The U.S. Food and Drug Administration has sent a letter to all infant formula manufacturers, distributors, packers, importers, exporters, and retailers asking them to double-check their food safety controls. Food and Drug Administration officials are urging the baby formula industry to help protect infants by ensuring their baby food products are safe. FDA Commissioner Robert M. Califf signed the FDA letters.
Last year, the FDA faced a national infant formula crisis caused by a Cronobacter sakazakii contamination issue at Abbott Nutrition’s Sturgis, Michigan facility. Following that catastrophe, the FDA examined its response to the problem and created a Cronobacter prevention strategy for powdered infant formula.
The FDA’s recent letter reflects discussions conducted between the FDA and infant formula manufacturers. Those previous meetings concerned the baby formula industry’s existing food safety practices. The FDA urged the industry to utilize the information provided in the letter to:
- Review existing production systems and in-process controls to prevent infant formula adulteration
- Ensure compliance with all applicable regulations
- Address food safety concerns outlined in the letter
- Notify the FDA immediately of any adulterated or misbranded baby formula products that have left the production facility
The FDA also requested that companies voluntarily notify them of any positive Cronobacter or Salmonella product samples, even if the affected product has not been distributed. To address food safety concerns in powdered infant formula manufacturing facilities, the FDA recommends that the industry:
- Control water in dry production areas
- Verify control effectiveness through environmental monitoring
- Take appropriate corrective actions following the isolation of pathogens from environmental or product samples
- Implement effective supply chain controls for biological hazards
- Identify all relevant biological hazards.
What is Cronobacter?
Cronobacter, formerly known as Enterobacter sakazakii, is a type of bacteria that can cause severe infections in infants. Cronobacter is found in the environment, including in soil, water, and plant material. It can also be found in powdered infant formula, although the risk of infection from the formula is relatively low.
Cronobacter infections in infants can cause severe and sometimes life-threatening illnesses, including sepsis, meningitis, and necrotizing enterocolitis (NEC), a serious intestinal disease that affects premature babies. Infants who are born prematurely, have weakened immune systems, or have other underlying health conditions may be at higher risk of developing a Cronobacter infection.
To reduce the risk of Cronobacter infection in infants, it’s important to practice good hygiene when preparing and handling powdered infant formula. This includes washing hands and equipment thoroughly, using safe water sources, and following the manufacturer’s instructions for preparing and storing formulas.
If you suspect that your infant may have a Cronobacter infection, it’s important to seek medical attention right away. Treatment may involve antibiotics and supportive care to manage symptoms and complications.
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