SACRAMENTO, Calif. – Activist and social entrepreneur Hilary Swank is urging California lawmakers to pass Senate Bill 646, which would require prenatal vitamin manufacturers to test for and disclose levels of potentially harmful heavy metals in their products.
At the California Senate health committee’s first hearing on the bill, on April 2, Swank testified in favor of it.
“As a mom and entrepreneur, I am deeply committed to protecting my family and your families,” she said. “We know prenatal vitamins are essential for maternal and fetal health, but recent studies show that far too many contain heavy metals that can harm developing babies.”
Swank spoke on behalf of the Environmental Working Group, which is co-sponsoring the bill along with the American College of Obstetricians and Gynecologists and Unleaded Kids. State Sen. Akilah Weber Pierson, M.D. (D-San Diego) introduced S.B. 646 in February.
The bill comes as a new study prompts concerns about the heavy metals in prenatal vitamins, including arsenic, cadmium, lead and mercury, and their health risks. Published in Environmental Research, the study revealed that 15 percent of the prenatal vitamins tested contained lead exceeding California’s Proposition 65 threshold of 0.5 micrograms per serving.
Swank, the mother of twins and chief innovation officer at HealthyBaby, said in the Senate hearing that S.B. 646 will help with identifying lead and other heavy metals in vitamins. She said forcing companies to disclose their heavy metals test results will empower consumers.
Swank also noted how HealthyBaby – a prenatal nutrition and baby products company – tests and screens product ingredients before and after manufacturing to meet the rigorous standards set by California’s Proposition 65 list for heavy metals.
“Producing products for babies requires a constant dedication to improving our standards,” said Swank. “Testing and transparency should empower consumers while giving companies a framework to do better, raising the bar for maternal and infant health. There is no question this should be an industry-wide standard.”
Exposure to lead is linked to developmental issues, reduced fertility, organ system toxicity, cancer and other serious health problems.
Safer prenatal nutrition
If enacted, S.B. 646 would make California the first state to require tests for and disclosure of heavy metals in prenatal vitamins, setting a new standard for maternal health protections. In the absence of new federal rules, it would also create a model for other states.
It would require manufacturers to regularly test a representative sample of their prenatal vitamins for heavy metals. The bill would also mandate that manufacturers publicly disclose results on their websites starting in 2027, including the name and level of each toxic element.
S.B. 646 would also set clear vitamin labeling requirements with a QR code on packaging, linking consumers directly to the company’s heavy metal test results.
“Pregnant people deserve to know what’s in the vitamins they rely on for their health and their baby’s development,” said Melanie Benesh, EWG vice president for government affairs. “The presence of heavy metals in prenatal vitamins is deeply concerning. S.B. 646 will empower consumers with the information they need and drive industry-wide reform.”
S.B. 646 builds on the success of California’s Assembly Bill 899, which passed in 2023 and similarly requires tests for and reporting of heavy metals in baby food.
“California has a proud history of setting the standard for public health protections,” added Benesh. “S.B. 646 is the next step in that legacy – putting the health of moms and babies first.”
More evidence of metals concerns
The newly published study by researchers at the University of Miami, Clean Label Project and Ellipse Analytics adds to evidence concerning heavy metal levels in prenatal vitamins.
Fifteen percent of the products tested exceeded California’s Proposition 65 safety limit of 0.5 micrograms per day for lead. That’s the threshold beyond which manufacturers must place a warning label on their products for ingredients of concern, including lead.
Gummy and soft gel prenatal vitamins were below the limit of quantification for lead in the study. But most tablets and capsules tested contained measurable amounts of heavy metals, consistent with findings in previous investigations. Other heavy metals like arsenic and cadmium that have been found in prenatal vitamins are also linked to potential health harms.
A 2023 Government Accountability Office report found half of the prenatal vitamins it randomly sampled contained lead, and some had cadmium. The levels detected did not exceed the Food and Drug Administration’s recommended exposure limit of 8.8 micrograms per day for pregnant women. Even low levels can have profound and lasting effects on a developing fetus.
For pregnant women, the stakes couldn’t be higher. Unlike other optional supplements, they’re expected to take a prenatal vitamin daily. The vitamin should nourish and protect their growing babies – they shouldn’t jeopardize the unborn baby’s health because they’re contaminated with heavy metals.
Empowering consumers
Responsible prenatal vitamin companies already test for heavy metals. But no uniform standard or mandate requires it – and most manufacturers do not publicly disclose their results. If enacted, S.B. 646 would change that by creating transparency and accountability across the industry.
There is little federal oversight of prenatal supplements. They fall into a broader category of dietary supplements, overseen by the FDA. They’re classified as food products and subject to basic FDA regulations against adulteration and misbranding.
Dietary supplement manufacturers are expected to follow good manufacturing practices, but these guidelines allow companies to police themselves.
“U.S. law does not require vitamin companies to test for heavy metals or disclose test results to the public. This lack of oversight leaves the industry with no accountability and creates zero transparency for consumers,” said Benesh.
If enacted, S.B. 646 would empower consumers with crucial information while pushing companies to reduce contamination and improve product safety.
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The Environmental Working Group (EWG) is a nonprofit, non-partisan organization that empowers people to live healthier lives in a healthier environment. Through research, advocacy and unique education tools, EWG drives consumer choice and civic action.
