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Category: Global Regulation

  • RJR Complaint Could Wreck Vaping Industry

    RJR Complaint Could Wreck Vaping Industry

    The implications could be far-reaching. Reynolds American Inc. (RAI)  has filed a U.S. International Trade Commission (ITC) complaint charging multiple manufacturers, distributors and retailers of several popular disposable vaping devices with unfair importation. It is one of several recent actions Reynolds has made to remove its competitor’s vaping products from store shelves.

    Reynolds is asking the ITC to investigate and issue an exclusion order preventing further U.S. imports of disposable vaping products. Several legal scholars have told Tobacco Reporter that if the ITC agrees with Reynolds, all flavored disposable vaping devices without marketing authorization could be stopped at the border and prevented from entering the U.S. market.

    Reynolds wants the ITC to issue a permanent “cease and desist order” prohibiting any businesses from selling illegal vaping products. The move would push nearly the entire vaping industry underground, with the exception of products owned by major tobacco companies such as Reynolds that have received marketing orders from the FDA.

    Several businesses were named specifically as “peddlers of illegal disposable vapes” in the Reynolds complaint, including the “manufacturers, importers, distributors and retailers” of Breeze, Elf Bar, Esco Bar, Hyde, Puff Bar, and R&M disposable vapes.

    Also named are several well-known U.S. wholesale and retailers of disposable vapes, including Element Vape, Flawless Vape, Magellan Technology, Mi-One Brands, Price Point Distributors, and Vape Sourcing.

    The ITC complaint accuses what amounts to the manufacturers of all unauthorized vaping products of importing “illegal disposable vapes” in violation of Section 337 of the Tariff Act of 1930. Specifically, Reynolds claims the named businesses either falsely advertised that their products are authorized for sale by the U.S. government, failed to comply with federal laws imposing registration and reporting requirements and limitations on sales, or violated customs laws and regulations.

    “As a result of the relentless influx of illegal vapor products flowing through U.S. borders, Reynolds American Inc. subsidiaries R.J. Reynolds Tobacco Co. and R.J. Reynolds Vapor Co. have filed a complaint with the U.S. International Trade Commission against more than 30 companies involved in illegally importing unregulated, youth appealing flavored disposable vapor products,” RAI wrote in a statement. “Many of the manufacturers of these disposable vapor devices intentionally and systematically market to youth, selling products with dessert and candy flavors and featuring cartoon characters.

    “These illegal disposable vapor devices, which have unknown ingredients and bypass regulations, are jeopardizing public health by refusing to adhere to the laws that regulate the sale of tobacco products. The complaint requests that the ITC institute an investigation into unfair acts in the importation and sale of these Chinese-manufactured, youth appealing flavored disposable vapor devices into the United States.”

    Reynolds owns the Vuse vaping brand, including the Vuse Alto. Last week, the FDA issued a marketing denial order, ordering Alto menthol refill pods off the market. The Alto device and tobacco-flavored pods are still under review by the agency. Two older Vuse vapes, the Solo and Vibe models (and their tobacco-flavored refills) are among the 23 products currently authorized by the FDA. The marketing denial order was subsequently stayed by the Fifth Circuit Court of Appeals.

    In its ITC complaint, Reynolds states it has the capacity to fill any void in the market if the illegal products were removed. “Reynolds has the capacity to replace any increase in demand if the Accused Products were excluded from importation,” the complaint states. “Reynolds is willing to meet any increased demand and can do so in a commercially reasonable time, given that it already supplies the industry with significant quantities of ENDS products, as well as oral tobacco and nicotine products.”

    The ITC has not yet made a decision on the complaint that was filed on Oct. 13.

  • Menthol Rule Advances to U.S. Budget Office

    Menthol Rule Advances to U.S. Budget Office

    Photo: Alicia

    The U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) sent its rules to prohibit the sale of menthol cigarettes and flavored cigars to the White House Office of Management and Budget (OMB) for final review, reports CNN.

    The final rules will be issued following this last regulatory step.

    The American Lung Association (ALA) said this regulation may be the most significant action the FDA has taken in the 14 years since it was given the authority to regulate tobacco.

    “It’s a big, vital and critical step on the way to banning these products,” said ALA Assistant Vice President of National Advocacy Erika Sward. “ Truly, it’s momentous.”

    According to a 2022 study published in Tobacco Control, prohibiting menthol cigarettes would save up to 654,000 lives in the U.S. within 40 years, including the lives of 255,000 members of the Black community.

