Editor’s note: U.S. Rep Rosa DeLauro, D-Conn, sent the following on letter March 3 to the Inspector General of the U.S. Department of Health and Human Services in relation to the ongoing outbreak tied to several infant formulas.
The Honorable Christi A. Grimm
Office of the Inspector General
Department of Health and Human Services
330 Independence Avenue, SW
Washington, DC 20201
Dear Ms. Grimm:
I write to seek your assistance in investigating whether the Food and Drug Administration (FDA) took prompt, appropriate, and effective action leading up to the recent recall involving powdered infant formula produced by Abbott Nutrition’s Sturgis, Michigan, plant. Based on reports, I am concerned the agency acted too slowly in pulling potentially dangerous infant formula off store shelves, which may have resulted in additional illnesses and death.
Abbott announced a recall of several of its powdered infant formulas on February 17 after multiple consumer complaints of infant illnesses related to Cronobacter sakazakii and Salmonella Newport infections. In their announcement, Abbott admitted that evidence of Cronobacter sakazakii was found in their facility.
According to the FDA, the agency first learned of the potential link between a case of Cronobacter sakazakii, a rare and deadly foodborne pathogen, and powdered infant formula manufactured by Abbott in September 2021. Near the same time, the agency inspected the same plant where this formula was made and uncovered numerous violations of regulations that are intended to prevent this type of contamination. Alarmingly, the FDA had also inspected the facility two years prior and uncovered similar issues.
Despite the agency’s awareness of these violations, public attention to this issue came to light only recently — nearly four months after the potential link was known. The FDA did not warn consumers about these products until another inspection in February 2022 uncovered cronobacter in several places in the Abbott facility. Through this inspection, the agency also was able to uncover company records that revealed Abbott had previously destroyed products due to the presence of Cronobacter sakazakii. While the company destroyed the products in June 2020, it was not noted in the agency’s September 2021 report, and the FDA has yet to explain why.
This February’s inspection was prompted after reports of three illnesses and one death related to Cronobacter sakazakii and Salmonella Newport. The delay between the September inspection and the recall raises serious questions about the FDA’s ability to adequately regulate the infant formula industry. It seems evident that the FDA could have acted sooner to prevent additional illnesses and deaths after the initial inspection.
As such, I request that you investigate whether the FDA’s inspection process and regulatory actions addressed this health hazard in an effective and timely manner. As part of this review, I encourage your office to on the following central questions:
- Why did it take several months and additional illnesses for the FDA to return to the plant for a follow-up inspection?
- Why were the company records showing destroyed products in June 2020 omitted from the FDA’s inspection report?
- Abbott is required to maintain production and testing records of each batch of infant formula and must provide those records to the FDA upon request. Did the agency request these records during the September 2021 inspection? If not, what is the agency’s justification for failing to do so?
- Two years prior to the September 2021 inspection, the FDA found that the Abbott facility failed to test a representative sample for Salmonella at the final stage of production cycle. Did the agency follow-up on this issue after that inspection?
- What presence does the FDA now have at the Abbott facility following the February 2022 inspection, and what steps are they taking to ensure the infant formula manufactured at this facility is now safe?
- Does the FDA intend to conduct more frequent inspections of the Abbott facility going forward?
- Did any of the FDA inspections included a significant review of the Abbott Hazard Analysis and Critical Control Points (HACCP) plans from the past incidents in order to determine its overall effectiveness, and if they were following correct procedures?
- Will the FDA start conducting its own testing on infant formula to monitor for these dangerous bacteria?
- How is the agency ensuring that all parent and caregivers, including those enrolled in the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC), have access to safe and affordable infant formula?
Thank you for your attention to this matter and your consideration of this request. Should you have any questions regarding this inquiry please contact Christian Lovell (firstname.lastname@example.org) on my staff at (202) 225-3661.
Rosa L. DeLauro
Committee on Appropriations