FDA Marketing Application Deadline Passes: What Happens Now?


    In late August, the FDA issued a statement saying that it plans to make publicly available a list of the deemed tobacco products that were subject to the Sept. 9, 2020, deadline that were on the market as of Aug. 8, 2016, and for which an SE or PMTA application was submitted to the agency by Sept. 9, 2020. However, because the agency needs time to review and accept or decline SE and PMTA applications as they are filed and to ensure that the SE and PMTA application information to be published complies with federal disclosure laws, that list of products for which an SE or PMTA application has been filed may not be published for some time. In the meantime, the FDA encourages retailers to contact manufacturers directly to obtain information and confirmation about whether SE or PMTA applications have been filed with the FDA.

    The agency also stated it will take compliance and enforcement action against those tobacco products for which an SE or PMTA application was required to be filed by the Sept. 9 deadline but which the manufacturer did not file. Enforcement action is allowed against those products as they would now be considered “misbranded and adulterated” by the FDA and illegally on the market. According to the agency, the initial focus of FDA enforcement actions will be electronic nicotine products for which a PMTA was not submitted.

    This story first appeared in the November/December 2020 issue of Tobacco Business magazine. Members of the tobacco industry are eligible for a complimentary subscription to our magazine. Click here for details.

    Contributed by Thomas Briant, Executive Director, National Association of Tobacco Outlets (NATO)