Category: Regulation

  • Philippines: New Vape Rules to Begin in June

    Philippines: New Vape Rules to Begin in June

    Credit: Adobe Photo

    The new Vape Law in the Philippines will take effect on June 1. The new rules also apply to all next-generation tobacco products, including heat-not-burn and e-cigarettes. The Department of Trade and Industry (DTI) will require all vape products to be registered with the agency on that date, an official said on Tuesday.

    At a forum organized by the Bantay Konsumer, Kalsada, Kuryente (BK3) in Makati, DTI Undersecretary Amanda Nograles said the “importation and manufacturing of vaporized nicotine and non-nicotine products and novel tobacco products must now undergo the DTI certification process.”

    This means that products must have the Philippine Standard (PS) mark and Import Commodity Clearance (ICC) sticker first before they can be sold on the market.

    Nograles said at least 3 companies have already applied for registration, and they urge others to begin the process since the registration may take some time. She clarified that there will be a 6-month transition period to allow all firms to comply.

    “We will allow them to sell all the existing inventory. On January 5, 2025, we will do market clearing. There should be no vape products without a PS license and ICC [sticker],” Nograles said, adding that the agency will continue to monitor shops to ensure that no minors will be allowed to buy vape products. They will also check if the vape has marijuana oil.

  • Cook Islands Bans Vapes, Smoking Age Raised to 21 

    Cook Islands Bans Vapes, Smoking Age Raised to 21 

    Credit: Fadlanbolang

    The Cook Islands is set to ban imitation tobacco products, such as e-cigarettes and heated tobacco products, and will raise the smoking age from 18 to 21.

    Importing and distributing imitation tobacco products could result in a NZD$100,000 ($61,000) fine or up to three months in prison for an individual.

    While businesses caught doing the same face a $1,000,000 fine, additionally, non-compliant businesses will incur a daily penalty of $100,000 for each day the violation continues.

    The Tobacco Control Amendment Bill 2024 passed its third reading in Parliament last week, with most members of parliament supporting it, according to media reports.

    Visitors over 21 will be exempt from the new rules and can bring one imitation tobacco device containing up to 30 milliliters of liquid.

    Other restrictions include the prohibition of displaying tobacco products for sale and the ban on smoking in public places, with limited exceptions.

    Businesses selling tobacco products will also need a license to do so.

    Nick Dun, the manager of South Seas, a store in Rarotonga that sells e-cigarette products, said he thought vaping provided a better alternative to tobacco products.

    “It means some people will unfortunately fall back into tobacco smoking, which may be harder to give up in the future and will impact them financially,” Dun said.

    He said his business felt there was a need for alternatives to tobacco products.

    “For a lot of people, they believed that they actually felt better, and when they started vaping [they] didn’t want to go back to tobacco smoking.

    “For a percentage of our customers, vaping was basically them trying to give up smoking and kind of the stepping stone to giving up.”

  • PMTA Filed for Njoy ACE 2.0 With Age Verification

    PMTA Filed for Njoy ACE 2.0 With Age Verification

    Credit: Kristina Blokhin

    Njoy, a subsidiary of Altria, submitted a supplemental premarket tobacco product application (PMTA) to the U.S. Food and Drug Administration for the commercialization and marketing of its ACE 2.0 device.

    The new device includes access restriction technology designed to prevent underage use. This is achieved through Bluetooth connectivity, which authenticates the user before unlocking the device. The company has also re-submitted PMTAs for blueberry- and watermelon-flavored pod products, which are exclusively compatible with the Njoy ACE 2.0 device.

    “Altria’s Vision is to responsibly lead the transition of adult smokers to a smoke-free future. We’re excited to build on our existing FDA-authorized products,” said Shannon Leistra, president & CEO of Njoy. “Njoy ACE 2.0 includes critical technology features to prevent underage access to flavored Njoy products while also responsibly providing flavored options for adult smokers and vapers.”

    The Njoy ACE is the only pod-based vaping product currently with marketing authorization from the FDA. In the first quarter of 2024, Njoy announced it had broadened distribution to over 80,000 stores and expects to expand to approximately 100,000 stores by year-end.

