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FDA’s Mayne: ‘We can do more with more’

Reacting to a Politico article that was critical of the Food and Drug Administration’s performance in regulating food, Susan Mayne, director of the Center for Food Safety and Applied Nutrition (CFSAN), today defended FDA’s performance on regulating food and assuring food safety, but added, “There is no question we could do more with more.”

Speaking in a webinar organized by the Alliance for a Stronger FDA, a lobbying group, Mayne said, “We take any and all criticism seriously as we work to execute our mission,” but she also reminded the advocates that the United States “has one of the safest food supplies in the world.”

Most people eat without thinking about food safety, she noted.



Mayne, who came to FDA in 2015 after three decades as a professor at Yale University, said, “I need to convey my perspective. I see a program that has gotten more done in the past seven years than at any time in history.” Mayne also noted that “FDA was under a deregulatory regime for four years,” a thinly veiled reference to the Trump administration.

The Politico article criticized FDA for slowness on implementing food regulations, but Mayne pointed out that in the last seven years the agency established a new nutrition facts label with an added sugars component, banned trans fat and has begun an initiative to establish sodium reduction targets including in restaurant food – the last a policy, she said, that other countries wish to emulate.



Mayne said President Biden’s FDA budget request to Congress for a $43 million increase for food safety modernization, including animal food safety oversight, would help FDA meet its goals, but she also pointed out the breadth of FDA’s food responsibilities and the smallness of the food division.

FDA oversees nearly 80% of the U.S. food supply, and unlike other divisions of FDA, does it “without meaningful user fees,” she said. The entire nutrition group is fewer than 70 people, and the tobacco products division budget is 30 times the budget for CFSAN, she said.

“We have more regulated industries we have to oversee than any other division,” she said, adding that “funding often doesn’t correlate to the work we have. In those other centers, they have user fees.

“We have to prioritize,” she added.

Regulatory agencies have to act within the authorities Congress gives them, she said.

CFSAN has a low attrition rate for employees but has to address retirements, she said. The food division has only normal hiring authority but could benefit from special hiring authority that the medical products division has, she explained.

Critics have complained that FDA has not yet published a final rule on water regulation for produce that is required under the Food Safety Modernization Act (FSMA), which Congress passed in 2010 and President Obama signed in 2011. But Mayne said, “Ag water is a tough one. We have to look at all the ways it is used across the food system.”

The water rule is an important element in the produce food safety rule, “but it is not the only one,” she said. The produce rules are important, she explained, because consuming fruits and vegetables is such an important part of healthy eating.

Mayne noted that under FSMA, FDA has put out eight rules and 50 guidance documents and hopes to publish the food traceability rule by fall.

Mayne declined to discuss the case of Abbott, whose infant formula was recently recalled, because it is an active investigation.

Toward the end of the hour-long session, Mayne said, “We know we can do more with more.”

Asked if the Biden administration had asked for enough money for her division, Mayne said, “You know the process” – a reference to agency budget requests going to the White House Office of Management and Budget, which makes final decisions.

Mayne noted that outside groups advocate “for more than what is in the budget.”

Mayne said the reason she agreed to talk to the Alliance for a Stronger FDA was “to talk about our resources.”

“With your support, we will do more with more,” she concluded.


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