This is the fifth post in our multipart series evaluating the Food and Drug Administration’s (FDA’s) response to the Reagan-Udall Foundation report (the Report) on the operations of the Center for Tobacco Products (CTP). If you missed our prior posts on the Report and FDA’s response, check them out at the links below:

In this segment of our series evaluating FDA’s response to the Report, we review a subset of the Report’s recommendations and responses from two CTP Task Forces — “Public Education Campaigns” and “Resources.”

Public Education Campaigns

The agency’s Public Education Campaigns Task Force responded to the Reagan-Udall report’s recommendation that “the center [] solicit broad public input as it continues to develop its tobacco public education campaigns, which are critical to the public health mission.” The report found that many stakeholders expressed a need for “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.” Stakeholders indicated that CTP should clarify the role of vaping beyond simply warning against youth use and communicate more clearly about harm reduction and the relative risks of various tobacco products. The report noted that CTP could improve communication about the “state of the science that informs its regulatory processes and decisions.”

In response, the FDA Public Education Campaign task force indicated that CTP will:

  • develop and implement a plan to develop, publish, and promote CTP resources that describe the mechanisms CTP currently uses to solicit and consider public input on its campaigns;
  • leverage opportunities to solicit and consider public input during upcoming public meetings on topics relevant to CTP campaign and public education strategy;
  • begin exploring a collaboration with an external entity known for scientific rigor and objectivity to develop and test a credible, sustainable, and comprehensive process for soliciting and considering public input on CTP’s campaign program.

Our Thoughts

Rather than address the report’s critiques directly, the Public Education Campaign task force seems focused on soliciting even more feedback about FDA’s efforts to educate the public about tobacco harm reduction. Providing consumers with accurate information about tobacco products’ relative risks is consistent with FDA’s public health mission, but the response makes it seem like FDA plans to crowd-source this information instead. FDA has been critiqued for not taking a more balanced approach to alternative nicotine products that are widely acknowledged to pose fewer health risks compared to combustible products, and CTP’s response to the Reagan-Udall Report’s recommendation fails to acknowledge the continuum of risk or commit to a different approach. The public input FDA receives on its public education campaigns will hopefully help it evolve its messaging on the topic so that consumers can make better informed decisions.

Resources

The Resources Task Force responded to the Reagan-Udall Report’s recommendation that “the FDA [] secure the agile hiring authorities and salary flexibility of the 21st Century Cures Act for the tobacco program to improve its ability to recruit, hire, and retain personnel with the needed skills to effectively meet its public health mandate around tobacco” and that FDA “continue to pursue securing user fees from each sector regulated by the center, including, for example, electronic nicotine delivery systems.”

In response, FDA indicated that

  • effective immediately, FDA will continue to work with Office of Personnel Management (OPM) to develop solutions to facilitate and expedite hiring professionals that match CTP’s needs; and
  • CTP will continue to engage with FDA, HHS, and OPM to identify solutions to facilitate more timely and efficient hiring of qualified and diverse professionals that match the center’s needs, including by partnering with OPM to potentially establish an Intra-Agency Agreement for additional hiring support and working with HHS to submit to OPM a new request for direct hire authority for the tobacco program.

The Resources Task Force further indicated that the agency has pursued user fees for all products it regulates, that it has requested an additional $100 million in user fees since 2020, and that it is working to educate the appropriate stakeholders, including Congress, about the beneficial impact additional user fees would have.

Our Thoughts

We support the stated efforts to more efficiently hire qualified personnel for CTP, which has been struggling under the volume of work and multitude of initiatives it is trying to manage in tandem. In our experience, FDA is not meeting any of the Tobacco Control Act’s stated deadlines to act on product applications. These administrative delays stifle innovation that stands to benefit adult smokers. We also hope to see improved collaboration between CTP’s scientists and its leadership, so that industry and the public can have confidence that CTP’s decisions are based on science rather than politics.

Lastly, while we acknowledge that user fees are critical to the CTP’s work, we believe that FDA should prioritize resources on enforcement against products being sold without marketing authorization (or pending applications). The fact that the market of unauthorized products continues to grow with little signs of slowing undermines CTP’s credibility and penalizes those operators working to sell their products in compliance with the Tobacco Control Act.

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Photo of Agustin Rodriguez Agustin Rodriguez

Agustin is sought after by clients for his strategic counsel on their most challenging competitive and regulatory compliance issues, including tobacco Master Settlement Agreement issues, federal and state enforcement investigations, licensing and excise tax issues, developing compliance programs, and evaluating advertising and marketing…

Agustin is sought after by clients for his strategic counsel on their most challenging competitive and regulatory compliance issues, including tobacco Master Settlement Agreement issues, federal and state enforcement investigations, licensing and excise tax issues, developing compliance programs, and evaluating advertising and marketing practices. A partner in the firm’s Regulatory Investigations, Strategy + Enforcement (RISE) Practice Group as well as its Tobacco and Cannabis law practices, he represents manufacturers, distributors, retailers, and suppliers in all aspects of their businesses, including regulatory compliance, FDA requirements, administrative disputes involving federal or state governmental entities, mergers and acquisitions, commercial agreements, and taxation matters.

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Bryan Haynes serves clients by developing and implementing creative solutions for complex issues. Specializing in tobacco industry regulatory compliance and enforcement matters, Bryan efficiently assists clients in complying with regulatory obligations and managing risk, consistent with clients’ business objectives.

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Christina is an attorney in the firm’s Regulatory Investigations, Strategy + Enforcement (RISE) Practice Group. She helps clients navigate local, state, and federal regulations affecting the tobacco, hemp, and cannabis industries – including ancillary service providers. She brings extensive experience in the cannabis…

Christina is an attorney in the firm’s Regulatory Investigations, Strategy + Enforcement (RISE) Practice Group. She helps clients navigate local, state, and federal regulations affecting the tobacco, hemp, and cannabis industries – including ancillary service providers. She brings extensive experience in the cannabis industry to her work in the tobacco, nicotine, and vapor space, giving her a deep understanding of the challenges and opportunities of launching new products and marketing campaigns in a shifting regulatory landscape.