The U.S. Food and Drug Administration (FDA) announced on its official website that it required the U.S. e-cigarette company Juul Labs to stop selling all of its e-cigarette products in the United States. The original text of the FDA is as follows:
A Marketing Denial Order (MDO) has been issued today to JUUL Labs Inc. for all products sold in the U.S., JUUL must stop selling and distributing these products, and those already on the market must also be taken off shelves or risk enforcement action . These products include JUUL units and four types of cartridges: Virginia tobacco-flavored cartridges with 5.0% and 3.0% nicotine concentrations and menthol-flavored cartridges with 5.0% and 3.0% nicotine concentrations. Retailers should contact JUUL with any questions regarding in-stock products.
“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. Resources to review products from companies that make up the majority of the U.S. market. We recognize that these form an important part of available products, many of which have played a disproportionate role in the rise of teen 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 the possession or use of JUUL products or any other tobacco product by individual consumers.
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. Conduct a risk assessment of the products specified in the company application.
To date, the FDA has not received clinical information indicating immediate harm associated with the use of JUUL devices or JUULpods. However, the MDO released today reflects the FDA’s decision that there is insufficient evidence to assess the potential toxicological risk of using JUUL’s products. There is also no way of knowing the potential hazards of using other authorized or unauthorized third-party e-liquid pods with JUUL devices or using JUULpods 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 mandate 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,” said Michelle Mittal, the company’s acting director. FDA Center for Tobacco Products. “Like all manufacturers, JUUL has the opportunity to provide evidence that its products are 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 required 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 our 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 continues to work to complete its review of the remaining pending applications that were deemed products submitted by the September 9, 2020 deadline.
