Category: Featured

  • Avail Loses MDO Case

    Avail Loses MDO Case

    Photo: Avail Vapor

    A U.S. court rebuffed Avail Vapor’s appeal of the Food and Drug Administration’s refusal to allow its products on the market, reports Reuters. The ruling is the latest in a series of court orders upholding the agency’s regulation of the e-cigarette industry.

    The 4th U.S. Circuit Court of Appeals on Dec. 12 found that the FDA had acted within its authority in rejecting Avail Vapor’s premarket tobacco product applications.

    In 2016, the FDA determined that e-cigarettes were subject to its regulation and gave manufacturers until 2020 to apply for approval of vapor products.

    Avail Vapor sought approval for its products in 2020, telling the FDA that they could help smokers quit by switching to e-cigarettes. The company said it had measures in place that would ensure that its liquids would not be sold to minors.

    The FDA denied the application in 2021, saying that the company had not presented long-term studies supporting its claim that its products, which included fruit flavors, were more effective at helping smokers quit than tobacco-flavored liquids, which the agency has said are less appealing to minors.

    Avail lost an administrative appeal and then petitioned the 4th Circuit to overrule the agency. The company argued that the FDA failed to inform applicants in 2019 that they would need long-term studies. It also said the agency was obligated to consider the sales plan.

    Circuit Judge J. Harvie Wilkinson wrote that Avail “encourages us to neglect the forest for the trees” by focusing on procedural objections rather than the FDA’s mandate to protect public health.

    The FDA has denied more than 55,000 applications from e-cigarette products. Those denials have been previously upheld by the D.C. Circuit, 3rd Circuit and 7th Circuit.

  • Juul Settles Marketing Suit With Pennsylvania

    Juul Settles Marketing Suit With Pennsylvania

    Photo: niroworld

    Juul Labs has agreed to pay Pennsylvania $38.8 million to end the state’s claims that the company targeted young people with its products, state Attorney General Josh Shapiro announced in a release. As part of the deal, Juul denied any wrongdoing.

    “Juul knowingly targeted young people with tactics similar to the tobacco companies’ playbook,” said Shapiro. “They disregarded their growing audience of young users, taking no action as their market share skyrocketed on the backs of American kids. About 13 percent of Pennsylvania students have vaped in the past 30 days—this settlement is only the beginning of keeping our kids safe from the dangers of vaping.”

    Filed in Philadelphia County court, the Pennsylvania settlement forbids Juul from marketing its products near schools and playgrounds, advertising at events that include kids or in media outlets where audiences are made up of 15 percent or more of kids.

    “This settlement is a continuation of Juul Labs’ progress to resolve issues from the past. We applaud the attorney general’s plan to deploy resources to address underage use in the commonwealth,” the company said in a statement. “The terms of the agreement are aligned with our current business practices, which we started to implement after our company-wide reset in the fall of 2019.”

    Earlier this month, Juul settled more than 5,000 lawsuits covering more than 10,000 individual plaintiffs, resolving much of the legal uncertainty that had driven the company close to bankruptcy.

    Juul announced on Dec. 6 that it has secured an investment to cover the cost of the settlement. The company has been in talks with two early investors to fund a bailout that would cover legal liabilities.

    A pioneer in the vaping business, Juul Labs has gone from dominating the U.S. e-cigarette market to fighting for its survival in a relatively short time.

    Following its initial success, the company quickly came under regulatory scrutiny over its marketing practices. Critics blame Juul Labs for contributing to an “epidemic” of underage vaping.

    Thousands of lawsuits have been filed against Juul over the past several years, alleging that the company marketed its e-cigarettes to children. Juul has said it never marketed to underage users.

    In September, Juul Labs agreed to pay nearly $440 million to settle a two-year investigation by 33 U.S. states into the marketing of its vaping products.

    Juul’s e-cigarettes were briefly banned in the U.S. in late June after the Food and Drug Administration concluded that the company had failed to show that the sale of its products would be appropriate for public health. But following an appeal, the health regulator put the ban on hold and agreed to an additional review of Juul’s marketing application.

    In October, Juul published the details of its marketing denial order appeal. In late September, Juul shareholder Altria Group exercised the option to be released from its noncompete deal with the e-cigarette maker.

  • Officials Urged to Fix Vaping Misinformation

    Officials Urged to Fix Vaping Misinformation

    Photo: Yeti Studio

    A group of public health experts along with the attorney general of Iowa have asked the U.S. Centers for Disease Control and Prevention (CDC) and the U.S. Surgeon General to correct misinformation overstating the dangers of e-cigarettes.

    In an editorial published Dec. 12 in Addiction, the authors cite the 2019 outbreak of EVALI and the Surgeon General’s 2016 youth vaping report, which claims that nicotine vaping is a gateway to smoking.

