Tag: flavor ban

  • FDA Grants $3.9 Million to Study Effects of Flavors

    FDA Grants $3.9 Million to Study Effects of Flavors

    Image: Tobacco Reporter archive

    The U.S. Food and Drug Administration has given the Center for Tobacco Research at The Ohio State University Comprehensive Cancer Center a $3.9 million grant to evaluate the effects of e-cigarette flavors on smoking behaviors of current adult smokers, according to News Medical Lifesciences.

    The study will be co-led by Theodore Wagener, director of Ohio State’s Center for Tobacco Research, and Tracy Smith from the Medical University of South Carolina Hollings Cancer Center.

    Wagener says, “the FDA must decide how to balance its goals of protecting young people and offering harm-reduction options to adults. This new trial will generate critical data to help make more informed public health decisions that have a lasting impact.”

    “The FDA is currently making regulatory decisions about e-cigarette flavors with incomplete scientific data,” Wagener said. “Existing data show that smokers also prefer flavored e-cigarettes, and while there are a few survey studies suggesting that flavored e-cigarettes may be more helpful for switching to vaping, these studies are not rigorous enough for the FDA to base its regulatory decisions on. Our study will be the first to provide the FDA with definitive information as to the benefit, if any, of e-cigarette flavors to adult smokers.”

    The national, randomized, controlled trial will recruit up to 1,500 cigarette users from across the country, and researchers will measure e-cigarette flavor impact on product uptake and appeal, cigarette craving, symptoms, dependence and smoking behavior. Combination nicotine-replacement therapy will be used as a comparator to determine potential increased benefit of e-cigarettes versus nicotine-replacement therapy.

    “If our study demonstrates no significant improvements in switching with flavored e-cigarette use, then the continued sale of these products is likely indefensible; however, if improvements are significant, these findings will provide a critical counterweight to the current FDA regulations and will aid future decision-making,” Wagener said.

  • Germany Readies to Ban Flavored Vape Products

    Germany Readies to Ban Flavored Vape Products

    Image: Tobacco Reporter archive

    The German Bundesrat approved a third amendment to the Tobacco Products Act, which would ban flavored heated-tobacco products, according to Dokumentations und Informationssytem fur Parlamentsmaterialien.

    The amendment includes “alignment of EU rules banning flavorings and distinctive flavors in heated-tobacco products; definition of the heated-tobacco product and its classification as a smoking tobacco product or smokeless tobacco product, extended labeling requirements in the form of combined text and image warnings and an information message, extension of the ban on placing cigarettes and roll-your-own tobacco with a characteristic flavor on heated-tobacco products; [and] amendment of various sections of the Tobacco Products Act,” according to the German Bundestag website.

  • New York City Accuses Vape Distributors of Racketeering

    New York City Accuses Vape Distributors of Racketeering

    Credit: Maria Kray

    New York City has filed a lawsuit in federal court charging four vaping product distributors and six persons associated with the companies for illegally selling flavored vaping products other than tobacco in the city. It is possible more companies will be added to the suit.

    The civil lawsuit, filed Monday in the U.S. District Court for the Southern District of New York, claims the defendants violated “nearly every federal, New York State and New York City law applicable to the marketing, distribution, and sale of flavored e-cigarettes, the sales of which are prohibited under laws enacted by all three jurisdictions.”

    Named in the suit are Magellan Technology Inc., Ecto World LLC (Demand Vape), Mahant Krupa 56 LLC (Empire Vape Distributors) and Star Vape Corp. Also named were Matthew Glauser, Donald Hashagen, Russell Rogers, Nikunj Patel, Devang Koya and Nabil Hassen. The suit also mentions Puff Bar, Elf Bar and Hyde products, however, those manufacturers were not named in the suit.

    The lawsuit alleges the defendants committed mail and wire fraud, alongside violations of New York City’s Administrative Code, New York State Public Health Law, and the federal Tobacco Control Act. The city also accuses the companies of violating both the federal Racketeering Influenced Corrupt Organizations (RICO) Act and the Prevent All Cigarette Trafficking (PACT) Act.

