Report

April 6

Update on Premarket Tobacco Product Application (PMTA) ruling

A recent announcement from The Food and Drug Administration (FDA) on the Premarket Tobacco Authorization (PMTA) final ruling means that the vaping and cigar industries, most impacted by the PMTA deadline, now have, subject to the final stages of the appeal process, until September 9, 2020 to file their PMTAs.

We asked our legal counsel, Patricia Kovacevic, to explain what this means to those companies.

The Ruling

Under the 2016 Deeming rule, as litigated in 2019 by a group of Non-Governmental Organization (NGOs), led by the American Academy of Pediatrics, Manufacturers and Importers of newly deemed tobacco products had until May 12, 2020 to file PMTAs or another form of premarket authorization application – such as substantial equivalence applications or exemptions from substantial equivalence applications – as a precondition to keep the respective products on the US market pending Food and Drug Administration (FDA) review of the application. This deadline resulted from a July 11, 2019 Memorandum Opinion and Order in the American Academy of Pediatrics, et al., v FDA, et al. litigation, whereby judge Grimm of the Maryland District Court had ordered that 1. the FDA shall require that, for new tobacco products on the market as of the August 8, 2016 effective date of the Deeming Rule (“New Products”), applications for marketing orders (i.e., PMTAs in the case of ENDS products) must be filed within 10 months of the date of the Memorandum Opinion and Order;  2. New  Products  for  which  applications  have  not  been  filed  within  this  period  shall  be  subject to FDA enforcement actions, in the FDA’s discretion;  3. New Products for which applications have been timely filed may remain on the market without being subject to FDA enforcement actions for a period not to exceed one year from the date of application while FDA considers the application;  4. The FDA shall have the ability to exempt New Products from filing requirements for good cause on a case-by-case basis.

Covid-19

On March 30, 2020, the Department of Justice (DOJ)– the branch of government which litigated the case on behalf of FDA -  submitted a letter to Judge Grimm describing their planned request for an indicative ruling on a Federal Rule of Civil Procedure 60(b) motion for a 120-day extension of the premarket application (PMTA) deadline imposed in the Court’s remedy order dating back to July 11, 2019, in light of the global outbreak of respiratory illness caused by COVID-19.

Department of Justice

The DOJ letter attached a sworn declaration by Mitch Zeller in support of this request, detailing, among other, that “The global coronavirus outbreak poses unforeseen challenges and has made the May 12 deadline a public health risk to those who cannot comply with the deadline through telework. As a result of the outbreak, many laboratories and contract research organizations, which perform required laboratory and clinical studies for manufacturers’ premarket applications, have shut down or suspended in-person work indefinitely.” Further, the DOJ letter goes on to indicate that Coronavirus-related travel restrictions have hampered travel between offices and factories to gather information for premarket applications., and factories in countries affected by the outbreak — like China, Honduras, and the Dominican Republic — have been unable to make timely deliveries of the tobacco products that manufacturers need for testing and premarket applications. Zeller’s declaration includes a statement regarding employees from the FDA’s Center for Tobacco Products (CTP) which have been deployed to work for the U.S. Public Health Service as a result of the outbreak. Notably, FDA anticipates that it will take additional time for its staff, which is now working remotely, to receive and process applications and conduct scientific review of those applications.

On April 2, the plaintiffs - the group of NGOs - wrote Judge Grimm in response to FDA’s letter describing their planned request for an indicative ruling. The plaintiffs were not opposing FDA’s motion to extend the deadline, given the unprecedented COVID-19 circumstances, however, the plaintiffs stated they would likely oppose requests for further similar relief and expressed concern with the length and breadth of the PMTA deadline extension.

What this means to ENDS companies

Judge Grimm granted FDA’s motion to extend the deadline. Thus, the Court’s April 3, 2020 indicative ruling modified paragraph 1 on page 12 of the July 2020 remedy order to read as follows: “1. the FDA shall require that, for new tobacco products on the market as of the August 8, 2016 effective date of the Deeming Rule (“New Products”), applications for marketing orders must be filed by September 9, 2020;” and all other references in the remedy order to the “ten-month deadline for submissions” to the “September 9, 2020” date. The ruling designation as “indicative” reflects the fact that an appeal from this case is pending before the US Court of Appeals.  Although this case is on appeal, the rules of procedure allow the lower Court to issue an indicative ruling in these circumstances, and the Court of  Appeals may remand the case to the original Maryland court for action on this specific matter, but would retain jurisdiction over the appeal. The respective trade associations’ members will, of course, benefit from the PMTA deadline extension. It is expected that the Court of Appeals will remand – meaning will send back this case, now on appeal, to Judge Grimm with respect to this particular issue of the motion to extend the May 12 deadline to September 9 within a reasonable period of time. This would likely not impact the appeal in a substantive manner.

September 9, 2020

As the plaintiffs in the original Maryland court case indicated no opposition in their April 2 letter to the Court, and the Circuit Court will likely allow judge Grimm to issue a final ruling, this practically means that the vaping and cigar industries, most impacted by the PMTA deadline, now have until September 9, 2020 to file the PMTAs and may continue to sell product subject to a PMTA filing at least until that date – unless, naturally,  local COVID-19 sales restrictions, or other restrictions are imposed at local level.

PMTA partners to support your ENDS business

Broughton Nicotine Services offer a team of scientific and regulatory experts to manage the full PMTA process on your behalf. We’ll generate and compile the data you require, consult with the FDA, and submit your PMTA. Book a meeting with us today to discuss your requirements.

Broughton Nicotine Services has taken the necessary Government guidance to protect the health and safety of our employees, customers and partners. We continue to operate fully and thank you for your continued loyalty and support during these challenging times.

 


 

 

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About the Author

Patricia Kovacevic is a global legal and compliance nicotine industry expert, and currently an independent consultant/principal at RegulationStrategy.com. Patricia I. Kovacevic’s experience comprises past General Counsel and Chief Compliance Officer roles at Nicopure Labs, and leading senior legal and regulatory positions at, among others, Philip Morris International and Lorillard.