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Category: Global Regulation

  • ‘FDA Botched Review’

    ‘FDA Botched Review’

    Image: Tobacco Reporter archive

    The U.S. Food and Drug Administration failed to conduct a proper analysis before rejecting premarket tobacco product applications (PMTAs) submitted by Fontem U.S. for certain vaping products, the U.S. Court of Appeals for the D.C. Circuit found on Aug. 29.

    The court upheld the regulatory agency’s denial of Fontem’s application to market flavored vaping products but rejected the FDA’s denial of Fontem’s application for unflavored products.

    “While the FDA identified multiple ‘deficiencies’ [in Fontem’s application], it failed to analyze the trade-offs necessary to make a public health finding,” the judges wrote in their ruling. “Nor did the agency explain how the specific deficiencies relate to its overall conclusion that Fontem failed to demonstrate its unflavored products were appropriate for the protection of public health. The agency’s denial therefore failed to comport with the requirements of the Tobacco Control Act.”

    The FDA’s failure to correctly apply the public health inquiry to Fontem’s unflavored products led it to make another serious error, according to the court. In its initial deficiency letter, the FDA requested certain information from Fontem, thereby indicating such information would be sufficient for the agency to approve Fontem’s products.

    But in its denial order, the agency changed its tune, reproaching Fontem for failing to provide information that the agency had never explicitly sought.

    “Shifting the regulatory goal posts without explanation is arbitrary and capricious,” the judges wrote. “By indicating in its deficiency letter that Fontem could resolve issues with its applications by providing specific information, the FDA represented such information would be sufficient to secure approval.”

  • Governments Urged to Raise Smoking Age

    Governments Urged to Raise Smoking Age

    Photo: Elena Shvoeva

    Researchers are urging governments to raise the legal smoking age to 22 after a study found that those who start smoking before the age of 20 find it more difficult to quit.

    The scientists analyzed the associations between nicotine dependency and successful smoking cessation according to the age participants started smoking. They presented their findings at the European Society of Cariology Congress, which took place Aug. 25–28 in Amsterdam.

    The study included 1,382 smokers, of whom 30 percent were women. Early starters reported a higher number of cigarettes per day (25) compared with late starters, who smoked 22 cigarettes per day. Those who started early had higher respiratory carbon monoxide levels compared with those who started late (19 ppm versus 16.5 ppm, respectively) and higher scores on the Fagerstroem test for nicotine dependence (7.4 versus 6.3, respectively).

    Less than half of early starters (46 percent) successfully quit smoking compared with 56 percent of late starters, for an odds ratio of 0.711 after adjusting for sex, age at clinic visit and smoking cessation aids—indicating that early starters were 30 percent less likely to successfully kick the habit compared with late starters.

    “Our results show that starting smoking early is linked with higher nicotine dependency, even in young adulthood,” said study author Koji Hasegawa of the National Hospital Organization Kyoto Medical Center in Japan in a statement. “The study indicates that increasing the legal age to buy tobacco to 22 years or older could lead to a reduction in the number of people addicted to nicotine and at risk of adverse health consequences.”

  • TPMP Comment Period Extended

    TPMP Comment Period Extended

    Credit: May1985

    The U.S. Food and Drug Administration has extended the comment period on its proposed rule for tobacco manufacturing practices.  

    Stakeholders now have until Oct. 6, 2023, to share their thoughts.

    The proposed rule would place new requirements for tobacco product manufacturers regarding the manufacture, design, packing and storage of their products. According to the FDA, these proposed requirements would help protect public health by, among other things, minimizing or preventing contamination and limiting additional risks by ensuring product consistency.

  • 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.