    Njoy also continued the roll-out of the brand’s first retail trade program, which is designed to help achieve optimal retail visibility and product fixture space, according to a press release.

    “Given the widespread illicit flavored e-vapor marketplace, this product offers the FDA a sound solution for balancing the known risk to youth with an opportunity to offer adults legal, regulated choices,” said Paige Magness, senior vice president of Regulatory Affairs of Altria Client Services. “We hope the FDA prioritizes the review and authorization of this application given its interest in device access restriction technologies to reduce youth access.”

    Njoy had previously received marketing denial orders for its blueberry (2.4% and 5% nicotine strengths) and watermelon (2.4% and 5% nicotine strengths) pods, noting that “…Rather, for flavored Electronic Nicotine Delivery System (ENDS), only the most stringent mitigation measures – specifically device access restrictions – have such mitigation potential.”

    Njoy stated that it believes these applications sufficiently address the FDA’s concerns regarding underage use by incorporating device age and identity-based access restriction and demonstrating that these restrictions are effective at preventing underage access in virtually all cases. Currently, the FDA has not authorized the marketing of any non-tobacco-flavored vaping product.

  • Colombia: President Signs Bill Regulating Vapes

    Colombia: President Signs Bill Regulating Vapes

    Credit: Andrea

    Colombian President Gustavo Petro approved new legislation on May 15 regulating the use of e-cigarette devices, according to the Colombian media outlet El Nuevo Siglo.

    The law, labeled by lawmakers as Anti-Tobacco Law 2.0, prohibits the direct or indirect sale of e-cigarettes and e-cigarette devices to minors within the country.

    The law went into effect on May 9. It amended the Anti-Tobacco Law No. 1335 of 2009 to address the emerging use of e-cigarette devices and electronic nicotine delivery system (ENDS) products.

    Vaping products are now subject to the same regulations as traditional tobacco products.

    The law prohibits the sale of these products to minors and mandates the Department of Health and Social Protection to run educational campaigns on the health risks of vaping.

    There is a transition period to allow the industry to adjust to the new regulations.

  • Age Rising to 21 to Purchase Vape, Tobacco in Ireland

    Age Rising to 21 to Purchase Vape, Tobacco in Ireland

    Image: FM2 | Adobe Stock

    New legislation is due to come before the Cabinet in Ireland, raising the legal age to buy tobacco and vaping products from 18 to 21.

    The Minister of Health, Stephen Donnelly, is due to seek Cabinet approval this week for the legislation to increase the legal age by three years, according to media.

    While less young people in Ireland are smoking cigarettes, the numbers seem to have plateaued in recent years. The hope iraising rising the age from 18 to 21 will deter younger from smokingo smoke cigarettvapingd vapes, lowering numbers once again.

    Minister Donnelly announced his intention to introduce this legislation back in March.

    “Really, it’s a measure aimed at people who are 15, 16, 17 years of age that with a smoking age at 18, they find it relatively easy to buy cigarettes…but that if you move to 21 it makes it much more difficult,” he said.

    A ban on the sale of tobacco and vape products from vending machines is also set to be introduced.

    Further legislation is planned to ban disposable vapes and address issues related to the flavors and bright colors of vape packaging.

  • Illinois Moving Ahead With ‘Highlighter’ Vape Ban

    Illinois Moving Ahead With ‘Highlighter’ Vape Ban

    Credit: Sharafmaksumov

    Illinois is one step closer to cracking down on e-cigarettes disguised as school supplies.

    Lawmakers in the state propose banning e-cig ads that could confuse adults into thinking they are everyday items, like highlighters and erasers.

    The Illinois Department of Revenue, Attorney General, and local law enforcement would enforce the legislation, media oulets are reporting.

    On Wednesday, Senate Bill 2662 was unanimously approved by the House Executive Committee. The bill is now headed to the House floor for further consideration.

  • Senator Demands FDA Testify Before Congress

    Senator Demands FDA Testify Before Congress

    Vapor Voice Archive

    After months of pressure from lawmakers to prevent the unauthorized sale of vaping devices, federal regulators may soon have to explain themselves before Congress.

