Lead in Infant Formula: FDA Testing, Updates on State Legislative Efforts

By Tom Neltner & Mariah Walters Orose

What Happened

Spring 2026 brought new insights into arsenic, cadmium, lead, and mercury levels in infant formula from FDA. In addition, several states charted a path to long-term industry transparency that parents can use to make informed choices. For background, see our February 2026 blog.

FDA’s Testing: FDA released the market-basket survey results of its three-year infant formula testing program in April, describing the effort as the “largest and most comprehensive examination of chemical contaminants in infant formula available on the U.S. market and affirm that infant formula is safe.” The agency tested 16 brands and 312 samples from 2023 to 2025, finding:

• Arsenic in 94% of samples with a high of 4.7 ppb and a median of 0.5 ppb.
• Lead in 80% of samples with a high of 1.1 ppb and a median of 0.2 ppb.
• Cadmium in 66% of samples with a high of 1.5 ppb and a median of 0.2 ppb.
• Mercury in 6% of samples with a high of 0.3 ppb.

FDA indicated it is “working to establish action levels for contaminants in infant formula” and engaging with manufacturers “to discuss potential ways through which these contaminants may enter the supply chain . . . as well as measures to reduce the levels of these contaminants to as low as possible.”

Three States Advance Testing and Disclosure Bills: Vermont, New York, and California took significant steps to require infant formula manufacturers to test their products for arsenic, cadmium, lead, and mercury, and then make the results publicly available on their website with links on product labels. These requirements follow the approach first enacted in California’s AB 899¹ in 2023 followed by Maryland (HB 97)² in 2024, and Virginia (HB 1844)³ and Illinois (SB 73)⁴ in 2025.

Vermont became the first state⁵ to enact a law, H.536⁶ requiring testing and disclosure for infant formula and the fifth state to do so for baby food other than infant formula. However, in an implicit recognition that the state may not be big enough to drive the market, the requirements do not go into effect until the state’s attorney general finds that a substantially comparable law has taken effect in California or in two other states. The law gives the AG the authority to suspend the requirements if there is “insufficient infant formula in the State to meet the need or evidence of a declining supply.”

New York’s legislature became the second state to pass a bill, A9026A, that would require testing and disclosure for infant formula, and the sixth state to do so for baby food other than infant formula. The bill awaits Gov. Kathy Hochul’s signature, which is expected in November 2026. If enacted, companies must begin testing by January 2028 and publicly disclose their results a year later.

California’s Assembly passed AB-2302, which would require testing and disclosure for infant formula beginning January 2028. Now the Senate considers the bill. See our letter of support for the bill.

Why It Matters

“For infants who are not exclusively breastfed, the [American Academy of Pediatrics] recommends the use of iron-fortified infant formula for healthy infants for the first year of life. Approximately 75 percent of infants in the United States are receiving formula at age 6 months: 42.7 percent are exclusively formula-fed.”⁷

For parents who are reliant on infant formula, they must buy an infant formula that meets FDA’s standards and has been reviewed by the agency.

Unfortunately, FDA does not yet have standards for heavy metals and many other chemical contaminants in the product. Even when the agency sets action levels, they are designed to exclude products with the most significant contaminant levels, usually the top 5 to 10%.

For substances like lead with no safe level of exposure, parents need to know about contaminant levels so they can choose the brands with the lowest levels.

Some Important Nuances

Closing Some Perceived Loopholes: In our analysis of 39 baby food brands, we identified two compliance problems. First, some companies were requiring the shopper to provide proof of purchase or enter in a UPC for the product. One company required the consumer to accurately enter up to 28 characters. Second, no company had links to test results for a product from the product webpage, making it difficult for an online shopper to find.

The Vermont Law protects the shopper by prohibiting brands from requiring that people provide the UPC code or proof of purchase to access the information. It also requires brands to directly link the product webpage to the testing results.⁸ In addition, it gives consumers the right to report problems to the state attorney general’s office. California’s AB 2302 addresses the first problem but not the second.

Arsenic is Not a Heavy Metal: Some of the laws and bills incorrectly designate arsenic as a “heavy metal” or a “toxic heavy metal” instead of using FDA’s term “toxic element.” This is scientifically inaccurate since arsenic is a metalloid not a heavy metal.⁹ We encourage use of the FDA term or, in the alternative, “heavy metal and other chemicals.”

Skeptical of Florida’s Mercury Results. Before FDA’s report, Florida Department of Health released results in January of 24 infant formula products it tested. A shocking 16 of the 24 products exceed the state agency’s maximum daily limit for mercury and found levels between 0.3 and 10.7 parts per billion (ppb).

In contrast, FDA only detected mercury in 5% of the tested products using much more sensitive methods than Florida, reporting levels down to 0.07 ppb. Its highest level found was 0.3 ppb. Consumer Reports had none. We do not know why Florida found mercury so often at such high levels, but given the state agency’s lack of transparency, we are skeptical of its findings.

FDA Shifts to Claim Lead is Natural: FDA also subtly shifted its description of the toxic elements in food saying, “Contaminants can be present in foods, even in small amounts, due to their natural occurrence in soil, water, and air.” This is misleading because the vast majority of lead in soil, water and air are from decades of use of lead in fuel, pipes, paint, and a myriad of other sources. For a better description, see FDA’s Closer to Zero program which says “These contaminants may occur in the environment naturally (as elements in the earth’s crust) and from human activities. Levels in the air, water, and soil used to grow crops, process foods, and raise animals can vary depending on natural geographical differences and proximity to past or current pollution.”

Concentration v. Serving Size: FDA focused on the concentration of arsenic, cadmium, lead, and mercury in the product. In contrast Consumer Reports, Clean Label Project, and Florida Department of Health focused on the amount of each toxic element in a serving. This difference is important because a baby may rely entirely on a single type and lot of infant formula for nutrition, resulting in some significant exposures even if the concentrations are low. We encourage companies to publicly disclose both concentration and amount per serving.

Our Take

We applaud Vermont for this crucial step to close the gap in infant formula, and we hope California and New York will enact their bills. Based on the experience from California’s AB 899 on baby food, mandating that infant formula brands make the test results publicly available will provide a strong marketplace incentive to reduce contaminant levels. And, by doing so, better protect babies and drive contaminant levels closer to zero.

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1. Codified by California at Health and Safety Code §§ 110962-110963. ↩︎
2. Codified by Maryland at Health – General Code § 21-330.4. ↩︎
3. Codified by Virginia at § 3.2-5125.1 ↩︎
4. Codified by Illinois at 410 ILCS 620/11.7. ↩︎
5. Vermont also became the fifth state to require testing and disclosure of baby food (other than infant formula). Michigan is still considering legislation (HB 4865) for baby food (but not infant formula). ↩︎
6. Codified by Vermont at 18 V.S.A. § 4091. ↩︎
7. USDA and HHS, Scientific Report of the 2020 Dietary Guidelines Advisory Committee, Part D. Chapter 4: Human Milk and/or Formula Feeding. ↩︎
8. See 18 V.S.A. § 4091(d) ↩︎
9. The amended Assembly bill refers to the four toxic elements as heavy metals. Scientifically, arsenic is a metalloid and not a heavy metal even though it is commonly referred to as such. See https://en.wikipedia.org/wiki/Arsenic. See also https://en.wikipedia.org/wiki/Metalloid. For technical accuracy, we refer to the four toxic elements as “heavy metals and other chemicals.” ↩︎