FDA Outlines Steps to Strengthen Tobacco Program
- For Immediate Release:
- Statement From:
Robert M. Califf, M.D., MACC
Commissioner of Food and Drugs - Food and Drug Administration
Today, the U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) outlined the steps it plans to take in response to an external evaluation I commissioned last year from an independent panel of evaluators working through the Reagan-Udall Foundation. The evaluation was an important opportunity to take a critical look at the Tobacco Program’s regulatory processes and operations.
We have made tremendous progress preventing death and disability caused by tobacco use, but I am a strong believer that we can always benefit from examining how we can work most effectively and proactively to protect public health, support our staff, and be as responsive as possible to external stakeholders. When I started my career in intensive cardiac care, hospitals were full of relatively young people with sudden death, heart attacks, strokes and cancer attributable to tobacco use. The effectiveness of the public health and medical communities to reduce the toll of tobacco products was enhanced when the FDA was granted the authority to regulate tobacco.
As we enter this era of declining use of combustible tobacco and continued innovation in the e-cigarette industry, the societal concerns are not subtle. Our ability to keep pace with these changes will depend on immediate, short-term and long-term actions the center is taking that we believe will position the agency to more successfully implement our regulatory oversight of tobacco products.
CTP Director Brian King, Ph.D., M.P.H., has provided more detail about our approach to respond to the evaluation recommendations and our new plans, which will include the release of a 5-year strategic plan and comprehensive policy agenda by the end of the year. CTP has committed to providing regular updates on the progress of these activities, including some noted here.
In the past several years in particular, CTP has made important progress in the review of applications for e-cigarette products – authorizing several tobacco-flavored e-cigarette products and devices and rejecting marketing applications for millions of products that did not meet the requirements in the law.
Given the ever-evolving tobacco marketplace, it is imperative that we optimize the framework for application reviews to ensure any products marketed meet the law’s public health and regulatory standards. This work will include, among other things:
- further streamlining of reviews when appropriate;
- increasing the use of the Tobacco Products Scientific Advisory Committee to discuss broader scientific matters central to premarket evaluation and individual product applications;
- posting current and future scientific policy memos and reviewer guides when appropriate; and
- working internally and through engagement with external stakeholders to better communicate on scientific issues and practices to support efficiency, effectiveness, and transparency. These critical efforts will be bolstered by a new director in CTP’s Office of Science, who will begin in late March.
To achieve these goals, we need to have the appropriate resources to hire and retain staff with the skills needed to effectively meet our public health mandate around tobacco. Since the agency’s fiscal year 2020 budget request, the FDA has advocated for the authority to collect user fees from e-cigarette companies, which currently do not pay user fees despite the enormous workload to review and make decisions regarding these products. The FDA also continues to explore ways, including engaging with the U.S. Department of Health and Human Services and the Office of Personnel Management, to identify solutions to facilitate more timely and efficient hiring of qualified and diverse professionals that match CTP’s needs.
Compliance and Enforcement
As the agency continues to make progress on its review of new and pending applications for novel products like e-cigarettes, the FDA will take additional action to remove illegal products from the market—particularly ones that have led to e-cigarettes being the most commonly used tobacco product among youth.
Between January 2021 and February 17, 2023, the FDA has issued more than 550 warning letters to companies for continuing to sell e-cigarette products that lacked the required FDA marketing authorization. These companies had millions of products listed with the FDA. After receiving warning letters, a majority of these companies have complied and removed their products from the market. However, in cases where companies did not do so, the FDA can pursue further enforcement action. For example, the FDA recently worked with the Department of Justice (DOJ) to file the first complaints for permanent injunctions against six e-cigarette manufacturers. Additionally, for the first time, the FDA this week filed civil money penalty complaints against four tobacco product manufacturers for manufacturing and selling new e-liquids without marketing authorization. The agency will continue to work as expeditiously as possible to remove illegal products from the market while identifying new ways to strengthen compliance and enforcement.
