The United States has decided to withdraw Juul electronic cigarettes from the market, both vapers and capsules.
The company, owned by Altria, the owner of Marlboro, had great success in the market, especially among teenagers.
It was presented as the iPhone of vapers due to its design and technology.
For three years it was in the doldrums due to the crisis in the sector, when regulatory clouds began to be seen on the horizon due to the growing addiction of young people to vaping.
The Food and Drug Administration of the United States (the FDA, for its acronym in English) announced this Thursday that it has issued marketing denial orders for all Juul Labs products currently marketed in the country: the Juul device and the capsules flavored with Virginia tobacco and menthol with nicotine concentrations of 5.0% and 3.0%.
The company must stop selling and distributing these products and withdraw those that are currently on the market.
The company plans to appeal the decision.
The FDA is attempting to reassure consumers that it has received no clinical information suggesting an immediate danger associated with the device or capsules that it prohibits sale.
However, there is also insufficient evidence to assess the potential toxicological risks and no way to know the potential harm from using other third-party pods with the Juul device or from using Juul pods with another device.
The success of its flavor refills among minors has already forced the withdrawal of fruity and sweet flavors such as mango.
In addition, as the market leader, in which it had a share of more than 70%, it was affected by the death of dozens of people and the serious lung diseases of hundreds due to the use of electronic cigarettes with prohibited chemical substances.
Europe has already placed restrictions on electronic cigarettes that caused Juul to leave numerous countries, including Spain, where it had arrived in 2019.
Juul has been accused of targeting its advertising campaigns at attracting new consumers among young people, rather than trying to get those who smoke to switch to electronic cigarettes.
She has been the subject of lawsuits and has reached agreements to pay multi-million dollar damages.
The 35% stake in Altria, in which it invested 12.8 billion dollars (about 12.2 billion euros at current exchange rates), was valued at 1.7 billion dollars at the end of 2021. After this decision, its value is much lower.
The decision of the regulatory body comes in full offensive against smoking, considered the leading cause of preventable death in the United States, with about 480,000 deaths annually.
The FDA last month announced a proposal to ban menthol as a flavor in cigarettes, as well as all flavors other than tobacco flavors in cigars.
In addition, it is also preparing to go a step further by forcing tobacco companies to reduce the levels of nicotine in cigarettes sold in the country to minimum or non-addictive levels, according to a government communication this week.
The regulation, if it goes ahead, would still take a long time to be effective.
A previous attempt in the same direction five years ago has already failed.
"Today's action is a further step forward in the FDA's commitment to ensure that all e-cigarette products and electronic nicotine delivery systems currently marketed to consumers meet our public health standards," said the FDA. FDA Commissioner Robert M. Califf in a statement.
“The agency has devoted significant resources to reviewing the products of companies that represent the majority of the US market.
We recognize that these make up a significant portion of the products available and that many of them have played a disproportionate role in the rise of youth vaping.”
Single Use
These recall orders only address the commercial distribution, importation, and retail sale of these products, and do not restrict possession or use by individual consumers: FDA cannot and will not impose the possession or use of these products. use by individual consumers of Juul products or any other tobacco product.
The FDA has determined that the marketing applications did not provide sufficient evidence about the toxicological profile of the products to demonstrate that their sale would be suitable for the protection of public health.
“In particular, some of the company's study results raised concerns due to insufficient data and existing conflicts ... that have not been adequately addressed and prevented the FDA from completing a full toxicological risk assessment. of the products”, indicates the agency in its statement.
“The FDA is tasked with ensuring that tobacco products sold in this country meet the standard set by law, but the onus of proving that a product meets those standards ultimately rests on the shoulders of the company. ”, said Michele Mital, acting director of the Center for Tobacco Products of the FDA, through a note.
“Like all manufacturers, Juul had the opportunity to provide evidence showing that the marketing of its products complies with these standards.
However, the company did not provide that evidence, and instead left us with serious questions.
Without the data necessary to determine the relevant health risks, the FDA is issuing these marketing denial orders.”