CTP’s Response to the Reagan-Udall Foundation Report

The Center for Tobacco Products (CTP) has responded to the recommendations of an independent expert panel facilitated by the Reagan-Udall Foundation, which conducted an operational evaluation of the CTP at the request of FDA Commissioner Dr. Robert Califf. The final report, issued on Dec. 19, 2022, included 15 recommendations across various areas, which the CTP says it is committed to addressing. The report identified several areas of improvement for the CTP, including the need to enhance the scientific basis for regulatory decision-making, strengthen stakeholder engagement, and improve the transparency of regulatory decision-making.

PCA is hopeful that CTP’s new commitment towards transparency will improve industry relations and facilitate compliance.  Similarly, we look forward to seeing CTP shift towards science-based regulation under Dr. King’s leadership and are encouraged by the statements on more direct industry engagement.  This will only serve to improve the agency’s work products and PCA is looks forward to participating with CTP in this process.

At the same time, we have concern that CTP continues to view industry engagement as an afterthought and not a means to effectively understand how its approach can be better designed in the developmental phase of regulations, guidance or strategic planning.  While we agree that all regulated industries should participate in the user fee pool, CTP has tremendous resources at its disposal.  Its failures have resulted from a culture focused on political outcomes not a lack of budget.

PCA continues to assert that youth tobacco use is not effectively addressed through new regulation, and neither will more equitable outcomes.  Appropriate guidance, education and enforcement of T-21 is the most effective tool at CTP’s disposal.  With this in mind, we continue to implore that tobacco product standards are not weaponized against consumers and businesses as has been proposed, since CTP has yet to address the overwhelming economic and social concerns these proposals would have on communities.

Finally, the CTP intimates that growing the bureaucracy and expanding its authorities may be necessary to improve its efficiency and meet its mission.  Nothing could be further from the truth.  Until the systemic failures are addressed, growing an agency that already spans over 1100 employees will only complicate and compound its problems.  Rather, CTP should embrace Congressional oversight, as does every other Federal Agency, to ensure that its ongoing efforts remain in-line with its statutory mission and public demands.  Operating for nearly 14 years without any traditional checks and balances is a failed experiment.  PCA will work with Congress to institute customary good governance practices, such as oversight of leadership and budget.  Until then, PCA must continue to oppose any new funding increases or expansion of authorities for the Center for Tobacco Products.