Category: Regulation

  • Philip Morris Fortune: Vape Law Paves Way for Future

    Philip Morris Fortune: Vape Law Paves Way for Future

    Credit: Alexander Ovsyannikov

    The enactment of a new vape law in the Philippines last year has paved the way for products that provide smokers with better alternatives to cigarettes, according to Philip Morris Fortune Tobacco Co. (PMFTC) President Denis Gorkun.

    In addition to moving regulation of vapes from the Philippine Food and Drug Administration to the Department of Trade and Industry, Republic Act 11900 lowered the purchase age for e-cigarettes and heated tobacco products from 21 to 18, removed a two-flavor limit on product flavors and allows companies to conduct corporate social responsibility-related activities.

    In an interview with the Manila Bulletin, Gorkin said PMFCT would soon launch IQOS Luma, which uses induction technology to heat tobacco, and ZYN nicotine pouches in the Philippines. Made by Swedish Match, which was acquired by PMFTC’s parent company, Philip Morris International in 2022, ZYN is the best-selling nicotine pouch in the United States today.

    Since PMFTC launched IQOS in the Philippines, around 75,000 local smokers had switched away from cigarettes, according to Gorkun.

    Gorkun said PMI aims to eliminate cigarette consumption in line with its vision to deliver a smoke-free future. “We will continue to work towards our smoke-free future vision with products that are found by numerous international health authorities to be far better compared to continuing to smoke cigarettes.”

    He said the passage of the landmark Vape Law a year ago is a “win” for public health. While providing smokers with less harmful options, the law also contains provisions to deter underage consumption, according to its proponents.

    One of the authors of the vape law, former Representative Sharon Garin, said Republic Act 11900 provides that vaping isn’t made appealing to minors. “We don’t want non-smokers to pick up the habit of vaporized or electronic cigarettes,” she was quoted as saying. “What we want is a less harmful alternative for current smokers.”

  • U.S. FDA Cracking Down on Kid Friendly Products

    U.S. FDA Cracking Down on Kid Friendly Products

    Credit: FDA

    Regulators in the United States are cracking down on online retailers selling vaping products that are attractive to youth. The Food and Drug Administration today issued warning letters to 16 (the agency reported 15, but lists 16) online retailers for selling and/or distributing unauthorized e-cigarette products packaged to look like cartoon characters, school supplies, toys, and drinks.

    “The design of these products is a shamelessly egregious attempt to target kids,” said Brian King, director of FDA’s Center for Tobacco Products (CTP). “It’s a tough sell that adults using e-cigarettes to transition away from cigarettes need them to look like SpongeBob in order to do so successfully.”

    The unauthorized products described in the warning letters include e-cigarettes that feature youth-appealing characters from TV shows, movies, and video games, including “SpongeBob,” “Lots-o’-Huggin’ Bear,” and “Mario.” The also imitate drinks from companies such as Starbucks and Dunkin coffee cups, soda and water bottles, according to press release.

    “The retailers receiving these warning letters sell and/or distribute e-cigarettes in the United States that lack authorization from FDA, which is a requirement under the Federal Food, Drug, and Cosmetic (FD&C) Act to legally market a new tobacco product,” the FDA states. “In addition to the specified products mentioned in the warning letters, the retailers were warned to address any violations that are the same as or similar to those stated in the warning letter, and promptly take any necessary actions to bring the tobacco products that they offer for sale in the United States into compliance with the FD&C Act.”

    The retailers were 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.

    “CTP will continue to closely monitor all those in the supply chain, including retailers, for compliance with federal law,” said attorney Ann Simoneau, director of the Office of Compliance and Enforcement within the CTP. “As always, we will hold anyone accountable that sells unauthorized tobacco products labeled, advertised, and/or designed to encourage use by our nation’s youth.”

    The companies receiving warning letters include:

    • VR Products I LLC d/b/a eJuiceDB
    • Titan Star Resources d/b/a Vape Vandal Ltd
    • Vapesstores.com
    • Disposable Vapes Wholesale
    • Vapestore.to
    • Venture Concept Groups d/b/a High Light Vape Co.
    • Best Vapes Store
    • Apex Vape
    • The Juice Machine
    • StrikesUSA
    • Finest Ounce Vape Stor d/b/a Finest Ounce Vape Malaysia
    • Spongbob Vape
    • Mini Cup Vape
    • Vape123
    • Viper Vapor d/b/a Viper Vapor Kelso
    • Mochivap

    These new warning letters mark another step in the FDA’s continued efforts to remove illegal e-cigarettes from the market, particularly those that appeal to youth, the agency states. As of August 2023, the FDA has issued approximately 600 warning letters to firms for manufacturing and/or distributing illegal tobacco products, including e-cigarettes, filed civil money penalty complaints against 26 e-cigarette manufacturers, and worked with the Department of Justice to seek injunctions against 6 e-cigarette manufacturers.

