FDA center struggling to regulate tobacco products, review finds

The staff at the Food and Drug Administration’s tobacco division are overwhelmed, leading to a division that is too reactionary and has “struggled to function as a regulator,” according to an outside report. 

The report by the Reagan-Udall Foundation found a division weighted down by the sheer volume of product applications, changes in agency leadership, and near constant litigation from both public health advocates and the tobacco and vaping industry.

The FDA was given the authority to regulate the marketing, manufacturing and distribution of tobacco products in 2009 when Congress passed the Tobacco Control Act. 

But instead of proactively creating regulations, the center has been “forced to operate primarily in a reactive mode, moving from one challenge to the next,” the review found.

Applying new regulations to a large, existing industry is difficult, and the center’s task “has been made even more difficult because of the sheer volume of product applications, changes in Agency leadership, and near constant litigation it has encountered,” the review stated. 

In its first thirteen years, the Center for Tobacco Products (CTP) has operated under seven different commissioners in three different administrations, and recently welcomed its third center director. 

“The Center’s current goals and priorities are unclear in communication and practice,” the review stated, and the panel, chaired by former FDA chief of staff Lauren Silvis, “was unable to identify a current comprehensive plan that clearly articulates CTP’s priorities, direction for the future, and its near-term and longer-term goals and objectives.”

That lack of clarity “hinders CTP’s ability to effectively carry out its mission, establish efficient programs to accomplish its goals and objectives, and set appropriate metrics to assess outcomes,” the review found.

The review noted a shared frustration among advocacy groups, some industry representatives and CTP staff that millions of e-cigarette products have entered and remain on the market illegally, without the required authorization.

In addition, once a product is on the market illegally, a company marketing the product has every incentive to delay FDA action that would stop its sale. Some companies have continued to market their products, in some cases reportedly submitting deficient applications or filing frivolous appeals to further delay enforcement action.

The review found that numerous companies have changed their company name after receiving a warning letter and continue to operate and sell illegal products.  

But the FDA can’t independently bring enforcement actions in court; only the Justice Department has that ability. But the review found that the current process of bringing enforcement actions is cumbersome, and ultimate decisions on whether to take enforcement action rest with DOJ rather than FDA.

FDA Commissioner Robert Califf, who commissioned the review in September under immense pressure from Congress, said the center’s leadership “will closely review the report’s findings and recommendations” and will provide an update by early February.

“The hardworking and talented individuals in CTP, and across the FDA, deserve the best support possible so they can fulfill their strong commitment to public health – and the American public that we serve,” Califf said in a statement. 

“It is my belief that this effort will continue strengthening the FDA and better position the agency to deal with the many immediate public health issues related to tobacco products we are facing, while preparing for challenges and opportunities in the future.”