Category: Regulation

  • Malaysia Scraps Endgame Clause

    Malaysia Scraps Endgame Clause

    Image: Zimmytws

    The government of Malaysia has eliminated the generational endgame (GEG) clause from its Control of Smoking Products for Public Health Bill 2023, reports CodeBlue.

    The move follows an opinion issued by Attorney-General Ahmad Terrirudin Mohd Salleh’s that the proposed age-based prohibition—which seeks to ban tobacco and vape products for anyone born from Jan. 1, 2007—is unconstitutional because it would create two sets of laws for two different groups of citizens based on age.

    Enacting the GEG would require a change to Malaysia’s constitution, according to the attorney general, and the government was reportedly not confident it would be able to secure the required two-thirds majority in Parliament.

    Anti-smoking activists were outraged, saying that the cabinet’s decision to drop the generational provision from the bill violates the Convention of the Rights of the Child, which Malaysia ratified in 1995.

    “We believe that this is a backward step that will lead the people of Malaysia, especially children and adolescents, into the realms of nicotine addiction and drug dependence,” said Family Medicine Specialists’ Association (FMSA) President Nor Hazlin Talib.

    The FMSA urged the government to reinsert the GEG clause into the bill. “The government needs to prioritize public health over political and economic interests,” Talib said.

    In addition to the now removed GEG clause, the bill includes provisions on registration of tobacco products, advertisement, packaging and smoke-free places, among other items.

  • Slovenia Bans Flavors and Smoking Rooms

    Slovenia Bans Flavors and Smoking Rooms

    Photo: Taco Tuinstra

    The government of Slovenia has banned most flavorings in electronic nicotine delivery systems such as e-cigarettes and tobacco-heating products, reports Euractiv. The only flavors still permitted are tobacco and mint.

    “There is mounting research showing that among adolescents who otherwise do not smoke, the use of electronic cigarettes raises the likelihood of them starting to smoke regular cigarettes by up to four times,” Health Minister spokesperson Valentina Prevolnik Rupel was quoted as saying.

    The government has also prohibited smoking rooms in public places such as bars and airports, as ventilation, filtration and other technologies have proven ineffective against exposure to tobacco smoke, according to Rupel.

    To discourage black market sales of flavored products, the government intends to introduce new rules prohibiting individuals from selling or importing tobacco products in bulk.

    Every year, 3,100 people die from smoking in Slovenia, according to Health Ministry data.

  • FDA Sends More Warnings                                              

    FDA Sends More Warnings                                              

    Image: Mucahiddin

    The U.S. Food and Drug Administration sent warning letters to seven online retailers for selling unauthorized e-cigarette products. The warning letters cite the sale of popular and youth-appealing disposable e-cigarette products marketed under the brand names Elf Bar, EB Design, Bang, Cali Bars and Lava.

    These warning letters were informed by the FDA’s ongoing monitoring of multiple surveillance systems to identify products that are popular among youth or have youth appeal, according to the agency. Findings released last week from the 2023 National Youth Tobacco Survey found that more than half of current youth e-cigarette users reported using the disposable e-cigarette brand Elf Bar; earlier this year, the manufacturer of Elf Bar began marketing the product under the name EB Design. In addition, the brands Bang, Cali Bars and Lava were identified as popular or youth appealing by the agency following review of retail sales data and emerging internal data from a survey among youth.

    “FDA’s robust surveillance of the e-cigarette landscape helps us to identify youth-appealing products and to act quickly to protect public health,” said Brian King, director of FDA’s Center for Tobacco Products. “The goal is to identify, prevent and reduce these risks to our nation’s youth before they escalate further.”

    The retailers receiving warning letters sold or distributed e-cigarette products in the United States that lack authorization from the FDA in violation of the Federal Food, Drug and Cosmetic Act. Warning letter recipients are given 15 working days to respond with the steps they’ll 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.

    To date, the FDA has authorized 23 tobacco-flavored e-cigarette products and devices. The distribution or sale of unlawfully marketed products is subject to compliance and enforcement action. For retailers looking for information on which e-cigarettes are legal to sell, the FDA created a printable, one-page flyer of these authorized products. This information is also available on the FDA’s website.

  • FDA Warns Nic Nac ‘Nicotine Mints’

    FDA Warns Nic Nac ‘Nicotine Mints’

    Image: FDA

    The U.S. Food and Drug Administration issued a warning letter to Nic Nac Naturals for the marketing of their unauthorized dissolvable nicotine products, which the company describes as “nicotine mints” and which resemble a pack of mints. These products are of particular concern because of their resemblance to popular candies and the potential to cause severe nicotine toxicity or even death if accidentally ingested by young children, according to the FDA.

    “FDA remains steadfast in our commitment to actively monitor the marketplace and to crack down on companies selling unlawful products, particularly those that can appeal to youth,” said Brian King, director of the FDA’s Center for Tobacco Products (CTP). “Our goal is to identify and prevent these emerging threats to our nation’s youth before they become mainstream.”

    The manufacturer markets these tobacco products in a variety of mint and fruit flavors, all of which come in two nicotine strengths (3 mg or 6 mg). The packaging states the products contain nontobacco nicotine. The FDA regulates tobacco products containing nicotine from any source, including nontobacco nicotine. Nic Nac Naturals does not have a marketing authorization order from the agency to sell or distribute these products in the U.S.

