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Category: Global Regulation

  • Belgium to Ban Sale of Disposables

    Belgium to Ban Sale of Disposables

    Photo: Bennphoto

    Belgium will ban the sale of disposable e-cigarettes effective Jan. 1, 2025, making it the first EU country to do so, reports The Brussels Times, citing Federal Health Minister Frank Vandenbroucke. The country has received approval from the European Commission for the ban.

    “The disposable e-cigarette causes a lot of damage to society and the environment,” said Vandenbroucke. “This harmful product mainly targets our young people. I am therefore pleased that we can remove this from the market.”

    Vandenbroucke said that marketing for vapes is “very savvy” and “youth-oriented” despite sales of vapes to minors being banned in Belgium. Youth use is widespread, and in 2023, about three in four points of sale sold disposables to minors, according to an inspection.

    “Belgium is playing a pioneering role in Europe to break the power of the tobacco lobby,” Vandenbroucke said upon receiving approval for the ban from the European Commission. “This is another milestone in our fight against tobacco.”

    “We strive for a smoke-free generation and want people, especially young people, to be better protected and to come into less contact with tobacco or alternative smoking methods,” Vandenbroucke said. “With this measure, we ensure that we remove an extremely harmful product from the market, which is also cheap and therefore attractive to young people.”

    Nondisposable e-cigarettes will still be allowed as many use them to quit smoking combustible cigarettes. “Still, we have been able to agree that they can no longer be offered with lights and other things to make them attractive,” Vandenbroucke said. “It should not be a product to start smoking but to stop smoking.”

  • Hong Kong Mulls Duty-Paid Labels

    Hong Kong Mulls Duty-Paid Labels

    Image: muh

    Hong Kong officials are considering putting designated labels on tobacco products so they can be easily identified as duty-paid, according to acting Health Minister Libby Lee, reports rthk.hk.

    Lawmakers expressed concern regarding efforts to combat illicit cigarettes following an increase in tobacco tax for the second year in a row. Lee noted that officials are looking into the feasibility of placing customs labels on duty-paid products and that progress will be reported in a few months.

    Lawmakers Johnny Ng and Peter Shiu stated that the 12 people prosecuted since 2021 for promoting tobacco products was too low a number, noting that it is common to see flyers promoting illicit tobacco products being handed out at public housing estates.

    Lee’s responded that it is difficult to enforce because officers cannot prosecute someone for holding flyers. She noted, however, that tobacco control officers remove around 50 websites monthly that sell illicit products, but they sometimes run into enforcement problems as well.

    “When it comes to overseas websites, we also have difficulty closing these websites or taking enforcement actions,” said Lee. “However, we’ll set up enforcement efforts … and publicity.”

  • Hong Kong Seizes $26.6 Million in Illegal Cigs

    Hong Kong Seizes $26.6 Million in Illegal Cigs

    Credit: Timothy Donahue

    Customs officers in Hong Kong seized illegal cigarettes worth more than HK$208 million ($26.6 million) in the first 15 days after a tobacco tax increase came into force as part of last month’s budget.

    Superintendent Jeff Lau Leung-chi of the Customs Revenue Crimes Investigation Bureau said on Monday that if the tobacco had been legally imported, the contraband products would have generated about HK$147 million in tax.

    Lau attributed the increase in cigarette seizures to enhanced enforcement action at all levels to combat the trade in illegal tobacco products and the operation’s longer duration in the second phase, according to media reports.

    “We also believe that crime syndicates anticipated the possibility of an increase in tobacco tax, so they stockpiled a larger quantity of illicit cigarettes ahead of time to supply the market after the tax hike,” he said.

    The untaxed cigarettes were discovered over the second phase of a citywide operation code-named “Tempest”, which involved the arrest of 776 people between February 29 and March 14.

    During the first round of the operation, which took place between February 19 and 28, Customs detained 538 people and seized HK$62 million worth of illegal tobacco products in 10 days.

  • Flava Pulled From Philippine Shelves

    Flava Pulled From Philippine Shelves

    Flava brand vaping products have been pulled from store shelves in the Philippines amid allegations of illegal marketing to minors and tax evasion, the Department of Trade and Industry has said.

    The DTI’s Fair Trade Enforcement Bureau (FTEB) on March 15 ordered Flava Corporation, Lilac’s Vape Shop, and social media influencer Lilac Sison Tayaban, CEO of Flava, to refrain from manufacturing, importing, selling, packaging and distributing imported Flava vapes, according to media reports.

