapor product sales were restricted to tobacco flavors, one-third of U.S. vapers between the ages of 18 and 34 would switch to smoking combustible cigarettes, according to a new study in Nicotine & Tobacco Research.

    The study analyzed data from February to May 2020 and looked at 2,159 young adults in Atlanta, Boston, Minneapolis, Oklahoma City, San Diego and Seattle, examining support for e-cigarette sales restrictions and the perceived impact of flavor and vaping bans.

    This study precedes the FDA’s impending Sept. 9 deadline for premarket tobacco product application (PMTA) decisions, which could potentially take most vapor products off the market.

    The FDA’s deadline will be “like watching an unstoppable object hit an immovable wall,” said Charles Gardner, executive director of INNCO, a global nonprofit supporting the rights of adults using safer nicotine products. “The FDA must know flavor bans will increase teen, young adult and older adult smoking.”

    “In general, the FDA does not comment on specific studies but evaluates them as part of the body of evidence to further our understanding about a particular issue and assist in our mission to protect public health,” an FDA spokesperson said.

    Two other recent studies showed similar results. A study in JAMA Pediatrics showed that following San Francisco’s flavor ban, teens were more likely to smoke than those in other school districts. A different study in Nicotine & Tobacco Research shows that teens who vape would be smoking cigarettes if vapes hadn’t become available.

    “All hell will break loose if [the FDA] authorize[s] flavors as ‘appropriate for the protection of public health,’” said Gardner. “The Truth Initiative and the Bloomberg-funded Campaign for Tobacco-Free Kids have staked their reputations on the public health benefits of flavor bans. And many key leaders in the U.S. Congress believe them.”

  • U.K. Retailers “Missed” in Menthol Buyback

    U.K. Retailers “Missed” in Menthol Buyback

    Photo: Miriam Doerr | Dreamstime.com

    U.K. retailers say tobacco companies have “missed” significant volumes of now-illicit menthol cigarettes during the initial returns phase following the country’s ban on such cigarettes.

    The U.K. prohibited sales of menthol cigarettes on May 20, 2020. Prior to the ban, tobacco companies pledged to take back and credit retailers for any noncompliant stock remaining once the legislation came into force.

    However, six retailers across England told Better Retailing that they still have menthol brands from Philip Morris Limited (PML) and British American Tobacco U.K., with some holding stock with a combined value worth several hundreds of pounds.

    BAT U.K. said it carried out a significant menthol pack return exercise from September to December 2020. “Despite our best efforts, some of our retail partners appear to have been missed in this initial returns phase; we are sorry for any inconvenience caused,” a BAT spokesperson said, adding that a second returns phase would be introduced at the end of this year.

    PML said it introduced a nationwide “buy-back” scheme from May to July 2020, which covered all plain packaging products with duty paid.

  • That Fleeting Scent

    That Fleeting Scent

    Photo: kasetch

    The FDA’s proposed ban on menthol cigarettes and cigars remains highly controversial.

    By Stefanie Rossel

    Almost exactly a year after the European Union imposed a ban on the manufacture and sale of menthol cigarettes, the U.S. Food and Drug Administration said it would ban menthol as a characterizing flavor in cigarettes and cigars at the federal level. With the move, the agency hopes to significantly reduce youth initiation to smoking, increase the chances of smoking cessation among current smokers and address health disparities experienced by communities of color, low-income populations and LGBTQ+ individuals, all of whom are more likely to use these tobacco products, according to acting FDA Commissioner Janet Woodcock.

    The proposed ban, announced on April 29, has been under discussion for more than a decade. While the 2009 Family Smoking Prevention and Tobacco Control Act (TCA), which gave the FDA regulatory authority over tobacco products, banned all characterizing flavors in cigarettes, it allowed the continued use of menthol cigarettes but instructed the agency to consider what to do about the additive. The FDA’s recent decision was forced by a federal lawsuit brought by public health groups in 2020 after the agency failed to respond to their 2013 petition, which called on the FDA to ban menthol products.

