Thank goodness for Rosa.

House Appropriations Committee Chair Rosa DeLauro (D-CT-03) today submitted for the record a report acquired from a whistleblower who worked at the Abbott facility which produces infant formula recalled by the United States Food and Drug Administration (FDA) in February. Chair DeLauro spoke about the report at the Fiscal Year 2023 Budget Request for the United States Department of Agriculture (USDA) hearing.  Here is the material – Redacted Confidential Disclosure re Abbott Laboratories – 10-19-2021_Redacted (1)

The release of this report follows DeLauro’s letter to the Inspector General of the Department of Health and Human Services (HHS), Office of Inspector General (OIG), Christi A. Grimm asking for her assistance in investigating whether the FDA took prompt, appropriate, and effective action leading to the recent recall involving infant formula produced by Abbott Nutrition.

Below are Chair DeLauro’s remarks. A video of the hearing can be found here.

I have questions I will submit for the record, but I want to speak about an extremely disturbing report I recently acquired from a whistleblower who worked at the Abbott facility which produces infant formula recalled by the FDA in February. Chairman Bishop, I appreciate you giving me the opportunity to share this during this hearing.

Mr. Secretary, to my knowledge you have not seen this report. I bring it to your attention because I know your deep commitment to child nutrition and the WIC program’s importance to maternal and child health outcomes. Abbott Nutrition is the exclusive supplier for the majority of state WIC agencies, and this has a serious impact on families served by WIC – over 1.2 million infants served by WIC are limited to specific brands of “contract formula,” like Similac. I believe you will be as outraged as I am by what this report means for the health of those infants.

In September 2021, FDA learned of the potential link between a rare and deadly foodborne pathogen and powdered infant formula manufactured by Abbott Laboratories in a facility in Sturgis, Michigan. This week I received a 34-page report from a whistleblower, a former employee at the plant which produced the contaminated formula – which led to at least 4 hospitalizations and the deaths of at least 2 babies. The whistleblower report lays out a damning list of allegations of wrongdoing at this factory, including:

  • Falsification of records relating to testing of seals, signing verifications without adequate knowledge, failure to maintain accurate maintenance records, shipping packages with fill weights lower than what was on the label, and more;
  • Releasing untested infant formula;
  • Hiding information during a 2019 FDA audit;
  • Lax practices associated with clean in place procedures;
  • Lack of traceability of the product;
  • Failure to take corrective measures once the company knew their testing procedures were deficient;
  • An atmosphere of retaliation against any employee who raised concerns about company practices.

And these are just a few of the allegations laid out in the report. I want to remind everyone we are talking about infant formula. Parents trust that formula will be safe and healthy for their newborn babies – it should be the most regulated of any product.

I am deeply concerned about the practices at this Abbott facility and their apparent failure to implement and enforce internal controls at this facility. We need to know exactly who in the company was aware of this failure and the alleged attempts to hide this information from the FDA.

I am equally concerned that the FDA reacted far too slowly to this report. The report was submitted to the FDA on October 20, 2021. The FDA did not interview the whistleblower until late December 2021. According to news reports, FDA did not inspect the plant in person until January 31, 2022, and the recall was not issued until February 17, 2022.

Why did the FDA not spring into action? Why did it take four months to pull this formula off store shelves? How many infants were fed contaminated formula during this time, by parents who trusted that the formula they were buying was safe? How many additional illnesses and deaths were there due to FDA’s slow response?

I have already requested that the HHS Inspector General look into this and I can assure you this Committee will also carry out its oversight role to find answers into how this happened and how we can prevent it from ever happening again.

I want to say thank you to this brave whistleblower for coming forward with this critical information. Mr. Chairman, with your permission I would like to submit this report for the Committee record of this hearing. Mr. Secretary, we look to you and USDA for leadership on issues of child nutrition and I strongly encourage you to investigate USDA’s contracts with Abbott Nutrition. If Abbott cannot guarantee the safety of infant formula purchased through the WIC program, the federal government should not be in business with them. I look forward to working with you on this.

Here is FDA’s “response:”