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FDA Bans Juul

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    An electronic cigarette from Juul Labs (AP/Brynn Anderson)


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U.S. health regulators on Thursday ordered Juul, a major manufacturer of electronic cigarettes, to pull its product from the market. The action is part of a sweeping effort by the Food and Drug Administration (FDA) to address the multi-billion-dollar vaping industry and a national surge in teen vaping.

The FDA says Juul must stop selling its vaping device and its tobacco and menthol flavored cartridges. Those products already on store shelves must be removed. But customers aren’t restricted from having or using Juul’s products, as long as they are of legal age.

Juul is not the only maker of vaping products. To stay on the market, companies must show that their e-cigarettes benefit public health. That means they must prove that adult smokers who use e-cigs are likely to quit or reduce their smoking, while not enticing teens to get hooked on them.

The FDA noted that some of the biggest sellers like Juul may play a “disproportionate” role in the rise of teen vaping. The agency said Thursday that Juul’s application to remain on the market didn’t have enough evidence to show that marketing its products “would be appropriate for the protection of public health.”

A representative from Juul says the company disagrees with the FDA’s findings. Juul will seek to put the ban on hold while considering options, including an appeal and talking with regulators.

In a statement, the FDA said Juul’s research included “insufficient and conflicting data” about things like potentially harmful chemicals leaching from Juul’s cartridges.

“Without the data needed to determine relevant health risks, the FDA is issuing these marketing denial orders,” Michele Mital, acting director of the FDA’s tobacco center, said in the statement.

Joe Murillo, Juul’s chief regulatory officer, disagreed, saying in the company’s statement that Juul submitted enough information and data to address all issues raised by regulators.

Since last fall, the FDA has given the OK to tobacco-flavored e-cigarettes from R.J. Reynolds, Logic, and other companies. The agency said Thursday that people who use Juul products or smokers who want to move away from cigarettes and cigars could switch to the FDA-authorized e-cigarettes.

Last year, the agency rejected applications for more than a million other e-cigarettes and related products, mainly due to their potential appeal to underage teens.

Anti-tobacco groups applauded the FDA’s move, with the American Lung Association calling it “long overdue and most welcome.” The American Vapor Manufacturers Association said it was a “shameful decision.”

E-cigarettes first appeared in the U.S. more than a decade ago with the promise of providing smokers a less harmful alternative. But studies have reached conflicting results about whether they truly help smokers quit. The vaping issue took on new urgency in 2018 when Juul’s high-nicotine, fruity-flavored cartridges quickly became a nationwide craze among middle and high school students. The company faces a slew of federal and state investigations into its early marketing practices, which included distributing free Juul products at concerts and parties hosted by young influencers.

The U.S. federal legal age for purchase of tobacco and vaping products is 21.

Whatever overcomes a person, to that he is enslaved. — 2 Peter 2:19

(An electronic cigarette from Juul Labs. AP/Brynn Anderson)