    Menthol can be extracted from mint plants or made synthetically. In tobacco, it is used to mask the harshness and irritation caused by cigarette smoke. The minty flavor creates a cooling, slightly anesthetic sensation, which, according to a 2013 FDA report, makes cigarettes more appealing to new smokers, thus getting them more easily addicted. The substance is also believed to increase the degree of addiction; menthol smokers are reportedly less likely than nonmenthol smokers to successfully quit smoking despite having a higher urge to end their tobacco dependence. Around the globe, mentholated smokes account for about 10 percent of cigarette consumption, according to the World Health Organization.

    In the U.S., menthol cigarettes represented 36 percent of all cigarette sales in 2018, according to the Centers for Disease Control and Prevention. Although U.S. smoking prevalence has dropped below 40 million, the share of mentholated cigarettes has risen significantly after the TCA prohibited all other characterizing flavors.

    What makes the FDA’s proposed ban controversial is the fact that menthol cigarettes are also considered a racial justice issue in the U.S. According to the 2019 National Survey on Drug Use and Health, 85 percent of African American smokers smoke menthol cigarettes compared to 30 percent of white smokers and compared to less than 10 percent of African American smokers in the 1950s—a situation that critics attribute to racially targeted marketing strategies by the tobacco industry. African Americans typically smoke fewer cigarettes and start smoking at an older age than white smokers, but they die from tobacco-related illnesses at much higher rates, CDC data indicates.

    Menthol cigarettes also appeal to Hispanic (48 percent) and Asian (41 percent) smokers, according to the survey, whereas about half of smokers aged 12–17 smoke menthols compared with about 40 percent for smokers aged 18 and older. With a market share of 49 percent, menthol cigarettes also featured prominently in in the LGBTQ+ community.

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    Great Expectations

    The FDA expects its proposed ban to have a significant impact. A Canadian study quoted by the agency suggests that the measure would prompt an additional 923,000 U.S. smokers to quit, including 230,000 African Americans, in the first 13 months to 17 months after taking effect. According to an earlier study, such a measure would avert 633,000 premature deaths, including 237,000 African American deaths.

    While many public health and civil rights groups welcomed the FDA’s decision, lauding it as a win for both public health and racial justice, critics cast doubt on the health effects and warned that it could create more problems for minorities.  

    “In this country, we have found out that prohibition doesn’t work,” says Jeff Stier, senior fellow at Taxpayers Protection Alliance. “The ban is supposed to protect African American smokers, but they are likely to switch to a different, nonmenthol combustible cigarette brand or buy their mentholated cigarettes on the black market. We already have a pretty active illicit market; a ban would make it even worse.”

    In the view of some civil rights organizations, a ban on menthol would create new, unwelcome opportunities for negative interactions between law enforcement and Black Americans.

    The FDA plans to implement its ban by 2022, but experts expect a flood of lawsuits from the tobacco industry. Apart from a long fight regulators may face in court, along with resistance in Congress, most notably from tobacco-state lawmakers, the process of shaping respective legislation is likely to take time as it will comprise two detailed proposals that are open to public comments and will then be reviewed by the White House. When the FDA last proposed to ban menthol cigarettes in 2013, it received 174,000 public comments. The agency is obliged by law to read every single one and consider them carefully.

    Questionable Effect

    While several countries, including Brazil and Turkey, have banned menthol cigarettes over the past decade, data on the impact of the measure remains scarce. Studies from Canada show that smokers of menthol cigarettes were considerably more likely to quit their habit altogether after that country banned menthol cigarettes nationwide in 2017. A more recent study by the National Bureau of Economic Research in Cambridge, Massachusetts, USA, however, concludes that there was “almost no direct evidence on [the] effects” of a menthol cigarette ban “using real-world policy variation.” The study also found that many youths switched to nonmenthol cigarettes and that many adults started buying their menthol cigarettes from Native Canadian reserves, which are exempted from the ban. With a pre-ban market share of 5 percent, the Canadian menthol cigarette market is also more like that of the EU, where menthol cigarettes account for 7 percent of all cigarette sales, than that of the U.S.

