FDA Releases Draft Guidance for Action Levels for Lead in Baby Food

On January 24, the U.S. Food and Drug Administration released the draft guidance, Action Levels for Lead in Food Intended for Babies and Young Children, for industry on action levels for lead in processed baby foods. The document provides action levels for a variety of foods, including processed food packaged in jars, pouches, tubs, and boxes. This action is part of Closer to Zero, which outlines FDA’s approach to reducing exposure to lead, arsenic, cadmium and mercury in foods eaten by babies and young children under two.

The FDA has included differing action levels to account for the variances in consumption levels of different food products. The levels also account for the differences in the amount of lead the food takes up from the environment. The draft guidance contains the following action levels:

  • 10 parts per billion (ppb) for fruits, vegetables (excluding single-ingredient root vegetables), mixtures (including grain and meat-based mixtures), yogurts. custards/puddings and single-ingredient meats.
  • 20 ppb for root vegetables (single ingredient).
  • 20 ppb for dry cereals.

The public can provide comments on the draft guidance until March 27.