Enforcement Discretion to Manufacturers to Increase Infant Formula Supplies
Background
A voluntary recall by Abbott Nutrition in February 2022 and subsequent voluntary cease in production at their Sturgis facility, combined with the overall strains on supply chains experienced during the COVID-19 pandemic, created concerns about the availability of certain types of infant formula.
To support the increased supply of infant formula, on May 16, 2022, the FDA issued a guidance to manufacturers of infant formula to announce the agency’s intention to temporarily exercise enforcement discretion, on a case-by-case basis, for certain requirements that apply to infant formula. This action was designed to increase infant formula supplies in the United States, while protecting the health of infants, for whom infant formula is often the sole source of nutrition during a critical period of growth and development. The guidance was in effect until November 14, 2022.
The guidance was related to both the importation into the U.S. of infant formula produced in other countries and infant formula that is produced domestically. It described the information that infant formula manufacturers should provide to the FDA if they want to introduce into U.S. commerce infant formula that is safe and nutritionally adequate but may not comply with all FDA requirements. The information sought included a list of and amount of all nutrients as well as ingredients, a copy of the product label and description of packaging, current or anticipated inventory of the formula, microbiological testing results and facility inspection history. The FDA used this information to consider on a case-by-case basis whether to exercise enforcement discretion. For example, for an infant formula with a label that did not list the nutrients in the order required, but that otherwise meets applicable requirements, the FDA indicated it would likely determine that enforcement discretion was appropriate. In contrast, an infant formula with meaningful differences in required nutrients might not have been an appropriate candidate for enforcement discretion. Certain labeling requirements, such as the clear identification of any allergens present in the product or adequate instructions for safe product preparation and use, are connected to food safety and were considered carefully in evaluating requests for enforcement discretion.
Under a guidance issued in September 2022, the FDA provided a transition plan for manufacturers of infant formula products that received a letter of enforcement discretion based on the May 2022 guidance to continue marketing these products while they worked toward meeting all applicable FDA requirements. Under the guidance, the period of enforcement discretion for these products was extended until January 6, 2023, with further extensions available for firms that took specific actions to make meaningful progress toward achieving compliance with the remaining statutory and regulatory requirements applicable to their infant formula products for the U.S. market.
Table. Manufacturers That Participated in the Transition Plan for Infant Formula
Manufacturer | Product Name | FDA Received New Infant Formula |
|---|---|---|
Bubs Australia Ltd.
| Bubs Essential Bubs 365 Day Grass Fed Bubs Goat | Yes |
| Danone | Aptamil Care Stage 1 Aptamil Care Stage 2 Pepticate | Yes |
| Kendal Nutricare Ltd | Kendamil Organic Kendamil Classic Kendamil Goat | Yes |
| The a2 Milk Company | a2 Platinum Premium | Yes |
| Reckitt/Mead Johnson Nutrition | Enfamil manufactured using Reckitt/Mead Johnson Nutrition base powder PurAmino Hypoallergenic | Yes |
| Vitaflo (Nestlé Health Science) | PKU start | Yes |
For more information, please visit FDA’s Infant Formula webpage.