FDA's Review of Tobacco Regulation Progress in 2023: More than 6800 MDO Issued

Editor's Note: Brian King, Director of the Center for Tobacco Products (CTP) at the U.S. Food and Drug Administration (FDA), published a retrospective article on the FDA's official website on February 22 regarding the progress of tobacco product regulation in the past year. The article mentions CTP's 5-year strategic plan and the regulation of e-cigarettes. In 2023, the FDA did not issue any marketing authorization orders (MGO) for any vape products and issued over 6,800 Marketing Denial Orders (MDO). Below is the full article.

At the FDA’s Center for Tobacco Products (CTP), we have kicked off 2024 productively,making several decisions on premarket applications, issuing warning letters and civil money penalties for selling unauthorized e-cigarettes, and announcing the continuation of the Population Assessment on Tobacco and Health (PATH) study. But as we continue to focus on the year ahead, it’s also important to acknowledge CTP’s many accomplishments throughout 2023.

CTP reached several important milestones in 2023, including the release of a new 5-year strategic plan in December. The plan was the outcome of a year-long development process that involved seeking input from CTP staff and external stakeholders, including through a public listening session held last summer. Woven throughout the plan is an unwavering commitment to advance four central themes – science, health equity, stakeholder engagement, and transparency – that underly each of the plan’s five goals. As part of the development of the strategic plan, we also refreshed the CTP vision and mission statements to reflect our charge as a public health regulatory agency and to reinforce the importance of strategies to advance health equity. Guided by the new strategic plan, CTP aims to reduce the negative health effects caused by tobacco product use by preventing people from starting to use tobacco products, encouraging people who use tobacco products to quit, and reducing the harm caused by tobacco product use.

Over the past year, we’ve also seen encouraging signs in certain tobacco product use behaviors among the U.S. population. For example, cigarette smoking – which is responsible for the overwhelming burden of tobacco-related disease and death in the United States – has declined steadily among adults and youth for decades and currently remains at unprecedented lows. Moreover, over the past year, there was a significant decrease in overall tobacco product use among high school students from 2022 to 2023, which was primarily driven by a decline in e-cigarette use. There are now less than half the number of U.S. youth using e-cigarettes as there were at the peak in 2019. However, despite these important wins for public health, our work is not finished. Tens of millions of U.S. adults continue to smoke cigarettes, and in 2023, more than 2 million U.S. youth currently used e-cigarettes.

The progress made in reducing youth tobacco products use has occurred alongside significant advances by CTP across key programmatic areas over the past year, including taking compliance and enforcement actions across the supply chain, reviewing applications before new tobacco products can be legally marketed, developing regulations to improve public health, and educating the public about the dangers of tobacco products. Details of these activities are outlined below, by programmatic area.

Programmatic Advancements

Taking Compliance and Enforcement Action Across 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 action against unauthorized products, including e-cigarettes. This data-driven approach has helped identify several youth-appealing products that have been the subject of compliance and enforcement actions, including warning letters, civil money penalties (CMP), and other actions across the supply chain in 2023.

Examples of compliance and enforcement actions against unauthorized tobacco products in 2023 include:

• Issuing warning letters to more than 120 manufacturers and distributors and more than 400 retailers;
• Filing CMP complaints totaling over 40 against manufacturers and over 65 against retailers;
• Collaborating with our federal partners at the U.S. Customs and Border Protection to seize approximately 1.4 million units of unauthorized e-cigarette products with an estimated retail value of more than $18 million;
• Issuing more than 25 warning letters to firms selling unauthorized e-cigarettes packaged to look like mints, alcohol bottles, or youth-appealing toys and drink containers; and
• Seeking an injunction in coordination with the U.S. Department of Justice against an e-cigarette manufacturer, which was the seventh injunction to date against manufacturers of unauthorized e-cigarette products. 

