Milk powder plant still a few months away from production

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Three and a half months after the U.S. Food and Drug Administration (FDA) began inspection and closure of Abbott Nutrition’s Sturgis, Michigan facility, the machines are still quiet and no infant formula is coming from the production line.

Located north of the city of 10,000, Abbott is nestled between the local airport and single-story homes and is one of the largest employers in the area. Local residents said they were shocked by the unsanitary conditions that led to the lockdown, which has led to a sharp decline in the supply of formula across the country and parents rushing to feed their newborns.

“In the past, we also talked about how employees should be prepared. And boy, if you go and touch something, you have to re-equip yourself. So when I heard about it, I was really blown away.” Cindy Conrod said as she stood behind the counter of her downtown Sturgis appliance store.

Experts say the milk powder crisis points to problems that go beyond the facilities operated by Abbott, the manufacturer of Similac and the nation’s largest milk powder producer. For years they have warned that the production of milk powder, a highly regulated product notoriously difficult to manufacture due to industrial consolidation, is left to a handful of manufacturers vulnerable to this kind of disruption.

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Four major companies: Abbott, Mead Johnson, Gerber and Perrigo Nutritionals control 90% of the US infant formula supply. Perrigo produces store-brand infant formula. Major stores including Walmart, Sam’s Club, Target, Kroger, CVS and Walgreens. Only three of Abbott, Mead Johnson and Gerber have a contract for a food assistance program for mothers and young children called the Special Nutritional Supplement Program for Women, Infants and Children (WIC). beneficiary Only products made by companies contracted with the state may be used. About half of all infant formula purchased came from WIC beneficiaries.

“How did these companies essentially build monopolies? And In addition, each company’s operations are highly centralized, so if one facility goes offline for even a few weeks, this can have ripple effects across the entire industry. , a non-profit advocacy organization representing providers and recipients.

This is exactly what happened.

In February, the FDA ordered Abbott to close Sturgis’ production facility, which produces Similac, EleCare, and several other key powder formulations. Cronobacter bacteria were found in infants fed formula produced by the Sturgis plant. Two infants became ill and two died. This prompted Abbott’s voluntary recall. As well as FDA inspection It has been found that the plants do not maintain acceptable sanitary conditions.

Abbott says After a rigorous investigation, the FDA was still unable to provide definitive evidence linking the formula for infant disease and death. Abbott officials said they had begun implementing the improvements and taking corrective action before receiving a letter from the FDA on April 8 detailing the necessary corrections. Increased imagery of products passing through facilities, sampling and testing of finished products.

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to statement If the FDA approves this week, production could resume within two weeks, the company said. When the facility is reopened, Abbott says It takes 6-8 weeks for the product to reach the shelf.

However, the FDA said it was still investigating the facility. of what is lacking it found According to the FDA report, leaks and stagnant water, workers not wearing appropriate protective equipment, and multiple swabs in the facility tested positive for cronobacter sakazakii bacteria. Abbott Nutrition has not responded to calls and emails requesting comment.

“Factories remain closed as companies work to rectify findings related to processes, procedures and conditions. FDA Observation Prior to FDA inspection, it raised concerns that the milk powder produced at this facility was at risk of contamination,” an FDA spokesperson said.

The FDA has said it is working with Abbott and other manufacturers to bring safe products to the US market, but it’s unclear when the facility will reopen. In the meantime, parents of children who depend on the formula. In April, grocery store shelves fell 43% from total inventory. Retailers distribute popular brands.

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FDA Commissioner Robert M. Califf said on Friday that the FDA plans to allow foreign manufacturers and suppliers to ship formula to the United States. as well as some additional flexibility for domestic manufacturers and suppliers. House Speaker Nancy Pelosi (Democrat-California) announced next week that the House will take urgent action to ensure that WIC beneficiaries can purchase all available formula.

“We know that many consumers are frustrated by the fact that they do not have access to, and cannot afford to, the infant formula and important medical foods they are accustomed to using. “We are committed to ensuring that the right product is available where and when it is needed,” Califf said in a statement on Wednesday.

