The Florida Senate
BILL ANALYSIS AND FISCAL IMPACT STATEMENT
(This document is based on the provisions contained in the legislation as of the latest date listed below.)
Prepared By: The Professional Staff of the Appropriations Committee on Agriculture, Environment, and General
Government
BILL: CS/SB 1006
INTRODUCER: Regulated Industries Committee and Senator Perry
SUBJECT: Nicotine Products and Dispensing Devices
DATE: February 20, 2024
ANALYST STAFF DIRECTOR REFERENCE ACTION
1. Oxamendi Imhof RI Fav/CS
2. Davis Betta AEG Pre-meeting
3. FP
Please see Section IX. for Additional Information:
COMMITTEE SUBSTITUTE - Substantial Changes
I. Summary:
CS/SB 1006 provides for the regulation of the wholesale and the retail sale of nicotine
dispensing devices (NDDs) products such as electronic cigarettes. The bill:
Requires manufacturers of NDDs to register with the Division of Alcoholic Beverages and
Tobacco (division) within the Department of Business and Professional Regulation by
December 1, 2024, and annually thereafter, any of its products that are sold in Florida and
which have received an order from the U.S. Food and Drug Administration (FDA)
authorizing the marketing of such products or has applied for such a marketing order.
Requires manufacturers to certify under penalty of perjury the NDDs with the division and
provide evidence specified in the bill of such approval from the FDA or that they have sought
approval from the FDA.
Requires the division to create a directory containing the registered NDDs.
Requires wholesale dealers of a NDD to have a permit issued by the division.
Requires manufacturers of NDDs to maintain certain records for a period of three years,
including identifying information regarding to whom the products were sold.
Prohibits wholesale dealers and retail dealers of NDDs from selling NDDs that are not on the
division’s directory of NDDs.
Prohibits the shipment into Florida of NDDs that the FDA has ordered removed from the
market, that have not been submitted for approval by the FDA, or that have not been
registered with the division.
Creates the following criminal violations and penalties:
REVISED: BILL: CS/SB 1006 Page 2
o Third degree felony for falsely misrepresenting any of the information required to register
a NDD with the division.
o First degree misdemeanor for nicotine product manufacturers who knowingly ships or
receives a NDD that the FDA has ordered removed from the market, that have not been
submitted for approval by the FDA, or that have not been registered with the division;
o Second degree misdemeanor for any person who knowingly ships or receives
unregistered NDDs;
o Second degree misdemeanor for any person who knowingly ships or receives NDDs from
a manufacturer that does not have a permit issued by the division; and
Provides administrative fines for violations and for the suspension and revocation of permits.
Provides that all NDDs sold, delivered, possessed, or distributed in contrary to the provisions
in the bill are contraband and are subject to seizure and confiscation under the Florida
Contraband Forfeiture Act.
Requires non-resident manufacturers of NDDs sold in Florida to have a registered agent in
Florida to accept service of process.
The bill has a significant, negative fiscal impact on state expenditures. See Section V., Fiscal
Impact Statement.
The bill provides an effective date of October 1, 2024.
II. Present Situation:
Florida Regulation of Tobacco Products and Nicotine Dispensing Devises
The Division of Alcoholic Beverages and Tobacco (division) within the Department of Business
and Professional Regulation (DBPR) is the state agency responsible for the regulation and
enforcement of tobacco products under part I of ch. 569, F.S., and nicotine products under part II
of ch. 569, F.S.
Tobacco Products Definitions
Section 210.01(1), F.S., defines the term “cigarette” to mean:
any roll for smoking, except one of which the tobacco is fully naturally
fermented, without regard to the kind of tobacco or other substances used
in the inner roll or the nature or composition of the material in which the
roll is wrapped, which is made wholly or in part of tobacco irrespective of
size or shape and whether such tobacco is flavored, adulterated or mixed
with any other ingredient.
Section 569.002(6), F.S., defines the term “tobacco products” to include loose tobacco leaves
and products made from tobacco leaves, in whole or in part, and cigarette wrappers, which can
be used for smoking, sniffing, or chewing, in the context of the taxation of cigarettes under part I
of ch. 210, F.S.
Section 210.25(12), F.S., provides a separate definition for the term “tobacco products” in the
context of the taxation of tobacco products other than cigarettes or cigars. It provides for the BILL: CS/SB 1006 Page 3
licensing of tobacco product manufacturers, importers, exporters, distributing agents, or
wholesale dealers under part II of ch. 210, F.S. In this context, the term “tobacco products”
means:
loose tobacco suitable for smoking; snuff; snuff flour; cavendish; plug and
twist tobacco; fine cuts and other chewing tobaccos; shorts; refuse scraps;
clippings, cuttings, and sweepings of tobacco, and other kinds and forms of
tobacco prepared in such manner as to be suitable for chewing; but “tobacco
products” does not include cigarettes, as defined by s. 210.01(1), or cigars.
The definition of “tobacco products” in s. 569.002(6), F.S., is limited to the regulation of tobacco
products by the division under ch. 569, F.S., and does not affect the taxation of such products
under ch. 210, F.S.
Nicotine Products
Section 569.31(3), F.S., defines the term “nicotine dispensing device” to mean:
any product that employs an electronic, chemical, or mechanical means to
produce vapor or aerosol from a nicotine product, including, but not limited to, an
electronic cigarette, electronic cigar, electronic cigarillo, electronic pipe, or other
similar device or product, any replacement cartridge for such device, and any
other container of nicotine in a solution or other form intended to be used with or
within an electronic cigarette, electronic cigar, electronic cigarillo, electronic
pipe, or other similar device or product.
Section 569.31(4), F.S., defines the term “nicotine product” to mean:
any product that contains nicotine, including liquid nicotine, which is intended for
human consumption, whether inhaled, chewed, absorbed, dissolved, or ingested
by any means. The term also includes any nicotine dispensing device. The term
does not include a:
(a) Tobacco product, as defined in s. 569.002;
(b) Product regulated as a drug or device by the United States Food and Drug
Administration under Chapter V of the Federal Food, Drug, and Cosmetic Act; or
(c) Product that contains incidental nicotine.
