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Category: Global Regulation

  • Expert Condemns Kazakh Vape Ban

    Expert Condemns Kazakh Vape Ban

    Delon Human (Photo: Taco Tuinstra)

    Leading international public health experts have expressed serious concern about Kazakhstan’s imminent ban on vapes as a “backward step” that contradicts the unprecedented success of more progressive countries that are dramatically reducing tobacco’s toll through the use of alternative nicotine products.

    The Kazakh government’s intention to enact the prohibition by Jan. 1, 2024, endangers the lives of the country’s 3.2 million smokers who will be deprived of their best chance to quit their deadly habit, according to the Smoke Free Sweden, a movement highlighting Sweden’s progress in becoming smoke-free.

    “We note with great concern this retrogressive move by the Kazakhstan Ministry of Health, which defies the extraordinary achievements of some countries that have adopted a progressive approach to modern products such as vapes and oral pouches,” said Delon Human, a global health advocate and founder of Smoke Free Sweden, in a statement.

    “Around the world, alternative nicotine products are helping to save millions of lives by giving smokers an escape from combustible cigarettes. They are proven to be at least 95 percent less harmful than cigarettes and the most effective way for smokers to quit.

    “To ban these reduced-risk products will simply condemn many smokers to stick with cigarettes and sentence them to an unnecessarily premature death.”

    Human urged Kazakh authorities to emulate the approach of Sweden, which is on course to drop below a 5 percent tobacco smoking prevalence in the next few months. This is the level at which a country is considered officially smoke-free.

    Sweden is the first EU country to achieve this milestone—17 years ahead of schedule—through its policy of making vapes and pouches available, acceptable and affordable to adult smokers.

    “Quitting smoking like Sweden saves lives,” says Human. “Compared to the rest of Europe, Sweden has 44 percent fewer tobacco-related deaths, a cancer rate that is 41 percent lower, and 38 percent fewer deaths attributable to any cancer.

    “Sweden is leading the way for other nations, such as the United Kingdom where the health service is giving free vape kits to smokers to help them quit. The government is funding the ‘swap to stop’ scheme with the aim of turning the country smoke-free by 2030.

    “Meanwhile, only last month, the largest study of its kind in the United States confirmed the immense value of vapes as cessation aids. Researchers at Hollings Cancer Center in South Carolina found that vapes nudged people towards quitting smoking – even those who had entered their trial saying they had no intention of quitting.

    “Such evidence is compelling and should be ignored no longer. If Kazakh authorities are serious about saving lives, they should be following the science and offering affordable access to vapes, instead of blocking this proven ‘fire escape’ for smokers,” concluded Human.

  • Esco Bar Challenges FDA Rejection

    Esco Bar Challenges FDA Rejection

    Credit: Waldemarus

    Pastel Cartel, manufacturer for Esco Bar, has filed a federal lawsuit challenging the U.S. Food and Drug Administration’s refuse-to-accept (RTA) decision for over 100 products included in multiple premarket tobacco product applications (PMTAs) filed by the company, according to Vaping360.

    The lawsuit was filed in the U.S. District Court for the Western District of Texas. It alleges that the FDA acted arbitrarily and capriciously when it issued an RTA for the PMTAs.

    Esco Bar is seeking: a preliminary injunction staying the RTA orders until the case is decided; a judgment finding that the RTAs violate the Administrative Procedure Act and the U.S. Constitution (due process and the Fifth Amendment); and a final judgment setting aside the RTA orders and remanding the company’s PMTAs back to the FDA for further review.

  • Indonesia Legalizes E-Cigarettes

    Indonesia Legalizes E-Cigarettes

    Image: Reezky

    The Indonesian Parliament recently passed Health Law No. 17 of 2023, which categorizes e-cigarettes as addictive substances, according to 2Firsts.

    Teguh Basuki A Wibowo, chairman of the Indonesian Electronic Nicotine Industry Alliance, stated that including e-cigarettes in the legal framework for solid and liquid tobacco products legalizes industry participants and allows smokers to find alternative products.

    The law puts Indonesia on equal footing with countries like the Philippines and the U.K., which have similar legislative frameworks for e-cigarettes, he said.

  • Bangladesh Set to Ban Vapes

    Bangladesh Set to Ban Vapes

    Image: luzitanija

    Bangladesh is set to ban vapes and nicotine pouches, according to Filter.

