The Tobacco Products Program (CTP), a subsidiary of the US Food and Drug Administration (FDA), recently announced that Anne Rancourt has been elected as the next director of the Office of Health Communications and Education.
The Tobacco Products Program (CTP), a subsidiary of the US Food and Drug Administration (FDA), recently announced that Anne Rancourt has been elected as the next director of the Office of Health Communications and Education. Langkull previously served as the Director of Communications at the National Institute on Drug Abuse (NIDA) of the National Institutes of Health (NIH) in the United States.
Langkul has over 20 years of experience in strategic communication, behavior change projects, and journalism, including nearly 14 years of work in the federal government. She is responsible for managing the communication department at NIDA, overseeing the dissemination of nearly $2 billion worth of scientific research on substance use and addiction, including the use of tobacco and e-cigarettes. Previously, she also served as the Director of the Communications Department at the National Institute of Allergy and Infectious Diseases (NIAID).
CTP stated that Langkul was selected after conducting extensive nationwide searches and passing important ethical and safety review procedures by the FDA. She will take effect on May 19th.
On January 14, 2025, the Tobacco Products Center (CTP) of the US Food and Drug Administration (FDA) released an article titled "A Year in Review: FDA's Progress in Tobacco Product Regulation in 2024". The article is signed by CTP Director Brian King. This article reviews the annual work and achievements of CTP in tobacco regulation in 2024 from the perspective of year-end summary.
Main achievements:
1. Decline in adolescent tobacco use: The use of tobacco products among American teenagers has dropped to its lowest level in 25 years. In the past five years, the use of electronic cigarettes among middle and high school students has decreased by nearly 70%.
2. Smoking rate hits historic low: Since 2009, the smoking rate among adults has decreased by half. In 2024, only 1.4% of middle and high school students reported using cigarettes.
Compliance and Enforcement:
1. Strengthen law enforcement: CTP has strengthened compliance supervision and enforcement actions in the tobacco product supply chain, with a focus on collaborating with federal partners.
2. Multi departmental Joint Working Group: In June 2024, the FDA and the US Department of Justice jointly established a federal working group focused on combating the distribution and sale of unauthorized electronic cigarettes.
3. Major seizure: In October 2024, a joint operation with the US Customs and Border Protection (CBP) resulted in the seizure of $76 million worth of unauthorized electronic cigarettes, including brands that appeal to teenagers such as Geek Bar.
4. Diversified enforcement measures: The FDA has adopted various enforcement methods, including warning letters, civil penalty complaints, etc. In 2024, the FDA issued warning letters to 50 manufacturers, distributors, and over 430 retailers.
Regulatory progress:
1. Product standards: CTP has promoted product standards that prohibit menthol in cigarettes and all characteristic flavors in cigars.
2. Strategic planning: In December 2023, a new five-year strategic plan was released, which clarified the goals of strengthening compliance supervision and protecting public health.
Public Education and Research:
1. PATH research continues to advance: The Population Tobacco and Health Assessment Study (PATH), in collaboration with the National Institute on Drug Abuse, provides important data on tobacco use behavior.
2. Public participation: CTP held multiple public meetings and webinars to educate stakeholders on regulatory processes and compliance knowledge.
CTP Director Brian King emphasized that a "whole of government" collaborative approach is crucial to achieving these milestones and reiterated the commitment to protecting public health through science based regulation.
