Prenatal multivitamins.

Document header changed from enrolled bill format (Senate/Assembly passage lines, Governor receipt line) to chaptered format with 'STATE OF CALIFORNIA AUTHENTICATED ELECTRONIC LEGAL MATERIAL' and 'CHAPTER 602' designation.

Page numbers changed from 91 to 90 and page headers changed from 'SB 646' to 'Ch. 602' throughout the document.

The blank approval line at the end was replaced with the Governor's initial and the formal approval date of October 11, 2025, confirming the bill became law on that date.

The term 'toxic elements' is replaced with 'heavy metals' throughout the bill. A new definition of 'heavy metals' (arsenic, cadmium, lead, and mercury) is added as a separate defined term.

The definition of 'manufacturer' is restructured: it now means either (1) a brand owner that manufactures a prenatal multivitamin, or (2) a person who manufactures but is not the brand owner. The old definition referenced whose name appears on the label or federal regulation identification.

The definition of 'brand owner' no longer requires that the person 'offers for sale or sells the prenatal multivitamin in the state.' It now only requires owning or licensing the most prominent trademark on the principal display panel.

The definition of 'prenatal multivitamin' removes 'Omega-3 fatty acids' from the list of qualifying ingredients. It now requires the product to contain 'one or more vitamins or minerals.' A new sentence adds that prenatal multivitamins may be in forms including capsules, tablets, gummies, liquids, or powder.

The testing requirement in Section 110424.1(a) now applies only to manufacturers, removing brand owners from the obligation to test. Brand owners retain the duty to provide test results upon request but no longer must conduct testing themselves.

The definition of 'packaged prenatal multivitamin product' removes the requirement that the label bear a unique UPC. It now states the label 'may include, but is not required to have, a unique universal product code (UPC),' broadening coverage to products without UPCs.

The disclosure requirement in Section 110424.2 now applies only to brand owners (previously both manufacturers and brand owners). The required website statement is replaced with new language about heavy metals occurring naturally or from human activities, and the supplement facts panel information is restructured.

A new requirement is added in Section 110424.2(f)(2): for products sold online or directly to consumers shipped on or after January 1, 2027, the product details page on the internet website where the product is sold must include a statement about heavy metal testing with a hyperlink to the disclosure page.

The laboratory analytical method requirement is strengthened from 'at least as sensitive' to 'at least as sensitive and specific,' and the FDA Elemental Analysis Manual reference is expanded with the full title of the referenced document.

Section 110424.3 changes the prohibited actor from 'a person or entity' to simply 'a person,' removing the explicit reference to entities.

The term 'toxic elements' is replaced with 'heavy metals' throughout the entire bill. The separate definition of 'toxic elements' (which had the same meaning: arsenic, cadmium, lead, and mercury) is eliminated, leaving only the 'heavy metals' definition.

The definition of 'prenatal multivitamin' no longer includes the reference to 'Reference Daily Intakes and Daily Reference Values that are specified for this intended group when calculating percent Daily Values as required by Section 101.9(c)(8) and (9) of Title 21 of the Code of Federal Regulations.' This removes a specific federal regulation cross-reference from the statutory definition.

A new prohibition is added in Section 110424.2(f)(3): on or after January 1, 2030, a person shall not sell, manufacture, deliver, hold, or offer for sale in the state a prenatal multivitamin that does not include the packaging or online statements required by paragraphs (1) and (2). This creates a specific enforcement deadline for the labeling requirements, separate from the general compliance date of January 1, 2027.

The mandatory public disclosure statement on brand owner websites is rewritten. The old language said 'Prenatal multivitamins may contain varying levels of toxic elements' and warned about higher levels unless ingredients came from low-level sources. The new language says '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,' adding context about natural and human-caused sources and noting that certain foods also contain heavy metals.

Section 110424.2(f) is restructured: previously it was a single paragraph covering retail store products. It is now split into (f)(1) for products sold in retail stores shipped to retailers on or after January 1, 2027, and (f)(2) for products sold online or directly to consumers shipped to consumers on or after January 1, 2027, making the two channels' requirements more clearly distinct.

In Section 110424.1(b)(3), the word 'at least' is removed from the proficiency threshold language, changing 'to at least heavy metal to 10 micrograms or less' to simply 'to 10 micrograms or less.'

The definition of 'prenatal multivitamin' was narrowed by removing 'or Omega-3 fatty acids' from the required ingredients. A product now only qualifies if it contains vitamins or minerals (not just Omega-3s) and is represented for use by pregnant, planning-to-be-pregnant, or lactating individuals.

The definition of 'manufacturer' was restructured to reference Section 109970 for the meaning of 'manufactures' and now distinguishes between (1) a brand owner that manufactures a prenatal multivitamin and (2) a person who manufactures but is not the brand owner.

The definition of 'brand owner' was narrowed by removing the requirement that the entity 'offers for sale or sells the prenatal multivitamin in the state.' It now only requires owning or licensing the most prominent trademark on the principal display panel of the product label.

A new compliance pathway was added in Section 110424.1(c): if a brand owner does not manufacture the product itself, it may satisfy the test results provision by providing the test results of the manufacturer it uses to produce the product.

The public disclosure obligation in Section 110424.2 was shifted from the 'manufacturer's internet website' to the 'brand owner's internet website,' making brand owners (not necessarily manufacturers) responsible for posting toxic element testing information publicly.

A new requirement was added in Section 110424.2(a)(2): the brand owner must include, on the same webpage as the toxic element data, the product's supplement facts panel information (level per serving of each nutrient ingredient) and a specific disclaimer statement advising consumers that toxic element levels vary and recommending they speak with their physician.

