FDA Makes Strides in Premarket Review of Tobacco Product Applications

April 20, 2021 by Alec Stone MA, MPA, Former ONS Director of Government Affairs and Advocacy

The U.S. Food and Drug Administration’s (FDA’s) Center for Tobacco Products has aggressively fought to obtain tighter tobacco product regulations to protect adolescent lungs. One of those ways is through premarket review, where e-cigarettes and other new tobacco products that were available as of August 8, 2016, were required to submitted applications to FDA (https://www.fda.gov/tobacco-products/manufacturing/submit-tobacco-product-applications-deemed-tobacco-products) for approval by Sept. 9, 2020.

As of April 12, 2021, FDA nearly completed the initial intake of the 4.8 million products submitted, and the acceptance, filing, and substantive review of applications is underway. 

Now, the agency is prioritizing enforcement against any electronic nicotine delivery system (ENDS) products that are being sold without providing a product application to the premarket review.

“Additionally, for deemed tobacco products—other than ENDS or ‘premium cigars’—that do not have premarket authorization, FDA will make enforcement decisions on a case-by-case basis and intends to prioritize enforcement based on the likelihood of youth use (https://voice.ons.org/advocacy/vaping-e-cigarettes-and-flavored-tobacco-are-reversing-20-years-of-decreasing-smoking) or initiation to make the most efficient use of its resources,” Mitch Zeller, JD, director of the Center for Tobacco Products, said (https://www.fda.gov/tobacco-products/ctp-newsroom/perspective-fdas-progress-review-tobacco-product-applications-submitted-sept-9-2020-deadline).

FDA posted a list of products (https://www.fda.gov/tobacco-products/market-and-distribute-tobacco-product/deemed-new-tobacco-product-applications-list) that were on the market as of August 8, 2016, are currently marketed, and are the subject of a pending, timely applications. It includes 2,000 items: about 1,100 cigars, more than 330 pipe tobacco products, and more than 660 waterpipe tobacco products. FDA also created a website (https://www.fda.gov/tobacco-products/market-and-distribute-tobacco-product/tobacco-product-applications-metrics-reporting) that explains the premarket approval process and provides more detailed updates of the agency’s progress on the review.

“We have worked for several years to prepare for premarket review of a large number of deemed products,” Zeller said (https://www.fda.gov/tobacco-products/ctp-newsroom/perspective-fdas-progress-review-tobacco-product-applications-submitted-sept-9-2020-deadline). “These efforts included improving information technology systems, engaging with stakeholders, significantly increasing hiring, streamlining review procedures, and providing and promoting guidance and resources to inform industry.”

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