“In the past, they talked about how to prepare staff. And boy, if you go and touch something, you have to get ready again. So he threw a bow at me when I found out, ”said Cindy Conrod, behind the counter at her Sturgis downtown home appliance store.
On Monday, Abbott announced that he had reached an agreement with the FDA to take the first step in resolving the security issues identified by the agency, reopening the factory and alleviating the shortage. But even after the FDA authorizes the plant to resume operation, it will take two weeks to restart production and another six to eight weeks to return the product to the shelves.
Experts say that the crisis in formulas is a problem beyond the conditions of the facilities run by Abbott, the manufacturer of Similac and the country’s largest milk formula producer. Experts have been warning for years that the consolidation of the industry has left the production of the formula, a highly regulated product, in the hands of a small number of manufacturers who are difficult to manufacture in the face of this type of disruption.
Four major U.S. companies control 90 percent of U.S. formula supply: Abbott, Gerber, Mead Johnson and Perrigo Nutritionals. Perrigo produces store-brand children’s formulas for major stores including Walmart, Target, Kroger, CVS, Walgreens and Sam’s Club. Only Abbott, Gerber and Mead Johnson have contracts for a nutrition support program for mothers and young children called the Special Supplemental Nutrition Program (WIC) for women, babies and children. Beneficiaries can only use products made by a company contracted with their state. About half of the total formula for purchased children is from WIC recipients.
“How did these companies basically build a monopoly? And each of these companies is highly centralized, so when a facility goes offline for a few weeks, this can have an impact on the industry as a whole, ”said Brian Dittmeier, National WIC Association Director General of Public Policy, representing supplier and recipient organizations. nonprofit promotion team.
Parents exchange and sell the formula, while the president becomes a scarcity
This is exactly what happened. In February, the FDA ordered Abbott to shut down its Sturgis production facility, which produces Similac, EleCare and many other major powder formulas. Cronobacter bacteria were found in children who consumed formulas 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, which found that the plant did not maintain acceptable sanitary conditions.
Abbott says after a thorough investigation, the FDA has not yet been able to produce clear evidence linking its formulas to childhood illness and death. Abbott officials said they began implementing improvements and corrective actions before receiving an FDA letter on March 18. They have installed non-porous, easy-to-clean and hygienic flooring, and increased sampling and testing of finished products.
Poor formula for children marks the final blow for parents
The FDA said Friday it was still investigating the facility. Deficiencies he found included water leaks and groundwater, staff with inadequate protective equipment, and some facility workers who tested positive for cronobacter sakazakii bacteria, according to the FDA report.
“The plant remains closed because the company is working to correct findings related to the processes, procedures and conditions that the FDA saw in inspecting the facility, which raised concerns about the risk of contamination of children produced at this facility before the FDA inspection.” one.
Although the FDA has said it is working with Abbott and other manufacturers to bring safe products to the U.S. market, it is unclear when the facility will open. Meanwhile, the parents of the children, who are based on the survival formula, are terrified. Grocery store shelves have recently fallen more than 40 percent below total stock, and retailers are rationalizing well-known brands.
On Friday, FDA Commissioner Robert M. Califf said the FDA wants to allow foreign manufacturers and suppliers to ship their formula to the United States, as well as some additional flexibility for domestic manufacturers and suppliers. The FDA’s strict labeling guidelines previously made it difficult for such companies to introduce infant formula into the country. Spokeswoman Nancy Pelosi (D-Calif.) Announced that the House would take emergency measures to buy the formulas available to WIC recipients.
“We recognize that many consumers have been unable to access the formulas and critical medical foods for children who are accustomed to using them, and their inability to do so is frustrated. in his appearance.
Experts say it would not be uncommon for the FDA to need more than three months to close a major investigation. Sarah Sorscher, deputy director of regulations for the Center for Science in the Public Interest, said the challenge is that the FDA has not yet been able to identify the source of the contamination.
