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Category: Global Regulation

  • Latest PATH Data Files Released

    Latest PATH Data Files Released

    Photo: Tobacco Reporter Archive

    The U.S. Food and Drug Administration’s Center for Tobacco Products and the National Institute of Health’s National Institute on Drug Abuse announced the availability and location of newly released and updated data files from the Population Assessment of Tobacco and Health (PATH) Study, including the following:

    New data sets:

    Updated datasets:

    The Wave 5.5 Special Collection data were collected from youth participants ages 13 to 19 between July and December 2020. Data in the PATH-ATS were collected between September and December 2020 from a subsample of adult participants ages 20 and older, complementing the Wave 5.5 Special Collection. Additionally, Restricted-Use Files have been updated to include Wave 5 Ever/Never Reference Data, and the Restricted-Use and Public-Use Master Linkage Files have been updated.

    Questions about the collection, content, weighting, documentation, or structure of PATH Study data (this excludes questions on statistical analysis or analytic guidance) may be submitted to PATHDataUserQuestions@Westat.com.

  • FDA Names New CTP Director

    FDA Names New CTP Director

    Photo courtesy of Robert Califf’s Twitter

    The U.S. Food and Drug Administration has named Brian A. King as the new Center for Tobacco Products (CTP) director.

    “After a robust executive search, I have selected Dr. Brian A. King as FDA’s new Center for Tobacco Products Director,” Robert Califf wrote on Twitter. “Dr. King brings extensive and impressive expertise in tobacco prevention and control and has broad familiarity with FDA from his more than 10-year tenure at CDC.”

    King is the deputy director for research translation in the Office on Smoking and Health (OSH) within the National Center for Chronic Disease Prevention and Health Promotion at the Centers for Disease Control and Prevention. In this capacity, he is responsible for providing scientific leadership and technical expertise to CDC/OSH, the lead federal agency for comprehensive tobacco prevention and control.

    King joined the CDC in 2010 as an epidemic intelligence service officer before which he worked as a research affiliate in the Division of Cancer Prevention and Population Sciences at Roswell Park Comprehensive Cancer Center in Buffalo, New York. During his time at Roswell Park, his primary research focus related to tobacco prevention and control.

    King has worked for over 15 years to provide sound scientific evidence to inform tobacco control policy and to effectively communicate this information to key stakeholders, including decision makers, the media and the general public. He has authored or co-authored over 200 peer-reviewed scientific articles pertaining to tobacco prevention and control, was a contributing author to the “50th Anniversary Surgeon General’s Report on Smoking and Health,” was the lead author of CDC’s 2014 update to the evidence-based state guide, “Best Practices for Comprehensive Tobacco Control Programs,” and was the senior associate editor of the 2016 Surgeon General’s report, “E-cigarette Use Among Youth and Young Adults” and the 2020 Surgeon General’s report, “Smoking Cessation.” He was also the renior official for the CDC’s emergency response to the 2019 outbreak of e-cigarette, or vaping, product use-associated lung injury.

    King holds a doctorate degree and a Master of Public Health degree in epidemiology from the State University of New York at Buffalo.

  • Senator Calls on U.S. FDA to End Enforcement Discretion

    Senator Calls on U.S. FDA to End Enforcement Discretion

    Photo: Tobacco Reporter Archive

    In a speech on the Senate floor, U.S. Senator Dick Durbin blasted the U.S. Food and Drug Administration for its delays in completing its public health review of e-cigarette premarket tobacco product applications (PMTAs). The deadline for the FDA to finish reviewing e-cigarette applications was Sept. 9, 2021, more than eight months ago.

    On June 13, the regulatory agency submitted an update on the agency’s review of e-cigarette applications and stated it will not finish reviewing e-cigarettes until July 2023 and that products under review may continue being sold.

    “These companies have flooded the market with addictive devices. Companies like Juul, partially owned by the tobacco companies, understand that they’ve promoted their products to children,” Durbin said, according to a release from his office. “For years, none of these products were legally authorized. Who was supposed to be the cop on the beat? The Food and Drug Administration, but they were nowhere to be found.”

    In March, Durbin led a bipartisan letter with 14 of his colleagues calling on the FDA to finish its review of e-cigarettes immediately; reject applications for e-cigarettes, especially kid-friendly flavors, that do not prove they will benefit the public health; and clear the market of all unapproved e-cigarettes.