(Emphasis added.)
Nicotine products, including nicotine dispensing devises such as electronic cigarettes (also
commonly known as “vapes”), may contain nicotine, which comes from tobacco, but they do not
contain tobacco. It is a non-tobacco “e-liquid” that is heated and aerosolized for inhalation by the
user of the device.
1
1
American Cancer Society, What Do We Know About E-cigarettes? at: https://www.cancer.org/cancer/risk-
prevention/tobacco/e-cigarettes-vaping/what-do-we-know-about-e-cigarettes.html (last visited Feb. 7, 2024). BILL: CS/SB 1006 Page 4
Heated Tobacco Products
Heated tobacco products heat a compressed stick or pod of tobacco and produce an inhalable
vapor or aerosol. These products do not produce smoke because the tobacco is not burned or
ignited.
2
It is not clear that heated tobacco products are subject to taxation under ch. 210, F.S., as
cigarettes or other tobacco products because the definitions for the terms cigarettes and tobacco
products under ch. 210, F.S., do not appear to describe heated tobacco products, e.g., heated
tobacco products are not smoked or chewed.
Retail Tobacco Products Dealer Permits
A person must obtain a retail tobacco products dealer permit from the division for each place of
business where tobacco products are sold, including sales made through a vending machine.
3
The
fee for an annual permit is established by the division in rule at an amount to cover the regulatory
costs of the program, not to exceed $50. The fees are deposited into the Alcoholic Beverage and
Tobacco Trust Fund within the DBPR.
4
Retail Nicotine Products Dealer Permit
A retail nicotine products dealer permit from the division is required for each place of business
where nicotine products are sold, including sales made through a vending machine.
5
There is no
fee for the permit. A person must be 21 years of age to qualify for a retail nicotine products
dealer permit.
6
Taxation of Tobacco Products Other than Cigarettes or Cigars
Part II of ch. 210, F.S., imposes a tax and a surcharge tax on tobacco products other than
cigarettes or cigars. Cigarettes are taxed under part I of ch. 210, F.S. Cigars are not subject to a
tax.
DBPR Annual Report
The DBPR is required to submit an annual report to the Governor, the President of the Senate,
and the Speaker of the House regarding the enforcement of tobacco products, including:
7
The number and results of compliance visits by the division;
The number of violations for failure of a retailer to hold a valid license;
The number of violations for selling tobacco products to anyone under the age of 21 and the
results of administrative hearings on such violations; and
The number of people under the age of 21 cited, including sanctions imposed as a result of
citation.
2
Campaign for Tobacco Free Kids, Heated Tobacco Products, Definition and Global Market, available at:
https://assets.tobaccofreekids.org/global/pdfs/en/HTP_definition_en.pdf (last visited Feb. 7, 2024).
3
Section 569.003, F.S.
4
Section 569.003(1)(c), F.S.
5
Section 569.32, F.S.
6
Section 569.32(2)(a), F.S.
7
Section 569.19, F.S. BILL: CS/SB 1006 Page 5
The DBPR is required to submit a comparable annual report to the Legislature regarding
compliance with the age restriction on the sale of nicotine dispensing devices.
8
Federal Regulation of Tobacco Products
The Family Smoking Prevention and Tobacco Control Act of 2009 (Tobacco Control Act) gives
the U.S. Food and Drug Administration (FDA) authority to regulate the manufacture,
distribution, and marketing of tobacco products to protect the public health. The Tobacco
Control Act provides advertising and labeling guidelines, provides standards for tobacco
products, and requires face-to-face transactions for tobacco sales with certain exceptions.
9
On August 8, 2016, the FDA extended the definition of the term “tobacco product” regulated
under the Tobacco Control Act to include “electronic nicotine delivery systems” (ENDS). ENDS
include nicotine delivery devices such as e-cigarettes, e-cigars, e-hookah, vape pens, personal
vaporizers, and electronic pipes. The definition of tobacco products also includes components
and parts such as e-liquids, tanks, cartridges, pods, wicks, and atomizers. On April 14, 2022, the
FDA’s authority was further expanded to include tobacco products containing nicotine from any
source, including synthetic nicotine.
10
Federal law preempts states from providing additional or different requirements for tobacco
products in regards to “standards, premarket review, adulteration, misbranding, labeling,
registration, good manufacturing standards, or modified risk tobacco products.” However,
federal law explicitly preserves the right of states, or any political subdivision of a state, to enact
laws, rules, regulations or other measures related to prohibiting the sale, distribution, possession,
exposure to, access to, advertising and promotion of tobacco products which are more stringent
than federal requirements.
11
Registration by Manufacturers
Under federal law, tobacco product manufacturers
12
are required initially and annually thereafter
to register with the FDA the name,
13
places of business, and all such establishments of that
manufacturer in any state.
14
These manufacturers are required to register any additional places
which they own or operate and start to manufacture, prepare, compound, or process a tobacco
product or tobacco products.
15
8
Section 569.44, F.S.
9
Federal Food, Drug, and Cosmetic Act, 21 USC § 351 et seq; 15 U.S.C. s. 1333, s. 1335; 21 U.S.C. s. 387g, s. 387f.
10
“Non-Tobacco Nicotine” (NTN) is the term used to describe nicotine that did not come from a tobacco plant. NTN
includes ‘synthetic’ nicotine.” U.S. Food and Drug Administration. Regulation and Enforcement of Non-Tobacco Nicotine
(NTN) Products, U.S. Food and Drug Administration, www.fda.gov/tobacco-products/products-ingredients-
components/regulation-and-enforcement-non-tobacco-nicotine-ntn-products (last visited Feb. 7, 2024).
11
21 U.S.C. § 387p.
12
The term “manufacture, preparation, compounding, or processing” includes “the repackaging or otherwise changing the
container, wrapper, or labeling of any tobacco product package in furtherance of the distribution of the tobacco product from
the original place of manufacture to the person who makes final delivery or sale to the ultimate consumer or user.”
