In wake of baby formula crisis, highly critical report recommends major food safety changes at FDA

By Jen Christensen, CNN

To help prevent outbreaks of food-related illness and problems like the formula shortage that left many parents in the US without adequate access to food for their babies, the US Food and Drug Administration needs a clearer mission and a different kind of leadership, and it has to act with more urgency, according to a highly critical new report.

After the agency faced serious criticism for its handling of the formula shortage, FDA Commissioner Dr. Robert Califf commissioned the review of the Human Foods Program in July from the Reagan-Udall Foundation, an independent group of experts.

The need for a review was considered so urgent that Califf asked the group to submit the report in 60 business days — lightning speed for government-focused reports. It was submitted to the FDA on Tuesday.

About 48 million Americans get some kind of foodborne illness every year, according to the US Centers for Disease Control and Prevention. Of those, 128,000 are hospitalized, and 3,000 die. Produce alone in 2019 was responsible for 46% of foodborne illness outbreaks, according to the US Department of Agriculture.

The FDA oversees the safety of 78% of the US human food supply.

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.

The US food supply is generally recognized as safe, the Reagan-Udall Foundation‘s report said, but the FDA needs to be much more proactive in dealing with foodborne pathogens in order to protect Americans.

“An approach that is primarily focused on identifying and reacting to acute outbreaks of foodborne illness and death is unacceptable,” the report says.

Americans’ nutrition can also improve, the report says. Most people don’t follow the US dietary recommendations, and more than a million die of diseases that can be linked to diet such as heart disease, type 2 diabetes and cancer each year, according to the FDA

“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.

Major changes recommended

The report suggests that the agency needs major reform in order to do a better job managing food in the US. Some of the proposed changes would require congressional approval.

The report has several suggestions for ways to reach these goals. One would create a separate Center for Nutrition within the US Department of Health and Human Services. Another would have the FDA develop a strategy to increase funding for the Human Foods Program, with help from Congress. The agency could also connect its technology systems so they better communicate with each other.

The FDA could seek to amend the Federal Food, Drug, and Cosmetic Act to allow the disclosure of more information to local agencies. Or it could get regulatory authority to request records from food manufacturers in advance or in lieu of inspection.

The report recommends that the FDA explore applying its authority to require infant formula manufacturers, for instance, to keep microbiological testing records that are available on request so there is real-time disclosure of results.

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 are usually voluntarily initiated by a manufacturer or food distributor.

The report also notes that the food program is run under the leadership of several managers. This “lack of a single, clearly identified person” to lead the program has led to a culture of “constant turmoil” and “indecisiveness and inaction” that has created “disincentives for collaboration,” according to the report.

That turmoil was partly to blame for the agency’s problematic handling of the formula shortage, the report says.

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.”

The report suggests that the FDA create a new structure with clear roles and leaders. It also encourages development of a culture that is more transparent, that acts quickly and collaborates.

“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.

‘A new vision’

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 a news release.

Some critics have suggested that food safety takes a back seat to the FDA’s regulations of drugs and medical devices. Califf acknowledged that food policy was important to the agency, citing the decline in life expectancy in the US largely due to chronic diseases that can be improved with good nutrition.

“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.”

The FDA will inform the public about how it is moving forward on the panel’s suggestions by the end of January and will provide additional updates at the end of February, including on any structural or procedural changes it will make, Califf said.

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.”

‘A very encouraging first step’

In April, a coalition of 30 organizations that represent industry, local regulators and consumers sent a letter to 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.

Ronholm called the new report a “very encouraging first step.”

“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.

The Consumer Brands Association, a trade association for food manufacturers that also signed the April letter, said Tuesday that the lack of a single leader on food policy leads to “a lot of inefficiencies.”

“A siloed approach across FDA makes it harder for industry to engage,” said Sarah 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.

Roberta Wagner, vice president of regulatory and technical affairs for the Consumer Brands Association, agreed that if there were one person in charge, they could make sure the inspection and policy parts of the FDA would work together.

Wagner added that the food industry has embraced a more prevention-oriented kind of philosophy when it comes to safety. “Quite frankly, the problem is, FDA’s inspection force has not modernized itself or its approaches to basically mirror that prevention-oriented system and philosophy,” Wagner said.

The FDA food division has its work cut out for it, though, added Wagner, who worked with the agency in several capacities before joining the association.

“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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