    The authors take issue with the CDC’s failure to amend the name EVALI (e-cigarette or vaping product use-associated lung injury) even after it became clear that the health problems were brought about by vitamin E acetate (mixed with cannabis oil by black market sellers) rather than nicotine vapes.

    “Smokers are still twice as likely to incorrectly identify e-cigarettes as the cause of a serious lung disease outbreak in 2019 than to correctly identify marijuana vape products contaminated by vitamin E acetate as the cause,” said lead author Michael Pesko of Georgia State University in a press note. “Because many smokers then falsely believe e-cigarettes to be as or more dangerous than cigarettes, the misinformation reduces smoking cessation that would otherwise occur. Population health suffers as a result.”

    The Surgeon General’s gateway claim, meanwhile, is simply untrue, according to the authors. “Significant evidence now exists that this association between vaping and smoking is not causal, which is a source of confusion for the lay public and healthcare professionals,” wrote Georgia State University health economist Pesko.

    “The lack of causation is underlined by real-life data collected since the SG report’s publication. Even as youth vaping hit its peak in 2019, youth smoking was sinking rapidly, and that decline has continued.”

  • 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.

  • Black Market Thrives in Bosnia and Herzegovina

    Black Market Thrives in Bosnia and Herzegovina

    Image: butenkow | Adobe Stock

    About 49 percent of citizens in Bosnia and Herzegovina buy tobacco products from the black market, according to 2020 research data published by the Center for Policies and Management, a Sarajevo think tank organization that deals with European integration and public administration reform, reports the Sarajevo Times.

    The legal sale of cigarettes decreased by 7.6 billion cigarettes per year from 2008 to 2020, though the number of smokers did not significantly decrease. The Liberal Forum, a nongovernmental organization, suggests that that means smokers turned to the black market for cheaper products.

    Illegal cigarettes and tobacco are often smuggled into Bosnia and Herzegovina from Montenegro, Serbia and Albania; Bosnia and Herzegovina is a transit country on the international smuggling route leading to European Union countries, according to the Indirect Tax Administration.

    The Bosnia and Herzegovina prosecutor’s office filed indictments against 13 people this year for illegal tobacco product trade, three of whom were border police members.

  • Egypt Shops Must Formalize Operations

    Egypt Shops Must Formalize Operations

    Image: efesenko | Adobe Stock

    Egypt has implemented a law requiring unlicensed shops to legalize their businesses and putting restrictions on cafes serving shisha, reports Ahram Online.

    The new law requires previously licensed shops to make a one-time payment of half the newly required fees to receive a permanent license. Licensed shops will have a two-year grace period to submit their permanent licenses.

    New businesses will receive their licenses within 60 days of applying.

    A fine of EGP20,000 ($811.19) to EGP50,000 will be imposed on unlicensed shops and those failing to adhere to the law will be sentenced to prison, according to the Cairo government.

    The law will specify fees based on the location of the shops as well as social and economic dimension of the shops’ activities.

    The law also puts restrictions on cafes serving shisha. Cafes and restaurants serving shisha must license their shops or face fines of EGP10,000 to EGP20,000.

    These cafes and restaurants must be located at least 1,000 meters away from places of worship, schools, educational institutions and fuel stations. They must also keep their doors closed except for entering and exiting, and they cannot serve shisha in more than 50 percent of their total area.

    Shop floors cannot be covered in flammable materials and used coals must be stored in specialized ceramic or metal containers. Stored coal must be located in isolated places.

  • Law Review Urges Action to Protect Youth

    Law Review Urges Action to Protect Youth

    Image: Tobacco Reporter archive

    While Canada’s Tobacco and Vaping Products Act (TVPA) is making progress toward meeting the objectives it set out in relation to vaping, more works remains to be done, particularly in terms of protecting youth, according to the first review of the legislation, which was recently tabled in Parliament by Minister of Mental Health and Addiction and Associate Minister of Health Carolyn Bennett, reports Health Canada.

    The review identifies areas for potential action, including examining access to vaping products by youth, communicating the potential benefits of vaping as a less harmful source of nicotine for people who smoke and completely switch to vaping as well as the health hazards, strengthening compliance and enforcement, and addressing scientific and product uncertainty to better understand the vaping product market and the health impacts of vaping.

    “Vaping products offer the 3.8 million Canadians who smoke a less harmful source of nicotine than tobacco products and do help people to stop smoking,” said Bennett. “These products, however, are not without risk—particularly to youth and people who do not smoke cigarettes. This first legislative review of the Tobacco and Vaping Products Act is a valuable opportunity to take stock of the progress we’ve made to address youth vaping—but there is more to do. Our government will continue to work to put the right safeguards in place to protect young people from the harms of vaping and nicotine addiction.” 