21 USCA § 387e(a)(1).
13
The term “name” includes the name of each partner in the case of a partnership and, in the case of a corporation, the name
of each corporate officer and director, and the State of incorporation.” 21 USCA § 387e(a)(2).
14
21 USCA § 387e(b)(c).
15
21 USCA § 387e(d). BILL: CS/SB 1006 Page 6
FDA Premarket Review Application Process for Tobacco Products
16
Before a new tobacco product
17
can be distributed into interstate commerce, the manufacturer is
required to submit a marketing application to the FDA and receive authorization.
18
These
applications are reviewed by the FDA to determine whether the product meets the proper
requirements to receive marketing authorization. Marketing authorization can be achieved
through a Premarket Tobacco Product Application (PMTA), Substantial Equivalence (SE)
Report, or Exemption from Substantial Equivalence Request (EX REQ).
19
The FDA may issue a
marketing granted order, temporarily suspend a marketing order, withdraw a marketing granted
order, or issue a marketing denial order.
20
Preexisting tobacco products, i.e., tobacco products that were commercially marketed in the U.S.
as of Feb. 15, 2007, or the modification of a tobacco product where the modified product was
commercially marketed in the U.S. before Feb. 15, 2007, may voluntarily submit an application
to the FDA by May 14, 2022,
21
to receive a determination that the product is a pre-existing
tobacco product. A tobacco manufacturer may challenge the FDA’sdetermination.
22
Manufactures must hold onto records that show their tobacco products are legally on the market.
September 9, 2020, was the deadline for submitting a PMTA application for other new deemed
tobacco products that were on the market as of August 8, 2016.
23
An applicant may submit a PMTA to demonstrate that a new tobacco product meets the
requirements to receive a marketing granted order.
24
The PMTA must contain information
25
for
the FDA to ascertain whether there are any applicable grounds for a marketing denial order. To
receive a marketing granted order:
A PMTA must demonstrate the new tobacco product would be appropriate
for the protection of the public health and takes into account the increased
or decreased likelihood that existing users of tobacco products will stop
16
See generally, 21 U.S.C. § 387j.
17
“A ‘new tobacco product’ is defined as any product not commercially marketed in the United States as of February 15,
2007, or the modification of a tobacco product where the modified product was commercially marketed in the U.S. after
February 15, 2007.” 21 U.S.C. § 387j(1).
18
U.S. Food and Drug Administration, Market and Distribute a Tobacco Product, www.fda.gov/tobacco-products/products-
guidance-regulations/market-and-distribute-tobacco-product (last visited Feb 7, 2024).
19
U.S. Food and Drug Administration, Tobacco Products Marketing Orders, https://www.fda.gov/tobacco-products/market-
and-distribute-tobacco-product/tobacco-products-marketing-orders Last visited Feb. 7, 2024).
20
21 U.S.C. § 387j.
21
U.S. Food and Drug Administration, Reminder: Electronic Submission of Premarket Applications for Non-Tobacco
Nicotine Products due May 14, https://www.fda.gov/tobacco-products/ctp-newsroom/reminder-electronic-submission-
premarket-applications-non-tobacco-nicotine-products-due-may-14 (last visited Feb. 7, 2024).
22
See U.S. Food and Drug Administration, Pre-Existing Tobacco Products, June 15, 2023, at https://www.fda.gov/tobacco-
products/market-and-distribute-tobacco-product/pre-existing-tobacco-products (last visited February 16, 2024).
23
FDA, Submit Tobacco Product Applications for Deemed Tobacco Products, Sept. 9, 2020, at:
https://www.fda.gov/tobacco-products/manufacturing/submit-tobacco-product-applications-deemed-tobacco-products (last
visited Feb 7, 2024).
24
21 CFR 1114.5.
25
The PMTA must include information, such as, full reports of investigations of health risks, effect on the population as a
whole, product formulation, statement of compliance and certification, and manufacturing. See 21 CFR § 1114.7(a). BILL: CS/SB 1006 Page 7
using such products, as well as the increased or decreased likelihood that
those who do not use tobacco products will start using such products.
26
A SE Report can be submitted by the tobacco manufacturer to seek an FDA substantially
equivalent order. The applicant must provide information on the new tobacco product’s
characteristics and compare its characteristics to another tobacco product.
27
The SE Report must
contain information to allow the FDA to determine whether the new tobacco product is
substantially equivalent to a tobacco product that was commercially marketed in the United
States as of February 15, 2007.
28
The FDA may exempt, from the requirements relating to the demonstration that a tobacco
product is substantially equivalent, tobacco products that are modified by adding or deleting a
tobacco additive, or increasing or decreasing the quantity of an existing tobacco additive if
certain conditions are met. A tobacco product may only receive an exemption from the
requirement of showing a substantial equivalence (Ex Req) if it is for a minor modification to a
tobacco product that can legally be sold as a legally marketed tobacco product.
29
The FDA made determinations on more than 99 percent of the nearly 26 million products for
which PMTSs have been submitted.
30
As of March 15, 2023, the FDA has authorized the
marketing of 45 products, including 23 tobacco-flavored e-cigarette products and devices.
31
However, the FDA tobacco premarket application process has been challenged. In 2022, the
Eleventh Circuit Court of Appeals set aside FDA marketing order denials as arbitrary and
capricious because the FDA failed to consider relevant factors in evaluating the applications
submitted by the six tobacco companies.
32
In 2024, the Fifth Circuit Court of Appeals stated, in
reference to the tobacco premarketing application process, that over several years, the FDA had
“sent manufacturers of flavored e-cigarette products on a wild goose chase.”
33
26
Supra note 16.
27
See 21 CFR 1107.16 and 21 CFR 1107.18.
