The Food and Drug Administration (FDA) has announced that they will ban the sale of JUUL e-cigarettes. The FDA has issued a marketing denial order (MDOs) to JUUL Labs Inc. This means that the company must stop distributing and selling these products, and any products that are on the market need to be removed or there will be an enforcement action.
The products that are included in this ban are the JUUL device and the four different types of JUULpods: menthol-flavored pods at nicotine concentrations of 5.0 percent and 3.0 percent and Virginia tobacco flavored pods at nicotine concentrations of 5.0 percent and 3.0 percent.
“Today’s 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, M.D.
“The agency has dedicated significant resources to review products from the companies that account for most of the U.S. 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.”
How did it come to this?
After reviewing the company’s premarket tobacco product applications (PMTAs), it was determined by the FDA that these applications lacked sufficient evidence on the products' toxicological profiles, and therefore the company could not demonstrate that marketing of the products would be appropriate for public health protection
There was also some concern for the findings of the company’s studies, which caused worries due to insufficient and conflicting data – especially regarding the potentially harmful chemicals that can leach from the proprietary e-liquid pods and their genotoxicity potential.
FDA mentioned that they had not received any clinical information to suggest that there is an immediate hazard if someone uses these devices or pods. However, the MDOs has been issued as FDA cannot determine the potential toxicological risks of using JUUL products.
“The FDA is tasked with ensuring that tobacco products sold in this country meet the standard set by the law, but the responsibility to demonstrate that a product meets those standards ultimately falls on the shoulders of the company,” said Michele Mital, acting director of the FDA’s Center for Tobacco Products, in a statement.
“As with all manufacturers, JUUL had the opportunity to provide evidence demonstrating that the marketing of their products meets these standards. However, the company did not provide that evidence and instead left us with significant questions. Without the data needed to determine relevant health risks, the FDA is issuing these marketing denial orders.”
The FDA also could not find the potential risk of using the other e-liquid pods with the JUUL device, or vice versa (using JUUL pod with a non-JUUL device).
The FDA also recommends that any users of the JUUL products that have any unexpected health or product problems report them to the FDA through the Safety Reporting Portal, and also seek medical attention as necessary.
This story will be updated as more information comes in.
