The Reagan Udall Foundation (RUF) recently released an Operational Evaluation of Certain Components of FDA’s Tobacco Program report. The report, which focused on the Food and Drug Administration’s Center for Tobacco Products (CTP), made several recommendations for improving the regulatory, enforcement, and compliance processes.
The Premium Cigar Association (PCA) provided written and oral recommendations for this report generated by an independent panel of experts. The association’s comments focused on necessary improvements to the Center’s communications, transparency, accountability, and objectivity in the regulatory process which were reflected in the final report.
“Between the NASEM and Reagan Udall Foundation recommendations and report, the FDA and CTP received a pretty pathetic report card and have a lot of homework to catch up on,” said Joshua Haburksy, PCA Deputy Executive Director and Head of Government Affairs who presented to the RUF alongside PCA Chairman Greg Zimmerman. “Hopefully CTP and its new leadership will recognize its past failures and act upon these recommendations to improve in all areas ranging from communications to regulatory review. PCA appreciates the work of the independent panel and the opportunity to engage in ways to better the Center for Tobacco Products,” said Habursky.
One of the key suggestions from the RUF was the importance of incorporating stakeholder input and outside expertise into the regulatory process. This will include input from industry groups, such as PCA and its membership.
Scott Pearce, the Executive Director of PCA called on the FDA and the CTP to be more fair and less biased in their approach. “The research has consistently supported the premium cigar industry’s positions and the FDA and CTP should put more emphasis on science and fact and less on politics and performative altruism. A sound approach based on facts determined by research will undoubtedly yield a more fair – and just – process.”
In addition to incorporating stakeholder input, the RUF report also emphasized the importance of using a risk-based approach to enforcement. This means that the FDA and CTP should prioritize enforcement efforts based on the potential health risks posed by different products or activities.
The PCA supports this recommendation, as it allows the FDA and CTP to focus its resources on the areas that pose a risk to public health and safety. This approach can also help to minimize the burden on industry and ensure that the enforcement process is targeted and effective. Another step in the right direction on the enforcement side is the suggestion from the RUF that CTP and the FDA ought to work closely with the states so there are not various government agencies enforcing the same law or regulation. Duplicative action and enforcement are particularly burdensome to small businesses.
PCA looks forward to working with the FDA, CTP, and other stakeholders to ensure that regulations are based on sound science and consider the perspectives of all impacted parties.