28
21 CFR 1107.18.
29
21 CFR 1107.1.
30
U.S. Food and Drug Administration, FDA Makes Determinations on More than 99% of the 26 Million Tobacco,
www.fda.gov/tobacco-products/ctp-newsroom/fda-makes-determinations-more-99-26-million-tobacco-products-which-
applications-were-submitted (last visited Feb 7, 2024); and U.S. Food and Drug Administration, Premarket Tobacco Product
Marketing Granted Orders,” updated as of Jan. 9, 2024, www.fda.gov/tobacco-products/premarket-tobacco-product-
applications/premarket-tobacco-product-marketing-granted-orders (last visited Feb 7, 2024).
31
Id.
32
See, Bidi Vapor LLC v. U.S. Food & Drug Admin., 47 F.4th 1191, 1205 (11th Cir. 2022), in which the FDA issued
marketing denial orders that specifically stated that it did not consider the marketing or sales-access-restriction plans in the
PMTSs submitted by six tobacco companies which included their proposed marketing and sales-access restrictions in their
applications.
33
Wages & White Lion Investments, L.L.C. v. Food & Drug Admin., 90 F.4th 357 (5th Cir. 2024) (the court held that the
FDA’s denial of marketing orders was arbitrary and capricious because FDA failed to give manufacturers fair notice of the
rules, did not explain or admit a change in position regarding application requirements, and disregarded the tobacco
manufacturers’ good faith reliance on previous FDA guidance). BILL: CS/SB 1006 Page 8
III. Effect of Proposed Changes:
Definitions
Section 1 revises the meaning of the term “nicotine dispensing device” (NDD) in s. 569.31, F.S.,
to provide that “each individual stock keeping unit is considered a separate nicotine dispensing
device.”
The bill defines the following terms:
“FDA” to mean the United States Food and Drug Administration.
“Nicotine products manufacturer” to mean any person who manufactures nicotine products.
“Sell” or “sale” to mean in addition to its common usage meaning, any sale, transfer,
exchange, theft, barter, gift, or offer for sale and distribution, in any manner or by any means
whatsoever.
“Timely filed premarket tobacco product application” to mean an application pursuant to
21 U.S.C. s. 387j for a nicotine dispensing device containing nicotine derived from tobacco
marketed in the United States as of August 8, 2016, that was submitted to the U.S. Food and
Drug Administration (FDA) on or before September 9, 2020, and accepted for filing.
“Wholesale nicotine products dealer" to mean the holder of a wholesale nicotine products
dealer permit who purchases nicotine dispensing devices or nicotine products from any
nicotine products manufacturer.
"Wholesale nicotine products dealer permit" to mean a permit issued by the division under
s. 569.316, F.S, as created by the bill.
The definition for the term “timely filed premarket tobacco product application” is limited to
NDDs required to file an application under 21 U.S.C. s. 387j., i.e., a new deemed tobacco
product, and for which September 9, 2020, was the deadline for submitting a Premarket Tobacco
Product Application (PMTA) application for new deemed tobacco products that were on the
market as of August 8, 2016.
34
This term does not apply to tobacco products that are “preexisting
tobacco products,” i.e., tobacco products that were commercially marketed in the U.S. as of
February 15, 2007, or the modification of a tobacco product where the modified product was
commercially marketed in the U.S. before February 15, 2007, that are not required to submit
marketing applications to the FDA by May 14, 2022, and not required to receive a marketing
order to permit the continued sale of the tobacco product.
35
Nicotine Product Directory
Section 2 creates s. 569.311, F.S., to provide a certification requirement for nicotine product
manufacturers.
Section 561.311(1), F.S., requires every nicotine product manufacturer who sells NDDs in
Florida to execute and deliver a form, which s. 569.311(4), F.S., refers to as a “certification,”
prescribed by the Division of Alcoholic Beverages and Tobacco (division), under penalty of
perjury for each NDD sold that meets either of the following criteria:
34
Supra note 23.
35
Supra note 21. BILL: CS/SB 1006 Page 9
The nicotine product manufacturer has timely filed a PMTA applied for a NDD; and
o The PMTA remains under review by the FDA, and either a PMTA remains under review
or has received a marketing denial order that has been stayed by the FDA or court order,
rescinded by the FDA, or vacated by a court; or
o The FDA has issued a marketing order for the NDD; or
The nicotine products manufacturer has received a marketing authorization or other
authorization, such as the Substantial Equivalence (SE) or Exemption from Substantial
Equivalence Request (EX REQ), for the NDD from the FDA.
Although the bill requires all NND’s to be registered or “certified” with the division if they meet
the specified criteria, the criteria for registration are limited to new deemed tobacco products
under 21 U.S.C. s. 387j., which are required to submit a PMTA with the FDA. Registration
requirements for pre-existing NDDs are not specified in the bill.
The form must be submitted to the division by December 1, 2024, and annually thereafter.
Section 569.311(2), F.S., requires each nicotine product manufacturer to set forth:
The name under which the nicotine product manufacturer transacts or intends to transact
business;
The address of the location of the nicotine product manufacturer's principal place of business,
The nicotine product manufacturer's e-mail address;
The brand name of the nicotine dispensing device, the device’s category (e.g., e-liquid,
power unit, device, e-liquid cartridge, e-liquid pod, disposable), the device’s name; and
Any flavor utilized with the device that is sold in this state.
The bill provides that the division may allow a nicotine product manufacturer to group its
nicotine dispensing devices on its certification.
Section 569.311(3), F.S., requires each nicotine product manufacturer to provide to the division a
copy of:
The cover page of the granted marketing order issued by the FDA for each device,
The acceptance letter issued by the FDA pursuant to 21 U.S.C. s. 387j for a timely filed
premarket tobacco product application for each device; or
A document issued by the FDA or by a court confirming that the premarket tobacco product
application has been received and denied, but the order is not yet in effect for each device.
Section 569.311(4), F.S., requires a nicotine product manufacturer to notify the division within
30 days after any material change to the certification, including, but not limited to, issuance by
the FDA of any of the following:
A denial of market authorization as a preexisting or new tobacco product;
A marketing order requiring a nicotine product manufacturer to remove a NDD from the
market either temporarily or permanently;
Any notice of action taken by the FDA affecting the ability of the NDD to be introduced or
delivered in this state for commercial distribution;
Any change in policy which results in a NDD no longer being an FDA enforcement priority;
or BILL: CS/SB 1006 Page 10
Any other change deemed material by the division pursuant to a rule of the division.