  • New Zealand Sets New Youth Vaping Regulations

    New Zealand Sets New Youth Vaping Regulations

    Photo: Molly

    New Zealand has set new regulations to limit youth vaping, effective Sept. 21, reports the Xinhua News Agency.

    New specialist vape shops will be banned in locations within 300 meters of schools and Maori meeting places, according to Health Minister Ayesha Verrall.

    “Vapes will need child safety mechanisms, and names like ‘cotton candy’ and ‘strawberry jelly donut’ will be prohibited,” Verrall said. Only generic names like “orange” or “berry” that accurately describe the flavors will be allowed.

    The new regulations also set the maximum allowed nicotine level and require that all vaping devices have removable batteries.

    “We’re creating a future where tobacco products are no longer addictive, appealing or as readily available, and the same needs to apply to vaping,” Verrall said.

  • U.S. FDA to Hold Public Meeting on PMTA Process

    U.S. FDA to Hold Public Meeting on PMTA Process

    The U.S. Food and Drug Administration will hold a two-day public meeting on the agency’s premarket tobacco product application (PMTA) process on Oct. 23–24, 2023.

    The meeting will be held on the FDA’s White Oak Campus in Silver Spring, Maryland, and will be in a hybrid format with the option to attend virtually.

    Staff from the Center for Tobacco Products’ Office of Science will present on topics related to the PMTA process and be available to respond to questions received from stakeholders on the topic, according to a press note.

    Additional information, including registration and question submission processes, will be available soon.

  • McKinney Regulatory Science Reveals New Website

    McKinney Regulatory Science Reveals New Website

    McKinney Regulatory Science Advisors has launch its new website that promises “a new era of innovation and transparency for their clients,” according to a press release.

    The new platform describes an array of advisory services to nicotine and cannabis clients, with an emphasis on providing McKinney clients with the best available regulatory services.

    Willie McKinney, CEO of McKinney, said the new website represents a significant milestone in journey to provide exceptional advisory services to our nicotine and cannabis clients.

    “The revamped platform reflects our dedication to innovation, transparency, and client satisfaction, making it easier for clients to explore our services and access valuable regulatory resources,” he said

    The new website offers a modern design that makes it easy for users to find the information they need quickly. It also features an intuitive navigation system that allows users to identify relevant services and access helpful resources rapidly, according to McKinney. Additionally, the site is optimized for mobile devices so that users can access the site from any device at any time.

    “McKinney RSA focuses on providing comprehensive solutions that meet complex regulatory requirements while also delivering superior customer service,” the release states. “With decades of industry experience under their belt, they are committed to helping their clients succeed by providing top-notch guidance every step of the way.”

  • Venezuela Officials Place Ban on All Vaping Products

    Venezuela Officials Place Ban on All Vaping Products

    Credit: Zero Photo

    Venezuela has banned all vaping products. The country’s Ministry of People’s Power for Health issued a resolution this week prohibiting the manufacture, storage, distribution, circulation, commercialization, import, export, use, consumption, advertising, promotion, and sponsorship of electronic nicotine delivery systems (ENDS).

    Additionally, electronic non-nicotine delivery systems (ENNS), consumables, tanks or cartridges, refill consumable containers and other accessories are also banned, according to an emailed press release.

    Venezuela joins Argentina and Brazil in banning vaping products in South America.

    The decision comes two months after Venezuelan President Nicolas Maduro asked his government’s medical and scientific team to consider the ban. According to the Ministry of Health, “the measure is taken in response to the alerts promoted by the World Health Organization (WHO).”

    Alberto Gomez, community manager for Spain and Latin America for the World Vapers’ Alliance, said the ban on reduced harm products in Venezuela is a setback for public health.

    “Thousands of Venezuelans had already quit traditional tobacco thanks to vaping and had managed to improve their health,” he said. “Now they will have difficulty accessing the products, and it will be more difficult for more smokers to switch to less harmful alternatives. Venezuela should follow the example of countries like Sweden or the United Kingdom, which are on the way to eradicating smoking, not the WHO’s biased and paternalistic approach.”

