The Center for Tobacco Products is developing a searchable public database of all tobacco products with a marketing order from the Food and Drug Administration. It has also launched a new webpage detailing its advisory and enforcement actions for unauthorized tobacco products and expanded its webpage with information on tobacco product retailer enforcement and investigations.
This follows the FDA’s recent tobacco inspection blitz where it warned 189 retailers, many of them convenience stores, for selling unauthorized e-cigarettes. And after NACS, as well as other organizations that service c-stores, asked the FDA for more transparency on its premarket tobacco product application process.
CTP Director Brian King shared these changes to the FDA’s website and more Thursday when he published an update on the progress the center has made in response to recommendations from the Reagan-Udall Foundation evaluation. FDA Commissioner Robert Califf commissioned the external evaluation on July 19, and the 39-page report detailing 15 recommendations for the FDA to make within the CTP was released Dec. 19.Then in February, the CTP outlined the changes it planned on making.
King said the searchable public database of tobacco products with a marketing order will build upon the FDA’s existing Tobacco Product Marketing Orders page. So far, the center has reviewed about 99% of PMTA submissions. As part of that review, the CTP had authorized 23 tobacco-flavored e-cigarette products, which are currently the only e-cigarettes that may be lawfully sold or distributed in the United States, he said.
He noted the CTP was planning a public meeting on enhancing the application review process this fall, for which more information would be shared soon.
When it comes to compliance and enforcement efforts, the CTP has issued more than 570 warning letters from January 2021-2023, King said. Other enforcement actions include filing 13 civil money penalties and six injunctions through the Department of Justice for firms marketing illegal e-cigarettes.
The center has also warned more than 200 retailers for illegal sales of various types of Puff, Hyde, Elf Bar and Esco Bars products, he said.
“I am proud of the significant progress the center has made to date in addressing the external evaluation recommendations, and I am confident that we’ll continue to make important strides in continuing to build and strengthen FDA’s tobacco program in the future,” King said. “As always, we’re moving forward with our guiding principles of sound science, strategic partnerships, health equity and clear communication and transparency.”
Other highlights from King’s update included:
- The CTP is working on a new strategic plan. It will announce proposed goals for it this summer, and it expects to release the final plan by December. A public meeting will be held this summer to seek stakeholder feedback.
- To increase transparency, the CTP’s Ombuds Office is leading the creation of an operational strategy to improve transparency and information sharing across all programmatic areas. The center is also planning for upcoming public meetings to gather input, and has published a webpage of all the tobacco products-related citizen petitions received by the center.
- To optimize the hiring process at the CTP, the center has established an interagency agreement with the Office of Personnel Management to review and evaluate position descriptions, and has begun utilizing these services. The CTP started 14 years ago and has 1,100 employees.
- The FDA is working with Congress on a potential framework for securing additional user fees from each regulated tobacco sector. President Joe Biden’s fiscal year 2024 budget included the agency’s request for an additional $100 million in user fees, indexed for inflation, and authority to include all deemed products among the tobacco classes for which FDA assesses and collects tobacco user fees.
More details on how the FDA is addressing recommendations from the Reagan-Udall report can be found here.
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