Realities of FDA’s “Closer to Zero” Heavy Metals Strategy

Originally Published: April 26, 2023
Last Updated: April 26, 2023
Realities of FDA’s “Closer to Zero” Heavy Metals Strategy -2023CLC

The FDA has long known of heavy metals, notably lead, cadmium, arsenic and mercury, in foods such as those made for infants and young children. The agency revealed its first draft guidance titled “Closer to Zero” in January 2023. FDA’s “Closer to Zero” heavy metals strategy begins with action levels for lead in infant foods.

Baby food samples and those made for young children (n=686) were collected and tested from 2014 to 2020. “All food categories had mean lead concentrations below 10ppb except for root vegetables, which had a mean concentration of 11.6ppb,” as reported in the Food Business News article “FDA Draft Guidance Establishes Lead Levels for Baby Food” [].

So, how do the results from 686 samples tested for lead compare to FDA’s “Closer to Zero” draft guidance? The proposed limits are:

  • 10 ppb for fruits, vegetables (excluding single-ingredient root vegetables); mixtures (including grain and meat-based mixtures); yogurts; custards/puddings and single-ingredient meats.
  • 20ppb for root vegetables (single ingredient)
  • 20 ppb for dry cereals.

[Source: “Food Safety Priorities for 2023,” Food Processing,]

The guideines seem reasonable, yet 13 industry groups, including the American Bakers Association and the North American Millers’ Association, question how these action levels were established, according to the Food Business News article “FDA Lead Proposal Lacking Details, Industry Groups Say,” [].

These industry groups expressed concern about whether the small sample sizes used sufficiently account for the variability of lead in different growing regions. Also of concern are challenges in the supply chain and growing region limitations (i.e., certain crops must be grown in certain climates and can’t simply be moved elsewhere if lead levels are higher in one region than another).

Walter Brandl, Regional Director of Chemistry, North America—Mérieux NutriSciences, and Bill Adams, MBA, Product Manager, North America—Mérieux NutriSciences, co-presenters at Global Food Forums’ 2023 Clean Label Conference, will provide clarity on many of the issues and realities surrounding the “Closer to Zero” Guidance Proposal [].

The FDA estimates its proposed “Closer to Zero” Heavy Metals strategy can potentially reduce lead exposure in food for babies and young children by as much as 24%-27%. Only time will tell.