The Food and Drug Administration said Thursday it will need more time before deciding on whether to pull Juul’s e-cigarettes from the market in the United States as the regulatory agency’s court-mandated deadline to decide passed.
Thursday marked a key deadline for the FDA to respond to applications from Juul and other e-cigarette makers, which were tasked with submitting their products for review to keep them on the US market.
The agency said Thursday that it has made decisions on more than 90 percent of the new tobacco products that were submitted for review, but it will need more time to complete its review of the remaining products, including the prolific Juul e-cigarettes.
In an effort to keep their products on the market, manufacturers had to submit data by Sept. 9 of last year demonstrating that their products are less harmful than cigarettes and that cigarette smokers would be more likely to stop smoking if they use it.
The FDA is also weighing whether the products are likely to appeal to young people or people who have never smoked cigarettes before.
Meredith Berkman and Dorian Fuhrman, the cofounders of Parents Against Vaping E-Cigarettes, slammed the FDA for not making a decision on Juul by Thursday.
“While we appreciate FDA’s announcement that it has made ‘significant progress’ in reviewing the applications of more than 6.5 million flavored e-cigarette products, we are disappointed in and frustrated by FDA’s delay in announcing a decision on JUUL despite today’s court-ordered deadline,” they said in a statement. “In fact, FDA has allowed JUUL and its many copycats to remain on the market without full regulation since 2016.”
“Millions of parents whose kids’ lives have been upended by the youth vaping epidemic created by JUUL have waited long enough.
“Every day that goes by without FDA action on JUUL increases the likelihood that more young people will begin using these nicotine-heavy, wildly-addictive tobacco products and will potentially become severely addicted to nicotine, suffering negative health consequences, as so many already have.”
Berkman and Fuhrman also urged the FDA to exercise regulatory discretion and pull Juul from the market until they have made a permanent decision.
“With 3.6 million kids currently vaping—and almost 40% of them using a menthol-flavored product, many of them using menthol JUUL—parents are relying on the agency to protect our kids from these dangerous devices. We don’t have another moment to waste,” they said.The court-mandated review comes after mounting pressure from public health advocates and politicians who say e-cigarettes ought to face the same amount of regulatory scrutiny as cigarettes and other Big Tobacco products.
Under the terms of the Thursday deadline, if the FDA doesn’t respond to an application in time, the products have to be pulled from shelves until the FDA makes its decision.
“We respect the central role of the FDA and the required thorough science- and evidence-based review of our applications, which is key to advancing harm reduction and earning a license to operate,” a spokesman for Juul Labs said. “We remain committed to transitioning adult smokers away from combustible cigarettes while combating underage use.“
The FDA previously said it would prioritize responding to market leaders like Juul, but so far, it’s only issued decisions on a handful of tiny e-cigarette makers.
“Lots of very good people who I respect deeply and who helped thousands of smokers quit, got told by our government that their products were illegal,” Amanda Wheeler, president of the American Vapor Manufacturers Association, wrote on Twitter Wednesday. “To all of you, I am so very sorry. To your customers, I am even more sorry.”
In 2019, the New York City Council voted overwhelmingly to ban flavored e-cigarettes, saying that they appealed largely to young people and new smokers.
That year, US health officials had been struggling to combat a mysterious vaping lung disease that sickened at least 2,800 and killed 42 people, two of whom lived in the Big Apple.
The Centers for Disease Control and Prevention later said that emergency department visits related to e-cigarette or vaping products declined since September 2019 and said that some of it may have been tied to e-cigarettes that contained THC.
The agency also said the removal of vitamin E acetate from some products may have also helped.
The Trump administration announced plans in 2019 to ban all flavored e-cigarettes, but federal officials wavered, instead leaving it to local officials.
The FDA review is the latest effort to reign in the sprawling vaporizer and e-cigarette industry, which saw booming growth in the US in recent years as industry giants like Juul asserted themselves.
A representative for Juul did not comment on the passing of the FDA’s deadline.