Lead in Cadmium: FDA’s Strange Draft Action Levels for Cadmium in Baby Food

What Happened

FDA released draft guidance on October 22 proposing action levels for cadmium in food intended for babies and young children (“baby food”). As with its January 2025 final guidance for lead in baby food, both documents are focused on processed, packaged food “represented or purported to be for babies and young children less than two years old.” Because they are not processed food, the agency excludes raw agricultural commodities and homemade foods, even though they may well have higher levels of toxic elements.

The agency also exempted snack foods, beverages, and infant formula from the action levels even when intended for babies and toddlers. Snack foods often have higher levels of cadmium (and lead) than many products covered by the proposal.

The proposed cadmium action levels in baby food covered by the draft guidance are: 

• 45 parts per billion (ppb) for dry infant cereals;¹
• 25 ppb for single-ingredient carrots and single-ingredient meats;
• 20 ppb for yogurts, puddings, and custards; and
• 10 ppb for the remainder.

For comparison, the lead action levels that FDA set almost two years ago for covered baby food are:

• 20 ppb for dry infant cereals or single-ingredient root vegetables;² and
• 10 ppb for the remainder.

Why It Matters

While Unleaded Kids is intensely focused on lead, we consider cadmium a priority because it is also a toxic element with many health effects that overlap those of lead. And both are commonly found in food, though cadmium is often found at higher levels. 

With long-term exposure, cadmium can accumulate³ in the body to levels that may damage kidneys and make bones weak and brittle. Dietary exposure is also associated with neurodevelopmental and endocrine effects. The National Toxicology Program classifies cadmium as a known human carcinogen.

Regarding young children, CDC’s draft Toxicological Profile for cadmium, released earlier this month, says “studies in animals indicate that exposure to cadmium during pregnancy and/or early life may damage the developing nervous system. Adverse effects observed in animal studies included alterations in learning and memory, social behavior, and sensory and motor function. These effects are presumed to be relevant for humans.”

How Do Lead and Cadmium in the Diet Compare?

In 2023, FDA’s scientists established a Toxicological Reference Value (TRV) for cadmium that they consider protective of health. The TRV is 0.21 to 0.36 micrograms of cadmium per kilogram of body weight per day (µg/kg-bw/day). The agency uses the lower level to evaluate the action level. This means that for an average 12-month-old infant weighing 10 kg (or 22 pounds), the dietary intake should be below 2.1 µg/day, slightly lower than the 2.2 µg/day interim reference level (IRL) that FDA has set for lead.⁴

Based on FDA’s 2024 dietary exposure study, more than 10% of infants and young children exceed the IRL for lead.⁵ The situation is far worse for cadmium, where almost half of infants and roughly three-quarters of children one to six years of age get too much from their diet.⁶

FDA’s Criteria to Set Cadmium Action Levels

The agency explains in the draft guidance that it uses four criteria to set action levels for cadmium. Specifically:

1. The action level should minimize the likelihood that a consumer will be exposed to cadmium levels exceeding the lower bound of the TRV (0.21 µg/kg-bw/day);
2. As appropriate, there should be a limited number of unique action levels for simplicity;
3. The action levels should result in a reduction in exposure to cadmium when implemented; and
4. For those baby foods where cadmium levels are already relatively low, the action levels should be established where achievability is near the 90th-95th percentile range.

These criteria are similar to those FDA used to finalize action levels for lead in baby food in January 2025.

Potential Impact of Proposed Cadmium Action Levels

FDA estimates that the 90^th percentile of dietary exposure for babies and young children with the action levels will be below 0.21 µg/kg-bw/day, the lower bound of the TRV. However, this calculation only counts the categories of food covered by the guidance. It appears to exclude the contribution from:

• Snacks, infant formula, and beverages even when they are marketed for children younger than two years of age;
• Raw agricultural products and homemade food that young children may eat; and
• Processed food that eaten by but not marketed to children under two years of age.

The table below provides the breakdown of mean and 95th percentile concentrations for food in each category and the estimated reduction for the children in the top 10% eating the food.

Processed baby food	Draft cadmium action level	Mean conc. of food in category	95th percentile conc. of food in category	Est. reduction in 90th percentile of dietary intake
Dry infant cereals	40 ppb	15 ppb	39.9 ppb	5%
Single-ingredient carrots	25 ppb	12.7 ppb	37.7 ppb	32%
Single-ingredient meats	25 ppb	0.5 ppb	1.6 ppb	0%
Yogurts, puddings, & custards	20 ppb	0.9 ppb	2.1 ppb	0%
Other fruits, vegetables, & mixtures	10 ppb	1 to 4.4 ppb*	3 to 15.1 ppb*	28%
Snack foods, infant formula, and beverages	None	Unknown	Unknown	0%
* The mean and 95th percentile were 1 ppb and 3 ppb for fruits; 4.4 ppb and 15.1 ppb for mixtures; and 4.2 ppb and 14 ppb for mixtures.

Our Take

For almost a decade, Unleaded Kids’ Tom Neltner has been working with FDA on the issue of lead, cadmium, arsenic, and mercury in baby food. We watched FDA make incremental progress from announcing a working group in 2017 to launching its Closer to Zero program in April 2021 in response to a scathing Congressional report and public outrage.

