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Category: Global Regulation

  • Cyprus Government to Ban Flavored HTPs

    Cyprus Government to Ban Flavored HTPs

    Image: Arid Ocean

    The Cyprus government is moving to ban the sale of flavored heated-tobacco products (HTPs) following the Ministerial Council’s decision to adopt the relevant European legislation, according to In-Cyprus.

    HTPs still allowed on the market will have to apply special warning labels and images to packaging, which will align the packaging with that of conventional cigarettes.

    The aim of these changes is to “harmonize national legislation with European directives, as today’s Ministerial Council approved an amendment to regulations regarding the withdrawal of certain exemptions for heated-tobacco products.”

    The council decided on the “extension of the ban on the sale of tobacco products with characteristic aroma/flavor or containing aromatic substances in any of their ingredients and on heated-tobacco products.”

    “It was also decided to include verbal warnings/notifications about the harmful effects of smoking on the packaging of heated-tobacco products. These warnings will be accompanied by deterrent images.”

    “In the legislation for smoking control, established in 2017, these products were exempted, and the sale of conventional cigarettes and rolling tobacco that contained aromatic substances in their ingredients was prohibited,” said Health Minister Popi Kanari. “With these regulatory amendments, the sale of heated-tobacco products containing aromatic substances in any of their ingredients is prohibited beyond conventional cigarettes and rolling tobacco.”

    “The amendment does not apply to vaping products that contain liquid but only to the category involving heated-tobacco products in which cigarettes with aromatic substances are placed,” said Kanari.

  • FDA Seeks Nominations for TPSAC

    FDA Seeks Nominations for TPSAC

    Image: freshidea

    The U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) is requesting nominations by Oct. 11, 2023, for a nonvoting representative of the interests of the tobacco manufacturing industry to serve on the Tobacco Products Scientific Advisory Committee (TPSAC). Individuals may self-nominate or be nominated by any interested person or organization.

    In addition, the CTP is seeking any industry organizations interested in participating in the selection of this TPSAC nonvoting representative.

    Nomination materials for prospective TPSAC candidates and letters from industry organizations interested in participating in the selection process should be sent to the CTP by Oct. 11, 2023. Please see the Federal Register notice for further details on the nomination and selection procedures.

    TPSAC advises the CTP in its responsibilities related to the regulation of tobacco products. The committee reviews and evaluates safety, dependence and health issues concerning tobacco products and provides appropriate advice, information and recommendations to the FDA commissioner.

  • FDA: Premium Cigars Exempt from User Fees

    FDA: Premium Cigars Exempt from User Fees

    Image: J A Nicoli

    The U.S. Food and Drug Administration will not assess user fees for premium cigars in the fourth quarter of fiscal year 2024, the agency told manufacturers and distributors, according to Halfwheel.

    The statement follows last month’s outcome of Cigar Association of America et al. v. United States Food and Drug Administration et al., which led to deeming regulations not being applied to cigars that meet the definition of “premium cigar.”

    User fees help fund the Center for Tobacco Products. The amount of user fees is set by Congress; companies that import or manufacture cigarettes, roll-your-own products, snuff, chewing tobacco, cigars or pipe tobacco are assessed fees, and individual shares are calculated based on excise taxes paid on each product compared to the total amount of excise taxes paid by all products.

    The FDA, however, does not know whether a cigar company is selling premium cigars, nonpremium cigars or a mixture of both. Due to this, the FDA is asking companies to submit dispute letters within 45 days of the assessment of user fees. The agency is allowing companies the option of either paying the full amount of user fees with the intent of getting refunded for user fees assessed to premium cigars or paying what the company believes it will owe for nonpremium cigars.

    The FDA has stated that it will introduce a better process going forward, but it has not released information regarding what that will look like.

    There was no mention as to whether the FDA plans to refund user fees paid for premium cigars from August 2016 to the second quarter of fiscal year 2023.

  • FDA Sends More Warning Letters

    FDA Sends More Warning Letters

    Image: theerakit

    On Sept. 14, 2023, the U.S. Food and Drug Administration issued warning letters to 15 online retailers and three manufacturers and/or distributors for selling or distributing unauthorized e-cigarette products. Additionally, in one case, the retailer illegally sold a product to an underage purchaser. The warning letters cite a range of popular and youth-appealing e-cigarette products, including disposable products, marketed under the brand names Elf Bar, EB Design, Lava, Cali, Bang and Kangertech. 

    According to the FDA, the youth-appealing e-cigarette products of focus were identified through rapid surveillance and a data-driven approach to investigations. Retail sales data, emerging internal data from surveys of youth, as well as other data sources helped the agency to identify the rising popularity of these youth-appealing products, which were subsequently prioritized for investigation across the supply chain, from manufacturers to distributors to retailers.

    “Given the rapidly evolving nature of the e-cigarette landscape, it’s essential that we have nimble surveillance tools that can best keep pace to protect public health,” said Brian King, director of the FDA’s Center for Tobacco Products. “They’re a critical component of our comprehensive surveillance toolbox, so that we can proactively identify and swiftly stave off emerging threats, particularly those affecting our nation’s youth.”

  • 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.

    A New Direction for ENDS

    Chris Allen explains the significance of FDA’s shift on flavored vapes and why it reflects a growing emphasis on evidence-based harm reduction, behavioral science and product safeguards.

  • 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.