FDA Issues Draft Guidance for Industry on Action Levels for Lead in Baby Foods

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The U.S. Food and Drug Administration issued for public comment “Action Levels for Lead in Food Intended for Babies and Young Children: Draft Guidance for Industry.”
The draft guidance supports the FDA’s goal of reducing dietary exposure to lead, arsenic, cadmium and mercury, and the associated health effects, while maintaining access to nutritious foods.
Foods covered by this draft guidance are those processed foods, such as food packaged in jars, pouches, tubs and boxes, that are represented or purported to be specifically for babies and young children less than two years of age. Lead may be present in these foods because agricultural commodities they are made from—fruits, vegetables, grains, and animals— take up contaminants in the environment in much the same way they take up nutrients. In this way, these foods can provide nutrients essential for child growth and development, but they may also be a source of exposure to contaminants.
The draft guidance contains the following action levels: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.
While it is not possible to remove lead entirely from the environment or the food supply, it is possible to lower lead levels in foods. Action levels are one regulatory tool the FDA uses to help lower levels of chemical contaminants in foods when a certain level of a contaminant is unavoidable. Action levels are not intended to set the lowest levels for the industry to achieve.
Although not binding, the FDA would consider these action levels, in addition to other information, when considering whether to bring an enforcement action in a particular case. For all foods, with or without action levels, when the agency finds that the level of the lead causes the food to be unsafe, we take action, which may include working with the manufacturer to resolve the issue and taking steps to prevent the product from entering, or remaining in, the U.S. market.
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