Here are the findings of the Abbott baby formula investigation. What does this mean for the shortage?
‘There is no evidence to link our formulas to these infant illnesses,’ Abbott said in a statement
The investigation launched after the U.S. Food and Drug Administration said to avoid certain powdered formulas that may have been tied to bacterial infections in four hospitalized babies, and may have led to the death of two of those babies, the Deseret News previously reported.
Here are the findings of that investigation, which were sent in a statement to the Deseret News.
In a nutshell: “After a thorough review of all available data, there is no evidence to link our formulas to these infant illnesses,” Abbott said in its statement.
- “Abbott conducts microbiological testing on products prior to distribution and no Abbott formula distributed to consumers tested positive for Cronobacter sakazakii or Salmonella,” the company said in the statement. “All finished product testing by Abbott and the FDA during the inspection of the facility came back negative for Cronobacter and/or Salmonella.
- “No Salmonella was found at the Sturgis facility,” the company continued. “The Cronobacter sakazakii that was found in environmental testing during the investigation was in non-product contact areas of the facility and has not been linked to any known infant illness.”
More details: Genetic sequencing helped in reaching this conclusion. Two available samples from ill infants did not match the strains of Cronobacter that were discovered in the Michigan facility, Abbott said. Additionally, samples from ill infants did not match each other, indicating that the two were not connected.
- The FDA and/or CDC tested samples of the Abbott formula used by the infants in all four reported cases, and all of the unopened containers tested negative.
- Open containers from the infants’ homes were also tested in three of the four cases, and two of the three tested negative. The one container that did test positive had two different strains of Cronobacter sakazakii — one matching the strain that caused the infant’s infection and the other matching a strain found on a bottle of distilled water used to mix the formula. Neither strain matched the one found at the Abbott facility.
What does the Abbott investigation mean for the baby formula shortage?
Abbott said it has been working to address issues brought forth in a 483 letter from the FDA as part of the inspection.
- “Some of these actions have included reviewing and updating education, training and safety procedures for both employees and visitors, as well as updating our protocols regarding water and cleaning and maintenance procedures at the facility,” the company said in a statement. “We’ve also been making upgrades to the plant, including installing nonporous, easily cleanable and sanitary floors.”
Abbott had announced it could return to production at the facility in two weeks, with approval from the FDA — although it would take another six to eight weeks for products to hit shelves, The Washington Post reported.
On May 16, the FDA reached an agreement with Abbott regarding the steps needed to reopen the Michigan plant, according to The New York Times. As part of the agreement, Abbott must hire a qualified expert to oversee changes and improvements. The company is also required to notify the FDA if it finds contamination, and to store any sample of cronobacter it finds for three years, The New York Times reported.
Violations of the agreement could lead to $30,000 daily fines, capped at $5 million in a year.
Other recent details on the baby formula shortage
The Atlantic previously pointed out that U.S. trade policies were also contributing to the shortage. FDA regulation is so rigid that most of the formula that comes out of Europe is illegal to buy in the United States — and the U.S. also restricts the importation of formula that meets FDA requirements.
On Monday, the White House said the FDA will work ease up on restrictions and work to expedite the importation of baby formula, CBS News reported.
- “FDA will prioritize review of applications that are most likely to be successful and will get the most formula to U.S. shelves as quickly as possible,” White House press secretary Karine Jean-Pierre said at the White House briefing, according to CBS News. “Companies will need to apply with the FDA, and FDA is prepared to review applications quickly and respond to them rapidly.
- “All companies will meet the FDA’s gold standard for quality control, and only safe products will come to America’s shelves.”
The White House also said Monday it has connected with the country’s major formula manufacturers to work on increasing production at their U.S. and FDA-approved facilities, and improving the speed of distribution throughout the country, NBC News reported.