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FDA suspends Juul ban


The U.S. Food and Drug Administration announced on Tuesday that it is temporarily suspending the marketing denial order it imposed on Juul Labs for the company’s products in the United States.

This means that Juul products will continue to remain on the market while the FDA considers “scientific issues unique to the JUUL application that warrant further review.” The agency noted that it was not canceling its order and that any vaping or nicotine delivery products still needed to have FDA clearance to remain on the US market.

Last month, the FDA denied Juul clearance and the company was ordered to stop selling and distributing its e-cigarettes and pens as well as its tobacco and menthol flavored pods in the United States. But a federal appeals court issued a temporary reprieve from the ban shortly after its publication, and the block was not applied.

The FDA will continue to review Juul’s application to remain in the market. When initially denying Juul clearance, the FDA said the company’s study findings “raise concerns due to insufficient and conflicting data, particularly with respect to genotoxicity and potentially harmful chemicals.” harmful substances leaking from the company’s proprietary e-liquid pods”.

Juul maintains that its products meet the “legal standard of fitness to protect public health,” Joe Murillo, Juul’s chief regulatory officer, said in a statement.

“We now look forward to re-engaging with the FDA on a science-based, evidence-based process for obtaining marketing clearance for JUUL products,” Murillo said.

Even when in effect, FDA orders will not affect consumers or punish people who use Juul products. The FDA “cannot and will not oppose an individual consumer’s possession or use of Juul products,” the agency said in a press release.

The clearance denial follows an extensive two-year review of Juul, which needed FDA clearance for its e-cigarettes to remain on the market. Electronic cigarettes were first marketed to former smokers to help them avoid the harmful effects of real cigarettes; they work by converting liquid nicotine in vapor. But experts have warned that the smooth delivery of high nicotine content, packaged in a sleek design, can promote nicotine addiction in people. younger people. Juul was specifically reprimanded by the FDA in the past for promoting the company’s products as being safer than other tobacco products.

The FDA took many steps to regulate the electronic cigarette and vaping industry, in particular by banning vaping products based on flavored cartridges. And while Juul is one of the biggest names in the industry, the company isn’t the only one selling e-cigarettes. The FDA has allowed several of Juul’s rivals, including Reynolds American and Njoy Holdings, to keep tobacco-flavored e-cigarettes on the market, according to The Wall Street Journal, which originally announced the FDA’s planned plans to ban Juul.

The FDA announcement came a day after the agency announced plans to set a maximum level of nicotine for tobacco products. The agency also offered ban all traditional menthol cigarettes. There is no deadline for the entry into force of these plans, but they are expected to be strongly pushed back by the tobacco industry.

Each year, 480,000 people die from diseases attributed to smoking, according to the FDA.

Read more: Juul Vape: What is it, why are teens addicted and is it safe?

The information in this article is for educational and informational purposes only and is not intended to constitute medical or health advice. Always consult a physician or other qualified health care provider with any questions you may have about a medical condition or health goals.

CNET

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