House Staff Analysis: PCS for CS/HB 1007 Nicotine Products and Dispensing Devices (Commerce Committee)
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- 2024 3220 Commerce Committee Proposed Committee Bill Analyses Fn Pcs1007 Com
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- 2024 3220 Commerce Committee Proposed Committee Bill Analyses Fn Pcs1007 Com
Summary
A House of Representatives staff analysis of the PCS for CS/HB 1007, Nicotine Products and Dispensing Devices, sponsored by the Commerce Committee and dated February 21, 2024. It describes a bill requiring manufacturers to certify nicotine dispensing devices with the Division of Alcoholic Beverages and Tobacco and directing the Division to maintain an online directory of certified manufacturers and devices. The analysis says the bill creates a wholesale nicotine products dealer permit, authorizes unannounced inspections, imposes fines and criminal penalties, and allows law enforcement to seize non-registered products. Background sections cover federal FDA regulation and premarket review of tobacco products and Florida permit rules. The analysis gives an effective date of October 1, 2024 and reports $278,875 in recurring funds for DBPR to implement the act.
Summary drafted by a model from the document's text below and checked by script against that text before publication. It is a navigation aid, not a reading of what the document proves. Where AI is used
Cite this document
“House Staff Analysis: PCS for CS/HB 1007 Nicotine Products and Dispensing Devices (Commerce Committee).”
Original at www.flhouse.gov. Archived at Pandemic Darlings, https://pandemicdarlings.com/source-documents/2024-3220-commerce-committee-proposed-committee-bill-analyses-fn-pcs1007-com/
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HOUSE OF REPRESENTATIVES STAFF ANALYSIS
BILL #: PCS for CS/HB 1007 Nicotine Products and Dispensing Devices
SPONSOR(S): Commerce Committee
TIED BILLS: IDEN./SIM. BILLS:
REFERENCE ACTION ANALYST STAFF DIRECTOR or
BUDGET/POLICY CHIEF
Orig. Comm.: Commerce Committee 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 the Fiscal
Analysis and Economic Impact Statement for details.
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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DATE: 2/21/2024
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 product[s]” 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. F ood
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 Jan. 19, 2024).
3 21 U.S.C. § 387p.
4 “The term ‘manufacture, preparation, compounding, or processing’ shall include repackaging or otherwise changing the containe r,
wrapper, or labeling of any tobacco product package in furtherance of the distribution of the tobacco product from the origin al 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 n ame 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.
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).
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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
Appeals set aside FDA marketing order denials as arbitrary and capricious 22 because FDA failed to
10 Market 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 https://www.fda.gov/tobacco-products/market-and-distribute-tobacco-product/tobacco-products-marketing-orders
12 21 U.S.C. § 387j.
13 See Melissa Kress, Bat to Challenge FDA’s Marketing Denial Order for Flavored Vuse Products, Convenience Store News, (Oct.
13, 2023), https://csnews.com/bat-challenge-fdas-marketing-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 populat ion 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-applications/premarket-tobacco-product-marketing-granted-orders (last
visited Jan. 24, 2024).
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 important aspect of the proble m.” Bidi
Vapor LLC v. U.S. Food & Drug Admin., 47 F.4th 1191, 1202 (11th Cir. 2022).
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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
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
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 e xplain 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, 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. S. 210.01(1), F.S.
27 26 U.S.C. s. 5712.
28 S. 210.01(6), F.S.
29 S. 210.01(14), F.S.
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Cigarette and Tobacco Products 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 Products 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 tobacc o
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 products at retail or allows a vending machine on the premises without a
permit is subject to a $500 fine.34
DBPR is required to submit an annual report to the Governor and Legislature regarding the
enforcement of tobacco products, including:35
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
such citation, for misrepresenting their age, purchasing tobacco products underage, and
misrepresenting military service for the purpose of obtaining tobacco products underage.
Florida also has an excise tax and surcharge on cigarettes and other tobacco products, not including
cigars. The tax and surcharge for cigarettes is $0.1695 to $0.42375 per pack and a surcharge of $0.50
to $1.25 per pack depending on the number of cigarettes in the pack. The excise tax for tobacco
products is 25 percent of the wholesale price and the surcharge is 60 percent of the wholesale price.