    The suit centers on disposable flavored vapes. However, the suit alleges that is seeking relief for any type of flavored e-cigarette product on the market. This would suggest the suit could grow into anyone entity that has sold flavored vaping products in the city.

    “Although this action speaks principally about (flavored disposables), the favorite type of electronic
    nicotine delivery system among youth and the most intentionally directed to that market, the City
    seeks relief for defendants’ violation of laws applicable to e-cigarettes regardless of the type of
    device with which the violation is committed,” the suit states. “Any non-FDA approved [the FDA authorizes for marketing; it does not approve products] e-cigarette containing a flavored e-liquid is governed by the laws under which the City’s claims are brought and the City seeks relief with respect to all such devices.”

    The city says it “seeks to recover monetary damages and civil penalties from the defendants, potentially totaling millions,” according to a press release. The suit also alleges the sales of disposable flavored vapes created a youth use crisis. The suit alleges the largest increase in youth use ever. The claim is unsupported by any facts.

    “By distributing devices that provide larger than normal doses of nicotine in a mild aerosol formulated to reduce or eliminate the harshness of burning tobacco and tasting pleasantly of fruit, candy or desserts, FDV manufacturers and distributors have triggered the largest increases in youth nicotine use ever seen,” the suit claims.

    The lawsuit states the city will seek triple the damages awarded at trial under the RICO law guidelines.

  • U.S. FDA Drops MDO on Myblu Menthol E-Cigarettes

    U.S. FDA Drops MDO on Myblu Menthol E-Cigarettes

    The U.S. Food and Drug Administration has issued a marketing denial order (MDO) for myblu Menthol 2.4%. Fontem US, a subsidiary of Imperial Brands, is banned from marketing or distributing the product in the United States, or they risk enforcement action by FDA.

    The company may resubmit a new application to address the deficiencies of the product subject to this MDO, according to an FDA press release.

    “Thorough scientific review of tobacco applications is a key pillar under FDA’s role to protect the public from the dangers of tobacco use,” said Matthew Farrelly, director of the Office of Science within the FDA’s Center for Tobacco Products. “This application lacked the scientific evidence needed to demonstrate that the product provided a net benefit to the public health that outweigh the known risks.”

    The FDA evaluates premarket tobacco product applications (PMTAs) based on a public health standard that considers the impact of the product on the population as a whole, including benefits (i.e., complete transitioning to the product or significant reduction in combustible cigarette use among adults who smoke) and risks (e.g., initiation among youth).

    “After reviewing the company’s PMTA, FDA determined that the application lacked sufficient evidence to demonstrate that permitting the marketing of the product 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,” the release states. “For example, among other deficiencies, the application did not present sufficient scientific evidence to show the menthol-flavored e-cigarette products provided an added benefit for adults who smoke relative to tobacco-flavored e-cigarettes.”

    The FDA has not authorized for sale of any flavored vaping product other than tobacco. Fontem is expected to challenge the denial order in court.

    In April of last year, The FDA issued MDOs to several myblu brand products manufactured by Fontem US. Fontem Ventures, a subsidiary of Imperial Brands PLC, owns the global e-cigarette brand blu.

  • Flavored Vape Ban in Ukraine Begins Tomorrow

    Flavored Vape Ban in Ukraine Begins Tomorrow

    Credit: Billion Photos

    A ban on advertising e-cigarettes in Ukraine, including heated-tobacco products, goes into effect on July 11. Flavored electronic nicotine-delivery systems (ENDS) products are also banned.

    The advertising rule applies to all types of media, including the Internet, social media, public transportation, and public events.

    “The advertising, sales promotion and sponsorship of electronic cigarettes, liquids used in them, and devices for consumption of tobacco products without burning them (including IQOS and glo devices) will be prohibited from 11 July 2023,” according to the WHO Framework Convention on Tobacco Control (FCTC).

