Juul Labs e-cigarette brand products must be withdrawn from the US market. The public body responsible for approving food and medicine in the country (FDA) announced the decision this Thursday (23).
For the FDA, Juul Labs did not respond to safety concerns about its products.
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This move “is a further step forward in the FDA’s commitment to ensuring that all e-cigarette products and electronic nicotine delivery systems that are marketed products meet our public health standards,” FDA Commissioner Robert Califf said in a statement. an announcement.
Juul Labs has announced that it will appeal the FDA decision.
“We do not agree with the FDA’s findings and decision. We continue to believe that we have provided sufficient information and high-quality research-based data to address all issues raised by the agency,” Juul’s chief regulatory officer said in a statement. Joe Murillo.
“We intend to seek a suspension and are exploring all of our options under FDA regulations and laws, including an appeal of the decision and our regulator’s involvement.”
The move paves the way for rival brands in the industry to increase their market share.
Affected products include the Juul vaporizer device and its pods, which are currently sold in Virginia tobacco and menthol flavors, with nicotine concentrations of 5% and 3%.
After completing a two-year review of the company’s market application, the FDA noted that the submitted data “did not have sufficient evidence regarding the toxicological profile of the products.”
“In particular, some of the company’s study findings raised concerns due to insufficient and contradictory data, including in relation to genotoxicity and leaching of potentially harmful chemicals from the company’s patented ‘e-liquid’ capsules,” he added.
Juul has been blamed for a rise in vaping among young people, for its marketing of fruit-flavored e-cigarettes and candy, which it stopped selling in 2019.
In January 2020, the FDA ruled it illegal to sell e-cigarettes with flavors other than tobacco or menthol unless the state specifically authorizes it.
Playback of video that shows a vape client — Photo: Reproduction GloboNews
The agency has approved some e-cigarette-related products from other manufacturers, such as Reynolds American, current market leader, NJOY and Logic Technology Development.
For its part, Juul argued that its products could provide a solution to the harmful health effects of conventional cigarettes.
Juul’s products “only exist for adult smokers to transition from combustible cigarettes,” Chief Executive KC Crosthwaite said on the company’s website, adding that it is “working hard” to rebuild its reputation after an “erosion of confidence in recent years”.
On Tuesday, the US government announced that it will develop a new policy to require cigarette producers to reduce nicotine level to non-addictive levels.
In Brazil, electronic cigarettes have been banned since 2009. Even so, the products are on sale in stores. The Brazilian Medical Association estimates that 650,000 people smoke with these devices, most of them young people.
Understand the electronic cigarette:
- The product uses liquid nicotine, which is heated inside the device;
- When the smoker inhales, a vapor is formed, and in this vapor there are substances that do not exist in traditional cigarettes;
- The electronic cigarette user increases by 42% the chance of having a heart attack;
- Teenagers who use e-cigarettes have a 50% chance of having asthma;
- A regular cigarette gives you 15 puffs; one pack in 300 puffs;
- A 1,500 puff vaporizer is the equivalent of five packs.