    The EU prohibited the manufacture and sale of menthol cigarettes in May 2020. The ban extends to the sale of rolling tobacco with mentholated filters or papers. Exempted from the ban are menthol-flavored e-liquids for vape products, separately available mentholated smoking accessories, menthol-flavored oral nicotine pouches and cigarillos. Outside of Germany, mentholated consumables for heated-tobacco products (HTPs) also remain legal.

    Cigarette manufacturers responded with innovative solutions to the ban. Apart from broadening their portfolios of menthol-flavored and mint-flavored reduced-risk products (RRPs), they introduced mentholated flavor cards, which smokers could buy separately to mentholate conventional cigarettes. Tobacco companies also started offering cigarillos with mentholated filter capsules. Cigarillos are exempt from the EU ban as they are wrapped in tobacco leaf.

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    Choosing Alternatives

    To determine whether the EU ban met its objective of discouraging people from smoking or encouraging them to quit, Euromonitor International, on behalf of the Foundation for a Smoke-Free World, surveyed more than 6,000 adult menthol cigarette smokers in eight EU countries before and after the menthol cigarette ban. While the pre-ban surveys queried awareness and intention to quit or switch, the post-ban surveys queried behavior.

    Main takeaways of the surveys included a lower rate of quitting smoking completely (8 percent) than indicated in the pre-ban survey (12 percent) and higher use of products that allow consumers to manually add a flavor to regular tobacco products. Thirteen percent of respondents said they had started buying products such as menthol flavor cards or menthol filter tips after the ban as opposed to 8 percent who had the pre-ban intention to do so.

    Thirty percent of respondents said they had reduced consumption of menthol cigarettes after the ban. Twenty-eight percent indicated they had stopped smoking menthol cigarettes but continued to consume regular cigarettes (pre-ban intention: 35 percent). Twelve percent said they had stopped consuming menthol cigarettes after the ban but increased their consumption of nonmenthol cigarettes (pre-ban intention: 13 percent). Eighteen percent stated post-ban they had switched to other menthol products not affected by the ban, such as menthol cigars, cigarillos, e-cigarettes and HTPs (pre-ban intention: 19 percent).

    Thirteen percent had started buying menthol cigarettes from other sources (pre-ban intention: 12 percent), more precisely from friends or family who had travelled to countries where menthol cigarettes were still legal or from online retailers shipping from other countries.

    Interestingly, when unprompted, only 43 percent of respondents considered menthol cigarettes to be illegal in the post-ban surveys. While 10 percent were unsure of the legal status of menthol products, 27 percent still believed them to be legal or to be banned in the future (20 percent).

    Harm Reduction Instead of Prohibition

    Interestingly, the EU menthol ban appears to have nudged smokers a bit toward less hazardous forms of nicotine consumption. Of the 18 percent of respondents who said they had switched to other menthol products not affected by the ban, the majority chose RRPs. On average, 57 percent of respondents said they had switched to e-cigarettes, with the highest percentages being observed in Poland (67 percent) and the U.K. (57 percent), two markets with high vaping prevalence. Overall, 12 percent of switchers indicated they had switched to nicotine-replacement therapy products.

    It’s a development Stier would like to see in the United States, which has yet to fully embrace the concept of tobacco harm reduction by promoting products such as e-cigarettes and snus as safer alternatives to combustible cigarettes. “Instead of going back to prohibition that will bring about unintended consequences, we should encourage smokers, as they do in the U.K., to quit smoking and switch to lower risk vape products. The FDA is sitting on applications to authorize these e-cigarettes now. Instead of banning products the African American community smokes, it should undo the misperceptions surrounding RRPs, offer better alternatives and be truthful about the risks,” he says.

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