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 Committee on Fiscal Policy
BILL: CS/CS/SB 1006
INTRODUCER: Appropriations Committee on Agriculture, Environment, and General Government;
Regulated Industries Committee; and Senator Perry
SUBJECT: Nicotine Products and Dispensing Devices
DATE: February 26, 2024 REVISED:
ANALYST STAFF DIRECTOR REFERENCE ACTION
1. Oxamendi Imhof RI Fav/CS
2. Oxamendi/Davis Betta AEG Fav/CS
3. Oxamendi Yeatman FP Favorable
Please see Section IX. for Additional Information:
COMMITTEE SUBSTITUTE - Substantial Changes
I. Summary:
CS/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.
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 Prohibits the sale, shipment, or distribution of NDDs if the FDA does not accept a premarket
application, denies an application, or other FDA or court action negatively affects the ability
of the product to be introduced or delivered into interstate commerce for commercial
distribution in the United States.
 Creates the following criminal violations and penalties:
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
BILL: CS/CS/SB 1006 Page 3
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
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
BILL: CS/CS/SB 1006 Page 4
contain tobacco. It is a non-tobacco “e-liquid” that is heated and aerosolized for inhalation by the
user of the device.1
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
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).
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.
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 The number of people under the age of 21 cited, including sanctions imposed as a result of
citation.
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 manufacturers12 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
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).
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which they own or operate and start to manufacture, prepare, compound, or process a tobacco
product or tobacco products.15
FDA Premarket Review Application Process for Tobacco Products16
Before a new tobacco product17 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’s determination.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 information25 for
the FDA to ascertain whether there are any applicable grounds for a marketing denial order. To
receive a marketing granted order:
15
21 USCA § 387e(d).
16