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                Infant Formula Guidance Documents & Regulatory Information

Infant Formula Guidance Documents & Regulatory Information

                        Regulations and Information on the Manufacture and Distribution of Infant Formula
          Enforcement Discretion to Manufacturers to Increase Infant Formula Supplies
          Immediate National Strategy to Increase the Resiliency of the U.S. Infant Formula Market
          Status Update on FDA’s Infant Formula Response Activities
          Progress Update on FDA’s Evaluation of the Infant Formula Response Home
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          Guidance Documents & Regulatory Information by Topic (Food and Dietary Supplements)
          Infant Formula Guidance Documents & Regulatory Information
          Enforcement Discretion to Manufacturers to Increase Infant Formula SuppliesInfant Formula Guidance Documents & Regulatory Information Enforcement Discretion to Manufacturers to Increase Infant Formula Supplies
  
  	
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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.

Regular Infant Formula
	Specialty Formulas for Infants with Special Medical Needs


****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

Cou**ntry**
			**Company**
			**Product Name
			(click to
			enlarge label)**
			**Company notif**ied
			the FDA it will
			take steps for
			these products
			to remain on U.S.
			marketAustralia
			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
			YesAustralia
			Bellamy's Organic
			Organic Infant Formula
			Step 1 (0-6 months)
			(PDF)

			Organic Follow-On Formula
			Step 2 (6-12 months)
			(PDF)
			YesAustralia
			Care A2+
			Care A2+ 0-12 Months
			YesIreland
			Abbott Nutrition
			Similac Advance 2’-FL
			NoIreland
			Danone
			Aptamil First Infant Milk

			*Note on iron content
			YesIreland
			Danone
			Aptamil Care Infant Milk
			Stage 1 (0-6 months)

			Aptamil Care Follow-on Milk
			Stage 2 (6-12 months)
			YesNew Zealand
			The a2 Milk Company
			a2 Platinum® Infant Formula
			Stage 1 (0-6 months)

			a2 Platinum® Follow-on Formula
			Stage 2 (6-12 months)
			YesNew Zealand
			Danone
			Aptamil Gold Plus
			NoSingapore
			Reckitt/Mead Johnson
			Enfamil
			manufactured using
			Reckitt/Mead Johnson
			base powder
			YesSpain
			Abbott
			Similac Total Comfort
			Stage 1 (0-12 months)

			Similac Total Comfort
			(up to 24 months)
			NoUnited
			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.
			marketMexico
			Reckitt/Mead Johnson
			PurAmino Hypoallergenic
			infant formula
			(amino acid-based
			formula with iron)
			manufactured using
			Reckitt/Mead Johnson
			base powder
			YesSpain
			Abbott
			Similac Neosure
			NoThe Netherlands
			Danone
			Nutricia UCD Anamix®
			Infant Formula
			YesThe Netherlands
			Nestlé Health Science
			SMA Nutrition Althera -
			Hypoallergenic,
			Extensively Hydrolyzed
			Infant Formula
			NoThe Netherlands
			Nutricia (Danone)
			Pepticate

			Pepticate Syneo
			YesThe 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

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)

                                                                                  Content current as of:
      02/27/2023
              
              
Regulated Product(s)
		 Food & Beverages
			  			     			  						              
			
			
			
			
			
						  Infant Formula & FoodsInfant Formula Guidance Documents & Regulatory Information

          
                        Regulations and Information on the Manufacture and Distribution of Infant Formula
          Enforcement Discretion to Manufacturers to Increase Infant Formula Supplies
          Immediate National Strategy to Increase the Resiliency of the U.S. Infant Formula Market
          Status Update on FDA’s Infant Formula Response Activities
          Progress Update on FDA’s Evaluation of the Infant Formula Response
 
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