Abbott Could Restart Baby Formula Production Within Two Weeks

Abbott said it would take six to eight weeks after restarting production before product is available on store shelves. The company said it would begin with producing specialty formulas, such as those for people with rare metabolic diseases, and then start production of its widely known brands like Similac.

An FDA spokeswoman didn’t immediately respond to a request for comment. On Tuesday, the agency said it was taking steps to alleviate the shortages, including helping to ensure that Abbott’s Michigan plant can safely resume making formula products.

In February, Abbott stopped production at its plant in Sturgis, Mich., and recalled certain lots of its powdered formulas, including those sold under the brand names Similac, Alimentum and EleCare because of the risk of possible contamination with cronobacter.

The recalls added to a baby formula shortage caused by supply-chain problems connected to the Covid-19 pandemic. In the week starting April 24, 40% of the most popular brand-name formulas were out of stock nationwide, The Wall Street Journal has reported.

“We know the recall has worsened an already existing industry-wide infant formula shortage in the U.S. and we’ve been seeing and hearing the stress and despair of parents who are facing empty shelves,” Abbott said in a statement. “We understand the situation is urgent—getting Sturgis up and running will help alleviate this shortage.”

In recent weeks, Abbott has strongly denied that the cronobacter infections were caused by contamination at its plant, despite the presence of the bacteria there found by the company and FDA inspectors. Where inspectors did find traces of the bacteria, the areas weren’t in contact with formula products, the company said.

Cronobacter is commonly present in the environment, and has been found on refrigerators, kitchen sinks and countertops, food safety experts have said.

The Centers for Disease Control and Prevention performed genetic testing on formula samples from two of the sick infants and found they didn’t match cronobacter strains discovered in Abbott’s plant. “It is possible that the cases included in this investigation occurred due to contamination of the formula after it was opened, which is how cronobacter often gets into powdered formula,” a CDC spokeswoman told the Journal in April.

Abbott said on Wednesday that all finished products made at the Michigan plant tested negative for cronobacter.

Open containers from the four infants were tested, and three of them tested negative, Abbott said. One container tested positive for two strains of cronobacter, one of which matched the strain that caused the infant’s infection and the other that matched a strain found on a bottle of distilled water that was used to mix the formula. Neither strain matched those found in Abbott’s Michigan plant, the company said.

“After a thorough review of all available data, there is no evidence to link our formulas to these infant illnesses,” Abbott said.

Write to Joseph Walker at [email protected]

Abbott said it would take six to eight weeks after restarting production before product is available on store shelves. The company said it would begin with producing specialty formulas, such as those for people with rare metabolic diseases, and then start production of its widely known brands like Similac.

An FDA spokeswoman didn’t immediately respond to a request for comment. On Tuesday, the agency said it was taking steps to alleviate the shortages, including helping to ensure that Abbott’s Michigan plant can safely resume making formula products.

In February, Abbott stopped production at its plant in Sturgis, Mich., and recalled certain lots of its powdered formulas, including those sold under the brand names Similac, Alimentum and EleCare because of the risk of possible contamination with cronobacter.

The recalls added to a baby formula shortage caused by supply-chain problems connected to the Covid-19 pandemic. In the week starting April 24, 40% of the most popular brand-name formulas were out of stock nationwide, The Wall Street Journal has reported.

“We know the recall has worsened an already existing industry-wide infant formula shortage in the U.S. and we’ve been seeing and hearing the stress and despair of parents who are facing empty shelves,” Abbott said in a statement. “We understand the situation is urgent—getting Sturgis up and running will help alleviate this shortage.”

In recent weeks, Abbott has strongly denied that the cronobacter infections were caused by contamination at its plant, despite the presence of the bacteria there found by the company and FDA inspectors. Where inspectors did find traces of the bacteria, the areas weren’t in contact with formula products, the company said.

Cronobacter is commonly present in the environment, and has been found on refrigerators, kitchen sinks and countertops, food safety experts have said.

The Centers for Disease Control and Prevention performed genetic testing on formula samples from two of the sick infants and found they didn’t match cronobacter strains discovered in Abbott’s plant. “It is possible that the cases included in this investigation occurred due to contamination of the formula after it was opened, which is how cronobacter often gets into powdered formula,” a CDC spokeswoman told the Journal in April.

Abbott said on Wednesday that all finished products made at the Michigan plant tested negative for cronobacter.

Open containers from the four infants were tested, and three of them tested negative, Abbott said. One container tested positive for two strains of cronobacter, one of which matched the strain that caused the infant’s infection and the other that matched a strain found on a bottle of distilled water that was used to mix the formula. Neither strain matched those found in Abbott’s Michigan plant, the company said.

“After a thorough review of all available data, there is no evidence to link our formulas to these infant illnesses,” Abbott said.

Write to Joseph Walker at [email protected]