New FDA Guidelines for Action Levels of Lead in Baby Food Products

Legislative and regulatory efforts to address consumer concerns about heavy metals in baby food have gained significant momentum. California’s Assembly Bill (AB 899) requiring monthly testing for contaminants such as arsenic, lead, cadmium, and mercury exemplifies this push. As of January 1, manufacturers must make heavy metal test results publicly accessible on their websites, with QR codes on product labels providing consumers an easy way to access detailed information. Although this law applies only to baby food produced or sold in California, major manufacturers like Gerber and Beech-Nut are implementing QR code transparency nationwide. 

Complementing state-level actions like AB 899, the U.S. Food and Drug Administration (FDA) issued final guidance establishing action levels for lead in processed foods intended for babies and young children under two years old, in January 2025. The guidelines set maximum allowable levels for lead in baby foods, including jarred fruits and vegetables, yogurts, and dry cereal. These regulations represent a critical step in reducing young children’s exposure to harmful contaminants while challenging manufacturers to ensure compliance and maintain consumer trust. 

The FDA’s Closer to Zero Initiative 

The FDA’s Closer to Zero initiative underscores its commitment to reducing childhood exposure to toxic heavy metals. The initiative has outlined a phased approach to achieving these reductions by introducing mandatory testing and labeling requirements as well as establishing science-based action levels for heavy metals and encouraging industry compliance. For manufacturers, these changes signal a shift toward more rigorous oversight and heightened accountability.   

Overview of New FDA Maximum Levels for Lead for Baby Food 

The latest update from FDA and the Closer to Zero initiative is guidance titled “Action Levels for Lead in Processed Food Intended for Babies and Young Children: Guidance for Industry.” The guidance helps to address how much lead is allowed in baby food. The action levels for Lead in processed foods described in the guidance 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; and 
• 20 ppb for dry infant cereals. 

These levels represent the thresholds at which the FDA may consider a food to be adulterated under the Federal Food, Drug, and Cosmetic Act. The FDA estimates that adherence to these action levels could result in a 24-27% reduction in exposure to lead from these foods. While these guidelines are currently non-binding, they serve as a critical benchmark for manufacturers to assess and adjust their products to ensure safety and compliance. 

Action levels for lead in juices are addressed in a separate draft guide, the FDA’s Guidance for Industry: Juice Hazard Analysis Critical Control Point Hazards and Controls Guidance (Juice HACCP Guidance). The guidance does not cover infant formula, beverages, or snack foods like puffs and teething biscuits.  

How Does Lead Get into Baby Food? 

Lead and other contaminants can enter baby food products through multiple pathways, primarily due to its presence in nature and the environment. Soil contamination from industrial pollution, past use of lead-based pesticides, and atmospheric deposition can result in lead uptake by crops. Ingredients like fruits, vegetables, and grains used in baby food production may absorb lead during growth if the soil or water contains trace amounts. Additionally, lead contamination can occur during manufacturing and processing through machinery or packaging materials. 

While these trace levels are often unavoidable due to the pervasive nature of lead in the environment, manufacturers can minimize their presence by sourcing raw materials from suppliers who adhere to stringent agricultural practices and implementing rigorous quality control measures. This highlights the importance of compliance with FDA action levels and the use of advanced testing protocols to ensure the safety of baby food products. 

Implications for Baby Food Manufacturers 

While the FDA guidelines are currently only recommendations and not legally enforceable, they still create a pressing need for manufacturers to adapt their practices and operations to align their products with the recommendations. Baby food manufacturers should begin evaluating their current nutritional testing partners and testing protocols. Understanding advancing nutritional analysis technologies, such as ICP-MS or atomic absorption spectrometry, may become standard to meet the precise requirements. 

Transparency is another critical aspect. With laws like California’s AB 899 mandating publicly accessible testing data via QR codes on product labels, manufacturers must invest in systems to communicate compliance effectively. 

Moving Forward 

The FDA’s new guidelines mark a significant shift in how manufacturers approach baby food production. By focusing on safety, transparency, and compliance, companies not only protect public health but also strengthen their position as trusted leaders in an industry where accountability and consumer trust are paramount. Although these changes present challenges, they align with the growing consumer demand for safer and healthier options for babies and young children.

To learn more, visit the FDA’s official pages on the Closer to Zero initiative and environmental contaminant testing or consult with industry experts for tailored compliance strategies.