| Old | New | Differences | |
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| 1 | - | ||
| 1 | + | Amended IN Senate March 24, 2025 CALIFORNIA LEGISLATURE 20252026 REGULAR SESSION Senate Bill No. 646Introduced by Senator Weber PiersonFebruary 20, 2025 An act to add Chapter 4.5 (commencing with Section 110424) to Part 5 of Division 104 of the Health and Safety Code, relating to public health.LEGISLATIVE COUNSEL'S DIGESTSB 646, as amended, Weber Pierson. Prenatal vitamins.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.Existing law requires a manufacturer of baby food for sale or distribution in this state to test a representative sample of each production aggregate of the manufacturers final baby food product, at a proficient laboratory meeting certain criteria, for toxic elements, as defined, at least once per month. elements, as specified. Existing law requires a manufacturer to provide test results to any authorized agent of the department upon their request, as specified. Existing law requires a manufacturer of a final baby food product sold, manufactured, delivered, held, or offered for sale in the state to provide specified information disclosures to consumers, including making publicly available on its internet website the name and level of each toxic element present in each production aggregate of the final baby food product. Existing law requires manufacturers to include on the product label a quick response (QR) code that links to a page on the manufacturers internet website containing, among other information, test results for the toxic element and a link to related United States Food and Drug Administration (FDA) guidance, as specified, if a product is tested for a certain toxic element subject to an action level, regulatory limit, or tolerance established by the FDA. Existing law also prohibits a person or entity from selling in the state or manufacturing, delivering, holding, or offering for sale in the state any baby food that does not comply with these provisions.This bill would require all of the provisions mentioned above for a manufacturer of prenatal vitamins, except for the prerequisite that the FDA establish an action level, regulatory limit, or tolerance. The bill would prohibit a person or entity from selling in the state or manufacturing, delivering, holding, or offering for sale in the state any prenatal vitamins that do not comply with these provisions. By creating a new crime, the 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 TextThe people of the State of California do enact as follows:SECTION 1. Chapter 4.5 (commencing with Section 110424) is added to Part 5 of Division 104 of the Health and Safety Code, to read: CHAPTER 4.5. Prenatal Vitamins110424. (a) For purposes of this section, all of the following definitions apply:(1) Final prenatal vitamin product means the finished product of prenatal vitamins with a unique universal product code (UPC). Final prenatal vitamin product does not mean the constituent ingredients of prenatal vitamins.(2) Prenatal vitamins means a dietary supplement that is used, or intended to be used, to support the health of individuals who are pregnant, planning to become pregnant, or breastfeeding.(3) Product label means a display of written, printed, or graphic material that is affixed to a product or its immediate container.(4) Product shelf life means the time, measured in the number of months, between the date of manufacture and the expiration date for a final prenatal vitamin product.(5) 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.(6) Proficient laboratory is a laboratory that meets the criteria listed in subdivision (c).(7) 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.(8) 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.(9) Toxic elements means arsenic, cadmium, lead, and mercury.(b) A manufacturer of prenatal vitamins for sale or distribution in this state shall comply with all of the following:(1) (A) Test a representative sample of each production aggregate of the manufacturers final prenatal vitamin product, at a proficient laboratory, for toxic elements.(B) A manufacturer may test the final prenatal vitamin product pursuant to subparagraph (A) before packaging individual units of prenatal vitamins for sale or distribution.(C)A manufacturer shall test each final prenatal vitamin product for toxic elements pursuant to subparagraph (A) at least once per month.(D)(C) A manufacturer 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) For final prenatal vitamin products sold, manufactured, delivered, held, or offered for sale in the state on and after January 1, 2027, disclose product information to consumers consistent with all of the following:(A) (i) Make publicly available on the manufacturers internet website, for the duration of the product shelf life for a final prenatal vitamin product plus one month, the name and level of each toxic element present in each production aggregate of a final prenatal vitamin product.(ii) Provide descriptive information on the internet website to enable accurate identification of the final prenatal vitamin product by consumers. Descriptive information may include, but is not limited to, product name, UPC, size, lot numbers, or batch numbers.(B) Include on the product label both of the following:(i) A QR code or other machine-readable code that links to a page on the manufacturers internet website containing all of the following information:(I) Test results for the toxic element, as provided pursuant to subparagraph (A).(II) An internet website link to a website of the United States Food and Drug Administration (FDA) where consumers can find the most recent 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 breastfeeding.(ii) A statement that reads: For information about toxic element testing on this product, scan the QR code.(c) The proficient laboratory that analyzes the final prenatal vitamin product for toxic elements 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 toxic element to at least six 10 micrograms of the toxic element to kilogram of supplement (g/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).(d) A person or entity shall not sell in the state or manufacture, deliver, hold, or offer for sale in the state any prenatal vitamin that does not comply with the requirements described in this section.SEC. 2. No reimbursement is required by this act pursuant to Section 6 of Article XIIIB 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 XIIIB of the California Constitution. | |