FDA also continued to educate and communicate to the public on compliance matters by creating and enhancing new web content and posting more than 10 new compliance webinars, with updates in multiple languages. The center also released a new fact sheet, based on existing web content, for the general public and those in the supply chain, which lists the 23 e-cigarette products and devices that have received authorization from FDA to date.

We remain committed to using the full scope of tools in our regulatory toolbox – in coordination with federal partners – to ensure entities that make, distribute, or sell illegal tobacco products, especially products that appeal to youth, are held accountable.

Making Important Progress on Tobacco Product Application Review

The premarket review process remains a cornerstone of CTP’s efforts, and we continue to work with regulated industry to provide information and resources. For example, in October 2023, we held a public meeting about the application review process to reiterate our commitment to transparency and to provide an opportunity for stakeholder engagement to improve public understanding of the review process.

We also made important progress on product application reviews in 2023. The center has received applications for more than 26 million deemed products since 2020 and has made determinations on 99 percent of these applications. This included completing acceptance review for 100 percent of the nearly one million applications for non-tobacco (or synthetic) nicotine products from more than 200 separate companies that were submitted by May 14, 2022; those that pass this stage of review will proceed forward to more substantial review. We remain committed to making determinations on all remaining applications as expeditiously as possible, while ensuring the decisions are scientifically accurate, legally defensible, and aligned with the authorities granted to us by Congress.

In 2023, the center issued marketing granted orders (MGOs) for three Marlboro HeatSticks heated tobacco products and authorized U.S. Smokeless Tobacco Company’s Copenhagen Classic Snuff, a loose moist snuff smokeless tobacco product, to be marketed as a modified risk tobacco product (MRTP). We also issued more than 6,800 marketing denial orders (MDOs) for non-tobacco flavored e-cigarette product applications that failed to meet the public health standard due to insufficient evidence demonstrating that the benefit to adult smokers outweighed risks to youth. CTP also continues to make progress resolving applications for higher market share products. Actions on applications in 2023 – including Vuse Solo, Vuse Alto, Vuse Vibe, Vuse Ciro, and myblu – together with recent MDO decisions for blu PLUS+, Suorin, SMOK, Bidi, and blu Disposable and myBlu e-cigarette products, means that the center has now acted on 94 percent of the higher market share applications it reports on to a federal court.

The center has made considerable progress in reviewing the massive volume of tobacco product applications submitted to the agency, thanks to the tireless efforts of our dedicated legion of civil servant scientists. Thorough scientific review of tobacco product applications is a key pillar of FDA’s comprehensive regulatory approach, and we remain committed to issuing more decisions in the year ahead. Importantly, it is the responsibility of the applicant to provide sufficiently robust scientific evidence to demonstrate that the necessary public health standard has been met. To date several applicants have successfully met the standard to authorize marketing of the product covered by the application.

Developing Regulations to Improve Public Health

Building on our efforts over the last few years, CTP made tremendous progress toward finalizing two separate rules establishing product standards prohibiting menthol as a characterizing flavor in cigarettes and characterizing flavors (other than tobacco) in cigars. Staff across CTP worked tirelessly and relentlessly throughout 2023 to continue to advance these important rules, resulting in their successful submission to the White House Office of Management and Budget in October 2023. Final regulations go through an extensive rulemaking process that requires considerable time and effort. I am proud of the center’s Herculean efforts on these two product standards to date, and finalizing them remains a top priority for FDA. We also continue to work toward proposing a rule that would establish a maximum nicotine level in cigarettes and certain other combustible tobacco products, which is another top priority for the center.

We also advanced other important rulemaking efforts in 2023. For example, in March, CTP proposed new requirements for tobacco product manufacturers regarding the manufacture, design, packing 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 seek recommendations on the requirements laid out in the proposed rule. In December 2023, in conjunction with the strategic plan release, CTP also published the center’s policy agenda of rules and guidance documents that are in development or planned for development. This policy agenda will create a more efficient approach to implementing CTP’s strategic plan and will be updated annually.