    “I am calling on the FDA to immediately halt its enforcement discretion and remove all unauthorized e-cigarettes from the market,” Durbin stated. “Don’t allow Juul and other tobacco companies one more day of endangering our children. Stop cowering before Big Tobacco’s highly paid lawyers.”

  • Cigarette Health Warnings Effective Date Postponed Again

    Cigarette Health Warnings Effective Date Postponed Again

    Photo: Tobacco Reporter Archive

    On May 10, the U.S. District Court for the Eastern District of Texas issued an order in the case of R.J. Reynolds Tobacco Co. et al. v. United States Food and Drug Administration et al., No. 6:20-cv-00176 to postpone the effective date of the “Required Warnings for Cigarette Packages and Advertisements” final rule.

    The new effective date of the final rule is July 8, 2023. Pursuant to the court order, any obligation to comply with a deadline tied to the effective date is similarly postponed. For example, the FDA strongly encourages entities to submit cigarette plans as soon as possible but no later than Sept. 8, 2022.

    This is not the first time the new health warnings have been delayed. The rule was most recently delayed to April 9, 2023, after being postponed multiple times before this over the past few years. The rule was originally supposed to go into effect in 2021.

    Additional details on the rule, as well as the new effective date and recommended date for submission of cigarette plans, can be found on the FDA’s website.

  • FDA Hands Court PMTA Status Report

    FDA Hands Court PMTA Status Report

    Photo: Tobacco Reporter Archive

    The U.S. Food and Drug Administration has submitted a status report for products that currently have a premarket tobacco product application (PMTA) under review. The regulatory agency states that it expects to have resolved 63 percent of the applications set out in its original priority by June 30, 2022, and 72 percent of the applications in its original priority set by the end of this year.

    “The FDA’s progress largely reflects the review priorities that the agency established in 2020, when review began. Given the large influx of concurrent applications, the FDA prioritized review of applications from manufacturers with the greatest market share at the time because decisions on those applications were expected to have the greatest impact on public health,” the report states. “As a result, the FDA allocated significant resources to review applications from the five companies whose brands represented over 95 percent of the e-cigarette market at that time: Fontem (blu), Juul, Logic, Njoy and R.J. Reynolds (Vuse).”

    In the order requiring the FDA to submit status reports, the Maryland court stated that covered applications are limited to applications for products that are sold under the brand names Juul, Vuse, Njoy, Logic, blu, SMOK, Suorin or Puff Bar. Additionally, any product with a reach of 2 percent or more of total “Retail Dollar Sales” in Nielsen’s Total E-Cig Market & Players or Disposable E-Cig Market & Players reports.

    To determine which applications are for products sold under the listed brand names, the FDA used its internal PMTA database, which organizes applications by manufacturer, according to the agency. The FDA searched its database for the brand names to identify the manufacturers related to each relevant brand name and then searched its database to identify applications submitted by the manufacturers.

    The FDA stated that it had conferred with the plaintiffs in the case who agreed that only one brand beyond those listed meets the 2 percent threshold. That brand was not identified. Of those applications the FDA deems requiring status reports, the agency stated that it had identified 240 covered applications. The agency estimates that, based on current information, the FDA will take action on:

    • 51 percent of covered applications by June 30, 2022;
    • 52 percent of covered applications by Sept. 30, 2022;
    • 56 percent of covered applications by Dec. 31, 2022;
    • 56 percent of covered applications by March 31, 2023; and
    • 100 percent of covered applications by June 30, 2023.

    The agency also states that not every covered application has an equal potential impact on the public health. For example, more than 25 percent of the covered applications are for products not currently on the market.

    The FDA identified two applications for products sold under the relevant brand names where the applicant stated that the products were not on the market as of Aug. 8, 2016. The FDA also identified three other applications for products sold under the relevant brand names where the applicant did not state whether the products were on the market as of Aug. 8, 2016. The FDA has not included information about these five applications in the current status report.

    “Also, some e-cigarette devices consist of a small number of components, resulting in a small number of individual product applications for the entire system. A disposable prefilled device, for example, could constitute a single product with one application. Other e- cigarette devices, by contrast, consist of many components with separate tanks, coils, tubes and pods, resulting in dozens of separate product applications for a single system,” the status report states. “Of the covered applications that the FDA anticipates will remain to be resolved beyond the end of 2022, more than half are for components of a limited number of e-cigarette device systems representing under 2.5 percent of the e-cigarette market. The FDA has made and will continue to make significant progress in reviewing and resolving applications for e-cigarette products to achieve the greatest impact on public health.”

