What Happened
Starting with California in 2023, four states (CA, IL, MD, and VA) have enacted bills requiring baby food companies to test each lot of their product for arsenic, cadmium, lead, and mercury (“toxic elements”1) and then make the results publicly available on the brands’ websites. This year, six more states (CT, MI, NY, PA, VT, and WV) are considering similar legislation. Based on California’s example, all ten currently exempt infant formula from the definition of baby food.
In response to three studies of toxic elements in infant formula (below), Maryland Delegate Deni Taveras introduced HB 196 to remove the exemption for infant formula. The Infant Nutrition Council of America (INCA), which represents several leading domestic manufacturers, opposed the bill, saying they already test their products, and results show they meet the European Union and international standards. The EU limits are between 5 and 20 parts per billion (ppb) depending on the source and whether it is sold as liquid or powder.2 INCA also argued that Maryland should wait for FDA to set action levels as part of Operation Stork Speed. Finally, the group said, the word “toxic” would be potentially alarming for parents, pushing them to unsafe options.
Unleaded Kids testified in support the bill, pointing out that FDA’s Closer to Zero Program acknowledges that there is no safe level of lead in children’s blood. We explained that FDA and EU limits are designed to remove from the market only those top 5% or 10% of products with the highest levels of toxic elements. They do not give parents the option to choose products with the lowest contaminant levels. Disclosing test results complements FDA’s action levels by giving manufacturers an incentive to drive toxic elements levels closer to zero rather than meet the action levels. In addition, claims that parents will overreact and buy unsafe alternatives are unfounded and contradict the experience with baby food.
We also asked for amendments to improve public availability of the results by not requiring parents to provide a UPC number, a lot number, or a proof of purchase when they seek to view the test results. It also would require webpages describing the product to include a link to the test results so parents know the information is available. We made the same requests in testimony before the Vermont House Committee.
What Did The Three Studies Say About Infant Formula?
| Summary of Three Studies of Toxic Elements in Infant Formula | |||
| Consumer Reports | Clean Label Project | Florida Dept. of Health | |
| Number of Products | 41 | 59 | 26 |
| Arsenic | ND to 19.7 ppb in inorganic form | 0.3 to 12.2 ppb | ND to 14.3 ppb |
| Cadmium | Below level of concern | ND to 8 ppb | ND to 8.4 ppb |
| Lead | 1.2 to 4.2 ppb | ND to 8.7 ppb | ND to 40.7 ppb* |
| Mercury | Not detected | Not provided | 0.3 to 10.7 ppb |
| Other Toxics Tested | BPA, acrylamide, and PFAS | Bisphenol A & S, two ortho-phthalates, and glyphosate | Pesticides |
| Published | March 2025 | September 2025 | January 2026 |
| Notes | Inorganic form of arsenic is primary risk. | More than four times the EU limit. No explanation of methods. | |
Consumer Reports said “some of the results were concerning: about half of the samples we tested contained potentially harmful levels of at least one contaminant. But it was also reassuring to see that the other half of the samples showed low or no levels of concerning chemicals — showing that there are many good options on the market.”
As part of Healthy Florida First Initiative, Governor Ron DeSantis said the Florida Department of Health “found elevated levels of heavy metals like mercury in 16 [of 26 samples], pointing to systemic problems in sourcing or manufacturing.” Note that one of the products, ironically one that touts its brain development benefits, apparently exceeded the EU limit for lead by 4 times, undermining INCA claims.
Why Did California Exempt Infant Formula?
The California bill that passed the Assembly in 2023 included infant formula, but the Senate exempted it in the face of industry opposition. The Assembly agreed to the change to enact the law.
The infant formula industry raised three primary concerns with requiring testing and disclosure of arsenic, cadmium, lead and mercury in their products:
- Avoid disruption to fragile market: In the summer of 2023, the infant formula market was slowly regaining its footing after massive recalls by Abbott Nutrition, a major manufacturer in February 2022. Those recalls resulted in widespread shortages and interventions by President Biden to stabilize the supply and meet parents’ demands. The market is now robust.
- Insufficient studies of toxic elements in infant formula: Unlike baby food, there were no comprehensive studies of toxic elements in infant formula. FDA’s Total Diet Study (TDS) regularly detected the toxic elements with lead as high as 10 ppb, and cadmium and arsenic around 6 ppb. It did not detect mercury. The TDS is based on a composite sample of several products, providing no insight into the variations that would be important to provide consumers with real choices. The three studies published in 2025 and 2026 have filled that gap and show parents have safer options.
- FDA already closely scrutinizes the products: Unlike baby foods, infant formulas require premarket approval by FDA for safety and nutrition. However, that review has come under intense scrutiny and prompted FDA to commit to improvements.
Why It Matters
For many babies, especially in their first few months, infant formula is their sole source of nutrition. As explained by Healthy Babies Bright Futures in its March 2025 comments on Operation Stork Speed, its “research found that, on average, formula contributes over a quarter of dietary lead exposure and a fifth of arsenic exposure for children under two. … The agency’s commitment to increasing testing for toxic heavy metals and other contaminants, alongside updating nutrient standards, has the potential to drive meaningful improvements in formula safety. These long-overdue measures can help reduce exposures that pose risks to infant brain development and ensure that all babies receive the best possible start in life.”
Our Take
The industry concerns that prompted California’s legislature to exempt infant formula have been resolved:
- The market is now stable. In addition, disclosure will not disrupt that stability because it only provides parents with options.
- The three studies in the past year show concerning levels of toxic elements in infant formula. They also show sufficient variation to give parents real options.
- The experience with baby foods shows that parents will not overreact to presence of toxic elements and companies will strive to reduce levels closer to zero.
We encourage states build on the success of baby food testing and disclosure laws by:
- Including infant formula in the program to enable parents to make more informed choices.
- Prohibiting companies from requiring parents to provide a UPC number, a lot number, or a proof of purchase when they seek to view the test results.
- Requiring webpages describing the product to include a link to the test results so parents know the information is available.
- Using the term “toxic element” on the product label instead of the inaccurate term of “toxic heavy metal.”
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- FDA, California, Maryland, and Illinois use the term “toxic element” for arsenic, cadmium, lead, and mercury. Some refer to them as toxic heavy metals, However, arsenic is neither heavy nor a metal. ↩︎
- EU’s limits for lead and arsenic are 20 ppb for products on market as powders and 10 ppb for liquid products. For cadmium, the limits are 10 ppb for powdered cow’s milk, 5 ppb for liquid cow’s milk, 20 ppb for powdered soy protein, 10 ppb for liquid soy. There are no EU limits for mercury. ↩︎