‘We never want to have this happen again,’ FDA official testifies about formula shortage | CNN



CNN
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In a rare moment of bipartisan agreement, lawmakers were highly critical of the US Food and Drug Administration’s handling of the infant formula shortage Thursday.

The hearing of the US House Oversight and Accountability Subcommittee on Health Care and Financial Services was one of several Congress has held to better understand what contributed to the recent formula shortage and to understand how to prevent more problems down the road.

Rep. Lisa McClain, R-Michigan, said that the FDA has not been fully forthcoming with Congress and the public.

“Why was the FDA unprepared for the crisis?” she asked in her opening statement.

She said that the agency failed to prioritize food safety. “The FDA has not taken the action needed to prevent a similar crisis from happening again.”

Rep. Katie Porter, D-California, said she agreed with McClain that another shortage could happen, “and that is a deadly serious problem.”

“There is a lot of blame to go around,” Porter added. “It’s clear with today’s witness selection that Republicans want to blame the FDA, and I’ll level with you, I think some of that blame is well-placed. We’ve had two subsequent infant formula recalls in 2023 already, and we’re still seeing that the FDA can make further improvements on internal processes, intervene in issues sooner and follow through with more inspections to prevent further contamination.”

Three major manufacturers in the US control over 90% of the formula market, and that consolidation is a “serious concern” that “contributed significantly to shortages,” according to Dr. Susan Mayne, director of the FDA’s Center for Food Safety and Applied Nutrition, who testified Thursday.

A shortage that started in 2021 was exacerbated when the country’s largest infant formula maker, Abbott Nutrition, recalled multiple products in mid-February 2022 and had to pause production at its plant in Sturgis, Michigan, after FDA inspectors found potentially dangerous bacteria.

The plant inspection was tied to an outbreak of Cronobacter sakazakii that had sickened at least four infants and killed two, although investigations did not find a genetic link between bacteria samples from the facility and bacteria found in the water and powder used to mix the formula that the infants had consumed.

Mayne testified that it was difficult to trace the cases and determine how big of a concern the outbreak was. The bacteria is a common pathogen in the environment “but one about which we have limited information.”

The FDA has urged the US Centers for Disease Control and Prevention to make Cronobacter infection a notifiable disease – meaning providers would be required to report cases to local or state public health officials – so public health experts would be able to more quickly determine the source of any contamination.

In addition to the bacteria, an FDA inspection of the Sturgis plant found unsanitary conditions and several violations of food safety rules.

A whistleblower had alerted the FDA to alleged safety lapses at the plant in February 2021, months before Abbott’s formula was recalled. The complaint suggested that the plant lacked proper cleaning practices and that workers falsified records and hid information from inspectors.

Like other FDA leaders who have been called before Congress, Mayne testified that she was not made aware of the complaint right away. She called it “a failure of escalation.”

“I do wish I had been made aware of this particular whistleblower complaint, but just to reiterate, the complaint was acted upon,” Mayne said. However, she noted, it was “less than ideal” how quickly there was an FDA inspection of the plant and how quickly the agency was able to act.

When the whistleblower made the complaint, there was no process within the FDA to escalate it. The process has since changed so that if a complaint meets certain criteria involving vulnerable populations, hospitalizations or deaths, leadership would be immediately informed. If a consumer complaint involves an infant death or hospitalization, it also immediately gets escalated to leadership.

To prevent future shortages, Mayne testified, it won’t just be the FDA that needs to change. The industry should do more to adopt enhanced food safety measures to “deliver the safest possible” infant formula, she said.

The agency would also like better regulations. There have been been two infant formula recalls already in 2023, and in neither case was the manufacturer required to notify the FDA that it had found contamination before the formula left the plant.

The FDA has asked formula makers to inform the agency about positive tests, but such reporting is only voluntary. If it were mandatory, the FDA could know about problems in real time and could take action.

“Our food safety experts, our compliance experts can work with the manufacturers,” Mayne said. In such a collaboration, they could quickly identify what product to focus on to prevent a shortage.

