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Category: PMTA

  • 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.

  • 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.