| 2 | 2 | ||
| 3 | - | ||
| 3 | + | Amended IN Senate March 24, 2025 CALIFORNIA LEGISLATURE 20252026 REGULAR SESSION Senate Bill No. 646Introduced by Senator Weber PiersonFebruary 20, 2025 An act to add Chapter 4.5 (commencing with Section 110424) to Part 5 of Division 104 of the Health and Safety Code, relating to public health.LEGISLATIVE COUNSEL'S DIGESTSB 646, as amended, Weber Pierson. Prenatal vitamins.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.Existing law requires a manufacturer of baby food for sale or distribution in this state to test a representative sample of each production aggregate of the manufacturers final baby food product, at a proficient laboratory meeting certain criteria, for toxic elements, as defined, at least once per month. elements, as specified. Existing law requires a manufacturer to provide test results to any authorized agent of the department upon their request, as specified. Existing law requires a manufacturer of a final baby food product sold, manufactured, delivered, held, or offered for sale in the state to provide specified information disclosures to consumers, including making publicly available on its internet website the name and level of each toxic element present in each production aggregate of the final baby food product. Existing law requires manufacturers to include on the product label a quick response (QR) code that links to a page on the manufacturers internet website containing, among other information, test results for the toxic element and a link to related United States Food and Drug Administration (FDA) guidance, as specified, if a product is tested for a certain toxic element subject to an action level, regulatory limit, or tolerance established by the FDA. Existing law also prohibits a person or entity from selling in the state or manufacturing, delivering, holding, or offering for sale in the state any baby food that does not comply with these provisions.This bill would require all of the provisions mentioned above for a manufacturer of prenatal vitamins, except for the prerequisite that the FDA establish an action level, regulatory limit, or tolerance. The bill would prohibit a person or entity from selling in the state or manufacturing, delivering, holding, or offering for sale in the state any prenatal vitamins that do not comply with these provisions. By creating a new crime, the 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 | |
| 4 | 4 | ||
| 5 | - | ||
| 5 | + | Amended IN Senate March 24, 2025 | |
| 6 | 6 | ||
| 7 | - | Amended IN Senate April 10, 2025 | |
| 8 | 7 | Amended IN Senate March 24, 2025 | |
| 9 | 8 | ||
| 10 | 9 | CALIFORNIA LEGISLATURE 20252026 REGULAR SESSION | |
| 11 | 10 | ||
| 12 | 11 | Senate Bill | |
| 13 | 12 | ||
| 14 | 13 | No. 646 | |
| 15 | 14 | ||
| 16 | 15 | Introduced by Senator Weber PiersonFebruary 20, 2025 | |
| 17 | 16 | ||
| 18 | 17 | Introduced by Senator Weber Pierson | |
| 19 | 18 | February 20, 2025 | |
| 20 | 19 | ||
| 21 | 20 | An act to add Chapter 4.5 (commencing with Section 110424) to Part 5 of Division 104 of the Health and Safety Code, relating to public health. | |
| 22 | 21 | ||
| 23 | 22 | LEGISLATIVE COUNSEL'S DIGEST | |
| 24 | 23 | ||
| 25 | 24 | ## LEGISLATIVE COUNSEL'S DIGEST | |
| 26 | 25 | ||
| 27 | 26 | SB 646, as amended, Weber Pierson. Prenatal vitamins. | |
| 28 | 27 | ||
| 29 | - | 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.Existing law requires a manufacturer of baby food for sale or distribution in this state to test a representative sample of each production aggregate of the manufacturers final baby food product, at a proficient laboratory meeting certain criteria, for toxic elements, as specified. Existing law requires a manufacturer to provide test results to any authorized agent of the department upon their request, as specified. Existing law requires a manufacturer of a final baby food product sold, manufactured, delivered, held, or offered for sale in the state to provide specified information disclosures to consumers, including making publicly available on its internet website the name and level of each toxic element present in each production aggregate of the final baby food product. Existing law requires manufacturers to include on the product label a quick response (QR) code that links to a page on the manufacturers internet website containing, among other information, test results for the toxic element and a link to related United States Food and Drug Administration (FDA) guidance, as specified, if a product is tested for a certain toxic element subject to an action level, regulatory limit, or tolerance established by the FDA. Existing law also prohibits a person or entity from selling in the state or manufacturing, delivering, holding, or offering for sale in the state any baby food that does not comply with these provisions.This bill would require all of the provisions mentioned above for a manufacturer of prenatal vitamins, | |
