Looking Back, Looking Ahead: FDA’s Progress on Tobacco Product Regulation in 2022
By Brian King, Director of FDA’s Center for Tobacco Products
January 31, 2023
Since July 2022, I have been proud to serve as the director of the Food and Drug Administration’s Center for Tobacco Products (CTP). After working in the field of tobacco control for the better part of the past two decades, I recognize how tremendously important CTP’s work is, and that we are at a critical moment in the history of tobacco product regulation.
Throughout 2022, we worked to advance our Center’s vision – which is to make tobacco-related disease and death a part of America’s past, not America’s future. CTP has continued making significant strides by proposing regulations to improve public health, reviewing applications before new tobacco products can be legally marketed, taking compliance and enforcement actions to hold companies accountable who violate the law, and educating the public about the risks of tobacco products. The Center also continues to make considerable progress to advance health equity – both in our workforce and programmatic activities.
Below are a just a few examples of our accomplishments within these areas in 2022.
Proposing Regulations to Improve Public Health
In April 2022, FDA announced proposed product standards to prohibit menthol as a characterizing flavor in cigarettes and to prohibit characterizing flavors (other than tobacco flavor) in cigars. When finalized, these product standards are expected to significantly reduce initiation and increase cessation. These proposed rules will also help address longstanding health disparities related to menthol cigarettes and flavored cigars, including among African Americans, who use these products at higher rates than other racial and ethnic groups.
We received a total of nearly 250,000 comments on the two proposed rules. As noted in the recent Unified Agenda, we are currently drafting the final rules and are committed to completing the rulemaking process in 2023. These product standards remain a top priority for FDA, and we will continue to provide updates on the status of these rules as they become available.
Reviewing Applications Before New Tobacco Products Can be Legally Marketed
This past year was an important year for reviewing new tobacco product applications before those products can be legally marketed. This is a sizable task given the sheer volume of applications and the rapidly evolving landscape, but we have been working diligently to ensure we are processing applications as quickly as possible while also ensuring the decisions are scientifically accurate, legally defensible, and aligned with the authorities granted by Congress.
To date, the agency has completed review and made determinations on more than 99% of the nearly 6.7 million deemed products for which applications were submitted by the Sept. 9, 2020 deadline. This is a monumental accomplishment, and we remain committed to completing the remaining 1% of applications as expeditiously as possible while also ensuring scientific and legal defensibility. FDA has authorized 23 tobacco-flavored e-cigarette products and devices, with 20 of those authorizations occurring in 2022. In October 2022 and recently in January 2023, we issued the first marketing denial orders for menthol-flavored e-cigarettes. We will continue to review and make authorization decisions on e-cigarettes, including flavored products, based on the strength of the scientific evidence provided by companies in their submitted applications.
In addition to these applications, FDA also received nearly 1 million applications for non-tobacco (or synthetic) nicotine products from more than 200 separate companies by May 14, 2022. These applications were submitted after Congress passed a new law in April 2022, clarifying FDA’s authority to regulate tobacco products containing nicotine from any source, including synthetic nicotine.
I am pleased to share that, to date, we have completed acceptance review of more than 99% of all non-tobacco nicotine applications submitted by May 14; review of the very small remaining percentage of applications will be completed imminently. As of Jan. 20, 2023, FDA has accepted over 8,600 applications, with the vast majority being for e-cigarette or e-liquid products. Importantly, acceptance is not a determination of the product’s authorization status; these applications will proceed forward to more substantial review. FDA has also issued refuse-to-accept (RTA) letters for more than 925,000 products in applications submitted by May 14 that do not meet the criteria for acceptance; the RTA letters state that it is illegal to sell or distribute the product in the U.S. marketplace without a premarket authorization.
Taking Compliance and Enforcement Action to Hold Companies Accountable Who Violate the Law
While our application review is ongoing, we remain vigilant in overseeing the market and continue to prioritize the use of our compliance and enforcement resources to curb the unlawful marketing of all tobacco products, including non-tobacco nicotine products. Since being given the authority by Congress to regulate non-tobacco nicotine products in April 2022, we have issued more than 75 warning letters to manufacturers through Jan. 20, 2023, including manufacturers of brands popular among youth, such as Puff Bar. We have also issued over 585 warning letters to retailers for sale of non-tobacco nicotine products to underage purchasers as of December 2022.
We are committed to using the full breadth of enforcement tools afforded to us by the Tobacco Control Act. For example, in October 2022, the U.S. Department of Justice (DOJ), on behalf of FDA, filed complaints for permanent injunctions in federal district courts against six e-cigarette manufacturers. In these cases, each of these defendants failed to submit premarket applications for their products and continued to illegally manufacture, sell, and distribute their products, despite receiving a previous warning letter from FDA notifying them that they were in violation of the law. These cases were the first of their kind and require the companies and named individuals to stop manufacturing, selling, and distributing their e-cigarettes.
We also remain committed to monitoring the continually changing product marketplace, with a focus on protecting youth. In August, FDA issued a warning letter for marketing illegal flavored nicotine gummies – the first warning letter for this type of product. We also issued warning letters in November to five firms for the unauthorized marketing of 15 different e-cigarette products that were packaged to look like toys, food, or cartoon characters and were likely to promote use by youth. The designs and packaging of these types of illegal products were a flagrant attempt to target kids, and FDA will continue to hold companies accountable for illegally selling unauthorized e-cigarettes, particularly those that shamelessly target youth.
