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FDA's tobacco control program should be proactive, not reactive, says independent panel after extensive review

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An independent expert panel says its review of the U.S. Food and Drug Administration’s tobacco control program found many wide-ranging issues that impede its ability to regulate the industry and reduce tobacco-related illness and death. tobacco.

FDA Commissioner Dr. Robert Califf requested the review in July, anticipating the complex issues that will come with an ever-growing number of tobacco products. Experts were invited to take a closer look at the agency’s regulatory process and operations, as well as how it handles application reviews, compliance and enforcement actions, and communication with stakeholders and the public. The panel did not review the FDA’s smoke-free policy itself.

In the wake of the infant formula crisis, Califf also called for a review of how the FDA handled its efforts to keep the baby safe. Safe for the US food supplyand the resulting report was highly critical.

Monday new report from a separate panel convened by the Reagan-Udall Foundation says the Center for Tobacco Products’ efforts have “had a measurable impact,” but the already difficult job of regulating a major industry is made even more difficult by a sheer volume huge number of product applications, repeated leadership changes and near-constant litigation.

Although the center “has the primary mission of protecting public health from tobacco-related disease and death and regulates products that have no inherent benefit and enormous social costs, it is a government regulatory program that has a duty to operate effectively, fairly and transparently,” the report says. Instead, it “has been forced to operate primarily in a reactive mode, shifting from challenge to challenge. ‘other”.

The panel found a lack of clarity even about the center’s goals and priorities, as well as gaps in transparency and communication. There were also concerns about the need for stakeholder and public input, as well as policy changes that seemed to be happening without notice and were not being implemented consistently.

The FDA received authority to regulate the marketing, manufacturing, and distribution of tobacco products in 2009 when Congress passed the Tobacco Control Act. Manufacturers were required to submit an application to the agency and receive marketing authorization before selling any new tobacco product.

The goal was to give a government agency the ability to create regulations that would protect Americans’ health, but critics say it was a fundamentally flawed task because these products are injurious to health.

The Center for Tobacco Products has also come under fire from tobacco control advocates who say the agency was too slow to act and exceeded court-ordered deadlines to regulate e-cigarettes.

This month, the Office of the Inspector General of the U.S. Department of Health and Human Services published a report criticizing the FDA for its lack of oversight of online tobacco retailers, saying that children’s tobacco use remains “of serious concern” and that online sales are a potentially easy way for children to buy products without have to verify their age.

In 2022, nearly 17% of high school students — or more than 2.14 million high school students — said they currently use e-cigarettes, according to the US Centers for Disease Control and Prevention. And 1 in 30 middle school students, or about 3.3%, said they had used an e-cigarette in the past 30 days. For high school students, it was 1 in 7 students, the CDC said. For cigarettes, in 2022 1 in 100 college students smoked a cigarette in the last 30 days, it was 2 in 100 high school students, according to the CDC.

Public health experts are concerned about the use of tobacco products among young people because it can become a lifelong habit. Nearly 9 out of 10 adults who smoke cigarettes daily try smoking for the first time when they are 18 years old.

In the years since its inception, the Tobacco Products Center’s workload has become “almost overwhelming”, the new report says: it received 432 pre-market applications for tobacco products through October 31, 2019. , but more than 8 million in fiscal year 2020… alone. This massive number of candidate reviews has fatigued staff members; the tobacco industry and public health advocates are in turn frustrated and are turning to litigation to address their concerns.

“Stakeholders note that the current application review process is extremely cumbersome and time-consuming, characterizing submission requirements as vague and changing frequently,” the report said. And with a huge backlog of applications, “the current environment reflects an unintended shift from what was structured by law as a pre-market licensing framework to the reality of a post-market regulatory environment.”

This environment has its own challenges. Some manufacturers continue to sell products even without marketing authorization due to a lack of action by the FDA, even going so far as to “submit flawed applications or file frivolous appeals to further delay enforcement action.” But the enforcement process is long and tedious, and the final decision on whether or not to take punitive action against a company rests not with the FDA but with the US Department of Justice.

The review panel recommended four broad areas for improvement and made recommendations “intended to help the center develop additional tools to achieve its public health goals,” panel chair Lauren Silvis said in a statement. communicated.

First and foremost, according to the report, the Tobacco Products Center should become more proactive and strategic, thinking about where it is and where it needs to go. “The CTP must invest time, now, with staff and public input, to create and implement a strategic plan that identifies the Centre’s strategic objectives and charts an operational roadmap of the steps the CTP will take over the over the next five years to achieve these goals.”

The panel also suggests improving transparency and communication, clarifying industry expectations and soliciting public feedback on topics such as its education campaigns.

The center should improve the application review process, the report says, by developing “a clearer and more predictable framework” and clearly identifying application requirements and expectations.

The panel also suggests working with other agencies on law enforcement. The FDA alone cannot change the current tobacco control paradigm. While tobacco law enforcement is considered a priority for the Agency and the Administration, particularly given the disproportionate public health impact of illegally marketed tobacco products on young people, significant resources must be devoted to establishing more effective enforcement processes to rid the market of illegal tobacco products. some products.”

An interagency task force including the FDA, DOJ, US Department of Health and Human Services, and Treasury Department could streamline the enforcement process and increase consequences for violations, the report said. The FDA could also consider independent approaches that don’t require DOJ assistance, including “high-profile actions against wholesalers and distributors.”

Health officials will review the report over the coming weeks, Califf said in a statement. statement Monday, and will have an update on next steps by early February.

“We have made significant progress and achieved science-based regulatory decisions for a wide range of products in the 13 years since Congress appointed the FDA to regulate tobacco products,” he said. he declares. “Even greater challenges and opportunities lie ahead as we determine how the agency will handle complex policy issues and determine enforcement activities for a growing number of new products that could potentially have a significant impact on public health. ”

The Tobacco Products Center is “a new center with a different mandate,” noted Erika Sward, assistant vice president of national advocacy for the American Lung Association. “Having a strategic direction and getting ahead of the game, and seeing that this can’t be the responsibility of just one center in the FDA, but it really needs the whole of government working together to reduce the root cause of preventable deaths in the United States, is a very important reminder.

Manufacturers who illegally market products “will end up thinking twice about selling their products in the United States” if they see law enforcement agencies like the Department of Justice cracking down on other companies, she said, “but we’re not at that tipping point yet. And we need a lot more follow-up when it comes to law enforcement.

However, “we want the FDA to be a public health agency first and foremost, and we want the Center for Tobacco Products to seek to protect public health,” Sward said. It is not the FDA’s responsibility or obligation under tobacco control law to promote harm reduction. … Its responsibility is to end the sale of products that do not meet the public health standard. And ultimately, that means the FDA needs to do more things, like remove all flavored tobacco products from the market, including menthol cigarettes and flavored cigars.

The tobacco industry is “doing everything it can to sabotage the center’s efforts,” she said, including flooding its system with apps “so it can then claim the FDA was late. and late”. But the American Lung Association “is confident that under the leadership of Dr. Calif and [Director Brian King]the center will improve,” Sward said.

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