On this day last year, the U.S. Food and Drug Administration faced the unprecedented task of reviewing applications for over 6.5 million “deemed” new tobacco products – many of which 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 made significant progress in the months since, working diligently to better understand these products and, as of today, taking 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, FDA notes there’s more work to be done to complete the remaining reviews and ensure that they 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 their 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, the FDA notes 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 their determination as to whether the statutory standard for marketing is met.
As of today, the agency has taken action on applications for over 6 million ENDS products, including refusing to file (RTF) one company’s applications for approximately 4.5 million products because required contents were missing as well as issuing 132 MDOs for more than 946,000 flavored ENDS products, including flavors such as Apple Crumble, Dr. Cola, and Cinnamon Toast Cereal.
The FDA continues to work expeditiously on the remaining applications that were submitted by the court’s Sept. 9, 2020, deadline, many of which are in the final stages of review. For premarket tobacco product applications, the FDA’s responsibility is to assess whether applicants meet the applicable statutory standard for marketing their new products. As the FDA has said before, the burden is on the applicant to provide evidence to demonstrate that permitting the marketing of their product meets the applicable statutory standard. Their continued review also includes a smaller number of pending applications that are being reviewed under the “substantial equivalence” standard, for cigars, pipes and hookah tobacco and for which the FDA granted marketing orders covering over 350 products.
All new tobacco products on the market without the statutorily required premarket authorization are marketed unlawfully and subject to enforcement action at the FDA’s discretion. The FDA is committed to completing the review of the remaining products as quickly as possible to provide regulatory certainty and will continue to keep the public informed of our progress. In the meantime, products for which no application is pending, including, for example, those with a Marketing Denial Order and those for which no application was submitted, are among our highest enforcement priorities. If such products are not removed from the market, the agency intends to follow its usual enforcement practices in these circumstances and will issue a warning letter before initiating enforcement action (such as civil money penalties, seizure, or injunction) and afford the recipient an opportunity to respond. 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. Among those warning letters, and in an effort to take action on products with a likelihood of youth use or initiation, the FDA issued a warning letter in July to a single company that did not submit an application and has more than 15 million products listed with the FDA.
The FDA is committed to working as quickly as possible to transition the current marketplace for deemed new tobacco products to one in which all products available for sale have undergone a careful, science-based review by the FDA and met the statutory standard. Continuing to take appropriate regulatory actions to protect the public, especially youth, from the harms of tobacco products remains one of the agency’s highest priorities.