We thought FDA had turned a corner when it proposed lead action levels for baby food in January 2023 and provided extensive comments to strengthen the proposal. Two years later, FDA finalized the proposal with few changes and failed to respond to any of our comments.⁷

Given his strong support of the Make America Healthy Again movement, we hoped that former FDA  Commissioner Makary would see the flaws, and we submitted a petition for reconsideration on February 7, 2025, asking him to fix the agency’s lead in baby food guidance by:

1. Removing the exemptions for packaged snack foods, beverages, and infant formula.
2. Setting an action level no higher than 4 ppb for infant formula and all its ingredients.
3. Narrowing the 20 ppb action level for dry infant cereal to only those products with rice as the primary ingredient and for single-ingredient root vegetables to only carrots or sweet potatoes.
4. Reducing the action level for all processed baby foods to 7 ppb with a delayed effective date of January 1, 2027.
5. Expanding the scope of the guidance to food intended for children younger than six years of age with a delayed effective date of January 1, 2028.

Twenty months later, FDA has failed to respond to the petition for reconsideration, and it has continued the flaws, all without its rationale. We will submit comments regarding these proposed action levels, but we have little hope for real fixes given the agency’s track record.

With the context in mind, we find the proposed action levels for cadmium to be strange and perplexing, largely because the agency has failed to follow its own criteria.

• The number of tiers of action levels have doubled from two for lead to four for cadmium without explaination. The four tiers undermine the goal of simplicity.
• Carrots and dry infant cereal have similar cadmium concentrations yet get dramatically different action levels. Their 90^th percentile and 95^th percentile concentrations are less than 5.5% apart.⁸ Yet baby food containing only carrots is assigned an action level of 25 ppb that 84% can achieve while dry infant cereal gets an action level of 45 ppb that 98% can achieve. FDA provides no explanation for letting cereals off the hook, while making deeper cuts for carrots than any other category. It is even more confusing because FDA acknowledged that “carrots are a source of several nutrients important in growth and development for babies and young children” while citing nothing similar for cereal.
• FDA makes “yogurts, puddings, and custards” a distinct category and assigns them an action level of 20 ppb. Based on the agency’s criteria, the action level should be ten times lower at 2 ppb, roughly the 95^th percentile. Given FDA’s apparent reluctance to set an action level below 10 ppb, these dairy products could easily have been folded into the default action level of 10 ppb and still have had 100% achievability. Unfortunately, FDA’s proposal removes the incentive for industry to drive cadmium levels closer to zero and could create the perverse incentive not to source ingredients with the lowest contamination.
• Similarly, FDA makes single-ingredient meats into a separate category and assigns them an action level of 25 ppb even though its 95^th percentile was 1.6 ppb, more than 15 times lower. As with dairy products, meats could easily have been folded into the default action level of 10 ppb and still have had 100% achievability.

While we think it would still be insufficient, applying FDA’s criteria, the action levels should be:

• 20 ppb for dry infant cereals or single-ingredient carrots;⁹ and
• 10 ppb for the remainder.

We also have a more fundamental concern with FDA’s approach: the agency is ignoring a wealth of more detailed data that covers all baby food, including snacks and beverages. As a result of legislation passed by California, Maryland, Virginia, and Illinois, since 2025 baby food companies have been required to test each lot of their product for arsenic, cadmium, lead, and mercury, and post the results on their website. The laws also require the companies to provide all the data to the state on request.

FDA should have worked with one or more of the states to obtain this data so they could understand in detail what is currently on the market and what the impact of the action levels would be. This data would strengthen—not necessarily replace—the agency’s own testing efforts.

FDA can and must do better to protect children from cadmium that harms their kidneys, bones, developing nervous system and may undermine their learning and memory, social behavior, and sensory and motor function. Given the overlap in risks, the agency should consider the combined effect of both lead and cadmium rather than treating them in isolation.

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1. Dried cereals without additions as well as dried cereals containing dried fruits or vegetables (e.g., apples, bananas, carrots). ↩︎
2. Food that consists of either carrots or sweet potatoes, with or without additional ingredients such as water or preservatives. ↩︎
3. FDA reports cadmium having a long half-life of 10 to 33 years. ↩︎
4. FDA sets the IRL to keep a child’s dietary contribution of lead to less than 0.35 µg/deciliter (µg/dL) of blood or 1/10^th of CDC’s Blood Lead Reference Value. FDA acknowledges “there is no known safe level of exposure to lead” and has a Closer to Zero program designed to iteratively reduce the exposure. ↩︎
5. One in ten children in each age group (0 to 11 months and 1 to 6 years) consumed at least 2.4 microgram of lead per day (µg/day), exceeding FDA’s IRL of 2.2 µg/day. Note that we use the hybrid method as the best estimate for lead exposure. Under this method, FDA set values for foods with no history of detections (using data from Total Diet Study collections 2013–2020) to zero and set non-detected values for foods in the same dataset that have one or more detected values to half the Reporting Level. This is based on Xue et al. 2010. The issue is important for lead where 86% of the samples had no detectable levels and 63% of the 307 food types had no detections from 2013-2020. The issue was less important for cadmium levels 39% of the samples had no detectable levels and 30% of the 307 food types had no detections from 2013-2020. ↩︎
6. FDA estimates that the mean dietary intake for an infant is 0.19 µg/kg-bw/day and the child is exposure to 0.43 µg/kg-bw/day. Compare these intakes to the lower bound of the TRV of 0.21 µg/kg-bw/day. ↩︎
7. Because action levels are established through guidance and not rulemaking, the agency does not think it has an obligation to respond to comments. ↩︎
8. Carrots have a mean of 12.7 ppb, 90th percentile of 30.5 ppb and 95th percentile of 37.7 ppb. Dry infant cereal has a mean of 15 ppb, 9oth percentile of 29.8 ppb, and 95th percentile of 39.9 ppb.  ↩︎
9. Food that consists of either carrots or sweet potatoes, with or without additional ingredients such as water or preservatives. ↩︎