Panel warns FDA’s beleaguered tobacco unit lacks direction

WASHINGTON (AP) — The lack of clear direction and priorities at the U.S. Food and Drug Administration's tobacco division has hampered its ability to regulate electronic cigarettes and other products, according to an expert panel assembled to examine problems at the agency.

A blistering report released Monday describes the FDA's tobacco program as “reactive and overwhelmed,” in its effort to oversee both traditional tobacco products and a sprawling market of largely unauthorized electronic cigarettes. The experts say FDA’s inconsistent approach to regulation is at least partially to blame for the spread of thousands of e-cigarette varieties that remain popular among teenagers.

The assessment comes from a panel of experts convened by the Reagan-Udall Foundation, a non-profit that works on FDA issues.

FDA chief Dr. Robert Califf commissioned separate reviews of the agency’s tobacco and food programs over the summer, after ongoing controversies in both units raised questions about his leadership at the FDA.

Califf said Monday he will review the recommendations with the aim of outlining the agency's next steps by February.

The Reagan-Udall group recommended that agency leaders set clear objectives and expectations for what the FDA Center for Tobacco Products can accomplish in coming years. That lack of clarity has been “detrimental” to FDA's work and staff morale, the group notes.

The group also calls for the creation of a task force including FDA and other government departments to help crack down on unauthorized e-cigarettes and other products that have become popular with teenagers.

The review comes as the FDA’s tobacco program is besieged by criticism from all sides — including congressional lawmakers, anti-smoking advocates and tobacco companies.

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