US FDA faces rare internal review of tobacco product regulation

The United States is about to embark on a somewhat rare internal review, which will affect the way the Food and Drug Administration (FDA) handles tobacco products and compel retailers to sell these products.

Source: Saad Chaudhry Last month, FDA Commissioner Robert M. Califf announced in a statement that as the agency deals with complex policy issues and identifies more and more new tobacco products for enforcement, these products could have "significant implications" for public health and will face "greater challenges" in the future.

The FDA has commissioned the Reagan-Udall Foundation, an independent partner organization based in Washington, D.C., to conduct an evaluation. The review will also examine the FDA's human food program, including the Office of Food Policy and Response (OFPR), the Center for Food Safety and Applied Nutrition (CFSAN), and the Office of Regulatory Affairs (ORA) departments.

Susan Winckler, CEO of the Reagan-Udall Foundation, told TrealingMagazine.com that the review of the FDA's Center for Tobacco Products (CTP) will focus on how the agency currently operates and how it can better function in a rapidly changing environment. Details of the exact content the foundation will review have not yet been disclosed, but Winckler noted that the FDA is currently facing "an onslaught" of work and the foundation will assess how the agency can better handle all situations related to CTP and be more strategic in its regulatory responsibilities.

The evaluation is expected to take 60 working days once it is initiated. Winckler stated that upon completion, a report with recommendations will be submitted. "We will all work to research the [CTP] and incorporate it into the information synthesis, and meet with stakeholders as much as possible," said Winckler.

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