U.S. federal health officials ordered Juul on Thursday to withdraw its e-cigarettes from the domestic market, the latest blow to the embattled company widely blamed for sparking a national surge in teen vaping.
The action is part of a major effort by the US Food and Drug Administration (FDA) to bring scientific scrutiny to the multi-billion dollar vaping industry after years of regulatory delays.
The FDA said Juul must stop selling its tobacco- and menthol-flavored vaping device and cartridges. Those that are already on the market must be eliminated. Consumers are not restricted from owning or using Juul products, the agency said.
To stay in business, companies must show that their e-cigarettes benefit public health. In practice, that means proving that adult smokers who use the devices are likely to quit or cut down, while teens are unlikely to get hooked.
The FDA noted that some of the biggest sellers like Juul may have played a “disproportionate” role on the rise of teen vaping. The agency said Thursday that Juul’s application had insufficient evidence to show that marketing its products “would be appropriate for the protection of public health.”
Juul said it disagrees with the FDA’s findings and will seek to suspend the ban while the company considers its options, including a possible appeal and talks with regulators.
‘Insufficient and conflicting data’
In a statement, the FDA said Juul’s application left regulators with important questions and did not include enough information to assess potential risks.
The agency said the company’s investigation included “insufficient and conflicting data” about things like the leaching of potentially harmful chemicals from Juul cartridges.
“Without the data necessary to determine the relevant health risks, the FDA is issuing these marketing denial orders.” Michele Mital, acting director of the FDA’s tobacco center, in the statement.
The agency has granted some e-cigarette applications. Since last fall, the agency has given its approval to tobacco-flavored e-cigarettes from RJ Reynolds, Logic and other companies.
But industry players and anti-tobacco advocates have complained that those products make up only a tiny slice of the $6 billion US vaping market.
Regulators repeatedly delayed making decisions on devices from market leaders, including Juul, which remains the best-selling vaping brand even though sales have fallen.
Last year, the agency turned down applications for more than a million other e-cigarettes and related products, primarily because of their potential appeal to underage teens.
The American Lung Association called Thursday’s decision “long overdue and very welcome,” saying Juul was “largely responsible” for what it called the “youth vaping epidemic.”
The rapid rise of vaping
E-cigarettes first appeared in the US more than a decade ago with the promise of providing smokers with a less harmful alternative. The devices heat a nicotine solution into a vapor that is inhaled, bypassing many of the toxic chemicals produced by burning tobacco.
But studies have come to conflicting results about whether they actually help smokers quit. And the FDA’s efforts to rule on vaping products and their claims have been repeatedly stymied by industry lobbying and competing political interests.
The vaping market grew to include hundreds of companies selling a variety of nicotine devices and solutions in various flavors and strengths.
The vaping problem took on a new urgency in 2018 when Juul’s fruity-flavored, high-nicotine cartridges quickly became a national craze among middle and high school students.
The company is facing a series of federal and state investigations into its early marketing practices, which included distributing free Juul products at concerts and parties hosted by young influencers.
In 2019, the company was pressured to stop all advertising and remove its fruit and dessert flavors. The following year, the FDA limited the flavors in small vaping devices to just tobacco and menthol. Separately, the US Congress raised the age of purchase for all tobacco and vaping products to 21 years.
But the question remained whether e-cigarettes should remain on the market.
The FDA has been working under a court order to issue its decisions; anti-tobacco groups successfully sued the agency to expedite its review.
FDA regulators warned companies for years that they would have to submit rigorous long-term data showing a clear benefit to smokers who switch to vaping. But all but the biggest e-cigarette makers have resisted doing that kind of costly and time-consuming research.
Reference-www.cbc.ca