For immediate publication:

Today, the United States Food and Drug Administration issued marketing denial orders (MDO) 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 being penalized. Products include the JUUL device and four types of JUULpods: Virginia tobacco-flavored pods with 5.0% and 3.0% nicotine strengths and menthol-flavored pods with 5.0% and 5.0% nicotine strengths. 3.0%. Retailers should contact JUUL with questions about the products in their inventory.

“Today’s action is a further step forward in the FDA’s commitment to ensure that all electronic nicotine delivery system and e-cigarette products currently marketed to consumers meet our public health standards,” said the commissioner. of the FDA, Robert M. Califf, MD. resources to review products from companies that represent the majority of the US market. We recognize that these make up a significant portion of the products available and many have played a disproportionate role in the rise of youth vaping.”

These MDOs only address the commercial distribution, importation, and retail sales of these products, and do not restrict the possession or use of these products by individual consumers; The FDA cannot and will not enforce the possession or use of JUUL products or any other tobacco products by individual consumers.

After reviewing the company Premarket Tobacco Product Applications (PMTAs), the FDA determined that the applications lacked sufficient evidence regarding the toxicological profile of the products to demonstrate that the marketing of 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 those related to genotoxicity and leaching of potentially harmful chemicals from the company’s proprietary e-liquid pods, which were not reported. adequately addressed and prevented the FDA from completing a full toxicology review. risk assessment of the products mentioned in the company’s applications.

To date, the FDA has received no clinical information suggesting an immediate 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 potential toxicological risks from the use of JUUL products. There is also no way to know the potential harm from using other authorized or unauthorized third party e-liquid pods with the JUUL device or using JUULpods with a non-JUL device. The FDA recommends not modifying or adding substances to tobacco products. JUUL users are encouraged to report any unexpected health issues or product problems to the FDA through the Security Reporting Portal and seek medical attention when necessary.

“The FDA is tasked with ensuring that tobacco products sold in this country meet the standard set by law, but the onus of proving that a product meets those standards ultimately rests 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 showing that the marketing of its products meets these standards. However, the company did not provide that evidence, and instead left us with important questions. Without the data necessary to determine the relevant health risks, the FDA is issuing these marketing denial orders.”

Any product 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 statutorily required premarket authorization are marketed illegally and are subject to enforcement action.

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

There are many means to help smokers who want to quit. Quitting 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 want to quit cigarettes and cigars may decide to switch to other EXTREME products that have been reviewed and cleared by the FDA based on their potential to benefit adult smokers.

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

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

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