    The government has been considering a vape ban since 2019 when the U.S. e-cigarette or vaping product use-associated lung injury outbreak occurred—later determined to be caused by adulterated illicit products.

    The health ministry has now drafted an amendment to Bangladesh’s Smoking and Using of Tobacco Products (Control) Act, which has been reviewed by the cabinet and must now be approved by parliament.

    If the proposed ban is approved, anyone caught vaping, regardless of nicotine content, will be subject to a fine of BDT5,000 ($46). Sales, production, import, export, storage and transportation of vapes would also be banned, with penalties starting at a higher fine, three months’ incarceration or both. Larger scale activity or repeat offenses would face longer sentences.

    The amendment would also ban flavors in tobacco products, increase the fine for smoking in public places and include further penalties for unlicensed tobacco sales.

    Organizations like the Bangladesh Medical Association support the proposed ban, equating vaping with smoking cigarettes.

    “A ban on vaping devices will have disastrous consequences for people trying to quit smoking cigarettes,” said Nafis Farhan, a member of Voice of Vapers Bangladesh. He attributed continued high smoking rates in the country to “limited availability of cessation tools, such as vapes.”

    The proposed ban represents “a missed opportunity for harm reduction and a setback for public health,” according to Michael Landl, director of the World Vapers’ Alliance.

  • Special Report: COP10

    Special Report: COP10

    Image: Maksym Yemelyanov

    From Nov. 20 to Nov. 25, delegates representing the countries that have signed to the Framework Convention on Tobacco Control (FCTC) will gather in Panama City to discuss tobacco and nicotine policies at the 10th Conference of the Parties (COP10). It’s an event that warrants close scrutiny because the decisions taken at COP tend to have profound implications on the nicotine business and its customers, impacting the future of manufacturers, suppliers and tobacco growers along with stakeholders such as smokers and vapers.

    In this section, Tobacco Reporter features a selection of its COP10 coverage.

  • Coalition Campaigns Against Menthol Ban

    Coalition Campaigns Against Menthol Ban

    Image: National Coalition of Justice Practitioners

    The National Coalition of Justice Practitioners, a group of Black and Hispanic law enforcement executives and experts, hosted the “When Good People Write Bad Policy” National Press Club panel event to educate people about the racial and criminal implications of a menthol ban, according to a PR Newswire release. The panel met before the U.S. Food and Drug Administration’s anticipated menthol ban announcement.

    “There are many groups who still do not understand the unintended consequences of this proposed ban,” said Benjamin Chavis, president and CEO of the National Newspaper Publishers Association and panel moderator. “For leaders in Washington to consider this ban without consulting Black and Brown officers is disastrous. Let’s sit down with the proponents and first conduct a Racial Impact Study. Targeting in the past doesn’t justify targeting now. We are against racial targeting and profiling. All of it.”

    Panelists Jiles Ship, Neill Franklin, Elliot Boyce, Corey Pegues, Sonia Pruitt, David Daniels III, John I. Dixon and Ron Hampton asked that President Joe Biden and Vice President Kamala Harris pull back on this menthol ban until further studies, like a Racial Impact Study, are done and more experts are heard.

    The Aug. 10 panel event urged lawmakers to study the effects of a menthol ban by launching a Racial Impact Study that gathers input from law enforcement, health experts and Black and Latino communities.

    The law enforcement experts listed these unintended consequences: Anything you ban becomes illegal, and it is a policing issue; enforcement of the menthol ban will be in more urban and Latino communities and used as a tool in racial profiling, stop-and-frisks and arrests; and the police do not need another reason for a stop-and-frisk that leads to life-threatening casualties in the Black community.

    Former Law Enforcement Action Partnership Executive Director Franklin stated, “Illicit markets breed violence. This menthol ban will flood the streets, especially Black and Latino communities, with unregulated products, and if you think the products are unhealthy now, wait until the unregulated products are pushed into our communities. You don’t want to see substances like fentanyl added to a street cigarette.”

    Overall, adult and youth smoking rates in the U.S. are at record lows, according to the coalition. Since over 80 percent of African Americans and 48 percent of Latinos who choose to smoke prefer menthol cigarettes, a proposed FDA ban is racially discriminatory since cigarettes preferred by white smokers will not be banned, they argue. There is no scientific basis to regulate menthol and nonmenthol cigarettes differently. Health concerns are more effectively managed through education, treatment and counseling, not by police, they state.