    “Flavored cigarettes and flavored liquids for ENDS will also be banned at that date. Further, from 11 January 2024, the combined textual plus pictorial warnings will be required to cover 65 percent of both sides of the pack of smoking tobacco products (conventional cigarettes).”

    The fine in the case of a violation is UAH30,000 ($812), and for each subsequent violation – UAH50,000. In addition, similar to the general smoking ban, the law prohibits the use of heated tobacco products in all public places and businesses.

    In 2021, Ukrainian lawmakers passed the law prohibiting the use of ENDS in public places as well as advertising, sponsorship, and promotion of e-cigarettes. The law also bans the sale of flavored e-liquids other than tobacco flavors.

  • New Louisiana Vape Law May be Defacto Flavor Ban

    New Louisiana Vape Law May be Defacto Flavor Ban

    Credit: Jet City Image

    Louisiana passed a law that raised taxes on nicotine e-liquids. However, the new rules could result in most vape products being taken off the shelves.

    The legislation, Act 414 by Rep. Paul Hollis, started out as a bill to increase the tax on vapes, with Hollis saying he wanted to discourage their use. But it quickly morphed into a broader law that dramatically scales back what vapes can be sold, after wholesalers, major tobacco companies and legislators concerned with youth use got involved.

    The law Edwards signed triples the tax on vape liquid from 5 cents per milliliter to 15 cents per milliliter and earmarks the revenue the tax will generate for pay raises for state troopers, according to NOLA.com.

    But the bigger impacts have to do with a new registry pushed by the major tobacco companies and large wholesalers.

    The law, which goes into effect in November, will require any vapes sold in Louisiana to be authorized by the U.S. Food and Drug Administration to be marketed in the U.S.

    Some other products could be sold if litigation is ongoing, but the state Office of Alcohol and Tobacco Control will be able to fine retailers for unapproved products.

    The new rules allow for only a handful of companies to sell vaping products in Louisiana, including R.J. Reynolds and Altria, major tobacco companies that sell Vuse and NJoy products, respectively.

    Both companies lobbied significantly on changes to the bill, including the registry.

    Effectively, the law could ban the vast majority of flavored vapes being sold in Louisiana. A wholesaler testified in a committee hearing that the list would tamp down on popular disposable vapes such as EscoBars, Puff Bars and Elf Bars, which have drawn the ire of regulators and lawmakers across the country.

    The FDA has cracked down on Elf Bars recently, telling retailers to stop selling them and halting imports.

    Hollis said Altria and Reynolds, along with wholesalers who argued the state was missing out on tax revenue by allowing retailers to bypass it and buy products from vape manufacturers, were among those who negotiated the final law.

    The new law now requires products to go through wholesalers.

    The law could also mean a de facto ban on flavored vapes because the FDA has not approved any flavored products other than tobacco. Reynolds, with its top-selling Vuse brand, only sells tobacco and menthol-flavored products.

    A Reynolds spokesperson said in a statement that “illegally marketed disposable” vapes, often imported from other countries, have “subpar regulatory oversight,” and that getting such products off the shelves will protect youth while allowing adult smokers options beyond combustible cigarettes.

    “The creation of a marketing order registry, and the state tax increase which will fund it, will help the public and retailers in assessing the legitimacy of vapor products before hitting the store shelves,” the company said. “Reynolds also urges the FDA to put together a list of products that can be legally sold in the US.”

    iMiracle, the maker of Elf Bars, said it was “concerned that the true objective of this law has been obscured from both the general public and Louisiana voters.”

    “Louisiana legislators should take a careful look at who promoted and who benefits from this legislation, and whether they want to limit their adult constituents’ access to harm-reduction products,” a company spokesperson said, adding it is evaluating the law’s “applicability and legality.”

    The state Office of Alcohol and Tobacco Control will be tasked with enforcing the new law by fining retailers who sell products not authorized by the FDA.

    ATC chief Ernest Legier said he hasn’t yet had time to closely review which products will be allowed, but that industry representatives have suggested as much as 60 percent of the products currently on the shelves could be removed.

