FDA Issues Final Guidance Setting Action Levels for Lead in Food Intended for Babies and Young Children

Background

The Final Guidance¹ substantially mirrors FDA’s Draft Guidance, issued in January 2023,² and represents a highly anticipated step in the agency’s Closer to Zero³ action plan to reduce childhood exposure to contaminants in food, such as lead. The Final Guidance reflects the agency’s view that lead exposure represents a substantial risk for babies and young children.

FDA has recognized that lead is an unavoidable contaminant in the food supply. Lead is widely present in the environment due to both natural occurrences and contamination from human activities. Because of this, lead may be present in the soil or water used to grow crops, which in turn may cause certain foods to absorb small amounts of lead.  

To determine whether this lead exposure could be a health concern, FDA developed interim reference levels (IRLs) for dietary lead intake, which represent a maximum recommended daily dietary intake of lead from food. The IRLs are not regulatory limits or action levels.  Rather, they are estimates used by the FDA in assessing the safety of lead exposure from food. FDA updated the IRLs for lead in 2022 and set the IRL for children at 2.2 µg/day.  Although no safe level of lead exposure has been identified for children’s health, the agency believes the IRL serves as a useful benchmark in evaluating the potential for adverse effects of dietary lead.  In setting the present action levels, FDA considered the intake of the covered foods at 90th percentile consumption levels and the maximum level of lead that could be in the food without causing the IRL to be exceeded if consumed at the 90th percentile consumption level.

The agency’s action levels are based on testing data collected through the agency’s Toxic Elements Program (TEP),⁴ Total Diet Study (TDS),⁵ and FDA special surveys⁶.  The agency used these data to conduct an exposure assessment, first by identifying current lead levels in foods intended for babies and young children, and second by evaluating the ability of industry to achieve lower lead levels with and without the proposed action levels. FDA’s review of the data show that different types of food exhibit different lead concentrations. For example, the agency noted root vegetables can absorb lead more readily from the soil than other crops. FDA then set the final action levels with several considerations in mind, including:

• 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 in the 90th-95th percentile range.

Final Action Levels

The final action levels represent the level at which FDA may consider a food adulterated within the meaning of section 402(a)(1) of the Federal Food, Drug, and Cosmetic Act (FFDCA). Although not binding, FDA considers action levels, in addition to other information, when considering whether to bring enforcement action in a particular case. FDA emphasized that these action levels are not intended to direct consumers in making individual food choices. FDA continues to recommend that 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 to support their growth and development.

According to the Final Guidance, the action levels apply to processed foods “represented or purported to be” for babies or children under two. “Processed foods,” in turn, includes “packaged foods (e.g., in jars, pouches, tubs, or boxes),” which may include ready-to-eat foods (e.g., purees) as well as semi-prepared foods (e.g., dry infant cereals). Notably, the Final Guidance does not apply to the following foods:

• Raw agricultural commodities
• Homemade foods (e.g., fruit purees prepared at home)
• Snack foods, including grain-based or freeze-dried snacks (e.g., arrowroot cookies, puffs, rusks, teething biscuits)⁷
• All beverages, including infant formula and toddler drinks
• Juice

While the Final Guidance does not apply to juice, FDA has issued a separate draft guidance that would set 10 ppb as the level for apple juice and 20 ppb for all other juices.⁸

FDA estimates that the proposed action levels would reduce dietary exposure to lead for babies and young children by 19-29% at the 90th percentile consumption levels for each of the covered food categories. The chart below summarizes the final action levels and their estimated achievability.

Next Steps

It is unclear what, if any, impact the new administration’s Executive Orders will have on this guidance.  The recent Regulatory Freeze Executive Order has created substantial confusion regarding the status of recent actions taken by the prior administration, including this guidance.⁹ At this time, it is unclear whether the Trump Administration will allow these recent actions to stand.

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Please contact us if you have any questions regarding the Final Guidance or any other matters.