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It enforces food safety regulations, works with local governments on food safety information, promotes dietary guidelines, and develops food safety information and education, as well as overseeing nutrition labels on most food and being responsible for promoting good nutrition practices to the US public.
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“An approach that is primarily focused on identifying and reacting to acute outbreaks of foodborne illness and death is unacceptable,” the report says.
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“Relying solely on food labeling and consumer education to drive the needed changes in the food supply is also an unacceptable strategy for reducing diet-related chronic diseases,” the new report says.
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It also suggests that the FDA use its mandatory recall authority more often and that there should be a process by which accommodations are made for products that are considered life-sustaining, like formula. At the moment, food recalls areusually voluntarilyinitiated by a manufacturer or food distributor.
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Experts have said the agency failed to act quickly enough on sanitation complaints at an Abbott Nutrition formula manufacturing facility in Michigan, and because of a lack of communication across departments, it didn’t circumvent what became a massive shortage of formula after the plant shut down.
“A review of events indicates that lack of communication and engagement across the Agency accounted, in part, for missteps,” the new report says. “There was little motivation, and apparently no requirement, to share information and interact across the Agency to facilitate critical thinking and proactive decision-making.
“This is especially problematic in a crisis, where decisions should be made quickly and be vetted properly.”
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“The current culture of the FDA Human Foods Program is inhibiting its ability to effectively accomplish this goal” of protecting public health,” the report says.
Califf said Tuesday that the agency has not had the opportunity to review the report in depth but that the report provides “significant observations” and options to consider.
“The work of these independent evaluators will help to inform a new vision for the FDA Human Foods Program,” Califf said in anews release.
US government seeks court injunctions against six e-cigarette manufacturers as FDA steps up enforcement
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“The Human Foods Program is a top priority for the agency. America’s food supply is as safe as it’s ever been,” he said. “That said, over the past several years, the program has been stressed by the increasing diversity and complexity of the nation’s food systems and supply chain, the ongoing impacts associated with climate change and rapid advances in the science underlying many of the foods we eat today.”
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He said he’s putting together a group of leaders at the FDA that will advise him on how to “operationalize these findings,” and he expects these leaders to be “bold and focused on the transformative opportunities ahead for the FDA’s food program.”
In April, a coalition of 30 organizations that represent industry, local regulators and consumerssent a letterto the FDA asking for the creation of a deputy commissioner for foods with direct line authority over all the agency’s food components.
One of the organizations, Consumer Reports, has called for months for more accountability and focused leadership from the FDA.
“We need strengthened leadership and accountability at the FDA to implement a culture of prevention, respond more quickly to problems as they arise, and take timely action on proposed food safety rules and initiatives,” Brian Ronholm, Consumer Reports’ director of food policy, said Tuesday.
“We cannot afford to tolerate the status quo and let this moment go by without adopting fundamental changes to improve the FDA’s ability to protect the public and ensure our food is safe,” he said in a statement.
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“A siloed approach across FDA makes it harder for industry to engage,” saidSarah Gallo, the organization’s vice president for product policy. “It is just really complicated when you don’t have somebody looking over the different parts of the agency that have some form of jurisdiction over all those things.
“We can’t ignore what happened with the formula crisis,” Gallo added, a tangible example of what can happen when the FDA is not functioning at its best.
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“Think about it: The FDA has to keep up with hundreds of thousands of farms and facilities,” she said. “If you have these siloed operations, you’re not having these really critical conversations about where we should be and what should we be doing out there.
“We all want an FDA with a strong foods program. We want consumers not to worry about what they’re eating or whether they’re going to be able to get that certain needed food product,” Wagner added.
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