Educating the Public about the Risks of Tobacco Products
Educating the public, especially youth, about the dangers of tobacco products is also a top priority. Results from the 2022 National Youth Tobacco Survey (NYTS) show that progress has been made in recent years in reducing the number of youth who use e-cigarettes; however, youth use of e-cigarettes remains too high, with 2.5 million (9.4%) of our nation’s middle and high school students reporting current e-cigarette use. There is more work to be done, and we remain steadfast in our commitment to use the full range of our authorities to address and prevent youth e-cigarette use, including through health education.
In June 2022, FDA launched “Next Legends” – a youth e-cigarette prevention campaign intended to educate American Indian/Alaska Native (AI/AN) youth, ages 12 to 17, about the harms of e-cigarette use. As part of the agency’s ongoing efforts to protect youth from the dangers of tobacco use, this campaign uses unique branding and tailored messaging created to inspire a new generation of AI/AN youth to live “Native strong” and free from e-cigarettes. This campaign is also important from a health equity standpoint, as studies show that AI/AN youth are more susceptible than their non-AI/AN peers to e-cigarette use and have disproportionately high rates of experimentation and current use of e-cigarettes than other racial and ethnic groups.
In 2022, FDA also launched the Vaping Prevention and Education Resources Center, a robust collection of science-based, standards-mapped classroom resources. These resources provide educators with tools to prevent and reduce e-cigarette use among middle and high school students. They can be used to start an open dialogue with students about e-cigarette use and help encourage a lifetime of healthy behaviors. Additional free resources for a variety of audiences are available on the Tobacco Education Resource Library.
Developed in 2022 and launched in January 2023, FDA’s “The Real Cost” youth cigarette prevention campaign announced two new ads earlier this month which, for the first time, will focus on the negative mental health effects of cigarette smoking and withdrawal in an ad.
In addition to youth prevention, we also recognize that adults also want and need help as they attempt to quit smoking combustible tobacco products, which are responsible for the overwhelming burden of death and disease from tobacco use. FDA developed a range of free adult cessation education materials built on the key research insight that many smokers require multiple quit attempts to achieve long-term cessation. These materials also underscore the health benefits of quitting and use positive messaging to encourage adult smokers to try to quit again. We are also continuing formative research into messaging among adult smokers 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. Formative scientific research is critical to inform any public messaging. This helps ensure that the messaging adequately reaches the intended target audience while not adversely affecting unintended audiences, including youth.
Advancing Health Equity
We have a tremendous opportunity to prioritize health equity and create meaningful change for populations that have been disproportionately affected by tobacco use. For example, smoking disproportionately affects communities including, but not limited to, certain racial and ethnic populations, low-income populations, people living with mental health conditions, and LGBTQI+ individuals.
One example of taking health equity into account in our work is expanding answer choices for gender identity and sexual orientation, along with improved measures of socioeconomic status, in the demographic questions we use in studies. For example, we have expanded questions in our routine population-based surveys, such as the Population Assessment of Tobacco and Health (PATH) Study. Inclusive, appropriately-worded survey questions help us to ensure that the data we collect is accurate and can effectively inform programmatic activities.
Reducing tobacco-related health disparities has been a foundational component of CTP’s policies and programs as part of our mission to protect and advance public health. However, there is more that can be done, and it is time to swing the spotlight onto these actions and intensify our efforts to address tobacco-related health disparities. Toward that end, we have recently announced the addition of the position of Senior Advisor for Health Equity to CTP’s leadership team, who will be responsible for leading our center’s work in this area.
Looking Ahead
Throughout 2022, CTP made significant progress in a number of key priority areas, and we are gearing up for another productive year.
FDA is vigorously working toward several key actions to address combustible tobacco products. This includes finalizing the product standards related to menthol cigarettes and flavored cigars. FDA is also working to develop a proposed product standard that would establish a maximum nicotine level to reduce the addictiveness of cigarettes and certain other combusted tobacco products. These proposed rules, when finalized, would be among the most impactful population-level actions to reduce the risk of combustible tobacco products in the history of U.S. tobacco product regulation.
We also recently received the findings from the Reagan-Udall Foundation’s independent evaluation of our program. We are in the process of closely reviewing this feedback and in February will provide an update on our planned actions in response to the evaluation.
As we head into 2023, we remain fully committed to transparency and stakeholder engagement, including both industry and public health organizations. In 2022, CTP participated in 52 meetings with stakeholders – averaging one per week – including 25 meetings since I arrived as Center Director. We look forward to continued engagement with stakeholders in 2023 through a variety of mechanisms, including individual meetings, scientific and trade conferences, as well as public meetings such as convenings of the Tobacco Product Scientific Advisory Committee.
The work we are doing is poised to have a significant impact on the health of our nation. As we continue our progress in the priority areas I discussed above, we will continue to use the best available evidence to make marketing authorization decisions and to enforce regulations that reduce the public health burden of tobacco products. While doing so, we remain committed to the utmost scientific rigor and transparency, including clear and timely communication with all stakeholders about our activities and progress.