In October 2025, California Governor Gavin Newsom signed into law Senate Bill
(SB) 646, which requires, among other things, the testing of prenatal multivitamins for heavy metals and public disclosure of the results. Below is a summary of SB 646's requirements, which are effective January 1, 2027 unless stated otherwise.
Heavy Metal Testing Requirements
Manufacturers of bulk or packaged prenatal multivitamins must test a representative sample of each lot of their product for heavy metals. Manufacturers and brand owners must provide the test results to California's Department of Public Health upon request.
The laboratory that does the testing must:
- Be accredited to ISO/IEC 17025:2017 standards for heavy metal testing
- Use an analytical method that is at least as sensitive and specific as the one in FDA's Elemental Analysis Manual for Food and Related Products − Section 4.7
- Demonstrate proficiency in quantifying each heavy metal to 10 μg/kg through an independent proficiency test. Proficiency means that a laboratory achieves a z-score of ≤ ±2
Public Disclosure Requirements for Brand Owners
Brand owners of packaged prenatal multivitamins must make publicly available on a single webpage (1) the name and level of each heavy metal present in each lot of product; (2) information from the Supplement Facts Panel, including the amount per serving of each ingredient; and (3) the following statement:
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 required webpage must be accessible during the shelf life of the product plus one month.
Packaging and Online Disclosure Statements
Brand owners must include certain information on product packaging or webpages, depending on whether the product is shipped to retailers or sold directly online to consumers. Products shipped to retailers must include on the outer packaging this statement: "For information about heavy metal testing on this product, visit" followed by the web address of the webpage discussed above. Products sold online, direct to consumer, must include on the product webpage the same statement followed by a hyperlink to the webpage containing the required information. Products that do not include these packaging or online statements may not be sold or offered for sale in California starting January 1, 2030, regardless of when they were manufactured.
Additional Obligations for Brand Owners
Last, SB 646 imposes additional duties on brand owners aimed at making consumer access to heavy metal testing results and information easier. These obligations include:
- Making the testing information publicly available without requiring a UPC number, a lot number, or proof of purchase
- Providing descriptive information (e.g., product name, UPC, size, or lot numbers) on their website so the public can accurately identify the product and view heavy metal levels by lot
- Including on their website a hyperlink to the most recent FDA webpage on heavy metals in food
- Prominently providing the statement "For information about heavy metal testing on this product" on the website describing the product, followed by a hyperlink to publicly available test results
Preparing for Compliance
Although many of SB 646's requirements do not take effect until 2027, it is important for manufacturers and brand owners to begin preparing now. For example, companies should assess their current heavy metal testing practices and confirm if their laboratory partners meet the bill's accreditation and proficiency standards.
Please contact Venable's Food and Drug Law team if you have any questions about SB 646's requirements or preparing for its implementation.