Current through Register Vol. 39, No. 18, March 17, 2025
(a) Initial
Certification Application - Beginning March 1, 2025, each certifying
manufacturer shall electronically submit to the Department an initial
certification application. The certifying manufacturer shall also
electronically submit to the Department the initial certification fee at the
time a certifying manufacturer submits the initial certification application.
(1) Manufacturers of vapor products or
consumable products, offered for sale in this State prior to March 1, 2025,
shall submit the initial certification application and initial certification
fee by April 15, 2025.
(2)
Manufacturers of vapor products or consumable products, who intend to offer
products for sale in this State after March 1, 2025, shall submit the initial
certification application and initial certification fee prior to shipping any
vapor products or consumable products to a retailer, distributor, or wholesaler
in this State for the purpose of making retail sales.
(b) The initial certification application and
initial certification fee shall be completed through the Department's website
at the following link:
https://www.ncdor.gov/taxes-forms/tobacco-products-tax.
(c) The initial certification application
shall include the following information:
(1)
the manufacturer's legal business name or assumed name for sole proprietors,
business mailing address, daytime telephone number, fax number, and email
address;
(2) federal employer
identification number (FEIN) or social security number for
proprietorships;
(3) a contact
person, including that person's legal name, telephone number, fax number, and
e-mail address.
(4) a designation
of whether the manufacturer is requesting an initial certification or updating
information to a previously submitted application;
(5) the seven-digit Secretary of State
identification number assigned by the North Carolina Secretary of State when
the manufacturer registered its business entity to do business in the
State.
(6) the name, address,
telephone number, fax number, and email address of a registered agent as
required in Rule .2006 of this Section;
(7) a manufacturer located outside of the
United States shall list the importers of any of the manufacturer's products to
be sold in this State, as well as the name, address, telephone number, fax
number, and email address of the importers registered agent.
(8) a list of each vapor product or
consumable product that is sold in this State to include the brand name,
category (e.g., e-liquid, power unit, device, e-liquid cartridge, e-liquid pod,
disposable), product name, product code or stock-keeping unit (SKU), and
flavor; and
(9) the Food and Drug
Administration (FDA) tracking number and order date for each vapor product and
consumable product offered by the manufacturer, and shall upload a copy of:
(A) the marketing granted order issued by the
FDA pursuant to 21 U.S.C. 387j;
(B)
the acceptance letter issued by the FDA pursuant to 21 U.S.C. 387j for a Timely
Filed Premarket Tobacco Product Application; or
(C) a document issued by the FDA or by a
court confirming that the premarket tobacco product application has received a
denial order that is not yet in effect and remains stayed or rescinded by FDA
or vacated by a court; and
(10) the total certification fee due and
remitted.
(d) Failure to
submit the required information for the initial certification application or
the initial certification fee will result in a denial of the application and
exclusion from the vapor product and consumable product directory, pursuant to
G.S. 143B-245.12(b). If an initial certification application is denied pursuant
to a provision of G.S. 143B-245.12(b), the certifying manufacturer shall
electronically resubmit to the Department a new initial certification
application and initial certification fee.
(e) Failure to submit the initial
certification application or initial certification fee to the Department 15-
days prior to the first of each month, when the Department makes the vapor
product and consumable product directory available for public inspection on the
Department's website, will result in a manufacturer's products offered for sale
to be prohibited from retail sale in this State, pursuant to G.S. 143B-245.13 until the manufacturer becomes certified.