There is no excise tax or surcharge for nicotine products or nicotine dispensing devices.36
Nicotine Regulations
“Nicotine dispensing device” means 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.
30 S. 210.40, F.S.
31 S. 210.15, F.S.
32 S. 569.003, F.S.
33 S. 569.003, F.S.
34 S. 569.005, F.S.
35 S. 569.19, F.S.
36 Ss. 210.011, 210.02, 210.276, and 210.30, F.S.; DBPR, Alcoholic Beverages & Tobacco – Tax & Reporting Information For
Licensees, http://www.myfloridalicense.com/ DBPR/alcoholic-beverages-and-tobacco/tax-and-reporting-information-for-
licensees/#1510753842753-25986d10-086f (last visited Jan. 20, 2024).
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“Nicotine product” means any product that contains nicotine, including liquid nicotine, which is intended
for human consumption, whether inhaled, chewed, absorbed, dissolved, or ingested by any means.
Retail Nicotine Products Dealers
The regulations for the sale of nicotine products and nicotine dispensing devices mirror the regulations
for the sale of tobacco products. However, nicotine products do not have a tax or permit fee similar to
tobacco products.
Administrative Penalties
The Division may suspend or revoke the permit of the retail tobacco products dealer or retail nicotine
product dealer upon sufficient cause appearing of the violation of chapter 569. The Division may also
assess and accept administrative fines of up to $1,000 against a dealer for each violation. The Division
shall deposit all fines collected into the General Revenue Fund as collected. An order imposing an
administrative fine becomes effective 15 days after the date of the order. The Division may suspend the
imposition of a penalty against a dealer, conditioned upon the dealer's compliance with terms the
Division considers appropriate.37
Consent to inspection and search without warrant
The place or premises covered by a permit for a retail tobacco products dealer or a permit for a retail
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 for and dealing.38
Effect of the Bill
Definitions
The bill modifies the definition of “nicotine dispensing device” by providing that “each individual stock
keeping unit is considered a separate nicotine product.” The bill provides the following definitions:
“Sell” or “sale” means in addition to its common usage meaning, any sale, transfer, exchange,
barter, gift, or offer for sale and distribution, in any manner or by any means whatsoever.
“Timely filed premarket tobacco product application” means either:
o An application pursuant to 21 U.S.C. s. 387j for a nicotine dispensing device containing
or utilizing nicotine derived from tobacco marketed in the United States as of August 8,
2016, that was submitted to the FDA on or before September 9, 2020, and accepted for
filing; or
o An application pursuant to 21 U.S.C. s. 387j for a nicotine dispensing device that:
Is not a single use electronic cigarette, electronic cigar, electronic cigarillo,
electronic pipe, or other similar device or product; and
Contains or utilizes nicotine derived from a non-tobacco source.
“Nicotine product manufacturer” means any person that manufactures nicotine products.
“Wholesale nicotine products dealer" means the holder of a wholesale nicotine products dealer
permit who purchases nicotine dispensing devices or nicotine products from any nicotine
product manufacturer.
"Wholesale nicotine products dealer permit" means a permit issued by the Division under s.
569.316.
Nicotine Dispensing Device Directory
Submission of Form and Applicable Copy Page for Certification
37 Ss. 569.006 and 569.35, F.S.
38 Ss. 569.004 and 569.33, F.S.
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By December 1, 2024, and annually thereafter, the bill requires every nicotine product manufacturer
that sells nicotine dispensing devices to any person for eventual retail sale in this state to execute and
deliver a form, prescribed by the Division, under penalty of perjury for each such nicotine dispensing
device sold that attests to meeting either of the following criteria:
The manufacturer of a nicotine dispensing device has submitted a timely filed premarket
tobacco product application for the nicotine dispensing device pursuant to 21 U.S.C. s. 387j to
the FDA and:
o has received a marketing denial order for the nicotine dispensing device from the FDA.
o the application either remains under review by the FDA, or
o has received a marketing denial order that has been and remains stayed by the FDA or
court order, rescinded by the FDA, or vacated by a court; or
The nicotine product manufacturer has received a marketing granted order under 21 U.S.C. s.
387j for the nicotine dispensing device from the FDA.
The Division’s form must require 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; and
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.
Such form must be delivered to the Division.
