3. Compositional Aspects

Infant Formula
USA

This section provides the compositional requirements for the food category and/or food products in scope and information on permitted nutrients, ingredients, and additives.

3.1 Composition Requirements

There are no specific requirements regarding the principal source of nutrition, such as bovine milk, or soy, but preference is given to those sources with a history of safe use. Instead of creating recipe-like regulations, the US has made requirements that are based on the "normal growth" of an infant should it be fed solely on this food. This has the advantage of some flexibility in the choice of ingredients, but it also places a great deal of responsibility on the manufacturer to have scientific evidence, referred to by the US as "Quality Factors" that demonstrates the infant formula meets the normal growth requirement as well as the clearly defined nutritional requirements. 

The US has also provided considerable guidance on what it expects as evidence that the infant formula meets both the quality factors and nutrient requirements. This can involve using existing science or embarking on new clinical trials depending on the choice of ingredients used in a formula.

The US FDA also requires that adding new ingredients to infant formula should have “reasonable certainty of no harm”. 

FDA has requirements for nutrients in infant formulas, which are located in section 412(i) of the FFDCA and 21 CFR 107.100. These nutrient specifications include minimum amounts for 29 nutrients and maximum amounts for 9 of those nutrients. A full table of the levels of required nutrients in infant formula can be found in Sub-part D at §107.100 Nutrient specifications. [1,2]

3.2 Raw Material Requirements

Raw material level compliance is not being regulated. It is subject to the manufacturer’s quality control. Finish products must comply with the Code of Federal Regulations (CFR). The same rules apply to both domestic and imported products.

3.3 Fortification

While the US does not specify in its regulations what ingredients must be used to meet its prescribed nutrient profile, the regulations clearly define what nutrients, and at what levels, must be present. Some nutrients have minimum and maximum levels, while others are a single accepted level.  

It is the intent that infant formula mimics human breast milk as closely as possible, hence the development of the US nutrient content requirements. Should there be sufficient scientific evidence to support additional nutrient supplementation, and that the nutrient is listed in CFR § 101.9 - Nutrition labeling of food with an established RDI - and as long as that ingredient meets the "reasonable certainty of no harm" requirement, it is possible to do so.

Refer to §107.100 - Nutrient specifications:

An infant formula shall contain the listed nutrients at a level not less than the minimum level specified and not more than the maximum level specified for each 100 kilocalories of the infant formula in the form prepared for consumption as directed on the container. [2]

3.4 Other Permitted Ingredients

3.5 Permitted Additives

Substances used in food, including infant formula, must be safe and lawful. Substances that may be used in infant formulas are food ingredients that are generally recognized as safe (GRAS) for use in infant formula and those that are used in accordance with the FDA's food additive regulations (FFDCA 201(s) and 409). The USA uses its quality factor requirements to identify which ingredients are appropriate for use in infant formula. [1,3,4]

3.6 Permitted Flavors and Colors 

Please refer to the permitted ingredients and additives in the sections above.

3.7 Permitted Processing Aids 

3.8 Additional Notes 

The requirement for quality factor requirements coupled with the list of required levels for mandated nutrients allows some variation in product formulation but places significant responsibility on the manufacturer to demonstrate their requirements are being met. The Center for Food Safety and Applied Nutrition is responsible for the regulation of infant formula. The Office of Nutritional Products, Labeling, and Dietary Supplements (ONPLDS) has program responsibility for infant formula. The Office of Food Additive Safety (OFAS) has program responsibility for food ingredients and packaging.

ONPLDS evaluates whether the infant formula manufacturer has met the requirements under section 412 of the FFDCA. ONPLDS consults with OFAS regarding the safety of ingredients in infant formula and of packaging materials for infant formula. Under sections 201(s) and 409 of the FFDCA, OFAS evaluates the safety of substances intended for use in or in contact with infant formula. [1]

3.9 References

1. U.S. Food & Drug Administration (FDA) - Questions & Answers for Consumers Concerning Infant Formula

https://www.fda.gov/food/people-risk-foodborne-illness/questions-answers-consumers-concerning-infant-formula#1

2. Code of Federal Regulations (CFR) PART 107—INFANT FORMULA

https://www.ecfr.gov/cgi-bin/text-idx?SID=a2c4de1caf02e54daa22f106c6099831&mc=true&node=pt21.2.107&rgn=div5

3. 21 USC 348: Food additives

https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section348&num=0&edition=prelim

4. Strengthening the Current Processes to Evaluate New Ingredients for Infant Formulas

https://www.ncbi.nlm.nih.gov/books/NBK215833/