  • Maine Senate Votes to Move Flavor Ban to House

    Maine Senate Votes to Move Flavor Ban to House

    Image: Tobacco Reporter archive

    The Maine Senate on Wednesday advanced a ban on flavored tobacco products, sending the bill down to the House for a potential vote today, reports WGME.

    The bill, which passed 18-16, if passed by the House, will ban the sale of flavors like mint, vanilla, fruits and menthol in vaping products.

    The ban does not include menthol combustible cigarettes.

    However, the bill will not penalize the use, purchase or possession of flavored products, only the sale by tobacco retailers.

    The ban seeks to make statewide prohibitions that are already in place in PortlandSouth Portland, Brunswick, Bangor and Bar Harbor have also voted for similar bans.

    A similar statewide effort failed last year when lawmakers adjourned without taking up the bill.

  • Criminal Reform Groups Push Back on Flavor Ban

    Criminal Reform Groups Push Back on Flavor Ban

    Image: Tobacco Reporter archive

    A coalition of more than 50 criminal justice reform groups sent a letter to U.S. President Joe Biden warning that the U.S. Food and Drug Administration’s proposed ban on flavored tobacco products will lead to overpolicing in communities of color, according to The Hill.

    Prohibition-style policies, like the one proposed, “have serious racial justice implications,” wrote the organizations, which include Blacks in Law Enforcement, the National Association of Criminal Defense Lawyers, the National Latino Officers Association and the Sentencing Project.

    “Banning the legal sale of menthol cigarettes through licensed businesses will lead—and, in fact, has already led in some states—to illegal, unlicensed distribution in communities of color while triggering criminal laws in all 50 states, increasing the incidence of negative interactions with police and ultimately increasing incarceration rates,” the letter said. “There are far better solutions for reducing menthol cigarette use than criminalizing these products and turning this issue over to the police.”

    The aim of the flavor ban is not only to make smoking less attractive but also to advance health equity, according to Health and Human Services Secretary Xavier Becerra

    “FDA has the power to provide smokers with less harmful options and information to help accelerate reductions in smoking,” the coalition wrote in its letter. “Rushing forward with a total ban without these alternatives in place contradicts everything we know—and everything the administration has been saying in other spheres—about why harm reduction works and criminalization doesn’t.” The coalition urged the FDA to reconsider the ban and find solutions opposed to criminalization.

  • Flavor Bans for Vapor and Heated Tobacco to Grow

    Flavor Bans for Vapor and Heated Tobacco to Grow

    man holding flavored vape products

    Bans on flavors in vapor and heated tobacco are likely to spread.

    By Barnaby Page

    Flavors are perhaps the biggest battleground of all in e-cigarette regulation—much more so than nicotine strength, for example. That may seem surprising on the surface given the widespread misperceptions of risk associated with nicotine itself (as opposed to smoking), but the underlying reason is revealing. Although occasionally there are other rationales associated with flavor bans (specific harmful ingredients, or a racial dimension in the case of menthol in the United States), nearly always the argument against flavors is a proxy for anxieties over youth vaping.

    To put it another way, if nobody thought that anyone other than adults would use mermaid-flavored caramel candy floss e-liquid, nobody would be very interested in banning it (and in fact, adult usage of these flavors is almost completely overlooked in the debate). It’s because kids use—or, more precisely, are perceived to be attracted by—these flavors that regulators, politicians, pundits and pressure groups pay so much attention to them.

    Underage vaping undoubtedly occurs; this is indisputable. Whether flavors (which in regulatory terms means nontobacco flavors) are in fact a significant driver of this is more debatable. It’s true that young people often use the more exotic flavors, but that doesn’t mean the nicotine users among them wouldn’t vape if those flavors weren’t available.

    Of course, those who are vaping nicotine-free flavored liquids presumably wouldn’t find nicotine-free tobacco-flavored liquid very appealing, and they probably wouldn’t vape at all if their favored flavors were unavailable. But these nicotine-free users are not the main concern.

