FDA Denies Marketing Authorization for JUUL Products

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For immediate release:

On July 5, 2022, the FDA administratively suspended the marketing denial order. The agency has determined that there are scientific issues unique to the JUUL application that warrant further review. This administrative suspension temporarily suspends the marketing refusal order during the additional review but does not cancel it. All Electronic Nicotine Delivery Systems, or ENDS products, including those manufactured by JUUL, are required by law to have FDA clearance to be legally marketed. Agency stay and review does not constitute authorization to market, sell, or ship JUUL products.

On June 24, 2022, the United States Court of Appeals for the DC Circuit issued a temporary administrative stay of the market refusal order for Juul Labs Inc. The court notes that the purpose of this administrative stay is to give the court a sufficient opportunity to consider the applicant’s forthcoming decision on an emergency stay motion pending the court’s review and shall in no way be construed as a decision on the merits of this motion.

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Today, the United States Food and Drug Administration issued marketing denial orders (MDOs) to JUUL Labs Inc. for all of their products currently marketed in the United States. Accordingly, the company must stop selling and distributing these products. In addition, those currently on the US market must be withdrawn or face enforcement action. Products include the JUUL Device and four types of JUUL Pods: Virginia Tobacco flavored pods in 5.0% and 3.0% nicotine strengths and Menthol flavored pods in 5.0 nicotine strengths % and 3.0%. Retailers should contact JUUL with any questions regarding products in their inventory.

“Today’s action is further progress in the FDA’s commitment to ensure that all e-cigarette and e-nicotine delivery system products currently marketed to consumers meet our public health standards.” , said FDA Commissioner Robert M. Califf, MD. resources to review products from companies that represent the bulk 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 increasing youth vaping.

These MDOs apply only to the commercial distribution, importation, and retail sale of these products, and do not restrict possession or use by individual consumers – the FDA cannot and will not oppose possession. or individual consumers’ use of JUUL Products or any other tobacco products.

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

To date, the FDA has not received any clinical information suggesting any immediate harm associated with the use of the JUUL Device or JUULpods. However, the MDOs released today reflect the FDA’s determination that there is insufficient evidence to assess the potential toxicological risks associated with the use of JUUL products. There is also no way to know about potential harms from using other authorized or unauthorized third-party e-liquid pods with the JUUL device or using JUULpods with a non-JUUL device. The FDA advises against modifying or adding substances to tobacco products. JUUL users are encouraged to report any unexpected health or product concerns to the FDA through the Safety Reporting Portal and seek medical attention if necessary.

“The FDA is responsible for ensuring that tobacco products sold in this country meet the standards set by law, but the responsibility for demonstrating that a product meets those standards ultimately rests with the company,” said Michele Mital, acting director of the FDA’s Tobacco Products Center. “As with all manufacturers, JUUL has had the opportunity to provide evidence demonstrating that the marketing of their products meets these standards. However, the company did not provide this proof and instead left us with important questions. Without the data needed to determine the relevant health risks, the FDA issues 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 generally, the FDA intends to ensure compliance by distributors and retailers. Specifically, the FDA notes that all new tobacco products on the market without the premarket authorization required by law 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 no application is 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 the marketing application or marketing authorization for a particular tobacco product. Manufacturers will be the best source of this information, and retailers should rely directly on manufacturers to inform decisions about which products to keep selling.

There are many resources 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 as a result of this action or current smokers who wish to give up cigarettes and cigars may decide to switch to other ENDS products that have been reviewed and cleared by the FDA based on of their potential benefits. adult smokers.

To date, the FDA has cleared 23 ENDS products. Under the PMTA pathway, applicants must demonstrate to the agency, among other things, that marketing authorization of the new tobacco product 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 of the United States Department of Health and Human Services, protects public health by ensuring the safety, efficacy, and safety of drugs, vaccines, and other biological products for human use, and medical devices. The agency is also responsible for the safety and security of the food supply, cosmetics, dietary supplements, electronic radiation emitting products and the regulation of tobacco products.