| 28 | + | 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.Existing law requires a manufacturer of baby food for sale or distribution in this state to test a representative sample of each production aggregate of the manufacturers final baby food product, at a proficient laboratory meeting certain criteria, for toxic elements, as defined, at least once per month. elements, as specified. Existing law requires a manufacturer to provide test results to any authorized agent of the department upon their request, as specified. Existing law requires a manufacturer of a final baby food product sold, manufactured, delivered, held, or offered for sale in the state to provide specified information disclosures to consumers, including making publicly available on its internet website the name and level of each toxic element present in each production aggregate of the final baby food product. Existing law requires manufacturers to include on the product label a quick response (QR) code that links to a page on the manufacturers internet website containing, among other information, test results for the toxic element and a link to related United States Food and Drug Administration (FDA) guidance, as specified, if a product is tested for a certain toxic element subject to an action level, regulatory limit, or tolerance established by the FDA. Existing law also prohibits a person or entity from selling in the state or manufacturing, delivering, holding, or offering for sale in the state any baby food that does not comply with these provisions.This bill would require all of the provisions mentioned above for a manufacturer of prenatal vitamins, except for the prerequisite that the FDA establish an action level, regulatory limit, or tolerance. The bill would prohibit a person or entity from selling in the state or manufacturing, delivering, holding, or offering for sale in the state any prenatal vitamins that do not comply with these provisions. By creating a new crime, the 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. | |
| 30 | 29 | ||
| 31 | 30 | 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. | |
| 32 | 31 | ||
| 33 | - | Existing law requires a manufacturer of baby food for sale or distribution in this state to test a representative sample of each production aggregate of the manufacturers final baby food product, at a proficient laboratory meeting certain criteria, for toxic elements, as specified. Existing law requires a manufacturer to provide test results to any authorized agent of the department upon their request, as specified. Existing law requires a manufacturer of a final baby food product sold, manufactured, delivered, held, or offered for sale in the state to provide specified information disclosures to consumers, including making publicly available on its internet website the name and level of each toxic element present in each production aggregate of the final baby food product. Existing law requires manufacturers to include on the product label a quick response (QR) code that links to a page on the manufacturers internet website containing, among other information, test results for the toxic element and a link to related United States Food and Drug Administration (FDA) guidance, as specified, if a product is tested for a certain toxic element subject to an action level, regulatory limit, or tolerance established by the FDA. Existing law also prohibits a person or entity from selling in the state or manufacturing, delivering, holding, or offering for sale in the state any baby food that does not comply with these provisions. | |
| 32 | + | Existing law requires a manufacturer of baby food for sale or distribution in this state to test a representative sample of each production aggregate of the manufacturers final baby food product, at a proficient laboratory meeting certain criteria, for toxic elements, as defined, at least once per month. elements, as specified. Existing law requires a manufacturer to provide test results to any authorized agent of the department upon their request, as specified. Existing law requires a manufacturer of a final baby food product sold, manufactured, delivered, held, or offered for sale in the state to provide specified information disclosures to consumers, including making publicly available on its internet website the name and level of each toxic element present in each production aggregate of the final baby food product. Existing law requires manufacturers to include on the product label a quick response (QR) code that links to a page on the manufacturers internet website containing, among other information, test results for the toxic element and a link to related United States Food and Drug Administration (FDA) guidance, as specified, if a product is tested for a certain toxic element subject to an action level, regulatory limit, or tolerance established by the FDA. Existing law also prohibits a person or entity from selling in the state or manufacturing, delivering, holding, or offering for sale in the state any baby food that does not comply with these provisions. | |
| 34 | 33 | ||
| 35 | - | This bill would require all of the provisions mentioned above for a manufacturer of prenatal vitamins | |
| 34 | + | This bill would require all of the provisions mentioned above for a manufacturer of prenatal vitamins, except for the prerequisite that the FDA establish an action level, regulatory limit, or tolerance. The bill would prohibit a person or entity from selling in the state or manufacturing, delivering, holding, or offering for sale in the state any prenatal vitamins that do not comply with these provisions. By creating a new crime, the bill would impose a state-mandated local program. | |