    Senate Majority Whip Dick Durbin, who chairs the Senate Judiciary Committee, has long urged the U.S. Food and Drug Administration to follow through on a court-ordered review of premarket tobacco product applications (PMTAs) from e-cigarette manufacturers.

    The U.S. Court for the District of Maryland mandated the survey, ruling in 2019 that the FDA had run afoul of federal law by allowing unauthorized vape sales. The review was supposed to have been completed in 2021, according to Court House News.

    Durbin, in a January letter, accused the agency of “granting a free pass to scores of vaping products that are harming the health of children in our country.”

    Now, Durbin is angling to haul FDA officials before Congress. He demanded in a letter Tuesday that Brian King, director of the agency’s Center for Tobacco Products, testify before the Senate Judiciary Committee.

    Durbin extended a similar invite to Brian Boynton, principal deputy assistant attorney general for the Justice Department’s civil division. Federal law enforcement is tasked with assisting the FDA in bringing enforcement for violations of the Tobacco Control Act, which includes marketing authorizations for vape manufacturers.

    Durbin met with Boynton and King in April during a private meeting to discuss the enforcement of unauthorized e-cigarettes. If the officials agree to testify publicly, the Judiciary Committee will hold a hearing in June.

    A spokesperson for the FDA did not immediately respond to a request for comment on whether it would comply with the request.

  • FDA Updates Authorized Products Database

    FDA Updates Authorized Products Database

    Photo: Andrey Kuzmin

    The U.S. Food and Drug Administration has uploaded the first update to its recently created Searchable Tobacco Products Database, which provides an overview of tobacco products and vapor products that may be legally marketed in the United States.

    Due to timing factors associated with the initial launch, the products included in this update cover a longer time period (January through mid-April 2024) than will typically be included in the future. The agency intends to update the database every month.

    The current database updates include the addition of several tobacco products that were issued a substantial equivalence or exempt order, a number of tobacco products that were determined to be preexisting tobacco products through voluntary submissions, and links to redacted and 508-compliant order letters, decision summaries and other documents for various authorized products that were already in the database.

    The database is available here.

  • Cook Islands Lawmakers to Table Bill Banning Vapes

    Cook Islands Lawmakers to Table Bill Banning Vapes

    Credit: Oleksii

    Lawmakers in the Cook Islands have proposed a ban on all next-generation tobacco products, including e-cigarettes.

    The proposal is included in the Tobacco Products Control Amendment Bill 2024, which will be tabled in Parliament this month.

    Cook Islands residents, permanent residents and work permit holders are not allowed to bring in any vaping or heated tobacco products for personal use, sale or distribution if they leave and return to the Cook Islands, according to the Bill.

    Tourists over the age of 21 are allowed to bring only one “imitation tobacco device” and up to 30 milliliters of e-liquid, according to media reports.

    The Bill says any breach of the regulations by individuals will result in a fine of $100,000 or up to three months in prison.

    Businesses caught importing imitation tobacco products face a $1 million fine. Additionally, non-compliant businesses will incur a daily penalty of $100,000 for each day the violation continues.

  • Development of Vaping Rules a Priority in Samoa

    Development of Vaping Rules a Priority in Samoa

    Credit: SC Stock

    Development of regulations to support the enforcement of e-cigarettes in Samoa, including their sale and usage, is in the pipeline.

    Parliament’s discussion on the topic last year and young people seen smoking e-cigarettes has prompted calls for the Ministry of Health (MOH) to take action.

    Vaping products were not readily available when the MOH developed Somoa’s Tobacco Control policy and legislation, but its availability in neighboring countries and the product being sold locally without control meant the Government had to reconsider whether tobacco rules applied to vaping, according to media reports.

    In those efforts, the Samoa Australia Tautua program funded by Australia has put out a vacancy for Technical Assistance assigned to develop a comprehensive set of regulations for e-cigarettes in Samoa as a means to support its enforcement and prevention of the harmful effects of its use.

    The term of reference for the Technical Assistance is to draft regulations to “prohibit the importation, distribution, sale, and usage” of e-cigarettes in Samoa.