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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.

Does FDA approve infant formulas before they can be marketed? No, FDA does not approve infant formulas before they can be marketed. However, all formulas marketed in the United States must meet federal nutrient requirements and infant formula manufacturers must notify the FDA prior to marketing a new formula.

The new infant formula submission must include: 1) the product name and a description of the physical form, 2) an explanation of why it is a new infant formula, 3) the quantitative formulation of the infant formula, 4) a description of any reformulation of the formula or change in processing of the infant formula, 5) ...

The FDA has very specific and rigorous manufacturing standards for Toddler Drinks. All Enfamil toddler drinks including Enfagrow® NeuroPro? and Enfagrow® PREMIUM? Toddler Next Step? are in compliance with all FDA food regulations.

To start transitioning to formula, replace breastfeeding with a bottle. Try choosing a feeding time your baby is the least interested in, or one that's inconvenient for you. As your baby adjusts to the change, gradually drop additional breastfeedings one at a time, until you've hit the schedule you're looking for.

Imported formulas ordered online from other countries are generally not reviewed by the FDA, which is a requirement for all infant formulas sold in the U.S. Because these imported formulas have not been checked, they may not meet U.S. standards for quality, nutrition or packaging.

If a consumer has a general complaint or concern about a food product including an infant formula, FDA is the appropriate agency to contact. These problems, complaints, or injuries can be reported in writing or by telephone, or by the Internet at Report a Problem.

Does FDA approve infant formulas before they can be marketed? No, FDA does not approve infant formulas before they can be marketed. However, all formulas marketed in the United States must meet federal nutrient requirements and infant formula manufacturers must notify the FDA prior to marketing a new formula.