FDA Releases Tobacco Product Regulatory Progress in 2023 And Work Outlook For 2024
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FDA releases tobacco product regulatory progress in 2023 and work outlook for 2024
Recently, Brian King, director of the FDA's Tobacco Products Center, announced the regulatory progress of tobacco products in 2023 and the work outlook for 2024.
At the FDA's Center for Tobacco Products (CTP), we have kicked off 2024 productively, making multiple decisions on premarket applications, issuing warning letters and civil penalties for the sale of unauthorized e-cigarettes, and announcing continuations Population Assessment of Tobacco and Health (PATH) study. As we continue to focus on the year ahead, it is important to recognize CTP's many accomplishments in 2023.
CTP achieved several important milestones in 2023, including the release of a new 5-year strategic plan in December. The plan was a year-long development process that included seeking input from CTP staff and external stakeholders, including through public hearings held last summer. The plan remains steadfast in its commitment to advancing four central themes-science, health equity, stakeholder engagement, and transparency-that underlie the plan's five goals. As part of developing our strategic plan, we also updated the CTP vision and mission statement to reflect our role as a public health regulator and emphasize the importance of strategies that advance health equity. Guided by the new strategic plan, the CTP aims to reduce the negative health consequences of tobacco product use by preventing people from starting to use tobacco products, encouraging people who use tobacco products to quit smoking, and reducing the harm caused by tobacco product use.
Over the past year, we have also seen encouraging signs about certain tobacco product use behaviors among the U.S. population. For example, smoking-which accounts for a huge burden of tobacco-related disease and death in the United States-has steadily declined among adults and adolescents for decades and remains at historically low levels. Additionally, overall tobacco product use among high school students dropped significantly over the past year from 2022 to 2023, primarily due to declines in e-cigarette use. Currently, the number of U.S. teenagers using e-cigarettes is less than half of the peak in 2019. Yet despite these important public health victories, our work is not yet done. Tens of millions of American adults continue to smoke, and more than 2 million American teenagers will currently use e-cigarettes in 2023.
In parallel with progress in reducing youth tobacco product use, CTP has made significant progress in key program areas over the past year, including taking compliance and enforcement actions throughout the supply chain, reviewing applications for new tobacco products before they are legally marketed, Enact regulations to improve public health and educate the public about the dangers of tobacco products. Details of these activities are outlined below by program area.
Programmatic Advances
Take compliance and enforcement actions throughout the supply chain
As the tobacco product landscape continues to evolve, CTP remains nimble by using rapid surveillance and a comprehensive range of available tools to identify and take enforcement and compliance actions against unauthorized products, including e-cigarettes. This data-driven approach helped identify several products that appeal to young people that have been the subject of compliance and enforcement actions, including warning letters, civil monetary penalties (CMPs), and other actions throughout the supply chain in 2023.
Examples of compliance and enforcement actions targeting unauthorized tobacco products in 2023 include:
Issued warning letters to more than 120 manufacturers and distributors and more than 400 retailers;
A total of more than 40 civil penalty complaints were filed against manufacturers and more than 65 against retailers;
Worked with federal partners at U.S. Customs and Border Protection to seize approximately 1.4 million unauthorized vaping products with an estimated retail value of more than $18 million;
Issuing more than 25 warning letters to companies selling unauthorized e-cigarettes in packaging that looks like mints, alcohol bottles, or toys and drink containers that appeal to young people;
Coordinated with the U.S. Department of Justice to seek an injunction against an e-cigarette manufacturer, the seventh injunction to date against an unauthorized manufacturer of vaping products.
FDA also continues to educate and communicate with the public on compliance issues by creating and enhancing new web content and releasing more than 10 new compliance webinars. The center also released a new fact sheet to the public and those in the supply chain, based on existing web content, that lists the 23 e-cigarette products and devices that have received FDA authorization to date.
We remain committed to coordinating with federal partners and using the full range of tools in the regulatory toolbox to ensure that entities that manufacture, distribute, or sell illegal tobacco products, especially those that appeal to youth, are held accountable.
Important progress in tobacco product application review
The Premarket Review Process (PMTA) remains a cornerstone of CTP's work and we will continue to work with regulated industry to provide information and resources. For example, in October 2023, we held a public meeting on the application review process to reaffirm our commitment to transparency and provide opportunities for stakeholders to participate to improve public understanding of the review process.
In 2023, we also made important progress in product application review. Since 2020, the center has received more than 26 million applications for certified products and made decisions on 99% of them. This includes a 100% acceptance review of nearly 1 million non-tobacco (i.e., synthetic) nicotine product applications submitted by more than 200 independent companies before May 14, 2022; companies that pass this stage of review will move on to more substantive Sexual censorship. We remain committed to making decisions on all remaining applications as quickly as possible while ensuring that decisions are scientifically accurate, legally defensible, and consistent with the authority Congress gave us.
In 2023, CTP issued marketing authorization orders (MGOs) for three Marlboro heated tobacco products and authorized American Smokeless Tobacco's Copenhagen Classic Snus, a bulk moist snus smokeless tobacco product, as a Modified Risk Tobacco Product (MRTP) Do marketing. We have also issued more than 6,800 marketing denial orders (MDOs) for non-tobacco flavored e-cigarette products that failed to meet public health standards because there was insufficient evidence that the benefits to adult smokers outweighed the risks to youth. CTP also continues to make progress in addressing applications for higher market share products. Actions on apps in 2023, including Vuse Solo, Vuse Alto, Vuse Vibe, Vuse Ciro and myBlu, as well as recent MDO decisions on blu PLUS+, Suorin, SMOK, Bidi, blu disposable and myBlu e-cigarette products, mean The center has now processed 94% of higher market share applications reported to the federal court.
