The FDA issued a PMTA application for rejecting JUUL products on its official website. JUUL must be removed from the US market and cannot be sold anymore.

The U.S. Food and Drug Administration issued a Marketing Denial Order (MDO) to JUUL Labs Inc. for all of its products currently sold in the United States. Therefore, JUUL must stop selling and distributing these products.

Additionally, those currently on the U.S. market must be removed or risk enforcement action.

These products include JUUL devices and four types of JUUL pods: Virginia tobacco flavored pods with 5.0% and 3.0% nicotine concentrations and menthol flavored pods with 5.0% and 3.0% nicotine concentrations.

Retailers should contact JUUL with any questions regarding products in stock.

"Today's action is a further step forward in FDA's commitment to ensuring that all e-cigarette and ENDS products currently sold to consumers meet our public health standards," said FDA Commissioner Robert M. Califf, MD. “We have spent a lot of time and resources reviewing products from companies that make up the majority of the U.S. market. We recognize that these form a significant part of the products available, many of which have played a role in the rise of youth vaping.”

These MDOs deal only with the commercial distribution, importation, and retail sale of these products and do not restrict individual consumer possession or use - FDA cannot and will not mandate individual consumer possession or use of JUUL products or any other tobacco product.

After reviewing the company's premarket tobacco product applications (PMTAs), the FDA determined that the applications lacked sufficient evidence regarding the product's toxicological profile to demonstrate that the product was marketed to protect public health.

In particular, some of the company's findings have raised concerns because insufficient and conflicting data -- including on genotoxicity and potentially harmful chemicals leached from the company's proprietary e-liquid cartridges -- have not been adequately addressed , and prevented the FDA from completing a full toxicology study to conduct a risk assessment of the product specified in the company's application.

To date, the FDA has not received clinical information indicating immediate harm associated with the use of JUUL devices or JUUL pods.

However, the MDO released today reflects the FDA's decision that there is insufficient evidence to assess the potential toxicological risk of using JUUL products, nor to know the use of other authorized or unauthorized third-party e-liquid pods with JUUL devices Or the potential hazards of using JUUL pods with non-JUUL devices.

FDA recommends against modifying or adding substances to tobacco products. JUUL users are encouraged to report any unexpected health concerns or product concerns to FDA through the Safety Reporting Portal and seek medical attention if necessary.

"The FDA's mission is to ensure that tobacco products sold in this country meet the standards set by the law, but the responsibility for demonstrating that products meet those standards ultimately rests with the companies." Michelle Mittal, acting director of the FDA's Center for Tobacco Products Say. “Like all manufacturers, JUUL had the opportunity to provide evidence that its products were marketed in compliance with these standards. However, the company did not provide that evidence and left us with important questions. In the absence of the necessary health risks to determine data, the FDA is issuing these marketing denial orders.”

Any MDO-bound product may not be sold or distributed in the United States or FDA may take enforcement action.

In addition to ensuring that JUUL complies with the order in the same way as unauthorized products in general, the FDA intends to ensure that distributors and retailers comply with the order.

Specifically, the FDA noted that all new tobacco products on the market without statutory premarket authorization are illegally marketed and subject to enforcement action.

As the FDA has said in the past, unauthorized electronic nicotine delivery system (ENDS) products, including those with MDOs, are one of the highest enforcement priorities.

Therefore, FDA encourages retailers to discuss with their suppliers the products in their inventory, including the current status of marketing applications or marketing authorizations for any particular tobacco product. The manufacturer will be the best source of this information, and retailers should rely directly on the manufacturer to decide which products to continue selling.

There are many resources available to help smokers who want to quit. Quitting all tobacco products is the best way to get healthy. Some current JUUL users who will not be able to use JUUL products after this action or current smokers who want to transition from cigarettes and cigars may decide to switch to other ENDS products reviewed and authorized by the FDA based on their potential to benefit adult smokers.

To date, the FDA has authorized 23 ENDS products. Under the PMTA pathway, applicants must demonstrate to the agency that, among other things, allowing the sale of new tobacco products would be appropriate to protect public health.

The FDA will continue to work to complete its review of the remaining pending applications for deemed products submitted prior to the September 9, 2020 deadline.

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