California Health and Safety Code § 110424

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.

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