September 30, 2022
Today the U.S. Food and Drug Administration issued a guidance announcing the agency’s plans to provide a pathway for manufacturers of infant formula under enforcement discretion to market infant formula products that may not currently comply with specific FDA requirements while they work toward meeting those requirements. The guidance balances the need to ensure that infant formula products meet regulatory requirements with the need for a more resilient infant formula supply.
In May 2022, the FDA issued guidance announcing that it was exercising temporary enforcement discretion, on a case-by-case basis, for certain requirements that apply to infant formula. Since the publication of the May 2022 guidance, many manufacturers have provided to FDA detailed information pertaining to particular infant formulas, and the FDA has carefully reviewed such information, including details about the products’ nutritional adequacy and safety, microbiological testing results, labeling information and details about the manufacturing facility’s food safety production practices and inspection history. Based on those reviews, FDA has issued letters of enforcement discretion related to the marketing of specific infant formula products in the United States through November 14, 2022. Under the new guidance, the period of enforcement discretion for those products identified in the letters of enforcement discretion will be extended until Jan. 6, 2023, with further extensions possible for firms that express interest in and take steps toward the lawful marketing of such products in the United States.
The disruption of infant formula supplies, caused in part by the temporary shutdown of a major infant formula manufacturing facility, has demonstrated the need to create a more resilient U.S. supply for infant formula products and help avoid future shortages. While the infant formula supply continues to improve, continued product availability is desirable for infants who started on a specific formula during the shortage and now are accustomed to that formula as an essential source of nutrition.
Flexibility to continue to market infant formula that may not comply with specific FDA requirements will be considered only in certain circumstances. Manufacturers currently marketing their products in the U.S. under enforcement discretion would need to send to the FDA by Dec. 5, 2022, a letter of intent to pursue compliance with all regulatory requirements. The FDA would evaluate each letter of intent, and where appropriate, issue a new letter of enforcement discretion by Jan. 6, 2023, to clarify that FDA intends to continue exercising enforcement discretion over the distribution of such products while the manufacturer works to bring its products into full compliance.
The guidance provides a recommended timetable for the actions manufacturers will be taking to achieve compliance with all requirements that apply to their products. In addition, the FDA will host industry webinars to provide an overview and answer questions on the recently released guidance to infant formula manufacturers. More information on the webinars will be released shortly.
For more information:
- Guidance for Industry: Infant Formula Transition Plan for Exercise of Enforcement Discretion
- Press Release: FDA Pathway Supports Long-Term Stability, Diversity of Safe and Nutritious Infant Formula Supply in the U.S.
- Enforcement Discretion to Manufacturers to Increase Infant Formula Supplies
- Resources for Parents and Caregivers on Imported Infant Formula