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.

Actions Taken to Date

The FDA has made several efforts to enhance the safety and quality of infant formula products. As of December 2023:

• The FDA conducted 47 routine annual inspections, aligning with its targets for FY23.
• An updated strategy was released, emphasizing continuous collaboration with industry stakeholders.
• A letter was issued to the infant food industry, emphasizing the importance of current safe practices, and urging action for process improvement.
• Further enhancements include the employment of auditors to inspect formula manufacturers and updates to bacteriological testing methods for infant formula.
• 3 warning letters to industry
• Updated resources related to infant formula including:
  •  Infant Formula guidance; and,
  •  Cronobacter sakazakii resources.

Resiliency in the Supply of Nutritious Infant Formula

Recognizing the critical nature of infant nutrition, the FDA has taken multiple steps to ensure a consistent and safe supply of infant formula:

• Prioritization of patients with medically essential formula needs.
• Collaboration with the US Department of Health and Human Services (HHS) to mobilize significant formula volumes via Operation Fly Formula.
• Efforts to facilitate importers by working with US Customs and Border Protection, including tariff relief initiatives.
• Released updated infant formula guidance
• Utilization of 21 Forward (a tool developed to ameliorate COVID-19 supply chain issues) to monitor and address potential supply chain challenges.
• Collaborative initiatives with the HHS to address raw material constraints and ensure a stable supply.

Operational Improvements

To bolster its operational efficacy and responsiveness:

• Streamlined consumer complaint procedures have been introduced.
• Enhanced protocols are now in place for whistleblowers and internal sources.
• Mechanisms to track and act on mail efficiently have been initiated.
• Updated compliance program for infant formula
• The establishment of the “Office of Critical Foods” is underway, empowered by the Food and Drug Omnibus Reform Act (FDORA) of 2022.
• Comprehensive updates and training initiatives for FDA investigators have been rolled out based on lessons learned in 2022.

What Does This Mean for Industry?

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.

How Can I Be Prepared?

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.