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FDA postpones long-awaited decision on Juuls vaping products




Juul mint flavored electronic cigarette packages are on display at the 2019 San Rafael Smokeshop in San Rafael, California.

Juul mint flavored electronic cigarette packages are on display at the 2019 San Rafael Smokeshop in San Rafael, California.

Justin Sullivan / Getty Images

Updated September 10, 2021 at 8:28 a.m. ET

The Food and Drug Administration said it has decided whether some e-cigarette products can stay on the market, but is also delaying action on products made by Juul, which accounts for 40 percent of the e-cigarette market.

FDA said Thursday it has issued market denial orders for more than 946,000 flavored vaping products because their applications “lacked sufficient evidence that they were of sufficient benefit to adult smokers to overcome the public health threat posed by the levels. alarming and well-documented use of these products by young people. “

The decisions affect 93% of applications submitted by companies for approval, but Juul, the largest vape company, was not included in Thursday’s action.

A federal judge had given the FDA one year to act on a flood of claims submitted by vape companies in a ruling stemming from a trial brought by anti-smoking groups. The agency said it had made progress but needed more time.

“We continue to work expeditiously on the remaining applications that were submitted before the September 9, 2020 deadline, many of which are in final review stages,” the FDA said.

The news comes after years in which critics have called for tighter federal controls on vaping to combat a further increase in nicotine use among underage people.

One in five high school students and more than 6% of American adults overall they now say they are vaping. The industry has swelled to over $ 6 billion, led by Juul.

The FDA has a long history of regulating the marketing and sale of traditional tobacco products such as cigarettes. But so far, the agency hasn’t demanded the same scrutiny for vapes, allowing the market to thrive.

Decisions are pending on many vaping products

Manufacturers of electronic cigarettes, including Juul, claim their products are safer than traditional tobacco products such as cigarettes. But the FDA has evaluated about 6.5 million products made by more than 500 companies to determine if they are “suitable for the protection of public health.”

Products subject to FDA review range from refillable vape pens and liquids that fill them to disposable electronic cigarettes. Each of them requires a demand for a tobacco product before marketing, or PMTA, to file with the government and these requests are what the FDA has considered.

In the most serious cases, certain products should be withdrawn from the market.

Last month, the FDA issued its first marketing denials for some 55,000 flavored vape products from three companies, directing them to remove their products from stores. He also turned down requests from companies marketing flavors designed to appeal to children, such as Apple Crumble and Cinnamon Toast Cereal.

Regulators said the FDA’s first round of denial requests “lacked sufficient evidence” that any benefit to adult smokers outweighed “the threat to public health posed by the alarming and well-documented levels of use of these products by young people “.

FDA assesses health effects of vaping

Although vaping allows users to avoid some of the harmful carcinogens caused by consuming traditional cigarettes, studies have shown that e-cigarettes are still harmful.

Inhaling vapes can introduce harmful chemicals into the lungs, including, in some cases, vitamin E acetate. Dozens of people have died in recent years from vaping complications in the United States, and thousands more have been hospitalized. Most of these vaping injury cases were related to products containing THC and not nicotine.

Virtually all e-cigarette products contain nicotine, some at high levels, including Juul 5% pods, each of which contains as much nicotine as a whole packet of cigarettes. Nicotine also affects prenatal and adolescent brain development, making it dangerous for both teens and pregnant women to vape.

“If an electronic cigarette could actually help a smoker quit smoking, it would seek to become a drug through avenues other than the FDA. [has], and they would be shown to be safe and effective in helping smokers quit, ”said Erika Sward of the American Lung Association, which has advocated denial of all FDA claims for any product in the flavored tobacco.

“Instead, what we have seen is another generation of addicted children and a whole situation in which millions of smokers who might otherwise try to end their addiction are trying to use this product,” she declared.

Why the FDA was due to announce its decisions on Thursday

In 2019, a federal judge ordered e-cigarette manufacturers to submit applications to the FDA by 2020. Their products would be allowed to stay on the market for a year while the agency reviewed them. That one-year deadline arrived on Thursday.

The agency was not expected to respond to every product request before Thursday’s deadline. This said it will prioritize companies according to their market share, i.e. Juul, as well as British American Tobacco and Imperial Brands which respectively own the Vuse (formerly Vype) brands and blu should have been the first to face decisions.

“We respect the central role of the FDA and the in-depth, evidence-based, scientific review of our applications which is critical to advancing risk reduction and obtaining a license to operate,” said a carrier. word of Juul Labs in a press release. “We remain committed to keeping adult smokers away from combustible cigarettes while combating underage use.”

Thursday’s deadline has left many industry watchers wondering if the FDA could impose a major crackdown on virtually all vape products, or if it could take a more targeted approach, like blocking the sale of flavored products or vape products. disposable electronic cigarettes or create marketing rules similar to those for traditional cigarettes.

The restrictions on marketing and packaging design are aimed “at reducing the initiation and use of young people,” said Kathleen Hoke, professor of public health law at the University of Maryland.

Some fear vaping limits will lead teens to smoke

Some researchers fear that a major crackdown on Juul and other manufacturers will simply send teens looking for traditional cigarettes instead.

“I think it would be a disaster for public health,” said Dr Michael Siegel, a researcher at Tufts University who studies tobacco and alcohol use among young people. “Vaping does not create a culture of smoking. It actually replaces that culture.”

Youth smoking rates have declined dramatically in recent years, as vaping has exploded in popularity. But other researchers are skeptical of reversing the trend.

“Whether these people choose to choose to go back to a cigarette that tastes like a cigarette or a vape product that tastes like a cigarette, I think anyone can guess,” Hoke said. ‘University of Maryland.

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