As parents across the country struggle to feed their babies, Abbott Nutrition has reached a consent decree with the FDA that should allow the company to resume operations at its main production plant for powdered infant formula.

The company, which has a 40 percent market share of the powdered infant formula in the United States, closed down its production plant in Sturgis, MI, because of an investigation into an outbreak of cronobacter infections in infants. Four infants were confirmed sick and two died.

Abbott officials said there were five strains of cronobacter found in the production plant, but that none were an exact match for those that infected the babies. The company recalled massive amounts of infant formula under the Similac, EleCare and Alimentum brands on Feb. 17 because of the investigation into the outbreak.

Officials with the Food and Drug Administration said the recall was voluntary. The investigation of the Sturgis plant is ongoing, but nationwide shortages of the infant formula — especially the top selling Similac — are fueling outrage among consumers and politicians. 

The proposed consent decree of permanent injunction between the FDA and Abbott Nutrition, as well as three Abbott principals, was filed in the U.S. District Court for the Western District of Michigan.

“The actions we are announcing today will help to safely increase the supply of baby formula for families,” said Attorney General Merrick B. Garland. “The Justice Department will vigorously enforce the laws ensuring the safety of our food and other essential consumer products, and we will work alongside our partners across government to help make sure those products are available to the American people.”

Pending approval of the court, Abbott has agreed to take corrective actions following an FDA inspection of its Sturgis, MI, facility.

The United States alleges that Abbott, Division Vice-President of Quality Assurance Lori J. Randall, Sturgis Director of Quality Keenan S. Gale, and Sturgis Site Director TJ Hathaway manufactured powdered infant formula under conditions and using practices that failed to comply with regulations designed to ensure the quality and safety of infant formula.

“The proposed consent decree obliges Abbott to take actions that are expected to ultimately result in an increase of infant formula products, while ensuring that the company undertakes certain actions that would ensure safe powdered infant formula is produced at the facility. When the company decides to restart production at this facility, it must conform with the provisions of the proposed consent decree and meet FDA food safety standards. If contamination is identified, the company must notify the FDA, identify the source of the problem and conduct a root-cause investigation before resuming production,” according to a statement from the FDA.

The proposed consent decree, filed by the U.S. Department of Justice, requires Abbott Nutrition to retain an independent expert to review the Sturgis facility’s operations to ensure compliance with the law. It also includes requirements for testing products, as well as ceasing production, and promptly notifying the FDA should contamination be detected. The proposed consent decree also requires the implementation of a sanitation plan, environmental monitoring plan and employee training programs.

“In the complaint, filed by the U.S. Department of Justice on behalf of the FDA, the government alleges that powdered infant formula products manufactured at Abbott Nutrition’s Sturgis facility were adulterated because they were made under insanitary conditions and in violation of current good manufacturing practice requirements,” according to the FDA.

“On Jan. 31, the FDA commenced a for-cause inspection and identified Cronobacter sakazakii, a bacterium that can potentially cause severe foodborne illness primarily in infants, in the facility and observed significant operational deficiencies. While the agency’s inspection was ongoing, Abbott Nutrition voluntarily recalled certain powdered infant formula products and voluntarily shut down its facility to implement corrective actions that address issues raised by the FDA.”

In a statement today Abbott officials said, providing approval from a court and the FDA, the plant should be reopened for production in about two weeks. The company officials say it will take six to eight weeks before the new supplies of infant formula to reach store shelves.

In the mean time Abbott has stepped up imports of formula from its production plant in Cootehill, Ireland.

“Our number one priority is getting infants and families the high-quality formulas they need, and this is a major step toward re-opening our Sturgis facility so we can ease the nationwide formula shortage. We look forward to working with the FDA to quickly and safely re-open the facility,” said Robert B. Ford, chairman and CEO of Abbott. “We know millions of parents and caregivers depend on us and we’re deeply sorry that our voluntary recall worsened the nationwide formula shortage. We will work hard to re-earn the trust that moms, dads and caregivers have placed in our formulas for more than 50 years.”

In its statement today Abbott repeated what the FDA and Centers for Disease Control and Prevention reported this past week: The CDC reports that it has declared the outbreak over. Both agencies have reported that a direct link between the implicated Abbott infant formulas and the sick babies has not been found.

Abbott contends that its product testing proves it does not have a problem, although there were five strains of cronobacter found in the product plant, which produces 90 percent of the country’s Similac, the most popular brand of infant formula in the United States.

The company’s product testing involves using small samples from huge batches of formula. Food safety experts at government agencies and independent university food safety programs across the country routinely express concerns that such product testing can easily miss key contamination because samples are generally less than a drop in the bucket of products.

According to its statement today, Abbott says it will begin production of EleCare and Alimentum as soon as it is cleared by the FDA to restart operations. Production of Similac formula would begin later.

Much of the infant formula produced at the Abbott facility in Sturgis, MI, goes for the government’s Special Supplemental Nutrition Program for Women, Infants and Children (WIC). Both the U.S. Department of Agriculture, which oversees the WIC program, and Abbott have been working with state agencies on replacing vouchers so mothers in need can use replacement formulas instead of the WIC approved Similac and other recalled formulas.

The FDA is also continuing important steps to improve the supply of infant and specialty formula products. The agency has been in ongoing discussions with all infant formula manufacturers who are reporting that they are all producing at an expanded capacity. In fact, Gerber has reported that it increased the amount of their infant formula available to consumers by approximately 50 percent in March and April and Reckitt is supplying more than 30 percent more product year to date.

This increased production is now evident in increased infant formula sales. According to data from Information Resources Inc. (IRI), national infant formula sales by volume for the month of April were up more than 13 percent compared to the month prior to the recall and national infant formula sales by unit for the month of April are also up by more than 5 percent compared to the month prior to the recall.

Abbott officials say they began updating policies and cleaning their facility on April 8 after receiving an inspection report from the FDA.

“Even before its formal response, Abbott had begun working to implement improvements and take corrective action. Some of these actions included reviewing and updating education, training and safety procedures for both employees and visitors, as well as updating protocols regarding water, cleaning and maintenance procedures at the facility,” the company’s statement says. “Abbott immediately implemented corrections to address the items that the FDA raised in its observations provided at the conclusion of the inspection. The company has also been making upgrades to the plant.”

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