The FDA has taken recent steps to improve. In February, it announced that it is restructuring its food division to be more responsive and that it is creating an office of critical foods. The FDA is also hiring specialized infant formula inspection staff, Mayne said.

The infant formula supply is generally in good shape, she said, but there are still some distribution issues.

The in-stock rate is near 90%, even higher than pre-recall levels. But some rural areas are having a hard time getting all the formula they need.

Formula manufacturers have been producing more than is being purchased week after week to build up supply, Mayne said. The Biden administration has also worked to bring in formula from manufacturers overseas.

But another shortage is not out of the question, particularly if one of the country’s main manufacturers is taken offline for any significant amount of time.

“We never want to have this happen again,” Mayne said.

Lawmakers have proposed significant cuts, about 22%, to the FDA’s budget for 2023. Mayne said that consumers and the industry would be “adversely affected” if the cuts go through.

“Broadly, across the FDA, I can say it would be devastating,” she said, resulting in a loss of 32% of domestic inspections and 22% of foreign inspections. The cuts would also disproportionately affect its food programs, which get much of their funding from the budget, unlike divisions involving drugs that get money from user fees.

“We would be unable to do what I think American consumers expect us to do,” Mayne said.

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Bacterial infection linked to recent baby formula shortage may join federal disease watchlist | CNN



CNN
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US health officials may soon ask states to notify them of any cases of infants with serious infections caused by Cronobacter sakazakii, bacteria that can contaminate infant formula.

Cronobacter infections typically strike infants who are less than 2 months old, and they can be fatal or permanently disabling.

In an outbreak that the US Centers for Disease Control and Prevention investigated last year, four babies were sickened, including two who died. All the infants had been fed baby formula manufactured at the same factory in Sturgis, Michigan, triggering an extensive investigation by the US Food and Drug Administration and ultimately stopping production at the facility for months. The shutdown worsened ongoing supply chain issues and threw the country into a nationwide shortage.

Ultimately, the FDA and the CDC could find no genetic links between Cronobacter samples from the facility and the bacteria found in the water and powder used to mix the formula that the infants had consumed.

These infections are thought to be infrequent, but the true burden in the US is unknown because Cronobacter is not currently part of the National Notifiable Diseases Surveillance System, a list of about 120 illnesses given special priority by the CDC because they’ve been deemed to be important to public health.

The Council of State and Territorial Epidemiologists, a nonprofit organization that advocates for effective disease surveillance, identified Cronobacter as a priority area for investigation this year.

A work group was formed in the winter to assess conditions, risks and surveillance processes related to the bacterial infection, and it will present recommendations to advance Cronobacter surveillance in June.

Adding Cronobacter infections to the national watchlist is among the strategies being considered.

“When we look back at large-scale outbreaks over the course of the last year, many of those outbreaks were associated with diseases and conditions that were nationally notifiable, but not all of them,” said Janet Hamilton, executive director of the council – and Cronobacter was one of the exceptions.

“So whenever we have something like that, that prompts the council to determine and assess whether we need to potentially be doing more.”

Adding an illness to the national list can have a sizable impact. After E. coli O157 was added to the notifiable disease list in 1994 and most states required doctors to report cases by 2000, the number of reported outbreaks tripled.

However, it would take quite some time for any changes to take effect.

If the Council of State and Territorial Epidemiologists votes in favor of adding Cronobacter infections to the national list of notifiable diseases, the recommendation will go to the CDC for approval. If the CDC deems an illness to be notifiable, it’s up to state and local governments to adjust their reporting laws and develop processes for doctors to report cases to health departments, which then forward those reports to the CDC.

The soonest that data collection could start is the beginning of 2024, and it would most likely be well into the year, depending on state legislative sessions.

Currently, only two states, Minnesota and Michigan, require doctors to report Cronobacter cases, which may be diagnosed more generically as sepsis or meningitis, conditions that can result from an infection.

“Unless detailed studies are done, the diagnosis as a Cronobacter illness may be missed,” FDA Commissioner Dr. Robert Califf wrote in a blog post last week. “The lack of mandatory reporting significantly hampers the ability to fully understand Cronobacter’s public health impact.”

