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AN ACT relating to nicotine products. 1
Be it enacted by the General Assembly of the Commonwealth of Kentucky: 2
SECTION 1. A NEW SECTION OF KRS 438.305 TO 438.340 IS CREATED 3
TO READ AS FOLLOWS: 4
(1) Each business entity shall, upon organizational filing or application for 5
certificate of authority to the Secretary of State and upon its annual report, state 6
whether it is involved in the retail sale of Tobacco Control Act covered products. 7
(2) The Secretary of State shall: 8
(a) Create a list of the retailers that sell the products identified in this section; 9
and 10
(b) Share the list of retailers monthly to the Department of Alcoholic Beverage 11
Control and the Department of Revenue. 12
SECTION 2. A NEW SECTION OF KRS 438.305 TO 438.340 IS CREATED 13
TO READ AS FOLLOWS: 14
The Department of Alcoholic Beverage Control shall: 15
(1) Enforce Sections 1 to 8 of this Act; 16
(2) On the first day of each month, update and publish online the retailers that are 17
involved in the retail sale of the products identified in Section 1 of this Act; and 18
(3) Develop, maintain, and utilize a coordinated tobacco noncompliance database 19
and reporting system to identify the retailers that have violated Sections 1 to 8 of 20
this Act and to publish that information online on the first day of each month. 21
SECTION 3. A NEW SECTION OF KRS 438.305 TO 438.340 IS CREATED 22
TO READ AS FOLLOWS: 23
As used in Sections 1 to 8 of this Act: 24
(1) "Authorized product" means: 25
(a) A Tobacco Control Act covered product for which the manufacturer has 26
obtained: 27 UNOFFICIAL COPY 24 RS HB 11/GA
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1. Authorization from the United States Food and Drug Administration 1
or 2
2. A safe harbor certification; 3
(b) Cigars; 4
(c) Pipe tobacco; or 5
(d) Tobacco Control Act covered products exempt from the substantial 6
equivalence or premarket tobacco product authorization process with the 7
United States Food and Drug Administration due to having been 8
commercially marketed in the United States of America as of February 15, 9
2007; 10
(2) "Cigar" means any roll of tobacco wrapped in leaf tobacco or in any substance 11
containing tobacco, other than a little cigar, or any roll of tobacco which is a 12
cigarette as defined in KRS 138.130; 13
(3) "Pipe tobacco" means any tobacco which, because of its appearance, type, 14
packaging, or labeling, is suitable for use and likely to be offered to or purchased 15
by consumers as tobacco to be smoked in a pipe; 16
(4) (a) "Safe harbor certification" means a certification provided by a 17
manufacturer establishing that a product falls within a safe harbor 18
established by the United States Food and Drug Administration by timely 19
pursuing one (1) of the following paths to market: 20
1. For any nicotine product containing tobacco-derived nicotine that 21
commercially marketed in the United States of America after February 22
15, 2007, but as of March 11, 2011, by submitting a substantial 23
equivalence report, on or before March 11, 2011, to the United States 24
Food and Drug Administration, that: 25
a. Remains under review, but has not received a substantial 26
equivalence authorization; or 27 UNOFFICIAL COPY 24 RS HB 11/GA
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b. Has been denied substantial equivalence authorization, but 1
remains under a stay by the United States Food and Drug 2
Administration or continues to be subject to an appeal to or 3
review by a court of competent jurisdiction; 4
2. For any nicotine product containing tobacco-derived nicotine that was 5
on the market in the United States of America as of August 8, 2016, 6
and submitted a premarket tobacco product application on or before 7
September 9, 2020, to the United States Food and Drug 8
Administration, that: 9
a. Remains under review, but has not received either a marketing 10
denial order or a marketing grant order; 11
b. Has received a marketing denial order, but remains under a stay 12
by the United States Food and Drug Administration or continues 13
to be subject to an appeal to or review by a court of competent 14
jurisdiction; or 15
c. Has had a marketing denial order that has been rescinded by the 16
United States Food and Drug Administration or vacated by a 17
court of competent jurisdiction; or 18
3. For any nicotine product containing nontobacco-derived nicotine that 19
was on the market in the United States of America as of April 14, 20
2022, and submitted a premarket tobacco product application, on or 21
before May 14, 2022, to the United States Food and Drug 22
Administration, that: 23
a. Remains under review, but has not received either a marketing 24
denial order or a marketing grant order; 25
b. Has received a marketing denial order, but remains under a stay 26
by the United States Food and Drug Administration or continues 27 UNOFFICIAL COPY 24 RS HB 11/GA
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to be subject to an appeal to or review by a court of competent 1
jurisdiction; or 2
c. Has had a marketing denial order that has been rescinded by the 3
United States Food and Drug Administration or vacated by a 4
