US FDA blocks sale of 55,000 flavored e-cigarette products

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(CNN) – The United States Food and Drug Administration on Thursday blocked the sale of more than 55,000 flavored e-cigarette products, its first ban on e-cigarette products since it began requiring manufacturers to apply for a pre-screening. marketed last September.

The FDA has issued denial-of-market orders for Electronic Nicotine Delivery System (ENDS) products, claiming they pose a threat to the public health of young people in the United States. Of the more than 55,000 products affected by the decision, those that have not yet been sold may not be introduced to the market, and those already on the market must be withdrawn or risk being applied.

Lawyers complained that the action did not cover big products like Juul, but the agency said more decisions are pending.

“Ensuring that new tobacco products undergo FDA review is an essential part of our goal of reducing tobacco-related illness and death,” said Acting FDA Commissioner Dr. Janet Woodcock. “We know that flavored tobacco products are very appealing to young people. Therefore, assessing the impact of the potential or actual consumption of young people is a critical factor in our decision making about which products can be marketed ”.

Although e-cigarette products are often marketed as tools to help adults quit smoking, health experts have been sounding the alarm bells for years about an alarming increase in consumption among children and teens.

Sales of electronic cigarettes in the United States increased nearly 300% between November 2016 and August 2019, according to the United States Centers for Disease Control and Prevention. Almost 20% of high school students and almost 5% of middle school students said they had used vaping products in 2020, according to a study published in the journal JAMA Network Open.

Many point to the sweet flavors and flashy packaging of these products as proof that companies know exactly who they are talking to.

The tobacco-free flavored e-cigarette products affected by Thursday’s ruling – which include flavors like Apple Crumble, Dr. Cola, and Cinnamon Toast Cereal – are made by three companies: JD Nova Group LLC, Great American Vapes and Vapor Salon.

Matthew Myers, chair of the Tobacco Free Kids Campaign, said the decision is a step in the right direction, but it does not go far enough.

“The FDA’s action covers only a fraction of the more than 6.5 million tobacco products for which the FDA has received marketing applications, and it does not include any e-cigarette brands with market share.” important or most popular with children, such as Juul, the number one brand for young people, ”Myers told CNN in a statement.

The FDA said it was making progress on those applications, submitted by 500 companies before the September 2020 deadline for new tobacco products deemed to seek pre-market review.

The agency is tasked with determining whether these products “provide sufficient benefit to adult smokers to overcome the threat to public health posed by the alarming and well-documented levels of use of these products by young people.”

“Flavored ENDS products are extremely popular among young people, with over 80% of e-cigarette users aged 12 to 17 using any of these products,” said Mitch Zeller, director of the Center for Tobacco Products at the FDA. “Companies wishing to continue marketing their flavored ENDS products must have strong and reliable evidence showing that the potential benefits of their products for adult smokers outweigh the known significant risks for young people.”

In February 2020, the Trump administration enacted a “flavor ban,” establishing that the Food and Drug Administration would prioritize the enforcement of flavored cartridge-based vaping products.

Since disposable vapers, some e-liquids, and tobacco and menthol flavored products were exempt from the policy, health experts expressed concern that it would simply redirect users to those available products.

“In 2020, over a million middle and high school students used menthol e-cigarettes, including 44.5% of youth who used flavored and pre-filled cartridges like Juul,” Myers said.

The FDA decision is “no substitute for comprehensive action to eliminate all flavored electronic cigarettes, including menthol flavored products which are popular and widely used by children,” he added.

The FDA noted that the scientific review of menthol e-cigarettes, as opposed to other non-tobacco flavored e-cigarettes, raises “unique considerations.”

Although menthol products were not included in Thursday’s decision, the FDA’s assessment of these applications will examine the same question: Do the benefits to adult users outweigh the risks to them? youth ?

This story first appeared on CNN.com “FDA blocks sale of 55,000 flavored e-cigarette products“.


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