Indicates Matter Stricken

Indicates New Matter

As Passed By The Senate

April 02, 2024

S. 994

Introduced by Senators Alexander, Hutto, Verdin, Grooms, Kimbrell, Gambrell, Shealy, Hembree, McElveen, Davis, Young, Loftis, K. Johnson, McLeod, Martin, Senn, Garrett, Fanning, Cromer, Devine, Williams and Setzler

S. Printed 04/02/24--S.                                                                            [SEC 4/3/2024 1:02 PM]

Read the first time January 25, 2024

________

A bill

TO AMEND THE SOUTH CAROLINA CODE OF LAWS BY ADDING SECTION 44-95-65 SO AS TO PROVIDE REGULATIONS FOR THE SALE OF ELECTRONIC NICOTINE DELIVERY SYSTEMS AND TO PROVIDE PENALTIES FOR VIOLATIONS OF THIS SECTION.

    Amend Title To Conform

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

SECTION 1.  Chapter 95, Title 44 of the S.C. Code is amended by adding:

    Section 44-95-65.  (A) As used in this section:

        (1) "ENDS product" means an electronic nicotine delivery system intended for eventual retail sale in this State that is a non-combustible product that employs a heating element, power source, electronic circuit, or other electronic, chemical, or mechanical means, regardless of shape or size to produce vapor from nicotine in a solution. ENDS product include a consumable nicotine liquid solution suitable for use in an electronic nicotine delivery system, whether sold with the ENDS product or separately, but does not include any product regulated as a drug or device under Chapter V of the federal Food, Drug, and Cosmetic Act.

        (2) "FDA" means the Federal Food and Drug Administration.

        (3) "Advertise" means the publication or dissemination of an advertisement.

        (4) "Advertisement" includes any written or verbal statement, illustration, or depiction which is calculated to induce sales of ENDS products, including any written, printed, graphic, or other material, billboard sign, or other outdoor display, public transit card, other periodical literature, publication, in a radio or television broadcast, or in any other media.

        (5) "Marketing" means any act or process of promoting or selling of ENDS products including, but not limited to, sponsorship of sporting events, and promotion of products specifically designed to appeal to certain demographics.

        (6) "Minor" means an individual under the age of eighteen years of age.

        (7) "Packaging" means any receptacle that contains a ENDS product.

        (B) Every manufacturer of ENDS products that are sold in this State, whether directly or through a distributor, retailer, or similar intermediary, shall annually execute and deliver under penalty of perjury to the Attorney General on a form prescribed by the Attorney General a certification verifying either:

       (1) the ENDS product was on the market in the United States as of August 8, 2016, and the manufacturer has applied for a marketing order pursuant to 21 U.S.C. Section 387j for the ENDS product by submitting a premarket tobacco product application on or before September 9, 2020, to the FDA and either the premarket tobacco product application for the product remains under review by the FDA or the FDA has issued a marketing denial order for the product from the FDA but the agency or a federal court has issued a stay order or injunction; or

       (2) the manufacturer has received a marketing authorization under 21 U.S.C. Section 387j for the product from the FDA.

    (C) In addition to the requirements in subsection (B) of this section, each manufacturer shall provide a copy of the premarket tobacco application with evidence of receipt of the application by the FDA or a copy of the marketing authorization issued pursuant to 21 U.S.C. Section 387j, whichever is applicable.

    (D) Any manufacturer submitting a certification pursuant to subsection (B) shall notify the Attorney General within thirty days of any material change to the certification, including issuance by the FDA of:

       (1) a marketing authorization pursuant to 21 U.S.C. Section 387j;

       (2) an order revoking a marketing authorization with respect to a manufacturer or an ENDS product; or

       (3) any notice of action taken by the FDA affecting the ability of the new ENDS product to be introduced or delivered into interstate commerce for commercial distribution.

    (E) The Attorney General shall develop and maintain a directory listing all manufacturers of ENDS products that have provided certifications that comply with this section and all ENDS products that are listed in those certifications.

    (F) The Attorney General shall:

       (1) make the directory available for public inspection on its website;

       (2) update the directory as necessary to correct mistakes and to add or remove manufacturers of ENDS products manufactured by those manufacturers on a monthly basis; and

       (3) send monthly notifications to each wholesaler, retailer, or manufacturer of ENDS products that have registered with the Attorney General by electronic communication containing a list of all changes that have been made to the directory in the previous month. In lieu of sending monthly notifications, the Attorney General may make the information available in a prominent place on the Attorney General's public website.

    (G) The Attorney General shall provide manufacturers of ENDS products notice and an opportunity to cure deficiencies before removing manufacturers or ENDS products from the directory.

       (1) The Attorney General may not remove the manufacturer or its ENDS products from the directory until at least fourteen days after the manufacturer has been given notice of an intended action. Notice shall be sufficient and be deemed immediately received by a manufacturer if the notice is sent electronically to an electronic mail address provided by the manufacturer in its most recent certification filed under subsection (B).

       (2) The manufacturer of an ENDS product shall have fourteen business days from the date of service of the notice of the Attorney General's intended action to establish that the manufacturer or its ENDS products should be included in the directory.

       (3) A determination by the Attorney General to not include or to remove from the directory a manufacturer or a manufacturer's ENDS product shall be subject to review in the manner provided by Article 3, Chapter 23 of Title 1.

    (H) A non-refundable fee of two thousand dollars for each ENDS product shall be paid the first time a manufacturer submits a certification form to offset the costs incurred by the Attorney General for processing the certifications and operating the directory. The Attorney General shall thereafter collect an annual renewal fee of five hundred dollars for each ENDS product to offset the costs associated with maintaining the directory and satisfying the requiremen