As recommended by the external evaluation, effective immediately, the FDA will begin planning to convene a summit with senior officials from the HHS and DOJ related to enforcement. The agency will also continue to work with other government agencies, such as U.S. Customs and Border Protection, the U.S. Postal Service, the Federal Trade Commission, Bureau of Alcohol, Tobacco, Firearms and Explosives, as well as with our compliance and enforcement partners at the state/local/territorial/tribal levels. This work will maximize compliance and enforcement activities where there are shared interests. Additionally, the FDA will explore alternative approaches to achieve compliance outside of judicial enforcement actions.
The agency acknowledges that some unlawful e-cigarette products continue to be sold in the U.S. Many companies have challenged the agency’s marketing denial orders in courts around the country. In some cases, this has constrained our ability to remove these products from the market while the legal cases are pending. It is also important for the public to understand that the agency does not have the authority to independently bring legal cases seeking injunction or seizure against those who violate the law. Instead, the agency must rely on DOJ, who must evaluate the legal risks of pursuing particular enforcement actions and decide whether to dedicate its finite resources to litigate cases on our behalf. The FDA will continue to use all the tools at our disposal to hold companies accountable; however, the agency cannot be everywhere at all times. The agency needs additional resources to ensure that companies comply and that we have the ability to take action against those who break the law and tie up the system in court proceedings.
Transparency and Communication
As part of the center’s work, the agency plans to enhance and increase its public communications to provide greater transparency about the agency’s approach to compliance and enforcement. By this spring, we plan to begin posting content to a new comprehensive webpage for all enforcement activities, which will include a searchable public database of all tobacco products that have an FDA marketing order to discourage the sale of illegal products. Additionally, the center plans to conduct additional public meetings and workshops, as well as provide more information regarding the application review process.
The center will also explore new ways for soliciting and considering public input on its public education campaigns, including input on formative research into messaging for adult smokers that nicotine – while highly addictive – is delivered through products that represent a continuum of risk.
The State of Tobacco Regulation in the U.S.
When Congress tasked the FDA with regulating tobacco products more than 13 years ago, the vision was to make tobacco-related disease and death part of America's past, not America's future, and, by doing so, ensure a healthier life for every family.
We’ve made notable progress, but important opportunities and challenges lie ahead as we seek to regulate an evolving marketplace. Current cigarette smoking among U.S. adults declined from 20.6% of the population in 2009 to 11.5% in 2021. Despite this progress, nearly 500,000 Americans still die every year from cigarette smoking and continued youth vaping is producing another generation plagued with addiction to products with unknown long-term health consequences.
We’ve announced plans to prevent initiation and help people quit the deadliest form of tobacco use – combustible tobacco products. The agency is working to finalize product standards that would ban menthol in cigarettes and characterizing flavors (including menthol) in cigars. We’ve also announced plans for future potential regulatory actions, including developing a proposed product standard that would establish a maximum nicotine level to reduce the addictiveness of cigarettes and certain other combusted tobacco products. These actions are key to achieving the Cancer Moonshot goal of cutting the cancer death rate in half over the next 25 years, a key pillar of President Biden’s Unity Agenda.
Additionally, we continue to make significant strides in our science-based review of more novel tobacco products, such as e-cigarettes. The FDA has authorized 23 tobacco-flavored e-cigarette products and devices. The agency has also issued marketing denial orders for more than one million flavored e-cigarette products that lacked sufficient evidence that they have a benefit to adult smokers sufficient to overcome the public health concerns posed by the well-documented, alarming levels of youth use of such products. While certain e-cigarettes may help adult smokers transition completely away from, or significantly reduce their use of more harmful combusted cigarettes, the law’s public health standard balances that potential with the known and substantial risk with regard to youth appeal, uptake, and use of these highly addictive products.
Unfortunately, the tobacco industry has fought the agency on many of the science-based actions we’ve taken – putting profits over public health. For example, despite being the only country with sweeping regulatory authority over the industry, unlike many other nations, legal challenges have twice prevented us thus far from implementing Congressionally mandated warnings on cigarette packs depicting the serious health risks of cigarette smoking. And, as noted earlier, many decisions about product applications have also been challenged in court, which has, among other things, required significant resources to defend.
The FDA will continue to undertake our critical work to improve public health. It’s imperative that we are able to meaningfully implement transformational regulations and make decisions based on the public health standard in the law, with the American public – not the interests of the tobacco industry – at the forefront. We’ve made progress, but there’s a lot more work to come.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
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