After the infant formula crisis, a critical report recommends major food safety changes at the FDA


The US Food and Drug Administration needs a clearer mission and different leadership to prevent problems such as food-related illnesses and formula shortages, where many parents in the US do not have enough access to food for their babies. must act more urgently, according to a highly critical new report.

After the agency faced severe criticism for its handling of formula shortages, FDA Commissioner Dr. Robert Califf commissioned a review of the Human Food Program in July from the Reagan-Udall Foundation, an independent think tank.

The need for a review was deemed so urgent that Califf asked the group to submit a report within 60 business days — lightning fast for government-centric reports. It was submitted to the FDA on Tuesday.

According to the US Centers for Disease Control and Prevention, approximately 48 million Americans contract some type of foodborne illness each year. 128,000 of them were hospitalized and 3,000 died. According to the US Department of Agriculture, in 2019, production alone caused 46% of foodborne illness outbreaks.

The FDA oversees the safety of 78% of human food in the United States.

It enforces food safety regulations, works with local governments on food safety information, promotes dietary guidelines, and conducts food safety information and education, oversees nutrition labels on most foods, and is responsible for promoting good nutritional practices to the U.S. public.

The U.S. food supply is generally considered safe, but the FDA needs to be more proactive in combating foodborne pathogens to protect Americans, according to a Reagan-Udall Foundation report.

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

Americans’ nutrition could also improve, the report says. According to the FDA, most people do not follow the U.S. dietary recommendations, and more than a million people die each year from diet-related diseases such as heart disease, type 2 diabetes, and cancer.

“Making necessary changes in the food supply based solely on food labeling and consumer education is also an unacceptable strategy for reducing diet-related chronic diseases,” the new report says.

The report says the agency needs major reforms To do a better job in food management in the United States. Some of the proposed changes will require Congressional approval.

The report contains several proposals to achieve these goals. A separate Nutrition Center will be established within the US Department of Health and Human Services. Another would be for the FDA, with help from Congress, to develop a strategy to increase funding for the Human Food Program. The agency can also integrate its technology systems so they can better communicate with each other.

The FDA may seek to amend the Federal Food, Drug, and Cosmetic Act to allow local agencies to release more information. Or it could gain regulatory authority to require records from food manufacturers in lieu of prior or inspection.

The report recommends that the FDA consider implementing its authority to require infant formula manufacturers, for example, to keep microbiological test records available upon request so that results can be disclosed in real time.

He also suggests that the FDA use its mandatory recall authority more often and have a placement process for life-sustaining products like formula. Currently, food recalls are usually voluntary by the manufacturer or food distributor.

The report also notes that the food program is run by several managers. According to the report, this “lack of a single, clearly defined person” to lead the program has led to “permanent confusion” and a culture of “indecision and inaction” that has created “barriers to cooperation.”

That confusion was partly to blame for the agency’s problematic handling of formula shortages, the report said.

Experts say the agency did not act quickly enough on sanitation complaints at an Abbott Nutrition formula manufacturing facility in Michigan, and a lack of communication between departments led to a major formula shortage after the plant closed. .

“Incident analysis shows that the lack of communication and engagement at the Agency is partly due to missteps,” the new report said. “There was little motivation, and apparently no demand, to share information and interact within the Agency to facilitate critical thinking and proactive decision-making.

“This is particularly problematic in a crisis where decisions must be made quickly and properly vetted.”

The report suggests the FDA create a new structure with clear roles and leaders. It also encourages the development of a more transparent, agile and collaborative culture.

“The current culture of the FDA Human Food Program impedes its ability to effectively achieve its goal of protecting public health,” the report states.

Califf said Tuesday that the agency had not had an opportunity to review the report in depth, but that the report offered “significant observations” and options to consider.

“The work of these independent evaluators will help inform a new vision for the FDA Human Food Program,” Califf said in a press release.

Some critics suggested this dish security Background to FDA drug and medical device regulations. Califf acknowledged that food policy is important to the agency, citing declining life expectancy in the U.S. largely due to chronic diseases that can be improved with good nutrition.

“The Human Food Program is a top priority for the agency. America’s food supply is more secure than ever.” “Over the past several years, the program has been highlighted by the increasing diversity and complexity of the nation’s food systems and supply chains, the ongoing impacts of climate change, and rapid advances in the science that underpins many of the foods we eat. today.”

The FDA will update the public on how it’s progressing on the panel’s recommendations by the end of January and will provide additional updates in late February, including any structural or procedural changes it makes, Califf said.

He said he has assembled a group of leaders at the FDA to advise him on “how to operationalize these findings” and expects those leaders to be “bold and focused on the transformational opportunities that lie ahead for the FDA’s food program.”

In April, a coalition of 30 organizations representing industry, local regulators and consumers sent a letter to the FDA asking the agency to create a deputy commissioner for foods with direct line authority over all food ingredients.

One organization, Consumer Reports, has been calling for more accountability and careful guidance from the FDA for months.

“We need strengthened leadership and accountability at the FDA to implement a culture of prevention, respond more quickly to problems, and take timely action on proposed food safety regulations 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 tolerate the status quo and let this moment pass without the FDA adopting fundamental changes to protect the public and ensure our food is safe,” he said.

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

“A silent approach at the FDA makes it difficult for industry to engage,” said Sarah Gallo, the agency’s vice president of product policy. “It’s really complicated if you don’t have someone looking at different parts of the agency.

“We can’t ignore what happened with the formula crisis,” Gallo added, a clear example of what can happen when the FDA isn’t doing its best.

Roberta Wagner, vice president of regulatory and technical affairs at the Consumer Brands Association, agreed that if there was 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 adopted a more prevention-oriented philosophy when it comes to safety. “Frankly, the problem is that the FDA’s inspection force has not modernized itself or modernized its approach to reflect this prevention-oriented system and philosophy,” Wagner said.

The FDA’s food division has its own business, though, added Wagner, who worked in several capacities with the agency before joining the association.

“Think about it: FDA has to keep up with hundreds of thousands of farms and facilities,” he said. “If you have these kinds of operations, you’re not really having critical conversations about where we are and what we need to do there.

“We all want an FDA with a strong food program. We want consumers to not have to worry about what they’re eating or whether they can get that particular essential food product,” Wagner added.

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