Frequently Asked Questions

Regulations

• What is an infant formula?

• How does FDA regulate infant formulas?

• Does FDA have nutrient specifications for infant formulas?

• Does FDA approve infant formulas before they are marketed?

Consumer Use

• How do parents know what formula to feed to their infant?

• Do infants fed infant formulas need to take additional vitamins and minerals?

• Do "house brand" or generic infant formulas differ nutritionally from name brand formulas?

• Some ingredient statements on infant formula labels include ingredients in addition to nutrients and familiar components such as milk. Why are those ingredients added?

• What does the "use by" date mean on infant formula product labels?

• What are counterfeit infant formulas? How can I avoid buying such products?

• I have seen bottled water marked for use in preparing infant formula. What does this mean?

• Are there approved recipes for homemade infant formulas?

"New" Ingredients

• I see formulas on the market that contain ingredients called DHA and ARA. What are these substances?

• What foods contain the fatty acids DHA (docosahexaenoic acid) and ARA (arachidonic acid)?

• Why is there interest in adding DHA and ARA to infant formulas?

• What is the evidence that addition of DHA and ARA to infant formulas is beneficial?

• I understand that oils containing DHA and ARA have been added to infant formulas for several years in other countries. Isn't there information from those countries on any long-term benefits or adverse consequences of formulas containing these fatty acids?

• Why has FDA asked infant formula manufacturers to do postmarket surveillance of infants consuming formulas containing ARA or DHA?

Reporting Problems

• How do I report a problem or illness caused by an infant formula?