FDA Takes Action On 93% Of ‘Deemed’ New Tobacco Product Applications

The U.S. Food and Drug Administration said it has taken actions on about 93 percent of the total applications for over 6.5 million “deemed” new tobacco products.

The move is part of the agency’s efforts to protect youth from the dangers of all tobacco products, including e-cigarettes, the most commonly used tobacco product.

The applications were submitted by a court-ordered deadline of September 9, 2020. In the applications, many of the over 6.5 million “deemed” new tobacco products were already in the market. Majority of them were for electronic nicotine delivery systems or ENDS products, such as e-cigarettes and e-liquids, which had never been through the FDA review process.

For FDA, the major consideration in its review of premarket tobacco product applications was to determine whether permitting the marketing of the product would be “appropriate for the protection of the public health.”

As of now, the FDA has taken action on applications for over 6 million ENDS products, while many of the remaining applications are in the final stages of review.

In the applications attended, the agency refused to file one company’s applications for around 4.5 million products because the required contents were missing. The FDA also issued Marketing Denial Orders or MDOs for more than 946,000 flavored ENDS products.

Flavored ENDS products are extremely popular among youth, with over 80% of e-cigarette users ages 12 through 17 using them.

Acting FDA Commissioner Janet Woodcock, and Mitch Zeller, director of the FDA’s Center for Tobacco Products, said, ” 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. … 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.”

Since January 2021, the FDA has issued a total of 170 warning letters to firms that collectively have listed more than 17 million ENDS with the FDA and that had not submitted premarket applications for these products.

In July, the agency issued a warning letter to a single company that did not submit an application and has more than 15 million products listed with the FDA.

In late August, the FDA rejected the marketing approval application for about 55,000 flavored ENDS products from three applicants. It was FDA’s first MDO for ENDS products, though it has issued other negative actions for some applications earlier.

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