The bill provides that the Division may allow a nicotine product manufacturer to group its nicotine
products on its certification.
In addition to completing the form prescribed by the Division, the bill requires each nicotine product
manufacturer to provide a copy of:
the cover page of the granted marketing order issued by the FDA pursuant to 21 U.S.C. s. 387j
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.
After the nicotine product manufacturer submits the form and the applicable cover page (certification)
as prescribed under the bill to the Division, the bill requires the 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 a market authorization pursuant to 21 U.S.C. s. 387j;
An order requiring a nicotine product manufacturer to remove a nicotine dispensing device or
nicotine product from the market either temporarily or permanently;
Any notice of action taken by the FDA affecting the ability of the nicotine dispensing device to be
introduced or delivered in this state for commercial distribution;
Any change in policy which results in a nicotine dispensing device becoming an FDA
enforcement priority; or
Any other change deemed material by the Division pursuant to a rule of the Division.
The bill provides that a nicotine product manufacturer that falsely represents any of the information in
the form prescribed by the Division or the applicable copy page in the certification process commits a
felony of the third degree for each false representation.
Directory
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The bill requires the Division to develop and maintain a directory listing all the:
nicotine product manufacturers that sell nicotine dispensing devices in this state; and
nicotine dispensing devices certified by those manufacturers with the Division which comply with
this requirement.
The bill requires the Division to:
Make the directory available January 1, 2025, on its or DBPR’s website.
Update the directory as necessary.
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
The bill requires the Division to establish by rule a process to provide a nicotine product manufacturer
notice and an opportunity to cure deficiencies before removing the manufacturer or any of its nicotine
dispensing devices from the directory.
The bill prohibits the Division from removing the nicotine product manufacturer or any of its nicotine
dispensing devices 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 product manufacturer in its most recent
certification.
The bill 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 any of its
nicotine dispensing devices should be included on the directory.
The bill provides that a determination by the Division not to include or to remove from the directory a
nicotine product manufacturer or nicotine dispensing device is subject to review under chapter 120. If a
nicotine product manufacturer seeks review of removal from the directory, the Division must keep the
nicotine dispensing device on the directory until conclusion of the hearing.
The bill provides that if a nicotine dispensing device is removed from the directory:
Each retailer and each wholesaler holding nicotine dispensing devices for eventual sale to a
consumer in this state has 30 days from the day such product is removed to sell the product or
remove the product from its inventory.
After 30 days following removal, the product identified in the notice of removal is contraband
and subject to s. 569.345, F.S.
Nicotine Dispensing Devices Not Listed on the Directory
The bill 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 product
manufacturer that offers for sale in this state a nicotine dispensing device not listed on the directory is
subject to a fine of $1,000 per day for each individual nicotine dispensing device 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.
The bill gives each retailer 60 days from the date that the Division first makes the directory available for
inspection on its public website to sell products that were in its inventory and not included on the
directory or remove those products from inventory.
The bill gives each distributor or wholesaler 60 days from the date that the Division first makes the
directory available for inspection on its public website to remove from inventory those products intended
for eventual retail sale to a consumer in this state.
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Unannounced Inspections
The bill 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.
Certification Renewal
The bill gives the Division rule making authority to develop a procedure to allow nicotine product
manufacturers to renew certifications without having to resubmit all the information for the certification
process.
Failure to Provide Information
The bill provides that failure of a nicotine product manufacturer to provide information or documents
required may result in:
a nicotine dispensing device not being included on the directory; or
the removal of a nicotine dispensing device from the directory.
The bill:
Authorizes the Division to assess an administrative fine of up to $1,000 for each nicotine
dispensing device offered for sale in this state 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.
Requires the Division to deposit all fines collected into the General Revenue Fund.
The bill specifies that an order imposing an administrative fine becomes effective 15 days after the date
of the order.
Maintenance and Inspection of Nicotine Dispensing Device Records
The bill requires each nicotine product manufacturer that sells nicotine dispensing devices in this state
to keep for a period of 3 years, at the address listed on the certification:
a complete and accurate record of the number of sales of nicotine dispensing devices sold or
delivered to a wholesaler in Florida; and
to whom each nicotine dispensing device was sold on a wholesale basis, 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. Such records may be kept in an
electronic or paper format.
