Tobacco manufacturers get FDA deadline extension for e-cigarettes

A federal court is allowing tobacco manufacturers four more months to submit applications to the Food and Drug Administration for e-cigarettes, cigars and other new products because of the coronavirus pandemic.

Manufacturers now have until Sept. 9 to submit applications to the FDA for review, a 120-day extension, according to a statement released Thursday. Last year, the U.S. District Court for the District of Maryland ordered the FDA to require manufacturers to submit premarket applications by May 12.

“We have steadily been working toward that deadline, but the coronavirus pandemic has drastically impaired the ability to adhere to this timeline,” said FDA Commissioner Stephen Hahn. “Requesting this extension was not an easy decision for the FDA. COVID-19 is impacting all FDA-regulated industries, including tobacco product manufacturers.”

He said the tobacco industry has expressed concern about being unable to submit applications by the original May deadline because of disruptions to their operations.

The FDA had previously postponed the deadline for application submissions for e-cigarettes until August 2022, prompting anti-tobacco advocacy groups to file a lawsuit against the agency. The court ruled in favor of the advocacy groups and had ordered the FDA to speed up its review, requiring manufacturers to submit applications by May.

“At this time, the FDA believes the public health is better protected by not having these firms compromise their employees’ health or take actions that would risk spreading COVID-19 to others by trying to meet the previous May 12 deadline,” Dr. Hahn said.

Although the deadline has been pushed back, the FDA said it can still exercise “enforcement discretion” against manufacturers.

The FDA also said that a number of its Center for Tobacco Products staff have been deployed to work on COVID-19 pandemic efforts, leaving fewer employees to process applications.

While in-person compliance checks and vape shop inspections have been put on hold, the FDA said it is still reviewing previous inspections and monitoring the online marketplace and will “take action as appropriate.”

Despite the delay, the FDA review of e-cigarettes and other tobacco products “remains as critical as ever given skyrocketing youth use of e-cigarettes and mounting concerns that smoking and vaping could increase risk of severe complications from COVID-19,” said Dave Lemmon, director of media relations for the Campaign for Tobacco-Free Kids.

E-cigarette use among youth has been rising the last several years. An estimated 4.7 million middle and high school students use at least one tobacco product, including e-cigarettes, according to the Centers for Disease Control and Prevention.

“These products should not be on the market without an FDA review of their health impact,” Mr. Lemmon said.

The Campaign for Tobacco-Free Kids and other public health and medical organizations sent a letter to Dr. Hahn Thursday, urging the FDA to publicly disclose the products for which premarket applications have been filed. The letter also calls on the FDA to identify products without an application that continue to be marketed and that are subject to enforcement.

“The disclosure of this information is necessary to allow the public to determine the extent of industry compliance with the court-ordered deadline for filing premarket applications, as well as to monitor the FDA’s enforcement of the Sept. 9 deadline going forward,” the letter says.

Last year, an outbreak of lung illnesses linked to vaping emerged in the U.S., although the vast majority of them were caused by vitamin E acetate oil, a product found in THC products, scientists found. The latest CDC data shows that 2,807 cases of vaping-related lung injuries have been reported from 50 states, the District, Puerto Rico and the U.S. Virgin Islands as of February. Sixty-eight people have died from vaping-related lung injuries.