    Similarly, it’s true that kids say they like the flavors they use. But this is hardly unexpected; nobody would use a flavor they don’t like. Again, it doesn’t conclusively point to what would happen in the absence of flavors, and this is an area where more research is needed—research that will become more viable on a large scale as more and more flavor bans are implemented.

    The results may prove to be unexpected: for example, work by Abigail Friedman at Yale suggests that the San Francisco flavor ban may have pushed young people not toward tobacco-flavored vapes but toward combustibles, and while one research project in one city is of course not the end of the story, it underlines the importance of looking at the real consequences of regulation in this area. If flavor bans do not keep kids away from nicotine, there is little purpose to them.

    For now, though, limiting flavors is rightly or wrongly seen as key to limiting youth vaping, and prohibitions are spreading worldwide—perhaps not as quickly as the heat of the conversation might suggest but steadily nonetheless.

    The United States is in an unusual situation here, partly because of the considerable autonomy enjoyed by sub-national levels of government compared with many other countries and partly because of slow movement by the Food and Drug Administration. There can be almost no doubt that the FDA would like to ban flavors; after all, it has even backed the idea of a menthol ban in combustibles, which is far more contentious than any restrictions on e-cigarette flavors, and seems likely to be preparing to finalize a rule to that effect this fall.

    Where vapor is concerned, there is no formal prohibition as such (though it is always conceivable that the anticipated combustibles ban could in fact cover all tobacco products), but a de facto ban on vapor flavors seems to have been in operation via the premarket tobacco product application (PMTA) process. To put it bluntly, flavored products don’t get through, and indeed this has been formally alleged by R.J. Reynolds Vapor Co. in a case against the FDA, as yet unresolved.

    In this context, it might seem odd that the FDA did grant modified-risk tobacco product (MRTP) status to menthol-flavored IQOS products from Philip Morris back in 2020—MRTP of course being an overt acknowledgment of reduced risk, not merely an authorization to sell like the PMTA. This might reflect the fact that youth usage is much less associated with heated-tobacco products like IQOS than with vapor; in fact, heated tobacco was barely known in the U.S. in 2020, has worldwide generally given rise to much less anxiety over underage use and is generally not found in the more unusual, supposedly youth-friendly flavors. Or it might simply be an anomaly. Either way, the IQOS decision seems unlikely to be any kind of precedent for a softening of FDA attitudes toward flavored vapor.

    In the absence of an official FDA rule, formal regulatory activity against flavored vape products in the United States has most significantly occurred at state level—for example, with bans in California, New Jersey, New York and Rhode Island, an almost complete prohibition in Massachusetts and heavy restrictions in Maryland and Utah. Some other states also instituted emergency bans in 2019 that have now ended. There has also been much activity at county and municipal level (most notably in California and Massachusetts and to a lesser extent in Minnesota).

    Elsewhere in the world, again partly reflecting the allocation of powers to national and sub-national governments, there are countrywide bans.

    Among those nations that allow e-cigarettes as a product category but ban flavors, China is potentially the most important given its sheer size. However, the Netherlands—a country where skepticism over vapor in official circles is high—has also received much attention, not least because it could pave the way for other European countries to follow suit. Finland has already passed a bill prohibiting flavors in all inhalable products, and we believe Norway is also likely to enact a vapor flavor ban; Belgium is another possibility, though one we consider less likely.

    Much of the forecasting in this article is drawn from the Tamarind Intelligence Policy Radar, which presents the regulatory situation in more than 50 markets for alternative tobacco products as it is today and as it is projected to be in five years. It monitors more than 150 bills and policies, many of which seek to substantially increase the regulatory burden on novel tobacco and nicotine products. Based on this, other countries where we see a vapor flavor ban as possible include Canada and Argentina, although the latter is a less likely contender.

