FDA update on redesigned foods program sets final proposal for fall, draws disappointment from industry stakeholders

By Deidre McPhillips, CNN

A month after announcing plans to make a sweeping redesign of its food safety programs, the US Food and Drug Administration said Tuesday that it has begun the search for a deputy commissioner for human foods and plans to have a final reorganization proposal to share in the fall. But key industry stakeholders say the latest update does not address major organizational issues assessed in a recent independent evaluation.

The FDA is in the midst of restructuring its Human Foods Program and Office of Regulatory Affairs after criticism of its response to a lengthy infant formula shortage and critiques that it was too slow to handle other nutrition and food safety issues.

According to Tuesday’s announcement, the new deputy commissioner would have a “clear line of authority” over the new Human Foods Program, which would include existing components of the Center for Food Safety and Applied Nutrition, the Office of Food Policy and Response and certain human foods-related aspects of the Office of Regulatory Affairs.

The new deputy commissioner would also join other program leads in “setting strategic direction for food inspections and have authority over program resource allocation” under a new Office of Integrated Food Safety Systems Partnerships.

“We’ve heard loud and clear that the current resource distribution and operational model between the FDA’s regulatory programs and field operations are siloed and there’s too much duplication. We intend to fix this and strengthen both the regulatory programs and field force,” FDA Commissioner Dr. Robert Califf said in a statement.

However, at a news conference Tuesday, a group of key stakeholders representing consumer organizations, food industry leaders and state and local regulators expressed disappointment in the latest update from the FDA. They said the announcement indicates a continuation of “matrix management” that will not allow the new deputy commissioner to make efficient decisions.

Califf is “choosing business as usual instead of the bold changes we’ve adamantly advocated for that would transform the Foods Program from one of inaction and indecision to one of action,” said Roberta Wagner, vice president of regulatory and technical affairs at the Consumer Brands Association, who spent decades at the FDA.

“Worse yet, he’s telling American consumers who rely on the FDA to ensure the foods they buy at the grocery store are safe that he’s rejecting objective expert recommendations on how to help prevent food shortages and the spread of food-related illnesses.”

Many stakeholders said that what’s known of the proposed structure so far will also make it hard to recruit a good deputy commissioner.

“What is being suggested by the commissioner will not allow him to recruit a deputy commissioner that is needed to drive structural and cultural change within the Foods Program,” said Donna Garren, executive vice president of science and policy at the American Frozen Food Institute. “Unfortunately, it will set up this person for failure on day one, with authorities continuing to be divided amongst the various programs.”

According to Tuesday’s announcement, the FDA plans to have a proposal this fall that would outline a new structure, budget and mapping of staff. It would then undergo thorough review and be submitted to Congress for comment.

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