FDA says there’s ‘a lot more work to come’ to improve the way it regulates tobacco products
With the decline in cigarette smoking and what the FDA labeled the “continued innovation” in the e-cigarette industry, “the societal concerns are not subtle,” a statement on the FDA’s website said.
“Our ability to keep pace with these changes will depend on immediate, short-term and long-term actions the center is taking that we believe will position the agency to more successfully implement our regulatory oversight of tobacco products,” FDA Commissioner Dr. Robert Califf said in a statement.
Optimizing tobacco product review process
Director Dr. Brian King said that his division will take an all-center approach to reform. The CTP has reviewed millions of applications for e-cigarette products and rejected millions of applications, it said, but King plans to optimize how the reviews will work.
Though e-cigarette products have been allowed to remain on the market for years, in 2020, the FDA asked the companies to submit applications to keep products on the market. The FDA said last March that it had reviewed 99% of the nearly 6.7 million e-cigarette products that have been submitted for premarket authorization, but many of those companies were small players in the market and there still are several outstanding decisions concerning companies that have a larger share of the market.
Under the new plans for the CTP, the division will streamline reviews when possible, increase the use of its Tobacco Products Scientific Advisory Committee to discuss broader scientific matters that are the basis for product applications, and plans to better communicate its practices.
Compliance and enforcement
The FDA will create a summit so that the US Department of Health and Human Services, the FDA and the US Department of Justice can discuss how the agency should enforce its compliance work.
The FDA does not have the independent authority to engage in litigation or seize products illegally sold on the market and will have to work with other departments to pursue companies that are in violation of the law.
To address the criticism that the agency was not transparent enough, this spring, the FDA says that it will create a new website where it will post what steps it has taken against companies that are found in violation of the law.
Policy and public education
The CTP will immediately begin the hiring process to create a new policy unit within the Office of the Center Director that would help coordinate policy across the tobacco division.
The CTP also plans to work with others in HHS and the FDA to figure out how to be more efficient in hiring.
By the spring, CTP will also publish materials that will help the public understand how it can have input on all of its education campaigns.
Today’s announcement is just the first step of money, the FDA said. It will immediately start work on a five-year strategic plan that the FDA will release by the end of the year, along with a new comprehensive policy agenda. The FDA said it will have routine updates about the plan throughout the year and will ask for input from the industry and other stakeholders by the summer.