Dr. Peter Lurie, executive director of the Center for Science in the Public Interest, applauded the potential move.

“I think it’s a necessary step. It is difficult to prevent diseases that you can’t count,” Lurie said.

In addition, Lurie says, manufacturers should be required to notify the FDA when a batch of baby formula tests positive for Cronobacter before it leaves the plant. The FDA has asked manufacturers to tell it about positive tests, but such reporting is voluntary.

Lurie says the FDA should also be doing more sampling and testing for Cronobacter in the environment to get a better understanding of where the bacteria can turn up.

“I think we have a lot to learn there,” he said.

Mitzi Baum, CEO of the group Stop Foodborne Illness, which has been advocating for the change, said she was grateful the Council of State and Territorial Epidemiologists was moving toward a vote on it.

She said greater awareness of the infection was long overdue.

“It’s always prefaced by ‘this is rare,’ but we don’t know how rare it is because it’s not reportable. And there needs to be a lot more education about this pathogen and a lot more research,” Baum said.

Baum said her group is working with the council to create an education campaign to raise awareness of the infection among doctors. The next step, she says, is getting funding.

The council’s Hamilton points out that “simply making something nationally notifiable doesn’t necessarily translate into awareness and recognition on the prevention side. If people don’t have the right set of information and education, by the time we’re doing public health surveillance for it, the disease or infection has already occurred.”

According to the FDA, Cronobacter sakazakii is a common natural pathogen that can enter homes and other spaces on hands, shoes and other contaminated surfaces. It is “especially good at surviving in dry foods,” such as powdered baby formula.

Infections are harmless for most people, but it can be life-threatening for infants, especially those who are born prematurely or with weakened immune systems. It’s particularly important to be sure that parents of high-risk infants know how to keep them safe, Hamilton said.

“Providing good education around how to stop infections is really what leads to the level of change that we would love to see,” she said.

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FDA proposes new levels for lead in baby food, but critics say more action is needed | CNN



CNN
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The allowable levels of lead in certain baby and toddler foods should be set at 20 parts per billion or less, according to new draft guidance issued Tuesday by the US Food and Drug Administration.

“For babies and young children who eat the foods covered in today’s draft guidance, the FDA estimates that these action levels could result in as much as a 24-27% reduction in exposure to lead from these foods,” said FDA Commissioner Dr. Robert Califf in a statement.

The

Baby foods covered by the new proposal – which is seeking public comment – include processed baby foods sold in boxes, jars, pouches and tubs for babies and young children younger than 2 years old, the agency said.

While any action on the part of the FDA is welcome, the suggested levels of lead are not low enough to move the needle, said Jane Houlihan, the national director of science and health for Healthy Babies Bright Futures, a coalition of advocates committed to reducing babies’ exposures to neurotoxic chemicals.

“Nearly all baby foods on the market already comply with what they have proposed,” said Houlihan, who authored a 2019 report that found dangerous levels of lead and other heavy metals in 95% of manufactured baby food.

That report triggered a 2021 congressional investigation, which found leading baby food manufacturers knowingly sold products with high levels of toxic metals.

“The FDA hasn’t done enough with these proposed lead limits to protect babies and young children from lead’s harmful effects. There is no known safe level of lead exposure, and children are particularly vulnerable,” Houlihan said.

The director of food policy for Consumers Reports, Brian Ronholm, also expressed concerns. In 2018, Consumer Reports analyzed 50 baby foods and found “concerning” levels of lead and other heavy metals. In fact, “15 of them would pose a risk to a child who ate one serving or less per day,” according to Consumer Reports.

“The FDA should be encouraging industry to work harder to reduce hazardous lead and other heavy metals in baby food given how vulnerable young children are to toxic exposure,” Ronholm said in a statement.

Exposure to toxic heavy metals can be harmful to the developing brain of infants and children. “It’s been linked with problems with learning, cognition, and behavior,” according to the American Academy of Pediatrics.

