FDA orders Juul products off shelves and company asks court to block it; rule to limit the level of nicotine in cigarettes arrives | Don’t miss it

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The federal government ordered Juul Laboratories to stop selling and distributing its products in the United States after denying the company’s request to continue selling them, saying the company failed to provide adequate data to determine “relevant health risks.”

During this time, the Food and drug administration plans to establish a maximum level of nicotine in cigarettes and other combustible tobacco products to reduce addiction to the products, which claim the lives of 480,000 Americans each year, including more than 8,000 in Kentucky.

“While we welcome the Juul ban – we think it’s a good thing – it’s not enough, and until they tackle the nicotine problem, they won’t solve it” , he added. said Ben Chandlerpresident of the Foundation for a Healthy Kentucky. “The central problem here is that we’re hooking a whole new generation of young people to nicotine.”

The FDA has issued marketing denial orders against Juul that require the company to remove its e-cigarette products from the US market or face enforcement action.

“Today’s action is further progress in the FDA’s commitment to ensure that all e-cigarette and e-nicotine delivery system products currently marketed to consumers meet our public health standards,” FDA Commissioner Robert M. Califf said in the statement. He also noted the role of electronic cigarettes in the rise of youth vaping.

The 2020 National Youth Smoking Survey found that Juul was the most popular e-cigarette brand used by teens with 25.4% of high school e-cigarette users and 35.1% of college users saying Juul was their most used brand.

According to the latest 2019 Youth Risk Behavior Surveillance System report, 26% of Kentucky high school students had used an electronic vaping product at least one day in the 30 days prior to the survey, while only 8 .9% had smoked cigarettes. A national survey found that youth vaping rates had declined during the pandemic, but a separate survey in late 2020 found that 34% of 400 Kentucky youth surveyed thought there had been a increase tobacco consumption due to the pandemic.

The FDA said the company’s marketing applications “lack sufficient evidence regarding the toxicological profile of the products to demonstrate that marketing of the products would be appropriate for the protection of public health.”

A key public health issue that the FDA looks for when reviewing e-cigarettes is whether the potential benefit to adult smokers who might use them to quit smoking outweighs the risks to young people.

The agency said it had not seen any clinical information to suggest there is an immediate risk from using Juul products, but “Some of the company’s study findings raised concerns due to insufficient and conflicting data, particularly with respect to genotoxicity and potentially harmful chemicals leaking from the company’s proprietary e-liquid pods – which have not been adequately addressed. “

Joe Murillo, chief regulatory officer at Juul Labs, released a statement saying the company had “provided enough information and high-quality research-based data to resolve all issues raised by the agency” and that the data meets the standard of being “appropriate for the protection of public health.” He added, “We intend to seek a stay and are exploring all of our options under FDA regulations and the law, including appealing the decision and engaging with our regulator.”

UPDATE, June 24: Juul asked a federal court in Washington to block the order.

Juul, which has long been blamed for the rise in teen vaping, had previously stopped selling its sweet-flavored e-cigarette pods, but continued to sell tobacco- and menthol-flavored cartridges while waiting for the FDA. reviews its marketing application. The company had also made efforts to prevent teenagers from buying its products, such as stopping television, print and digital advertising. ”

Anti-tobacco advocates hailed the FDA’s decision.

Ellen Hahn, a University of Kentucky nursing professor and director of Bridging Research and Advocacy Efforts for Healthy Environments (BREATHE), said in an email that the decision “is long overdue. This decision is particularly important [for] our ability to breathe in Kentucky. Young people in Kentucky smoke e-cigarettes or vapes, more than double the rate of high school students in the United States (26.1% vs. 11.3%). E-cigarette aerosol contains highly addictive nicotine that damages the lungs and developing brain. Vaping causes severe lung damage and makes it harder for the user to fight infections. The lung damage caused by vaping is comparable to using conventional cigarettes.”

That said, Hahn cautioned that since the FDA’s decision to limit flavors in Juul products, other “disposable” vapes have become more popular as they continue to offer a variety of flavors. “So while today’s decision shows the power of FDA premarket review, many other e-cigarette products are still on the market,” she said.

Matthew L. Myers, President of the Campaign for tobacco-free childrensaid the decision “represents the most significant action the FDA has taken to reverse the e-cigarette epidemic among young people.”

Harold Wimmer, President and CEO of The American Lung Associationpraised the FDA for “following the science and denying Juul the ability to sell its products which are clearly marketed to addict a new generation of young people to tobacco.”

Limit nicotine: The FDA’s goal in limiting nicotine in cigarettes and other burnt tobacco products is to reduce youth consumption, addiction and death, the FDA press release announcing the effort states.

The FDA notes that while nicotine isn’t what makes cigarettes so toxic, it’s the ingredient that makes it hard to quit. And says that if the proposed reduction succeeds, it “would make these products little or not addictive”.

“The US Surgeon General has reported that 87% of adult smokers start smoking before age 18, and that about two-thirds of adult daily smokers started smoking daily by age 18. Reducing nicotine levels to minimally addictive or non-addictive levels would decrease the likelihood that future generations of young people will become addicted to cigarettes and further assist currently addicted smokers to quit,” Califf said in the statement.

Internal health policy reports that the FDA is expected to release its proposed rule in December. It was originally scheduled for July.

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