The action is part of a sweeping effort by the Food and Drug Administration to bring scientific control to the multi-billion dollar steam industry after years of regulatory delays.
Parents, politicians and anti-tobacco advocates have called for a ban on devices that many accuse of boosting juvenile vaporization. Proponents say it could help smokers reduce regular cigarettes.
The FDA noted that Juul may have played a “disproportionate role” in raising teen vaporization and that its implementation did not have enough evidence to suggest that marketing its products “would be appropriate for the protection of public health”.
The organization has granted some applications for e-cigarettes. Since last fall, the body has given ok to tobacco-flavored e-cigarettes from RJ Reynolds, Logic and other companies.
However, industry insiders and anti-tobacco advocates have complained that these products represent only a small percentage of the US $ 6 billion vapor market.
Regulators have repeatedly delayed making decisions about devices from market leaders, including Juul, which remains the most-selling vaporizer brand, although sales have fallen.
Last year, the agency turned down applications for more than a million other e-cigarettes and related products, largely because of their potential impact on juveniles.
To stay in the market, companies need to show that their products benefit public health. In practice, this means that it turns out that adult smokers who use the products are likely to quit or reduce smoking, while teens are unlikely to stick to them.
E-cigarettes first appeared in the US more than a decade ago with the promise of offering smokers a less harmful alternative. The devices heat an inhaled nicotine solution with steam, bypassing many of the toxic chemicals produced by the combustion of tobacco.
But studies have shown conflicting results as to whether they really help smokers quit. And the FDA’s efforts to rule on vaporizers and their claims have been repeatedly slowed down by industry lobbies and competing political interests.
The vapor market has grown to include hundreds of companies selling a range of nicotine devices and solutions in a variety of flavors and strengths.
The issue of steam became a new urgency in 2018, when Juul cartridges with high nicotine content, fruity taste quickly became a national craze among high school and high school students. The company is facing a series of federal and state inquiries into its early marketing practices, including distributing free Juul products to concerts and parties hosted by young influencers.
In 2019, the company was pressured to stop all advertising and eliminate fruit and sweet flavors. The following year, the FDA limited flavors to small vaporizers to tobacco and menthol only. Separately, Congress raised the market age for all tobacco and vaporizers to 21.
However, the question of whether e-cigarettes should remain on the market remained.
The FDA is working with a court order to issue its decisions. Anti-tobacco groups have successfully sued the organization to expedite its review.
FDA regulators have been warning companies for years that they should submit stringent, long-term data that clearly show a benefit to smokers. But everyone except the major manufacturers of e-cigarettes resisted this kind of costly, time-consuming research.
While Juul remains a top seller, a recent federal survey shows teens are moving away from the company. Last year ‘s research showed that Juul was the fourth most popular e – cigarette among high school students who smoke regularly. The most popular brand was a disposable electronic cigarette called the Puff Bar which is available in flavors such as pink lemonade, strawberry and mango. The company’s disposable e-cigarettes were able to circumvent the regulation because they use synthetic nicotine, which until recently was outside the jurisdiction of the FDA. Congress has recently closed this gap.
Overall, the survey showed a drop of almost 40% in adolescent vaporization rates, as many children were forced to learn at home during the pandemic. However, federal officials warned against interpreting the results as they were first collected on the Internet instead of in the classroom.
The spiritual son of two Stanford University students, Juul started in 2015 and within two years has risen to the top of the vapor market. Juul, which is partly owned by tobacco giant Altria, still accounts for nearly 50% of the US e-cigarette market. He once controlled more than 75%.
On Tuesday, the FDA also unveiled plans to introduce a maximum nicotine level for some tobacco products to reduce their addiction. In the announcement, the organization also noted that it has invested in a multimedia education campaign for public education aimed at warning young people about the potential dangers of using e-cigarettes.
AP Health author Tom Murphy contributed to this report.
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