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Update on FDA Request to Extend PMTA Application Deadline

The following is an update from the National Association of Tobacco Outlets (NATO) sourced through their April 3rd online bulletin. Reposted with permission.

As previously reported in the NATO News Bulletin, the U.S. Department of Justice (DOJ), on behalf of the U.S. Food and Drug Administration (FDA), submitted letters on March 30, 2020 to the U.S. District Court for the District of Maryland and the U.S. Circuit Court of Appeals for the Fourth Circuit with a request for a 120-day extension of the court-ordered May 12, 2020 pre-market tobacco product application filing deadline.  The FDA is seeking the 120-day extension due to the exceptional circumstances presented by the coronavirus outbreak and the new filing deadline, if allowed by these courts, would be September 9, 2020.

In response to the FDA’s extension request, Federal District Court Judge Paul Grimm issued an order allowing the plaintiffs in the underlying litigation (numerous health organizations) to file a reply with the court by April 15, 2020 to the FDA’s request for the 120-day extension of the filing deadline.  Then, the federal judge also allowed the FDA to submit a reply to the plaintiffs’ response by April 30th.

Yesterday, the plaintiffs submitted a letter to Judge Paul Grimm which indicates that they are not opposing the FDA’s motion for a 120-day extension of the pre-market tobacco product application deadline.  Then, late yesterday, the DOJ submitted a letter in response to the plaintiffs’ correspondence acknowledging that the plaintiffs do not oppose the FDA’s request and asking Judge Paul Grimm to approve the 120-day extension request by Tuesday, April 7th due to the urgency of the upcoming May 12th deadline.

NATO will report on the final outcome of this matter once Federal District Court Judge Paul Grimm and the U.S. Circuit Court of Appeals for the Fourth Circuit issue decisions on the FDA’s deadline extension request.

Copies of Letters Filed with the Courts:  Copies of the plaintiffs’ letter and the Department of Justice letter are below:

State Legislative Bill Introductions

State tobacco-related legislative bills that have been introduced in the past week are listed below alphabetically by state:

New York:  Senate Bill 8135 requires a business that is shown to have sold a tobacco product to a minor to close pending the completion of an investigation; provides for the Commissioner of Taxation and Finance to revoke the dealer’s registration for a period not less than five years if they are found to have sold such tobacco product to a minor.

State Legislative Bill Actions

State tobacco-related legislative bills that have been acted on by a state legislative committee or state legislature are listed below alphabetically by state:

Kentucky:  Senate Bill 56, which prohibits the sale of tobacco products and vapor products to persons under the age of 21, passed the House and was sent to and signed by the Governor on March 26, 2020.  CORRECTION: House Bill 32, which was amended to remove tax increases on tobacco products and impose a tax on vapor products ($1.50 per closed vapor cartridge and 15% of the distributor price for open vaping systems), was sent to the Rules Committee with filed floor amendments on March 19, 2020.  House Bill 352 (Governor’s Budget Bill), which was amended to include taxes on vapor products ($1.50 per closed vapor cartridge and 15% of the distributor price for open vaping systems), was adopted in the House and Senate and delivered to the Governor on April 1, 2020.