The bill provides similar maintenance requirements for retail nicotine products dealers; wholesale
nicotine products dealers; wholesale dealers, and distributing agent. They must keep a record of the
quantity of each nicotine dispensing device received, delivered, or sold in Florida and to whom each
nicotine dispensing device was sold or delivered or from whom they received each nicotine dispensing
device, 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 are allowed to kept in electronic or paper format.
The bill provides that within seven calendar days after receiving a request by the Division, a nicotine
product manufacturer that sells nicotine dispensing devices in this state, including a nicotine product
manufacturer selling nicotine products directly to consumers; a retail nicotine products dealer; a
wholesale nicotine products dealer; a wholesale dealer, and a distributing agent provide such records,
must provide to the Division or its representative, copies of records related to the nicotine dispensing
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devices received, delivered, or sold in this state and to whom those nicotine dispensing devices were
sold or delivered or from whom they were received.
The bill allows the Division to examine such records, issue subpoenas 39 to such persons or entities;
administer oaths; and take depositions of witnesses within or outside of Florida. The bill states that the
Division or its representative issue and serve subpoenas and subpoenas duces tecum 40 to compel the
attendance of witnesses and the production of all materials relevant to an examination or
investigation41. Subpoenas shall be served and enforceable in the manner provided by law and the
Division may enforce such in the same manner as provided in section 210.161 regarding the
examination of records for cigarettes 42. The bill provides that issued subpoena may be used to compel
such witness to:
Appear before the Division, or its representative;
Give his or her testimony; and
Produce such records as may be required for examination.
The bill provides that the Division or its representative may bring a legal action against a witness who
refuses to appear or testify before the circuit court. Failure to comply with such subpoena may be
punishable as contempt of court.43 Under the bill, if a person is subpoenaed, the Division may pay such
attendance and mileage fees as are permitted to be paid to witnesses in civil cases appearing before
the circuit court.
For each violation regarding maintenance and inspection of records, the Division is authorized to
assess an administrative fine of up to $1,000. The bill requires the Division to deposit all fines collected
into the General Revenue Fund, and specifies that an order imposing an administrative fine becomes
effective 15 days after the date of the order.
Shipment of Unregistered Nicotine Dispensing Devices
The bill prohibits a nicotine product manufacturer from distributing nicotine dispensing devices for
eventual retail sale to a consumer in Florida, in which:
there is an FDA order requiring the nicotine product manufacturer to remove the product from
the market either temporarily or permanently;
has not submitted a timely filed premarket tobacco product application for a nicotine dispensing
device that remains pending with the FDA; or
has not submitted the certification required for such nicotine dispensing device.
The bill states that a nicotine product manufacturer who knowingly ships or receives such nicotine
dispensing devices, commits a first degree misdemeanor. The bill:
39 A subpoena is an order to compel someone to testify. Subpoena, Legal Information Institute, www.law.cornell.edu/wex/subpoena
(last visited Feb. 19, 2024).
40 “A subpoena duces tecum commands the person to whom it is directed to produce the books, papers, docume nts or tangible things
designated therein. While a subpoena duces tecum is not an order issued by a judge, it is process of the court enforceable by contempt
proceedings.” Fla. Att'y Gen. Op. 94-86 (1994). “A subpoena duces tecum commands production by any ‘witness who has in his
possession or control’ a document pertinent to a pending controversy.”
Whittier v. City of Sunrise, 07-60476-CIV, 2007 WL 9706152, at *4 (S.D. Fla. Aug. 22, 2007).
41 “[A]n [state administrative agency] investigation does not determine guilt or innocence, but serves as the means by which agencies
can collect the information needed to decide whether to file an action. Because liability will be determined in a later proce eding at
which the defendant will be able to assert a vigorous defense, courts give agencies ‘more latitude ... in considering the foundation for a
subpoena.” Roger B. Handberg, The Enforcement of Investigative Subpoenas Issued by Administrative Agencies an Analysis of
Common Defenses, Fla. B.J., October 2002, at 40, 40–42.
42 A subpoena “…may be enforced by writ of attachment to be issued by the division, or any employee designated by it, for such
witness to compel him or her to attend before the division, or any employee designated by it, and give testimony and to bring and
produce such books, papers, and documents as may be required for examination.” S. 210.161, F.S. According to Black’s Law
Dictionary, a writ of attachment can either mean an “arrest of a person who either is in contempt of court or is to be held as security
for the payment of a judgment”, or “a writ ordering legal seizure of property (esp. to satisfy a creditor's claim) or of a pe rson.”
