FDA taking action against makers of several million tobacco products submitted under court order and falsely labeled as “new.”

Sept. 14, 2021

Food and Drug Administration officials plan to take action against makers of 6.5 million tobacco products that were recently submitted for approval. The majority of the products, according to an FDA statement, were for electronic nicotine delivery system products (ENDS) such as e-cigarettes and e-liquids.

According to FDA Acting Commissioner Janet Woodcock, M.D., and Mitch Zeller, J.D., director of the FDA’s Center for Tobacco Products, the products were misidentified as “new” but were already on the market.

A majority of the applications submitted by a court-ordered deadline of Sept. 9, 2020, were for electronic nicotine delivery systems (ENDS) products, such as e-cigarettes and e-liquids, which had never been through the FDA review process.

The FDA has been working diligently to better understand these products and has taken action on about 93% of the total timely-submitted applications. This includes issuing Marketing Denial Orders (MDO) for more than 946,000 flavored ENDS products because their applications lacked sufficient evidence that they have a benefit to adult smokers sufficient to overcome the public health threat posed by the well-documented, alarming levels of youth use of such products.

Flavored ENDS products are extremely popular among youth, with over 80% of e-cigarette users ages 12 through 17 using them. However, there’s more work to be done to complete our remaining reviews and ensure that we continue taking appropriate action to protect our nation’s youth from the dangers of all tobacco products, including e-cigarettes, which remain the most commonly used tobacco product by youth in the United States.

As required by statute, a key consideration in our review of premarket tobacco product applications submitted for products like e-cigarettes is to determine whether permitting the marketing of the product would be “appropriate for the protection of the public health,” taking into account the risks and benefits to the population as a whole. This determination includes consideration of how the products may impact youth use of tobacco products and the potential for the products to completely move adult smokers away from use of combustible cigarettes. Importantly, we know that flavored tobacco products are very appealing to young people. Therefore, assessing the impact of potential or actual youth use is a critical factor in our determination as to whether the statutory standard for marketing is met.

FDA announcement