FDA says there's 'a lot more work to come' to improve the way it regulates tobacco products

In December, an independent panel of experts said in its 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.

While the number of people who smoke is at one of the lowest levels ever 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,” 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.

The independent panel — known as 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 also said that the agency is too slow to act and it has repeatedly blown even court ordered deadlines to regulate e-cigarette products.

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.

The announcement said that the FDA will continue to advocate for the ability to collect user fees from e-cigarette companies like it does with medical products. So far it does not have the ability to do that, even though the CTP says it has a huge workload. That would require authorization from Congress.

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.

US tobacco control in 2022 gets a mixed review from the American Lung Association

Just this past week, in what it called 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 first. 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.

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.

Next steps

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.

The FDA 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 if it should develop a standard that would create a maximum nicotine level, so that cigarettes and other tobacco products would be less addictive.

“The FDA will continue to undertake our critical work to improve public health,” the FDA’s Califf said in a statement. “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.”

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Optimizing tobacco product review process

Compliance and enforcement

Policy and public education

Next steps

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