For immediate release:

Today, the U.S. Food and Drug Administration issued marketing denial orders (MDOs) to JUUL Labs Inc. for all of its products currently marketed in the United States. As a result, the company must stop selling and distributing these products. Additionally, those currently on the US market must be removed, or risk enforcement action. Products include the JUUL device and four types of JUULpods: Virginia tobacco flavored pods at 5.0% and 3.0% nicotine concentrations and menthol flavored pods at 5.0% and 3.0% nicotine concentrations, 0%. Retailers should contact JUUL with any questions about products in their inventory.

“Today’s action is further progress in the FDA’s commitment to ensuring that all e-cigarette products and electronic nicotine delivery systems currently being marketed to consumers meet our public health standards,” said FDA Commissioner Robert M. Califf, MD. resources to evaluate products from companies that account for most of the North American market. We recognize that they constitute a significant part of the products available and many have played a disproportionate role in the rise of youth vaping.”

These MDOs pertain only to the commercial distribution, import and retail sales of these products and do not restrict individual consumer possession or use – the FDA cannot and will not enforce individual consumer possession or use of JUUL products or any other tobacco products.

After reviewing the company’s applications for pre-market tobacco products (PMTAs), the FDA determined that the applications lacked sufficient evidence about the toxicological profile of the products to demonstrate that marketing the products would be appropriate for the protection of public health. In particular, some of the company’s study findings raised concerns due to insufficient and conflicting data – including regarding genotoxicity and leaching of potentially harmful chemicals from the company’s proprietary e-liquid capsules – that were not addressed properly and prevented the FDA. to complete a full toxicology study. risk assessment of the products indicated in the company’s applications.

To date, the FDA has not received clinical information to suggest an immediate risk associated with using 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. There is also no way to know the possible harm from using other authorized or unauthorized third-party e-liquid pods with the JUUL device or from using JUULpods with a non-JUUL device. The FDA does not recommend modifying or adding substances to tobacco products. JUUL users are encouraged to report any unexpected health issues or product issues to the FDA through the Safety Reporting Portal and to seek medical attention as needed.

“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 rests on the company’s shoulders,” said Michele Mital, acting director of the FDA Tobacco Products Center. “As with all manufacturers, JUUL has had the opportunity to present evidence demonstrating that the marketing of its products meets these standards. However, the company did not provide this evidence and instead left us with significant questions. Without the necessary data to determine the relevant health risks, the FDA is issuing these marketing denial orders.”

Any products subject to an MDO may not be offered for sale or distributed in the United States, or the FDA may take enforcement action.

In addition to ensuring that JUUL complies with this order, as with unauthorized products in general, the FDA intends to ensure compliance by distributors and retailers. Specifically, the FDA notes that all new tobacco products on the market without the legally required pre-marketing authorization are illegally marketed and subject to enforcement action.

As the FDA has stated in the past, unauthorized electronic nicotine delivery system (ENDS) products for which no claims are pending, including, for example, those with an MDO, are among our highest enforcement priorities. Therefore, the FDA encourages retailers to discuss the products in their inventory with their suppliers, including the current status of any marketing order or marketing authorization for any specific tobacco product. Manufacturers will be the best source of this information, and retailers must rely directly on manufacturers to inform decisions about which products to continue to sell.

There are many resources to help smokers who want to quit. Giving up all tobacco products is the best possible 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 smoking cigarettes and cigars may decide to switch to other ENDS products that have been reviewed and authorized by the FDA based on their potential to benefit smokers. adults.

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

FDA continues to work to complete its review of the remaining pending orders for products deemed to have shipped by the September 9, 2020 deadline.

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The FDA, an agency of the US Department of Health and Human Services, protects the public health by ensuring the safety, efficacy and safety of drugs, vaccines and other biological products for human use and medical devices for human and veterinary use. The agency is also responsible for the security of the supply of food, cosmetics, dietary supplements, products that emit electronic radiation, and the regulation of tobacco products.