Both Section 110424.2 (disclosure) and Section 110424.3 (prohibition) were expanded to explicitly cover prenatal multivitamins sold by a retailer as well as those sold directly to consumers, closing a potential gap in the bill's applicability to different sales channels.

The FDA link requirement was simplified from directing consumers to 'FDA guidance and information about the health effects of the toxic elements on fetuses, infants, children, and individuals who are pregnant, planning to become pregnant, or lactating' to simply an 'FDA webpage relating to toxic elements in food.'

Header changed from amendment tracking dates to 'Passed the Senate September 13, 2025' and 'Passed the Assembly September 13, 2025,' reflecting final passage by both chambers.

Line-number annotations (e.g., 'line 1', 'line 2') that were present in the amended version were removed in the enrolled version, as is standard for final bill formatting.

The legislative counsel's digest changed from 'SB 646, as amended, Weber Pierson' to 'SB 646, Weber Pierson,' dropping the 'as amended' language now that the bill is in its final enrolled form.

A Governor's approval block was added at the end of the document with blank fields for date and time of receipt by the Governor.

A new 'brand owner' definition is added, and all major obligations (testing, providing results to the department, public disclosure) now apply to both manufacturers AND brand owners. A brand owner is defined as the person or entity who owns or licenses the most prominent trademark on the product label and offers for sale in the state.

A new explicit definition of 'manufacturer' is added, covering either a person/entity whose name appears on the product label or a person/entity for whom the product is manufactured or distributed as identified under federal regulations (16 CFR 500.5(a)).

The definition of 'prenatal multivitamin' is expanded to include products containing Omega-3 fatty acids in addition to vitamins or minerals, and adds language referencing FDA Reference Daily Intakes and Daily Reference Values for the intended population group.

A new federal preemption provision states that if ISO/IEC 17025:2017 accreditation standards contradict federal regulations under the Federal Food, Drug, and Cosmetic Act pertinent to supplements, the federal regulations shall control.

The QR code requirement on product labels (requiring a machine-readable code linking to test results and FDA guidance) is removed from the disclosure section.

A new retail store labeling requirement is added: for products sold in retail stores, the outermost package must include a statement reading 'For information about toxic element testing on this product, visit' followed by the relevant website URL.

The bill is restructured from a single Section 110424 containing all requirements into separate sections: 110424 (definitions), 110424.1 (testing and laboratory requirements), 110424.2 (public disclosure), and 110424.3 (prohibitions). The old 'final prenatal vitamin product' definition is replaced with separate 'bulk' and 'packaged' product definitions.

The laboratory accreditation standard language is narrowed from general competence of testing and calibration laboratories to competence 'as they pertain to the testing of toxic elements.'

The bill now covers 'prenatal multivitamins' in addition to 'prenatal vitamins.' The new category is broader: it includes any dietary supplement containing one or more vitamins or minerals represented for use by individuals who are pregnant, planning to become pregnant, or lactating (changed from 'breastfeeding').

New definitions added for 'bulk prenatal multivitamin product' (finished dosage form before packaging and labeling) and 'packaged prenatal multivitamin product' (packaged for sale with a UPC on the label).

New Section 110424.1 requires manufacturers of prenatal multivitamins to test a representative sample of each lot of bulk or packaged product at a proficient laboratory for toxic elements (arsenic, cadmium, lead, mercury). Unlike the original section which only covered 'final' products, this allows testing at the bulk stage before packaging.

New Section 110424.2 requires that, starting January 1, 2027, manufacturers of packaged prenatal multivitamin products disclose toxic element testing information publicly on their website for the duration of product shelf life plus one month. A key consumer protection: the information must be accessible without the user providing a UPC number, lot number, or proof of purchase.

Section 110424.1(b) explicitly permits a manufacturer's in-house laboratory to serve as the proficient laboratory for prenatal multivitamin testing, whereas the original section did not address this.

New Section 110424.3 prohibits selling, manufacturing, delivering, holding, or offering for sale any prenatal multivitamin that does not comply with the new requirements, creating a separate enforcement provision from the existing one for prenatal vitamins.

The testing unit changed from 'production aggregate' to 'lot' throughout. The definition of 'product shelf life' was clarified to reference the time 'as printed on the product label.'

Subparagraphs in subdivision (b)(1) were renumbered: the original had subparagraphs (A) through (D), and the amended version shows a blank (D) line followed by what was previously (D) now labeled (C). This appears to be a clerical renumbering rather than a substantive change, as all four requirements (testing, pre-packaging testing option, monthly testing frequency, and providing results to the department) remain intact.

Page numbers throughout the bill changed from 99 to 98, reflecting minor pagination shifts due to formatting adjustments.

Added a new definition of 'lot' as a batch or specific identified portion of a batch that is uniform and intended to meet specifications for identity, purity, strength, and composition, with a separate provision for continuous-process dietary supplements.

Changed the testing requirement from each 'production aggregate' to each 'production aggregate lot,' tying the testing obligation to a more specific unit of product.

Changed the consumer disclosure requirement from disclosing toxic element levels for each 'production aggregate' to each 'production aggregate lot.'

Removed the requirement that manufacturers test each final prenatal vitamin product for toxic elements at least once per month, eliminating a specific minimum testing frequency.

Added the phrase 'as specified' to the bill summary's description of what provisions apply to prenatal vitamin manufacturers, providing a slightly broader reference to the detailed requirements in the operative text.