| 36 | 35 | ||
| 37 | 36 | 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. | |
| 38 | 37 | ||
| 39 | 38 | This bill would provide that no reimbursement is required by this act for a specified reason. | |
| 40 | 39 | ||
| 41 | 40 | ## Digest Key | |
| 42 | 41 | ||
| 43 | 42 | ## Bill Text | |
| 44 | 43 | ||
| 45 | - | The people of the State of California do enact as follows:SECTION 1. Chapter 4.5 (commencing with Section 110424) is added to Part 5 of Division 104 of the Health and Safety Code, to read: CHAPTER 4.5. Prenatal Vitamins110424. (a) For purposes of this section, all of the following definitions apply:(1) Final prenatal vitamin product means the finished product of prenatal vitamins with a unique universal product code (UPC). Final prenatal vitamin product does not mean the constituent ingredients of prenatal vitamins.(2) | |
| 44 | + | The people of the State of California do enact as follows:SECTION 1. Chapter 4.5 (commencing with Section 110424) is added to Part 5 of Division 104 of the Health and Safety Code, to read: CHAPTER 4.5. Prenatal Vitamins110424. (a) For purposes of this section, all of the following definitions apply:(1) Final prenatal vitamin product means the finished product of prenatal vitamins with a unique universal product code (UPC). Final prenatal vitamin product does not mean the constituent ingredients of prenatal vitamins.(2) Prenatal vitamins means a dietary supplement that is used, or intended to be used, to support the health of individuals who are pregnant, planning to become pregnant, or breastfeeding.(3) Product label means a display of written, printed, or graphic material that is affixed to a product or its immediate container.(4) Product shelf life means the time, measured in the number of months, between the date of manufacture and the expiration date for a final prenatal vitamin product.(5) 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.(6) Proficient laboratory is a laboratory that meets the criteria listed in subdivision (c).(7) 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.(8) 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.(9) Toxic elements means arsenic, cadmium, lead, and mercury.(b) A manufacturer of prenatal vitamins for sale or distribution in this state shall comply with all of the following:(1) (A) Test a representative sample of each production aggregate of the manufacturers final prenatal vitamin product, at a proficient laboratory, for toxic elements.(B) A manufacturer may test the final prenatal vitamin product pursuant to subparagraph (A) before packaging individual units of prenatal vitamins for sale or distribution.(C)A manufacturer shall test each final prenatal vitamin product for toxic elements pursuant to subparagraph (A) at least once per month.(D)(C) A manufacturer 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) For final prenatal vitamin products sold, manufactured, delivered, held, or offered for sale in the state on and after January 1, 2027, disclose product information to consumers consistent with all of the following:(A) (i) Make publicly available on the manufacturers internet website, for the duration of the product shelf life for a final prenatal vitamin product plus one month, the name and level of each toxic element present in each production aggregate of a final prenatal vitamin product.(ii) Provide descriptive information on the internet website to enable accurate identification of the final prenatal vitamin product by consumers. Descriptive information may include, but is not limited to, product name, UPC, size, lot numbers, or batch numbers.(B) Include on the product label both of the following:(i) A QR code or other machine-readable code that links to a page on the manufacturers internet website containing all of the following information:(I) Test results for the toxic element, as provided pursuant to subparagraph (A).(II) An internet website link to a website of the United States Food and Drug Administration (FDA) where consumers can find the most recent 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 breastfeeding.(ii) A statement that reads: For information about toxic element testing on this product, scan the QR code.(c) The proficient laboratory that analyzes the final prenatal vitamin product for toxic elements 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 toxic element to at least six 10 micrograms of the toxic element to kilogram of supplement (g/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).(d) A person or entity shall not sell in the state or manufacture, deliver, hold, or offer for sale in the state any prenatal vitamin that does not comply with the requirements described in this section.SEC. 2. No reimbursement is required by this act pursuant to Section 6 of Article XIIIB 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 XIIIB of the California Constitution. | |
| 46 | 45 | ||
| 47 | 46 | The people of the State of California do enact as follows: | |
| 48 | 47 | ||
| 49 | 48 | ## The people of the State of California do enact as follows: | |
| 50 | 49 | ||
| 51 | - | SECTION 1. Chapter 4.5 (commencing with Section 110424) is added to Part 5 of Division 104 of the Health and Safety Code, to read: CHAPTER 4.5. Prenatal Vitamins110424. (a) For purposes of this section, all of the following definitions apply:(1) Final prenatal vitamin product means the finished product of prenatal vitamins with a unique universal product code (UPC). Final prenatal vitamin product does not mean the constituent ingredients of prenatal vitamins.(2) | |
