Truth Initiative welcomes FDA actions in response to Reagan-Udall report

Statement from Robin Koval, CEO and President

Following the release this past December of the Reagan-Udall Foundation’s evaluation of the Center for Tobacco Products (CTP), we applaud the response from the Food and Drug Administration (FDA) in moving to address the report’s evaluations. Under the leadership of Dr. Brian King, we are encouraged by the clear steps laid out for a path forward and urge the FDA to implement its proposed actions quickly.

We are pleased to learn that CTP will develop and implement a five-year strategic plan by December 2023 and welcome the opportunity to provide input in the months to come. It is critical for CTP to pivot from a reactive mindset to a proactive one, and a long-term road map will play a key role in making that shift. We encourage the agency to place the advancement of health equity at the heart of this plan to combat the tobacco industry’s long-term exploitation of communities that continue to face a disproportionate burden from tobacco-related death, diseases and addiction. Moreover, we hope this plan will identify a clear, scientifically sound, and executable strategy to regulate and enforce the continued proliferation, illegal marketing, and predatory behavior of the industry in recruiting millions of young people to become users of e-cigarettes and other high nicotine, flavored tobacco products and simultaneously provide a well supervised, common-sense approach for existing adult smokers to quit smoking and ideally the use of all tobacco products.

As we have raised concerns around the FDA’s enforcement processes in the past, we are encouraged that the agency will take actions to make enforcement a higher and government-wide priority and hope this will result in increasing the pace and effectiveness of its enforcement actions. Tobacco product manufacturers are openly flouting the law and playing a game of catch me if you can with FDA. The FDA’s current weak enforcement processes have resulted in a de-facto post-market review process, rather than a pre-market review of products as is required by the Tobacco Control Act. We welcome the agency’s commitment to greater transparency and its pledge to publicly share a list of legally marketed products. This will enable the public, consumers, and retailers to understand what products are actually allowed to be on the market and will help discourage the sale of illegal products.

We are also pleased to hear that FDA will increase the use of the Tobacco Products Scientific Advisory Committee (TPSAC) for input on scientific issues and policy development; and we urge the agency to utilize this group of experts for the premarket review process, as it does for the modified risk tobacco product application process.

CTP’s public health education campaigns are important to its mission to educate the public, especially youth, about tobacco products and the dangers their use poses to themselves and others. While we support transparency about the mechanisms used by the FDA to develop these vital campaigns, it is important that the tobacco industry not be given an opportunity to influence these campaigns and thus diminish their impact on the targeted audiences.

As youth vaping nicotine remains a serious public health threat with more than 2.5 million middle and high school students reporting current use of e-cigarettes last year alone, it is critical for the FDA to pursue this work in an efficient and timely manner. We applaud them for taking these steps to do so, and we look forward to our continued work together to protect public health.