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| 1 | + | Amended IN Assembly March 27, 2019 CALIFORNIA LEGISLATURE 20192020 REGULAR SESSION Assembly Bill No. 1178Introduced by Assembly Member QuirkFebruary 21, 2019 An act to add Section 110422.1 to the Health and Safety Code, relating to public health. LEGISLATIVE COUNSEL'S DIGESTAB 1178, as amended, Quirk. Dietary supplements: labeling: live microorganisms.Existing law, the Sherman Food, Drug, and Cosmetics Law, provides for the regulation of various subjects relating to the processing, labeling, advertising, and sale of food under the administration and enforcement of the State Department of Public Health. Existing applicable federal law includes dietary supplements, as defined, within the definition of food for these purposes. Existing law requires, to the extent permitted by federal law, that any warning label on products defined as dietary supplements pursuant to specified federal law, that are manufactured or distributed in the state, be clear and conspicuous. Under existing law, a violation of that requirement constitutes an infraction, punishable by specified fines.This bill would, commencing January 1, 2022, and to the extent permitted by federal law, require a manufacturer or distributor of dietary supplements sold in the state that contain live microorganisms to include on its label the genus, species, and strain of each live microorganism in the dietary supplement and the total estimated quantity count of all live microorganisms in the dietary supplement at the end of its shelf life, as measured by colony forming units. The bill would provide that life. Because a violation of this requirement is an infraction, punishable by specified fines. By would be an infraction, by creating a new crime, this bill would create 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. Section 110422.1 is added to the Health and Safety Code, to read:110422.1. (a) Commencing January 1, 2022, a manufacturer or distributor of dietary supplements, as defined in Section 321(ff) of Title 21 of the United States Code, sold in the state that contain live microorganisms shall include both of the following on the label of the dietary supplement:(1) The genus, species, and strain of each live microorganism in the dietary supplement.(2) The total estimated quantity count of all live microorganisms in the dietary supplement at the end of its shelf life, as measured by colony forming units (CFU). life.(b) This section does not in any way limit or restrict any rights, remedies, or duties otherwise applicable by law.(c) This section shall be implemented to the extent permitted by federal law.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 Assembly March 27, 2019 CALIFORNIA LEGISLATURE 20192020 REGULAR SESSION Assembly Bill No. 1178Introduced by Assembly Member QuirkFebruary 21, 2019 An act to add Section 110422.1 to the Health and Safety Code, relating to public health. LEGISLATIVE COUNSEL'S DIGESTAB 1178, as amended, Quirk. Dietary supplements: labeling: live microorganisms.Existing law, the Sherman Food, Drug, and Cosmetics Law, provides for the regulation of various subjects relating to the processing, labeling, advertising, and sale of food under the administration and enforcement of the State Department of Public Health. Existing applicable federal law includes dietary supplements, as defined, within the definition of food for these purposes. Existing law requires, to the extent permitted by federal law, that any warning label on products defined as dietary supplements pursuant to specified federal law, that are manufactured or distributed in the state, be clear and conspicuous. Under existing law, a violation of that requirement constitutes an infraction, punishable by specified fines.This bill would, commencing January 1, 2022, and to the extent permitted by federal law, require a manufacturer or distributor of dietary supplements sold in the state that contain live microorganisms to include on its label the genus, species, and strain of each live microorganism in the dietary supplement and the total estimated quantity count of all live microorganisms in the dietary supplement at the end of its shelf life, as measured by colony forming units. The bill would provide that life. Because a violation of this requirement is an infraction, punishable by specified fines. By would be an infraction, by creating a new crime, this bill would create 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 Assembly March 27, 2019 | |
| 6 | 6 | ||
| 7 | - | Amended IN Senate June 03, 2019 | |