    The Campaign for Tobacco-Free Kids called for the White House and the OMB to expedite their review and issue the final rule by the end of 2023.

  • PMI: COP10 Missed Opportunity

    PMI: COP10 Missed Opportunity

    Image: PMI

    Philip Morris International is concerned that participants in the upcoming Conference of the Parties to the World Health Organization Framework Convention on Tobacco Control (FCTC) will promote prohibitionist policies for noncombustible tobacco products, according to an article in The Guardian.

    “The agenda and meeting documents have been made public for the main part,” PMI Senior Vice President of External Affairs Gregoire Verdeaux wrote in an email. “Unfortunately, they reconfirmed every concern we had that this conference may remain as the biggest missed opportunity ever in tobacco control’s history … WHO’s agenda is nothing short of a systematic, methodical, prohibitionist attack on smoke-free products.”

    Without “reasonable, constructive outcomes,” Verdeaux wrote, the “WHO will have irreversibly compromised the historic opportunity for public health presented by the recognition that smoke-free products, appropriately regulated, can accelerate the decline of smoking rates faster than tobacco control combined.”

    While tobacco companies are not invited to the Conference of the Parties to the FCTC, Verdeaux said he will be in Panama “to publicly denounce the absurdity of being excluded from it while PMI today [is] undoubtedly the most helpful private partner WHO could have in the fight against smoking.”

    Last year, PMI made $10.19 billion in revenue from products like heated-tobacco and electronic cigarettes.

  • Supreme Court Declines to Hear Avail Vapor Case

    Supreme Court Declines to Hear Avail Vapor Case

    Image: Clinton

    The U.S. Supreme Court declined on Oct. 10 to hear Avail Vapor’s objections to the Food and Drug Administration’s regulatory authorization process.

    In 2021, the regulatory agency denied Avail Vapor’s request to approve fruit-flavored and dessert-flavored e-cigarettes. The company protested that the agency had made the application process intentionally difficult.

    In a Supreme Court brief filed Aug. 3, Avail claimed the FDA failed to inform companies of a change in policy that would only allow for approval if the applications included data from studies conducted over time comparing the effectiveness of the multi-flavored products to that of tobacco-flavored products as an aid in adult smoking cessation.

    Avail Vapor had asked the U.S. Supreme Court to examine a lower court’s refusal to review a marketing denial order issued by the FDA to Avail products.

    In its petition, Avail asked the Supreme Court to consider the lower court’s legal reasoning and decision.

    Among other things, Avail argues that the FDA’s decision-making was arbitrary and capricious; that another court sided with a different petitioner against the FDA on the same basic arguments; and that the case is significant not only for Avail but for the entire industry and its customers.

  • EU Considering Ban on Tobacco-Free Snus

    EU Considering Ban on Tobacco-Free Snus

    Image: Andrii

    In a tweet from Member of Parliament Charlie Weimers, news of a potential ban on snus in the EU has come to light.

    “A secret report I shouldn’t have landed on my desk,” the tweet said. “In the report that will be presented to the EU member states this week, there are two notable writings: (1) praise for how successful the snus ban has been and (2) a recommendation that the EU should extend the snus ban to the tobacco-free white snus (nicotine portions).”

    “That the EU snus ban is a success is completely wrong,” he wrote. “It is actually snus that makes Sweden the only country in the EU that is on the way to reaching the U.N.’s goal of a smoke-free society (defined as less than 5 percent smokers), which has saved many lives. A ban on nicotine pouches would have been a hard blow to the attempt to eradicate smoking in the EU.

    “Unfortunately, the Swedish exception for tobacco snus does not apply to nicotine pouches. If the EU Commission and the member states accept the report’s recommendation, nicotine pouches will also be banned in Sweden. Men have largely opted out of smoking in favor of snus while women looking for less dangerous alternatives choose nicotine pouches more often. Therefore, such a ban would hit women extra hard.

    “The report has been written by consultants who work for DG SANTE (the EU’s health bureaucrats), and the writings probably would not have crept into the report if they did not have the support of the bureaucrats. Most likely, this is a test balloon from the bureaucracy. If the proposal falls to the ground at the meeting with the member states, the bureaucrats can blame the consultants, and if the proposal does not meet resistance, the bureaucrats can interpret it as a clear support and work on with a sharp proposal. This is how you often work in the EU’s bureaucracy.