court of competent jurisdiction. 5
(b) Safe harbor certifications shall contain a copy of the first page of the 6
communication from the United States Food and Drug Administration 7
reflecting an acceptance for review or the submission tracking number or, if 8
on appeal, a copy of the first page of the document filed with the applicable 9
agency or court. 10
(c) Safe harbor certifications may be provided and maintained in hard copy or 11
in electronic form; 12
(5) "Tobacco Control Act covered product" means products covered by the Family 13
Smoking Prevention and Tobacco Control Act, Pub. L. No. 111-31; and 14
(6) (a) "Unauthorized product" means any Tobacco Control Act covered product 15
that has not been authorized by the United States Food and Drug 16
Administration. 17
(b) "Unauthorized product" does not include a Tobacco Control Act covered 18
product for which: 19
1. The manufacturer has received a marketing grant order or other 20
authorization to market from the United States Food and Drug 21
Administration; or 22
2. The manufacturer has a safe harbor certification. 23
SECTION 4. A NEW SECTION OF KRS 438.305 TO 438.340 IS CREATED 24
TO READ AS FOLLOWS: 25
(1) A manufacturer of Tobacco Control Act covered products shall only sell 26
authorized products. 27 UNOFFICIAL COPY 24 RS HB 11/GA
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(2) A manufacturer shall provide a safe harbor certification to a wholesaler or 1
retailer when selling a product that has not been authorized by the United States 2
Food and Drug Administration. 3
(3) If the United States Food and Drug Administration or a court of competent 4
jurisdiction takes final action which removes a product from the safe harbor or 5
authorized to market status, the manufacturer shall provide notice of the final 6
action to any wholesaler or retailer which has purchased the product from the 7
manufacturer within thirty (30) days of the final action being taken. 8
(4) It shall be a violation of this section for a manufacturer to provide false or 9
misleading information in a safe harbor certification or other notice to retailers 10
or wholesalers. 11
(5) A manufacturer that violates this section shall be subject to a fine of twenty-five 12
thousand dollars ($25,000) for a first citation issued for a violation of this section, 13
fifty thousand dollars ($50,000) for a second citation issued for a violation of this 14
section, and seventy-five thousand dollars ($75,000) for a third or subsequent 15
citation issued for a violation of this section. 16
SECTION 5. A NEW SECTION OF KRS 438.305 TO 438.340 IS CREATED 17
TO READ AS FOLLOWS: 18
(1) A wholesaler shall not sell: 19
(a) Authorized products to a retailer until the wholesaler verifies that the 20
retailer is not in the tobacco noncompliance database and reporting system; 21
or 22
(b) Unauthorized products. 23
(2) Any wholesaler that violates this section shall be subject to a fine of five thousand 24
dollars ($5,000) for a first citation issued for a violation of this section and fifteen 25
thousand dollars ($15,000) for a second or subsequent citation issued for a 26
violation of this section. 27 UNOFFICIAL COPY 24 RS HB 11/GA
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SECTION 6. A NEW SECTION OF KRS 438.305 TO 438.340 IS CREATED 1
TO READ AS FOLLOWS: 2
(1) A retailer shall be prohibited from selling authorized products to any person 3
under twenty-one (21) years of age. 4
(2) It shall be an affirmative defense for a retailer for a violation of selling 5
authorized product to a person under twenty-one (21) years of age if the retailer 6
meets the standards set forth in KRS 244.080. 7
(3) (a) For the first citation issued for a violation of this section, a retailer shall be 8
subject to a fine of not less than one hundred dollars ($100) nor more than 9
five hundred dollars ($500). 10
(b) A retailer shall be subject to fine of one thousand dollars ($1000) for the 11
second citation issued for a violation of this section, and a fine of five 12
thousand dollars ($5000) for a third or subsequent citation issued for a 13
violation of this section not subject to paragraph (c) of this subsection. 14
(c) For any fourth or subsequent citation issued for a violation of this section 15
within a two (2) year period, a retailer shall be placed in the tobacco 16
noncompliance database and reporting system and lose the ability to sell 17
Tobacco Control Act covered products for one (1) year. 18
(3) Any retailer with unpaid fines that are more than sixty (60) days overdue shall 19
become ineligible to sell Tobacco Control Act covered products until the fines are 20
paid. 21
SECTION 7. A NEW SECTION OF KRS 438.305 TO 438.340 IS CREATED 22
TO READ AS FOLLOWS: 23
(1) A retailer shall be prohibited from selling unauthorized products to any person. 24
(2) Any retailer selling Tobacco Control Act products shall obtain from the 25
manufacturer a safe harbor certification. The retailer shall maintain a copy 26
thereof at the physical location where the product is being sold. 27 UNOFFICIAL COPY 24 RS HB 11/GA
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(3) A retailer is not required to obtain a safe harbor certification for Tobacco Control 1
