The US Food and Drug Administration said on Thursday it will need more time to decide whether the biggest-selling e-cigarette products may remain on the market – a delay that infuriated pediatricians and anti-tobacco advocates.
The FDA said it has taken action on about 93% of the submitted applications, something it called “significant progress.” The agency did not announce a decision yet on products from the leading e-cigarette company Juul Labs.
E-cigarette products have been allowed to remain on the market for years, even though none have been given the official green light by the FDA. Manufacturers were given until September 9 of last year to submit applications for the agency’s authorization to remain on the market.
The FDA had a year to review those applications. Now, the agency says it needs to do more.
A long, regulatory road
“However, there’s more work to be done to complete our remaining reviews and ensure that we continue taking appropriate action to protect our nation’s youth from the dangers of all tobacco products, including e-cigarettes, which remain the most commonly used tobacco product by youth in the United States,” acting FDA Commissioner Dr. Janet Woodcock and Mitch Zeller, director of the FDA’s Center for Tobacco Products, said in a joint statement on Thursday.
Advocacy groups slammed the delay.
The American Cancer Society Cancer Action Network, the lobbying arm of the American Cancer Society, had joined a lawsuit to force the September 9 deadline.
“The FDA’s failure today to act on applications by JUUL, the manufacturer with the single biggest e-cigarette market share, is extremely disappointing and will allow the industry to further endanger public health and hook more kids on their highly addictive products,” Lisa Lacasse, president of ACS CAN, said in a statement.
“The FDA has had ample time to review the applications and allowing additional delays is unconscionable. There is overwhelming data to demonstrate the negative impact these kinds of flavored products have had on public health and their role in the youth e-cigarette epidemic. The time to act is now,” Lacasse added.
Dr. Lee Savio Beers, president of the American Academy of Pediatrics, said the FDA was in essence giving companies such as Juul a pass.
“Even though products like JUUL are technically being marketed illegally, FDA signaled that it will not take imminent action to remove them. This is a reckless decision that will allow products proven to addict and endanger young people to continue being sold,” Beers said.
“The AAP, along with our public health partners, will be looking closely at our legal options to compel FDA to do the right thing and once and for all get dangerous e-cigarette products off the market. We must do everything we can to protect young people from nicotine addiction. We have not a moment more to waste when it comes to keeping children and teens safe.”
Robin Koval, president and CEO of the Truth Initiative, said millions of teens have become addicted to nicotine.
“Postponing decisions on those with the lion’s share of the market further empowers the big, rich, tobacco companies to continue to grow their business and profits on the backs of young people putting millions at risk for a lifetime of nicotine addiction,” Koval said in a statement.