    Once the Sampaloc, Manila-based business receives the preliminary order issued by DTI-FTEB, all of Flava’s commercial activities must immediately stop.

    Flava was the respondent to formal charges alleging violations of Republic Act No. 11900, or the Vaporized Nicotine and Non-Nicotine Products Regulation Act, filed before the DTI-FTEB on March 14.

    In turn, the DTI-FTEB gave the preliminary order to confiscate Flava products that violate RA 11900, to prevent the disposition or tampering of evidence and the continuation of the acts being complained of.

    The DTI is the lead implementing and enforcement agency of RA 11900, the landmark law aimed at protecting minors from vaping. The House Ways and Means Committee earlier estimated as much as P728 million ($1.3 million) in foregone tax revenues from the alleged technical smuggling of P1.4 billion worth of illicit Flava devices last year.

    After laboratory testing, The House panel discovered that Flava had not declared the vapes it imported from China. Flava allegedly mislabeled its ingredient as freebase nicotine, which has a lower excise tax than nicotine salt — the nicotine used in Flava products.

    Also, the House committee discovered Flava’s aggressive marketing of its flavored vapes to minors, most especially on social media—a violation of RA 11900. Last week, Bureau of Internal Revenue commissioner Romeo Lumagui Jr. disclosed that the taxman seized 1,029 master boxes of Flava vapes from a warehouse in San Pablo City, Laguna, with tax deficiencies totaling P75.7 million.

    The BIR raid conducted together with the Laguna provincial field unit of the Philippine National Police’s Criminal Investigation and Detection Group (PNP-CIDG) also led to the arrest of two individuals manning the warehouse.

    As such, the BIR will file criminal tax evasion charges against Flava.

    “This successful raid of a vape warehouse containing 102,900 bottles of Flava vape products will be one of many. The BIR supports the whole of the government’s approach to eradicating illicit vape products. We have warned you as early as 2022. Our raids are successful. We won the criminal cases. You already have pending warrants of arrest. Register and pay your proper taxes, or suffer the consequences,” Lumagui said.

    Meanwhile, Consumer Protection Group spokesperson, Trade Assistant Secretary Amanda Nograles said they will check the report of the Philippine Drug Enforcement Agency that marijuana-laced electronic cigarettes or vapes are now proliferating in the market.

    “That report alarms us, especially when these will be sold to minors. Since the information was just new, then we will get additional information. But the DTI will continue to confiscate vape products with flavor descriptors and have cartoon characters that are appealing to minors, and products that use influencers,” Nograles said in a radio interview.

    She said if the DTI encountered or confiscated vapes with marijuana oil, then they would refer it to the PDEA.

    On Thursday PDEA operatives seized cannabis oil and ‘kush’, and assorted vaping devices, with an estimated total value of P842,000 in simultaneous raids in Taguig City.

  • Massachusetts Court OKs Generational Ban

    Massachusetts Court OKs Generational Ban

    Brookline, Massachusetts (Credit: Wangkun Jia)

    The highest court in Massachusetts ignored objections from vape shop owners and tobacco retailers and upheld the legality of a novel bylaw that bars cigarette sales to anyone born after January 1, 2000, in the town of Brookline. The restriction, the first of its kind in the United States, is designed to prevent future generations from using not only tobacco but also nicotine.

    Retailers argued that the 2021 Brookline bylaw was pre-empted by a state law approved in 2018 that raised the minimum age for purchasing a tobacco product from 18 to 21, according to media reports. The retailers pointed out that the Brookline bylaw effectively means someone born after January 1, 2000, will not be able to purchase a nicotine product regardless of their age.

    Over time, as the population ages, the bylaw will effectively ban the sale of tobacco products in the town.

    In the Supreme Judicial Court’s unanimous opinion, written by Justice Dalila Wendlandt, the court acknowledged the Brookline bylaw is more restrictive than the state’s minimum age standard, but the justices had no issues with that. They said the bylaw “augments the state statute” by further limiting access to tobacco products to persons under the age of 21.

    The court rejected claims by the tobacco retailers that the state law was designed to clarify what had become a muddled regulatory environment as municipality after municipality raised the minimum age for buying tobacco products.

