FDA Proposes Cadmium Action Levels for Baby Food, From 10 to 45 Parts Per Billion
The draft guidance covers purees, cereals, yogurts and meats for children under two. FDA estimates the biggest exposure cuts would come from carrots and from fruits, vegetables and mixed foods.
FDA has proposed action levels for cadmium in packaged food for babies and toddlers. The draft guidance, issued Oct. 22, proposes levels from 10 to 45 parts per billion for foods meant for children under two.
TLDR
- The proposed levels range from 10 parts per billion for most fruits, vegetables and mixed foods to 45 for dry infant cereals.
- They are not legally binding, but FDA says a food at those levels may be regarded as adulterated.
- Infant formula, beverages, toddler drinks and snack foods are not covered.
- The Federal Register notice sets a Dec. 22 comment date, and FDA will hold a webinar on Nov. 16.
The Proposed Levels
FDA’s draft proposes five action levels. It also reports how many sampled foods already meet each one.
- Fruits, vegetables and mixed foods: 10 parts per billion, with 93% of samples at or below it. Single-ingredient carrots are excluded from this group.
- Single-ingredient carrots: 25 parts per billion, 84%.
- Dry infant cereals: 45 parts per billion, 98%.
- Yogurts, puddings and custards: 20 parts per billion, 100%.
- Single-ingredient meats: 25 parts per billion, 100%.
FDA based the levels on 1,430 samples of domestic and imported products collected from fiscal 2009 to fiscal 2024.
What It Would Change
FDA estimates the effect among the babies and toddlers who eat the most of these foods. Exposure would fall 32% for single-ingredient carrots and 28% for fruits, vegetables and mixed foods. Dry infant cereals would see a 5% cut.
Yogurts, puddings, custards and meats would see no change, because their levels are already very low. FDA says it set limits for them so those levels stay low.
The agency says cadmium has a half-life in humans of about 10 to 33 years, and that even low-level chronic dietary exposure can affect bones and kidneys. It also says cadmium is present in nature as an element in the earth’s crust and through pollution.
FDA says the levels are not meant to steer food choices, and it recommends that parents and caregivers feed children a varied, nutrient-dense diet.
What Comes Next
The Federal Register notice sets a Dec. 22 comment date for consideration before FDA begins the final guidance. FDA’s guidance page lists Jan. 21, 2027, a date Keller and Heckman ties to the companion chemical hazards guidance. FDA is still collecting data on grain-based snacks to decide whether an action level would be appropriate.
The Nov. 16 webinar will also cover a new draft chapter on controlling chemical hazards in food, part of a larger guidance for manufacturers.
Why It Matters
This is the latest step in Closer to Zero, the FDA program launched in 2021 to reduce heavy metals in food for babies and young children. FDA calls the levels achievable and says it expects industry to keep reducing them over time.
Sources: FDA draft guidance, Federal Register, FDA webinar notice, Keller and Heckman, Nutrition Insight.