Thanks to the tireless efforts of our team of scientists, the Center has made considerable progress in reviewing the large number of tobacco product applications submitted to regulatory agencies. Thorough scientific review of tobacco product applications is a key pillar of FDA's comprehensive regulatory approach, and we remain committed to issuing additional decisions in the year ahead. Importantly, the onus is on the applicant to provide sufficiently reliable scientific evidence to demonstrate that the necessary public health standards have been met. To date, a number of applicants have successfully met the criteria for authorization to market the applied products.
Enact regulations to improve public health
Building on our efforts over the past several years, CTP has made great progress in finalizing two separate product standards, banning menthol as a characteristic flavor of cigarettes and as a characteristic flavor of cigars (other than tobacco). CTP staff worked tirelessly throughout 2023 to continue advancing these important rules, which were successfully submitted to the White House Office of Management and Budget in October 2023. The final regulations underwent an extensive rulemaking process that required significant time and effort. I am proud of the Center's tremendous efforts to date on these two product standards, and finalizing them remains a top priority for FDA. We also continue our efforts to propose a rule establishing maximum nicotine levels in cigarettes and certain other combustible tobacco products, another top priority for the Center.
We are also advancing other important rulemaking work in 2023. For example, in March, the CTP imposed new requirements on tobacco product manufacturers regarding the manufacturing, design, packaging and storage of their products. While no tobacco product is safe, these proposed requirements are intended to minimize or prevent additional risks associated with tobacco products and help protect public health. The Center held a public meeting of the Tobacco Products Scientific Advisory Committee (TPSAC) in April 2023 to solicit input on the requirements specified in the proposed rule. In December 2023, while releasing the strategic plan, CTP also released a policy agenda for rules and guidance documents that are being developed or planned to be developed. This policy agenda will create a more effective approach to implementing CTP's strategic plan and will be updated annually.
Educate the public about the risks of tobacco products
One of the most important ways we achieve our public health mission is to prevent youth use of tobacco products. In 2023, FDA's Youth Tobacco Prevention Campaign continues to lead the way in effectively communicating important tobacco prevention messages to youth. Our campaigns are conducted 50 to 60 times per quarter through various media channels, reaching 90 to 95 percent of the approximately 25 million youth ages 12 to 17 in the United States. We also launched a Spanish version of the Vaping Prevention and Education Resource Center, an online hub that provides free, science-based, standards-aligned lesson plans and materials that teachers and others can use to help youth learn about vaping. danger.
In addition, CTP has prioritized research efforts over the past year to provide public education opportunities for adults who smoke, recognizing that adults also need help when trying to quit smoking. I also published an article in the journal Addiction pointing out the opportunity to educate adults who smoke about the relative risks of tobacco products, including e-cigarettes. As noted in the comments, it is important that these efforts be accompanied by efforts to prevent youth use of tobacco products; encourage frontline use of FDA-approved cessation therapies; and, for adults who both smoke and use e-cigarettes, emphasize the complete transition to The importance of e-cigarettes. Since no tobacco product is safe, the ultimate goal should be to quit smoking all tobacco products, including e-cigarettes.
Finally, public input, transparency, and collaboration are important considerations as we plan for future education efforts. To support this, CTP has launched a new webpage describing how to solicit public feedback and incorporate it into public health education campaigns.
workforce development and expansion
We would not be able to advance all of our planned initiatives in 2023 without the tireless efforts of CTP staff and partners across FDA. Last year, CTP's employee count exceeded 1,100. We have welcomed many talented additions in 2023, including Dr. Matthew Farrelly as Director of CTP's Office of Science and Dr. Charlene Le Fauve as CTP's first Senior Advisor for Health Equity. We are recruiting for several other leadership positions, including the Associate Director for Policy and Partnerships, Director of the Office of Health Communications and Education, Director of the Office of Compliance and Enforcement, and Director of the Office of Management. Through all of our recruitment efforts, we aim to recruit a diverse workforce.
The Center continues to support the growth and development of our workforce by advancing operational improvements, such as an interagency agreement with the Office of Personnel Management that allows us to quickly review position classifications to reduce hiring delays and further assist recruiting through placement announcements and evaluations. applicant. In October 2023, CTP was granted direct hire authority, which allows CTP to hire qualified candidates for key positions more quickly.
Looking to the future
CTP's significant achievements in 2023 provide a springboard for success in 2024. Over the coming year, key areas of focus will be ensuring that our activities are aligned with the goals, outcomes and targets outlined in our 5-year strategic plan to be published in December 2023. As we outlined in our most recent quarterly status update, we continue to make organizational changes to improve our success while embarking on our strategic plan. We will also continue to prioritize transparency, including sharing updates on implementation of the strategic plan and other program initiatives, as appropriate.
As we move into 2024, we will undoubtedly face challenges in the area of tobacco product regulation. But with CTP's comprehensive program foundation and productivity, coupled with our dedicated workforce and our collective commitment to our public health mission, our future is bright, and I look forward to the new year working with our stakeholders to embrace it. As for CTP, we remain committed to advancing our important life-saving vision to ensure a healthier future for the American people and advance equity.
