Enforcement Discretion to Manufacturers to Increase Infant Formula Supplies
What's New
January 9, 2023
To increase the diversity of and support a stable supply of infant formula in the U.S., the FDA is providing a pathway for manufacturers of infant formula products that were imported, sold, and/or distributed under a letter of enforcement discretion received based on factors described in a guidance to industry issued on May 16, 2022 (see “Background” for additional information), to continue marketing their products while they work toward meeting all applicable FDA requirements. The tables below indicate which infant formula companies have expressed interest in taking steps to remain on the U.S. market and the specific formulas they intend to transition to lawful marketing. As described in a September 2022 guidance, FDA intends to continue exercising enforcement discretion beyond Jan. 6, 2023, if the companies demonstrate that they are working to meet all U.S. requirements according to a recommended timetable specified by the FDA. For companies that did not provide a Letter of Intent to FDA by December 5, 2022, enforcement discretion ended on Jan. 6, 2023. The FDA stopped accepting new requests for enforcement discretion on Nov. 14, 2022.
Companies That Received a Letter of Enforcement Discretion for Regular Infant Formula
Tips for Preparing Imported Infant Formula (Consejos para preparar la fórmula infantil importada) PDF
|
Country |
Company |
Product Name |
Company is |
|---|---|---|---|
|
Australia
|
Bubs Australia Ltd.
|
Bubs Organic Grass Fed Bubs Organic Grass Fed Bubs Supreme Bubs Supreme |
Yes |
|
Australia |
Bellamy's Organic |
No |
|
|
Australia |
Care A2+ |
No |
|
|
Ireland |
Abbott Nutrition |
No |
|
|
Ireland |
Danone |
No |
|
|
Ireland |
Danone |
Aptamil Care Infant Milk Aptamil Care Follow-on Milk |
Yes |
|
New Zealand |
The a2 Milk Company |
a2 Platinum® Infant Formula a2 Platinum® Follow-on Formula |
Yes |
|
New Zealand |
Danone |
No |
|
|
Singapore |
Reckitt/Mead Johnson |
Enfamil |
Yes |
|
Spain |
Abbott |
No |
|
|
United |
Kendal |
Kendamil Classic |
Yes |
*This infant formula is appropriate for most infants and meets U.S. nutrient requirements, but it may not be suitable for infants born prematurely, or with a low birth weight, infants who had low iron levels at birth, or infants who are at risk for becoming iron deficient due to illness. Parents and caregivers of infants born prematurely, or with a low birth weight, infants who had low iron levels at birth, or infants who are at risk for becoming iron deficient due to illness should check with their child’s health care provider to determine if this formula is appropriate for their child. Additional iron may be needed in these instances.
Companies That Received a Letter of Enforcement Discretion for Specialty Formulas for Infants with Special Medical Needs
Tips for Preparing Imported Infant Formula (Consejos para preparar la fórmula infantil importada) PDF
|
Country |
Company |
Product Name |
Company is |
|---|---|---|---|
|
Mexico |
Reckitt/Mead Johnson |
PurAmino Hypoallergenic |
Yes |
|
Spain |
Abbott |
No |
|
|
The Netherlands |
Danone |
Yes |
|
|
The Netherlands |
Nestlé Health Science |
SMA Nutrition Althera - |
No |
|
The Netherlands |
Nutricia (Danone) |
Yes |
|
|
The Netherlands |
Vitaflo USA LLC |
Yes |
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 is appropriate. In contrast, an infant formula with meaningful differences in required nutrients might not be 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 new guidance issued in September 2022, the FDA provided a pathway 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 work toward meeting all applicable FDA requirements. Under the new guidance, the period of enforcement discretion for these products was extended until January 6, 2023, with further extensions possible for firms that express interest in and take steps toward remaining on the U.S. market.
For More Information
- Outline of FDA’s Strategy to Help Prevent Cronobacter sakazakii Illnesses Associated with Consumption of Powdered Infant Formula
- Infant Formula Information and Ongoing FDA Efforts to Increase Supply
- Food Safety for Infants & Toddlers
- Outbreak Investigation: Cronobacter Infections - Powdered Infant Formula (2022)
- Guidance for Industry: Infant Formula Transition Plan for Exercise of Enforcement Discretion
- Webinar Series to Discuss the Infant Formula Transition Plan for Exercise of Enforcement Discretion