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FDA Launches Deep Review of Infant Formula with June 4 Roundtable

Health Secretary Robert F. Kennedy Jr. ordered a yearlong examination of formula composition with public input due September 11.

FILE - Yury Navas, 29, of Laurel, Md., kisses her two-month-old baby Jose Ismael Gálvez, at Superbest International Market in Laurel, Md., May 23, 2022, while looking for formula. (AP Photo/Jacquelyn Martin, file)
A woman holds a bottle of baby formula as she feeds her infant son in San Antonio on May 13, 2022.

Overview

  • The FDA convened a two-hour roundtable on June 4 under “Operation Stork Speed,” marking the first in-depth ingredient review since 1998.
  • Officials will increase testing for heavy metals and other contaminants and seek data on whether required nutrients should be added, removed or adjusted.
  • Experts are urging the agency to align U.S. formula standards with the latest global research and consider harmonizing benchmarks like iron levels with European rules.
  • Families, manufacturers and government agencies have until September 11 to submit feedback as the agency undertakes its comprehensive review.
  • About 75% of U.S. infants use formula in their first six months, with 40% relying on it exclusively, highlighting the review’s stakes for early nutrition.