[2Firsts] January 14, 2024 – The U.S. Food and Drug Administration’s (FDA) Center for Tobacco Products (CTP) published an article titled “A Year in Review: FDA’s Progress in Tobacco Product Regulation in 2024.” The article, authored by CTP Director Brian King, provides a year-end perspective on CTP’s annual work and achievements in tobacco regulation during 2024.
Key Achievements:
• Decline in Youth Tobacco Use: Current tobacco product use among U.S. youth has reached its lowest level in 25 years, driven by a nearly 70% reduction in e-cigarette use among middle and high school students over the past five years.
• Record Low Smoking Rates: Adult cigarette smoking rates have halved since 2009, and only 1.4% of middle and high school students reported current cigarette use in 2024.
Compliance and Enforcement:
• Enhanced Actions: CTP has intensified compliance and enforcement across the tobacco product supply chain, emphasizing collaboration with federal partners.
• Multi-Agency Task Force: In June, the FDA and the U.S. Department of Justice established a federal task force to curb unauthorized e-cigarette distribution and sales.
• Significant Seizures: In October, a joint operation with U.S. Customs and Border Protection resulted in the seizure of $76 million worth of unauthorized e-cigarettes, including youth-appealing brands like Geek Bar.
• Diversified Enforcement Measures:The FDA has employed a variety of enforcement tools, including warning letters and civil money penalty complaints. In 2024, the FDA issued warning letters to 50 manufacturers and distributors, as well as more than 430 retailers.
Regulatory Developments:
• Product Standards: CTP has advanced product standards to prohibit menthol in cigarettes and all characterizing flavors in cigars.
• Strategic Plan: A new five-year strategic plan was released in December 2023, outlining goals to strengthen compliance oversight and protect public health.
Public Education and Research:
• PATH Study Continuation: The Population Assessment of Tobacco and Health (PATH) study, a collaboration with the National Institute on Drug Abuse, continues to provide critical data on tobacco use behaviors.
• Public Engagement: CTP has hosted public meetings and webinars to educate stakeholders on regulatory processes and compliance.
CTP Director Brian King emphasized the importance of an “all government” approach in achieving these milestones and reiterated the agency’s commitment to protecting public health through science-based regulation.
At the end of 2024, 2Firsts published an article reviewing the FDA’s 2024 regulatory efforts on e-cigarettes:
The FDA also provided insights into the related regulatory actions to 2Firsts:
As we move into 2024, the FDA’s Center for Tobacco Products (CTP) has issued multiple announcements, including:
FDA Guidelines on Tobacco Product Analysis and Testing Methods Validation
FDA Updates Import Alert List for Tobacco Products, BAT Velo Included
U.S. Agencies Seize Over $7 Million in Illegal E-Cigarettes as FDA Pledges Continued Crackdown
Below is the full text of the latest FDA announcement:
A Year in Review: FDA’s Progress on Tobacco Product Regulation in 2024
By Brian King, Director of FDA’s Center for Tobacco Products
January 14, 2025
With a new year upon us, FDA’s Center for Tobacco Products (CTP) continues to work diligently to protect the public health of the U.S. population from tobacco-related disease and death. At the same time, we also celebrate significant public health wins that have occurred over the past year, including current tobacco product use among U.S. youth dropping to the lowest recorded level in the past quarter century. This historic decline was largely driven by a significant drop in the number of youth who reported using e-cigarettes; current e-cigarette use among U.S. middle and high school students has declined nearly 70 percent over the past five years, including a half million fewer youth who reported using these products over the past year alone.
Additionally, smoking rates—which are the deadliest forms of tobacco product use—are at an all-time low. Cigarette smoking among U.S. adults is about half what it was when FDA was first granted the authority to regulate tobacco products in 2009. Moreover, in 2024, 1.4 percent of U.S. middle and high school students reported currently using cigarettes.
The progress made has occurred alongside concerted efforts by CTP, guided by our strategic plan, across numerous programmatic areas. These efforts include enhanced compliance and enforcement actions across the supply chain, reviewing applications before new tobacco products can be legally marketed, developing regulations and guidance, and educating the public about the risks of tobacco products. Additional details and examples of these actions over the past year are outlined below.
Ramping Up Compliance and Enforcement Efforts Across the Supply Chain
Compliance and enforcement efforts across the tobacco product supply chain continue to be a top priority for CTP. Progress has been made in taking escalated enforcement and compliance actions. But we can’t do it alone; an “all government” approach is needed, including support from federal partners. Toward that end, in June, FDA and the U.S. Department of Justice announced the creation of a federal multi-agency task force focused on curbing the distribution and sale of unauthorized e-cigarettes. The task force meets regularly and has hit the ground running.
In October, FDA and U.S. Customs and Border Protection, a task force partner, announced a joint federal operation that seized a monumental $76 million in unauthorized e-cigarettes, including popular, youth-appealing, foreign-owned brands like Geek Bar. This operation was just one of several ongoing law enforcement operations across federal agencies—which are increasing in frequency with the creation of the task force—to address unauthorized e-cigarettes.
In April, for the first time, FDA, in coordination with U.S. Department of Justice, announced the U.S. Marshals Service seized unauthorized e-cigarettes valued at more than $700,000 at a warehouse in California.