| 8 | 7 | Amended IN Assembly March 27, 2019 | |
| 9 | 8 | ||
| 10 | 9 | CALIFORNIA LEGISLATURE 20192020 REGULAR SESSION | |
| 11 | 10 | ||
| 12 | 11 | Assembly Bill No. 1178 | |
| 13 | 12 | ||
| 14 | 13 | Introduced by Assembly Member QuirkFebruary 21, 2019 | |
| 15 | 14 | ||
| 16 | 15 | Introduced by Assembly Member Quirk | |
| 17 | 16 | February 21, 2019 | |
| 18 | 17 | ||
| 19 | 18 | An act to add Section 110422.1 to the Health and Safety Code, relating to public health. | |
| 20 | 19 | ||
| 21 | 20 | LEGISLATIVE COUNSEL'S DIGEST | |
| 22 | 21 | ||
| 23 | 22 | ## LEGISLATIVE COUNSEL'S DIGEST | |
| 24 | 23 | ||
| 25 | 24 | AB 1178, as amended, Quirk. Dietary supplements: labeling: live microorganisms. | |
| 26 | 25 | ||
| 27 | - | Existing law, the Sherman Food, Drug, and Cosmetics Law, provides for the regulation of various subjects relating to the processing, labeling, advertising, and sale of food under the administration and enforcement of the State Department of Public Health. Existing applicable federal law includes dietary supplements, as defined, within the definition of food for these purposes. Existing law requires, to the extent permitted by federal law, that any warning label on products defined as dietary supplements pursuant to specified federal law, that are manufactured or distributed in the state, be clear and conspicuous. Under existing law, a violation of that requirement constitutes an infraction, punishable by specified fines.This bill would, commencing January 1, 2022, and to the extent permitted by federal law, require a manufacturer or distributor of dietary supplements sold in the state that contain live microorganisms to include on its label the genus, species, and strain of each live microorganism in the dietary supplement and the total estimated count of all live microorganisms in the dietary supplement at the end of its shelf life | |
| 26 | + | Existing law, the Sherman Food, Drug, and Cosmetics Law, provides for the regulation of various subjects relating to the processing, labeling, advertising, and sale of food under the administration and enforcement of the State Department of Public Health. Existing applicable federal law includes dietary supplements, as defined, within the definition of food for these purposes. Existing law requires, to the extent permitted by federal law, that any warning label on products defined as dietary supplements pursuant to specified federal law, that are manufactured or distributed in the state, be clear and conspicuous. Under existing law, a violation of that requirement constitutes an infraction, punishable by specified fines.This bill would, commencing January 1, 2022, and to the extent permitted by federal law, require a manufacturer or distributor of dietary supplements sold in the state that contain live microorganisms to include on its label the genus, species, and strain of each live microorganism in the dietary supplement and the total estimated quantity count of all live microorganisms in the dietary supplement at the end of its shelf life, as measured by colony forming units. The bill would provide that life. Because a violation of this requirement is an infraction, punishable by specified fines. By would be an infraction, by creating a new crime, this bill would create 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. | |
| 28 | 27 | ||
| 29 | 28 | Existing law, the Sherman Food, Drug, and Cosmetics Law, provides for the regulation of various subjects relating to the processing, labeling, advertising, and sale of food under the administration and enforcement of the State Department of Public Health. Existing applicable federal law includes dietary supplements, as defined, within the definition of food for these purposes. Existing law requires, to the extent permitted by federal law, that any warning label on products defined as dietary supplements pursuant to specified federal law, that are manufactured or distributed in the state, be clear and conspicuous. Under existing law, a violation of that requirement constitutes an infraction, punishable by specified fines. | |
| 30 | 29 | ||
| 31 | - | This bill would, commencing January 1, 2022, and to the extent permitted by federal law, require a manufacturer or distributor of dietary supplements sold in the state that contain live microorganisms to include on its label the genus, species, and strain of each live microorganism in the dietary supplement and the total estimated count of all live microorganisms in the dietary supplement at the end of its shelf life | |
