The U.S. Food and Drug Administration (FDA) has shared a press release to report that it has denied authorization to market JUUL products, issuing marketing denial orders (MDOs) that require the removal of all of the company’s electronic cigarette products from the U.S. market. JUUL may no longer sell and distribute its JUUL device and four types of JUULpods, including Virginia tobacco flavored pods at nicotine concentrations of 5.0% and 3.0%, and all products that are currently on the market should be removed by retailers who would prefer not to face enforcement action. The FDA’s decision against JUUL stems from various worries, such as the potential for “harmful chemicals leaching from the company’s proprietary e-liquid pods.” JUUL was founded in 2015 and became one of the most popular companies to offer alternatives to traditional cigarettes.
“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.”
“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. “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.”
To date, the FDA has not received clinical information to suggest an immediate hazard associated with the use of the JUUL device or JUULpods. However, the MDOs issued today reflect FDA’s determination that there is insufficient evidence to assess the potential toxicological risks of using the JUUL products. There is also no way to know the potential harms from using other authorized or unauthorized third-party e-liquid pods with the JUUL device or using JUULpods with a non-JUUL device. The FDA recommends against modifying or adding substances to tobacco products. JUUL users are encouraged to report any unexpected health problems or product problems to the FDA through the Safety Reporting Portal and to seek medical attention as necessary.