    The TVPA was implemented in 2018 to respond to the increasing availability of vaping products in Canada and to help ensure that Canadians would be informed about and protected from the health hazards associated with vaping. It regulates the manufacture, sale, labeling and promotion of vaping products sold in Canada.

    The TVPA includes a requirement for a legislative review three years after coming into force and every two years thereafter to provide a means to examine and respond to tobacco-related and/or vaping-related issues that may emerge over time.

    The review was informed by a public consultation that ran from March 16, 2022, to April 27, 2022.

  • Push to Close Tobacco Advertising ‘Loophole’

    Push to Close Tobacco Advertising ‘Loophole’

    Image: RomanR | Adobe Stock

    U.S. Senators Jeanne Shaheen and Richard Blumenthal reintroduced the No Tax Subsidies for E-Cigarette and Tobacco Ads Act, which would end a tax provision that allows manufacturers to claim federal tax deductions for the cost of advertising for e-cigarettes and tobacco products, according to Shaheen’s website. Senators Brown, Reed, Durbin, Van Hollen and Merkley also joined in reintroducing the bill.

    “E-cigarettes are fueling a public health crisis—particularly among teenagers. E-cigarette and Big Tobacco companies must be held responsible for deliberately advertising these dangerous products to youth,” said Shaheen. “It’s outrageous that a tax loophole allows companies to write off the costs of their ads, having taxpayers foot the bill and subsidize the advertising of harmful products. That’s why I’m reintroducing legislation to close this loophole and hold e-cigarette companies accountable for their harmful marketing practices.”

    “Old regulatory loopholes are helping Big Tobacco addict more Americans to lethal products,” said Blumenthal. “This bill will close a gaping tax loophole, putting an end to Big Tobacco’s tax write-offs of dangerous ads and preventing young people from starting up a deadly addiction.”

    The bill also bars tax deductions for advertising expenses related to tobacco cigarettes, cigars, snuff, chewing tobacco, pipe tobacco and roll-your-own tobacco.

  • Power Shortages Hamper Zim Curing

    Power Shortages Hamper Zim Curing

    Photo: Taco Tuinstra

    Power shortages in Zimbabwe are creating headaches for farmers who rely on electricity to cure their leaf tobacco, according to an article in The Herald.

    Due to low water levels, the Zambezi River Authority has ordered the Zimbabwe Power Co. to stop production at its Kariba South hydroelectric plant, which is the largest electricity generator in the country.

    The shortfall in power supply from the national grid means that tobacco growers must generate up to 70 percent of their electricity through diesel-driven generators, according to Rodney Ambrose, chief executive of the Zimbabwe Tobacco Association, which represents mostly large-scale farmers.

    In a letter to the Ministry of Land, Agriculture, Water, Fisheries and Rural Development, Ambrose asked the government to give farmers access to discounted fuel to help prevent losses to the 2022–2023 tobacco crop and an associated decline in foreign currency earnings.

    Tobacco is Zimbabwe’s most lucrative export after gold. In the 2022 marketing season, the country earned $650 million, up from $589 million in 2021.

    According to Ambrose, the cost of production per hectare is at a record high in Zimbabwe. The power shortage, he warned, has the potential to increase cost to the point where farmers’ tobacco is no longer competitive.

    Zimbabwean farmers have bought at least 925 kg of tobacco seed with the capacity to cover 184,999 ha this year, according to the Tobacco Research Board. This would be the largest hectarage ever planted if all the seed sold is sown.

  • Inflation Boosts Discount Cigarette Sales

    Inflation Boosts Discount Cigarette Sales

    Photo: pkstock

    U.S. smokers are switching to lower priced cigarettes in the wake of inflation, reports The Wall Street Journal. Cheaper tobacco brands increased their share of the U.S. cigarette market to 27.1 percent in the third quarter of 2022, up 1.8 percentage points from a year ago.

    While the tobacco industry tends to weather economic downturns better than other sectors, smokers are sensitive to inflation because they have lower incomes than the average consumer. In the U.S., smoking prevalence among people earning less than $35,000 a year is about 21 percent compared with 7 percent for those earning more than $100,000.

    The trend toward lower priced cigarettes favors smaller players like Vector Group, which reported record tobacco revenues in the third quarter of 2022. The company sold 30 percent more cigarettes during the quarter than it did the same time last year. Driven by the significant growth of its price-fighting Montego brand, Vector’s wholesale market share reached 5.7 percent in the quarter—its highest market share since 1984.

    The Wall Street Journal notes that Vector’s position is strengthened by the fact that, due to the company’s relatively small market share, about one-third of its volumes are exempt from payments under the 1998 Master Settlement Agreement.

    Imperial Brands, which has a big portfolio of discount cigarette brands in the U.S., has also been gaining market share as smokers look for bargains.