Frequently Asked Questions

Regulations for Industry

• Guidance for Industry: FDA's Regulation of Infant Formula March 1, 2006
  • 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 Questions

• 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?

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?