FDA sets standards for infant formulas

The US Food and Drug Administration (FDA) recently published an interim final rule, revising its infant formula regulations to help ensure the quality of these manufactured foods.

The rule, along with 2 drafts of documents containing guidance for manufacturers of infant formulas, establishes requirements for good manufacturing practices and minimum nutritional quality.

According to the interim final rule, the requirements are meant to “prevent the manufacture of adulterated infant formula and ensure that nutrients . . . are present in a form that is bioavailable and safe.”

The rule identifies 2 important quality factors in infant formulas. It stipulates that formulas must provide for normal physical growth and that the protein component must be of sufficient biologic quality.

To satisfy the first factor, manufacturers must conduct a growth monitoring study using the formula. To satisfy the biologic protein quality factor, manufacturers must conduct a Protein Efficiency Ratio rat bioassay.

Prior to this rule, manufacturers were not required to demonstrate either of these quality factors to the FDA.

The FDA notes that many companies currently manufacturing infant formula in the United States already voluntarily adhere to many of the requirements and procedures included in the new interim final rule.

Major health organizations around the world advocate breastfeeding, especially for the first 6 months of life. However, according to the Centers for Disease Control and Prevention’s data on babies born in 2010, only about half are exclusively breastfed by 7 days of age; about one-third are exclusively breastfed by 3 months of age; and only about 16% are exclusively breastfed by 6 months of age, meaning the remainder are receiving at least some infant formula.

The FDA is accepting comments from the public on the interim final rule for 45 days at www.regulations.gov (Docket Number FDA-1995-N-0036).

To get weekly clinical advice for today's pediatrician, subscribe to the Contemporary Pediatrics eConsult.