Abbott Nutrition, maker of Similac, still months away from production at the Sturgis plant

Abbott Nutrition, maker of Similac, still months away from production at the Sturgis plant

Placeholder while article actions load

Three and a half months after the US Food and Drug Administration began an inspection and closure of Abbott Nutrition’s Sturgis, Michigan facility, the machines are still silent, no infant formula coming off the production line.

On the north side of the city of 10,000, nestled between the local airport and a neighborhood of single-story homes, Abbott is among the region’s biggest employers. Residents say they were shocked by allegations of unsanitary conditions that led to the shutdown, which drastically reduced the availability of formula across the country and left parents struggling to feed their newborns.

“In the past, employees would even talk about how, like, they would have to equip themselves. And man, if you went and touched something, you’d have to re-equip yourself. So it really turned me on when I heard about it,” said Cindy Conrod, standing behind the counter at her home appliance store in downtown Sturgis.

Experts say the formula crisis points to problems beyond conditions at facilities operated by Abbott, maker of Similac and the country’s biggest dairy formula producer. For years, they have been warning that industry consolidation has left formula production – a highly regulated and notoriously difficult product to manufacture – in the hands of a small number of manufacturers vulnerable to this type of disruption.

Parents trade and sell infant formula as Biden focuses on shortages

Four major companies control 90% of the infant formula supply in the United States: Abbott, Mead Johnson, Gerber and Perrigo Nutritionals. Perrigo produces its own brand infant formulas for major stores including Walmart, Sam’s Club, Target, Kroger, CVS and Walgreens. Only three of them – Abbott, Mead Johnson and Gerber – have contracts for a food assistance program for mothers and young children called the Special Supplemental Nutrition Program for Women, Infants and Children (WIC). Benefit recipients are authorized to use only products manufactured by the company contracted with their state. About half of all infant formula purchased is from WIC beneficiaries.

“How did these companies essentially build a monopoly? AND The operations of each of these companies are also highly centralized, so when a facility is offline for just a few weeks, you can have this ripple effect across the entire industry,” said Brian Dittmeier, Senior Director of Public Policy at National WIC. Association, a non-profit advocacy group representing provider and recipient agencies.

This is precisely what happened.

In February, the FDA ordered Abbott to close its production facility in Sturgis, which makes Similac, EleCare and several other leading powder formulas. Cronobacter bacteria were found in babies who consumed formula produced at the Sturgis plant. Two children became ill and two died. This led to a voluntary recall by Abbott as well as an FDA inspection that found that the plant did not maintain acceptable sanitary conditions.

Abbott says that, after a meticulous investigation, the FDA has yet to produce clear evidence linking its formulas to infant illnesses and deaths. Abbott officials said they began implementing improvements and taking corrective action before receiving the FDA letter detailing the necessary corrections on April 8. product images as it moves through the facility and increased sampling and testing of finished products.

Infant formula shortage is the latest blow to parents

In a statement this week, the company said it could resume production within two weeks if the FDA approves. Once the unit reopens, Abbott says that it will take six to eight weeks before the product is available on shelves.

The FDA, however, says it is still investigating the facility. Among the deficiencies found were water leaks and standing water on the floor, workers not wearing proper protective gear, and multiple cotton swabs at the facility that tested positive for the Cronobacter sakazakii bacteria, according to the FDA report. Abbott Nutrition did not respond to phone calls and an email seeking comment.

“The plant remains closed while the company works to correct findings related to the processes, procedures and conditions that the FDA observed during its inspection of the facility, which raised concerns that powdered infant formula produced at this facility prior to the FDA inspection has a risk of contamination,” said an FDA spokeswoman.

While the FDA has said it is working with Abbott and other manufacturers to bring safe products to the US market, it is unclear when the facility will be able to reopen. Meanwhile, parents of formula-dependent children. In April, supermarket shelves fell 43% below full stock. Retailers are rationing popular brands.

The shortage of infant formula in the US is worrying parents. Here’s what to know.

On Friday, FDA Commissioner Robert M. Califf said the FDA intends to allow foreign manufacturers and suppliers to ship their formulas to the United States — the FDA’s strict labeling guidelines previously made it difficult for these companies to bring their formulas to the United States. babies in the United States – as well as some additional flexibilities for domestic manufacturers and suppliers. House Speaker Nancy Pelosi (D-Calif.) announced that next week the House will take emergency steps to allow WIC beneficiaries to purchase any available formula.

