WASHINGTON — A federal court judge agreed to a request from the U.S. Food and Drug Administration (FDA) to push back the May 12 deadline for tobacco and nicotine manufacturers to submit applications to keep e-cigarettes and other new products on the market pending FDA review, according to court documents. The decision moves a possible 120-day extension that much closer to reality.
On April 3, Judge Paul Grimm of the United States District Court for the District of Maryland agreed to an FDA request filed March 30 for a 120-day extension of the premarket tobacco application (PMTA) deadline for many e-cigarettes, cigars and other tobacco products.
In the FDA’s motion, the agency said the extension was needed solely because of the coronavirus outbreak and that it would not do so “but for these highly unusual circumstances.”
The extension would move the deadline to Sept. 9, 2020.
The judge’s decision is part of a process that will also involve the U.S. Court of Appeals for the Fourth Circuit, according to officials with NATO, which the Lakeville, Minn.-based tobacco association said will take “several days.”
“FDA remains aware of the recent surge in youth use of e-cigarettes and the public health imperative that these and other deemed new tobacco products undergo premarket review,” the FDA said in a statement released March 31. “The agency is committed to implementing and enforcing the premarket requirements in the law.”
In March, NATO submitted a letter to the FDA’s Center for Tobacco Products (CTP) asking for an extension of the deadline, pointing out that the deadline would create an undue burden on retailers who are serving the public with essential products during the ongoing health emergency.
FDA officials strongly encouraged applicants who are able to submit applications to do so as soon as possible, asking companies with a large number of submissions to contact the agency to discuss their plans and method of submission.
On July 12, 2019, the U.S. District court ordered the FDA to require submission of applications for premarket review by May 12, 2020, for deemed new tobacco products on the market as of Aug. 8, 2016.
The FDA said it would revise its January 2020 enforcement priorities guidance to be consistent with the new deadline. Also, following the original court order, the agency would provide companies that submit timely applications with continued enforcement discretion for a period of up to one year from the date an application was submitted—up to Sept. 9, 2021—or unless a negative action is taken by the FDA during that time. The FDA encouraged manufacturers who have concerns about meeting the new deadline for any reason to contact the agency directly.
For its part, Richmond, Va.-based Altria Group on March 25 sent a letter to the CTP, expressing concerns about the effects of the coronavirus outbreak. The tobacco manufacturer said the company and many of the third-party contractors involved in creating its PMTAs have mandated remote-working requirements and social distancing. “We are on track for the original deadline, and we are committed to submitting our applications according to whatever timeline is imposed,” an Altria spokesperson said. “We asked that the FDA consider these extraordinary circumstances and how they impact employees, and the agency has heard similar requests from many manufacturers.”
A spokesperson for R.J. Reynolds Tobacco Co., Winston-Salem, N.C., said the company is “singularly focused” on the May 12 deadline for the rest of its deemed products. With that deadline moving toward a postponement, the company hoped the FDA “allows for companies to supplement submitted applications with data from studies that were in progress or scheduled to start prior to the May deadline, and which have been impacted by the coronavirus.”
For many makers of e-cigarettes and tobacco products, word of the delay was “promising,” said Chris Howard, vice president, general counsel and chief compliance officer for E-Alternative Solutions, Jacksonville, Fla. Many companies had been working to meet the May 12 deadline but were experiencing delays because of COVID-19, he said.
Retailers would also have a reprieve, Howard said. “C-store retailers would have more time to assess which manufacturers are planning to submit PMTAs for their products,” he said. “They should be seeking for manufacturers to provide evidence of submission prior to Sept. 9.”
In addition, Howard said retailers can request letters of filing or acceptance from the FDA, which manufacturers should expect to receive in later stages of the FDA review process.
“We are very encouraged by the court’s [agreement] to extend the PMTA submission deadline to Sept. 9, 2020,” said Jason Carignan, president of Dryft Sciences, Moorpark, Calif. “This additional time will afford [companies] the ability to ensure complete applications in light of the burdens being placed on labs, clinical trials and the general travel bans posed by the COVID-19 pandemic.”
“Although Swisher was in a good position to meet the original May 12 deadline, the company appreciates the action taken by the FDA,” said Jane Green, vice president of marketing operations for Swisher International, Jacksonville, Fla. “In addition to recognizing the potential impact of COVID-19 on necessary work related to the filings, such as lab testing, FDA expressed concerns about its own ability to review the applications under current circumstances. Swisher hopes that the [proposed] 120-day delay will allow the agency to dedicate the personnel and resources necessary to the review of the many applications it will be receiving.”
Also noting how the FDA questioned its own internal capabilities amid the crisis, Gerry Roerty, vice president and general counsel for Richmond, Va.-based Swedish Match, said manufacturers were facing an almost impossible task. “COVID-19 has created human and technological challenges that make submission of quality [applications] not possible by May 12, 2020,” Roerty said.
Commenting on the PMTA deadlines in general, a spokesperson for San Francisco-based Juul Labs said, “We are committing all necessary resources to submit a scientifically rigorous PMTA designed to provide FDA with the science and evidence needed to assess the role our products can play moving smokers away from cigarettes, while combating underage use. We respect the PMTA process and look forward to sharing our comprehensive scientific research program.”
Two additional suppliers that CSP reached out to did not respond by posting time.
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