Chapter 4.5 - Prenatal Multivitamins

California Health and Safety Code — §§ 110424-110424.3

Sections (4)

Added by Stats. 2025, Ch. 602, Sec. 1. (SB 646) Effective January 1, 2026.

For purposes of this chapter, the following definitions apply:

(a)“Brand owner” means the person who owns or licenses the trademark that is the most prominent trademark on the principal display panel of the prenatal multivitamin product label. The manufacturer of a prenatal multivitamin for another person who owns the trademark is not the brand owner.

(b)“Bulk prenatal multivitamin product” means the bulk prenatal multivitamin product in finished dosage form before it is packaged and labeled. Bulk prenatal multivitamin product does not mean the constituent ingredients of prenatal multivitamins.

(c)“Heavy metals” means arsenic, cadmium, lead, and mercury.

(d)“Lot” means a batch, or a specific identified portion of a batch, that is uniform and is intended to meet specifications for identity, purity, strength, and composition or, in the case of a dietary supplement produced by continuous process, a specific identified amount produced in a specified unit of time or quantity in a manner that is uniform and that is intended to meet specifications for identity, purity, strength, and composition.

(e)“Manufacturer” means a person who is either of the following:

(1)A brand owner who manufactures, as defined in Section 109970, a prenatal multivitamin.

(2)A person who manufactures, as defined in Section 109970, but is not the brand owner of a prenatal multivitamin.

(f)“Packaged prenatal multivitamin product” means the bulk prenatal multivitamin product that has been packaged for sale or distribution to the public or health care

professionals. The product label may include, but is not required to have, a unique universal product code (UPC).

(g)“Prenatal multivitamin” means a dietary supplement that contains one or more vitamins or minerals and is represented or purported to be specifically used, or intended to be used, to support the health of an individual who is pregnant, planning to become pregnant, or lactating.

Prenatal multivitamins may be in the form of, but are not limited to, capsules, tablets, gummies, liquids, or powder.

(h)“Product label” means a display of written, printed, or graphic material that is affixed to a product’s immediate container.

(i)“Product shelf life” means the time, measured in the number of months, as printed on the product label, between the date of manufacture and the expiration date for a packaged prenatal multivitamin product.

(j)“Proficient laboratory” is a laboratory that meets the criteria listed in subdivision (b) of Section 110424.1.

(k)“Representative sample” means a sample that consists of a number of

units that are drawn based on rational criteria, such as random sampling, and intended to ensure that the sample accurately portrays the material being sampled.

§ 110424.1

Added by Stats. 2025, Ch. 602, Sec. 1. (SB 646) Effective January 1, 2026.

(a)Commencing January 1, 2027, a manufacturer of a bulk prenatal multivitamin product or a packaged prenatal multivitamin product that is sold, manufactured, delivered, held, or offered for sale in the state shall test a representative sample of each lot of the manufacturer’s bulk prenatal multivitamin product or packaged prenatal multivitamin product at a proficient laboratory for heavy metals.

(b)The proficient laboratory, including a manufacturer’s in-house laboratory, that analyzes the bulk prenatal multivitamin product or packaged prenatal multivitamin product for heavy metals shall meet all of the following criteria:

(1)(A) Be accredited under the standards of the International Organization for Standardization’s (ISO) and the International Electrotechnical Commission’s (IEC) ISO/IEC 17025:2017 international standard regarding the general requirements for the competence of testing and calibration laboratories as they pertain to the testing of heavy metals.

(B)To the extent such standards contradict the requirements of any federal regulations promulgated pursuant to the Federal Food, Drug, and Cosmetic Act pertinent to supplements, the federal regulations shall control.

(2)Use an analytical method that is at least as sensitive and specific as that described in

Section 4.7 of the United States Food and Drug Administration’s Elemental Analysis Manual for Food and Related Products: Inductively Coupled Plasma-Mass Spectrometric Determination of Arsenic, Cadmium, Chromium, Lead, Mercury, and Other Elements in Food Using Microwave Assisted Digestion.

(3)Demonstrate proficiency in quantifying each heavy metal to 10 micrograms or less of the

heavy metal to kilogram of supplement (μg/kg) through an independent proficiency test. Proficiency means that a laboratory achieves a z-score that is less than, or equal to, plus or minus two (≤ ±2).

(c)Both manufacturers and brand owners shall provide test results to an authorized agent of the department upon their

request pursuant to Article 2 (commencing with Section 110140) of Chapter 2 or Article 11 (commencing with Section 111015) of Chapter 5. If a brand owner does not manufacture the bulk prenatal multivitamin product or packaged prenatal multivitamin product, they may comply with this subdivision by providing the test results of the manufacturer they use to produce the bulk prenatal multivitamin product or packaged prenatal multivitamin product.

§ 110424.2

Added by Stats. 2025, Ch. 602, Sec. 1. (SB 646) Effective January 1, 2026.

Commencing January 1, 2027, a brand owner of a packaged prenatal multivitamin product that is sold, manufactured, delivered, held, or offered for sale in the state, including, without limitation, prenatal multivitamins that are sold by a retailer or that are sold directly to consumers, shall disclose product information to the public consistent with all of the following:

(a)(1) Make publicly available on the brand owner’s internet website, for the duration of the product shelf life for a packaged prenatal multivitamin product plus one month, all of the following:

(A) The name and level of each heavy metal present in each lot of a packaged prenatal multivitamin product.

(B) Information from the product’s supplement facts panel, including the amount per serving of each ingredient.

“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.”

(2)The information required in paragraph (1) shall all be provided on the same web page.

(b)The heavy metal testing information shall be available to the public without having to provide a UPC number, a lot number, or a proof of purchase.

(c)Provide descriptive information on its internet website to enable accurate identification of the packaged prenatal multivitamin product by the public, including information that makes the levels of heavy metals available to

the public by lot.

Descriptive information may include, but is not limited to, product name, UPC, size, or lot numbers.

(d)An internet website hyperlink to the United States Food and Drug Administration (FDA) where the public can find the most recent FDA internet website relating to heavy metals in food.

(e)On the brand owner’s internet website describing a packaged prenatal multivitamin product, include a prominent statement that reads “For information about heavy metal testing on this product” followed by a hyperlink to the internet website that contains the publicly available test results.

(f)(1) For a product sold in a retail store that is shipped to retailers

on or after January 1, 2027, the outermost “package,” as defined in Section 1459(b) of Title 15 of the United States Code, of a packaged prenatal multivitamin product shall include a statement that reads: “For information about heavy metal testing on this product, visit” followed by the web address where the information required by subdivision

(a)is posted.

(2)For a product sold online or directly to consumers that is shipped to consumers on or after January 1, 2027, the product details page for the product, on an internet website where the product is sold, shall include a statement that reads: “For information about heavy metal testing on this product, visit” followed by a hyperlink to the internet website where the information required by subdivision (a) is posted.

(3)On or after January 1, 2030, a person shall not sell in the state or manufacture, deliver, hold, or offer for sale in the state a prenatal multivitamin, including, without limitation, a prenatal multivitamin that is sold by a retailer or that is sold directly to consumers, that does not include

the packaging or online statements specified in paragraphs (1) and (2).

§ 110424.3

Added by Stats. 2025, Ch. 602, Sec. 1. (SB 646) Effective January 1, 2026.

A person shall not sell in the state or manufacture, deliver, hold, or offer for sale in the state a prenatal multivitamin, including, without limitation, a prenatal multivitamin that is sold by a retailer or

that is sold directly to consumers, that does not comply with the requirements described in this chapter.