    “The retailers claim that the purpose of the Tobacco Act was ‘actually to benefit tobacco retailers . . . by eliminating the confusion that arises when the minimum age for purchasing tobacco varies from town to town and city to city across the Commonwealth,’” the opinion said. “To the contrary, the act reflects the legislative intent to protect young persons and other vulnerable populations from the deleterious health effects of tobacco product use.”

    The case drew attention in Massachusetts and around the nation and the world and the outcome is likely to prompt more communities to follow Brookline’s lead, creating a patchwork quilt of regulation of tobacco products.

  • More FDA Warnings

    More FDA Warnings

    Photo: Ljupco Smokovski

    The violations involve products sold under the Elf Bar/EB Design/EB Create, Funky Republic, Lost Mary brands.

    The U.S. Food and Drug Administration has warned five more online retailers for selling flavored disposable vaping products.

    On Feb. 28, the regulatory agency announced that the warning letters cite the sale of disposable e-cigarette products marketed under popular brand names such as Elf Bar/EB Design/EB Create, Funky Republic, Lost Mary, Hyde, Breeze and Cali Bars, according to a press release.

    “Protecting our nation’s youth from the harms of tobacco products is crucial to our center’s public health mission,” said Brian King, director of the FDA’s Center for Tobacco Products in a statement. “We’re committed to continuing to use a data-driven approach to identify and prevent the sale of unauthorized tobacco products and to take compliance and enforcement action when appropriate.”

  • FDA Denies Marketing of Flavored Blu Products

    FDA Denies Marketing of Flavored Blu Products

    The U.S. Food and Drug Administration issued marketing denial orders (MDOs) to Fontem U.S. for four Blu disposable products and one MyBlu e-cigarette product.

    The denied products include a closed menthol e-liquid and several flavored disposable e-cigarettes. As a result, the company may not legally market or distribute these products in the United States. However, the company may submit new applications for the products that are subject to these MDOs.

    The products that received MDOs are Blu Disposable Menthol 2.4 percent; Blu Disposable Vanilla 2.4 percent; Blu Disposable Polar Mint 2.4 percent; Blu Disposable Cherry 2.4 percent; and MyBlu Menthol 1.2 percent.

    After reviewing the company’s premarket tobacco product applications, the FDA determined that the applications lacked sufficient evidence to demonstrate that permitting marketing of the products would be appropriate for the protection of the public health, which is the standard legally required by the 2009 Family Smoking Prevention and Tobacco Control Act. 

    More specifically, the FDA said the application lacked sufficient evidence regarding harmful and potentially harmful ingredients in the aerosol for one product and battery safety for several products. Additionally, the applicant did not present sufficient data demonstrating that the new products have a potential to benefit adult smokers, in terms of complete switching or significant cigarette use reduction, that would outweigh the risk to youth, according to the agency.

  • FDA Warns More Sellers of Flavored Vapes

    FDA Warns More Sellers of Flavored Vapes

    The U.S. Food and Drug Administration has again issued warning letters to several small business owners for selling flavored disposable vaping products.

    The regulatory agency issued letters to 14 online businesses for selling unauthorized e-cigarette products. The warning letters cite the sale of disposable e-cigarette products marketed under brand names, including Elf Bar/EB Design, Lava Plus, Funky Republic/Funky Lands, Lost Mary, Cali Bars, Cali Plus, and Kangvape.

    “These warning letters were informed by FDA’s ongoing monitoring of multiple surveillance systems to identify products that are popular among youth or have youth appeal, an agency press release states. “Findings from the 2023 National Youth Tobacco Survey found that more than 50 percent of youth who use e-cigarettes reported using the disposable e-cigarette brand Elf Bar; in 2023, the manufacturer of Elf Bar began marketing the product under the name EB Design.”

    In addition, the brands Lava Plus, Funky Republic/Funky Lands, Kangvape, Cali, and Breeze were identified as popular or youth-appealing by the agency following a review of retail sales data and emerging internal data from a survey among youth, according to the agency.

    Retailers receiving warning letters sold or distributed e-cigarette products in the United States that lack marketing authorization from the FDA violate the Federal Food, Drug, and Cosmetic Act.

    Warning letter recipients are given 15 working days to respond with the steps they will take to correct the violation and to prevent future violations. Failure to promptly correct the violations can result in additional FDA actions such as an injunction, seizure, and/or civil money penalties.