| 50 | + | SECTION 1. Chapter 4.5 (commencing with Section 110424) is added to Part 5 of Division 104 of the Health and Safety Code, to read: CHAPTER 4.5. Prenatal Vitamins110424. (a) For purposes of this section, all of the following definitions apply:(1) Final prenatal vitamin product means the finished product of prenatal vitamins with a unique universal product code (UPC). Final prenatal vitamin product does not mean the constituent ingredients of prenatal vitamins.(2) Prenatal vitamins means a dietary supplement that is used, or intended to be used, to support the health of individuals who are pregnant, planning to become pregnant, or breastfeeding.(3) Product label means a display of written, printed, or graphic material that is affixed to a product or its immediate container.(4) Product shelf life means the time, measured in the number of months, between the date of manufacture and the expiration date for a final prenatal vitamin product.(5) 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.(6) Proficient laboratory is a laboratory that meets the criteria listed in subdivision (c).(7) 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.(8) 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.(9) Toxic elements means arsenic, cadmium, lead, and mercury.(b) A manufacturer of prenatal vitamins for sale or distribution in this state shall comply with all of the following:(1) (A) Test a representative sample of each production aggregate of the manufacturers final prenatal vitamin product, at a proficient laboratory, for toxic elements.(B) A manufacturer may test the final prenatal vitamin product pursuant to subparagraph (A) before packaging individual units of prenatal vitamins for sale or distribution.(C)A manufacturer shall test each final prenatal vitamin product for toxic elements pursuant to subparagraph (A) at least once per month.(D)(C) A manufacturer 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) For final prenatal vitamin products sold, manufactured, delivered, held, or offered for sale in the state on and after January 1, 2027, disclose product information to consumers consistent with all of the following:(A) (i) Make publicly available on the manufacturers internet website, for the duration of the product shelf life for a final prenatal vitamin product plus one month, the name and level of each toxic element present in each production aggregate of a final prenatal vitamin product.(ii) Provide descriptive information on the internet website to enable accurate identification of the final prenatal vitamin product by consumers. Descriptive information may include, but is not limited to, product name, UPC, size, lot numbers, or batch numbers.(B) Include on the product label both of the following:(i) A QR code or other machine-readable code that links to a page on the manufacturers internet website containing all of the following information:(I) Test results for the toxic element, as provided pursuant to subparagraph (A).(II) An internet website link to a website of the United States Food and Drug Administration (FDA) where consumers can find the most recent 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 breastfeeding.(ii) A statement that reads: For information about toxic element testing on this product, scan the QR code.(c) The proficient laboratory that analyzes the final prenatal vitamin product for toxic elements 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 toxic element to at least six 10 micrograms of the toxic element to kilogram of supplement (g/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).(d) A person or entity shall not sell in the state or manufacture, deliver, hold, or offer for sale in the state any prenatal vitamin that does not comply with the requirements described in this section. | |
| 52 | 51 | ||
| 53 | 52 | SECTION 1. Chapter 4.5 (commencing with Section 110424) is added to Part 5 of Division 104 of the Health and Safety Code, to read: | |
| 54 | 53 | ||
| 55 | 54 | ### SECTION 1. | |
| 56 | 55 | ||
| 57 | - | CHAPTER 4.5. Prenatal Vitamins110424. (a) For purposes of this section, all of the following definitions apply:(1) Final prenatal vitamin product means the finished product of prenatal vitamins with a unique universal product code (UPC). Final prenatal vitamin product does not mean the constituent ingredients of prenatal vitamins.(2) | |
| 56 | + | CHAPTER 4.5. Prenatal Vitamins110424. (a) For purposes of this section, all of the following definitions apply:(1) Final prenatal vitamin product means the finished product of prenatal vitamins with a unique universal product code (UPC). Final prenatal vitamin product does not mean the constituent ingredients of prenatal vitamins.(2) Prenatal vitamins means a dietary supplement that is used, or intended to be used, to support the health of individuals who are pregnant, planning to become pregnant, or breastfeeding.(3) Product label means a display of written, printed, or graphic material that is affixed to a product or its immediate container.(4) Product shelf life means the time, measured in the number of months, between the date of manufacture and the expiration date for a final prenatal vitamin product.(5) 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.(6) Proficient laboratory is a laboratory that meets the criteria listed in subdivision (c).(7) 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.(8) 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.(9) Toxic elements means arsenic, cadmium, lead, and mercury.(b) A manufacturer of prenatal vitamins for sale or distribution in this state shall comply with all of the following:(1) (A) Test a representative sample of each production aggregate of the manufacturers final prenatal vitamin product, at a proficient laboratory, for toxic elements.