Educating the Public About the Risks of Tobacco Products

One of the most important ways we can achieve our public health mission is by preventing youth from using tobacco products. In 2023, FDA’s youth tobacco prevention campaigns continued to lead the way by effectively reaching teens with key tobacco prevention messaging. Of the approximately 25 million 12- to 17-year-olds in the United States, our campaigns reached 90 to 95 percent of them 50 to 60 times per quarter across various media channels. We also launched a Spanish-language version of the Vaping Prevention and Education Resource Center, which is an online hub with free science-based, standards-mapped lesson plans and materials that teachers and others can use to help youth understand the dangers associated with e-cigarette use and nicotine addiction.

Additionally, CTP prioritized research efforts throughout the past year to inform public education opportunities for adults who smoke, recognizing that adults also want and need help as they attempt to quit smoking. For example, CTP is conducting formative research among adults who smoke to assess their comprehension and perceptions of messaging that nicotine – while highly addictive – is delivered through products that represent a continuum of risk, and that combustible products such as cigarettes have the greatest risk. I also authored an article published in the journal Addiction noting that opportunities exist to educate adults who smoke about the relative risks of tobacco products, including e-cigarettes. As was noted in the commentary, it’s important that these efforts be accompanied by efforts to prevent youth tobacco product use; encourage first-line use of FDA-approved cessation therapies; and for adults who both smoke and use e-cigarettes, reinforce the importance of completely transitioning to e-cigarettes. Because no tobacco product is safe, the eventual goal should be quitting all tobacco product use, including e-cigarettes. 

Finally, as we plan future education efforts, public input, transparency, and collaboration are vital considerations. To support this, CTP launched a new webpage to describe how feedback from the public is solicited and incorporated into public health education campaigns.

Workforce Development and Expansion

Advancing all of our programmatic initiatives in 2023 would not have been possible without the tireless efforts and continued dedication of CTP staff, as well as our partners in other parts of FDA. Over the past year, the center has surpassed 1,100 staff members. Among the many talented individuals we have welcomed to CTP in 2023 are Dr. Matthew Farrelly as the Director of CTP’s Office of Science and Dr. Charlene Le Fauve as CTP’s first Senior Advisor for Health Equity. We are engaged in the hiring process for several additional leadership positions, including the Associate Director for Policy and Partnerships, Director of the Office of Health Communication and Education, Director of the Office of Compliance and Enforcement, and Director of the Office of Management. Through all our hiring efforts, we aim to recruit a diverse workforce.

The center continues to support the growth and development of our workforce by advancing operational enhancements, such as interagency agreements with the Office of Personnel Management that enable us to expeditiously review position classifications to reduce hiring delays and further assist with hiring by posting job announcements and evaluating applicants. In October 2023, CTP was granted direct hire authority, which allows CTP to hire qualified candidates more quickly for critical positions. Additionally, CTP continues to educate interested parties on a potential framework for securing user fees for all products CTP regulates.

Looking Ahead

CTP’s significant accomplishments in 2023 have provided a springboard to success in 2024. Moving into the year ahead, a key area of focus will be ensuring our activities are aligned with the goals, outcomes, and objectives outlined in the 5-year strategic plan published in December 2023. As outlined in our recent quarterly status updates to address recommendations from the external Reagan-Udall evaluation, we have continued to make organizational changes to enhance our success as we embark on the implementation of the strategic plan. We will also continue to prioritize transparency, including by sharing updates on the implementation of the strategic plan and other programmatic initiatives, as appropriate.

As we continue to embark into 2024, we can undoubtedly expect challenges, which comes with the territory of tobacco product regulation. But with CTP’s comprehensive programmatic 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 embracing this next year alongside our stakeholders. For CTP’s part, we remain committed to advancing our important, life-saving vision to ensuring a healthier future and advancing health equity for those living in the United States.