FDA investigates Abbott infant formula after reports of illness and one death

22 Feb 2022 --- The US, Canada, Australia and China are sending out warnings to the public over Abbott infant formula products after the US Food and Drug Administration (FDA) announced it was investigating four consumer complaints of Cronobacter sakazakii and Salmonella Newport infections.

“All four cases related to these complaints were hospitalized, and Cronobacter may have contributed to a death in one case,” the FDA says. 

The investigation so far has been associated with three Cronobacter illnesses and one for Salmonella.

All of the cases are reported to have consumed powdered infant formula produced from Abbott Nutrition’s Sturgis, Michigan facility, the regulator adds. The infants were in Minnesota, Ohio and two were in Texas. The complaints were received between September 6 and December 18, 2021. The recalled items have been distributed in more than 30 countries.

Following the FDA’s announcement, Abbott has initiated a voluntary recall of potentially affected products, including Similac, Alimentum and EleCare powdered formulas manufactured at the Sturgis facility in Michigan.One of the items recalled from the market.

Traces of bacteria?
NutritionInsight reached out to Abbott for comment, which specified that during testing in the Sturgis facility, the company found evidence of Cronobacter sakazakii in the plant in non-product contact areas. 

“Retained samples related to the three complaints for Cronobacter sakazakii tested negative for Cronobacter sakazakii, and the retained sample related to the complaint for Salmonella Newport tested negative for Salmonella Newport,” says Vicky Assardo, senior director, global public affairs, Abbott Nutrition.

The FDA’s statement outlines the regulator initiated an onsite inspection at the facility. 

“Findings to date include several positive Cronobacter sakazakii results from environmental samples taken by the FDA and adverse inspectional observations by the FDA investigators.” 

Assardo stipulates that “no distributed product has tested positive for the presence of either of these bacteria, and we continue to test.” 

“Abbott conducts extensive quality checks on each completed batch of infant formula, including microbiological analysis prior to release. All infant formula products are tested for Cronobacter sakazakii, Salmonella Newport and other pathogens, and they must test negative before any product is released.” 

Destroying the product
The FDA also specifies that a review of the firm’s internal records “also indicate environmental contamination with Cronobacter sakazakii and the firm’s destruction of product due to the presence of Cronobacter.”

Asked to comment on the FDA’s point, Assardo notes that the destruction of the product “occurred a while back.” 

“All our nutrition products undergo rigorous testing for pathogens, and any product that tests positive is destroyed. No finished product that tests positive has been released.”The CDC advises using formula sold as a liquid, as it is made to be sterile and should not transmit Cronobacter infection when handled carefully.

Global governments react
Products made at the Sturgis facility can be found across the US and were likely exported to other countries, the FDA specifies.

According to the firm, recalled products were distributed to Australia, Bahrain, Barbados, Bermuda, Canada, Chile, China, Colombia, Costa Rica, Dominican Republic, Ecuador, Egypt, Guam, Guatemala, Hong Kong, India, Indonesia, Israel, Jordan, Kuwait, Lebanon, Malaysia, Mexico, New Zealand, Oman, Peru, Puerto Rico, Qatar, Saudi Arabia, Singapore, South Africa, Sudan, Taiwan, Thailand, United Arab Emirates, United Kingdom and Vietnam.

Australia’s department of health on Monday issued an alert to consumers and health professionals, advising that Abbott Australasia Pty Ltd and Abbott US have initiated recalls of certain batches of items due to potential microbial contamination. Parents and carers are advised to change to an alternative product as soon as possible and stop using the Abbott items once an alternative product is obtained. 

China Customs also issued a statement warning consumers from buying and eating the Abbott products announced by the FDA. The authority specified that the items have not entered China through general trade but consumers who purchased them through cross-border e-commerce should stop using them. 

The Canadian government also issued a recall warning the public not to consume, use, sell, serve or distribute the products in question. 

Tracking the bacteria
The FDA specified the investigation is ongoing with the US Centers for Disease Control and Prevention, as well as state and local partners. Abbott is also working with the FDA. 

The FDA’s advice to consumers is not to use Similac, Alimentum or EleCare powdered infant formulas if:

• the first two digits of the code are 22 through 37; and 
• the code on the container contains K8, SH or Z2; and 
• the expiration date is 4-1-2022 (APR 2022) or later.

According to the FDA, Cronobacter sakazakii is a germ found naturally in the environment. The germs can live in dry foods, such as powdered infant formula, powdered milk, herbal teas and starches. 

Cronobacter can cause diarrhea and urinary tract infections in people of all ages, but infection can be very serious in infants. The germs can cause a dangerous blood infection (sepsis) or make the linings surrounding the brain and spinal cord swell (meningitis). 

Salmonella can be spread by food handlers who do not wash their hands or the surfaces and tools they use between food preparation steps and when people eat raw or undercooked foods. 

Most people infected with Salmonella will begin to develop symptoms 12 to 72 hours after infection, such as diarrhea, fever, and abdominal cramps.

Children younger than five, the elderly and people with weakened immune systems are more likely to have severe salmonellosis infections.

Companies have previously described the future of the nutrition industry as one of cautious innovation, with a strong focus on providing highly-qualified food safety.

By Andria Kades