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The FDA has very specific and rigorous manufacturing standards for medical foods. All Enfamil® medical foods including PurAmino™ Toddler Medical Food, PurAmino™ Jr, Enfamil® Enfalyte®, and Portagen® are in compliance with all FDA medical food regulations.

Infant or baby formula may be imported to the United States without prior sanction by the Food and Drug Administration (FDA), as long as the facilities that produce, store, or otherwise handle the products are registered with FDA, and prior notice of incoming shipments are provided to FDA.

The US Food and Drug Administration (FDA) regulates commercial infant formulas to make sure they meet minimum nutritional and safety requirements. Iron-fortified infant formulas are recommended, and most commercial infant formulas sold in the United States contain iron.

Developed to Meet a Child's Nutritional Needs Baby's Only® Organic Toddler Formulas meet the nutritional recommendations made by a task force of pediatricians and other experts* convened at the request of the FDA.

The European Union requires DHA in formulas in amounts that are higher than a few brands available in the US, and while the FDA does not require DHA, most US infant formulas have it. The World Health Organization recommended amount of DHA is 0.2%-0.36%↗ of total fatty acids.

The ACCC has reauthorised an agreement among infant formula manufacturers and importers that prohibits them from advertising and promoting infant formula directly to the public.

Frequently asked questions about baby formula The formula most structurally similar to human breast milk is Similac 360 Total Care. This formula contains an unprecedented 5 HMOs, which are prebiotics found in breast milk that should help babies digest and absorb nutrients.

The FDA does not approve infant formulas; however, infant formula manufacturers must notify the agency before marketing a new formula. FDA's highly trained staff review these notifications to make sure new formulas meet federal nutrition, labeling, and other requirements.

The FDA has very specific and rigorous manufacturing standards for medical foods. All Enfamil® medical foods including PurAmino™ Toddler Medical Food, PurAmino™ Jr, Enfamil® Enfalyte®, and Portagen® are in compliance with all FDA medical food regulations.

Infant or baby formula may be imported to the United States without prior sanction by the Food and Drug Administration (FDA), as long as the facilities that produce, store, or otherwise handle the products are registered with FDA, and prior notice of incoming shipments are provided to FDA.

The US Food and Drug Administration (FDA) regulates commercial infant formulas to make sure they meet minimum nutritional and safety requirements. Iron-fortified infant formulas are recommended, and most commercial infant formulas sold in the United States contain iron.

Developed to Meet a Child's Nutritional Needs Baby's Only® Organic Toddler Formulas meet the nutritional recommendations made by a task force of pediatricians and other experts* convened at the request of the FDA.

The European Union requires DHA in formulas in amounts that are higher than a few brands available in the US, and while the FDA does not require DHA, most US infant formulas have it. The World Health Organization recommended amount of DHA is 0.2%-0.36%↗ of total fatty acids.

The ACCC has reauthorised an agreement among infant formula manufacturers and importers that prohibits them from advertising and promoting infant formula directly to the public.

Frequently asked questions about baby formula The formula most structurally similar to human breast milk is Similac 360 Total Care. This formula contains an unprecedented 5 HMOs, which are prebiotics found in breast milk that should help babies digest and absorb nutrients.

The FDA does not approve infant formulas; however, infant formula manufacturers must notify the agency before marketing a new formula. FDA's highly trained staff review these notifications to make sure new formulas meet federal nutrition, labeling, and other requirements.