§926.1. Vapor product and alternative nicotine product directory
A. Every vapor product manufacturer whose products are sold in this state, whether
directly or through a wholesale dealer, retail dealer, or similar intermediary or intermediaries,
shall execute and deliver on a form prescribed by the commissioner a certification to the
commissioner affirming, under penalty of perjury, either of the following:
(1)The 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. 387j for the vapor
product or alternative nicotine product by submitting a premarket tobacco product
application on or before September 9, 2020, to the United States Food and Drug
Administration, hereinafter referred to in this Section Free access — add to your briefcase to read the full text and ask questions with AI
§926.1. Vapor product and alternative nicotine product directory
A. Every vapor product manufacturer whose products are sold in this state, whether
directly or through a wholesale dealer, retail dealer, or similar intermediary or intermediaries,
shall execute and deliver on a form prescribed by the commissioner a certification to the
commissioner affirming, under penalty of perjury, either of the following:
(1) The 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. 387j for the vapor
product or alternative nicotine product by submitting a premarket tobacco product
application on or before September 9, 2020, to the United States Food and Drug
Administration, hereinafter referred to in this Section as "FDA", and either of the following
is true:
(a) The premarket tobacco product application for the vapor product remains under
review by the FDA.
(b) The FDA has issued a no marketing order for the vapor product, but the agency
or a federal court has issued a stay order or injunction during the pendency of the
manufacturer's appeal of the no marketing order, or the order has been appealed either to the
FDA or a challenge to the order filed with a federal court and the appeal or challenge is still
pending.
(2) The manufacturer has received a marketing order or other authorization under 21
U.S.C. 387j for the vapor product from the FDA.
B. Every alternative nicotine product manufacturer whose products are sold in this
state, whether directly or through a wholesale dealer, retail dealer, or similar intermediary
or intermediaries, shall execute and deliver on a form prescribed by the commissioner a
certification to the commissioner affirming, under penalty of perjury, either of the following:
(1) The product was on the market in the United States as of April 14, 2022, and the
manufacturer has applied for a marketing order pursuant to 21 U.S.C. 387j for the vapor
product or alternative nicotine product by submitting a premarket tobacco product
application on or before May 14, 2022, to the FDA, and either of the following is true:
(a) The premarket tobacco product application for the alternative nicotine product
remains under review by the FDA.
(b) The FDA has issued a no marketing order for the alternative nicotine product, but
the agency or a federal court has issued a stay order or injunction during the pendency of the
manufacturer's appeal of the no marketing order, or the order has been appealed either to the
FDA or a challenge to the order filed with a federal court and the appeal or challenge is still
pending.
(2) The manufacturer has received a marketing order or other authorization under 21
U.S.C. 387j for the alternative nicotine product from the FDA.
C. In addition to the requirements of Subsections A and B of this Section, each
manufacturer shall provide a copy of the cover page of the premarket tobacco application
with evidence of receipt of the application by the FDA or a copy of the cover page of the
marketing order or other authorization issued pursuant to 21 U.S.C. 387j, whichever is
applicable.
D. Any manufacturer submitting a certification pursuant to Subsection A or B of this
Section shall notify the commissioner within thirty days of any material change to the
certification, including issuance by the FDA of any of the following:
(1) A market order or other authorization pursuant to 21 U.S.C. 387j.
(2) An order requiring a manufacturer to remove a product from the market either
temporarily or permanently.
(3) Any notice of action taken by the FDA affecting the ability of the new product
to be introduced or delivered into interstate commerce for commercial distribution.
(4) Any change in policy that results in a product no longer being exempt from
federal enforcement oversight.
E. The commissioner shall develop and maintain a directory listing all vapor product
manufacturers and alternative nicotine product manufacturers that have provided
certifications that comply with Subsections A and B of this Section and all products that are
listed in those certifications.
F. The commissioner shall do all of the following:
(1) Make the directory available for public inspection on the public website of the
office of alcohol and tobacco control.
(2) Update the directory as necessary in order to correct mistakes and to add or
remove vapor product manufacturers and alternative nicotine product manufacturers or
products manufactured by those manufacturers.
(3) Send monthly notifications to each wholesale dealer, retail dealer, and
manufacturer of vapor products and manufacturer of alternative nicotine products that has
qualified or registered with the commissioner, 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 commissioner may make the information available in a prominent
place on the public website of the office of alcohol and tobacco control.
G. Notwithstanding Subsections A and B of this Section, if a vapor product
manufacturer or alternative nicotine product manufacturer can demonstrate to the
commissioner that the FDA has issued a rule, guidance, or any other formal statement that
temporarily exempts a vapor product or alternative nicotine product from the federal
premarket tobacco application requirements, the vapor product or alternative product may
be added to the directory upon request by the manufacturer if the manufacturer provides
sufficient evidence that the vapor product or alternative nicotine product is compliant with
the federal rule, guidance, or other formal statement, as applicable.
H. Each certifying vapor product manufacturer or alternative nicotine product
manufacturer shall pay an initial fee of one hundred dollars per product stock keeping unit
or SKU to offset the costs incurred by the commissioner for processing the certifications and
operating the directory. The commissioner shall collect an annual renewal fee of one
hundred dollars per product stock keeping unit or SKU to offset the costs associated with
maintaining the directory and satisfying the requirements of this Section. The fees received
pursuant to this Section by the commissioner shall be used by the office of alcohol and
tobacco control exclusively for processing the certifications and operating and maintaining
the directory.
I. Beginning on the date that the commissioner makes the directory available for
public inspection on the public website of the office of alcohol and tobacco control as
provided in Subsection F of this Section, a vapor product manufacturer or alternative nicotine
product manufacturer who offers for sale a vapor product or alternative nicotine product not
listed on the directory is subject to a one thousand dollar daily fine for each vapor product
or alternative nicotine product offered for sale in violation of this Section until the offending
product is removed from the market or until the offending product is properly listed on the
directory.
J.(1) The sale, possession, or transportation of vapor products or alternative nicotine
products not listed on the directory by any person, including a permitted wholesale dealer or
retail dealer, shall be subject to provisions of R.S. 47:858, 859, and 860 as if such wholesale
dealer or retail dealer did not possess a valid permit.
(2) Each unit of vapor product or alternative nicotine product sold or offered for sale,
possessed, or transported shall constitute a separate violation for purposes of Paragraph (1)
of this Subsection.
K. Any other violation of this Section shall result in a fine of five hundred dollars
per offense.
L. The commissioner shall adopt rules for the implementation and enforcement of
this Section.