CNN —
To prevent outbreaks of diet-related diseases and problems like the infant formula shortage that has left many US parents without adequate access to food for their babies, the US Food and Drug Administration needs a clearer mission and a different kind of leadership, according to one extremely critical new report to act more urgently.
After the agency faced serious criticism for its handling of the food shortage, FDA Commissioner Dr. Robert Califf commissioned the Reagan-Udall Foundation, an independent expert group, to review the Human Foods Program in July.
The need for a review was deemed so urgent that Califf asked the group to submit the report within 60 business days – lightning fast for government-oriented reports. It was submitted to the FDA on Tuesday.
According to the US Centers for Disease Control and Prevention, about 48 million Americans contract a foodborne illness each year. Of these, 128,000 are hospitalized and 3,000 die. Production alone was responsible for 46% of foodborne outbreaks in 2019, according to the US Department of Agriculture.
The FDA oversees the safety of 78% of the US 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, oversees nutritional labeling of most foods, and is responsible for promoting good nutritional practices among the US public.
The U.S. food supply is widely recognized as safe, the Reagan-Udall Foundation report said, but the FDA needs to be much more proactive in dealing with foodborne pathogens to protect Americans.
“An approach that primarily focuses on detecting and responding to acute outbreaks of foodborne illness and death is unacceptable,” the report said.
According to the report, the diet of Americans could also be improved. Most people don’t follow U.S. dietary recommendations, and according to the FDA, more than a million people die each year from diet-related diseases, such as heart disease, type 2 diabetes and cancer
“Relying solely on food labeling and consumer education to drive the necessary changes in the food supply is also an unacceptable strategy for reducing diet-related chronic diseases,” the new report says.
The report suggests that the agency needs a major reform to better manage food in the US. Some of the proposed changes would require congressional approval.
The report makes several suggestions as to how these goals can be achieved. A separate center for nutrition would be created within the US Department of Health and Human Services. Another would have the FDA, with help from Congress, develop a strategy to increase funding for the Human Foods Program. The agency could also connect its technology systems so they communicate better with each other.
The FDA may seek to amend the Federal Food, Drug, and Cosmetic Act to allow more information to be disclosed to local authorities. Or it could prompt regulators to request records from food manufacturers in advance or in lieu of an inspection.
The report recommends that the FDA should consider using its power to require, for example, infant formula manufacturers to keep records of microbiological tests that are available on request so that the results can be disclosed in real time.
It also suggests that the FDA use its mandatory recall power more frequently and that there should be a process by which adjustments should be made for products considered life-support, such as formulas. Currently, food recalls are usually initiated voluntarily by a manufacturer or food retailer.
The report also notes that the nutrition program is run under the direction of several managers. This “absence of a single, clearly identified person” to lead the program has created a culture of “continuous unrest” and “indecisiveness and inaction” that has created “disincentives to work together,” according to the report.
That turmoil was partly to blame for the agency’s troubled handling of the formula shortage, the report said.
Experts have said the agency did not respond quickly enough to hygiene complaints at an Abbott Nutrition formula manufacturing facility in Michigan and was not circumvented due to a lack of communication between departments, which became a massive shortage of formulas after the facility closed.
“A review of events shows that a lack of communication and engagement across the agency was partly to blame for missteps,” the new report says. “There was little motivation and no apparent need to share information and interact with the whole agency to facilitate critical thinking and proactive decision-making.
“This is particularly problematic in a crisis where decisions should be made quickly and thoroughly reviewed.”
The report suggests that FDA create a new structure with clear roles and leaders. It also encourages the development of a culture that is more transparent, quick to act and collaborative.
“The current culture of the FDA Human Foods Program impedes its ability to effectively achieve this goal of protecting public health,” the report states.
Califf said on Tuesday that the agency has not had an opportunity to examine the report in depth, but that the report contains “significant observations” and options to consider.
“The work of these independent reviewers will help create a new vision for the FDA’s Human Foods Program,” Califf said in a press release.
Some critics have suggested this meal security takes a backseat to FDA drug and medical device regulations. Califf acknowledged that nutrition policy is important to the agency, citing the decline in life expectancy in the US, which is largely due to chronic diseases that good nutrition could improve.
“The Human Foods Program is a top priority for the agency. America’s food supply is as secure as ever,” he said. “In recent years, however, the program has been strained by the increasing diversity and complexity of the country’s food systems and supply chains, the ongoing impacts of climate change, and rapid advances in the science underlying much of the food we eat today.”
FDA will update the public on how it is progressing on the panel’s proposals by the end of January and will provide additional updates, including any structural or procedural changes it may be making, in late February, Califf said.
He said he is assembling a group of executives at FDA who would advise him on “operationalizing these findings” and expects those executives to be “bold and focused on the transformative opportunities ahead of FDA’s food program.” .
In April, a coalition of 30 organizations representing industry, local regulators and consumers sent a letter to the FDA asking for the creation of a deputy food commissioner with direct line authority over all food components of the agency.
One of the organizations, Consumer Reports, has been calling for more accountability and focused leadership from the FDA for months.
“We need stronger leadership and accountability at FDA to implement a culture of prevention, respond more quickly to issues as they arise, and take timely action on proposed food safety rules and initiatives,” said Brian Ronholm, Director of Food Policy at Consumer reports. said Tuesday.
Ronholm called the new report a “very encouraging first step”.
“We cannot afford to tolerate the status quo and let this moment pass without making fundamental changes to improve the FDA’s ability to protect the public and ensure the safety of our food,” he said in one Explanation.
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 in food policy is creating “many inefficiencies.”
“A siled approach within the FDA makes it difficult for industry to get involved,” said Sarah Gallo, the organization’s vice president of product policy. “It’s just very complicated when you don’t have someone to take care of the different parts of the agency that are responsible for all these things in some way.
“We cannot ignore what happened with the formula crisis,” Gallo added, a tangible example of what can happen when the FDA isn’t functioning optimally.
Roberta Wagner, vice president of regulatory and technical affairs at the Consumer Brands Association, agreed that if there was a responsible person, they could ensure that FDA’s inspection and regulatory departments would work together.
Wagner added that the food industry has had a more preventative philosophy when it comes to safety. “Honestly, the problem is that the FDA’s inspection force hasn’t modernized itself or its approaches to essentially reflect this prevention-centric system and philosophy,” Wagner said.
But the FDA food department is busy, added Wagner, who worked with the agency in various capacities before joining the association.
“Think about it: The FDA has to keep up with hundreds of thousands of farms and facilities,” she said. “When you have these isolated operations, you don’t have these really critical conversations about where we should be and what we should be doing out there.
“We all want an FDA with a strong food program. We want consumers not to have to worry about what they are eating or whether they will be able to get the specific grocery product they need,” Wagner added.