    Other countries have taken steps toward banning flavors in all alternative products. Nations such as Spain, Belgium, Russia and the Czech Republic have raised concerns about flavors in new tobacco and nicotine products in their policies, which include, for example, national tobacco plans and health strategies. However, it should be noted that we forecast some of these first steps toward a flavor ban to have a low likelihood to medium likelihood of adoption. This may be because the measure has not been a pressing issue for a government faced with elections in the near future, as with Spain, or because the policy has remained stuck in the legislative process for years, as is the case with the bill in Belgium.

    Comprehensive bans like these could be expected to also cover heated tobacco. Some countries, however, may choose to treat it separately; among these, we think a ban is likely in Taiwan and possible in the United States.

    In terms of sheer number of countries, however, by far the most important limitation on heated-tobacco flavors is the European Union ban, which entered into force late last year via a European Commission directive.

    Such directives do not have automatic legal power in all 27 EU member states, but the individual countries are obliged to incorporate them into domestic law, a process known as “transposition,” which must in this case be completed by October (and which also applies to the European Economic Area members Norway, Iceland and Liechtenstein). When this is complete (and though the deadline could be missed in some cases, it will almost certainly be completed), heated-tobacco flavors will be banned across most of Europe, leaving the post-Brexit United Kingdom—the most friendly of all European nations toward reduced-risk nicotine products—as the major outlier where flavors are still permitted.

    In this context, the ongoing revision of the EU Tobacco Products Directive (TPD) itself is also noteworthy. It was the 2014 version of the TPD that laid the groundwork for the e-cigarette regulatory frameworks in all EU member states (at that point including the U.K.), for example with limitations on nicotine strength, and with the next incarnation of the directive currently being drawn up, there is at the very least a possibility that it could include a flavor ban for alternative products, including vapor.

    If that happens, it might well be enough to sway undecided countries outside the EU and persuade them to enact their own flavor bans—perhaps even the U.K. It is also possible that, amid environmental concerns about the sudden rise of disposables, “flavor” will become a proxy for “disposable” in exactly the same way it has been for “underage.”

    At the same time, it is always conceivable that some yet unknown nicotine-delivery technology might escape these prohibitions if there are no concerns about youth usage.

    But it is unlikely that bans that do come into force will be reversed, regardless of their outcomes; perception is often as important as reality in regulating this area. Though it hasn’t happened yet, the alternative nicotine products sector may be facing a flavorless future.

    Barnaby Page is the editorial director of Tamarind Intelligence, the publisher of ECigIntelligence, TobaccoIntelligence and CannIntelligence. As a journalist, he has been covering the worldwide reduced-risk nicotine sector since 2014, with a particular focus on public health and regulatory issues.In his current role, he manages Tamarind’s editorial and reporting teams, producing a wide range of nicotine-related content. He previously spent 30 years as a reporter and editor for newspapers, magazines and online services, specializing in technology and business. He is based near London, England.

    Tamarind Intelligence analysts Berta Camps Bisbal and Sergi Riudalbas also contributed research to this article.

  • Conference of Mayors Approves Flavor Ban

    Conference of Mayors Approves Flavor Ban

    Image: Tobacco Reporter archive

    At their annual meeting in Columbus, Ohio, the U.S. Conference of Mayors approved a resolution that supports prohibiting all flavored tobacco products, including flavored e-cigarettes, menthol cigarettes and flavored cigars.

    The Campaign for Tobacco-Free Kids (CTFK) welcomed the move. “We are grateful for the strong leadership provided by the sponsors of this resolution, including Mayors Andy Schor of Lansing, Michigan, Justin Bibb of Cleveland, Ohio, Satya Rhodes-Conway of Madison, Wisconsin, and Alix Desulme of North Miami, Florida,” said John Bowman, the CTFK’s executive vice president for U.S. programs, in a statement.

    According to the CTFK, youth e-cigarette use remains a public health crisis driven by flavored products. In 2022, over 2.5 million U.S. youth were current e-cigarette users, and 85 percent of them reported using flavored products.

    The resolution also supports prohibiting menthol cigarettes.