AB 2302

AB2302:v95#DOCUMENT

Bill Start

CALIFORNIA LEGISLATURE— 2025–2026 REGULAR SESSION

Assembly Bill

No. 2302

An act to add Article 8.6 (commencing with Section 110964) to Chapter 5 of Part 5 of Division 104 of the Health and Safety Code, relating to food.

LEGISLATIVE COUNSEL'S DIGEST

AB 2302, as amended, Celeste Rodriguez. Food safety: infant formula.

Existing law, the Sherman Food, Drug, and Cosmetic Law, provides for the regulation of various subjects relating to the manufacturing, processing, labeling, advertising, and sale of food, drugs, and cosmetics, under the administration and enforcement of the State Department of Public Health. A violation of these provisions is punishable as a misdemeanor.

This bill would require a manufacturer of infant formula for sale or distribution in this state to test its final infant formula product for arsenic, cadmium, lead, and mercury at least once per month. The bill also would, commencing on January 1, 2028, require a brand owner, as defined, to provide information to consumers on its internet website or package label regarding specific information about its infant formula that includes, among other things, certain test results for arsenic, cadmium, lead, and mercury. The bill would specifically prohibit a person from selling in the state or manufacturing, delivering, holding, or offering for sale in the state any infant formula that does not comply with these requirements. The bill would require the manufacturer and brand owner to provide test results to the department upon request, as specified.

By expanding the requirements relating to infant formula under the Sherman Food, Drug, and Cosmetic Law, the violation of which would be a crime, this bill would impose a state-mandated local program.

The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.

This bill would provide that no reimbursement is required by this act for a specified reason.

Digest Key

Vote: MAJORITY Appropriation: NO Fiscal Committee: YES Local Program: YES

Bill Text

The people of the State of California do enact as follows:

SECTION 1.

Article 8.6 (commencing with Section 110964) is added to Chapter 5 of Part 5 of Division 104 of the Health and Safety Code, to read:

Article 8.6. Infant formula Formula

110964.

(a) For purposes of this section, the following definitions apply:

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

(2) “Final infant formula product” means the finished product of infant formula with a unique universal product code (UPC). “Final infant formula product” does not mean the constituent ingredients of infant formula.

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

(4) “Infant formula” means the same as defined in Section 321(z) of Title 21 of the United States Code.

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

(A) A brand owner who manufactures, as defined in Section 109970, an infant formula.

(B) A person who manufactures, as defined in Section 109970, but is not the brand owner of, an infant formula.

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

(7) “Product shelf life” means the time, measured in the number of months, between the date of manufacture and the expiration date for a final infant formula product.

(8) “Production aggregate” means a quantity of product that is intended to have uniform composition, character, and quality, and is produced according to a master manufacturing order.

(9) “Proficient laboratory” is a laboratory that meets the criteria listed in subdivision (c).

(10) “Quick response (QR) code” means a machine-readable code, consisting of an array of squares, used for storing an internet website in order to access a web page.

(11) “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.

(b) (1) A manufacturer of infant formula for sale or distribution in this state shall test a representative sample of each production aggregate of the final infant formula product, at a proficient laboratory, for heavy metals.

(2) A manufacturer may test the final infant formula product pursuant to paragraph (1) before packaging individual units of infant formula for sale or distribution.

(3) A manufacturer shall test each final infant formula product for heavy metals pursuant to paragraph (1) at least once per month.

(c) Commencing January 1, 2028, for final infant formula products sold, manufactured, delivered, held, or offered for sale in the state, including, without limitation, final infant formula products that are sold by a retailer or that are sold online or directly to consumers, a brand owner shall disclose information to consumers consistent with all of the following:

(1) (A) (i) Make publicly and easily available on the brand owner’s internet website, in English and Spanish, for the duration of the product shelf life for a final infant formula product plus one month, the name and level of each heavy metal present in each production aggregate of a final infant formula product.

(ii) Provide descriptive information on the internet website to enable accurate identification of the final infant formula product by consumers. Descriptive information may include, but is not limited to, product name, UPC, size, lot numbers, or batch numbers.

(B) The information required pursuant to this paragraph shall be made available to consumers without requiring them to provide a UPC number, lot number, or proof of purchase.

(2) If a product is tested for a certain heavy metal subject to an action level, regulatory limit, or tolerance established by the United States Food and Drug Administration (FDA) pursuant to Part 109 (commencing with Section 109.3) of Title 21 of the Code of Federal Regulations, include on the product label both of the following:

(A) A QR code or other machine-readable code that links to a page on the brand owner’s internet website containing both of the following:

(i) Test results for the heavy metal, as provided pursuant to paragraph (1).

(ii) An internet website link to an internet website of the FDA where consumers can find the most recent FDA guidance and information about the health effects of the heavy metal on children.

(B) A statement that reads: “For information about heavy metal testing on this product, scan the QR code.”

(d) The proficient laboratory that analyzes the final infant formula product for heavy metals shall meet all of the following criteria:

(1) Be accredited under the standards of the International Organization for Standardization (ISO) / International Electrotechnical Commission (IEC) 17025:2017 regarding the general requirements for the competence of testing and calibration laboratories.

(2) Use an analytical method that is at least as sensitive as that described in the FDA Elemental Analysis Manual 4.7.

(3) Demonstrate proficiency in quantifying each heavy metal to at least six micrograms of the heavy metal to kilogram of food (μg/kg) through an independent proficiency test. Proficiency means that laboratories achieve a z-score that is less than, or equal to, plus or minus two (≤ ±2).

(e) (1) Both manufacturers and brand owners shall provide test results to any 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 this chapter.

(2) If a brand owner does not manufacture the infant formula or final infant formula product, they may comply with this subdivision by providing the test results of the manufacturer they use to produce the infant formula or final infant formula product.

110964.5.

A person or entity shall not sell in the state or manufacture, deliver, hold, or offer for sale in the state infant formula that does not comply with the requirements described in Section 110964.

SEC. 2.

No reimbursement is required by this act pursuant to Section 6 of Article XIII B of the California Constitution because the only costs that may be incurred by a local agency or school district will be incurred because this act creates a new crime or infraction, eliminates a crime or infraction, or changes the penalty for a crime or infraction, within the meaning of Section 17556 of the Government Code, or changes the definition of a crime within the meaning of Section 6 of Article XIII B of the California Constitution.