438.308 Duties and responsibilities of manufacturers of nicotine vapor products.

318 words·~1 min read·/ky/chapter-438/438-308

A research copy — for the controlling text, always check the official state or federal source. Not legal advice.

(1)A manufacturer of nicotine vapor products shall:

(a)Only sell authorized nicotine vapor products;

(b)Provide information necessary to establish its product meets the definition of

an authorized nicotine vapor product as defined in KRS 438.305 directly to a

wholesaler or retailer distributing or selling the manufacturer's product in

accordance with paragraph

(d)of this subsection;

(c)Comply with paragraph

(b)of this subsection by providing:

1. Proof of authorization by the FDA;

2. A copy of the first page of the communication from the FDA reflecting

an acceptance for review or the submission tracking number; or

3. If an appeal is pending, a copy of the first page of the document filed

with the applicable agency or court;

which may be provided and maintained in hard copy or electronic form; and

(d)Provide the information from paragraph

(b)of this subsection directly to a:

1. Kentucky-licensed wholesaler that the manufacturer is utilizing to

distribute its product; or

2. Retailer if the manufacturer is not utilizing a Kentucky-licensed

wholesaler to distribute its product.

(2)If the FDA or a court of competent jurisdiction takes final action that removes an

authorized nicotine vapor product from the market, the manufacturer shall provide

notice of the final action to any wholesaler or retailer that has purchased the vapor

product from the manufacturer within thirty

(30)days of the final action being

taken.

(3)A manufacturer that fails to provide the information required in subsection

(1)of

this section or provides false or misleading information to retailers or wholesalers

violates this section and shall be subject to a fine of:

(a)Twenty-five thousand dollars ($25,000) for a first citation issued for a

violation of this section;

(b)Fifty thousand dollars ($50,000) for a second citation issued for a violation of

this section; and

(c)Seventy-five thousand dollars ($75,000) for a third or subsequent citation

issued for a violation of this section.