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  1. Infant Formula Guidance Documents & Regulatory Information

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

Infant Formula

Country

Company

Product Name
(click to
enlarge label)

Company notified
the FDA it will
take steps for
these products
to remain on U.S.
market

Australia

 

Bubs Australia Ltd.

 

Bubs Organic Grass Fed
Infant Formula Stage 1

Bubs Organic Grass Fed
Follow-On Formula Stage 2

Bubs Supreme
A2 Beta-Casein Protein
Infant Formula Stage 1

Bubs Supreme
A2 Beta-Casein Protein
Follow-On Formula Stage 2

Bubs Easy-digest Goat Milk
Infant Formula Stage 1

Bubs Easy-digest Goat Milk
Follow-On Formula Stage 2

Yes

Australia

Bellamy's Organic

Organic Infant Formula
Step 1 (0-6 months)

(PDF)

Organic Follow-On Formula
Step 2 (6-12 months)

(PDF)

Yes

 

Australia

Care A2+

Care A2+ 0-12 Months

Yes

Ireland

Abbott Nutrition

Similac Advance 2’-FL

No

Ireland

Danone

Aptamil First Infant Milk
 

*Note on iron content

Yes

Ireland

Danone

Aptamil Care Infant Milk
Stage 1 (0-6 months)

Aptamil Care Follow-on Milk
Stage 2 (6-12 months)

Yes

New Zealand

The a2 Milk Company

a2 Platinum® Infant Formula
Stage 1 (0-6 months)

a2 Platinum® Follow-on Formula
Stage 2 (6-12 months)

Yes

 

New Zealand

Danone

Aptamil Gold Plus

No

Singapore

Reckitt/Mead Johnson

Enfamil
manufactured using
Reckitt/Mead Johnson
base powder

Yes

Spain

Abbott

Similac Total Comfort
Stage 1 (0-12 months)

Similac Total Comfort
(up to 24 months)

No

United
Kingdom

 

Kendal
Nutricare Ltd.

 

Kendamil Classic
First Infant Milk Stage 1

Kendamil Organic
First Infant Milk Stage 1

Kendamil Goat
First Infant Milk Stage 1

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

Infant Formula

Country

Company

Product Name
(click to
enlarge label)

Company notified
the FDA it will
take steps for
these products
to remain on U.S.
market

Mexico

Reckitt/Mead Johnson

PurAmino Hypoallergenic
infant formula
(amino acid-based
formula with iron)
manufactured using
Reckitt/Mead Johnson
base powder

Yes

Spain

Abbott

Similac Neosure

No

The Netherlands

Danone

Nutricia UCD Anamix®
Infant Formula

Yes

The Netherlands

Nestlé Health Science

SMA Nutrition Althera -
Hypoallergenic,
Extensively Hydrolyzed
Infant Formula

No

The Netherlands

Nutricia (Danone)

Pepticate

Pepticate Syneo

Yes

The Netherlands

Vitaflo USA LLC
(Nestlé Health Science)

PKU Start

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

 
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