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Posted in Our Blog on September 11, 2023
The United States Food and Drug Administration (FDA) issued warning letters to three different infant formula manufacturers on August 30, 2023. These warning letters came after several serious recalls and subsequent shortages occurred when infant formula was found to be potentially contaminated with the harmful bacteria, Cronobacter sakazakii. Many infants were sickened. Some even died.
These letters were sent to ByHeart Inc., Mead Johnson Nutrition (Reckitt), and Perrigo Wisconsin, LLC and reflected the findings they found in each of their recalls.
The FDA indicates that this announcement is not intended to advise parents and caregivers of purchasing decisions, nor is it to indicate that any product currently on the market is unsafe. These letters are intended to call out these manufacturers on what they are doing to prevent contamination events in the future, based primarily on what was discovered upon previous inspections.
At this time, the FDA does not anticipate this activity to impact availability of infant formula to the market.
This formal action requires each firm to respond within 15 working days and indicate the corrective actions they have taken and continue to take.
Warning Letters are used by the FDA to communicate violations of the Federal, Food, Drug, and Cosmetic Act, and are the agency’s primary mode of gaining prompt voluntary compliance with the Act. These Warning Letters are available to the public at the FDA website.
In this case, the letters are meant to engage the manufacturers to perform root cause investigations, cleaning and sanitation activities, and corrective actions. These responses will be used during the FDA’s next facility inspection to be sure that they are doing what they say they are doing, and what they are doing will work.
In a statement made by Donald Prater, acting director of the FDA’s Center for Food Safety and Applied Nutrition, he explains the reason for these recent warning letters.
“Infant formula manufacturers are responsible for ensuring they make safe products, and the agency has remained in ongoing discussions with the infant formula industry to address the agency’s concerns. The FDA is committed to identifying and acting on issues early to prevent any firms from reaching the level of concern that prompted last year’s large-scale recall and contributed to the infant formula shortage.
Over the last year the FDA has continued to increase our oversight of powdered infant formula facilities. These letters are a reflection of this enhanced oversight and are intended to help the industry continuously improve the safety of their manufacturing practices, so that parents and caregivers can be confident that the formula they feed their children is safe and nutritious.”
— Donald Prater, Acting Director, FDA Center for Food Safety and Applied Nutrition
At this time, the current in-stock rates of the U.S. infant formula supply is healthy and at 85% or higher since the beginning of the year. The FDA attributes this to the hard work of people working behind the scenes in the FDA and manufacturers complying with FDA and U.S. government partners requests, outlined in the FDA’s National Strategy to Increase the Resiliency of the Infant Formula Market.
Each Warning Letter was created specifically for the addressed manufacturer based on observations during their respective recalls and inspections.
The ByHeart, Inc letter was addressed to CEO and Co-Founder, Ron Belldegrun citing observations from inspections between December 21, 2022 and February 17, 2023.
Key points included the following:
The Mead Johnson Nutrition warning letter was addressed to Niall Mullane, Director of Nutrition and Commercial Quality, North American & Latin America and focused on two manufacturing facilities, the letter describes as “Zeeland Facility” inspected from February 7, 2023 through February 23, 2023 and “Wanamingo Facility” inspected from November 28, 2022 through January 9, 2023.
Key points with respect to the Zeeland Facility include the following:
Key points with respect to the Wanamingo Facility include the following:
The Perrigo Wisconsin, LLC warning letter was addressed to Bart d. Shrode, the firm’s Vice President of Quality Operations in response to three separate contamination events linked back to the manufacturing facility.
Key points include the following:
The FDA recommends that parents and caregivers follow manufacturer instructions when preparing powdered infant formula. Additionally, the FDA recommends that ready-to-feed liquid infant formula should be fed to babies less than 2 months old, those who were born prematurely, and those with weakened immune systems. Liquid infant formula is made to be sterile and is the safest option.
Heating water to at least 158 °F is also recommended to help protect against Cronobacter. The water can be heated, powdered infant formula added, and then allowed to cool to body temperature prior to feeding. However, the FDA advises that certain packaging instructions for certain metabolic and specialty products may not be suitable for this procedure as it could result in loss of vitamin and nutrients.
The FDA will continue oversight and monitoring activities, conducting annual inspections of infant formula facilities to assist in prevention activities with respect to the infant formula distributed in the United States.
By: Heather Van Tassell