    One container of 15 of these mints can have as much as 90 mg of nicotine total. According to research, the FDA stated, ingesting 1 mg to 4 mg of nicotine could be toxic or severely toxic to a child under 6 years old, depending on body weight. This means ingesting one mint could be severely toxic to a child under 6 years old. Nicotine toxicity among youth of any age can lead to nausea, vomiting, abdominal pain, increased blood pressure and heart rate, seizures, respiratory failure, coma and even death. The FDA also stated that nicotine is highly addictive and exposure during adolescence can harm the developing brain.  

    “Today’s action is another example of our ongoing efforts against illegal nontobacco nicotine products,” said Ann Simoneau, director of the CTP’s Office of Compliance and Enforcement. “We remain unwavering in our use of compliance and enforcement resources to curb unlawful marketing of tobacco products, particularly those that youth could easily confuse with something that they consume regularly—like candy.”

    The company has 15 working days to respond to the FDA with steps they will take to correct and prevent future violations. Failure to respond and correct violations may result in addition FDA action, such as an injunction, seizure and/or civil money penalties.

  • Cigar Group Wants Better Justification for U.S. Flavor Rule

    Cigar Group Wants Better Justification for U.S. Flavor Rule

    Image: razoomanetu

    The Premium Cigar Association (PCA) testified before the White House Office of Management and Budget’s Office of Information and Regulatory Affairs (OIRA) as part of the administration’s review of the U.S. Food and Drug Administration’s draft Final Rule “Tobacco Product Standard for Characterizing Flavors in Cigars.”

    PCA President Scott Regina provided several examples of the impact that the rule would have on specialty tobacco retail, emphasizing that the FDA had not conducted a proper small business impact analysis. The PCA also outlined how the rule would directly affect regulatory matters outside of the FDA’s jurisdiction, including law enforcement, international trade and foreign policy.

    “It’s questionable whether FDA has the authority to issue standards that result in a product ban, especially when they are acknowledging that the regulation does not address a specific risk,” said Regina in a statement.

    “Ultimately, we asked OIRA to consult with a host of affected federal agencies and to remit the draft Final Rule back to FDA for better justification of authority, cost-benefit analysis and small business impact,” said Scott Pearce, executive director of the PCA.

    The OIRA has scheduled meetings with additional stakeholders throughout the month as well as proponents of the characterizing flavor product standard for cigars.

    The PCA published a full list of recommendations on the draft Final Rule.

  • King’s Speech: Activists Decry Generational Ban

    King’s Speech: Activists Decry Generational Ban

    Image: Michael

    Smokers’ rights group Forest condemned the U.K. government’s official announcement of legislation that will deny future generations of adults the right to purchase tobacco.

    During the opening of the new session of Britain’s parliament today, King Charles presented the government’s plans for new legislation, which includes a generational tobacco bill, as reported by the BBC and other news outlets.

    The proposed legislation would make it illegal for anyone born on or after Jan. 1, 2009, to ever legally buy cigarettes, effectively raising the legal age of purchase by one year, every year.

    The government is also looking to bring in rules regulating the flavors and descriptions of vapes that critics say are targeted at children.

    “This is the worst form of nanny state regulation because it treats consenting adults like children,” said Forest Director Simon Clark.

    “If you’re old enough to vote, drive a car, join the army, and purchase alcohol, you’re old enough to buy cigarettes and other tobacco products.

    Clark warned that the legislation would boost the black market.

    “The biggest benefactor from prohibition won’t be public health but criminal gangs and other illicit traders,” he said.

    “Given everything else that is going on in the world, at home and abroad, it’s staggering that a Conservative government would waste valuable parliamentary time banning the sale of tobacco to adults who are perfectly capable of making informed decisions for themselves.”

  • Quebec: Flavor Ban Takes Effect

    Quebec: Flavor Ban Takes Effect

    Image: Pixel-Shot

    Quebec’s ban on flavored vapes took effect Oct. 31.

    The measure includes vaping products with flavors other than tobacco and will prohibit e-liquid sold in bottles with a capacity greater than 30 mL and prefilled devices with a capacity greater than 2 mL.

    The ban was announced in a draft published in April. More than 30,000 citizens of Quebec commented on the proposed ban, according to the Quebec Vaping Rights Coalition, but the health ministry reportedly didn’t make any changes to the rules in response.   

    Quebec is the largest province in Canada to enact a flavor ban. Four other provinces and territories already ban flavors, and one has passed a ban but has not set an effective date yet. Three other provinces restrict flavored products to adult-only stores.

    Darryl Tempest

    “It’s high time for provinces like Quebec, New Brunswick, Nova Scotia and PEI to reevaluate their stance and stop yielding to the influence of big tobacco companies. These regions must come to the realization that they are inadvertently supporting the very issues they claim to be combating.”

    Darryl Tempest, government relations counsel to the CVA

    The Canadian Vaping Association (CVA) has expressed concerns to the Quebec government, arguing that this regulation will not achieve its intended goal of curbing youth experimentation.

    According to the CVA, the consequences will include the closure of specialty vape shops within the province, the loss of over 1,000 jobs and a shift in consumer demand toward foreign suppliers and the illicit market.

    “It’s high time for provinces like Quebec, New Brunswick, Nova Scotia and PEI to reevaluate their stance and stop yielding to the influence of big tobacco companies. These regions must come to the realization that they are inadvertently supporting the very issues they claim to be combating,” said Darryl Tempest, government relations counsel to the CVA.

    The available data consistently finds that flavor bans fail to effectively protect youth and lead to increased tobacco sales among both young people and adults.

  • 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.