(B) A manufacturer may test the final prenatal vitamin product pursuant to subparagraph (A) before packaging individual units of prenatal vitamins for sale or distribution.(C)A manufacturer shall test each final prenatal vitamin product for toxic elements pursuant to subparagraph (A) at least once per month.(D)(C) A manufacturer 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) For final prenatal vitamin products sold, manufactured, delivered, held, or offered for sale in the state on and after January 1, 2027, disclose product information to consumers consistent with all of the following:(A) (i) Make publicly available on the manufacturers internet website, for the duration of the product shelf life for a final prenatal vitamin product plus one month, the name and level of each toxic element present in each production aggregate of a final prenatal vitamin product.(ii) Provide descriptive information on the internet website to enable accurate identification of the final prenatal vitamin product by consumers. Descriptive information may include, but is not limited to, product name, UPC, size, lot numbers, or batch numbers.(B) Include on the product label both of the following:(i) A QR code or other machine-readable code that links to a page on the manufacturers internet website containing all of the following information:(I) Test results for the toxic element, as provided pursuant to subparagraph (A).(II) An internet website link to a website of the United States Food and Drug Administration (FDA) where consumers can find the most recent 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 breastfeeding.(ii) A statement that reads: For information about toxic element testing on this product, scan the QR code.(c) The proficient laboratory that analyzes the final prenatal vitamin product for toxic elements 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 toxic element to at least six 10 micrograms of the toxic element to kilogram of supplement (g/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).(d) A person or entity shall not sell in the state or manufacture, deliver, hold, or offer for sale in the state any prenatal vitamin that does not comply with the requirements described in this section. | |
| 58 | 57 | ||
| 59 | - | CHAPTER 4.5. Prenatal Vitamins110424. (a) For purposes of this section, all of the following definitions apply:(1) Final prenatal vitamin product means the finished product of prenatal vitamins with a unique universal product code (UPC). Final prenatal vitamin product does not mean the constituent ingredients of prenatal vitamins.(2) | |
| 58 | + | CHAPTER 4.5. Prenatal Vitamins110424. (a) For purposes of this section, all of the following definitions apply:(1) Final prenatal vitamin product means the finished product of prenatal vitamins with a unique universal product code (UPC). Final prenatal vitamin product does not mean the constituent ingredients of prenatal vitamins.(2) Prenatal vitamins means a dietary supplement that is used, or intended to be used, to support the health of individuals who are pregnant, planning to become pregnant, or breastfeeding.(3) Product label means a display of written, printed, or graphic material that is affixed to a product or its immediate container.(4) Product shelf life means the time, measured in the number of months, between the date of manufacture and the expiration date for a final prenatal vitamin product.(5) 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.(6) Proficient laboratory is a laboratory that meets the criteria listed in subdivision (c).(7) 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.(8) 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.(9) Toxic elements means arsenic, cadmium, lead, and mercury.(b) A manufacturer of prenatal vitamins for sale or distribution in this state shall comply with all of the following:(1) (A) Test a representative sample of each production aggregate of the manufacturers final prenatal vitamin product, at a proficient laboratory, for toxic elements.(B) A manufacturer may test the final prenatal vitamin product pursuant to subparagraph (A) before packaging individual units of prenatal vitamins for sale or distribution.(C)A manufacturer shall test each final prenatal vitamin product for toxic elements pursuant to subparagraph (A) at least once per month.(D)(C) A manufacturer 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) For final prenatal vitamin products sold, manufactured, delivered, held, or offered for sale in the state on and after January 1, 2027, disclose product information to consumers consistent with all of the following:(A) (i) Make publicly available on the manufacturers internet website, for the duration of the product shelf life for a final prenatal vitamin product plus one month, the name and level of each toxic element present in each production aggregate of a final prenatal vitamin product.(ii) Provide descriptive information on the internet website to enable accurate identification of the final prenatal vitamin product by consumers. Descriptive information may include, but is not limited to, product name, UPC, size, lot numbers, or batch numbers.(B) Include on the product label both of the following:(i) A QR code or other machine-readable code that links to a page on the manufacturers internet website containing all of the following information:(I) Test results for the toxic element, as provided pursuant to subparagraph (A).(II) An internet website link to a website of the United States Food and Drug Administration (FDA) where consumers can find the most recent 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 breastfeeding.(ii) A statement that reads: For information about toxic element testing on this product, scan the QR code.(c) The proficient laboratory that analyzes the final prenatal vitamin product for toxic elements 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 toxic element to at least six 10 micrograms of the toxic element to kilogram of supplement (g/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).(d) A person or entity shall not sell in the state or manufacture, deliver, hold, or offer for sale in the state any prenatal vitamin that does not comply with the requirements described in this section. | |