Lead, arsenic, cadmium and mercury are in the World Health Organization’s top 10 chemicals of concern for infants and children.

As natural elements, they are in the soil in which crops are grown and thus can’t be avoided. Some crop fields and regions, however, contain more toxic levels than others, partly due to the overuse of metal-containing pesticides and ongoing industrial pollution.

The new FDA guidance suggests manufactured baby food custards, fruits, food mixtures — including grain and meat-based blends — puddings, vegetables, yogurts, and single-ingredient meats and vegetables contain no more than 10 parts per billion of lead.

The exception to that limit is for single-ingredient root vegetables, such as carrots and sweet potatoes, which should contain no more than 20 parts per billion, according to the new guidance.

Dry cereals marketed to babies and toddlers should also not contain more than 20 parts per billion of lead, the new FDA guidance said.

However, the FDA didn’t propose any lead limit for cereal puffs and teething biscuits, Houlihan said, even though the products account for “7 of the 10 highest lead levels we’ve found in over 1,000 baby food tests we have assessed.”

The limit set for root vegetables will be helpful, Houlihan added. Because they grow underground, root vegetables can easily absorb heavy metals. For example, sweet potatoes often exceed the 20 parts per billion limit the FDA has proposed, she said.

Prior to this announcement, the FDA had only set limits for heavy metals in one baby food — infant rice cereal, Houlihan said. In 2021, the agency set a limit of 100 parts per billion for arsenic, which has been linked to adverse pregnancy outcomes and neurodevelopmental toxicity.

There is much more that can be done, according to Scott Faber, senior vice president of government affairs for the Environmental Working Group, a nonprofit environmental health organization.

“We can change where we farm and how we farm to reduce toxic metals absorbed by plants,” Faber said. “We also urge baby food manufacturers to conduct continuous testing of heavy metals in all their products and make all testing results publicly available.”

Companies can require suppliers and growers to test the soil and the foods they produce, and choose to purchase from those with the lowest levels of heavy metals, Houlihan added.

“Growers can use soil additives, different growing methods and crop varieties known to reduce lead in their products,” she said.

What can parents do to lessen their child’s exposure to toxic metals? Unfortunately, buying organic or making baby food at home isn’t going to solve the problem, as the produce purchased at the grocery store can also contain high levels of contaminants, experts say.

A 2022 report by Healthy Babies, Bright Futures found lead in 80% of homemade purees or store-bought family foods. Arsenic was found in 72% of family food either purchased or prepared at home.

The best way to lessen your child’s exposure to heavy metals, experts say, is to vary the foods eaten on a daily basis and choose mostly from foods which are likely to have the least contamination. Healthy Babies, Bright Futures created a chart of less to most contaminated foods based on their testing.

Fresh bananas, with heavy metal levels of 1.8 parts per billion, were the least contaminated of foods tested for the report. After bananas, the least contaminated foods were grits, manufactured baby food meats, butternut squash, lamb, apples, pork, eggs, oranges and watermelon, in that order.

Other foods with lower levels of contamination included green beans, peas, cucumbers and soft or pureed home-cooked meats, the report found.

The most heavily contaminated foods eaten by babies were all rice-based, the report said. Rice cakes, rice puffs, crisped rice cereals and brown rice with no cooking water removed were heavily contaminated with inorganic arsenic, the more toxic form of arsenic.

After rice-based foods, the analysis found the highest levels of heavy metals in raisins, non-rice teething crackers, granola bars with raisins and oat-ring cereals. But those were not the only foods of concern: Dried fruit, grape juice, arrowroot teething crackers and sunflower seed butter all contained high amounts of at least one toxic metal, according to the report.

While buying organic cannot reduce the levels of heavy metals in infant food, it can help avoid other toxins such as herbicides and pesticides, Dr. Leonardo Trasande, director of environmental pediatrics at NYU Langone Health told CNN previously.

“There are other benefits to eating organic food, including a reduction in synthetic pesticides that are known to be as bad for babies, if not even more problematic,” Trasande said.

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