    Prohibition always fails and brings unintended consequences, according to Gomez, adding that users will turn to the illicit market or return to smoking, while smokers can no longer switch to less risky products.

    “Public health will worsen, and smoking will mean higher costs for the health system. In addition, the illicit market does not control the sale to minors, the products do not pass safety and quality controls, and no taxes are paid. Prohibition does not solve anything.

    “More than 15,000 people die every year in Venezuela from tobacco-related diseases. Promoting the use of less harmful alternatives has the potential to save thousands of lives and improve public health. The Venezuelan government has an obligation to listen to those who have been able to quit smoking and improve their health thanks to vaping and establish risk-based regulation.”

  • New BAT Boss Calls for ‘Better’ Vaping Rules

    New BAT Boss Calls for ‘Better’ Vaping Rules

    Tadeu Marroco says issues such as youth use continue as many countries adopt a tougher stance on vaping products.

    The newly appointed head of British American Tobacco has expressed a desire for governments to apply more “better regulations” towards vaping products and other tobacco alternatives, as the public debate over them is growing in intensity and becoming an issue for the industry.

    Tadeu Marroco told the Financial Times that the FTSE 100-listed owner of Lucky Strike and Dunhill was “very keen” to work with regulators to address problems such as vaping’s use among teenagers and its environmental impact.

    “We need to have better regulations. We cannot ignore the benefit of migrating smokers out of cigarettes, but being unregulated, we have issues related to youth access and the environment,” Marroco said.

    “The problem is that this is a phenomenon that has grown so fast and the regulators are always catching up. But there are clearly opportunities for us to improve the level playing field.”

    Since Marroco took the helm in May of this year, there has been an increased push around the globe to restrict flavored e-cigarettes, due in part to advice from anti-nicotine groups and World Health Organization. India, Thailand, and Argentina have all implemented full bans on all forms of vaping products.

    NHS guidelines in the UK suggest vapes can help people stop smoking although they also state that the activity “is not completely risk-free”. The government said in April it would offer 1 million smokers vape starter kits. Selling vapes to under-18s is illegal.

  • Kazakhstan Readies to Enact Ban on Vape Products

    Kazakhstan Readies to Enact Ban on Vape Products

    Photo: natatravel

    Lawmakers in Kazakhstan voted on July 29 to ban the sale, import, export and production of e-cigarettes and liquids, reports Atlas News.

    “The harm of vapes is undeniable,” said Deputy Nurgul Tau. “That is why the Ministry of Health has been sharply raising the issue of introducing a ban on the circulation of vapes since 2021. In my request, I proposed a complete ban on the sale of vapes.”

    The legislation has been in the works since May 10 following a ban of the use of e-cigarettes in public spaces. The ban was triggered by concern about increased vaping among minors.

  • FDA Makes Next TPSAC Meeting Materials Available

    FDA Makes Next TPSAC Meeting Materials Available

    The U.S. Food and Drug Administration’s Tobacco Products Scientific Advisory Committee (TPSAC) met on May 18 to discuss the “Requirements for Tobacco Product Manufacturing Practice” proposed rule. All the meeting materials, including the recording, transcript and summary minutes, are now available online.

    The proposed rule, if finalized, lays out the FDA’s requirements for tobacco product manufacturers regarding the manufacture, design, packing and storage of tobacco products.

    Comments on the proposed rule must be submitted by 11:59 p.m. Eastern Time on Sept. 6, 2023.

  • FDA Seeks Input on 5-Year Tobacco Center Strategic Plan

    FDA Seeks Input on 5-Year Tobacco Center Strategic Plan

    Credit: FDA

    The U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) will hold a virtual listening session on Aug. 22 to give the public an opportunity to comment on the five-year plan it developed to advance its mission.

    As part of its response to the Reagan-Udall Foundation evaluation, the CTP plan includes five proposed goal areas that are interconnected with the themes of health equity, science, transparency and stakeholder engagement.

    The proposed goals and the questions that the CTP would like commenters to address are on the agency’s virtual listening session event page.

    Following receipt and consideration of public input, the CTP intends to publish its strategic plan by the end of 2023.

    After introductions, the center will begin the listening session with an overview of the process used to develop the CTP’s strategic plan. Registered speakers will then have approximately four minutes each to verbally share their comments on any topics related to the strategic plan.

    Request to verbally provide open public comment must be submitted by Aug. 14 at 11:59 p.m. Eastern Time.

    In addition to this listening session, the public can submit electronic or written comments to the Federal Register notice. Electronic comments must be submitted and written comments must be postmarked by Aug. 29.