The U.S. Food and Drug Administration (FDA) has issued a guidance announcing the agency’s plans to allow manufacturers who are producing infant formula under enforcement discretion to market products that may not currently comply with specific FDA requirements, while working toward meeting those requirements. The decision aims to stabilize the U.S. infant formula supply while providing manufacturers a pathway to ensuring their infant formula products are safe and quality.
The present guidance follows FDA’s May 2022 guidance granting enforcement discretion for certain requirements that apply to infant formula on a case-by-case basis. Since the publication of the May 2022 guidance, many manufacturers have provided FDA with detailed information pertaining to particular infant formulas, and FDA has reviewed such information, including details about the products’ nutritional adequacy and safety, microbiological testing results, labeling information, and details about manufacturing facilities’ food safety production practices and inspection histories.
Based on its reviews, FDA has issued letters of enforcement discretion related to the marketing of specific infant formula products in the U.S. 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 January 6, 2023, with further extensions possible for firms that express interest in and take steps toward the lawful marketing of such products in the U.S.
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 work to avoid future shortages. While the infant formula supply continues to improve, continued product availability is important 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. By December 5, 2022, manufacturers currently marketing their products in the U.S. under enforcement discretion must submit a letter of intent to pursue compliance with all regulatory requirements. FDA will evaluate each letter of intent and, where appropriate, issue a new letter of enforcement discretion by January 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 must take to achieve compliance with all requirements that apply to their products. In addition, FDA will host industry webinars to provide an overview of and answer questions on the present guidance. More information on the webinars will be released in the near future.
Update, October 4, 2022: FDA will host a call for stakeholders on Wednesday, October 5, 2022 at 2 P.M. Eastern Time to provide a high-level overview of the "Infant Formula Transition Plan for Exercise of Enforcement Discretion" and address questions. The call can be viewed via YouTube.
Update, November 15, 2022: Effective November 14, 2022, the FDA is no longer accepting requests for enforcement discretion for certain requirements that apply to infant formula based on the May 2022 guidance.
