STORY: E-cigarette maker Juul was banned from selling its nicotine products in the U.S. on Thursday.
After a nearly two-year-long review, the FDA said Juul submitted insufficient and conflicting data to show that its e-cigarettes met public health standards.
The regulator also said the findings raised "significant questions," including whether potentially harmful chemicals could leach out of Juul pods.
The decision potentially deals a fatal blow to the once high-flying San Francisco company.
Juul did not immediately respond to a Reuters request for comment.
The FDA had to judge whether Juul's products, which have been sold for years without being officially authorized by the agency, were effective in getting smokers to quit and, if so, whether the benefits to smokers outweighed the potential health risks to new e-cigarette users, including teenagers.
"They prey on children."
Democratic Senator Dick Durbin hailed the decision by the FDA on Thursday, but said "they're in for a legal battle for sure."
Earlier this week, the Biden administration said it also plans to propose a rule establishing a maximum nicotine level in cigarettes and other tobacco products to make them less addictive.