Update 6/23/2022 11:15am ET: The Food and Drug Administration this morning denied marketing authorization for all Juul products sold in the US, effectively shutting down the e-cigarette giant that once dominated the US market. The authorization denial applies specifically to Juul Devices and the company’s four types of Juul pods: Virginia tobacco flavored pods and menthol flavored pods, both of which have nicotine content of 5.0 percent and 3.0 percent.
In a statement Thursday, the FDA said the reason for the denial was that Juul failed to provide enough toxicology data to demonstrate the products are safe. In particular, some of the company’s study findings raised concerns due to insufficient and conflicting data – including genotoxicity and leaching of potentially harmful chemicals from company-owned e-liquid pods – that were not adequately addressed. and has been prevented from completing a full FDA toxic risk assessment,” the FDA wrote.
Michelle Mittal, acting director of the FDA’s Center for Tobacco Products, said it is Juul’s responsibility to demonstrate to the FDA that its products meet all legal standards. “As is the case with all manufacturers, Juul had the opportunity to provide evidence that the marketing of their products met these standards,” Mittal said. “However, the company did not provide that evidence and instead left us with important questions. Without the data needed to determine the relevant health risks, the FDA is issuing these marketing denial orders.”
Juul must now immediately stop selling all of its products, and retailer must recall any products currently on sale. Marketing refusal does not affect possession or use by consumers, only sales, the FDA notes.
In an emailed statement to Ars, Juul’s Chief Regulatory Officer Joe Murillo said the company disagrees with the FDA’s decision and is exploring all of its options, including seeking a stay, appealing the decision, and seeking a stay on the FDA. Including joining.
“In our applications, which we submitted two years ago, we believe that we have appropriately characterized the toxic profile of Juul products, including comparisons to flammable cigarettes and other vaping products, and to combine this data with the totality of the evidence. meet the statutory standard of being ‘fit for the protection of public health,'” Murillo said.
Original Story 6/22/2022 6:28pm ET:According to a report in The Wall Street Journal, the Food and Drug Administration is reportedly preparing to deny authorization of Juul’s tobacco- and menthol-flavored products, effectively making e-cigarette giant American is out of the market.
In its reporting, the Journal cited unidentified people familiar with the matter, who also said the FDA may announce its denial today, Wednesday, June 22.
If the reports are correct, the move comes after an announcement from the FDA on Tuesday that the regulator is working on a plan to establish maximum nicotine levels for cigarettes and other combustible tobacco products. This is a move that aims to make the products less attractive, less addictive and less lethal to the youth.
“Nicotine is powerfully addictive,” FDA Commissioner Robert Calif said in a statement. “The US Surgeon General has reported that 87 percent of adult smokers begin smoking before the age of 18, and that nearly two-thirds of adult daily smokers begin smoking daily by age 18 Nicotine levels have to be reduced to at least addictive or non-addictive levels. There is a possibility that the youth of the future generation may become addicted to cigarettes and the current smokers to quit smoking. Help me.”
Juul has become notorious for its relationships with youth that have skyrocketed to “pandemic” levels in recent years. Health advocates also allege that Juul made its products more potent and addictive, increasing the risk that teens experimenting with vaping would become potentially addicted for life.
A 2019 investigation by the Los Angeles Times found that Juul swiped an idea from RJ Reynolds, the maker of Camel cigarettes, to allow e-cigarette users to take deep drugs without the risk of high levels of nicotine. Nicotine salts and softening chemicals were used. Vomiting or burning in their throat. Health researchers have similarly found that Juul aerosol can deliver significantly more nicotine than other tobacco products. In one study, rodents exposed to Joule aerosol had blood nicotine levels five to eight times higher than those seen after exposure to other e-cigarettes and cigarette products.
High nicotine levels are of particular concern because Juul has often been accused of marketing its potent products to underage youth. In 2015 and 2016, the company used young, trendy models in marketing materials and purchased banner ads on websites allegedly aimed at teenagers and children, including Cartoon Network’s cartoonnetwork.com and Nickelodeon’s sites Nick.com and NickJr. com is included.
In later years, both Juul’s profits and youth vaping grew. Between 2017 and 2018, Juul’s dollar sales grew 783 percent, reaching $942.6 million, according to a Wells Fargo analysis of Nielsen data. And according to the Centers for Disease Control and Prevention, the percentage of middle school students who recently reported e-cigarette use rose from 0.6 percent in 2011 to 10.5 percent in 2019. For high school, utilization increased from 1.5 percent to 27.5 percent over that time frame. ,
As alarm grew over youth vaping trends, Juul announced in 2019 that it would end sales of flavored products popular with youth, such as mango, fruit, crme (creme brlée), and cucumber.
Juul CEO Casey Crosthwaite said at the time, “We must reset the vaping category by earning the trust of society and working closely with regulators, policy makers and stakeholders, to provide an alternative to adult smokers at a young age.” to counter its use.”
In 2020, the FDA banned sweet and fruity e-cigarette products and began reviewing vaping products, including the rest of Juul’s.
The Wall Street Journal noted that a denial for Juul would also be bad news for Marlboro maker Altria, which in 2018 paid $12.8 billion for a 35 percent stake in Juul. The deal valued Juul at around $35 billion, but its current value has fallen significantly. As of March 31, Altria valued its Juul stake at $1.6 billion.