Abbott to Release Certain Baby Formulas Made at Troubled Michigan Plant

In February, Abbott recalled certain lots of different powdered baby formulas, including the popular Similac brand, because of concerns that they had been contaminated with a bacteria known to survive in dry foods.

Abbott ceased production at the Sturgis, Mich., plant where the formula was made, exacerbating a shortage of baby formula around the U.S.

A number of other formulas for babies with rare metabolic conditions that weren’t recalled were placed on hold before they could be distributed while Abbott conducted enhanced testing of the products for bacterial contamination, the FDA said.

The enhanced testing isn’t completed yet, the FDA said, but the benefit of access to the formulas may outweigh the risks of bacterial infections.

“The FDA is concerned that the risk of not having certain specialty and metabolic products available could significantly worsen underlying medical conditions and in some cases pose life-threatening risks for infants and individuals who rely on these products,” the agency said.

The formulas being released have undergone standard product testing, the FDA and Abbott said.

The formulas are used by patients under the care of healthcare professionals and require a medical referral to obtain, Abbott said. They include formulas for people with so-called maple syrup urine disease, which prevents the body from properly processing protein.

The FDA is also allowing Abbott to release certain lots of Similac PM 60/40, a low-iron formula for infants with kidney impairment. A single lot of 60/40 formula was previously recalled, Abbott said, but not the lots to be released.

Abbott said it has limited supplies of the metabolic and 60/40 formulas, and that new product isn’t currently being manufactured.

The FDA said it is continuing an investigation into Abbott’s Michigan plant to determine whether it was the source of bacterial illness in four babies who consumed formula made there.

The CDC has said that genetic testing of a bacteria called cronobacter in formula used by two of the babies didn’t match cronobacter strains found in Abbott’s plant. The CDC has said that the formula may have become contaminated after the formula was opened, which is often how cronobacter gets into powdered formula.

Abbott said it is unlikely that the four cronobacter infections were caused by formula produced at its Michigan plant, and that there wasn’t an outbreak caused by products from the facility.

Abbott said that none of the formula distributed to consumers has tested positive for cronobacter, and that tests of finished product at the plant also came back negative. Cronobacter found at the plant was in areas not in contact with the formula, the company says.

“We know this situation has worsened the industrywide infant-formula supply shortage, and we regret the anxiety and stress this is causing,” said

Joe Manning,

Abbott executive vice president for nutritional products. “Abbott is committed to working with the FDA to address this situation so we can resume operations at this facility and continue serving the nutritional needs of people who rely on our infant and specialty formulas.”

Write to Joseph Walker at [email protected]