FDA investigate another baby death following Abbott infant formula consumption

23 Jun 2022 --- The US Food and Drug Administration (FDA) is investigating another death potentially linked to Abbott infant formula. The revelations come amid an ongoing probe over two infant deaths and a number of hospitalizations linked to the company products, which led to a temporary halt to Abbott's productions and findings of unhygienic conditions at its Sturgis, Michigan plant.

The information of a new fatal case came to the attention of the FDA on June 10 this year but was only made public in a press release issued by the agency yesterday (June 22). 

Details of which Abbott formula the infant consumed and when, were not specified. The investigation is in its early stages and the FDA will “provide an update as soon as possible.” 

Earlier this year, Abbott faced lawsuits from consumers due to Cronbacter sakazakii and Salmonella found in their Sturgis plant and infant formulas. Four infants were hospitalized, and two died. The FDA shut down the plant in February, and the company voluntarily recalled its products.

Exception for urgent casesAbbotts Michigan plant shut down twice this year and is once again linked to another infant death.
Due to the ongoing infant formula shortage crisis in the US, the FDA allowed sales of Abbotts recalled products – Similac, Alimentum and EleCare powdered formulas – in “urgent cases.” Even though its investigation showed five positive environmental subsamples for Cronobacter sakazakii. However, the bacteria were not found in the product samples.

Infants requiring specialty formulas were even more affected as access to the items became increasingly challenging during the shortage. The scramble for formula amid price gouging across the country served as one of the premises the FDA used to allow Abbott to sell its formula again. 

“Some of these products have been available on a case-by-case basis from Abbott Nutrition over the last several months because the risk of not having access to them could significantly worsen underlying medical conditions and in some cases pose life-threatening risks,” notes the FDA.

Nonetheless, the agency has come under fire by lawmakers for not acting soon enough. FDA Commissioner Dr. Robert Calif was accused of prioritizing Abbott’s corporate interests rather than the general public, amid revelations the agency was tipped off by a whistleblower months before the investigation, outlining poor safety practices. 

Mere weeks after Abbott’s Michigan plant reopened, it shut down again in June, caused by thunderstorms that paused production. Due to severe flooding, the production was put on hold until the FDA approves it to resume. 

Formula shipments flying in
The FDA announced increased efforts to increase the supply of infant formulas. The Biden-Harris operation fly formula is in full swing, and recently announced is the import of 16 million 8-ounce bottles of formula from Gerber, Mexico, to be shipped on June 24. Additionally, more than 8.5 million 8-ounce bottles have been imported from Global Kosher, UK. 

Additional air-borne imports are taking place on June 26, where 5.5 million 8-ounce bottles will be shipped from Bubs Australia, and 1.65 million 9-ounce bottles will be shipped from Nestlé, Germany.

FDA flexibilities – loosened regulations during the shortage to fill the supply gap – have provided approximately 365 million full-size, 8-ounce bottles of infant formula, according to the FDA. Imported from six countries, the agency says that there are more products to come shortly and will “appear on store shelves over the coming weeks and months.”

Domestic actions have been taken as well. “I have personally spoken with infant formula manufacturers over the past several weeks and all have significantly increased their production efforts, which is resulting in more supply that will be available on store shelves moving forward,” says Robert Califf, FDA commissioner.

“Special safety attention”The US Senate Finance Committee criticized financial decisions taken by Abbott as the plant should have been prioritized. 
Even though flexibilities have been implemented, the FDA highlights that the safety standards have not been compromised. This goes for all foods, but special attention is put on infant formula. 

“The FDA has a policy of annually inspecting infant formula manufacturers because the products serve as the sole source of nutrition for some of our most vulnerable consumers,” says the agency. Also mentioned is that the FDA stresses the importance of company quality systems but that the responsibility lies on the firm to correct issues when addressed.

Yet, the US Senate Committee of Finance previously reported that instead of repairing and making the necessary investments to fix critical issues on the manufacturing plant in Michigan, the company “spent US$5 billion buying their own shares,” boosting the company's share price. 

“As Abbott spent billions buying back its own stock, it appears that it failed to make necessary repairs to fix a critical manufacturing plant of infant formula located in Michigan. As a result of the company’s mismanagement, the plant’s condition deteriorated to the point where it was shut down by the FDA in February over safety concerns,” says Ron Wyden, chair, Senate Finance Committee.

Edited by Beatrice Wihlander