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FDA Reveals Final Lead Action Levels for Processed Baby Food

The FDA has provided final guidance on the amount of lead allowed in processed food for babies and young children.

FDA headquarters
The FDA's updated guidelines are designed to help reduce lead levels in processed baby foods.
Sara Silbiger via Getty Images

The FDA has established final lead action levels for processed baby food to reduce contamination exposure in infants under two years old. The limits range from 10 to 20 parts per billion depending on food type.

  • Action levels set: 10 ppb for fruits, vegetables, mixtures, yogurts, custards, and single-ingredient meats
  • Root vegetables and cereals: 20 ppb for single-ingredient root vegetables and dry infant cereals
  • Scope: Applies to jarred, pouched, and boxed baby foods; excludes formula, beverages, and snack foods
  • Why it matters: Babies and young children are more susceptible to adverse health effects from lead contamination
  • FDA initiative: Part of Closer to Zero program to minimize dietary contaminant exposure while maintaining nutritious food access

The U.S. Food and Drug Administration (FDA) has issued industry guidance on the action levels of lead in processed food intended for babies and young children. The levels reflect the point at which the organization can render such food products containing led as having diminished quality and safety, per a Jan. 6 press announcement.

“The guidance titled ‘Action Levels for Lead in Processed Food Intended for Babies and Young Children: Guidance for Industry’ supports our Closer to Zero initiative to reduce dietary exposure to contaminants, including lead, in foods to as low as possible over time, while maintaining access to nutritious foods," the FDA says.

The action levels are intended for babies and children under the age of two. The levels are as follows:

  • 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 single-ingredient root vegetables
  • 20 ppb for dry infant cereals

The FDA’s final guidance covers food products in jars, pouches, tubs or boxes, and may include ready-to-eat foods such as purees and semi-prepared foods like dry infant cereals. The organization says the guidance is not intended to cover infant formula, beverages, or snack foods like puffs and teething biscuits.

The FDA informs that lead contamination occurs naturally and as an environmental pollutant in air, water, and soil. Lead can enter the food supply when plants and animals ingest the contaminant. Food possessing small traces of lead can still be a source of essential nutrients. However, babies and young children are more prone to adverse health effects from such contaminants. Thus, the FDA aims to reduce exposure to foods that contain higher levels of impurities.

Action levels help lower the amount of lead present in food products, which is helpful considering a certain level of contamination is unavoidable, the FDA states. The organization conducted a thorough process to identify action levels and continues to collect data to keep manufacturers updated and in regulatory compliance for their products. 

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