The FDA has issued a significant recall alert concerning Nutramigen, a product manufactured by Reckitt/Mead Johnson Nutrition. This product was positive for Cronobacter sakazakii, leading the FDA to inspect the company’s facility in Zeeland, MI. As a proactive measure, Reckitt/Mead Johnson Nutrition has voluntarily recalled Nutramigen products produced between June 6 and June 29. This development is reminiscent of Abbott’s 2022 recall, which sparked the FDA’s evaluation of the agency’s infant formula response, the Reagan-Udall Foundation’s evaluation of the FDA’s Human Foods Program, and subsequent actions by the FDA. The Canadian Food and Drug Regulations (FDR) have established regulations for Food for Special Dietary use (FSDU) as well as food for infants, covered under Divisions 24 and 25 of the FDR. Health Canada is working towards modernizing these regulations to unlock potential for research, innovation, and flexibility within the regulations while keeping safety, nutrition, and support for these food categories top of mind.
The FDA has made several efforts to enhance the safety and quality of infant formula products. As of December 2023:
Recognizing the critical nature of infant nutrition, the FDA has taken multiple steps to ensure a consistent and safe supply of infant formula:
To bolster its operational efficacy and responsiveness:
With such significant regulatory changes and heightened scrutiny, it is paramount for industry stakeholders to revisit and ensure compliance with FDORA and the updated inspection requirements. Proactive engagement and adherence to these regulations will not only ensure compliance but also bolster consumer trust and safety.
Stay Informed: to be well-prepared, we recommend reading the FDA’s full status report and reviewing all applicable guidance documents.
Get Expert Advice: Our consultants are here to assist you in reviewing your products and ingredients and provide you with a tailored compliance strategy to help ensure you remain compliant with the regulatory requirements. Do not hesitate to get in touch today.