FDA Issues Tip Sheet to Shore-up the Supply Chain for Infant Formula and Critical Food

In the effort to enhance product quality and the integrity of the infant formula supply chain after contamination resulted in the 2022 baby formula shortage, Congress and the FDA took steps to ensure that infants and parents have a readily available supply of high-quality, nutritious infant formula.

On November 21, 2023, the Food and Drug Administration (FDA) published a one-page tip sheet for the makers of infant formula and other critical foods to educate the industry about a new requirement mandating that companies plan for supply chain or other disruptions that could impact the availability of infant formula.

On December 29, 2022, President Biden signed into law the Food and Drug Omnibus Reform Act of 2022 (FDORA) which amends the Federal Food, Drug, and Cosmetic Act (FDC Act).   FDORA requires manufacturers of critical foods to develop plans for responding to supply disruptions.   The FDA established an Office of Critical Foods within the Center for Food Safety and Applied Nutrition (CFSAN) to coordinate activities related to “critical foods,” which includes infant formula and medical foods because they are products formulated to meet the nutritional requirements of a disease or condition and used under a physician’s supervision.

Manufacturers of critical foods must implement a redundancy risk management plan that evaluates risks to the food supplied at each manufacturing establishment. Further, manufacturers of a critical foods are obligated to notify the FDA within five business days of any interruption or permanent discontinuance likely to lead to a meaningful disruption in the supply of food.

The FDA’s Tip Sheet for Manufacturers

The FDA’s tip sheet identifies steps manufacturers can take to plan for supply disruptions, such as establishing alternative production sites or alternative suppliers and stockpiling inventory. 

The guidance recommends manufacturers evaluate redundancy in risk management plans by:

• identifying and evaluating risks to the supply of more than one critical food, or critical food category, manufactured at the same establishment; and
• identifying mechanisms by which the manufacturer would mitigate the impacts of a supply disruption through alternative production sites, alternative suppliers, stockpiling of inventory, or other means.

Key Takeaways

Manufacturers should develop thoughtful systems to ensure the infant formula and other foods manufactured meet the appropriate quality standards and customer expectations.

Manufacturers should evaluate manufacturing risks and implement contingency plans to address issues before they arise during the manufacturing process.

Manufacturers should also prepare for inspection, review, and to promptly copy and deliver required records to the FDA.

A reliable supply and consistently high-quality infant formula are critical to support the health and well-being of newborn infants.  Manufacturers need to ensure that the infant formula products produced and marketed meet the highest standards and that there are no disruptions in the supply chain. Foley is here to help you address the short- and long-term impacts in the wake of regulatory and supply chain changes. We have the resources to help you navigate these and other important legal considerations related to business operations and industry-specific issues. Please reach out to the authors or your Foley relationship partner with any questions.