Directory
Section 569.311(5), F.S., requires the division to develop and maintain a directory listing all the
NDDs certified with the division which comply with the requirements discussed above. On
January 1, 2025, the division must make the directory available on the DBPR website or the
website of the division, and update the directory as necessary. The bill requires the division to
establish a process to provide retailers, distributors, and wholesalers notice of the initial
publication of the directory and changes made to the directory in the prior month.
Process for Removal from the Directory
Section 569.311(6), F.S., requires the division to establish by rule a process to provide a nicotine
product manufacturer a notice and an opportunity to cure deficiencies before removing the
manufacturer or its NDD from the directory. The division may not remove the nicotine product
manufacturer or its NDD from the directory until at least 30 days after the nicotine product
manufacturer has been given notice of an intended action.
Notice is sufficient and deemed immediately received by a nicotine product manufacturer if the
notice is sent either electronically or by facsimile to an e-mail address or facsimile number
provided by the nicotine products manufacturer in its most recent certification filed.
Section 569.311(6)(b), F.S., provides that the nicotine product manufacturer has 15 days from
the date of service of the notice of the division's intended action to establish that the nicotine
product manufacturer or its NDD should be included in the directory.
Section 569.311(6)(c), F.S., provides that a determination by the division not to include or
remove a nicotine product manufacturer or NDD on the directory is subject to review under ch.
120, F.S., the Florida Administrative Procedure Act. If a nicotine products manufacturer seeks
review of the decision to remove it from the directory, the division must keep the NDD on the
directory until conclusion of the hearing.
Section 569.311(6)(d), F.S., provides that retailers and wholesalers have 30 days from when the
product is removed from the directory to remove the product from their inventory and return the
NDD to the nicotine product manufacturer.
Section 569.311(6)(d), F.S., also provides that a NDD identified in the notice of removal is
considered contraband 30 days after its removal from the directory, and is subject to
s. 569.345, F.S., relating to the seizure and destruction of contraband nicotine products.
Nicotine Products Not Listed on the Directory
Section 569.311(7), F.S., provides that, beginning March 1, 2025, or on the date that the division
first makes the directory available for public inspection on its or the DBPR's website, whichever
is later, a nicotine products manufacturer who offers for sale a NDD not listed on the directory is
subject to a fine of $1,000 per day for each NDD 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. In addition, within 60 days from the date that the division first makes the BILL: CS/SB 1006 Page 11
directory available for inspection on its public website, each retailer and each nicotine product
manufacturer must sell products that were in its inventory and not included on the directory or
remove those products from inventory.
False Representation
Section 569.311(8), F.S., provides that a nicotine product manufacturer who falsely represents
any of the information required to be provided to the division commits a felony of the third
degree
36
for each false representation.
Unannounced Inspections
Section 569.311(9), F.S., provides that each retail nicotine products dealer and wholesale
nicotine products dealer is subject to unannounced inspections or audit checks by the division for
purposes of enforcing compliance with the certification process and the directory. The division is
required under the bill to conduct unannounced follow-up compliance checks of all
noncompliant retail nicotine products dealers or wholesale nicotine products dealers within 30
days after a violation. The bill requires the division to publish the results of all inspections at
least annually and make the results available to the public on request.
Renew Certification
Section 569.311(10), F.S., authorizes the division to adopt by rule a procedure to allow nicotine
product manufacturers to renew certifications without having to resubmit all the information for
the certification process.
Enforcement
Section 569.311(11), F.S., provides that a nicotine product manufacturer’s failure to provide
required information or documents to the division may result in a NDD not being included on the
directory or the removal of a NDD from the directory.
The bill authorizes the division to assess an administrative fine of up to $1,000 for each NDD
offered for sale in Florida if a nicotine product manufacturer fails to provide notice to the
division of a material change to its certification within 30 days after that material change. The
bill requires the division to deposit all fines collected into the General Revenue Fund. Under the
bill, an order imposing an administrative fine becomes effective 15 days after the date of the
order.
Maintenance and Inspection of Nicotine Product Records
Section 3 creates s. 569.312, F.S., to require nicotine product manufacturers who sell a NDD in
Florida to maintain specified records.
Section 569.312(1), F.S., requires nicotine product manufacturers to keep for a period of three
years, at the address listed on the certification:
36
Section 775.082, F.S., provides that a felony of the third degree is punishable by a term of imprisonment not to exceed five
years. Section 775.083, F.S., provides that a felony of the third degree is punishable by a fine not to exceed $5,000. BILL: CS/SB 1006 Page 12
A complete and accurate record of the number of NDD sold or delivered to a wholesaler in
Florida; and
To whom each NDD was sold on a wholesale basis.
The records must include the business name, license number, shipping and business addresses, e-
mail address, and telephone number for the person or entity to which each product was sold.
Such records may be kept in an electronic or paper format.
Section 569.312(2), F.S., provides that retail nicotine product dealers, wholesale nicotine product
dealers, wholesale dealers of cigarettes, and distributing agents of cigarettes must keep a record
of the amount of each NDD received, delivered, or sold in Florida and to whom each NDD was
sold or delivered or from whom they received each NDD, including the business name, license
number, shipping and business addresses, e-mail address, and telephone number for the person or
entity to which each product was sold or delivered or from which each product was received.
The records may be kept in electronic or paper format.
Section 569.312(3), F.S., provides that retail nicotine product dealers, wholesale nicotine product
dealers, wholesale dealers of cigarettes, and distributing agents of cigarettes, who sell directly to
consumers, are not required to keep and maintain these identifying records of the consumers who
purchase or receive NDDs.