At the end of 2024, Two Supremes published a review of the FDA's electronic cigarette regulatory work in 2024:
Annual Review of FDA Electronic Cigarette Enforcement in the United States: Multi style Enforcement Across the Entire Chain, Focusing on Keyknapp and Love Miracle
The FDA has also interpreted the relevant regulatory actions towards two top 2 firsts:
FDA Interprets Recent Regulatory Actions to 2Firls: Full Chain Regulation Will Promptly Introduce Policies Adapting to Market Changes
Entering 2025, CTP has issued multiple consecutive announcements, such as:
US law enforcement agencies have seized over $7 million worth of illegal electronic cigarettes, and the FDA emphasizes that enforcement actions will continue to advance
The US FDA has released the final version of guidelines for tobacco product analysis and testing methods to standardize the market access process
US FDA updates import alert: All unauthorized electronic cigarettes may be seized without physical inspection
The following is the full text of this FDA announcement
Reviewing a Year: FDA's Progress in Tobacco Product Regulation in 2024
Author: Brian King, Director of FDA Tobacco Products Center
Date: January 14th, 2025
As the New Year approaches, the FDA Tobacco Products Center (CTP) continues to work hard to protect the American public from the health threats of tobacco related diseases and deaths. At the same time, we also celebrate the significant public health victories achieved in the past year, including the current tobacco product usage rate among American teenagers dropping to the lowest level in the past 25 years. This historic decline is mainly due to a significant decrease in the number of teenagers using electronic cigarettes; In the past five years, the current use of electronic cigarettes among American high school and high school students has decreased by nearly 70%, with less than 500000 teenagers reporting using these products in just the past year.
In addition, smoking rates - the deadliest form of tobacco product use - have also reached historic lows. The smoking rate of adult cigarettes in the United States is approximately half of what it was when the FDA first gained regulatory authority over tobacco products in 2009. In addition, in 2024, the current proportion of American high school and high school students reporting the use of cigarettes is only 1.4%.
These advances have been made through the joint efforts of CTP, guided by our strategic plan covering multiple project areas. These efforts include strengthening compliance and enforcement actions in the supply chain, reviewing applications for new tobacco products before they are legally marketed, developing regulations and guidelines, and promoting the risks of tobacco products to the public. More details and examples of these actions over the past year are as follows.
Strengthen compliance and enforcement actions in the supply chain
Compliance and enforcement actions in the tobacco product supply chain continue to be the top priority for CTP. Progress has been made in taking upgraded enforcement and compliance actions. But we cannot complete this task alone; We need a 'whole of government' approach, including support from federal partners. To this end, in June 2024, the FDA and the US Department of Justice announced the establishment of a federal multi agency task force focused on curbing the distribution and sale of unauthorized electronic cigarettes. The working group meets regularly and takes prompt action.
In October 2024, the FDA and U.S. Customs and Border Protection (CBP) - partners of the working group - announced a joint federal action to seize $76 million worth of unauthorized e-cigarettes, including popular, adolescent friendly, foreign owned brands such as Geek Bar. This action is just one of several law enforcement actions being carried out by federal agencies - with the establishment of the working group, the frequency of these actions continues to increase - to address the issue of unauthorized electronic cigarettes.
In April 2024, the FDA coordinated with the US Department of Justice for the first time and announced that the US Marshals Service had seized unauthorized electronic cigarettes worth over $700000 from a warehouse in California.
In addition, the agency has taken numerous compliance and enforcement actions against unauthorized tobacco products in 2024, particularly those that are most appealing to young people. For example, the center issued warning letters to over 50 manufacturers and distributors, as well as over 430 retailers, bringing the total number of warning letters from manufacturers and distributors to over 710 and from retailers to over 800. CTP has also filed an unprecedented number of civil fine complaints against unauthorized products in the past year: 44 against manufacturers and over 100 against retailers, bringing the total number of manufacturers to 80 and retailers to 175.
CTP remains committed to using all tools in its regulatory toolbox - in coordination with federal partners using its unique powers - to ensure that those who manufacture, distribute, or sell illegal tobacco products are held accountable to the law.
Strict scientific basis pre-market review process
The pre-market review process remains the cornerstone of CTP's work, as CTP continues to release decisions and provide information to assist applicants. Strict scientific methods are crucial for this process. Following this approach, in 2024, the center issued several market authorization orders, including the first authorization for non tobacco flavored electronic cigarette products and tobacco flavored electronic cigarette products. The agency also issued modified risk authorization orders for eight generic snuff products.
Meanwhile, CTP has issued market refusal orders for individuals who fail to meet legal public health standards, including over 65000 applications for non tobacco flavored electronic cigarette products. Through these decisions, the center has processed over 26 million applications, including 99.5% of electronic cigarette products with high market share.
