WASHINGTON — Federal health officials on Thursday ordered Juul to withdraw its electronic cigarettes from the U.S. market, the latest blow to the embattled company widely blamed for the national boom in teenage vaping.
The action is part of a broader effort by the Food and Drug Administration to put the multi-billion dollar e-cigarette industry under scientific scrutiny after years of regulatory delays.
The FDA said Juul should stop selling its tobacco and menthol flavored vaping devices and cartridges. Those already on the market should be removed. The agency said consumers are not prohibited from owning or using Juul products.
To stay in the market, companies must demonstrate that their e-cigarettes benefit public health. In practice, this means evidence that adult smokers who use them are more likely to quit or reduce smoking, while adolescents are not likely to become dependent.
The FDA found that some of the biggest sellers, like Juul, may have played an “irregular” role in the rise of teenage vaping. The agency said Juul’s request did not have sufficient evidence that marketing its products “would be appropriate to protect public health.”
Juul said it disagrees with the FDA’s findings and that the company will seek to impose restrictions as it evaluates its options, including potential appeals and discussions with regulators.
In a statement, the FDA said Juul’s application left regulators with important questions and didn’t provide enough information to assess potential risks. The agency said the company’s research contains “inadequate and conflicting data” on things like potentially harmful chemicals released by Joule cartridges.
“Without the necessary data to determine the relevant health risks, the FDA is issuing these marketing denial orders,” Michelle Mittal, acting director of the FDA’s Tobacco Center, said in the statement.
The agency has approved some e-cigarette applications. Since last fall, the agency has given its OK to tobacco-flavored e-cigarettes from companies like RJ Reynolds, Logic, and others.
The American Lung Association called Thursday’s decision “long overdue and most welcome,” citing Jual as a youth instigator.
E-cigarettes first appeared in the US more than a decade ago with the promise of offering smokers less harmful alternatives. These devices heat the nicotine solution into vapor, which bypasses many of the toxic chemicals produced when tobacco is burned.
However, studies have had conflicting results about whether they actually help smokers quit. And the FDA’s efforts to rule on vaping products and their claims have been stymied by repeated industry lobbying and competing political interests.
FILE – File photo taken on Tuesday, February 25, 2020 shows packaging for Juul Labs electronic cigarettes and menthol capsules in Pembroke Pines, Florida. Juul Labs Inc. North Carolina pays $40 million and takes more action to stop underage use. and the sale, according to a landmark legal settlement announced Monday, June 18, 2021, after years of allegations that the company had a blast at teen vaping. (AP Photo / Brian Anderson)