| 30 | + | This bill would, commencing January 1, 2022, and to the extent permitted by federal law, require a manufacturer or distributor of dietary supplements sold in the state that contain live microorganisms to include on its label the genus, species, and strain of each live microorganism in the dietary supplement and the total estimated quantity count of all live microorganisms in the dietary supplement at the end of its shelf life, as measured by colony forming units. The bill would provide that life. Because a violation of this requirement is an infraction, punishable by specified fines. By would be an infraction, by creating a new crime, this bill would create a state-mandated local program. | |
| 32 | 31 | ||
| 33 | 32 | 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. | |
| 34 | 33 | ||
| 35 | 34 | This bill would provide that no reimbursement is required by this act for a specified reason. | |
| 36 | 35 | ||
| 37 | 36 | ## Digest Key | |
| 38 | 37 | ||
| 39 | 38 | ## Bill Text | |
| 40 | 39 | ||
| 41 | - | The people of the State of California do enact as follows:SECTION 1. Section 110422.1 is added to the Health and Safety Code, to read:110422.1. (a) Commencing January 1, 2022, a manufacturer or distributor of dietary supplements, as defined in Section 321(ff) of Title 21 of the United States Code, sold in the state that contain live microorganisms shall include both of the following | |
| 40 | + | The people of the State of California do enact as follows:SECTION 1. Section 110422.1 is added to the Health and Safety Code, to read:110422.1. (a) Commencing January 1, 2022, a manufacturer or distributor of dietary supplements, as defined in Section 321(ff) of Title 21 of the United States Code, sold in the state that contain live microorganisms shall include both of the following on the label of the dietary supplement:(1) The genus, species, and strain of each live microorganism in the dietary supplement.(2) The total estimated quantity count of all live microorganisms in the dietary supplement at the end of its shelf life, as measured by colony forming units (CFU). life.(b) This section does not in any way limit or restrict any rights, remedies, or duties otherwise applicable by law.(c) This section shall be implemented to the extent permitted by federal law.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. | |
| 42 | 41 | ||
| 43 | 42 | The people of the State of California do enact as follows: | |
| 44 | 43 | ||
| 45 | 44 | ## The people of the State of California do enact as follows: | |
| 46 | 45 | ||
| 47 | - | SECTION 1. Section 110422.1 is added to the Health and Safety Code, to read:110422.1. (a) Commencing January 1, 2022, a manufacturer or distributor of dietary supplements, as defined in Section 321(ff) of Title 21 of the United States Code, sold in the state that contain live microorganisms shall include both of the following | |
| 46 | + | SECTION 1. Section 110422.1 is added to the Health and Safety Code, to read:110422.1. (a) Commencing January 1, 2022, a manufacturer or distributor of dietary supplements, as defined in Section 321(ff) of Title 21 of the United States Code, sold in the state that contain live microorganisms shall include both of the following on the label of the dietary supplement:(1) The genus, species, and strain of each live microorganism in the dietary supplement.(2) The total estimated quantity count of all live microorganisms in the dietary supplement at the end of its shelf life, as measured by colony forming units (CFU). life.(b) This section does not in any way limit or restrict any rights, remedies, or duties otherwise applicable by law.(c) This section shall be implemented to the extent permitted by federal law. | |
| 48 | 47 | ||
| 49 | 48 | SECTION 1. Section 110422.1 is added to the Health and Safety Code, to read: | |
| 50 | 49 | ||
| 51 | 50 | ### SECTION 1. | |
| 52 | 51 | ||
| 53 | - | 110422.1. (a) Commencing January 1, 2022, a manufacturer or distributor of dietary supplements, as defined in Section 321(ff) of Title 21 of the United States Code, sold in the state that contain live microorganisms shall include both of the following | |
| 52 | + | 110422.1. (a) Commencing January 1, 2022, a manufacturer or distributor of dietary supplements, as defined in Section 321(ff) of Title 21 of the United States Code, sold in the state that contain live microorganisms shall include both of the following on the label of the dietary supplement:(1) The genus, species, and strain of each live microorganism in the dietary supplement.(2) The total estimated quantity count of all live microorganisms in the dietary supplement at the end of its shelf life, as measured by colony forming units (CFU). life.(b) This section does not in any way limit or restrict any rights, remedies, or duties otherwise applicable by law.(c) This section shall be implemented to the extent permitted by federal law. | |
