The Food and Drug Administration asked a federal judge to grant a 120-day delay for a deadline for e-cigarette manufacturers to submit applications to keep their products on the market.
Citing “the exceptional circumstances presented by the global coronavirus outbreak,” the agency proposed moving the deadline to Sept. 9, from May 12.
The existing deadline was the product of a legal agreement in federal court, after regulators, public-health groups and vaping companies fought over the timing for years.
In the wake of the coronavirus situation, tobacco retailing association National Association of Tobacco Outlets (NATO) has asked the U.S. Food and Drug Administration (FDA) to push back its May 12 deadline for tobacco manufacturers to turn in Premarket Tobacco Applications (PMTAs), which would allow them to continue selling vaping and other new products in the United States.
Lakeville, Minn.-based 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 submitted 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 comply 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.
“FDA remains acutely aware of the recent surge in youth use of e-cigarettes and the public health imperative to ensure that these and other deemed new tobacco products undergo premarket review,” Mitch Zeller, the FDA’s Director of the Center for Tobacco Products, said in a letter to Judge Paul Grimm filed Monday.
The new coronavirus has closed laboratories in the U.S. and shuttered factories overseas, making it difficult for companies to complete their applications, Zeller said. Some of the FDA’s staff have also been pulled into the pandemic response.
Zeller said that as of March 25 he had received over 15 letters and emails from the industry asking for a delay. Tobacco giant Altria Group Inc. last week sent a letter seeking an extension.
The main reason for the extension is the ongoing COVID-19 crisis, Briant said. The way things stand, retailers would have to comply with FDA tobacco regulations on top of the daily task of providing necessities to the public during the coronavirus pandemic.
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