    The agency stated that it will file another status report by July 29, 2022, that will include any revisions to the estimates disclosed in the first report.

  • Marketing Orders for Vuse Vibe and Vuse Ciro

    Marketing Orders for Vuse Vibe and Vuse Ciro

    The U.S. Food and Drug Administration on May 12 gave R.J. Reynolds Vapor Co. (RJRVC) permission to continue marketing the original-flavor varieties of its Vuse Vibe and Vuse Ciro products. In October 2021, the FDA authorized the marketing of Vuse Solo original flavor.

    “These authorizations represent the broadest portfolio of market authorizations provided to any company in the U.S for premarket tobacco product applications (PMTA),” said David O’Reilly, director of scientific research at RJRVC’s parent company, BAT, in a statement. “Continued focus on science and innovation has supported the robust submissions, which have enabled FDA to evaluate and authorize the marketing of these products.

    “We are proud of the work undertaken by the team to achieve this significant regulatory milestone and are confident in the quality of our applications.”

    While approving the original-flavor varieties, the FDA denied RJRVC’s applications for the marketing of Vuse-branded products with other flavors. Those flavored vapor products are not currently marketed or sold in the U.S., according to BAT. The company says it is reviewing the FDA’s decision on those applications to determine next steps.

    RJRVC’s application to market menthol-flavored Vuse products remains under FDA review and those products can remain on market pending a decision from the agency.

  • PMTA Deadline Approaching

    PMTA Deadline Approaching

    Courtesy: US FDA

    Manufacturers of nontobacco nicotine (NTN) products on the market as of April 14, 2022, that wish to continue to market their products are required to submit a premarket tobacco product application (PMTA) to the U.S. Food and Drug Administration by May 14, 2022.

    The May 14 deadline is only for applicants submitting electronically, as required by the FDA. Applicants can, however, request a waiver from the FDA to submit a PMTA in a different format. An application submitted in hard copy must be received by the FDA no later than 4 p.m. Eastern Daylight Time on Friday, May 13.

    The FDA received from the U.S. District Court of Maryland a 14-day extension to file the first PMTA status reports required by the court’s revised remedial order on April 29.

    “The extension request is supported by good cause. Compiling the information needed for the status report has required considerable time and effort, and defendants have been working with plaintiffs to resolve any ambiguities about which applications will be covered in the status report,” the motion states.

    The new law additionally provides that an NTN product with a tobacco-derived “previous version” that received a negative action on a PMTA from the FDA, such as a refuse-to-file or marketing denial order, may not continue to be marketed after May 14, 2022, without receiving a marketing granted order from the FDA.

    Such products must be removed from the market, even if a new PMTA is submitted, until the marketing granted order is received, according to the agency. Products on the market after July 13, 2022, without an FDA marketing granted order are in violation of section 910 of the Food, Drug and Cosmetic Act and may be subject to FDA enforcement.

    For products not on the market on April 14, 2022, a PMTA must be submitted to the FDA and marketing authorization must be received before the product can be sold in the United States.

  • Finland Tightens Tobacco Laws

    Finland Tightens Tobacco Laws

    Photo: sezerozger

    On May 1, 2022, a revised Tobacco Act took effect in Finland as part of a long-term strategy to eliminate smoking, according to reports by YLE News and Business Standard.

    Smoking at playgrounds and on public beaches is now banned. The beach ban is in effect annually from the beginning of May to the end of September.

    The ban aims to protect youth from secondhand smoke as well as reduce littering and environmental damage related to smoking.

    Tobacco flavoring products including flavor cards are also banned under the revised legislation. Characterizing flavors such as menthol or strawberry in cigarettes were illegal already. The new rules are targeted at products that enable consumers to flavor their unflavored tobacco products.

    Products already in stores and warehouses have until the end of April 2023 to be sold.

    By May 2023, stricter regulations on product packaging will go into effect. Brand images will no longer be allowed on packaging, with the goal of reducing the appeal of tobacco products.

    Finland has been gradually restricting public smoking since 1976, starting with bans on public transport and later extending to all public indoor areas.

  • FDA Gets Until May 16 to File PMTA Reports

    FDA Gets Until May 16 to File PMTA Reports

    Courtesy: US FDA

    UPDATE: The order has been granted. First reports are due May 16.

