The U.S. Food and Drug Administration (FDA) has provided an update to its previous response regarding the Reagan-Udall Foundation expert panel that was conducted earlier this year, according to the National Association of Tobacco Outlets (NATO). The panel evaluated the operational aspects of the FDA’s tobacco regulatory program and issued a report titled “Operational Evaluation of Certain Components of FDA’s Tobacco Program.”
The FDA issued its response to the expert panel report in March of this year.
Now, the FDA has issued a response summarizing its progress and next steps in following through on the Reagan-Udall Foundation report. Some of the key areas of progress as announced by FDA Director Dr. Brian King are as follows:
- The FDA’s Center for Tobacco Products (CTP) is on track to issue proposed goals this summer for a five-year strategic plan and intends to release the final version of the new strategic plan by December 2023. The agency also plans to conduct a public meeting this summer to seek stakeholder input and feedback about the strategic plan.
- By the end of 2023, the CTP’s Office of Compliance and Enforcement will develop a new strategic plan related to new enforcement priorities and ensure that such a plan will be in alignment and coordination with the CTP’s new five-year strategic plan referenced above.
- The CTP Ombudsman Office is leading the creation of an operational strategy to improve public communications to provide greater transparency about the agency’s approach to compliance and enforcement. The issue of transparency will also be included in the upcoming public meeting to obtain feedback from the public.
- The CTP has completed its review of 99% of tobacco product pre-market applications. As a result of this review process, the FDA has authorized 23 tobacco-flavored e-cigarette products and devices. The CTP is planning to conduct a public meeting during the fall of 2023 regarding the pre-market application review process.
- The CTP is in the process of finalizing new regulations banning menthol in cigarettes and characterizing flavors in cigars and continues to work toward publishing a proposed regulation that would establish a maximum nicotine level to reduce the addictiveness of cigarettes and other certain combustible tobacco products.
- The CTP is collaborating with the Department of Justice, the Bureau of Alcohol, Tobacco, Firearms, and Explosives, the Federal Trade Commission and the U.S. Customers and Border Protection Agency to discuss opportunities for leveraging resources to support enforcement actions. One outcome of this collaboration was the adding of several firms marketing unauthorized tobacco products to the FDA import alert. Products on an active import alert are subject to being detained upon reaching the United States without physical examination.
- The CTP is considering whether changes to the federal Family Smoking Prevention and Tobacco Control Act should be made to streamline the tobacco enforcement process and assist the CTP in enforcing the law. If changes to the law are necessary, CTP will work in coordination with the relevant FDA and Department of Health and Human Services offices and the Biden administration to seek such changes from Congress.
- The CTP plans to create a comprehensive webpage for all enforcement activities for products that are illegally marketed without FDA authorization, routinely reach out to industry trade groups and other industry stakeholders to keep them apprised of the development of new enforcement priorities and updates, enhance FDA’s Tobacco Product Marketing Order webpage, and develop a searchable public database of all tobacco products that have an FDA marketing order. This work has already begun and new web content began being posted this spring and will continue to be posted.