Act products if those products were purchased from a Kentucky-licensed tobacco 2
wholesaler. 3
(4) (a) Any retailer that receives a citation issued for a violation of this section 4
shall be subject to a fine of one thousand dollars ($1,000) for a first 5
violation and five thousand dollars ($5,000) for a second or subsequent 6
citation issued for a violation not subject to paragraph (b) of this subsection. 7
(b) For any third or subsequent citation issued for a violation within a two (2) 8
year period, a retailer shall be placed in the tobacco noncompliance 9
database and reporting system and lose the ability to sell Tobacco Control 10
Act covered products for one (1) year. 11
(5) A retailer on the tobacco noncompliance database and reporting system found to 12
be selling Tobacco Control Act covered products that are not authorized products 13
shall be subject to a fine of ten thousand dollars ($10,000) per unlawful 14
transaction. 15
(6) Any retailer with unpaid fines that are more than sixty (60) days overdue shall 16
become ineligible to sell Tobacco Control Act covered products until the fines are 17
paid. 18
(7) It shall be an affirmative defense for a retailer for a violation of selling 19
unauthorized product if any of the following exists: 20
(a) Official proof that there has been a material change in the status of a 21
product under review by the United States Food and Drug Administration 22
within forty-five (45) days of the issuance of the citation; or 23
(b) A safe harbor certification exists onsite at the retail location at the time the 24
citation was issued. 25
SECTION 8. A NEW SECTION OF KRS 438.305 TO 438.340 IS CREATED 26
TO READ AS FOLLOWS: 27 UNOFFICIAL COPY 24 RS HB 11/GA
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(1) All certified peace officers with general law enforcement authority and 1
investigators of the Department of Alcoholic Beverage Control may issue a 2
uniform citation for a violation of Sections 1 to 8 of this Act. 3
(2) A citation shall not be issued to a minor and an arrest of a minor shall not be 4
made for a violation of Sections 1 to 8 of this Act. 5
(3) (a) All citations issued pursuant to Sections 1 to 8 of this Act shall be reported 6
to and enforced by the Department of Alcoholic Beverage Control. 7
(b) Multiple violations found during one (1) visit shall be reported on a single 8
citation and shall result in one (1) violation for purposes of the penalties set 9
forth in Sections 6 and 7 of this Act. 10
(c) Each violation shall be specific to the physical location in which the 11
violation occurred. 12
Section 9. KRS 241.060 is amended to read as follows: 13
The board shall have the following functions, powers, and duties: 14
(1) To promulgate reasonable administrative regulations governing procedures relative 15
to the applications for and revocations of licenses, the supervision and control of the 16
use, manufacture, sale, transportation, storage, advertising, and trafficking of 17
alcoholic beverages, and all other matters over which the board has jurisdiction. 18
The only administrative regulation that shall be promulgated in relation to the direct 19
shipper license is to establish the license application, as set forth in KRS 20
243.027(4). To the extent any administrative regulation previously promulgated is 21
contrary to the provisions of KRS 13A.120(2), the board shall repeal or amend the 22
administrative regulation as necessary by January 1, 2022. Administrative 23
regulations need not be uniform in their application but may vary in accordance 24
with reasonable classifications; 25
(2) To limit in its sound discretion the number of licenses of each kind or class to be 26
issued in this state or any political subdivision, and restrict the locations of licensed 27 UNOFFICIAL COPY 24 RS HB 11/GA
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premises. To this end, the board may make reasonable division and subdivision of 1
the state or any political subdivision into districts. Administrative regulations 2
relating to the approval, denial, and revocation of licenses may be different within 3
the several divisions or subdivisions; 4
(3) To hold hearings in accordance with the provisions of KRS Chapter 13B. The 5
department may pay witnesses the per diem and mileage provided in KRS 421.015; 6
(4) To conduct hearings and appeals under KRS 241.150, 241.200, 241.260, 243.470, 7
[and ]243.520, 438.340, and Sections 1 to 8 of this Act and render final orders upon 8
the subjects of the hearings and appeals; 9
(5) To order the destruction of evidence in the department's possession after all 10
administrative and judicial proceedings are conducted; 11
(6) To suspend, revoke, or cancel for cause, after a hearing in accordance with KRS 12
Chapter 13B, any license; and 13
(7) To prohibit the issuance of a license for the premises until the expiration of two (2) 14
years from the time the offense was committed if a violation of KRS Chapters 241 15
to 244 has taken place on the premises which the owner knew of or should have 16
known of, or was committed or permitted in or on the premises owned by the 17
licensee. 18
Section 10. This Act takes effect January 1, 2025. 19