FDA bans sale of Juul vape products in U.S.

This Food and Drug Administration Have prohibit Electronic cigarette machine Yule from selling and distributing its products in the United States. It ordered the company to remove its merchandise from the market or face enforcement action.

reports earlier this week Suggest An FDA ban on Juul products is looming. After a two-year review, the agency rejected Juul’s application to continue selling tobacco and menthol-flavored pods and its e-cigarettes.

The decision does not apply to Juul products already owned by the company’s customers. However, it will be difficult, if not impossible, to find its pens and pods in the near future.

In 2020, the FDA began a comprehensive review of all vaping products sold in the United States. It weighs the potential benefits of e-cigarettes versus cigarettes for adult smokers and the prevalence of e-cigarettes among underage users. The agency has allowed other manufacturers to continue selling vaping products, including Reynolds American, the parent company of NJOY and Vuse. To date, the agency has authorized 23 “electronic nicotine delivery systems” (given the official name for vaping pens).

In Juul’s case, though, the FDA said the company’s application “lacks sufficient evidence about the product’s toxicological profile to justify the product’s marketing as appropriate to protect public health. In particular, some of the company’s study findings were deficient and conflicting due to insufficient data.” — including about genotoxicity and potentially harmful chemicals leached from the company’s proprietary e-cigarette liquid — raised concerns that the data had not been adequately addressed and prevented the FDA from completing a review of the products named in the company’s drug labeling. comprehensive toxicological risk assessment application.”

The agency went on to say it had no clinical information to suggest there was an “immediate risk” from Juul’s pens or pods. “But that [marketing denial orders] The results released today reflect the FDA’s decision that there is insufficient evidence to assess the potential toxicological risk of using Juul’s products,” the FDA said. It noted that it is impossible to grasp the use of other cartridges in Juul vape pens or the company’s e-cigarettes Possible hazards of .pods in third-party devices.

“The FDA’s mandate is to ensure that tobacco products sold in this country meet the standards set by the law, but the responsibility for demonstrating that products meet those standards ultimately rests with the companies,” said Michelle Mittal, the company’s acting director. FDA Center for Tobacco Products. “Like all manufacturers, Juul had the opportunity to provide evidence that its products were marketed in compliance with these standards. However, the company did not provide that evidence and left us with important questions. In the absence of what is needed to determine the associated health risks data, the FDA is issuing these marketing denial orders.”

Juul can appeal the decision or challenge it in court. Engadget has reached out to the company for comment.

The company became the U.S. e-cigarette market leader in 2018. However, after a series of controversies, sales fell. In terms of U.S. market share, Juul slipped to second place after Vuse. Most of the company’s revenue comes from the United States, Wall Street Journal Noticed this week.

Juul was charged federal agency, state attorneys general and other officials who market their products to teens.The company agrees to pay an eight-figure settlement related to the lawsuit North Carolina and Washington Stateand it faces lawsuits in several other states.

Company stops selling Mint- and fruity 2019 vape pods before the FDA prohibit The most flavorful variant of early 2020. according to In a survey by the U.S. Centers for Disease Control and Prevention, nearly 85 percent of young people who have tried e-cigarettes said they used flavored varieties. However, according to 2021 data, vaping has become less popular among teens overall. In 2019, Juul disclose A new connected version of its e-cigarette pen that can authenticate users to prevent underage use.

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