HOUSE OF REPRESENTATIVES STAFF ANALYSIS
BILL #: CS/CS/HB 1007 Nicotine Products
SPONSOR(S): Commerce Committee, Appropriations Committee, Overdorf and others
TIED BILLS: IDEN./SIM. BILLS: CS/CS/SB 1006
REFERENCE ACTION ANALYST STAFF DIRECTOR or
BUDGET/POLICY CHIEF
1) Regulatory Reform & Economic Development 11 Y, 1 N Larkin Anstead
Subcommittee
2) Appropriations Committee 19 Y, 9 N, As CS Helpling Pridgeon
3) Commerce Committee 16 Y, 0 N, As CS Larkin Hamon
SUMMARY ANALYSIS
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.
The bill:
 Provides definitions for “nicotine product manufacturer”, “wholesale nicotine products dealer", and
“wholesale nicotine products dealer permit”.
 Requires manufacturers to certify nicotine dispensing devices with the Division and provide evidence
that they have sought approval with the Food and Drug Administration (FDA).
 Requires the Division to develop and maintain an online directory that lists:
o nicotine product manufacturers that sell nicotine dispensing devices in this state; and
o nicotine dispensing devices certified by those manufacturers with the Division which comply with
this requirement.
 Creates a new wholesale nicotine product dealer permit and requires wholesalers who do not have a
tobacco permit to register, and only buy products on the directory.
 Authorizes the Division to conduct unannounced inspections of nicotine product manufacturers.
 Provides administrative fines and imposes criminal penalties for violations of certain provisions.
 Mandates retail nicotine product permit holders, other than nicotine manufacturers selling direct to
consumers, to purchase only from permitted wholesalers and only purchase registered products.
 Modifies retail nicotine product dealer permit requirements.
 Allows law enforcement to seize and destroy non-registered nicotine products.
The bill may have an indeterminate fiscal impact on state government and the private sector. See Fiscal
Analysis and Economic Impact Statement.
Except as otherwise provided, the effective date of the bill is October 1, 2024.
This docum ent does not reflect the intent or official position of the bill sponsor or House of Representatives .
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 FULL ANALYSIS
I. SUBSTANTIVE ANALYSIS
A. EFFECT OF PROPOSED CHANGES:
Current Situation
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.1
On August 8, 2016, the FDA extended the definition of “tobacco products” regulated under the Act to
include electronic nicotine delivery systems (ENDS). ENDS include e-cigarettes, e-cigars, e-
hookah, vape pens, personal vaporizers and electronic pipes. Additionally, the definition of tobacco
products 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.2
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.3
Registration by Manufacturers
Under federal law, manufacturers 4 are required initially, and annually thereafter, to register the name5,
places of business, and all such establishments of that manufacturer in any State with the FDA. 6 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. 7
FDA Premarket Review Application Process for Tobacco Products 8
Before a new tobacco product9 can be distributed into interstate commerce, the manufacturer is
required to submit a marketing application to the FDA and receive authorization. 10 These applications
1 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.
2 “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-enforc ement-
non-tobacco-nicotine-ntn-products (last visited Jan. 19, 2024).
3 21 U.S.C. § 387p.
4 “The term ‘manufacture, preparation, compounding, or processing’ shall inc lude 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).
5 “The term ‘name’ shall include in the case of a partnership the name of each partner 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).
6 21 USCA § 387e(b)(c).
7 21 USCA § 387e(d).
8 See generally, 21 U.S.C. § 387j.
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 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).11 The FDA may issue a marketing granted order, temporarily suspend
a marketing order, withdraw a marketing granted order, or issue a marketing denial order. 12 Preexisting
tobacco products were required to submit marketing applications to the FDA and receive authorization
by a particular date depending on the kind of tobacco product. A tobacco manufacturer may challenge
the FDA’s marketing denial.13 Manufactures must hold onto records that show their tobacco products
are legally on the market.
An applicant may submit a PMTA to demonstrate that a new tobacco product meets the requirements
to receive a marketing granted order.14 The PMTA must contain certain information15 for the FDA to
ascertain whether there are any applicable grounds for a marketing denial 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 using such products, as well as the increased or decreased likelihood that those who do not use
tobacco products will start using such products. 16
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. 17 The SE Report must contain certain
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, 2007.18
On the other hand, 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. An EX REQ from the requirement of showing a substantial equivalence may be
made only by the manufacturer of a legally marketed tobacco product for a minor modification to that
tobacco product.19
The FDA receives millions of applications.20 “To date, the FDA has authorized marketing of 45
products, including 23 tobacco-flavored e-cigarette products and devices.” 21 However, the FDA
tobacco premarket application process has been challenged. In 2022, the Eleventh Circuit Court of
9 “A ‘new tobacco product’ is defined as any product not 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. after Feb. 15, 2007.”
21 U.S.C. § 387j(1).
10 Mark et and Distribute a Tobacco Product, U.S. Food and Drug Administration, www.fda.gov/tobacco-
products/products-guidance-regulations/market-and-distribute-tobacco-product (last visited Jan. 19, 2024).
11 Tobacco Products Mark eting Orders, U.S. Food and Drug Administration, www.fda.gov/tobacco-products/market-and-
distribute-tobacco-product/tobacco-products-marketing-orders (last visited Jan. 19, 2024).
