Recommends Changes to FDA’s Center for Tobacco Products
[Washington, DC — Oct 24, 2022] Today, the Premium Cigar Association (PCA) presented to the Reagan Udall Foundation’s Independent Expert Panel conducting the operational evaluation of certain activities of the Food & Drug Administration’s Center for Tobacco Products. PCA was represented by the association’s President Greg Zimmerman of The Tobacco Company (Harrisburg, PA) and PCA Deputy Executive Director and Head of Government Affairs Joshua Habursky.
The Reagan-Udall Foundation for the FDA (FDA Foundation) is an independent 501(c)(3) created by Congress to advance regulatory science to help the U.S. Food and Drug Administration accomplish its mission. The FDA Foundation works to improve health and safety through stakeholder engagement and public-private partnerships that facilitate innovation, foster the use of real-world evidence, and identify modern tools and polices to keep pace with today’s rapidly evolving science.
The session’s focus was on regulation & guidance process as part of a three-part stakeholder input session that also includes sessions on “Application Process” and “Compliance & Enforcement: Public Education & Communication”. During the session PCA representatives took the time to highlight its membership, premium cigar industry overview, historical challenges with FDA’s Center for Tobacco Products, and offered recommended changes to improve stakeholder relations, transparency, and accountability at the Center for Tobacco Products.
“Working with FDA and CTP has historically been adversarial, and we have been in high profile regulatory and legal battles with them for many years. With recent changes in leadership and evaluation efforts like the Reagan Udall Foundation’s Review, we are hoping to improve communications with CTP as long as they remain our primary regulator,” said Zimmerman.
According to the Reagan Udall Foundation, “The tobacco evaluation focuses on Center programs for regulations and guidance, application review, compliance and enforcement, and communication with the public and other stakeholders. The panel is not addressing tobacco policy issues, which are outside the scope of this evaluation. The report will be presented to FDA Commissioner Robert Califf and posted publicly on December 19, 2022.”
“This forum gave us an opportunity to air some grievances about the regulatory process, but also to offer some solutions and areas of improvement,” said Habursky. “This presentation and exercise sparked conversation on ways to improve working with the Center for Tobacco Products, which will go beyond the stakeholder session and enter the legislative and regulatory orbit as part of our overall government affairs strategy.”