Section 569.312(4), F.S., requires nicotine product manufacturers that sell NDDs in Florida,
including nicotine products manufacturers selling nicotine products directly to consumers, retail
nicotine products dealers; wholesale nicotine products dealers, wholesale dealers of cigarettes,
and distributing agents of cigarettes to provide these records within seven calendar days of
receiving a request by the division.
Section 569.312(5), F.S., provides that the division is allowed to examine such records, issue
subpoenas to persons or entities, administer oaths, and take depositions of witnesses within or
outside of Florida.
Section 569.312(6), F.S., provides that the division may assess an administrative fine of up to
$1,000 for each violation regarding maintenance and inspection of records. The division must
deposit all fines collected into the General Revenue Fund. Under the bill, an order imposing an
administrative fine becomes effective 15 days after the date of the order.
Shipment of Unregistered Nicotine Products into Florida
Section 4 creates s. 569.313, F.S., to prohibit the unregistered shipment of NDDs into Florida.
Section 569.313(1), F.S., prohibits nicotine product manufacturers from distributing nicotine
products in Florida for which the manufacturer has:
Been ordered by the FDA to remove the product from the market either temporarily or
permanently and the order has not been stayed;
Not submitted a timely filed PMTA for a NDD that remains pending with the FDA; or BILL: CS/SB 1006 Page 13
Not submitted the certification required for any of the NDD intended for eventual retail sale
to a consumer in Florida.
Section 569.313(2), F.S., provides that any person who knowingly ships and receives an
unregistered NDD in violation of s. 569.313, F.S., commits a first degree misdemeanor.
37
Section 569.313(3), F.S., authorizes the division to impose an administrative fine of up to $5,000
for each violation. The division must deposit all fines collected into the General Revenue Fund.
Under the bill, an order imposing an administrative fine becomes effective 15 days after the date
of the order.
Wholesale Nicotine Products Dealers
Section 5 creates a wholesale nicotine products dealer permit which is issued by the division.
Section 561.316(1)(a), F.S., requires each person, firm, association, or corporation that seeks to
deal, at wholesale, in nicotine products that will be sold at retail within this state, or to sell
nicotine products or NDDs to any retail nicotine products dealer who intends to sell nicotine
products in Florida, must obtain a wholesale nicotine products dealer permit for each place of
business or premises at which nicotine products are sold.
Section 561.316(1)(b), F.S., specifies the identifying information that must be provided to the
division on the application form, adopted by the rule of the division, for the permit. A permit is
required for each place of business. The application must be signed and verified by the owner, if
a sole proprietor; or, if the owner is a firm, association, or partnership, by the members or
partners; if the owner is a corporation, by an executive officer of the corporation or by a person
authorized by the corporation to sign the application. Written evidence of the authority to sign
the application must be provided.
Section 561.316(2), F.S., sets forth the qualification for a wholesale nicotine products dealer
permit. The permit may only be issued to a person who is 21 years of age or older or to a
corporation whose officers are 21 years of age or older. In addition, a permit may not be issued
to any to any person, firm, association, or corporation whose permit has been revoked by any
jurisdiction; to any corporation an officer of which has had such permit revoked by any
jurisdiction; or to any person who is or has been an officer of a corporation whose permit has
been revoked by any jurisdiction.
Section 561.316(3), F.S., provides that, once issued, a wholesale nicotine products dealer permit
is only valid for the person and place of business for which it was issued.
Section 561.316(4), F.S., exempts wholesale dealers of cigarettes and distributing agents of
cigarettes from the requirement to have a wholesale nicotine products dealer permit for each
place of business, but such persons must comply with the requirements in ch. 569, F.S. However,
37
Section 775.082, F.S., provides that a misdemeanor of the first degree is punishable by a term of imprisonment not to
exceed one year. Section 775.083, F.S. provides that a misdemeanor of the first degree is punishable by a fine not to exceed
$1,000. BILL: CS/SB 1006 Page 14
distributors of tobacco products other than cigarettes are not specifically exempted from the
permit requirements, thus are required to have a wholesale nicotine products dealer permit for
each place of business. However, it is not clear that such persons are subject to the records
maintenance requirements in s. 569.312, F.S., which references the requirements as applicable to
wholesale dealers and distributing agent of cigarettes, but does not reference the permittees under
part II of ch. 210, F.S.
Wholesale Nicotine Products Dealer Permitholders
Section 6 creates s. 569.317, F.S., to provide that a wholesale nicotine products dealer
permitholder may only purchase and sell for retail in Florida NDDs contained on the division’s
NDD directory. It authorizes the division to suspend or revoke the permit of a wholesale nicotine
products dealer if the dealer fails to comply. The division may also impose an administrative fine
up to $5,000 for each violation. The division must deposit all fines collected into the General
Revenue Fund. Under the bill, an order imposing an administrative fine becomes effective 15
days after the date of the order.
Retail Nicotine Products Dealer Permit
Section 7 amends s. 569.32, F.S., to provide that permits must be issued annually. The holder of
a permit may renew each year. A dealer that does not timely renew must pay a $5 late fee for
each month or portion of a month occurring after expiration and before renewal of the permit.
The bill forbids the division from granting an exemption from the permit fees for any applicant.
The bill also requires the division to “establish by rule a renewal procedure that, to the greatest
extent feasible, combines the application and the permitting procedure for permits with the
application and licensing system for alcoholic beverages.” The meaning and intent of this
directive to the division is unclear.
Section 569.32(2)(b), F.S., provides that the division may refuse to issue a retail nicotine
products dealer permit if the person, including as an officer in a corporation, has had a permit
revoked by another jurisdiction. Current law provides a basis for the division to deny an
application for a prior revocation but not on the basis of a revocation by another jurisdiction.
Section 8 provides that the place or premises covered by a permit for a wholesale nicotine
product dealer is subject to inspection and search without a search warrant by the division or its
authorized assistants, and by sheriffs, deputy sheriffs, or police officers, to determine compliance
with requirements. Currently, this inspection and search provision only applies to retail nicotine
products dealer permitholders.
