The US Food and Drug Administration (FDA) has issued marketing denial orders (MDOs) to JUUL Labs for all of their products currently marketed in the country.
The products include the JUUL device and four types of JUULpods: Virginia tobacco flavored pods at nicotine concentrations of 5.0 percent and 3.0 percent and menthol flavored pods at nicotine concentrations of 5.0 percent and 3.0 percent.
The company cannot sell or distribute these products in the US market. In addition, those currently on the US market must be removed, or risk enforcement action, the FDA statement said.
The “action is further progress on the FDA’s commitment to ensuring that all e-cigarette and electronic nicotine delivery system products currently being marketed to consumers meet our public health standards”, said FDA Commissioner Robert M. Califf, MD, in the statement.
“The agency has dedicated significant resources to review products from the companies that account for most of the US market. We recognize these make up a significant part of the available products and many have played a disproportionate role in the rise in youth vaping,” he added.
The ban on e-cigarettes made by Juul is part of the agency’s review of 6.5 million e-cigarette-related products.
In September last year, the FDA rejected more than 946,000 flavored electronic nicotine delivery systems (ENDS) products, such as e-cigarettes and e-liquids, prohibiting them from being marketed or sold due to a lack of sufficient evidence of health benefits.
The agency said Juul’s product lacked sufficient evidence that claimed to protect public health.
In particular, some of the company’s study findings also raised concerns due to insufficient and conflicting data, including regarding genotoxicity and potentially harmful chemicals leaching from the company’s proprietary e-liquid pods, that have not been adequately addressed and precluded the FDA from completing a full toxicological risk assessment of the products named in the company’s applications.
While the restrictions pertain to the commercial distribution, importation, and retail sales of these products, it does not restrict individual consumer possession or use.
The FDA said it cannot and will not enforce against individual consumer possession or use of JUUL products or any other tobacco products.