In addition to these scientific reviews, CTP remains committed to ensuring clear communication and transparency regarding the tobacco product review process and market decisions. For example, in April 2024, CTP resumed the publication of scientific review policy memoranda on certain topics in the pre marketing tobacco review process. In 2024, CTP released 26 policy memoranda, including chemistry and toxicology, providing a snapshot of FDA's internal thinking on these topics.
In addition, in March 2024, CTP launched a searchable tobacco product database, which is a user-friendly list of tobacco products - including e-cigarettes - that can be legally sold in the US market. In the new year, CTP plans to continue optimizing the upcoming CTP portal next-generation, which is an improved online portal for submitting applications for certain new tobacco products.
Publish rules and guidelines to protect public health
As a regulatory agency, one of the key ways the FDA has made progress is by issuing rules that establish certain requirements for those who manufacture and sell tobacco products. For example, in August 2024, the FDA issued a final tobacco 21 regulation to further prevent tobacco products from falling into the hands of teenagers and young adults. This regulation requires retailers to confirm the age of any person under the age of 30 attempting to purchase tobacco products (including e-cigarettes) through photo identity verification. The rule also prohibits retailers from selling tobacco products through vending machines in any facility that is accessible or allowed to be accessed by anyone under the age of 21.
In 2024, the FDA and the Treasury Department also announced a proposed rule requiring importers to input the submission tracking number of FDA issued electronic cigarette market applications into the electronic import system operated by the U.S. Customs and Border Protection. This new requirement will help simplify the process of reviewing the acceptability of electronic cigarette products entering the United States.
Promote the risks of tobacco products to the public
Promoting the risks of using tobacco products to the public, especially young people, is a key part of FDA's public health mission. Given that the majority of adult tobacco product use begins during adolescence, CTP can bring lasting and cost-effective health improvements to the country by preventing teenagers from using tobacco products first. For example, in 2024, the FDA's award-winning "Real Cost" Youth Tobacco Prevention Campaign commemorated 10 years of delivering key tobacco product prevention messages to young people. In the past year, the organization has released new advertisements that focus on the health impacts and social consequences of youth e-cigarette use.
In addition, CTP has prioritized research work in the past year to inform adult smokers of public education opportunities. For example, CTP and the National Institutes of Health (NIH) have awarded funding to study how to best accurately communicate the relative risks of tobacco products to adult smokers, while ensuring that this information does not appeal to other audiences, including adolescents. The center also educates the public on this issue through other means. CTP has launched a new online resource aimed at communicating the relative risks of tobacco products to the public. To further convey these ideas, I co authored a review article published in the journal Nature Medicine, pointing out the relative risks of educating adult smokers about tobacco products, including e-cigarettes.
CTP continues to promote the benefits of quitting smoking to the public. CTP continues to collaborate with federal partners of the National Cancer Institute to provide information on smoking cessation and other tobacco health resources through Smokefree.gov, a website that offers tailored materials to meet individual needs. CTP has recently expanded its adult smoking cessation education material kit, including 15 new posters targeted at additional audiences. As the year comes to an end, these posters will be available at CTP's conference and exhibition booths and will be made available to the public through CTP's tobacco education resource library by 2025.
Looking ahead to the future
Significant progress has been made in the past year, but further success must also be supplemented by sufficient resources. The law provides comprehensive power for tobacco regulation; However, given the size and dynamism of the market, challenges increase when resources fail to keep up with workload. The FDA's tobacco budget has remained flat over the past five years, which will continue to pose challenges for important work in the future.
For the FDA, it is also crucial to continue engaging meaningfully with the public. Over the past year, our interactions with stakeholders have been beneficial and productive - including leaders giving speeches at conferences, holding hearings to listen to stakeholders' opinions, and participating in over 25 meetings. CTP values interaction with the public and is committed to continuing these efforts in 2025. Continuous transparency and communication are also crucial - the center remains committed to communicating with stakeholders through various means to ensure timely, accurate, and relevant information about its activities.
As we continue to move towards 2025, our future is bright, and I look forward to welcoming the new year with our stakeholders. CTP remains committed to our mission of protecting the American public from the health threats of tobacco related deaths and diseases.