The action is part of a massive effort by the Food and Drug Administration to put the multi-billion dollar vaping industry under scientific scrutiny after years of regulatory delays.
Parents, politicians and tobacco advocates wanted to ban the devices that many blame for the rise in underage vaping. Proponents say they can help smokers cut down on regular cigarettes.
The FDA noted that Juul may have played a “disproportionate role in the rise of vaping among teenagers, and there was not enough evidence to show that marketing of its products is “fit to protect public health.”
The agency has granted several applications for e-cigarettes. Since last fall, the agency has approved tobacco-flavored e-cigarettes from RJ Reynolds, Logic, and others.
But industry players and tobacco advocates complain that these products account for only a tiny percentage of the US $6 billion vaping market.
Regulators have repeatedly delayed decisions on devices from market leaders, including Juul, which remains the top-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, largely due to their potential appeal to underage teens.
To stay in the market, companies must show that their products benefit public health. In practice, this means proving that adult smokers who use the products are more likely to quit or reduce the amount of smoking while teenagers are less likely to become addicted to them.
E-cigarettes first appeared in the US over a decade ago with the promise of providing smokers with a less harmful alternative. The devices convert the nicotine solution into vapor that is inhaled, bypassing many of the toxic chemicals produced when tobacco is burned.
But studies have reached conflicting results as to whether they actually help quit smoking. And the FDA’s efforts to rule on vaping products and their claims have been repeatedly slowed down by industry lobbying and competing political interests.
The vaping market has grown to hundreds of companies selling many devices and nicotine solutions in various flavors and strengths.
Vaping took on new urgency in 2018, when Juul’s high-nicotine, fruit-flavoured cartridges quickly became a nationwide craze among middle and high school students. The company is facing multiple 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 forced to stop all advertising and abandon its fruit and dessert flavors. The following year, the FDA restricted flavors in small vaping devices to only tobacco and menthol. Separately, Congress raised the purchase age for all tobacco and vaping products to 21.
But the question of whether e-cigarettes should remain on the market at all remains.
The FDA worked by court order to make its decisions; anti-tobacco groups successfully sued the agency to expedite its review.
FDA regulators have warned companies for years that they will have to provide rigorous long-term data showing clear benefits for smokers who switch to vaping. But all but the largest manufacturers of e-cigarettes have resisted this kind of costly and time-consuming research.
While Juul remains a top seller, a recent federal survey shows teens are leaving the company. Last year’s survey showed that Juul was the fourth most popular e-cigarette among high school students who vape regularly. The most popular brand was a disposable e-cigarette called Puff Bar with pink lemonade, strawberry and mango flavors. The company’s disposable e-cigarettes were able to bypass regulation because they use synthetic nicotine, which until recently fell under the jurisdiction of the FDA. Congress recently closed this loophole.
Overall, the survey showed a nearly 40% drop in teen vaping as many children were forced to homeschool during the pandemic. However, federal officials caution against interpreting the results given that they were collected online for the first time and not in classrooms.
The brainchild of two students from Stanford University, Juul was launched in 2015 and within two years has skyrocketed to the top of the vaping market. Juul, which is partially owned by tobacco giant Altria, still holds almost 50% of the e-cigarette market in the US. It once controlled over 75%.
On Tuesday, the FDA also outlined plans to set maximum levels of nicotine for certain tobacco products to reduce addiction. In the announcement, the agency also noted that it has invested in a multimedia education campaign aimed at warning young people about the potential risks of using e-cigarettes.
AP Health contributor Tom Murphy contributed to this report.
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