The U.S. Food and Drug Administration (FDA) has announced new recommended action levels for lead in certain processed baby foods. The proposed action levels supports the Closer to Zero initiative to continually reduce babies’ and young children’s exposure to toxic heavy metals from food.

The FDA draft guidance, titled, Action Levels for Lead in Food Intended for Babies and Young Children, covers processed foods—such as products packaged in jars, pouches, tubs, and boxes—intended for babies and children less than two years of age. Lead may be present in the aforementioned foods because the agricultural commodities the products are derived from—fruits, vegetables, grains, and animals—take up contaminants in the environment, as well as nutrients. Therefore, the covered foods can provide nutrients that are essential for child growth and development, but may also be a source of exposure to contaminants.

The draft guidance sets the following action levels: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 and puddings, and single-ingredient meats
  • 20 ppb for single ingredient root vegetables
  • 20 ppb for dry cereals.

FDA estimates that the new action levels could reduce babies’ and young children’s exposure to lead from the covered foods by 24–27 percent. To determine action levels for the different food categories, the agency considered, among other factors, variances in consumption levels of different food products and which foods take up higher amounts of lead from the environment. FDA also took into account the level of lead that could be present in a food without causing dietary exposure to exceed FDA’s Interim Reference Level, which is a measure of the contribution of lead in food to human blood lead levels.

Action levels are one regulatory tool 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 industry to achieve, but are meant to cause manufacturers to implement agricultural and processing measures to lower lead levels in food products.

The agency also set action levels for lead in juice in 2022.

Although not binding, FDA can reference proposed action levels when considering whether to bring enforcement action in a particular case. For all foods, with or without action levels, the agency will take action when it finds that the level of lead in a food is unsafe, which may include working with the manufacturer to resolve the issue and removing product from the U.S. market.

FDA will monitor industry’s progress in reducing the levels of lead in the foods identified in the draft guidance, while ensuring that manufacturers are putting in place any needed preventive controls to reduce or eliminate the presence of lead in products. In addition, FDA will continue to evaluate scientific advances in reducing the levels of lead in foods and the role nutrition plays in reducing the health impact of lead exposure.

Before finalizing the action levels, FDA will assess stakeholder comments, alongside other information and data, to determine if further adjustments are needed. The agency will also host a webinar to provide an overview of the draft guidance and answer stakeholder questions on Thursday, March 2, 2023 at 1:00 P.M. ET. Visit the registration page to register for the webinar or submit questions. FDA asks that questions be submitted by Thursday, February 9, 2023.

FDA asks stakeholders to submit written or electronic comments by March 27, 2023. Submit comments electronically on Regulations.gov to docket number FDA-2022-D-0278. Submit written submissions to: Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. All submissions received must include the Docket No. FDA-2022-D-0278 for Action Levels for Lead in Food Intended for Babies and Young Children: Draft Guidance for Industry.

Update, January 26, 2023: The article has been updated to include newly announced information about the FDA webinar on the action levels for lead in baby foods.

Update, March 28, 2023: FDA will reopen the comment period for 30 days for the proposed guidance.