FDA investigated up to nine infant deaths linked to baby formula, documents show: report

• New documents reveal nine deaths linked to baby formula, an FOI request by eFoodAlert shows.
• FDA had previously only reported the investigation of two deaths linked to formula.

The Food and Drug Administration has investigated reports that up to nine infants died after consuming baby formula made by Abbott Nutrition at its Michigan factory – seven more than had previously been known, new documents indicated.

In a filing obtained by the website eFoodAlert under the Freedom of Information Act, nine deaths linked to baby formula were among 128 consumer complaints to the FDA between December 1 last year and and March 3.

The Washington Post first reported the filing.

The documents showed two of the deaths were part of a Cronobacter sakazakii outbreak reported by the Center for Disease Control (CDC) that infected four people.

An FDA investigation found several instances of Cronobacter sakazakii in the environment of Abbott's Sturgis factory.

Two deaths mentioned "Salmonella" in the report, while 25 other instances were categorized as "Life Threatening Illness/Injury." None of the infants could be named, and were only identified by reference numbers.

The symptoms in the 128 cases were mostly consistent with those found in a gastrointestinal infection, including 31 babies with a fever, 42 with vomiting, 47 with diarrhea, and 6 with blood in their stool, while most of the babies suffered with multiple symptoms.

The FDA previously said it was investigating two deaths of babies who contracted bacterial infections after consuming Abbott formula, raising questions about the regulator's response to the outbreak, as well as the safety of the Abbott plant that makes much of the formula consumed in the US.

The outbreak led Abbott to shut down its Sturgis plant, triggering widespread shortages that led the FDA and the White House to take unprecedented measures including importing formula from Europe and Australia.

In May, Abbott and the FDA reached an agreement about restarting production at the plant this month.

The FDA told Insider: "Based on FDA's thorough review and investigation of all 128 consumer complaints reported to the agency and recently released to media in response to a [Freedom of Information Act] request, only four complaints could be included in the case series associated with the Abbott Nutrition investigation."

In an emailed statement, Abbott told Insider no causal relationship had been identified between its baby formula and the deaths.

"Abbott conducts microbiological testing on products prior to distribution and no Abbott formula distributed to consumers tested positive for Cronobacter sakazakii or Salmonella. All retained product tested by Abbott and the FDA during the inspection of the facility came back negative for Cronobacter sakazakii and/or Salmonella. No Salmonella was found at the Sturgis facility," the company told the newspaper.