What Happened
The California legislature unanimously passed SB-646 requiring that, starting in 2027, prenatal multivitamins must be tested for arsenic, cadmium, lead, and mercury, with the results disclosed on the brand’s website. Senator Akilah Weber Pierson, an obstetrician-gynecologist practicing in San Diego, authored the bill. Unleaded Kids, Environmental Working Group, and District IX of the American College of Obstetricians and Gynecologists (ACOG District IX) cosponsored it. Governor Gavin Newsom must now sign the bill for it to become law.
What Would be Required by SB-646?
Beginning January 1, 2027, a manufacturer of a prenatal multivitamin product that is sold, manufactured, delivered, held, or offered for sale in California must test a representative sample of each lot of the product for arsenic, cadmium, lead, and mercury. The lab analyzing the product must meet specific standards including demonstrating proficiency in testing for the four toxic elements to 10 parts per billion (ppb or µg/kg) or less. The manufacturer must provide those results to California Department of Public Health upon request.
A manufacturer can be the owner of the brand under which the product is sold or a separate company making the product under contract for a brand owner. The testing requirement applies even if the product made in the state is exported.
Also beginning January 1, 2027, the brand owner of a packaged prenatal multivitamin product that is sold, manufactured, delivered, held, or offered for sale in California must “make publicly available” the test results as follows:
- Post testing results for each lot of each product on its website for the shelf life of the product plus one month. The results must be accompanied by mandatory language1 that explains that minerals may contain trace levels of heavy metals2 and the levels may vary based on the ingredients in the product. The posting must also provide a link to FDA’s website relating to heavy metals in food.
- The brand owner’s webpage describing the product must have a statement that reads “For information about heavy metal testing on this product” followed by a hyperlink to the webpage that contains the publicly available test results.”
- For a product sold in a retail store, the outermost package must have the same statement followed by the web address where the information is posted.
- For a product sold online or directly to consumers, the product details page on a website (not just the brand owner’s) where the product is sold, must include a similar statement followed by the web address where the information is posted.
The brand owner is not allowed to require the public to provide a UPC number, a lot number, or proof-of-purchase to access the testing results.
Why it Matters
Prenatal lead exposure presents significant risks to both the pregnant person and their fetus. Even low level exposures are associated with subtle harms that can last a lifetime. These risks, which include preeclampsia and embolisms, were made clear at the recent National Lead and Healthy Housing Conference, where Eric Bind of New Jersey Department of Health presented the results of mercury and lead biomonitoring for thousands of parent-child pairs tested at birth in Newark, New Jersey.
While pregnant people are exposed to lead from many significant sources, prenatal multivitamins represent an opportunity to drive down the risk by using marketplace transparency to empower informed choices by pregnant people. As explained in our April blog, a study of 156 brands of commercially available prenatal multivitamins averaged 79 ppb of lead with a maximum of 900 ppb. One in six of these products have levels below 10 ppb.
With this much variation in lead levels, clearly there are opportunities to reduce exposure closer to zero, consistent with FDA’s goals.
Our Take
We applaud Senator Weber Pierson for authoring the bill and were honored to be a cosponsor. Through our analysis of baby food manufacturer’s compliance with California’s AB-899, enacted in 20233 in collaboration with Consumer Reports, we have seen that this type of transparency provides a compelling marketplace incentive for companies to source and process ingredients that are lower in arsenic, cadmium, lead, and mercury without compromising quality or nutrition. The model is so powerful that Maryland, Virginia, and Illinois have followed California’s lead.
Importantly, SB-646 improves on the AB-899 approach by addressing several shortcomings that have arisen as companies have made it unnecessarily difficult for consumers to access the test results that are supposed to be publicly available.
How does SB-646 improve on the approach used for baby food?
California’s SB-646 used AB-899 as a starting point but made the following improvements to help consumers:
- Prohibits brand owners from requiring the public to provide a UPC number, a lot number, or a proof-of-purchase to access the testing results. As explained in our blog, 18 of 39 baby food companies require consumers to accurately type in a lot code. One company requires entry of as many as 28 characters to see the test results.
- Linking the brand owner’s webpage describing a product to the test results. We found that no baby food company provided this connection, leaving many consumers unaware that the test results are available and could help them as they make buying decisions.
- Requiring the brand owners to provide a link to the test results when third-parties such as Amazon, Walmart, Target, or other online retailers sell their products. The linkage will help consumers who do not buy directly from the brand owner become aware that the test results are available so they could consider it when selecting a prenatal multivitamin.
There are two other differences between SB-646 and AB-899’s approaches:
- SB-646 uses 10 ppb as the upper limit for lab testing in contrast with the 6 ppb in AB-899. We understand that because of the other minerals in prenatal multivitamins, the lower reporting limit could pose problems for labs. As with the baby food counterparts, we hope that prenatal multivitamin manufacturers will seek out and use labs that go beyond the minimum.
- SB-646 refers to arsenic, cadmium, lead, and mercury as heavy metals even though arsenic is not heavy and not really a metal. AB-899 refers to them as toxic elements, consistent with FDA. The legislature settled on heavy metals for SB-646 because it was believed to be more informative for consumers.
- “Prenatal multivitamins containing certain minerals critical to support an expectant person’s health and proper development of their fetus may contain trace levels of heavy metals that occur in the environment naturally or from human activities. The levels of heavy metals in prenatal multivitamin ingredients may vary depending on whether and at what levels the prenatal multivitamin contains these ingredients, as well as the location from which the ingredients are sourced. Certain foods containing minerals critical to support an expectant person’s health and proper development of their fetus may also contain heavy metals. For more information, speak with your physician about choosing a prenatal multivitamin that meets your specific nutrient needs.” ↩︎
- The four toxic elements are referred to as heavy metals even though arsenic is not heavy nor a metal. ↩︎
- Amending §§ 110962-3 to California’s Health and Safety Code. ↩︎