Section 9 creates s. 569.34(4), F.S., to provide that on or after March 1, 2025, it is unlawful for a
person, a firm, an association, or a corporation in Florida to deal, at retail, in NDDs that are not
listed on the division’s NDD directory. Any person who knowingly ships or receives such NDDs
in violation of this prohibition commits a misdemeanor of the second degree.
38
38
Section 775.082, F.S., provides that a misdemeanor of the second degree is punishable by a term of imprisonment not to
exceed 60 days. Section 775.083, F.S., provides that a misdemeanor of the second degree is punishable by a fine not to
exceed $500. BILL: CS/SB 1006 Page 15
Section 569.34(5), F.S., provides that on or after January 1, 2025, it is unlawful for a retail
nicotine products dealer in Florida to purchase NDDs from a source that is not a wholesale
nicotine products dealer permitholder, a wholesale dealer of cigarettes, a distributing agent of
cigarettes, or a tobacco products distributor of tobacco products other than cigarettes. The bill
exempts from this prohibition nicotine product manufacturers who have a permit as a retail
nicotine products dealer and sell their own products directly to consumers.
Under the bill, a person who knowingly ships or receives NDDs in violation of s. 569.34(5), F.S.,
prohibition commits a misdemeanor of the second degree.
Section 569.34(6), F.S., authorizes the division to suspend or revoke a retail nicotine products
permit for a violation of part II of ch. 569, F.S., and to assess an administrative fine of up to
$1,000 for each violation. The division must deposit all fines collected into the General Revenue
Fund. Under the bill, an order imposing an administrative fine becomes effective 15 days after
the date of the order.
Seizure and Destruction of Contraband Nicotine Products
Section 10 creates s, 569.345, F.S., to provide that all NDDs sold, delivered, possessed, or
distributed contrary to the provisions of ch. 569, F.S., are contraband and are subject to seizure
and confiscation under the Florida Contraband Forfeiture Act.
39
The bill requires the court
having jurisdiction to order the destruction and forfeiture of contraband NDDs.
Section 569.345(2), F.S., requires that the division keep a full and complete record of:
The exact kinds, quantities, and forms of such nicotine products or nicotine dispensing
devices;
The persons from whom they were received and to whom they were delivered;
By whose authority they were received, delivered, and destroyed; and
The dates of the receipt, disposal, or destruction.
Under the bill, this record must be open to inspection by all persons charged with the
enforcement of tobacco and nicotine product laws.
Section 569.345(3), F.S., provides that the cost of seizure, confiscation, and destruction of
contraband NDDs must be borne by the person from whom the contraband NDDs are seized.
Agent for Service of Process
Section 11 creates s. 569.346, F.S., to require non-resident manufacturers of NDDs to have a
registered agent in Florida to accept service of process. The manufacturer must have such an
agent for service of process in Florida in order to register a product with the division’s NDD
directory. The manufacturer must provide the name, address, telephone number, and proof of the
appointment and availability of such agent to the division. The manufacturer must notify the
39
Sections 932.701-932.7062, F.S., comprise the Florida Contraband Forfeiture Act, which provides for the seizure and civil
forfeiture of property related to criminal and non-criminal violations of law. BILL: CS/SB 1006 Page 16
division with 30 days of any change related to the agent, including notice to the division of any
termination within five calendar days of an existing agency appointment with proof to the
satisfaction of the division of the appointment of a new agent.
If an agent is not appointed by a manufacturer whose NDD is sold in Florida, the Secretary of
State is deemed to be the agent. However, the appointment of the Secretary of State does not
satisfy the condition precedent for inclusion or retention in the directory.
Conforming Provision
Section 12 amends s. 569.002, F.S., to conform a cross-reference changed in the bill.
Effective Date
Section 13 provides that the bill takes effect October 1, 2024.
IV. Constitutional Issues:
A. Municipality/County Mandates Restrictions:
None.
B. Public Records/Open Meetings Issues:
None.
C. Trust Funds Restrictions:
None.
D. State Tax or Fee Increases:
Section 19(a), Article VII of the State Constitution limits the authority of the legislature
to enact legislation that imposes a new state tax or fee by requiring such legislation to be
approved by a two-thirds vote in each chamber of the legislature. Section 19(e), Article
VII of the Florida Constitution provides that a state tax or fee imposed, authorized, or
raised must be contained in a separate bill that contains no other subject. SB 1006
provides for the regulation of nicotine products, including permit requirements for whole
sale dealers of such products, and also amends s. 569.32, F.S., to provide a new $5 late
fee for the retail nicotine products dealer permit. By imposing a late renewal fee on retail
nicotine products dealer permitholders and addressing other subjects, the bill may violate
the single-subject requirement of s. 19(a), Article VII of the State Constitution.
E. Other Constitutional Issues:
None. BILL: CS/SB 1006 Page 17
V. Fiscal Impact Statement:
A. Tax/Fee Issues:
None.
B. Private Sector Impact:
Manufacturers, distributers, and retail dealers of nicotine products will incur costs related
to complying with the registration and permitting requirements in the bill. Additionally,
retail dealers of nicotine products would have to pay a $5 dollar late renewal fee for
nicotine products retail dealer permit.
C. Government Sector Impact:
The Division of Alcoholic Beverages and Tobacco (division) will incur costs in
implementing, administering, and enforcing the requirements in the bill, including the
creation of the nicotine products directory. According to the Department of Business and
Professional Regulation (DBPR), the division estimates that it will need an additional
nine positions with $562,497 of budget authority ($65,553 nonrecurring) to implement
the bill.
40
Modifications to DBPR’s licensing system (Versa: Regulation) and online system (Versa:
Online) related to creating and maintaining online accounts and changes to licensure
processes, are required. The DBPR states these changes can be made using existing
resources.
41
The bill establishes new fines and penalties that the division may impose. The revenue
generated from these penalties will vary each year depending on the number of violations
enforced. Collected fines established in the bill are to be deposited into the General
Revenue Fund. However, the division currently deposits fines and other revenues into the
Alcoholic Beverage and Tobacco Trust Fund. These funds are used for the purposes of
operating the division as requested by the DBPR in their legislative budget request.
