Abbott facility, Abbott Nutrition, contract formua, falsification of records, HHS, hygiene, infant formula, infant formula recall, Michigan, OIG, powdered baby formula, product recall, quality control, recall, Regulation, Similac, supply chain tracking, testing, tracking, US Congresswoman DeLauro, US FDA, USDA, welfare, whistleblower, WIC
“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.” (US Congresswoman DeLauro)
“Infants eligible for and receiving the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) are less likely to ever be breastfed (76.9%) than infants eligible, but not receiving WIC (83.3%), and infants ineligible for WIC (91.6%).”https://www.cdc.gov/breastfeeding/data/facts.html. This is “ever” breast fed with the percentage dropping over time. In 2020, by three months only 1/3rd of WIC participants were breast feeding (32.6%), which dropped to 1/5th ( 22.1%) by 6 months. https://www.fns.usda.gov/sites/default/files/resource-files/WICPC2020-Appendix.pdf
Families are still eligible for WIC with earnings at 185% of the poverty level, which accounts for the high percentage of eligible families. WIC buys around half of infant formula, so the high level of infant formula use should come as no surprise. While formula is necessary for some people, and WIC is supposed to encourage breast-feeding, there appears to be no motivation to breast feed for WIC participants, since the baby formula is free. The state contracts are to (a) certain provider (s), which means that if there is a production problem by the contractor then it would particularly impact WIC dependent users. Such has been the case with the Abbott recall.
Update: CDC reports suggests that the infant formula may not be to blame https://miningawareness.wordpress.com/2022/05/16/baby-formula-us-cdc-whole-genome-sequencing-findings-analysis-ongoing-abbott-statement/
“DeLauro Shares Whistleblower Report, Contaminated Infant Formula Led to Hospitalizations and Deaths” April 28, 2022 Press Release
Report Shows Falsification of Records, Untested Infant Formula, Hiding Information During 2019 FDA Audit
WASHINGTON, DC— 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 on the report at the Agriculture Appropriations Subcommittee hearing on the fiscal year 2023 budget request for the United States Department of Agriculture (USDA).
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. https://appropriations.house.gov/events/hearings/fiscal-year-2023-budget-request-for-the-department-of-agriculture
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. https://delauro.house.gov/media-center/press-releases/icymi-delauro-shares-whistleblower-report-contaminated-infant-formula
This was under Janet Woodcock’s watch: January 20, 2021 – February 17, 2022 https://en.wikipedia.org/wiki/Janet_Woodcock
“Chair DeLauro Requests Investigation into FDA Handling of Abbott Powdered Infant Formula Recall
March 4, 2022 Press Release
4+ Months Between Product Recall and When FDA First Learned of Potential Link
WASHINGTON, DC — House Appropriations Committee Chair Rosa DeLauro (CT-03) sent a 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 Food and Drug Administration (FDA) took prompt, appropriate, and effective action leading to the recent recall involving infant formula produced by Abbott Nutrition.
“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,” wrote Congresswoman DeLauro. “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.”
In September 2021, FDA first learned of the potential link between a rare and deadly foodborne pathogen and powdered infant formula manufactured by Abbott. On February 17, 2022, Abbot announced a recall of several of its powdered infant formulas. During this more than four-month window, at least four infants were hospitalized, and two babies died. This number is expected to increase as the investigation into this contamination continues.
The full text of the letter is below and here. https://delauro.house.gov/sites/delauro.house.gov/files/documents/DeLauro_OIG%20Request%20Infant%20Formula%20Recall.pdf
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 product 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 focus 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 September 2021 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 the 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 include a significant review of the Abbott Hazard Analysis and Critical Control Points (HACCP) plans from past incidents in order to determine its overall effectiveness, and if they were following correct procedures?
* Will the FDA start conducting its own testing of infant formula to monitor for these dangerous bacteria?
* How is the agency ensuring that all parents 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. https://delauro.house.gov/media-center/press-releases/chair-delauro-requests-investigation-fda-handling-abbott-powdered-infant
“Cronobacter, which used to be called Enterobacter sakazakii, is a germ that can live in very dry places. Cronobacter has been found in dry foods, like powdered infant formula, powdered milk, herbal teas, and starches. It has also been found in sewer water. Cronobacter infections are often very serious for babies; they can die. Cronobacter infection can also be very serious for older people and people whose bodies have trouble fighting germs, like people with HIV, organ transplants, or cancer.”https://www.cdc.gov/cronobacter/index.html
Baby Formula: US CDC Whole Genome Sequencing Findings; Analysis Ongoing; Abbott Statement