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FDA postpones Juul’s E-Cigarettes decision, but orders others from the market

On Thursday, the Food and Drug Administration postponed the long-awaited ruling on whether Juul Labs and other major e-cigarette companies could continue to sell their products in the United States.

Both companies are at the heart of the agency’s vaping industry reviews over the past year. The FDA said Thursday that it had previously refused to use 946,000 flavors of e-cigarette products in the market, most of which are manufactured by small businesses.

No e-cigarettes have been approved through the application process, according to agency officials.

“The FDA is committed to completing a review of the remaining products as soon as possible,” the FDA said in a statement Thursday afternoon.

The FDA had previously suggested that it would dominate large corporations by Thursday, a year after the application to stay in the market was due. Many public health professionals wanted the market leader’s decision to clarify the conditions under which a company could operate.

Eric Lindblom, a tobacco policy expert at Georgetown University Law Center, said: “I was expecting a little more, and I’m not an optimist.”

In response to authorities’ move, Juul said in a statement that it “respects the FDA’s central role” in completing a “thorough” review of the application.

While e-cigarette proponents see the product as a way to separate smokers from the more toxic traditional tobacco, critics say they are just another nicotine delivery system that seduces young people into drugs. It states that it is doing.

Market leader Juul has been the center of debate as its sophisticated device has led to a surge in e-cigarettes among teens who have never smoked. By deferring decisions about the company, the FDA seems to be delaying a larger decision as to whether the FDA considers these devices to be more harmful than profitable.

The FDA is considering applying for about 500 e-cigarette products, many of which are small. Companies must show that vaping products are less harmful than traditional tobacco and that the usefulness of helping smokers quit smoking outweighs the risk that some people will start using nicotine through the product. ..

Matthew Myers, president of the campaign for non-smoky children, said the FDA’s inaction against Jul and other companies could lead to additional proceedings. “The decisions the FDA still has to make are more important than the decisions they have already made,” Myers said. “If they don’t promise to make them quickly, we have to ask them to intervene in court.”

Although overall smoking rates have fallen sharply since the mid-1960s, smoking is the leading cause of preventable death in the United States, killing nearly 500,000 Americans each year. E-cigarettes that deliver vaporized nicotine in flammable tobacco without inhaling many carcinogens are a safer alternative, despite unresolved science about their broader public health implications. It is on sale.

Since e-cigarettes went on the market in the United States in the mid-2000s, Youth vaping is steadily increasing.. By 2019, more than 27% of high school students reported vaped in the survey. According to experts, that number dropped to less than 20% during the coronavirus pandemic. This may partially reflect the fact that teens are isolated and less likely to use social drugs.

The fate of Juul and other market leaders is also part of a larger conversation about the best way to further discourage the use of tobacco. Some experts believe that the most effective step is to limit the amount of nicotine levels in traditional cigarettes and make them less attractive.

Juul initially marketed himself as an enemy of Big Tobacco.However, in December 2018, the company Sold 35% stake to Altria, One of the largest cigarette companies in the world, for $ 12.8 billion.

Critics claim that Juul’s first marketing campaign and flavors like cool cucumbers and creme brulee have attracted a new generation of young people to nicotine, many of whom have become addicted.

Recent company Agreed to pay $ 40 million to settle the proceedings Over North Carolina and its marketing practices, Juul has made it possible to avoid public testimony from suffering teens and families. The company is still facing thousands of other proceedings.

Juul officials have long stated that the company has never sought a youth market. They claim that Juul is taking positive steps to discourage the use of young people, including the suspension of advertising in the United States.

Under pressure from the FDA, the company withdrew almost all flavors from the market in 2019. Since then, we have submitted applications for menthol and tobacco flavored products only. There are two strengths seeking approval for nicotine pods: 5% and 3%, which is the equivalent of nicotine in the average tobacco pack.

As part of a request for nicotine pod approval, Juul submitted a 125,000-page application to the FDA, claiming that its product would provide public health benefits. According to a company-funded study, the device could be effective in helping smokers quit smoking. A survey initiated with 55,000 adult Juul users found that 58% of the 17,000 smokers who stayed in the survey quit smoking in 12 months. Another 22% continued to smoke both e-cigarettes and traditional cigarettes, but reduced tobacco smoking by at least half.

Several major medical institutions, including the American Heart Association, the American Lung Association, the American Pediatric Society, and the American Cancer Society Cancer Behavior Network, have requested the FDA to reject Juul’s application.

On Thursday, the American Heart Association said, like Jul, the Heart Association “for years has targeted teens in our country and contributed to the epidemic of tobacco use among young people.” He said he was disappointed by the FDA’s omission of a large company.

FDA postpones Juul’s E-Cigarettes decision, but orders others from the market

Source link FDA postpones Juul’s E-Cigarettes decision, but orders others from the market

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