VI. Technical Deficiencies:
None.
VII. Related Issues:
The bill revises the meaning of the term “nicotine dispensing device” (NDD) in s. 569.31, F.S.,
to provide that “each individual stock keeping unit is considered a separate nicotine product.”
40
See Department of Business and Professional Regulation, 2024 Agency Legislative Bill Analysis for SB 1006
(Dec. 20, 2023) (on file with the Senate Regulated Industries Committee). The analysis indicated a need of 16 FTE and
$1,304,523 of budget authority ($111,378 nonrecurring) to implement the bill; however, an updated estimate was provided by
the DBPR legislative affairs staff via a phone call on February 11, 2024.
41
Id. BILL: CS/SB 1006 Page 18
The meaning of this provision is unclear in regards to what types of “stock keeping unit” this
provision is meant to encompass.
Section 569.311(6)(c), F.S., provides that, if a nicotine product manufacturer seeks review of the
decision under ch. 120, F.S., to remove it from the directory, the division must keep the NDD on
the directory until conclusion of the hearing. The conclusion of a hearing under ch. 120, F.S.,
does not constitute final agency action under ch. 120 F.S.
42
The bill sponsor may wish to
consider amending the bill to provide for removal of a NDD from the directory upon the issuance
by the division of a final order determining that the NDD be removed from the directory.
Section 569.311(10), F.S., authorizes the division to adopt by rule a procedure to allow nicotine
products manufacturers to renew certifications without having to resubmit all the information for
the certification process. However, the bill does not provide a requirement that the certification
of a NDD must be renewed after a prescribed period. There are parts of the bill that have unclear
language or misuse legal terms.
Under the bill, it is not clear if the record keeping requirement in ss. 569.312(2) and (4), F.S,
applies to distributors of tobacco products other than cigarettes, because the record maintenance
requirements in those provisions reference wholesale dealers of cigarettes under part I of
ch. 210, F.S., but not distributors of other tobacco products under part II of ch. 210, F.S.
Section 569.313(1)(b), F.S., prohibits the sale, at retail, of an unregistered NDD if the nicotine
product manufacturer has not submitted a timely filed Premarket Tobacco Product Application
(PMTA) for a NDD that remains pending with the U.S. Food and Drug Administration (FDA).
The intent and meaning of this provision is unclear. If a nicotine product manufacturer did not
submitted a timely file PMTA for a NDD, there would not be a pending PMTA with the FDA.
Section 561.316(4), F.S., exempts wholesale dealers of cigarettes and distributing agents of
cigarettes from the requirement to have a wholesale nicotine products dealer permit for each
place of business, but such persons must comply with the requirements in ch. 569, F.S. However,
distributors of tobacco products other than cigarettes are not specifically exempted from the
permit requirements, thus are required to have a wholesale nicotine products dealer permit for
each place of business. However, it is not clear that such persons are subject to the records
maintenance requirements in s. 569.312, F.S., which references the requirements as applicable to
wholesale dealers and distributing agents of cigarettes, but does not reference the permittees
under part II of ch. 210, F.S.
The bill amends s. 569.32, F.S., relating to the retail nicotine products dealer permit, to require
the division to “establish by rule a renewal procedure that, to the greatest extent feasible,
combines the application and the permitting procedure for permits with the application and
licensing system for alcoholic beverages.” The meaning and intent of this directive to the
division is unclear.
42
See s. 120.569, F.S. BILL: CS/SB 1006 Page 19
VIII. Statutes Affected:
This bill substantially amends the following sections of the Florida Statutes: 569.002, 569.31,
569.32, 569.33, and 569.34.
This bill creates the following sections of the Florida Statutes: 569.311, 569.312, 569.313,
569.316, 569.317, 569.345, and 569.346.
IX. Additional Information:
A. Committee Substitute – Statement of Substantial Changes:
(Summarizing differences between the Committee Substitute and the prior version of the bill.)
CS by Regulated Industries on February 5. 2024:
The committee substitute:
Changes the title from an act relating to nicotine products to an act relating to nicotine
products and nicotine dispensing devices.
Provides that each individual stock keeping unit is a considered a separate “nicotine
dispensing device” (instead of a separate “nicotine product”).
Defines the terms “sell,” “sale,” and “timely filed premarket tobacco product
application.”
Amends the requirements for the directory in s. 569.311, F.S., to apply to nicotine
dispensing devices (NDDs) instead of nicotine products, requires manufacturers and
retailers of NDDs to submit the required form by December 1, 2024, and annually
thereafter, and revises the criteria for the types of products that must be registered,
including deleting products derived from a non-tobacco source.
Requires additional information be include in the registration application to include
brand name of the NDD, the device’s category (e.g., e-liquid, power unit, device, e-
liquid cartridge, e-liquid pod, disposable), the device’s name, and flavor utilized with
the device.
Requires the Division of Alcoholic Beverages and Tobacco (division) to establish a
process to provide retailers, distributors, and wholesalers notice of the initial
publication of the directory and changes made to the directory in the prior month.
Prohibits retailers from selling or having in inventory the products that have been
removed from the directory 30 days after (instead of 21 days after) such removal.
Requires retailers and distributors, within 60 days after the initial posting of the
directory, to sell or remove from inventory the products that are not included in the
directory.
Provides an administrative fine of up to $1,000 for each NDD offered for sale in
Florida if a NDD manufacturer fails to provide notice to the division of a material
change to its certification within 30 days after that material change.
Requires permitholders to respond to a records request from the division with 7
calendar days of a request (instead of upon a request).
Disqualifies persons, including officers of a corporation, for a wholesale nicotine
products dealer permit and a retail nicotine products dealer permit if a permit has
been revoked in any jurisdiction. BILL: CS/SB 1006 Page 20
Requires non-resident manufacturers of NDDs sold in Florida to have a registered
agent in Florida to accept service of process.
B. Amendments:
None.
This Senate Bill Analysis does not reflect the intent or official position of the bill’s introducer or the Florida Senate.