FDA Responds to Tobacco Application Spikes

The Food and Drug Administration’s (FDA) Center for Tobacco Products (CTP) has reached its court-ordered deadline to review new tobacco products, but there’s still work to be done as the agency concludes its evaluations.

In the summer of 2019, courts ordered pre-market applications for newer tobacco products like e-cigarettes, pipes, hookahs and certain types of cigars to be submitted to FDA by Sept. 9, 2020, to ensure that all products available for sale have undergone a careful, science-based review by the agency. FDA had until Sept. 9, 2021, to review these new submissions.

“By implementing the premarket review process for all deemed new tobacco products, we are taking steps to transform the marketplace,” said Matt Holman, director of CTP’s Office of Science, at an FDA webinar earlier this year. “This undertaking represents a major milestone for tobacco product regulation and for public health as a whole.”

Following the court order, CTP experienced a massive increase in tobacco product submissions, as companies rallied to meet the 2020 deadline. Over the past year, FDA has been reviewing approximately 6.5 million products made by more than 500 companies to determine whether they are “appropriate for the protection of public health.”

To accommodate these demands, CTP has ramped up its IT systems and increased hiring to streamline review procedures and provide additional guidance to industry.

“Our IT systems performed as designed and were able to handle both a high number of submissions within a short period of time and extremely large individual submissions,” said CTP Director Mitch Zeller in an FDA perspective piece.

In June, FDA’s acting commissioner Janet Woodcock said the agency would prioritize applications based on market share. If an application hadn’t been approved or denied by the deadline, the products will be pulled from the market until the FDA makes a decision.

Based on its review, FDA could implement new restrictions on Electronic Nicotine Delivery Systems (ENDS) products, like banning certain flavors or implementing additional guidelines to improve governance. A key consideration of FDA’s reviews are how these products impact youth.

In late August, FDA issued the first set of marketing denial orders (MDOs) for ENDS products after determining the applications for about 55,000 flavored ENDS products from three applicants, stating that they did not include sufficient evidence that the products benefit adult smokers compared to levels of use of these products among youths.

As of Sept. 9, FDA said the agency had reviewed 93% of the submitted applications, issuing MDOs to more than 946,000 flavored ENDS products. From Sept. 10 and beyond, FDA said that it would continue to review the “small percentage” of the remaining products and plans to issue its decisions on a rolling basis.

“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,” Woodcock and Zeller said in a joint statement.