Health

FDA Proposes First Major Update to Infant Formula Standards in 30 Years

FDA Proposes First Major Update to Infant Formula Standards in 30 Years

By Basant El-Faramawy

The FDA on Thursday proposed a rule to update nutrient requirements for infant formula, marking the first major overhaul of standards in nearly three decades, according to the Department of Health and Human Services.

Updated nutrient requirements

The proposed rule would revise requirements for vitamin A, vitamin D, iodine and manganese while reaffirming existing standards for chloride, potassium, selenium and sodium. It would also change the units of measure for two nutrients and seek public input on adding ingredients such as arachidonic acid (ARA), docosahexaenoic acid (DHA) and L-carnitine, which some studies link to infant growth and brain development.

Phased review and contaminant testing

The FDA said additional phases will examine remaining required nutrients, potential new requirements and carbohydrate sources. The agency also released new data showing most infant formula samples tested had low or non-detectable levels of chemical contaminants.

Officials emphasize safety

“Parents deserve confidence in every bottle they feed their baby,” HHS Secretary Robert F. Kennedy Jr. said in a statement. “We will hold infant formula manufacturers to rigorous scientific standards and put babies’ health first.”

Background

Last year, HHS and the FDA launched “Operation Stork Speed” to review the nutritional quality of infant formula. Under current law, the HHS secretary reviews the table of required nutrients every four years. The FDA currently mandates 30 nutrients in infant formulas, with minimum amounts for all and maximum amounts for 10.

Seed oil debate

Former FDA commissioner Dr. Marty Makary last year suggested removing seed oils from formulas, citing inflammation concerns. However, doctors have told ABC News that seed oils are not pro-inflammatory and can improve cholesterol and insulin sensitivity.

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