On January 6, 2025 FDA issued a Final Guidance for Industry on Action Levels for Lead in Processed Food Intended for Babies and Young Children. The Guidance establishes the following action levels for when FDA may consider a product adulterated:
- 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.
The Guidance clarifies that the action levels are not intended to direct consumers in making food choices. FDA recommends parents and caregivers feed children a varied and nutrient-dense diet across and within the main food groups of vegetables, fruits, grains, dairy, and protein foods.
The Final Guidance replaces the Draft Guidance issued on January 25, 2023. While the action levels remain the same, the Final Guidance clarifies the foods that the guidance addresses, including the age range of the foods’ intended consumers; adds information about the method that FDA uses to test for lead in food; and updates the exposure and achievability assessments based on the analysis of additional samples from FDA’s Toxic Elements Program and special FDA surveys.
Background
In 2021, FDA established Closer to Zero as an action plan to reduce babies’ and young children’s dietary exposure to contaminants to the lowest levels possible while maintaining access to nutritious foods. FDA acknowledges that heavy metals occur naturally in the environment and cannot be completely avoided in fruits, vegetables or grains that are often the basis for baby foods, juices, and infant cereals. As part of Closer to Zero, FDA is establishing action levels for lead, arsenic, cadmium, and mercury in various food categories, through an iterative process over a few years, on a timeline set forth on the agency’s website.
FDA defines action levels as concentration levels for poisonous or deleterious substances at which the agency may deem a food to be adulterated within the meaning of section 402(a)(1) of the Federal Food, Drug, and Cosmetic Act (FDCA). See 21 CFR 109.6(d). While action levels are not binding, FDA will consider them, among other factors, when deciding whether to bring enforcement action in a particular case. Over the past few decades, even before Closer to Zero, FDA has issued action levels in various food categories under this authority through guidance.
Lead Action Levels
While no safe level of lead exposure has been identified, FDA developed interim reference levels (IRLs) of 2.2 μg/day for children and 8.8 μg/day for women of child-bearing age. The IRLs are tied to blood lead levels and represent the dietary lead needed to achieve a blood lead level 10 times lower than that associated with the Centers for Disease Control and Prevention’s blood level reference value. The IRLs represent the maximum daily dietary intake of lead from food.
The Final Guidance specifies that the action levels apply to processed foods, meaning “packaged food (e.g., in jars, pouches, tubs, or boxes) represented or purported to be for babies and young children less than two years old.” Processed foods may include “ready-to-eat foods (e.g., purees) as well as semi-prepared foods (i.e., dry infant cereals).” FDA makes no mention of dietary supplements, which do not appear to be intended to be covered by this Final Guidance.
In developing the action levels for foods intended for babies and young children, FDA considered the population’s intake of the food (exposure) and the maximum level of lead that could be in the food without causing the IRLs to be exceeded. As part of the evaluation, FDA reviewed data collected from its Toxic Elements Program (TEP), special FDA surveys, and the agency’s Total Diet Study (TDS). FDA also considered achievability, i.e., manufacturers’ ability to achieve the lead action levels. Achievability is based on percentiles of lead concentrations in individual samples surveyed.
The agency explained that it took into account the following considerations in evaluating possible action levels:
- the action level should minimize the likelihood that a consumer will be exposed to lead levels exceeding the IRL;
- as appropriate, there should be a limited number of unique action levels for simplicity;
- the action levels should result in a reduction in exposure to lead; and
- for those baby foods where lead levels are already relatively low, the action levels should be established where achievability is near the 90th-95th percentile range.
Based on these considerations, FDA identified the action levels for lead in processed food intended for babies and young children listed above. The agency set these action levels based on both the levels of lead found in these food categories and the exposure of babies and young children to these foods.
- FDA found fruits, vegetables (excluding single-ingredient root vegetables), mixtures, yogurts, custards/puddings, and single-ingredient meats tend to have low levels of lead, and therefore established an action level of 10ppb with an achievability rate of 97%.
- Single-ingredient root vegetables have higher lead levels for which FDA found the achievability rate at 10 ppb to be difficult, only 79%. Consequently, FDA established a 20 ppb action level for single-ingredient root vegetable products. In establishing this action level, FDA also considered that root vegetables are a source of several nutrients important in the growth and development for babies and young children.
- A 10 ppb action level was also determined to be too difficult for dry infant cereals, which FDA acknowledges is often the only solid food consumed for an extended period of time for many infants. FDA therefore established an action level of 20 ppb with an achievability rate of 91%.
Although these action levels are not binding, the agency will consider them in determining whether to bring enforcement action against a product as adulterated. FDA encourages manufacturers to maintain these action levels to reduce risks associated with dietary lead exposures.
If you have any questions concerning the material discussed in this client alert, please contact the members of our Food, Beverage, and Dietary Supplements practice.
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