Enforcement Discretion to Manufacturers to Increase Infant Formula Supplies
What's New
Effective November 14, 2022, the FDA is no longer accepting requests for enforcement discretion for certain requirements that apply to infant formula based on its May 2022 guidance. Under a new guidance issued in September 2022, the FDA is providing a pathway for manufacturers of infant formula products listed below, which received enforcement discretion based on the May 2022 guidance, to continue marketing these products while they work toward fully meeting FDA requirements. Under the new guidance, the period of enforcement discretion for these products is being 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.
Companies Receiving Enforcement Discretion for Regular Infant Formula
Tips for Preparing Imported Infant Formula (Consejos para preparar la fórmula infantil importada) PDF
Resources for Parents and Caregivers on Imported Infant Formula
Country |
Company |
Product Name |
Date Added/ |
Estimated |
Estimated Full-size 8oz Bottles of Infant Formula |
---|---|---|---|---|---|
Ireland |
Danone |
Aptamil Care Infant Milk Aptamil Care Follow-on Milk |
November 2, 2022 |
N/A |
N/A |
New Zealand |
The a2 Milk Company |
a2 Platinum® Infant Formula a2 Platinum® Follow-on Formula, |
November 2, 2022 |
N/A |
N/A |
Australia |
Care A2+ |
July 8, 2022 |
4.875 million
|
121 million |
|
New Zealand |
Danone |
June 29, 2022 |
555,000 |
16.5 million |
|
Ireland |
Abbott Nutrition |
June 28, 2022 |
33,619* *total revised |
963,500* *total revised |
|
Australia |
Bellamy's Organic |
June 27, 2022 |
696,000 |
21 million |
|
United |
Global Kosher |
June 22, 2022* *On July 26, 2022, |
4.8 million |
128 million |
|
Ireland |
Danone |
June 17, 2022 |
750,000 |
19 million |
|
Singapore |
Mead Johnson/ |
Base powder to |
June 15, 2022 |
4.5 million pounds of base powder that will be used to produce about 5.7 million cans |
4.5 million pounds of base powder that will be used to produce about 5.7 million cans |
Spain |
Abbott |
June 10, 2022 |
(includes amount |
16.5 million (includes amount |
|
Germany
|
Nestlé
|
June 9, 2022 |
28,200
|
745,000
|
|
Mexico
|
Nestlé
|
June 3, 2022 |
1.3 million |
33 million |
|
Germany
|
Nestlé
|
June 2, 2022 |
249,500
|
6.5 million
|
|
Australia
|
Bubs
|
Bubs Organic Grass Fed Bubs Organic Grass Fed Bubs Supreme Bubs Supreme |
May 27, 2022
|
1.25 million
|
33 million* *total revised
|
United
|
Kendal
|
Kendamil Classic |
May 24, 2022 |
2 million
|
58.1 million
|
*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 Receiving 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
Resources for Parents and Caregivers on Imported Infant Formula
Country |
Company |
Product Name |
Date Added/ Press Release |
Estimated Cans of Infant Formula |
Estimated Full-size 8oz Bottles of Infant Formula |
---|---|---|---|---|---|
The Netherlands |
Danone |
November 14, 2022 |
N/A |
N/A |
|
Mexico |
Reckitt Nutrition/ |
Base powder to manufacture PurAmino Hypoallergenic infant formula (amino acid-based formula with iron) |
August 10, 2022 |
469,000 |
6 million |
The Netherlands |
Nestlé Health Science |
SMA Nutrition Althera - |
August 5, 2022 |
37,500 |
495,000 |
The Netherlands |
Nutricia (Danone) |
July 29, 2022 |
50,000 24,000 |
605,368 326,899 |
|
The Netherlands |
Vitaflo USA LLC |
July 6, 2022 |
3,192 |
39,844 |
|
Spain |
Abbott |
June 10, 2022 |
see Abbott |
see Abbott |
|
United Kingdom |
Nutricia (Danone) |
May 26, 2022 |
195,885
|
2.5 million
|
Background
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.
Among the requirements for infant formulas, the FDA regulations specify minimum amounts for 30 nutrients that must be included. For 10 of these nutrients, there are maximum amounts as well. In addition, any ingredient used in infant formula must be safe and suitable. The FDA also has specific requirements for labeling infant formulas. They include directions for preparation and use, a pictogram showing the major steps for preparing infant formula and use by date.
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. The FDA took steps to support the increased supply of infant formulas, including regular meetings with infant formula manufacturers to better understand their capacity to increase production and expediting review of notifications of manufacturing changes that would help increase supply—particularly of specialized formulas for medical needs such as metabolic disorders.
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
- Press Release: FDA Provides Update on Efforts to Increase Supply and Availability of Safe and Nutritious Infant Formula (June 22, 2022)
- Press Release: FDA Encourages Importation of Safe Infant Formula and Other Flexibilities to Further Increase Availability (May 16, 2022)