Recently, parents of infants made an unpleasant discovery about the complexity and limitations of supply chains for products as specialized as infant formula. As a result of product contamination that resulted in two infant deaths, the nation’s largest manufacturer of infant formula (Abbott Nutrition) was forced to close one of its factories, cease production, and issue a voluntary recall of the product. On behalf of FDA, the Department of Justice filed a complaint against Abbott Nutrition, resulting in a proposed consent decree of permanent injunction that imposes mandatory corrective actions on the manufacturer. The resulting shortage has forced parents to scramble to find formula, often without success.
For any other food, it might be a simple matter of other companies ramping up production to fill in the gaps. However, nothing related to the marketing of infant formula in the U.S. is simple, with strict limitations on ingredients, mandatory nutrient levels, and a complicated infant formula notification that must be submitted to FDA.
To address the current shortage of infant formula in the U.S., FDA has issued an enforcement discretion policy to allow for the temporary marketing of infant formulas that might not normally meet the regulatory requirements.
FDA’s Exemptions Under the Enforcement Policy
The severity of the infant formula shortage has prompted FDA to take immediate (and somewhat unprecedented) action to modify how the agency usually regulates this product. For those companies that are currently permitted to market infant formula, FDA has been prioritizing review of notifications, meeting with manufacturers to increase production, expediting the necessary certificates for imported products, and other efforts to streamline the process.
For companies that have never marketed infant formula in the U.S., FDA is temporarily waiving the normal regulatory requirements. FDA will consider on a case-by-case basis, whether to exercise enforcement discretion to allow a particular company to market their product(s).
Companies will be required to provide FDA with detailed information about their product formulation, current good manufacturing practices, facility inspection results, testing data/methods, and labeling. FDA will evaluate the submission to determine whether the information demonstrates that the formula can be used safely and provides adequate nutrition. FDA intends to exercise this enforcement discretion policy until November 14, 2022, at which point the agency will determine if an extension is necessary.
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