| 60 | 59 | ||
| 61 | 60 | CHAPTER 4.5. Prenatal Vitamins | |
| 62 | 61 | ||
| 63 | 62 | CHAPTER 4.5. Prenatal Vitamins | |
| 64 | 63 | ||
| 65 | - | 110424. (a) For purposes of this section, all of the following definitions apply:(1) Final prenatal vitamin product means the finished product of prenatal vitamins with a unique universal product code (UPC). Final prenatal vitamin product does not mean the constituent ingredients of prenatal vitamins.(2) | |
| 64 | + | 110424. (a) For purposes of this section, all of the following definitions apply:(1) Final prenatal vitamin product means the finished product of prenatal vitamins with a unique universal product code (UPC). Final prenatal vitamin product does not mean the constituent ingredients of prenatal vitamins.(2) Prenatal vitamins means a dietary supplement that is used, or intended to be used, to support the health of individuals who are pregnant, planning to become pregnant, or breastfeeding.(3) Product label means a display of written, printed, or graphic material that is affixed to a product or its immediate container.(4) Product shelf life means the time, measured in the number of months, between the date of manufacture and the expiration date for a final prenatal vitamin product.(5) 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.(6) Proficient laboratory is a laboratory that meets the criteria listed in subdivision (c).(7) 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.(8) 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.(9) Toxic elements means arsenic, cadmium, lead, and mercury.(b) A manufacturer of prenatal vitamins for sale or distribution in this state shall comply with all of the following:(1) (A) Test a representative sample of each production aggregate of the manufacturers final prenatal vitamin product, at a proficient laboratory, for toxic elements.(B) A manufacturer may test the final prenatal vitamin product pursuant to subparagraph (A) before packaging individual units of prenatal vitamins for sale or distribution.(C)A manufacturer shall test each final prenatal vitamin product for toxic elements pursuant to subparagraph (A) at least once per month.(D)(C) A manufacturer 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) For final prenatal vitamin products sold, manufactured, delivered, held, or offered for sale in the state on and after January 1, 2027, disclose product information to consumers consistent with all of the following:(A) (i) Make publicly available on the manufacturers internet website, for the duration of the product shelf life for a final prenatal vitamin product plus one month, the name and level of each toxic element present in each production aggregate of a final prenatal vitamin product.(ii) Provide descriptive information on the internet website to enable accurate identification of the final prenatal vitamin product by consumers. Descriptive information may include, but is not limited to, product name, UPC, size, lot numbers, or batch numbers.(B) Include on the product label both of the following:(i) A QR code or other machine-readable code that links to a page on the manufacturers internet website containing all of the following information:(I) Test results for the toxic element, as provided pursuant to subparagraph (A).(II) An internet website link to a website of the United States Food and Drug Administration (FDA) where consumers can find the most recent 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 breastfeeding.(ii) A statement that reads: For information about toxic element testing on this product, scan the QR code.(c) The proficient laboratory that analyzes the final prenatal vitamin product for toxic elements 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 toxic element to at least six 10 micrograms of the toxic element to kilogram of supplement (g/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).(d) A person or entity shall not sell in the state or manufacture, deliver, hold, or offer for sale in the state any prenatal vitamin that does not comply with the requirements described in this section. | |
| 66 | 65 | ||
| 67 | 66 | ||
| 68 | 67 | ||
| 69 | 68 | 110424. (a) For purposes of this section, all of the following definitions apply: | |
| 70 | 69 | ||
| 71 | 70 | (1) Final prenatal vitamin product means the finished product of prenatal vitamins with a unique universal product code (UPC). Final prenatal vitamin product does not mean the constituent ingredients of prenatal vitamins. | |
| 72 | 71 | ||
| 73 | - | (2) | |
| 72 | + | (2) Prenatal vitamins means a dietary supplement that is used, or intended to be used, to support the health of individuals who are pregnant, planning to become pregnant, or breastfeeding. | |
| 74 | 73 | ||
| 75 | - | ( | |
| 74 | + | (3) Product label means a display of written, printed, or graphic material that is affixed to a product or its immediate container. | |
| 76 | 75 | ||
| 77 | - | ||
| 78 | - | ||
| 79 | - | (3) Prenatal vitamins means a dietary supplement that is used, or intended to be used, to support the health of individuals who are pregnant, planning to become pregnant, or breastfeeding. | |
| 80 | - | ||
| 81 | - | (3) | |
| 82 | - | ||
| 83 | - | ||
| 84 | - | ||
