Florida 2024 2024 Regular Session

Florida Senate Bill S1006 Analysis / Analysis

Filed 02/02/2024

                    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 Regulated Industries  
 
BILL: SB 1006 
INTRODUCER:  Senator Perry 
SUBJECT:  Nicotine Products 
DATE: February 2, 2024 
 
 ANALYST STAFF DIRECTOR  REFERENCE  	ACTION 
1. Oxamendi Imhof RI Pre-meeting 
2.     AEG   
3.     FP  
 
I. Summary: 
SB 1006 provides for the regulation of the wholesale and the retail sale of nicotine products such 
as electronic cigarettes. The bill: 
 Requires manufacturers of nicotine products to register with the Division of Alcoholic 
Beverages and Tobacco (division) within the Department of Business and Professional 
Regulation 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 nicotine products with the 
division and provide evidence 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 nicotine products. 
 Requires wholesale dealers of a nicotine product to have a permit issued by the division. 
 Requires manufacturers of nicotine products to maintain certain records for a period of three 
years, including identifying information on to whom the products were sold. 
 Prohibits wholesale dealers and retail dealers of nicotine products from selling nicotine 
products that are not on the division’s directory of nicotine products. 
 Prohibits the shipment into Florida of nicotine products 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: 
o First degree misdemeanor for nicotine products manufacturers who knowingly ships or 
receives a nicotine product 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 nicotine products; 
REVISED:   BILL: SB 1006   	Page 2 
 
o Second degree misdemeanor for any person who knowingly ships or receives nicotine 
products from a manufacturer that does not have a permit issued by the division; and 
o Third degree felony for falsely misrepresenting any of the information required to register 
a nicotine product with the division.  
 Provides administrative fines for violations and for the suspension and revocation of permits.  
 Provides that all nicotine products 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. 
 
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 
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. 
  BILL: SB 1006   	Page 3 
 
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
  
 
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.  
 
                                                
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 Jan. 17, 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 Jan. 20, 2024).  BILL: SB 1006   	Page 4 
 
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. 
 
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 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
 
                                                
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. 
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.  BILL: SB 1006   	Page 5 
 
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
 
 
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) 
                                                
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 Jan. 29, 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). 
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 Jan. 29, 2024).  BILL: SB 1006   	Page 6 
 
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, were required to submit marketing 
applications to the FDA by May 14, 2022,
21
 and receive a marketing order to permit the 
continued sale of the tobacco product. A tobacco manufacturer may challenge the FDA’s 
marketing denial.
22
 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.
23
 The PMTA must contain information
24
 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 
using such products, as well as the increased or decreased likelihood that 
those who do not use tobacco products will start using such products.
25
  
 
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.
26
 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.
27
  
 
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 
                                                
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 Jan. 29, 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 Jan. 29, 2024).  
22
 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. 
29, 2024).  
23
 21 CFR 1114.5. 
24
 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). 
25
 Supra note 16.  
26
 See 21 CFR 1107.16 and 21 CFR 1107.18. 
27
 21 CFR 1107.18.  BILL: SB 1006   	Page 7 
 
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.
28
  
 
The FDA made determinations on more than 99 percent of the nearly 26 million products for 
which PMTSs have been submitted.
29
 As of March 15, 2023, the FDA has authorized the 
marketing of 45 products, including 23 tobacco-flavored e-cigarette products and devices.
30
  
 
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.
31
 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.”
32
 
III. Effect of Proposed Changes: 
Definitions 
Section 1 of the bill revises the meaning of the term “nicotine product” in s. 569.31, F.S., to 
provide that “each individual stock keeping unit is considered a separate nicotine product.”  
 
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.  
 “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" means a permit issued by the division under 
s. 569.316, F.S, as created by the bill. 
 
                                                
28
 21 CFR 1107.1. 
29
 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 Jan. 29, 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 Jan. 29, 2024). 
30
 Id. 
31
 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. 
32
 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: SB 1006   	Page 8 
 
Nicotine Product Directory  
Section 2 of the bill creates s. 569.311, F.S., to provide a certification requirement for 
manufacturers of nicotine products. 
 
