FDA issues final rule for baby formula labels

Starting June 22, baby formula labels will be required to list the mineral selenium under required nutrients.

The Food and Drug Administration (FDA) rule also establishes a safe range for selenium in infant formula. According to the agency, the mineral found in breast milk is an essential nutrient for infants. Among its benefits, it helps the body defend against oxidative stress and helps in the regulation of thyroid hormones.

But in its final rulemaking, which will be published in the Federal Register later this week, the FDA said evidence exists for both deficiency and toxicity of selenium.

“Because infant formula often serves as a sole source of nutrition for infants, selenium in infant formula is needed to ensure that formula-fed infants are getting this essential nutrient at appropriate levels,” the agency said in a news release.

Under the rule, 2.0 micrograms of selenium per 100 kilocalories is the minimum level, and 7.0 micrograms per 100 kilocalories is the maximum level of selenium in infant formula.

The agency said U.S. manufacturers began adding selenium to infant formula after the Institute of Medicine recognized it to be an essential nutrient for infants in 1989. All infant formulas on the U.S. market now contain selenium.