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FDA, Abbott Nutrition agreement to help reopen infant formula plant

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A major infant formula manufacturer is moving closer to reopening one of its plants, which could help ease the formula shortage that is plaguing parents nationwide.

The Food and Drug Administration (FDA) has entered into an agreement with Abbott Nutrition on the steps needed to address issues at its Sturgis, Mich., facility so that it can resume operations. Once a judge signs off and the FDA finds initial requirements have been met, Abbott said it can restart the site within two weeks and formula would hit the shelves six to eight weeks later. It will begin with EleCare, Alimentum and metabolic formulas, followed by Similac and other formulas.

“We know many caregivers and parents are feeling frustrated by their inability to access needed or desired infant formula and critical medical foods,” FDA Commissioner Robert M. Califf, M.D., said in a press briefing Monday. “Please know we at the FDA are doing everything in our power to address these challenges as quickly as possible.”

In February, Abbott recalled certain lots of Similac, Alimentum and EleCare powdered infant formula following complaints of bacterial infections among four infants who had consumed the formula, including two who died. Dr. Califf said the FDA found Cronobacter sakazakii bacteria at the plant and “observed significant operational deficiencies.” As health officials investigated, Abbott stopped production at the Sturgis facility to take corrective actions.

The recall and plant closure came on top of supply chain issues related to the COVID-19 pandemic, leaving parents and caregivers struggling to find food for their infants.

"We know millions of parents and caregivers depend on us, and we're deeply sorry that our voluntary recall worsened the nationwide formula shortage,” Abbott Chairman and CEO Robert B. Ford said in a news release. “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 addition to taking steps to help reopen Abbott’s Sturgis plant, the FDA said Monday it is increasing flexibility on formulas being imported from other countries as well as formulas manufactured in the U.S. that typically are exported. Currently, 98% of infant formula consumed in the U.S. is produced here, according to the FDA. Officials said the new flexibility will not come at the expense of nutrition and safety.

The FDA also has been working with infant formula manufacturers to increase production and has been looking at better ways to expedite the review process and improve distribution. Officials cited progress in a report from Information Resources Inc. showing 80% in-stock rates during the week ending May 8, although specialty and metabolic products continue to be a concern.

Abbott is releasing limited quantities of metabolic and Similac PM 60/40 for patients in urgent need. Health care providers can request them by downloading the form at and faxing the completed form with a physician order to 877-293-9145.

Abbott also said in a letter to health care providers it has increased production of liquid infant formulas and Similac Advance 12.4-ounce powder. In addition, it has shipped millions of cans of formula to the U.S. from its FDA-registered facility in Ireland.

The Biden administration recently announced it is urging states to allow participants in the Supplemental Nutrition Program for Women, Infants, and Children (WIC) to use their benefits on a wider variety of products. The administration also is calling on the Federal Trade Commission and state attorneys general to crack down on price gouging.

The FDA recommends parents and caregivers speak with a child’s health care provider for recommendations if their regular formula is not available. Parents should never dilute infant formula or make their own. They also should not purchase imported formula online as it could be counterfeit. Using cow’s milk could be a short-term option for some children 6 months and older who is usually on regular milk-based formula, but families should talk to their pediatrician first. Drinking cow’s milk should not become routine for infants.



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