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  6. Enforcement Discretion to Manufacturers to Increase Infant Formula Supplies
  1. Infant Formula Guidance Documents & Regulatory Information

Enforcement Discretion to Manufacturers to Increase Infant Formula Supplies

What's New 

July 6, 2022

The FDA has announced that it will exercise enforcement discretion with respect to the specific infant formula products listed below, to increase infant formula supplies in the United States. 

These lists will be updated on a regular basis.

Total Estimated Quantities

18.3 million cans (400 million 8oz bottles)


Companies Receiving Enforcement Discretion for Regular Infant Formula

Tips for Preparing Imported Infant Formula (PDF)
Consejos para preparar la fórmula infantil importada (PDF)

Country

Company

Product Name 
(click to enlarge label)

Date Added/
Press Release

Estimated
Cans of
Infant Formula

Estimated Full-size
8oz Bottles of
Infant Formula

New Zealand

Danone

Aptamil Gold Plus

June 29, 2022

Press Release

555,000

16.5 million

Ireland

Abbott Nutrition

Similac Advance 2'-FL

June 28, 2022

Press Release

33,619* 

*total revised for accuracy

963,500*

*total revised for accuracy

Australia

Bellamy's Organic

Organic Infant Formula 
Step 1 (0-6 months)
 (PDF)


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

June 27, 2022

Press Release

696,000

21 million

United
Kingdom

Global Kosher

Kendamil First Infant Formula with Iron
(Kosher formula)

June 22, 2022

Press Release

4.8 million 

128 million 

Ireland

Danone

Aptamil First Infant Milk
Stage 1
 

*Note on iron content

June 17, 2022

Press Release

750,000

19 million

Singapore

Mead Johnson/
Reckitt

Base powder to
manufacture Enfamil
Stage 1

June 15, 2022

Press Release

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
(66 million 8-ounce bottles)

Spain

Abbott

Similac Total Comfort
Stage 1 (0-12 months)


Similac Total Comfort
(up to 24 months)

June 10, 2022

Press Release

686,530

(includes amount for 
Similac Neosure in the 
Specialty Formula table)

16.5 million

(includes amount for 
Similac Neosure in the 
Specialty Formula table)

Germany

 

Nestlé 

 

Nestle NAN Expert Pro
Sensi Pro

June 9, 2022

Press Release

28,200

 

745,000

 

Mexico

 

Nestlé 

 

Gerber Good Start
Gentle

June 3, 2022

Press Release

1.3 million

33 million 

Germany

 

Nestlé

 

Nestlé NAN
Supreme Pro 1


Nestlé NAN
Supreme Pro 2

June 2, 2022

Press Release

249,500

 

6.5 million

 

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
 

May 27, 2022

Press Release

 

1.25 million

 

33 million*

*total revised for accuracy

 

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

May 24, 2022

Press Release

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 (PDF)
Consejos para preparar la fórmula infantil importada (PDF)

Country

Company

Product Name 
(click to enlarge label) 

Date Added/
Press Release
Estimated
Cans of
Infant Formula
Estimated 
8oz Bottles of
Infant Formula

The Netherlands

Vitaflo USA LLC

PKU Start 

July 6, 2022

Press Release

3,192

39,844

Spain

Abbott

Similac Neosure

June 10, 2022

Press Release

see Abbott
entry above

see Abbott
entry above

United Kingdom

Nutricia (Danone)

Neocate Infant DHA/ARA 

May 26, 2022

Press Release

195,885

 

2.5 million

 


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 is 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 will be in effect until November 14, 2022, and we will evaluate whether any extension is necessary.

The guidance is related to both the importation into the U.S. of infant formula produced in other countries and infant formula that is produced domestically.  It describes 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 includes 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 will use 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 does not list the nutrients in the order required, but that otherwise meets applicable requirements, the FDA 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 will be 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, have created concerns about the availability of certain types of infant formula. The FDA has already taken steps to support the increased supply of infant formulas, including regular meetings with infant formula manufactures to better understand their capacity to increase production and expediting review of notifications of manufacturing changes that will help increase supply—particularly of specialized formulas for medical needs such as metabolic disorders.

Requests for enforcement discretion should be sent to:
infant_formula_flexibility@fda.hhs.gov 

For More Information 

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