| 85 | - | (4) Product label means a display of written, printed, or graphic material that is affixed to a product or its immediate container. | |
| 86 | - | ||
| 87 | - | (4) | |
| 88 | - | ||
| 89 | - | ||
| 90 | - | ||
| 91 | - | (5) Product shelf life means the time, measured in the number of months, between the date of manufacture and the expiration date for a final prenatal vitamin product. | |
| 76 | + | (4) Product shelf life means the time, measured in the number of months, between the date of manufacture and the expiration date for a final prenatal vitamin product. | |
| 92 | 77 | ||
| 93 | 78 | (5) 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. | |
| 94 | - | ||
| 95 | - | ||
| 96 | 79 | ||
| 97 | 80 | (6) Proficient laboratory is a laboratory that meets the criteria listed in subdivision (c). | |
| 98 | 81 | ||
| 99 | 82 | (7) 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. | |
| 100 | 83 | ||
| 101 | 84 | (8) 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. | |
| 102 | 85 | ||
| 103 | 86 | (9) Toxic elements means arsenic, cadmium, lead, and mercury. | |
| 104 | 87 | ||
| 105 | 88 | (b) A manufacturer of prenatal vitamins for sale or distribution in this state shall comply with all of the following: | |
| 106 | 89 | ||
| 107 | - | (1) (A) Test a representative sample of each production aggregate | |
| 90 | + | (1) (A) Test a representative sample of each production aggregate of the manufacturers final prenatal vitamin product, at a proficient laboratory, for toxic elements. | |
| 108 | 91 | ||
| 109 | 92 | (B) A manufacturer may test the final prenatal vitamin product pursuant to subparagraph (A) before packaging individual units of prenatal vitamins for sale or distribution. | |
| 93 | + | ||
| 94 | + | (C)A manufacturer shall test each final prenatal vitamin product for toxic elements pursuant to subparagraph (A) at least once per month. | |
| 95 | + | ||
| 96 | + | ||
| 97 | + | ||
| 98 | + | (D) | |
| 99 | + | ||
| 100 | + | ||
| 110 | 101 | ||
| 111 | 102 | (C) A manufacturer 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. | |
| 112 | 103 | ||
| 113 | 104 | (2) For final prenatal vitamin products sold, manufactured, delivered, held, or offered for sale in the state on and after January 1, 2027, disclose product information to consumers consistent with all of the following: | |
| 114 | 105 | ||
| 115 | - | (A) (i) Make publicly available on the manufacturers internet website, for the duration of the product shelf life for a final prenatal vitamin product plus one month, the name and level of each toxic element present in each production aggregate | |
| 106 | + | (A) (i) Make publicly available on the manufacturers internet website, for the duration of the product shelf life for a final prenatal vitamin product plus one month, the name and level of each toxic element present in each production aggregate of a final prenatal vitamin product. | |
| 116 | 107 | ||
| 117 | 108 | (ii) Provide descriptive information on the internet website to enable accurate identification of the final prenatal vitamin product by consumers. Descriptive information may include, but is not limited to, product name, UPC, size, lot numbers, or batch numbers. | |
| 118 | 109 | ||
| 119 | 110 | (B) Include on the product label both of the following: | |
| 120 | 111 | ||
| 121 | 112 | (i) A QR code or other machine-readable code that links to a page on the manufacturers internet website containing all of the following information: | |
| 122 | 113 | ||
| 123 | 114 | (I) Test results for the toxic element, as provided pursuant to subparagraph (A). | |
| 124 | 115 | ||
| 125 | 116 | (II) An internet website link to a website of the United States Food and Drug Administration (FDA) where consumers can find the most recent 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 breastfeeding. | |
| 126 | 117 | ||
| 127 | 118 | (ii) A statement that reads: For information about toxic element testing on this product, scan the QR code. | |
| 128 | 119 | ||
| 129 | 120 | (c) The proficient laboratory that analyzes the final prenatal vitamin product for toxic elements shall meet all of the following criteria: | |
| 130 | 121 | ||
| 131 | 122 | (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. | |
| 132 | 123 | ||
| 133 | 124 | (2) Use an analytical method that is at least as sensitive as that described in the FDA Elemental Analysis Manual 4.7. | |
| 134 | 125 | ||
| 135 | - | (3) Demonstrate proficiency in quantifying each toxic element to at least 10 micrograms of the toxic element to kilogram of supplement (g/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). | |
| 126 | + | (3) Demonstrate proficiency in quantifying each toxic element to at least six 10 micrograms of the toxic element to kilogram of supplement (g/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). | |
| 136 | 127 | ||
| 137 | 128 | (d) A person or entity shall not sell in the state or manufacture, deliver, hold, or offer for sale in the state any prenatal vitamin that does not comply with the requirements described in this section. | |
| 138 | 129 | ||
| 139 | 130 | SEC. 2. No reimbursement is required by this act pursuant to Section 6 of Article XIIIB 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 XIIIB of the California Constitution. | |
| 140 | 131 | ||
| 141 | 132 | SEC. 2. No reimbursement is required by this act pursuant to Section 6 of Article XIIIB 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 XIIIB of the California Constitution. | |
| 142 | 133 | ||
| 143 | 134 | SEC. 2. No reimbursement is required by this act pursuant to Section 6 of Article XIIIB 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 XIIIB of the California Constitution. | |
| 144 | 135 | ||
| 145 | 136 | ### SEC. 2. |