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Category: Global Regulation

  • Public Meeting on PMTA Process

    Public Meeting on PMTA Process

    Credit: JHVEPhoto

    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’s New Website

    McKinney Regulatory Science’s 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.”

  • Warnings for Unauthorized Smokeless Products

    Warnings for Unauthorized Smokeless Products

    Image: calypso77

    The U.S. Food and Drug Administration sent a warning letter to Amarillo Snuff Co. on Aug. 11, 2023, for manufacturing, selling and/or distributing unauthorized smokeless nicotine products, including products that are made with corn husks instead of tobacco leaves, according to an FDA release.

    The unauthorized products contain nontobacco nicotine, which falls under the FDA’s regulation authority. 

    “Last year, Congress clarified FDA’s authority to regulate tobacco products containing nicotine from any source, which closed a loophole that several companies were using to try to evade regulation,” said Brian King, director of the FDA’s Center for Tobacco Products (CTP). “Our authority over these products is clear, and FDA is committed to holding those responsible for illegal products accountable for their actions.” 

    The cited products lack FDA marketing authorization. To date, the FDA has not authorized any nontobacco nicotine products.

    After receiving a warning letter, recipients have 15 working days to respond with steps they will take to correct and prevent future violations; failure to promptly correct violations can result in additional FDA actions such as injunction, seizure and/or civil money penalties.

    “A majority of firms that receive warning letters correct their violations, but if they fail to do so, the products are subject to enforcement,” said Ann Simoneau, director of the CTP’s Office of Compliance and Enforcement. “FDA continues to bring enforcement actions, including injunctions and civil money penalties, as appropriate.”

    As of July 28, 2023, the FDA has issued about 600 warning letters to manufacturers of unauthorized tobacco products, with 100 of the letters being for unauthorized nontobacco nicotine products. As of June 30, 2023, the FDA has issued more than 2,800 warning letters and 825 civil money penalties for sales of e-cigarettes to underage purchasers, with over 1,000 warning letters and more than 140 civil money penalties relating to sales violations of nontobacco nicotine products to underage consumers.

  • Registration Open for CTP Listening Session

    Registration Open for CTP Listening Session

    Credit: Postmodern Studio

    Registration is open for the virtual listening session on the development of the Center for Tobacco Products’ (CTP) five-year strategic plan, which will take place on Aug. 22 beginning at 10 a.m. EDT.

    The virtual listening session is an opportunity to verbally provide open public comment on the development of the new strategic plan, including proposed strategic goals. After introductions, the center will begin the listening session with an overview of the process used to develop the CTP’s strategic plan, including proposed goal areas. Registered speakers will then have approximately four minutes each to verbally share their comments on any topics related to the strategic plan. Submit a request to verbally provide open public comment by Aug. 14 at 11:59 p.m. EDT.

    Registration also includes a “listen-only” option for those who want to attend the session but do not request to speak. Listen-only registration slots are unlimited, but registration is required. There is no deadline to register for listen-only slots.

    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.

  • Kazakhstan to Ban Vapes

    Kazakhstan to Ban Vapes

    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.

  • TPSAC Meeting Materials Available

    TPSAC Meeting Materials Available

    Credit: Postmodern Studio

    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.

  • CTP Invites Input on Strategic Plan

    CTP Invites Input on Strategic Plan

    Credit: Monticello

    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 its five-year plan it developed to advance its mission.

    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.

  • FDA Grant to Study Effects of Flavors

    FDA Grant to Study Effects of Flavors

    Image: Tobacco Reporter archive

    The U.S. Food and Drug Administration has given the Center for Tobacco Research at The Ohio State University Comprehensive Cancer Center a $3.9 million grant to evaluate the effects of e-cigarette flavors on smoking behaviors of current adult smokers, according to News Medical Lifesciences.

    The study will be co-led by Theodore Wagener, director of Ohio State’s Center for Tobacco Research, and Tracy Smith from the Medical University of South Carolina Hollings Cancer Center.

    Wagener says, “the FDA must decide how to balance its goals of protecting young people and offering harm-reduction options to adults. This new trial will generate critical data to help make more informed public health decisions that have a lasting impact.”

    “The FDA is currently making regulatory decisions about e-cigarette flavors with incomplete scientific data,” Wagener said. “Existing data show that smokers also prefer flavored e-cigarettes, and while there are a few survey studies suggesting that flavored e-cigarettes may be more helpful for switching to vaping, these studies are not rigorous enough for the FDA to base its regulatory decisions on. Our study will be the first to provide the FDA with definitive information as to the benefit, if any, of e-cigarette flavors to adult smokers.”

    The national, randomized, controlled trial will recruit up to 1,500 cigarette users from across the country, and researchers will measure e-cigarette flavor impact on product uptake and appeal, cigarette craving, symptoms, dependence and smoking behavior. Combination nicotine-replacement therapy will be used as a comparator to determine potential increased benefit of e-cigarettes versus nicotine-replacement therapy.

    “If our study demonstrates no significant improvements in switching with flavored e-cigarette use, then the continued sale of these products is likely indefensible; however, if improvements are significant, these findings will provide a critical counterweight to the current FDA regulations and will aid future decision-making,” Wagener said.

  • FDA Denies Marketing of Myblu Menthol

    FDA Denies Marketing of Myblu Menthol

    Image: Tobacco Reporter archive

    The U.S. Food and Drug Administration on July 10 issued a marketing denial order (MDO) for Myblu Menthol 2.4 percent, an e-cigarette product made by Fontem US. The order prohibits the company from marketing or distributing this product in the United States.

    “Thorough scientific review of tobacco applications is a key pillar under FDA’s role to protect the public from the dangers of tobacco use,” said Matthew Farrelly, director of the Office of Science within the FDA’s Center for Tobacco Products. “This application lacked the scientific evidence needed to demonstrate that the product provided a net benefit to the public health that outweighs the known risks.”

    Among other shortcomings, the application presented insufficient scientific evidence to show that the menthol-flavored e-cigarette products provided an added benefit for adults who smoke relative to tobacco-flavored e-cigarettes, according to the FDA.

    Fontem US may resubmit a new application to address the deficiencies for the product subject to this MDO.

    To date, the FDA has authorized 23 tobacco-flavored e-cigarette products and devices. Last year, the FDA issued MDOs to Fontem US for several other Myblu products, which are the subject of ongoing litigation.

  • Ghana Outlaws Vape Sales and Promotion

    Ghana Outlaws Vape Sales and Promotion

    Ghana has banned all recreational use of vaping and e-cigarette products.

    In a press release, the country’s Food and Drugs Authority (FDA) states that the “sale, advertisement and recreational use of electronic nicotine delivery systems (ENDS) such as vapes and other non-nicotine tobacco products by the public” is illegal.

    However, ENDS can be registered as a prescription-only medicine for the purposes of cessation therapy.

    The FDA claims it has sent notice to manufacturers, importers, wholesalers, and retailers to remove all advertisements on social media, billboards and neon signs immediately and refrain from the importation of the products.

    The FDA states that there “will be repercussions including sanctions” for failure to adhere to the rules.