Experts say it’s not uncommon for the FDA to complete such an important investigation for more than three months. One problem is that the FDA has not yet been able to identify the root cause of the contamination, said Sarah Sorscher, deputy director of regulatory affairs at the Center for Public Interest Sciences.

“They don’t understand where and why the milk powder was contaminated, so they’re struggling with the corrective action to take to prevent another outbreak,” she said. “There are only a limited number of companies that can safely make these products. So, if you need a standard formula right now, it’s a grim scavenger hunt and you may have to visit multiple stores, but those in the most difficult situations are those who need special formulas for rare metabolic problems. Parents are desperate.”

Most milk powder is made from a concentrated protein mixture of milk, rice starch, corn syrup and oil. They are sold in powder form that is ready to drink and must be reconstituted with water. Because the minimum amounts of protein, fat, calcium and many vitamins are very tightly regulated, many babies get 100% of their nutrition through formula during the first 6 months of life. Only a limited number of manufacturers can effectively produce milk powder. .

However, there are contamination risks associated with formula. Parents can introduce contaminants through dirty spoons, improperly cleaned bottles, or water sources. The Centers for Disease Control and Prevention found Chronobacter bacteria in a bottle of distilled water used to blend formula while testing the home of a sick infant.

Some members of Congress have been frustrated by the problems seen with both Abbott and the FDA. House Appropriations Committee Chair Rosa L. DeLauro (D-Conn.) said she had received a 34-page report from a former Abbott employee who filed a complaint about factory condition with the FDA in October 2021. No whistleblower interview until the end of December; DeLauro spoke at a USDA hearing in April. According to FDA documents, FDA began an inspection of the plant on January 31, and the recall was issued on February 17.

“Why didn’t the FDA take action? DeLauro said at the USDA hearing in April:

Former FDA Deputy Commissioner Peter Pitts said this situation “represents a serious problem across the FDA portfolio with a limited number of manufacturers. Consolidation will happen, as making milk powder is a sophisticated and expensive affair. The downside is that one of these facilities goes offline.”

He pointed to other integrated industries with only three major producers, such as the production of insulin for diabetes. He said more competition will make the system more resilient.

“The FDA did the right thing. The FDA has found no bacteria in Abbott’s product line that makes children sick, but Abbott has acknowledged the loose safety protocol. Ultimately, the responsibility for allowing for loose safety protocols rests with Abbott.”

Dittmeier of the National WIC Association said the shortage of Abbott products was not made up for by other manufacturers.

“They promised to increase production for a few weeks, but that didn’t lead to increased inventory on the shelves,” he said. Countries have seen more empty milk powder shelves than cities do.

Perrigo operates its official facilities at full capacity 24 hours a day, 7 days a week, said Bradley Joseph, vice president of corporate communications. He said that in the three months through March 31, Perrigo shipped 37% more formula than during the same period last year. Gerber spokeswoman Dana Stambaugh said Gerber is running its milk powder mill with the ability to accelerate product availability to retailers, online and to hospitals for the most vulnerable. Mead Johnson did not respond to a request for comment on Friday.

Abbott said another plant in Columbus, Ohio, has shifted another liquid manufacturing line to making liquid Similac, preferring to focus on infant formula production.

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For millions of American families busy finding food for their babies, another 10 weeks could not last, assuming the FDA quickly approves the facility to resume manufacturing.

The situation is particularly acute for the 1.2 million infants who benefit from WIC’s formula. In many parts of the country, there are few products available on the shelves and few alternatives.

In mid-February, when Abbott announced a national recall of milk powder and shut down its Sturgis plant, it had disproportionately impacted American families who are most in need.

In states where Abbott has major WIC contracts, the company has agreed to respect rebates on competitor products. This means that families can replace their approved WIC benefits with other items on the store shelves, and Abbott will reimburse the state as if it were theirs. product. They extended the contract until the end of June, but it’s unclear what will happen if Abbott’s own products don’t show up by then, Dittmeier said.

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

Graphics by Hannah Dormido. Easter was reported in Sturgis, Michigan.

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