    The U.S. Food and Drug Administration is asking the U.S. District Court of Maryland for a 14-day extension to file the first status report required by the Court’s revised remedial order.

    The plaintiffs in the case consent to the requested extension, according to the motion filed today.

    “The extension request is supported by good cause. Compiling the information needed for the status report has required considerable time and effort, and Defendants have been working with
    Plaintiffs to resolve any ambiguities about which applications will be covered in the status report,” the motion states. “Also, a number of FDA employees helping to prepare the status report were out of the office on pre-planned leave last week, and a key FDA employee responsible for the status report will be out of the country on pre-planned leave next week.

    “Defendants do not seek to modify any other deadline, and the FDA’s second status report would remain due July 28, 2022. Defendants are prepared to have this letter serve as their consent motion for a 14-day extension.”

    Judge Grimm is expected to grant the motion’s request. The new deadline for first PMTA status reports would be May 16 if motion is granted.

  • Smoore Flattered by FDA Marketing Orders

    Smoore Flattered by FDA Marketing Orders

    Photo: Timothy S. Donahue

    When the U.S. Food and Drug Administration authorized the NJOY Ace vaporizer and its tobacco-flavored e-liquid pods on April 26, the Ace became the first e-cigarette authorized by the FDA equipped with a ceramic coil. That coil is manufactured by FEELM, Smoore International’s flagship atomization tech brand.

    The Ace marketing orders mark the first approval by the FDA of a pod vaping product. It is also the first approval of any vaping product manufactured by a company that is independent of the tobacco industry.

    Smoore products have a good record of securing FDA authorizations. The first brand to receive marketing orders through the premarket tobacco product application (PMTA) pathway, Vuse Solo, is a strategic partner of Smoore, a Smoore representative told Tobacco Reporter’s sister publication, Vapor Voice. The second set of approved electronic nicotine-delivery system (ENDS) products, produced by Logic, are also manufactured by Smoore.

    “NJOY has partnered with Smoore since 2009. The NJOY Ace was launched in 2018 and is powered by FEELM inside, the world’s first black ceramic atomization coil with metallic film. As the first ceramic coil e-cigarette and pod vape authorized by the FDA, NJOY Ace’s approval for sale fully showcases the harm reduction potential of FEELM ceramic coil,” the representative said.

    “According to the FDA, NJOY Ace is authorized for sale because ‘chemical testing was sufficient to determine that overall harmful and potentially harmful constituent (HPHC) levels in the aerosol of these products is lower than in combusted cigarette smoke.’”

    Based on PMTA requirements, Smoore established a comprehensive analytical testing and safety assessment system, including the vaping industry’s first corporate toxicology laboratory, which explores the health impacts of exposure to e-cigarette vapor by means of cytotoxicity test, evaluating the reaction of living cells to different components of e-cigarette vapor, according to Smoore.

    The company has also developed the third generation of in-house safety standards—Smoore 3.0—that covers all of the PMTA tests, including harmful and potentially harmful constituents (HPHCs) listed by the FDA.

    “The principle of PMTA is to scientifically and systematically substantiate harm reduction performance of the vaping product and show it is appropriate for the protection of the public health (APPH),” said Long, director of the Smoore Analytical Testing and Safety Assessment Center. “The manufacturer must demonstrate the product’s potential to switch adult smokers while preventing youth and non-smokers from nicotine addiction.”

    Long said this could explain why all the FDA-authorized vaping products so far have been for tobacco flavors, and popular flavored products the agency has said promote youth use have been issued marketing denial orders. It is also an indication that vaping manufacturers should focus on “tobacco flavor reproduction and improve harm reduction performance” in order to be approved under the PMTA pathway.

    According to Nielsen, for the two weeks ended April 9, 2022, Vuse has now surpassed Juul and become No.1 in U.S. e-cigarette sales with a market share of 35 percent. Its flagship product Vuse Alto is also equipped with FEELM ceramic coils.

    As the No. 3 player in the U.S., NJOY accounts for approximately 3.1 percent market share. Moreover, a federal judge has required the FDA to provide progress reports on PMTAs submitted by major vaping brands and the first reports are due on April 29.

    The FDA also found that the risk to youth initiation with NJOY’s Ace was outweighed by the benefit to adult smokers, warning that NJOY must comply with strict post-marketing requirements.