- For immediate release:
Today, the U.S. Food and Drug Administration issued Do Not Market Orders (MDOs) for JUUL Labs Inc. for all of their products currently sold in the United States. As a result, the company must stop selling and distributing these products. Also, those currently on the US market must be removed or enforcement action could be taken. Products include the JUUL device and four types of JUULpods: Virginia tobacco flavored pods with nicotine concentrations of 5.0% and 3.0% and menthol flavored pods with nicotine concentrations of 5.0% and 3.0%. Retailers should contact JUUL with any questions about products in their range.
“Today’s actions are further progress in fulfilling the FDA’s commitment to ensuring that all e-cigarettes and electronic nicotine delivery systems currently sold to consumers meet our public health standards,” said FDA Commissioner Robert M. Califf, MD. . “The agency has dedicated significant resources to reviewing products from companies that account for the majority of the US market. We understand that they make up a significant portion of the products available, and many of them have played a disproportionate role in the rise of vaping among young people.”
These MDOs apply only to the commercial distribution, importation, and retail sale of these products and do not restrict individual consumer possession or use—the FDA cannot and will not take action against individual consumer possession or use of JUUL products or any other tobacco products.
After reviewing the company’s Tobacco Premarket Applications (PMTAs), the FDA determined that the applications did not provide sufficient evidence regarding the products’ toxicological profile to demonstrate that marketing of the products would be appropriate to protect public health. In particular, some results of the company’s study raised concerns due to insufficient and inconsistent data, including on genotoxicity and leaching of potentially harmful chemicals from the company’s branded e-liquid capsules, which were not properly reviewed and prevented the FDA from completing a full toxicological analysis. risk assessment of the products specified in the company’s applications.
To date, the FDA has received no clinical information to suggest an imminent hazard associated with the use of the JUUL device or JUULpods. However, the MDOs issued today reflect the FDA’s determination that there is insufficient evidence to assess the potential toxicological risks of using JUUL products. It is also impossible to learn about the potential harm from using other authorized or unauthorized third-party e-liquid pods with a JUUL device, or using JUUL pods with a non-JUUL device. The FDA does not recommend changing or adding substances to tobacco products. JUUL users are encouraged to report any unexpected health or product concerns to the FDA via Security Reporting Portal and seek medical attention if necessary.
“The FDA is tasked with ensuring that tobacco products sold in this country meet the standard set by law, but the responsibility for demonstrating that a product meets those standards ultimately rests with the company,” said Michel Mital, acting director of the FDA Tobacco Products Center. “Like all manufacturers, JUUL has had the opportunity to provide proof that their product marketing meets these standards. However, the company did not provide this evidence and instead left us with serious questions. Without the data needed to determine the relevant health risks, the FDA issues do-not-market orders.”
Any products covered by the MDO may not be offered for sale or distributed in the United States, or enforcement action may be taken by the FDA.
In addition to ensuring that JUUL complies with this order, as with unauthorized products in general, the FDA intends to ensure that distributors and retailers comply. In particular, the Food and Drug Administration notes that all new tobacco products that enter the market without premarket authorization required by law are sold illegally and are subject to enforcement action.
As the FDA has stated in the past, unauthorized electronic nicotine delivery systems (ENDS) that are not pending applications, including, for example, products with MDO, are among our highest enforcement priorities. Thus, the FDA encourages retailers to discuss with their suppliers what products they have, including the current status of a marketing application or authorization to sell any particular tobacco product. Manufacturers will be the best source of this information, and retailers should rely directly on manufacturers when making decisions about which products to continue to sell.
There are many resources available to help smokers who want to quit. Quitting all tobacco products is the best path to good health. Some current JUUL users who will not have access to JUUL products after this action, or current smokers who wish to quit cigarettes and cigars, may decide to switch to other ENDS products that have been FDA tested and approved based on their potential benefit. adult smokers.
To date, the FDA has approved 23 ENDS products. Under the PMTA program, applicants must demonstrate to the agency, among other things, that marketing authorization for a new tobacco product meets public health requirements.
The FDA continues to work to complete its review of the remaining pending applications for intended products submitted by the September 9, 2020 deadline.
The U.S. Food and Drug Administration, an agency within the U.S. Department of Health and Human Services, protects public health by ensuring that medicines for humans and animals, vaccines and other biological products for humans, and medical devices are safe, effective, and secure. . The agency is also responsible for food safety, cosmetics, dietary supplements, products that emit electronic radiation, and for the regulation of tobacco products.