South Carolina H 3096: Gene Therapy

Bill Text

2025-2026 Bill 3096 Text of Previous Version (Dec. 06, 2024) - South Carolina Legislature Online 

South Carolina General Assembly
126th Session, 2025-2026

Bill 3096

Indicates Matter Stricken
Indicates New Matter

(Text matches printed bills. Document has been reformatted to meet World Wide Web specifications.)

A bill

TO AMEND THE SOUTH CAROLINA CODE OF LAWS BY ADDING CHAPTER 
141 TO TITLE 44 SO AS TO PROVIDE FOR THE REGULATION OF GENE THERAPY BY 
REQUIRING CERTAIN LABELING OF GENE THERAPY PRODUCTS, DISCLOSURE OF INFORMATION, 
AND INFORMED CONSENT.

Be it enacted by the 
General Assembly of the State of South Carolina:

SECTION 1. Title 44 of the S.C. Code is amended by adding:

CHAPTER 141

Gene Therapy

 Section 
44-141-10. For purposes of this chapter:

 (1) 
"Cosmetic" has the same meaning as defined in Section 39-25-20, except that the 
term "cosmetic" shall include soap.

 (2) 
"Expose" means transmit to another through skin-to-skin contact, sexual 
activity, droplets or aerosols suspended in the air, introduction into the 
blood supply or food supply, or any other means.

 (3) 
"Food" has the same meaning as defined in Section 39-35-20.

 (4) 
"Gene therapy product" means any product with any capacity to alter, interfere 
with, or otherwise act in any manner similar or equivalent to genes.

 (5) 
"Genetically modified" means the alteration of genetic material through modern 
biotechnology, directed evolution, or any other mechanism in a way that does 
not occur naturally or that does not occur at its natural rate.

 (6) 
"Product" means any product that is:

 (a) 
a food, cosmetic, or other substance intended to be ingested, introduced into, 
or applied to the human body or intended to induce physiological effects; and

 (b) 
made available for sale in this State to the general public at retail.

 Section 
44-141-20. (A) 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 must be conspicuously labeled with the words 
"Potential Gene Therapy Product" unless the product is known to be a gene 
therapy product. Reasonable steps must be taken to ensure the potential 
purchaser or user of the product is made aware of the presence of this label.

 (B) 
If a product is known to be a gene therapy product, the product must be 
conspicuously labeled with the words "Gene Therapy Product."

 (C) 
The provisions of this section must be liberally construed in favor of 
disclosure of any potential gene therapy product.

 Section 
44-141-30. (A) Upon the written 
request of any resident of this State, any entity that produces, sells, or 
distributes a product in this State with the capacity to infect an individual 
with a disease or to expose an individual to genetically modified material 
including, but not limited to, vaccines, gene therapy products, drugs, and 
medical interventions, shall provide any and all information related to the 
ways in which individuals who did not directly obtain or use such product may 
be exposed to the product or a component of the product. Any product 
manufacturer, governmental agency, or organization of any type that has an 
interest in the production, sale, or distribution of such product shall be 
subject to the disclosure requirement of this section and shall provide all 
relevant reports, research, and knowledge upon request under this section.

 (B) 
Any entity described in subsection (A) shall provide the information requested 
under subsection (A) as soon as reasonably practicable, but at least within 
twenty-one days, after receipt of the written request to the resident who made 
the request.

 (C) Any 
entity that makes a product available in this State 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 shall obtain fully 
informed consent from all individuals who could be exposed to such product 
before exposure could occur. Fully informed consent requires, at a minimum, 
that an individual is made aware of all benefits and risks of the product, 
including side effects, any adverse events of special interest, and any other 
reasonably possible impacts of the product.

SECTION 2. This act takes effect upon approval 
by the Governor.

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