    As of Jan. 30, 2024, FDA issued more than 440 warning letters and 88 CMPs to retailers for the sale of illegal e-cigarettes, including through a series of nationwide inspection efforts of brick-and-mortar retailers, according to the release.

    Earlier this week, the FDA issued complaints for civil money penalties (CMPs) against 21 brick-and-mortar retailers for selling unauthorized Esco Bars e-cigarettes.

    In a press release, the agency stated that it had previously issued each retailer a warning letter for their sale of unauthorized tobacco products. However, follow-up inspections revealed that the retailers had failed to correct the violations.

    The agency now seeks the maximum penalty of $20,678 from each retailer.

  • Civil Money Penalties for 21 Vape Shops

    Civil Money Penalties for 21 Vape Shops

    The U.S. Food and Drug Administration has issued complaints for civil money penalties (CMPs) against 21 brick-and-mortar retailers for selling unauthorized Esco Bars e-cigarettes.

    In a press release, the agency stated that it had previously issued each retailer a warning letter for their sale of unauthorized tobacco products. However, follow-up inspections revealed that the retailers had failed to correct the violations.

    The agency now seeks the maximum penalty of $20,678 from each retailer.

    The complaints announced today represent the first set of CMPs FDA has filed for the sale of unauthorized Esco Bars e-cigarettes. “These retailers were duly warned of what could happen if they continued selling these unauthorized e-cigarettes,” said Brian King, director of the FDA’s Center for Tobacco Products (CTP). “They should have acted responsibly to correct the violations, but they chose not to do so and now must face the consequences of that decision. FDA won’t sit back and tolerate inaction to comply with the law.”

    Currently, $20,678 is the maximum civil money penalty amount FDA can seek for a single violation from each retailer, consistent with similar CMPs sought against retailers for the sale of unauthorized Elf Bar products in Sept., Nov., and Dec. of 2023.

    The retailers can pay the penalty, enter into a settlement agreement based on mitigation factors, request an extension of time to file an answer to the complaint, or file an answer and request a hearing. Retailers that do not take action within 30 days after receiving a complaint risk a default order imposing the full penalty amount, according to the release.

    “Today’s CMP actions are just the latest in the continued, comprehensive push by FDA to take action across the supply chain to remove unauthorized e-cigarettes, particularly those that are popular among youth, from the marketplace,” the release states. “As of Jan. 30, 2024, FDA has issued more than 440 warning letters and 88 CMPs to retailers, including brick and mortar and online retailers, for selling unauthorized tobacco products.

    “In addition to actions involving retailers, FDA has issued more than 660 warning letters to firms for illegally manufacturing and/or distributing unauthorized new tobacco products, including e-cigarettes.

    “The agency has also filed civil money penalty complaints against 48 e-cigarette firms for manufacturing unauthorized products and sought injunctions in coordination with the U.S. Department of Justice against seven manufacturers of unauthorized e-cigarette products.”

  • Bidi Vapor Appeals MDO of Tobacco Bidi Stick

    Bidi Vapor Appeals MDO of Tobacco Bidi Stick

    Bidi Vapor will appeal the U.S. Food and Drug Administration’s January 2024 decision to deny the company’s premarket tobacco product application (PMTA) for Bidi Vapor’s “Classic” tobacco-flavored Bidi Stick electronic nicotine-delivery system.

    Bidi Vapor has asked the U.S. Court of Appeals for the 11th Circuit to review the marketing denial order (MDO), which Bidi Vapor believes violates the Administrative Procedure Act. Bidi Vapor will also be seeking a stay of the MDO pending the outcome of the litigation.

    “Bidi Vapor disagrees with the FDA’s decision and is taking immediate action accordingly,” said Bidi Vapor founder and CEO Niraj Patel in a statement. “In the meantime, it is important to note that the decision only affects the ‘Classic’ or tobacco-flavored Bidi Stick. The remaining ten Bidi Stick flavors are still under FDA scientific review and remain in distribution in the United States through Kaival Brands, subject to the FDA’s enforcement discretion.”

    With its recent legal challenge, Bidi Vapor hopes to build on its record of successfully contesting adverse FDA decisions. In August 2022, the 11th Circuit set aside the original MDOs issued for its 10 nontobacco-flavored products. That ruling put the 10 PMTAs back into scientific review and allowed those flavors to remain available for sale pursuant to the FDA’s compliance policy for deemed tobacco products. During this evaluation period, the 10 nontobacco-flavored products are still under FDA enforcement discretion.