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FDA Proposes New Nutrient Limits and Labeling Rules for Infant Formula

The move signals a phased overhaul with external scientific review, public comment, industry cost estimates, tighter supplier oversight, and more rulemaking to follow.

Overview

  • The FDA published a proposed rule that would change required levels for iodine, vitamin A, vitamin D and manganese and would set a maximum for manganese.
  • The proposal would change how vitamins A and D are measured on labels and allow a new form of vitamin A to be used in formula.
  • The agency reviewed chloride, selenium, potassium and sodium and found their current required levels appropriate, keeping them unchanged.
  • The action follows Operation Stork Speed, increased testing for heavy metals and recent product recalls and infant botulism cases that prompted the FDA to press companies to strengthen supplier oversight.
  • The FDA said it will seek public input, hold external peer review of the science, propose additional nutrient rules and then issue a single final rule, while estimating annualized industry compliance costs between $8.4 million and $31.7 million.