The brand that was once wildly popular in the US may be ending.
The FDA ordered Juul off the market. The agency said that the current products for sale must be removed from shelves.
The FDA's order doesn't stop consumers from using or buying Juul products.
The agency denied the company's premarket tobacco product application because it didn't have enough evidence to show that marketing of the products would be appropriate. The FDA said that Juul had failed to address its concerns about insufficient and conflicting data.
FDA Commissioner Robert M. Califf said in the press release that today's action is further progress on the FDA's commitment to ensure that all e-cigarette and electronic nicotine delivery system products currently being marketed to consumers meet our public health standards. It was reported by the Wall Street Journal.
Joe Murillo, Juul's Chief Regulatory Officer, disagreed with the FDA's findings. He said that the company might appeal the ban.
In our applications, which we submitted over two years ago, we believe that we appropriately characterized the toxicological profile of JUUL products, and believe this data, along with the totality of the evidence, meets the statutory standard of being 'appropriate'.
According to a statement released Tuesday, the FDA is proposing to slash the amount of nicotine in traditional cigarettes to reduce their addictiveness as well as to decrease youth use and smoking related deaths.
Experts have raised questions about the safety of the product. The company claims to offer adult smokers an alternative to cigarettes but is accused of marketing to children.
According to one lawsuit, many teens have been hospitalized or even died from using the device. Despite marketing that portrays the company's products as a healthier alternative to cigarettes, Juul Pods contain large amounts of nicotine and are highly addictive, often hooking young people who were never previously addicted to smoking. Vaping advocates contend that the FDA's decision doesn't consider the benefits it may offer to current and ex- smokers. More than 30 million people in the US smoke cigarettes.
At the end of last year, the tobacco giant Altria acquired a 35% stake in Juul for $38 billion, making it the most valuable e-cig company in the world. The federal government warned that a ban was imminent and Juul stopped selling flavors. In addition, it stopped advertising in the US and scaled back sales in Europe and Asia.
It has been difficult for the brand that was once the nation's leading e-cig brand. Hundreds of employees have been laid off, the company's valuation has plummeted, and it has been accused of marketing to children.
The FDA's decision was the result of a review process that began almost two years ago, when Juul and other e-cigarette manufacturers submitted applications to argue that their devices were a net benefit to public health. The Vuse from R.J. Reynolds has been authorized by the FDA. E-cigarettes were in a gray area before the agency started regulating them.
Teens craving a nicotine fix have turned to disposable flavoured e-cigarettes, like Puff Bars, that circumvent federal standards. Sales of traditional cigarettes increased for the first time in over two decades.
The American Vaping Association said that the FDA's denial of Juul's applications was a sign of things to come because it ignores the potential benefits these products provide for current and former adult smokers. The number of people under the age of 30 who use nicotine is on a decline.
The FDA has banned a lot of products. The FDA knows how low the health of adult smokers and ex-smokers is.
Some studies suggest that e-cigarettes with nicotine can be used to quit smoking. Nicotine gum and patches can be used to break a nicotine addiction. They aren't effective in the long run.
The company assumed that the FDA would cater to it because of its large customer base, instead of trying to work with regulators from the beginning, according to a former employee speaking on the condition of anonymity. The ex-employee said that they would see this as a missed chance to do good in the future. That was messed up by leadership.
An application for another version of Juul that has age verification technology is still in the works. The FDA's latest announcement meshes a pathway for these other products to enter the US market.
When it moves away from the phone it is connected to, the device will automatically lock up.
If you want to buy this product, you need to pass an age verification and facial recognition process. Some health experts couldn't agree more with the company's claim that this technology could "combat underage use and support a more responsible marketplace."
The American Lung Association's national assistant vice president of advocacy said that Juul worked to addict them to their products. We have urged the FDA to deny all marketing orders to Juul, and we don't believe that the company should be allowed to collect any data about kids, which is exactly what would happen with an age verification product. The FDA can deny or grant marketing orders for tobacco products.
Sward said that the decision should mean the end of Juul and that the company can come back and apply for another product.
Sward said that they were troubled by all of this and that they welcomed the FDA's announcement.
E-cigarettes are more addictive than traditional cigarettes according to studies. The amount of nicotine found in a single Juul Pod is equivalent to a pack of cigarettes.
Sward said that it was important for parents to speak with their doctors about the best ways to quit smoking for their children. The FDA needs to act quickly to make sure that no one buys a Juul product in the US.