12 21 U.S.C. § 387j.
13 See Melissa Kress, Bat to Challenge FDA’s Mark eting Denial Order for Flavored Vuse Products , Convenience Store
News, (Oct. 13, 2023), https://csnews.com/bat-challenge-fdas-mark eting-denial-order-flavored-vuse-products (last visited
Jan. 20, 2024).
14 21 CFR 1114.5.
15 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).
16 Supra note 9.
17 See 21 CFR 1107.16 and 21 CFR 1107.18.
18 21 CFR 1107.18.
19 21 CFR 1107.1.
20 “FDA Makes Determinations on More than 99% of the 26 Million Tobacco.” U.S. Food and Drug Administration,
www.fda.gov/tobacco-products/ctp-newsroom/fda-makes-determinations-more-99-26-million-tobacco-products-which-
applications-were-submitted (last visited Jan. 24, 2024).
21 “Premarket Tobacco Product Marketing Granted Orders”, U.S. Food and Drug Administration, (updated as of Jan. 9,
2024), www.fda.gov/tobacco-products/premarket-tobacco-product-applic ations/premarket-tobacco-product-marketing-
granted-orders (last visited Jan. 24, 2024).
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 Appeals set aside FDA marketing order denials as arbitrary and capricious 22 because FDA failed to
consider relevant factors in evaluating the applications submitted by the six tobacco companies.23 In
2024, the Fifth Circuit Court of Appeals stated in reference to the tobacco premarketing application
process, that “[o]ver several years, the Food and Drug Administration sent manufacturers of flavored e-
cigarette products on a wild goose chase.”24
Florida Regulation of Tobacco and Nicotine Products
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.
Under Florida law, tobacco products and nicotine products have different definitions. This differs from
federal law where tobacco products include nicotine products.
Regulation of Tobacco Products
“Tobacco products” 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. 25
Section 210.25(11), F.S., relating to the tax on tobacco products other than cigarettes or cigars, defines
the term “tobacco products” differently as “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.”
“Tobacco products” in either definition does not include nicotine products or nicotine dispensing
devices.
Under Section 210.01, F.S.:
“Wholesale dealer” means any person located inside or outside this state who sells cigarettes 26 to retail
dealers or other persons for purposes of resale only. Such term shall not include any cigarette
manufacturer, export warehouse proprietor, or importer with a valid permit 27if such person sells or
distributes cigarettes in this state only to dealers who are agents and who hold valid and current
permits under s. 210.15, F.S. or to any cigarette manufacturer, export warehouse proprietor, or importer
who holds a valid and current permit under 26 U.S.C. s. 5712. 28
“Distributing agent” means every person, firm or corporation in this state who acts as an agent for any
person, firm or corporation outside or inside the state by receiving cigarettes in interstate or intrastate
22 Arbitrary and capricious means “founded on prejudice or preference rather than on reason or fact. ” ARBITRARY,
Black's Law Dictionary (11th ed. 2019); see also, “…[A]n agency action is lawful only if it rests ‘on a consideration of the
relevant factors. An agency rule would be arbitrary and capricious if the agency ... entirely failed to consider an impo rtant
aspect of the problem.” Bidi Vapor LLC v. U.S. Food & Drug Admin., 47 F.4th 1191, 1202 (11th Cir. 2022).
23 See, Bidi Vapor LLC v. U.S. Food & Drug Admin., 47 F.4th 1191, 1205 (11th Cir. 2022) (where 6 tobacco companies
included their proposed marketing and sales-access restrictions in their application, and the FDA marketing denial orders
specifically stated that it did not consider the marketing or sales -access-restriction plans in the companies' applications.).
24 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).
25 S. 569.002(6), F.S.
26 “’Cigarette” means any roll for smoking, except one of which the tobacco is fully naturally fermented, wi thout 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. S. 210.01(1), F.S.
27 26 U.S.C. s. 5712.
28 S. 210.01(6), F.S.
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 commerce and storing such cigarettes subject to distribution or delivery upon order from said principal
to wholesale dealers and other distributing agents inside or outside this state.29
Cigarette and Tobacco Product Wholesalers, Distributors, and Manufacturers
A person must obtain a permit from the Division in order to distribute tobacco products, not including
cigarettes or cigars. A person must obtain a permit for each place of business. The fee for such permit
is $25.30
A person must obtain a cigarette permit from the Division in order to import, export, manufacture, deal
at wholesale, or distribute cigarettes in the state. A person must obtain a permit for each place of
business in the state or its principal place of business if the person does not have a business in this
state. The fee for such permit is $100. The Division may only issue permits to persons who are 18
years or older or corporations with officers who are 21 years or older.31
Retail Tobacco Product Dealers
In order to sell tobacco products at retail or operate a tobacco products vending machine in Florida, a
person must obtain a retail tobacco products dealer permit from the Division. A tobacco products dealer
permit holder is allowed to sell nicotine products and nicotine dispensing devices, in addition to tobacco
products. A person must obtain a permit for each place of business or premises where tobacco
products are sold. Any person who owns, leases, furnishes, or operates a vending machines that
dispense tobacco products must also obtain a permit for each machine. The fee for such permit is
$50.32 The Division may only issue permits to persons who are 21 years or older or corporations with
officers who are 21 years or older.33
Anyone who deals in tobacco produc