“We recognize that many consumers have not been able to access critical infant formula and medical foods that they are used to and are frustrated with their inability to do so. We are doing everything in our power to ensure that there are suitable products available where and when they need them,” Califf said Wednesday in a statement.

Experts say it would not be unusual for the FDA to take more than three months to close such a significant investigation. Sarah Sorscher, deputy director of regulatory affairs for the Center for Science in the Public Interest, said one challenge is that the FDA has yet to identify the root cause of the contamination.

“They didn’t understand where or why the formula was contaminated, so they are struggling with corrective measures to prevent another outbreak,” she said. “There are a limited number of companies that can make these products and make them safely. So now if you need a standard formula it’s a scavenger hunt and you may need to visit multiple stores but the people in the hardest situation are the ones who require special formulas for rare metabolic problems. Parents are getting desperate.”

Most formulas are made from a mixture of cow’s milk protein concentrate, rice starch, corn syrup and oils. They are sold ready to drink and in powder form that must be reconstituted with water. Because the minimum amounts of protein, fat, calcium and various vitamins are so tightly regulated – many babies get 100% of their nutrition from formula during the first six months of life – a limited number of manufacturers have the ability to produce it. effectively.

However, there are contamination risks associated with powdered formula. Parents can introduce contaminants through a dirty spoon, a poorly cleaned bottle, or even a water source. When testing sick babies’ homes, the Centers for Disease Control and Prevention found cronobacter bacteria in a bottle of distilled water used to mix the formula.

Some members of Congress have been frustrated by the problems they see with Abbott and the FDA. House Appropriations Committee Chair Rosa L. DeLauro (D-Conn.) did not interview the whistleblower until late December, DeLauro said at a USDA hearing in April. The FDA began its inspection of the plant on Jan. 31, and the recall was issued on Feb. 17, according to FDA documents.

“Why didn’t the FDA take action? Why did it take four months to pull this formula off store shelves,” DeLauro said at a USDA hearing in April.

Peter Pitts, former FDA associate commissioner, said the situation illustrates “a serious problem across the entire FDA portfolio where there are a limited number of manufacturers. Making infant formula is a sophisticated and expensive proposition, so consolidation is going to happen. The downside is when one of these facilities goes offline.”

He pointed to other established industries, such as the production of insulin for diabetes, where there are only three main producers. More competition, he said, would create greater resilience in the system.

Still, he said, “the FDA did exactly the right thing. The FDA found none of the bacteria that sickened children in Abbott’s product line, but Abbott admitted that safety protocols were lax. Ultimately, it’s Abbott’s fault for allowing lax security protocols.”

Dittmeier of the National WIC Association said Abbott’s product shortfall was not made up by other manufacturers.

“They promised to ramp up production for several weeks, but that didn’t translate to increased shelf inventory,” he said, adding that the formula is not evenly distributed across the country and that, interestingly, rural grocery stores across the country have I’ve seen more empty baby formula shelves than urban ones.

Perrigo operates its formula facility at full capacity, 24 hours a day, seven days a week, said Bradley Joseph, vice president of corporate communications. He said that during the three months ending March 31, Perrigo shipped 37% more formula than in the same period last year. Gerber is operating formula factories with the capacity to accelerate product availability to retailers and online, as well as to hospitals for the most vulnerable, said Gerber spokeswoman Dana Stambaugh. Mead Johnson did not respond to requests for comment on Friday.

Abbott said it prioritized infant formula production at its other plant in Columbus, Ohio, converting other liquid manufacturing lines to liquid Similac.

The lack of infant formula is an outrage. A sane country would solve this.

For the millions of American families struggling to find food for their babies, another 10 weeks is unsustainable — assuming the FDA grants speedy approval for the facility to resume manufacturing.

The situation is particularly dire for the 1.2 million babies who receive WIC formula benefits. In many parts of the country, shelves are empty of products they can buy and there are few alternatives.

When, in mid-February, Abbott issued a nationwide recall of infant formula and closed operations at its Sturgis plant, it disproportionately affected American families most in need.

For states where Abbott held major WIC contracts, the company agreed to honor the discount for competing products, meaning that families could substitute other items on store shelves for their approved WIC benefits and that Abbott would reimburse the state. as if it were your own products. They’ve extended that deal through the end of June, but if Abbott’s products aren’t on shelves by then, Dittmeier said, it’s unclear what will happen.

“WIC will be limited in what it can cover,” he said.

Graphics by Hannah Slept. Easter reported from Sturgis, Michigan.

Leave a Reply

Your email address will not be published.