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FDA Announces Baby Food Draft Guidance

Specialty Food Association

The FDA announced the release of draft guidance on action levels for lead in processed foods that are intended for babies and children under two years of age. The modification will help reduce potential health effects in babies and children from dietary exposure to lead.

The action levels would result in significant reductions in lead exposure from food while ensuring the availability of nutritious foods. The action is part of the Closer to Zero initiative, the FDA's science-based approach to reducing exposure to lead, arsenic, cadmium, and mercury to the lowest levels possible in foods eaten by babies and young children.

"For more than 30 years, the FDA has been working to reduce exposure to lead, and other environmental contaminants, from foods. This work has resulted in a dramatic decline in lead exposure from foods since the mid-1980s. The proposed action levels announced today, along with our continued work with our state and federal partners, and with industry and growers to identify mitigation strategies, will result in long-term, meaningful and sustainable reductions in the exposure to this contaminant from foods," said FDA commissioner Robert M. Califf, M.D., in a statement. "For babies and young children who eat the foods covered in today's draft guidance, the FDA estimates that these action levels could result in as much as a 24-27 percent reduction in exposure to lead from these foods."

Foods covered by the draft guidance, Action Levels for Lead in Food Intended for Babies and Young Children, are those processed foods intended for babies and young children less than two years old.

The draft guidance contains the following lead action levels:

• 10 parts per billion for fruits, vegetables, mixtures, yogurts. custards/puddings, and meats.

• 20 ppb for root vegetables.

• 20 ppb for dry cereals.

Baby foods have differing action levels to account for variances in consumption levels of different food products and due to some foods taking up higher amounts of lead from the environment, explained the FDA. 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, for example, due to environmental factors.

"This approach helps your children get important nutrients and may reduce potential harmful effects from exposure to contaminants from foods that take up contaminants from the environment," said Susan Mayne, Ph.D., director of the FDA's Center for Food Safety and Applied Nutrition, in a statement.   

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