17 NCAC 04C .2004         ANNUAL CERTIFICATION RENEWAL

(a)  Beginning January 1, and not later than March 1, of each subsequent year, certifying manufacturers of vapor products shall electronically submit to the Department an annual renewal application. The certifying manufacturer shall also electronically submit to the Department the annual renewal fee at the time a certifying manufacturer submits the annual renewal application.

(b)  The annual certification renewal application and annual renewal fee shall be completed through the Department's website at the following link: www.ncdor.gov.

(c)  The annual certification renewal 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 a renewal 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 the 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)  The certifying manufacturer shall submit the annual renewal application and annual renewal fee to the Department during the annual renewal period to be timely. Failure of a certifying manufacturer to renew its certification or remit the annual renewal fee with the Department shall result in the expiration of the manufacturer's certification and exclusion from the vapor product and consumable product directory, pursuant to G.S. 143B-245.12(b).

(e)  If a certifying manufacturer's certification expires, the certifying manufacturer shall electronically submit to the Department a new initial certification application and initial certification fee as set out in Rule .2003 of this Section, to be recertified.

History Note:        Authority G.S. 143B-245.11; 143B-245.12; 143B-245.13; 143B-245.16;

Eff. March 1, 2025.