ATTACHMENT, Black's Law Dictionary (11th ed. 2019).
43 “Failure by any person without adequate excuse to obey a subpoena served on that person may be deemed a contempt of the court
from which the subpoena issued.” Fla. R. Civ. P. 1.410(f).
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Authorizes the Division to impose an administrative fine up to $5,000 for each violation.
Requires the Division to deposit all fines collected into the General Revenue Fund.
The bill specifies that an order imposing an administrative fine becomes effective 15 days after the date
of the order.
Wholesale Nicotine Products Dealer
The bill creates a wholesale nicotine products dealer permit which is issued by the Division. The
provisions of the bill that address a wholesale nicotine products dealer permit mirror the provisions for a
retail tobacco dealer and a retail nicotine dealer. The bill provides that a wholesale dealer or a
distributing agent is not required to have a separate or additional wholesale nicotine products dealer
permit to deal, at wholesale, in nicotine products in Florida. Furthermore, the bill states that a wholesale
dealer, a distributing agent, or a tobacco products distributor, which deals, at wholesale, in nicotine
products is subject to, and must be in compliance with ch. 569, F.S., regarding nicotine and tobacco.
The bill requires that wholesale nicotine products dealer may only purchase and sell for retail sale in
this state nicotine dispensing devices contained on the directory created by the Division. The Division is
authorized to:
Suspend or revoke the permit of a wholesale nicotine products dealer if the dealer fails to
comply.
Impose an administrative fine up to $5,000 for each violation. The Division shall deposit all fines
collected into the General Revenue Fund.
The bill specifies that an order imposing an administrative fine becomes effective 15 days after the date
of the order.
The bill 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.
Retail Nicotine Products Dealer
The bill adds dealing at retail in nicotine dispensing devices to the criteria that requires a retail nicotine
product dealer permit.
The bill provides that retail nicotine products dealer permits may be renewed each year. Under the bill,
a retail nicotine products dealer that does not timely renew its permit must pay a late fee of $5 for each
month or portion of a month occurring after expiration, and before renewal, of the dealer's permit. The
Division shall establish by rule a renewal procedure that, to the greatest extent feasible, combines the
application and permitting procedure for permits with the application and licensing system for alcoholic
beverages. The bill prohibits the Division from granting an exemption from the permit fees for any
applicant.
The bill specifies that the Division’s current authority to refuse to issue a permit is based on such
revocations by any jurisdiction.
The bill provides that on or after March 1, 2025, it is unlawful for a person, a firm, an association, or a
corporation to deal, at retail, in nicotine products that are not listed on the Division’s directory. Any
person who knowingly ships or receives such nicotine products commits a misdemeanor of the second
degree.
The bill provides that on or after January 1, 2025, it is unlawful for a retail nicotine products dealer to
purchase nicotine dispensing devices from a wholesaler, manufacturer, or other source that is not a
wholesale nicotine products dealer permitholder, a wholesale dealer, a distributing agent, or a tobacco
products distributor. The bill states that any person who knowingly ships or receives nicotine dispensing
devices in violation of this section commits a second degree misdemeanor. The bill authorizes the
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Division to suspend or revoke a retail nicotine products permit and may also assess an administrative
fine of up to $1,000 for each violation.
Seizure and Destruction of Contraband Nicotine Dispensing Devices
The bill declares all nicotine dispensing devices sold in contravention of ch. 569, F.S., to be
contraband. The contraband may be searched and seized per the Florida Contraband Forfeiture Act.
The bill requires that a Judge order the destruction and forfeiture of contraband nicotine dispensing
devices. The bill requires that the Division document the place where the contraband was seized, the
kind and quantities of contraband seized, the cost of destruction, the time, place, and manner of
destruction, the chain of custody of the contraband, and the cost of destruction.
The bill provides funding and positions to implement the act.
Agent for Service of Process
The bill requires any nonresident manufacturer of nicotine dispensing devices that has not registered to
do business in the state as a foreign corporation or business entity to, as a condition precedent to being
included on the nicotine directory, appoint and continually engage without interruption the services of
an agent in this state to act as agent for the service of process on whom all process, and any action or
proceeding against it concerning or arising out of the enforcement of ch. 569, F.S., may be served in
any manner authorized by law.
