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UPDATE: 5/17/2024 - SB 1186 died, it failed to be scheduled for a hearing in the Senate Agriculture, Food Production, and Outdoor Resources Committee before the 2024 session ended on 5/17/2024.
UPDATE: 1/25/2024 - SB 1186 was referred to the Senate Agriculture, Food Production, and Outdoor Resources Committee on 1/25/2024.
SB 1186 was prefiled in the Senate for the 2024 session on 12/1/2023. This bill is sponsored by Senator Mike Moon.
SB 1186 requires conspicuous labeling for any product that has potential to act as gene therapy or that could introduce genetic material to product's users.
SB 1186 establishes a new section (196.1400) to Chapter 196 regarding Food, Drugs and Tobacco Regulations to require disclosure for certain products produced, sold, or distributed in Missouri.
Subsection (2) requires any product that has been created to act as, or exposed to processes that could result in the product potentially acting as a gene therapy, or that could otherwise possibly impact, alter, or introduce genetic material or a genetic change into the user of the product, individuals exposed to the product, or individuals exposed to others who have used the product, to be conspicuously labeled with the words "Potential Gene Therapy Product". This subsection also requires reasonable steps to be taken to ensure the potential purchaser or user of the product is made aware of the presence of this label.
Subsection (3) requires any product reasonably known to be a gene therapy product to be conspicuously labeled with the words "Gene Therapy Product".
Subsection (4) specifies that the provisions of this section will be liberally construed in favor of disclosure of any potential gene therapy product.
SB 1186 establishes a new section (196.1405) to Chapter 196 regarding Food, Drugs and Tobacco Regulations to create disclosure requirements for entities producing, selling, or distributing vaccines and organizations interested in the production, sale, or distribution of vaccines.
Subsection (2) requires entities that produce, sell, or distribute products that can infect an individual with a disease or expose individuals to genetically modified materials, such as vaccines, gene therapies, drugs, and medical interventions, to provide all information, upon the written request of a Missouri resident, related to the ways in which individuals who do not directly obtain or use the product may be exposed to the product or a component of the product. This subsection includes any product manufacturer, government agency, or organization that has an interest in the production, sale, or distribution of such a product to be subject to the disclosure requirement and must provide all relevant reports, research, and knowledge upon request.
Subsection (3) requires the information requested to be provided as soon as reasonably practicable, but at least within 21 days, after receipt of the written request.
SB 1186 establishes a new section (196.1410) to Chapter 196 regarding Food, Drugs and Tobacco Regulations to require any entity that makes a product available that could infect, transmit to, or be absorbed in any individual in any way that would act as a medical intervention, vaccine, drug, or genetic modification to obtain fully informed consent from all individuals who could be exposed to such product before exposure could occur. This subsection also establishes the requirement for fully informed consent to minimally include that an individual is made aware of all benefits and risks, including side effects of the product, any adverse events of special interest, and any other reasonably possible impacts of the product.
Upon passage, SB 1186 will be effective on August 28, 2024.
SB 1186 is identical to HB 1169 from the 2023 session.
NVIC SUPPORTS SB 1186 because gene therapy products, including experimental mRNA vaccines, have not been sufficiently studied and have unknown effects on the human body. NVIC supports informed consent for parents and individuals. Without this disclosure, those who want to avoid exposure to these types of vaccines that fall under this category, would have a difficult time. While this legislation cannot guarantee fully informed consent regarding gene therapy products, it is a step in the right direction to raising consumer awareness. NVIC does not take a position on the rest of the bill's provisions which are unrelated to vaccines.
https://www.senate.mo.gov/24info/BTS_Web/Bill.aspx?SessionType=R&BillID=398 - text, status, and history of SB 1186
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