Overview of Infant Formulas
What is an Infant Formula?
Infant formulas are liquids or reconstituted powders fed to infants and young children. They serve as substitutes for human milk. Infant formulas have a special role to play in the diets of infants because they are often the only source of nutrients for infants. For this reason, the composition of commercial formulas is carefully controlled and FDA requires that these products meet very strict standards.
How does FDA regulate Infant Formulas?
The safety and nutritional quality of infant formulas are ensured by requiring that manufacturers follow specific procedures in manufacturing infant formulas. In fact, there is a law -- known as the Infant Formula Act -- which gives FDA special authority to create and enforce standards for commercial infant formulas. Manufactures must analyze each batch of formula to check nutrient levels and make safety checks. They must then test samples to make sure the product remains in good condition while it is on the market shelf. Infant formulas must also have codes on their containers to identify each batch and manufacturers must keep very detailed records of production and analysis.
How do I report a problem or illness caused by an infant formula?
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.
If you think your infant has suffered a serious harmful effect or illness from an infant formula, your health care provider can report this by calling FDA's MedWatch hotline at 1-800-FDA-1088 or by using the website www.fda.gov/medwatch/report/hcp.htm. The MedWatch program allows health care providers to report problems possibly caused by FDA-regulated products such as drugs, medical devices, medical foods and dietary supplements. The identity of the patient is kept confidential.
Consumers may also report an adverse event or illness they believe to be related to the use of an infant formula by calling FDA at 1-800-FDA-1088 or using the website www.fda.gov/medwatch/report/consumer/consumer.htm. FDA would like to know when a product causes a problem even if you are unsure the product caused the problem or even if you and the baby do not visit a doctor or clinic.
Are there approved recipes for homemade infant formulas?
FDA regulates commercially available infant formulas, which are in liquid and powder forms, but does not regulate recipes for homemade formulas. Great care must be given to the decision to make infant formulas at home, and safety should be of prime concern. The potential problems associated with errors in selecting and combining the ingredients for the formula are very serious and range from severe nutritional imbalances to unsafe products that can harm infants. Because of these potentially very serious health concerns, FDA does not recommend that consumers make infant formulas at home.
Product that consumers have inquired about: Recipe for Homemade Formula Developed by a Naturopath
- Recently FDA has become aware of a homemade infant formula
recipe which is attributed to a naturopath at a company that makes
nutritional supplements. It has been distributed to at least one
Down's Syndrome support group. The recipe includes the ingredients
flaxseed oil, maple syrup, and beta-carotene. A review of the recipe
suggests that a formula made using the recipe would have several
deficiencies including too few calories and a nutrient content that would
be insufficient, or in some cases too high. In addition, the
instructions for use are imprecise and susceptible to error.
For more information, see the FDA Letter to American Academy of Pediatrics.
I have seen bottled water marked for use in preparing infant formula. What does this mean?
The manufacturers of infant formula provide directions for mixing their products with water and usually do not specify the source of water other than to indicate that the water should be safe to drink. In most situations, it is safe to mix formula using ordinary cold tap water that is brought to a boil and boiled for one minute or as directed on the label of the infant formula. Some water companies wish to make available bottled waters which are marketed for infants and for use in mixing with infant formula. When manufacturers label their water as intended for infants, the water must meet the same standards established for tap water by the Environmental Protection Agency. The label must also indicate that the bottled water is not sterile. As with tap water, consumers should boil bottled water one minute before mixing with infant formula. Water that is sterilized by the manufacturer and intended for use with infants must meet certain strict FDA standards.
Office of Special Nutritionals, May 1997
Reproduced from the Food and Drug Administration.