The bill:
Provides that such service constitutes legal and valid service of process on the manufacturer.
Requires the manufacturer to provide the name, address, telephone number, and proof of the
appointment and availability of such agent to the Division.
Requires the manufacturer to provide notice to the Division 30 calendar days before termination
of the authority of an agent and further provide proof to the satisfaction of the Division of the
appointment of a new agent no less than 5 calendar days before the termination of an existing
agent appointment.
Requires, in the event an agent terminates an agency appointment, the manufacturer to notify
the Division of the termination within 5 calendar days and include proof to the satisfaction of the
Division of the appointment of a new agent.
Requires any manufacturer whose nicotine dispensing devices are sold in this state who has not
appointed and engaged the services of an agent as required to be deemed to have appointed
the Secretary of State as its agent for service of process. The appointment of the Secretary of
State as agent does not satisfy the condition precedent to be included or retained on the
nicotine dispensing device directory.
B. SECTION DIRECTORY:
Section 1: Amends s. 569.31, F.S., relating to definitions.
Section 2: Creates s. 569.311, F.S., relating to nicotine dispensing device directory.
Section 3: Creates s. 569.312, F.S., relating to maintenance and inspection of nicotine dispensing
device records.
Section 4: Creates s. 569.313, F.S., relating to shipment of unregistered nicotine dispensing
devices sold for retail sale in this state.
Section 5: Creates s. 569.316, F.S., relating to wholesale nicotine products dealer permits;
application; qualifications; renewal; duplicates.
Section 6: Creates s. 569.317, F.S., relating to wholesale nicotine products dealer permitholder;
administrative penalties.
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Section 7: Amends s. 569.32, F.S., relating to retail nicotine products dealer permits.
Section 8: Amends s. 569.33, F.S., relating to consent to inspection and search without warrant.
Section 9: Amends s. 569.34, F.S., relating to operating without a retail nicotine products dealer
permit.
Section 10: Creates s. 569.345, F.S., relating to seizure and destruction of contraband nicotine
dispensing devices.
Section 11: Creates s. 569.346 Agent for service of process.
Section 12: Amends s. 569.31, F.S., relating to definitions.
Section 13: Provides appropriations.
Section 14: Provides an effective date.
II. FISCAL ANALYSIS & ECONOMIC IMPACT STATEMENT
A. FISCAL IMPACT ON STATE GOVERNMENT:
1. Revenues:
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.
2. Expenditures:
The bill provides funding for four positions with a total salary rate of 180,000. Additionally, the bill
provides $278,875 in recurring funds and $20,268 in nonrecurring funds from the Alcoholic
Beverage and Tobacco Trust Fund to DBPR to implement the act.
B. FISCAL IMPACT ON LOCAL GOVERNMENTS:
1. Revenues:
None.
2. Expenditures:
None.
C. DIRECT ECONOMIC IMPACT ON PRIVATE SECTOR:
Businesses that are distributing nicotine products and operating as manufacturers, retailers, or
wholesales will be penalized by fines or a criminal offense if they are distributing nicotine products
without being on the directory or without proper permitting.
D. FISCAL COMMENTS:
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 DBPR in their
legislative budget request.
III. COMMENTS
A. CONSTITUTIONAL ISSUES:
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1. Applicability of Municipality/County Mandates Provision:
Not applicable. This bill does not appear to require counties or municipalities to spend funds or take
action requiring the expenditures of funds; reduce the authority that counties or municipalities have
to raise revenues in the aggregate; or reduce the percentage of state tax shared with counties or
municipalities.
2. Other:
None.
B. RULE-MAKING AUTHORITY:
The bill empowers the Division to develop and maintain a directory listing all the certified nicotine
products and to develop a procedure to allow nicotine products manufacturers to renew certifications
without having to resubmit all the information for the certification process. The bill provides that the
Division must develop a form for the nicotine manufacturers to certify their businesses and nicotine
products.
C. DRAFTING ISSUES OR OTHER COMMENTS:
None.
IV. AMENDMENTS/COMMITTEE SUBSTITUTE CHANGES
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