What the FDA’s Center for Tobacco Products Needs to Improve: Report

WASHINGTON —A panel commissioned to review the U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) has made several recommendations on how the agency can strengthen its program. 

The CTP should pivot from a reactive mode to a proactive mode, develop a clearer framework for premarket tobacco product application (PMTA) reviews and provide greater transparency about its approach to compliance and enforcement. These are just a few of the 15 recommendations the FDA received from the Reagan-Udall Foundation for the FDA in a 39-page report released Dec. 19.

FDA Commissioner Robert Califf, who has been in the role for nearly a year, commissioned the external evaluation on July 19. The panel was asked to assess the tobacco programs regulatory processes and agency operations relating to regulations and guidance; application review; compliance and enforcement; and communication with the public and other stakeholders.

The CTP will review the report’s findings and recommendations to determine next steps and will provide an update by early February, Califf said.

“This work is particularly critical as we focus on preventing initiation, while also helping people quit, especially the deadliest form of tobacco use, combustible tobacco products,” he said. “Despite meaningful declines in cigarette use over the past several decades, nearly 500,000 Americans still die every year from cigarette smoking. Additionally, with more than 3 million youth reporting current use of a tobacco product in 2022, and e-cigarettes being the most used product, we risk another generation becoming addicted to these products.”

Potential improvements to operations and processes for tobacco product regulation will be clearly communicated, Califf said, adding that it is critical to ensure the CTP has what it needs to meet the recommendations in the report.

Click through to see highlights of the foundation’s findings ...

Although the CTP has a vision and mission statement, the center’s goals and priorities are unclear in communication and practice, the report said.

It is difficult for stakeholders to determine which parts of the FDA’s regulatory plan—which it announced in 2017 to shift the trajectory of tobacco-related disease and death by placing nicotine and the issue of addiction at the center of the agency’s tobacco regulation efforts—are still being pursued today, making it challenging to measure the center’s progress toward its public health goals.

That’s why the foundation recommends the CTP make a strategic plan to help it pivot from reactive mode to proactive mode. The plan should identify key policy issues that need to be addressed and ones that it has already resolved.

The panel creating the report said some issues before the CTP are fundamental policy questions that must be informed by science but are not, themselves, scientific issues. They are instead policy issues with profound societal impacts, the report said.

One of those questions that scientific analysis alone won’t resolve is how to weigh the public health benefits of adults who use electronic nicotine delivery systems (ENDS) to stop smoking combustible cigarettes with the potential public health harms to youth who use ENDS and acquire a lifelong addiction to nicotine, the report said.

“At times, a lack of clarity about the distinction between, and the intersection between, policy and science has created controversy within CTP and may lead to a perception that the center’s scientific integrity is being challenged when, in fact, policy decisions that transcended the science are being made. During the strategic planning process, the distinction between policy and scientific issues should be explored, the decisionmaker with the responsibility for each type of decision should be identified and staff roles and responsibilities in contributing to issue resolutions should be clarified,” according to the report.

The foundation also recommended the CTP improves its ability to recruit, hire and retain personnel with the needed skills to effectively meet its public health mandate around tobacco.

The CTP should develop a clearer and more predictable framework for high-quality PMTA and modified risk tobacco product (MRTP) application submission and review, the report suggested. Part of this includes prioritizing the timely development and completion of policies and scientific standards necessary for those submissions, as well as simplifying review procedures.

The panel also suggested the CTP provide more details in public summaries of marketing granted orders and reasons why marketing denial orders (MDOs) were issued to provide applicants more insight into the CTP’s regulatory decision-making process.

Several MDOs the CTP has issued so far have been contested by applicants. In one case, an appeals court said several MDOs given to ENDS companies were “arbitrary and capricious” because the agency did not adequately consider the companies’ marketing plans.  

The FDA has issued nearly 300 warning letters to tobacco firms that have failed to submit a timely premarket application for new tobacco products released or modified after Feb. 15, 2007. Those firms have more than 17 million e-cigarette products listed with the agency.

The FDA recently initiated its first injunction proceedings with the Department of Justice to enforce the premarket review requirements for new tobacco products, but more needs to be done, according to the review.

“Because companies have seen that FDA is not taking action for those products for which an application is pending, some companies have continued to market their products, in some cases reportedly submitting deficient applications or filing frivolous appeals to further delay enforcement action,” the report said. “Some companies have engaged in other techniques to evade enforcement. The panel heard that numerous companies have, for example, changed their company name after receiving a warning letter and continue to operate and sell illegal products.”

The FDA should seek higher-level administration involvement to establish a task force to make the enforcement of the tobacco laws a government-wide priority, the report said, particularly to address the marketing of illegal products and the risks of youth use.

It should also consider increased consequences for Tobacco Control Act violations, explore alternative approaches to achieving compliance and enhance its use of public communications to provide greater transparency about the agency’s approach to compliance and enforcement, the report said.

The CTP should obtain public input during the development of its strategic plan and should also solicit broad public input as it continues to develop its tobacco public education campaigns, the report said.

“Many stakeholders stated that additional truthful and accurate information to help adult consumers make informed decisions about the role of nicotine and the risks of combustible and smoke-free products is needed,” the report said. “In particular, some stakeholders were interested in CTP clarifying the role of vaping, beyond warning against youth use and communicating more clearly about harm reduction and the relative risk of tobacco products.”

The center should also improve the overall transparency of its tobacco program, particularly with respect to the regulatory process and its scientific underpinnings, the panel said.

The panel was comprised of former federal public health leaders, regulatory strategists and process improvement specialists including Lauren Silvis, Jane Axelrad, Keith Flanagan, Charlene Frizzera and Alberto Gutierrez.

“The panel provided recommendations to help the agency’s tobacco program strengthen its operations as it works to reduce the harm associated with tobacco use,” said Silvis, who chaired the panel. “The [CTP, which was created in 2009] has made significant progress in establishing a regulatory program for tobacco products and our recommendations are intended to help the center develop additional tools for achieving its public health objectives.”

The panel collected its information from stakeholders through multiple listening sessions, interviews and an online portal. It received input from a range of stakeholders including FDA staff, the public and tobacco companies.

The Washington-based Reagan-Udall Foundation for the FDA is an independent 501(c)(3) created by Congress to advance regulatory science to help the FDA accomplish its mission.