CTP Announces Five-Year Strategic Plan with Little New Policy

[jefslat]

Because, I suppose, losing is not an option?

WASHINGTON, DC (December 18, 2023) - Today, the US Food and Drug Administration’s (FDA) Center for Tobacco Products (CTP) released a five-year Strategic Plan, setting out its current thinking about priorities in tobacco science and regulation. The Strategic Plan is intended to address criticisms made by the Reagan-Udall Foundation (RUF) one year ago about operational effectiveness at the Center. Despite engaging in a lengthy process of public engagement in the wake of that report, the plan released today by FDA contains little new policy and does not adopt many of the key recommendations.

In July 2022, FDA Commissioner Dr. Robert Califf requested that RUF undertake a review of CTP operations in the wake of widespread criticism that the Agency had been slow to adopt needed regulations, process applications, and effectively set priorities. In December 2022, RUF issued its findings, including a series of recommendations for CTP. RUF found, among other suggestions, that CTP needed to identify key policy issues, establish clear priorities for regulation, acknowledge scientific uncertainty, and set metrics for success.

While Cigar Rights of America (CRA) is pleased to see that FDA has not announced any new regulatory measures related to premium cigars, we are disappointed to see that the Agency’s plan largely ignores those recommendations.

The Plan includes nearly no discussion of the differences in risk or in the level of scientific knowledge for the different categories of tobacco products that it regulates. Instead, it treats all tobacco products as a monolith, requiring blanket regulation. This is exactly the approach that the RUF criticized in finding that the Agency has consistently failed to set appropriate priorities in a manner that allocates resources to maximize the protection of public health, the lode star of the CTP.

CRA believes that CTP should effectively address the points raised by RUF and should reconsider its approach by focusing first on the categories of products that pose the greatest risk to public health.