    “The government must therefore already make it clear at the meeting this week that our country opposes a ban on white snus and work to ensure that citizens continue to have the opportunity to choose the least harmful way to use nicotine. Our negotiators are also welcome to raise the issue of the risks to public health of having too many do-gooding bureaucrats in DG SANTE.”

    The news has left many angry, with calls for “SWEXIT” if the proposal passes—meaning, those against the measure are calling for Sweden to leave the EU if the ban passes.

  • DOJ Appeals FDA Premium Cigar Decision

    DOJ Appeals FDA Premium Cigar Decision

    The premium cigar industry recently declared victory in the fight against oversight by the U.S. Food and Drug Administration. Celebrations may have been premature.

    The U.S. Department of Justice has filed an appeal on behalf of the FDA for a decision handed down from the United States District Court for the District of Columbia that fully vacated the Deeming Rule as it applied to premium cigars, according to media reports.

    The lawsuit was filed by the Cigar Association of America, the Cigar Rights of America (CRA) and the Premium Cigar Association. The case focused in part on the rulemaking process, which requires the FDA to inform the public about upcoming regulations and solicit feedback on those proposed rules.

    In last month’s decision in Cigar Association of America et al. v. United States Food and Drug Administration, Judge Amit P. Mehta made a sweeping, albeit expected, ruling that granted relief to the three cigar industry trade groups that sued the regulatory agency in 2016 on behalf of the premium cigar industry.

    The news confirms industry fears that warning labels, premarket tobacco product application (PMTA) review of cigars and other limitations that have impeded the ability of cigarmakers are still a possibility.

    Recently, the FDA acknowledged the decision and one of its impacts, telling cigar companies that it did not plan to assess user fees for “premium cigars” sold during Q4 FY23.

    The Department of Justice, which represents FDA on legal matters, had 60 days to appeal the ruling. It’s unclear whether the agency will ask a court for a stay, which could reenact the deeming regulations for “premium cigars” as the appeal process works itself out.

  • Retailers Face Civil Money Penalties

    Retailers Face Civil Money Penalties

    The retailers selling illegal flavored disposable vapes are under scrutiny. The U.S. Food and Drug Administration issued complaints for civil money penalties (CMPs) against 22 retailers for the illegal sale of Elf Bar/EB Design.

    The FDA previously warned each retailer in the form of a warning letter to stop selling unauthorized tobacco products, according to the agency. During follow-up inspections, the FDA observed the retailers had not corrected the violations, which resulted in the civil money penalty actions. 

    “The FDA has been abundantly clear that we are committed to using the full scope of our authorities, as appropriate, to hold those who break the law accountable,” said Brian King, director of the FDA’s Center for Tobacco Products (CTP). “These retailers were duly warned of what could happen if they failed to correct their violations. They chose inaction and will now face the consequences.”

    The complaints seek the maximum civil money penalty of $19,192 for a single violation from each retailer. While the FDA has issued civil money penalty complaints to retailers for selling unauthorized tobacco products in the past, this is the first time the agency is seeking CMPs for the maximum amount against retailers for selling illegal flavored disposable vapes.

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

    Courtesy: US FDA

    In addition to the CMP complaints, today the FDA announced an additional 168 warning letters to brick-and-mortar retailers for illegally selling Elf Bar/EB Design products. These warning letters were the result of a coordinated nationwide retailer inspection effort conducted throughout the month of August, according to the agency.

    Warning letter recipients have 15 working days to respond with the steps they have taken to correct the violation and ensure compliance with the law. Failure to promptly correct the violations can result in additional FDA actions such as injunction, seizure or civil money penalties.

    “We continue to monitor closely all those in the supply chain, including retailers, for compliance with federal law,” said Ann Simoneau, director of the Office of Compliance and Enforcement in the CTP. “This includes follow-up inspections and surveillance of those who have received a warning letter, and taking additional action, as appropriate, to enforce the law.” 

  • Turkiye Expands Ban on Selling Tobacco

    Turkiye Expands Ban on Selling Tobacco

    Image: ubonwanu

    Turkiye has expanded the scope of its ban on serving and selling tobacco and alcohol products, according to Xinhua News Agency.

    Sales of tobacco products and alcoholic beverages are banned on all premises of health, education and cultural and sports facilities. The ban does not apply to points of sale in accommodation, recreational and camping areas, however.

  • 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.