In addition, the agency has taken numerous compliance and enforcement actions against unauthorized tobacco products in 2024, especially those most appealing to youth. For example, the center issued warning letters to more than 50 manufacturers and distributors and more than 430 retailers for selling unauthorized tobacco products. These bring the total number of warning letters to more than 710 for manufacturers and distributers and more than 800 for retailers. CTP also filed an unprecedented volume of civil money penalty complaints for unauthorized products over the past year: 44 against manufacturers and more than 100 against retailers, bringing the total number to 80 for manufacturers and 175 for retailers.
CTP remains committed to using the full scope of tools in the regulatory toolbox—in coordination with federal partners using their unique authorities—to ensure that those that make, distribute, or sell illegal tobacco products are held accountable to the law.
Rigorous Science-Based Premarket Review Process
The premarket review process remains a cornerstone of CTP’s efforts, and CTP continues to both issue decisions and provide information to assist those submitting applications. A rigorous, science-based approach is essential to this process. Following such an approach, in 2024, the center issued several marketing granted orders, including the first authorizations for non-tobacco flavored e-cigarette products, as well as for tobacco-flavored e-cigarette products. The agency also issued modified risk granted orders for eight General Snus products. At the same time, CTP issued marketing denial orders for those who have failed to meet the necessary public health standard required by law, including issuing marketing denial orders for more than 65,000 non-tobacco flavored e-cigarette product applications. With these decisions, the center has acted on more than 26 million applications, including 99.5 percent of the higher-market share e-cigarette products.
In addition to these scientific reviews, CTP remains committed to ensuring clear communication and transparency about the tobacco product review process and marketing decisions. For example, in April, CTP resumed posting scientific review policy memos on certain topics within the premarket tobacco review process. During 2024, CTP posted 26 policy memos, including chemistry and toxicology, that provide a snapshot of FDA’s internal thinking on these topics.
Furthermore, in March, CTP launched the Searchable Tobacco Products Database, a user-friendly list of the tobacco products—including e-cigarettes—that may be legally marketed in the United States. In the year ahead, CTP plans to continue to optimize the upcoming CTP Portal Next Generation, an improved web portal for the submission of applications for certain new tobacco products.
Issuing Rules and Guidance to Protect Public Health
As a regulatory agency, one of the key ways in which FDA makes progress is by issuing rules to establish certain requirements for those making and selling tobacco products. For example, in August, FDA issued a Tobacco 21 final regulation to further keep tobacco products out of the hands of youth and young adults. The regulation requires retailers to verify with photo identification the age of anyone under the age of 30 trying to purchase tobacco products, including e-cigarettes. The rule also prevents retailers from selling tobacco products via vending machine in facilities where anyone under 21 is present or allowed to enter.
Also in 2024, FDA and the Department of the Treasury announced a proposed rule that would require an importer to submit the FDA-issued Submission Tracking Number from a marketing application of e-cigarettes into the electronic imports system operated by U.S. Customs and Border Protection. This new requirement will help streamline the process of reviewing the admissibility of e-cigarette products into the United States.
Educating the Public About the Risks of Tobacco Products
Educating the public, especially youth, about the risks of using tobacco products, is a critical part of FDA’s public health mission. Given that most adult tobacco product use begins during adolescence, CTP can achieve long-lasting, cost-saving health improvements for the nation by preventing youth from using tobacco products in the first place. For example, in 2024, FDA’s award-winning “The Real Cost” youth tobacco prevention campaign commemorated 10 years of reaching teens with key tobacco product prevention messaging. Over the past year, the agency released new ads, including ads focused on the health effects of youth e-cigarette use and social consequences of nicotine addiction.
Additionally, CTP prioritized research efforts throughout the past year to inform public education opportunities for adults who smoke. For example, CTP and the National Institutes of Health (NIH) awarded funding to examine how best to accurately convey the relative risks of tobacco products to adults who smoke while ensuring these messages do not appeal to other audiences, including youth. The center also worked to educate the public on this issue in other ways. CTP launched a new web resource aimed at educating the public about the relative risks of tobacco products. To further communicate those ideas, I co-authored a commentary published in the journal Nature MedicineExternal Link Disclaimer noting that opportunities exist to educate adults who smoke about the relative risks of tobacco products, including e-cigarettes.
CTP also continues to educate the public about the benefits of smoking cessation. CTP continues to work with federal partners at the National Cancer Institute to provide information on quitting smoking and other tobacco health resources via Smokefree.gov, which offers materials tailored to meet individuals’ needs. CTP also recently expanded its suite of adult cessation education materials to include 15 new posters tailored for additional audiences. As we closed out the year, these posters were available at CTP’s conference exhibit booth, and will be available to the public to order via CTP’s Tobacco Education Resource Library in 2025.
Looking Ahead
The past year was highlighted by marked progress, but further successes must also be complemented by ample resources. The law provides comprehensive authorities for tobacco regulation; however, given the size and dynamic nature of the marketplace, challenges are compounded when resources do not keep pace with the workload. FDA’s tobacco budget has been flat for the last five years, which will continue to pose a challenge given the important work ahead.
It's also critically important for FDA to continue to meaningfully engage with the public. We’ve had helpful and productive engagement with stakeholders over the last year—including leadership presenting at conferences, holding listening sessions to hear from interested parties, and exhibiting at over 25 conferences. CTP values engaging with the public and is committed to building upon these efforts in 2025. Continued transparency and communication is also paramount—and the center remains committed to communicating with stakeholders through a variety of means to ensure information shared on the center’s activities is timely, accurate, and relevant.
As we continue to embark into 2025, our future is bright, and I look forward to embracing this next year alongside our stakeholders. CTP remains committed to our mission to protect the public health of the U.S. population from tobacco-related death and disease.
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