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Tobacco product regulation: FDA says ‘there is much more work to be done’ Story-level





On Friday, the US Food and Drug Administration’s Center for Tobacco Products. announced the 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 far-reaching problems that impeded its ability to regulate the industry and reduce tobacco-related illnesses and deaths.

Although the number of people who smoke is at one of the lowest levels, smoking remains the leading preventable cause of death in the United States. In 2021, about 11.5% of American adults smoked cigarettes, according to the US Centers for Disease Control and Prevention.. That’s a decrease from the 20.6% who smoked in 2009, but there are still more than 24 million people who smoke cigarettes, according to the CDC.

Every day, some 1,600 young people try their first cigarette. And that’s not even including the growing number of kids using e-cigarettes. in 2022, the CDC found that more than 2.5 million middle and high school students reported current use of e-cigarettes. About 5.66 million adults vape, a 2020 study found.

With cigarette consumption declining and what the FDA called “continued innovation” in the e-cigarette industry, “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 being taken by the center that we believe will position the agency to more successfully implement our regulatory oversight of tobacco products,” the commissioner said. of the FDA, Dr. Robert Califf said in the statement.

The independent panel, the Reagan-Udall Foundation, generally criticized the FDA for not being proactive enough, saying there was a real lack of clarity on the part of the Center for Tobacco Products, including about its goals. The panel also found that the center had some real communication problems. Critics of the FDA have said the agency is too slow to act and 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, he said, but King plans to streamline how the reviews work. .

Although e-cigarette products have been allowed to remain on the market for years, in 2020, the FDA required manufacturers to file applications to keep the products on the market. The FDA said in March that it had reviewed 99% of the nearly 6.7 million e-cigarette products that had been submitted for premarket authorization, but many of those companies were small players in the market, and there are still several pending decisions on companies that have a greater market share.

Under the new plans for the Center for Tobacco Products, the division will streamline reviews where possible, increase use of its Tobacco Products Scientific Advisory Committee to discuss broader scientific issues underlying product applications, and communicate better their practices.

The announcement says that the FDA will continue to advocate for the ability of collect user fees from e-cigarette companies just as it does with medical products. He doesn’t have the ability to do that, although the Center for Tobacco Products says he has a heavy 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 enforcement work.

The FDA does not have the independent authority to engage in litigation or seize products sold illegally on the market and will have to work with other departments to prosecute companies that violate the law.

To address criticism that the agency was not transparent enough, this spring the FDA says it will create a website posting steps it has taken against companies that break the law.

Just last week, in a “wake up call” industry, the FDA announced that the center first civil complaints of pecuniary fines against four e-cigarette manufacturers who violated the law by selling e-liquids without obtaining FDA authorization. Before e-cigarette companies can sell their products, they must obtain premarket authorization from the FDA.

The FDA has sent 1,500 warning letters to sellers, manufacturers, and online stores that are in violation of the law since 2009. It has also sent 120,000 warning letters to stores for repeat violations of the law.

The Center for Tobacco Products will begin hiring immediately 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 at HHS and the FDA to figure out how to be more efficient in recruiting.

For the spring, the center will also publish materials that will help the public understand how they can participate in all of its educational campaigns.

The American Lung Association said it was pleased to see the FDA’s response to the Reagan-Udall report and is encouraged that its commitment to implementing the Tobacco Control Act appears to have improved over the past six months. However, the group encourages the FDA to do even more.

“The FDA must improve its transparency to build trust with the public and the broader Story-level community. We remain disappointed that the FDA continues to allow products for which premarket tobacco applications have not been completed to remain on the market,” President and National CEO Harold Wimmer said in a statement.

Friday’s announcement is just the first step of many, the FDA said. He will immediately begin work on a five-year strategic plan for launch at the end of the year, along with a comprehensive new policy agenda. The FDA said it will have routine updates on the plan throughout the year and will solicit input from 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. He is also considering whether he should develop a standard that would create a nicotine peak to make cigarettes and other tobacco products less addictive.

“The FDA will continue to do our critical work to improve public Story-level,” Califf saying. “It is imperative that we implement transformative regulations in meaningful ways and make decisions based on the public Story-level standard in law, with the American public, not tobacco industry interests, at the forefront. We have made progress, but much work remains to be done.” “.

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