“They didn’t understand where or why the formula was contaminated, so they’re taking corrective steps to prevent another outbreak,” he said. “There are a limited number of companies that can make these products safely. So if you need a standard formula right now, it’s a tough prey hunt and you may need to visit several stores, but the hardest people are the ones who need special formulas for rare metabolic problems. Her parents are giving up. ‘
Most formulas are made with a mixture of cow’s milk, rice starch, corn syrup and oil concentrate. They are ready to drink and sold in powdered form to be rebuilt with water. Because the minimum amounts of fat, protein, calcium, and vitamins are so tightly regulated that many children get 100 percent of their diet formula in the first six months of life, it has the ability to be produced by a limited number of manufacturers. effectively.
However, there are risks of contamination associated with the dust formula. Parents can inject contaminants with a dirty spoon, a poorly cleaned bottle, or even from a water source. In the homes of sick children, 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. Rosa L. DeLauro (D-Conn.), Chair of the House Budget Committee, said she received a lengthy report from a former Abbott employee that she filed a complaint with the FDA about the condition of the Sturgis plant last October.
But the agency did not interview the whistleblower until the end of December, DeLauro said in a hearing in April. The FDA began inspecting the plant on Jan. 31, and the summons was issued Feb. 17, according to FDA documents.
“Why wasn’t the FDA launched? Why did it take four months to get this formula off the store shelves,” DeLauro said at an April hearing.
Tell Mail: How did the poor formula affect you?
Peter Pitts, a former FDA associate commissioner, said the situation “shows a serious problem in the FDA’s portfolio, where there is a limited number of manufacturers. when “.
Pitts noted other established industries, such as insulin production for diabetes, where there are only three major producers. More competition, he said, would create greater resilience in the system. However, he said, “The FDA did the exact same thing. The FDA did not find any disease-causing bacteria in Abbot’s product line, but Abbott accepted lax safety protocols. The fault, after all, is for Abbott to adopt lax safety protocols.”
Dittmeier, in conjunction with the WIC National Association, said the shortage of Abbott products has not been met by other manufacturers.
“They have promised to increase production in a few weeks, but it has not led to an increase in shelf stock,” he said, adding that the formula is not evenly distributed across the country and, anecdotally, in rural grocery stores. across the country they’ve seen more empty formula shelves for kids than in cities.
Perrigo has been able to run his formula facility at full capacity, 24 hours a day, seven days a week, said Bradley Joseph, vice president of corporate communications. He said that in the three months ending March 31, Perrigo had sent in 37 percent more formula than in the same period last year.
Gerber runs formula factories to boost the availability of retailers and online products, as well as hospitals for the most vulnerable, said Gerber spokeswoman Dana Stambaugh. Mead Johnson did not respond to requests for comment Friday.
Abbott said he preferred to produce formula for children at another plant in Columbus, Ohio, turning other liquid manufacturing lines into liquid Similac.
The shortage of formula for babies is the anger that healthy countries would solve
For millions of American families trying to find food for their babies, another 10 weeks cannot be tolerated if the FDA gives the facility a quick permit to resume manufacturing. The situation is particularly dire for the 1.2 million children receiving WIC formula benefits. In many parts of the country, shelves are empty of products that can be bought, and there are few alternatives.
Abbott’s call for infant formula nationwide in February and the closure of his Sturgis plant at the Sturgis plant have disproportionately affected the poorest American families. For states that had large WIC contracts, Abbott agreed to allow the company to accept a competing product rebate, which would allow families to replace other items on store shelves for approved WIC benefits, and Abbott would return them to the state as if it were his own. product.
This deal was initially extended until the end of June, but by the time Abbott products were no longer on the shelves, Dittmeier said it was unclear what it would mean for WIC recipients. “The WIC will be limited in what they can cover,” he said.
On Friday, in the wake of consumer and policy concerns, and with no clear date for the FDA to reopen its Sturgis facility, Abbott announced that the return date would be extended to August 31st.