  • ‘FDA Botched Review’

    ‘FDA Botched Review’

    Image: Tobacco Reporter archive

    The U.S. Food and Drug Administration failed to conduct a proper analysis before rejecting premarket tobacco product applications (PMTAs) submitted by Fontem U.S. for certain vaping products, the U.S. Court of Appeals for the D.C. Circuit found on Aug. 29.

    The court upheld the regulatory agency’s denial of Fontem’s application to market flavored vaping products but rejected the FDA’s denial of Fontem’s application for unflavored products.

    “While the FDA identified multiple ‘deficiencies’ [in Fontem’s application], it failed to analyze the trade-offs necessary to make a public health finding,” the judges wrote in their ruling. “Nor did the agency explain how the specific deficiencies relate to its overall conclusion that Fontem failed to demonstrate its unflavored products were appropriate for the protection of public health. The agency’s denial therefore failed to comport with the requirements of the Tobacco Control Act.”

    The FDA’s failure to correctly apply the public health inquiry to Fontem’s unflavored products led it to make another serious error, according to the court. In its initial deficiency letter, the FDA requested certain information from Fontem, thereby indicating such information would be sufficient for the agency to approve Fontem’s products.

    But in its denial order, the agency changed its tune, reproaching Fontem for failing to provide information that the agency had never explicitly sought.

    “Shifting the regulatory goal posts without explanation is arbitrary and capricious,” the judges wrote. “By indicating in its deficiency letter that Fontem could resolve issues with its applications by providing specific information, the FDA represented such information would be sufficient to secure approval.”

  • Governments Urged to Raise Smoking Age

    Governments Urged to Raise Smoking Age

    Photo: Elena Shvoeva

    Researchers are urging governments to raise the legal smoking age to 22 after a study found that those who start smoking before the age of 20 find it more difficult to quit.

    The scientists analyzed the associations between nicotine dependency and successful smoking cessation according to the age participants started smoking. They presented their findings at the European Society of Cariology Congress, which took place Aug. 25–28 in Amsterdam.

    The study included 1,382 smokers, of whom 30 percent were women. Early starters reported a higher number of cigarettes per day (25) compared with late starters, who smoked 22 cigarettes per day. Those who started early had higher respiratory carbon monoxide levels compared with those who started late (19 ppm versus 16.5 ppm, respectively) and higher scores on the Fagerstroem test for nicotine dependence (7.4 versus 6.3, respectively).

    Less than half of early starters (46 percent) successfully quit smoking compared with 56 percent of late starters, for an odds ratio of 0.711 after adjusting for sex, age at clinic visit and smoking cessation aids—indicating that early starters were 30 percent less likely to successfully kick the habit compared with late starters.

    “Our results show that starting smoking early is linked with higher nicotine dependency, even in young adulthood,” said study author Koji Hasegawa of the National Hospital Organization Kyoto Medical Center in Japan in a statement. “The study indicates that increasing the legal age to buy tobacco to 22 years or older could lead to a reduction in the number of people addicted to nicotine and at risk of adverse health consequences.”

  • TPMP Comment Period Extended

    TPMP Comment Period Extended

    Credit: May1985

    The U.S. Food and Drug Administration has extended the comment period on its proposed rule for tobacco manufacturing practices.  

    Stakeholders now have until Oct. 6, 2023, to share their thoughts.

    The proposed rule would place new requirements for tobacco product manufacturers regarding the manufacture, design, packing and storage of their products. According to the FDA, these proposed requirements would help protect public health by, among other things, minimizing or preventing contamination and limiting additional risks by ensuring product consistency.

  • Public Meeting on PMTA Process

    Public Meeting on PMTA Process

    Credit: JHVEPhoto

    The U.S. Food and Drug Administration will hold a two-day public meeting on the agency’s premarket tobacco product application (PMTA) process on Oct. 23–24, 2023.

    The meeting will be held on the FDA’s White Oak Campus in Silver Spring, Maryland, and will be in a hybrid format with the option to attend virtually.

    Staff from the Center for Tobacco Products’ Office of Science will present on topics related to the PMTA process and be available to respond to questions received from stakeholders on the topic, according to a press note.

    Additional information, including registration and question submission processes, will be available soon.