FDA Pressed To Take E-Cigs Off Market During Pandemic

By Emily Field
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Law360 (August 11, 2020, 3:59 PM EDT) -- Lawmakers on Tuesday called on the U.S. Food and Drug Administration to take e-cigarettes temporarily off the market during the pandemic, saying that there's scientific evidence that e-cigarette users are more likely to be diagnosed with COVID-19.

Rep. Raja Krishnamoorthi, D-Ill., wrote in the letter that a study released on Tuesday shows that young vapers between the ages of 13 and 24 are five times more likely than nonvapers to be diagnosed with COVID-19. Additionally, those who both vape and smoke are almost seven times more likely to be diagnosed with the disease and five times more likely to have symptoms, according to Krishnamoorthi.

"This is true in vapers as young as 13, which is particularly concerning, given that young people are increasingly driving the spread of COVID-19, threatening the health and safety of Americans of all ages," Krishnamoorthi said in the letter sent by the House Committee on Oversight and Reform's Subcommittee on Economic and Consumer Policy.

The study was released by Stanford University's Dr. Bonnie Halpern-Felsher in the Journal of Adolescent Health, according to the letter.

The study also found that users of both cigarettes and e-cigarettes are nine times more likely to to be tested for COVID-19 than nonusers, according to the letter.

"If we reduce the number of vapers in America, we will reduce the unnecessary stress we are putting on our testing system," Krishnamoorthi said. "People should not have to wait weeks for COVID-19 test results — removing the risk posed by vaping will help."

The representative gave the FDA a week to respond to the letter.

An FDA spokeswoman told Law360 that the agency has received the letter and will respond directly to the congressman.

In April, a Maryland federal judge said that he would grant a 120-day extension to the deadline for e-cigarette regulatory applications in light of the novel coronavirus outbreak that has strained FDA resources and disrupted supply chains.

The FDA had asked the Fourth Circuit to extend the current May 12 deadline in light of the coronavirus outbreak, saying that many of the laboratories and research organizations conducting the clinical trials for the regulatory applications have shut down or otherwise halted in-person testing in light of the COVID-19 pandemic.

In a one-page indicative ruling, U.S. District Judge Paul W. Grimm said he would agree to extend the deadline for e-cigarette premarket tobacco applications to Sept. 9.

The FDA told the Fourth Circuit on March 31 that many of its staff have been enlisted by the U.S. Public Health Service to help fight the pandemic, limiting the agency's ability to review applications.

Travel restrictions around the world have also limited the FDA's ability to gather information about vape manufacturers in countries including Italy, China, Honduras, the Dominican Republic, Nicaragua and Mexico, the FDA said.

On the industry side, the pandemic has disrupted supply chains, including shuttering factories abroad that manufacture vape products. The FDA said it has received 15 letters from groups representing thousands of market players requesting a 180-day deadline extension in light of COVID-19 disruptions.

--Editing by Rebecca Flanagan.

Update: This article was updated to include comment from the FDA.

For a reprint of this article, please contact reprints@law360.com.

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