New Baby Formula Bill Mandates Toxic Metal Limits Within 90 Days, Targeting Lead and Arsenic

The new Safe Baby Formula Act of 2025 is short, but it packs a serious punch for parents and anyone concerned about what’s in the food supply. Simply put, this bill mandates that the Department of Health and Human Services (HHS) must set hard limits on four specific heavy metals—arsenic, cadmium, mercury, and lead—in infant formula. This action has to happen fast: HHS only gets 90 days from the bill’s signing to establish these measurable limits (SEC. 3).

The 90-Day Regulatory Sprint

For busy parents, this is the most critical part: the bill forces the government’s hand on setting safety standards for known toxins in formula. Right now, safety guidelines can be vague or voluntary. This bill changes that by requiring HHS to set formal limits, either as “enforcement action levels” (triggers for regulatory intervention) or as official “maximum contamination levels” (SEC. 3). The 90-day turnaround is incredibly aggressive for a federal agency. While it’s great for getting action quickly, it means HHS will be under immense pressure to set standards without the usual long rulemaking process. If they choose the faster “enforcement action level” route, it gets the job done, but those levels might be easier to adjust later than formal contamination levels.

What They Are Studying (And Why)

Before the limits are set, the bill also requires a dedicated study. HHS must investigate the health effects of these four heavy metals found in infant formula on babies (SEC. 2). They have one year to complete this study. While the 90-day deadline for setting the limits is immediate, the one-year study provides the scientific backup needed to refine those standards later. For example, if a formula manufacturer has to overhaul its supply chain to meet the new 90-day lead limit, the one-year study will give them and the public better data on why that limit was chosen and how it affects infant development.

Impact on the Supply Chain

For infant formula manufacturers, this bill means compliance costs are coming, and they’re coming fast. They will need to ensure their products meet the new, measurable standards set by HHS within that 90-day window. This could involve stricter testing protocols, changes in sourcing ingredients, or new manufacturing processes. While the goal is safer formula for babies, the industry will bear the cost of compliance, which, depending on the severity of the new limits, could eventually be passed down to consumers. The bill keeps things straightforward by defining “infant formula” using the existing definition in the Federal Food, Drug, and Cosmetic Act (SEC. 4), so there’s no confusion about which products are covered.