| 54 | 53 | ||
| 55 | - | 110422.1. (a) Commencing January 1, 2022, a manufacturer or distributor of dietary supplements, as defined in Section 321(ff) of Title 21 of the United States Code, sold in the state that contain live microorganisms shall include both of the following | |
| 54 | + | 110422.1. (a) Commencing January 1, 2022, a manufacturer or distributor of dietary supplements, as defined in Section 321(ff) of Title 21 of the United States Code, sold in the state that contain live microorganisms shall include both of the following on the label of the dietary supplement:(1) The genus, species, and strain of each live microorganism in the dietary supplement.(2) The total estimated quantity count of all live microorganisms in the dietary supplement at the end of its shelf life, as measured by colony forming units (CFU). life.(b) This section does not in any way limit or restrict any rights, remedies, or duties otherwise applicable by law.(c) This section shall be implemented to the extent permitted by federal law. | |
| 56 | 55 | ||
| 57 | - | 110422.1. (a) Commencing January 1, 2022, a manufacturer or distributor of dietary supplements, as defined in Section 321(ff) of Title 21 of the United States Code, sold in the state that contain live microorganisms shall include both of the following | |
| 56 | + | 110422.1. (a) Commencing January 1, 2022, a manufacturer or distributor of dietary supplements, as defined in Section 321(ff) of Title 21 of the United States Code, sold in the state that contain live microorganisms shall include both of the following on the label of the dietary supplement:(1) The genus, species, and strain of each live microorganism in the dietary supplement.(2) The total estimated quantity count of all live microorganisms in the dietary supplement at the end of its shelf life, as measured by colony forming units (CFU). life.(b) This section does not in any way limit or restrict any rights, remedies, or duties otherwise applicable by law.(c) This section shall be implemented to the extent permitted by federal law. | |
| 58 | 57 | ||
| 59 | 58 | ||
| 60 | 59 | ||
| 61 | - | 110422.1. (a) Commencing January 1, 2022, a manufacturer or distributor of dietary supplements, as defined in Section 321(ff) of Title 21 of the United States Code, sold in the state that contain live microorganisms shall include both of the following | |
| 60 | + | 110422.1. (a) Commencing January 1, 2022, a manufacturer or distributor of dietary supplements, as defined in Section 321(ff) of Title 21 of the United States Code, sold in the state that contain live microorganisms shall include both of the following on the label of the dietary supplement: | |
| 62 | 61 | ||
| 63 | 62 | (1) The genus, species, and strain of each live microorganism in the dietary supplement. | |
| 64 | 63 | ||
| 64 | + | (2) The total estimated quantity count of all live microorganisms in the dietary supplement at the end of its shelf life, as measured by colony forming units (CFU). life. | |
| 65 | 65 | ||
| 66 | + | (b) This section does not in any way limit or restrict any rights, remedies, or duties otherwise applicable by law. | |
| 66 | 67 | ||
| 67 | - | (2)The total estimated count of all live microorganisms in the dietary supplement at the end of its shelf life. | |
| 68 | - | ||
| 69 | - | ||
| 70 | - | ||
| 71 | - | (b) This section does not apply to dietary supplements containing live microorganisms manufactured before July 1, 2021, that are sold prior to January 1, 2023. | |
| 72 | - | ||
| 73 | - | (b) | |
| 74 | - | ||
| 75 | - | ||
| 76 | - | ||
| 77 | - | (c) This section does not in any way limit or restrict any rights, remedies, or duties otherwise applicable by law. | |
| 78 | - | ||
| 79 | - | (c) | |
| 80 | - | ||
| 81 | - | ||
| 82 | - | ||
| 83 | - | (d) This section shall be implemented to the extent permitted by federal law. | |
| 68 | + | (c) This section shall be implemented to the extent permitted by federal law. | |
| 84 | 69 | ||
| 85 | 70 | 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. | |
| 86 | 71 | ||
| 87 | 72 | 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. | |
| 88 | 73 | ||
| 89 | 74 | 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. | |
| 90 | 75 | ||
| 91 | 76 | ### SEC. 2. |