On Friday, the US Food and Drug Administration’s Center for Tobacco Products announced steps it would take to do a better job regulating tobacco products.
In December, an independent panel of experts said in a report that the FDA’s tobacco program had a number of wide-ranging problems that hindered its ability to regulate the industry and to reduce tobacco-related disease and death.
Although the number of people who smoke is at one of the lowest levels recorded, smoking is still the leading cause of preventable death in the United States. In 2021, about 11.5% of US adults smoked cigarettes, according to the US Centers for Disease Control and Prevention. That’s a decline from the 20.6% who smoked in 2009, but there are still more than 24 million people who smoke cigarettes, according to the CDC.
Each day, about 1,600 young people try their first cigarette. And that doesn’t even include the growing number of kids who use e-cigarettes. In 2022, the CDC found that more than 2.5 million middle and high schoolers reported current e-cigarette use. About 5.66 million adults vape, a 2020 study found.
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,” the agency says in a statement.
“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 the statement.
The independent panel – the Reagan-Udall Foundation – generally criticized the FDA for not being proactive enough and said that there was a real lack of clarity from the Center for Tobacco Products, even about its goals. The panel also found that the center had some real communication issues. Critics of the FDA have said that the agency is too slow to act, and it has repeatedly missed even court-ordered deadlines to regulate e-cigarette products.
Dr. Brian King, director of the center, said his division will take a comprehensive approach to reform. The center 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.
Alhough e-cigarette products have been allowed to remain on the market for years, in 2020, the FDA asked the manufacturers to submit applications to keep products on the market. The FDA said in 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 Center for Tobacco Products, 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 better communicate its practices.
The announcement saysthe FDA will continue to advocate for the ability to collect user fees from e-cigarette companies like it does with medical products. It does not have the ability to do that, even although the Center for Tobacco Products says it has a huge workload. That would require authorization from Congress.
The FDA will create a summit to discuss with the US Department of Health and Human Services and the US Department of Justice how it 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 website where it will post what steps it has taken against companies that are found to be in violation of the law.
Just this past week, in a “wakeup call” to the industry, the FDA announced the center’s first civil money penalty complaints against four e-cigarette manufacturers that were in violation of the law for selling e-liquids without getting the FDA’s authorization. Before e-cigarette companies can sell their products, they need to get premarket authorization from the FDA.
The FDA has sent 1,500 warning letters to online sellers, manufacturers and shops that are in violation of the law since 2009. It’s also sent 120,000 warning letters to stores for repeated violations of the law.
The Center for Tobacco Products will immediately begin hiring to create a policy unit within the Office of the Center Director that would help coordinate policy across the tobacco division.
The center also plans to work with others in HHS and the FDA to figure out how to be more efficient in hiring.
By the spring, the center will also publish materials that will help the public understand how it can have input on all of its education campaigns.
The American Lung Association said it was pleased to see the FDA’s response to the Reagan-Udall report and is encouraged that over the past six months, it seems to have improved its commitment to implementing the Tobacco Control Act. The group is, however, encouraging the FDA to do even more.
“FDA must improve its transparency to build trust with the public and the broader health community. We remain disappointed that FDA continues to allow products for which premarket tobacco applications have not been completed to remain on the market,” National President and CEO Harold Wimmer said in a statement.
Friday’s announcement is just the first step of many, the FDA said. It will immediately start work on a five-year strategic plan for 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.
The agency is still working on its product standards that would ban menthol in cigarettes and flavors – other than tobacco flavor – in cigars. It is also looking into whether it should develop a standard that would create a maximum nicotine level so cigarettes and other tobacco products would be less addictive.
“The FDA will continue to undertake our critical work to improve public health,” Califf said. “It’s imperative that we are able to meaningfully implement transformational regulations and make decisions based on the public health standard in the law, with the American public – not the interests of the tobacco industry – at the forefront. We’ve made progress, but there’s a lot more work to come.”