This content is intended to be objective and factual, and for general informational purposes only. It does not express the opinions of Swisher International or any other person or entity, and does not, is not intended to, and shall not be deemed to, constitute legal advice. Further, the content presented here is intended to reflect selected, recent legislative activity only, and is expressly not a comprehensive summary of past, present, or future legislative activity within any particular geographic area or with respect to any particular subject matter. No reader, user, or browser of this site should act or refrain from acting on the basis of information on this site without first seeking legal advice from counsel in the relevant jurisdiction. Only your individual attorney can provide assurances that the information contained herein – and your interpretation of it – is applicable or appropriate to your particular situation. Use of, and access to, this website or any of the links or resources contained within the site do not create an attorney-client relationship between the reader, user, or browser and Swisher International, Inc. or its attorneys. All liability with respect to actions taken or not taken based on the contents of this site are hereby expressly disclaimed. The content on this site is provided “as is,” and no representations are made that the content is error-free.

NATO Requests FDA to Petition Court for PMTA Deadline Extension

The following is an update from the National Association of Tobacco Outlets (NATO) sourced through their March 24th online bulletin. Reposted with permission.

Today, NATO submitted a letter to FDA Director Mitchell Zeller requesting that the FDA’s Center for Tobacco Products consider petitioning the U.S. District Court for the District of Maryland for an extension of the current May 12, 2020 pre-market tobacco application filing deadline.  Since this federal district court had issued an order in July of 2019 setting the filing deadline date, the FDA would need to request that the court agree to extend the May 12, 2020 filing deadline.  The request sumbitted by NATO was made due to the Coronavirus pandemic and its impact on all segments of the tobacco industry, including the retail segment.

With uncertainty surrounding how long the Coronavirus pandemic will significantly impact the nation, NATO requested that the FDA petition the court for either: (1) an indefinite extension of time to file pre-market applications or, (2) a minimum eight-week extension of the filing deadline with the FDA also authorized to exercise its enforcement discretion without an additional court order to further extend a new filing deadline if the national emergency related to the Coronavirus continues or even worsens.

One of the main arguments in NATO’s letter focused on retailers needing to divert their already limited staff away from the daily task of providing basic necessities to the public during the Coronavirus pandemic and assign them to complying with FDA tobacco regulations.  That is, retail employees would need to determine whether hundreds of deemed tobacco products can remain on store shelves if pre-market tobacco applications are submitted to the FDA by May 12, 2020 or need to be removed from stores if such applications are not submitted to the agency by that deadline.  Given the enormous number of products that require pre-market application submissions, retailers would be very hard pressed to continue their critical workplace function of providing food, beverages, groceries, medications, and gasoline to the public while simultaneously attempting to comply with FDA tobacco regulations.

Other industry members are also submitting requests to the FDA to consider an extension of the May 12, 2020 filing deadline for pre-market tobacco applications.  In its letter, NATO did ask the FDA to make a decision as soon as possible on petitioning the federal court for an extension of the deadline because retailers need to know whether they will be able to focus all of their time and energy on responding to the public’s need for food, groceries, medicine, and gasoline or will need to divert employee resources to try and determine how to comply with FDA marketing regulations as of May 13, 2020.