On Nov. 22, 2023, the U.S. Food and Drug Administration (FDA) published a new resource for manufacturers of critical foods — defined as any infant formula or medical food — reminding manufacturers of their obligation to develop and maintain a redundancy risk management plan.
The requirements became effective in December 2022 with the passage of the Food and Drug Omnibus Reform Act of 2022 (FDORA). FDORA was passed in response to the monthslong infant formula shortage that year, caused by insanitary conditions at one of the nation’s largest infant formula facilities leading to voluntary recalls and production shutdowns. The shortage highlighted the need for manufacturers to establish and implement plans for mitigating supply chain and manufacturing disruptions for these types of foods.
FDORA added Section 424 to the Food, Drug, and Cosmetic Act (FDCA), which defines a risk management plan as one that (1) may identify and evaluate risks to the supply of one or more critical foods or critical food categories manufactured in the same establishment, and (2) may identify 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. The new resource clarifies that risk management plans may address more than one critical food or critical food category per manufacturer.
While it has been more than a year since passage of the law, this one-page resource is a helpful reminder to industry that these plans are essential for compliance with FDA requirements.
Manufacturers of critical foods, and companies investing in manufacturers, should remember to evaluate redundancy risk management protocols as part of good manufacturing practice and investment diligence. Please contact one of the authors of this article to learn more about FDORA or FDCA compliance matters.