Section 561.311(1), F.S., requires every nicotine products manufacturer who sells nicotine 
products in Florida to execute and deliver a form, which s. 569.311(4), F.S., refers to as a 
“certification,” prescribed by the division, under penalty of perjury for each nicotine product sold 
that meets either of the following criteria: 
 The nicotine product manufacturer has applied for a marketing order for the nicotine product 
derived from a tobacco source or nontobacco source by submitting a premarket tobacco 
product application to the FDA on or before May 14, 2022; and 
o The premarket tobacco product application for the nicotine product remains under review 
by the FDA, and neither a marketing authorization nor a marketing denial order has been 
issued; or 
o The FDA issued a marketing denial order for the nicotine product, but the FDA or a 
federal court issued a stay or an injunction during the pendency of the manufacturer's 
appeal of the marketing denial order or either the order has been appealed to the FDA or 
a challenge to the order has been filed with a federal court and the appeal or challenge is 
still pending; or 
 The nicotine products manufacturer has received a marketing authorization or other 
authorization, such as the SE or EX REQ, for the nicotine product from the FDA. 
 
Section 569.311(2), F.S., requires each nicotine products manufacturer to set forth: 
 The name under which the nicotine products manufacturer transacts or intends to transact 
business; 
 The address of the location of the nicotine products manufacturer's principal place of 
business, 
 The nicotine products manufacturer's e-mail address; and  
 Any other information the division requires 
 
The bill provides that the division may allow a nicotine products manufacturer to group its 
nicotine products on its certification.  
 
Section 569.311(3), F.S., requires each nicotine products manufacturer to provide to the division 
a copy of the cover page of the premarket tobacco application with evidence of the receipt of the 
application by the FDA, or a copy of the cover page of the marketing authorization or other 
authorization issued by the FDA, whichever is applicable. 
 
Section 569.311(4), F.S., requires a nicotine products manufacturer to notify the division within 
30 days of any material change to the certification, including, but not limited to, issuance by the 
FDA of any of the following: 
 A market authorization as a preexisting or new tobacco product; 
 A marketing order requiring a nicotine products manufacturer to remove a product from the 
market either temporarily or permanently;  BILL: SB 1006   	Page 9 
 
 Any notice of action taken by the FDA affecting the ability of the nicotine product to be 
introduced or delivered in this state for commercial distribution; 
 Any change in policy which results in a nicotine product no longer being exempt from 
federal enforcement oversight; or 
 Any other change deemed material by the division pursuant to a rule of the division. 
 
The bill provides that a nicotine products manufacturer who 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 
Section 569.311(5), F.S., requires the division to develop and maintain a directory listing all the 
nicotine products 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.  
 
Process for Removal from the Directory 
 
Section 569.311(6), F.S., requires the division to provide nicotine products manufacturer a notice 
and an opportunity to cure deficiencies before removing the manufacturer or its nicotine product 
from the directory. The division may not remove the nicotine products manufacturer or its 
nicotine product from the directory until at least 15 days after the nicotine products manufacturer 
has been given notice of an intended action. 
 
Notice is sufficient and deemed immediately received by a nicotine products 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 products manufacturer has 15 days from 
the date of service of the notice of the division's intended action to establish that the nicotine 
products manufacturer or its nicotine product should be included in the directory. 
 
Section 569.311(6)(c), F.S., provides that a determination by the division not to include a 
nicotine product 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 nicotine product on the directory until 
conclusion of the hearing.  
 
Section 569.311(6)(d), F.S., provides that retailers and wholesalers have 21 days from when the 
product is removed from the directory to remove the product from their inventory and return the 
nicotine product to the nicotine products manufacturer. Each nicotine products manufacturer 
shall provide to the division information regarding the return of such product and how the 
returned product was disposed of within 21 days after receipt.  
  BILL: SB 1006   	Page 10 
 
Section 569.311(6)(d), F.S., also provides that a nicotine product identified in the notice of 
removal is considered contraband 21 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 nicotine product not listed on the 
directory is subject to a fine of $1,000 per day for each nicotine product 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. 
 
False Representation 
Section 569.311(8), F.S., provides that a nicotine products manufacturer who falsely represents 
any of the information required to be provided to the division commits a felony of the third 
degree
33
 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 
products manufacturers to renew certifications without having to resubmit all the information for 
the certification process. 
 
Maintenance and inspection of nicotine product records 
Section 3 of the bill creates s. 569.312, F.S., to require nicotine product manufacturers to 
maintain specified records.  
 
Section 569.312(1), F.S., requires nicotine products manufacturers to keep for a period of three 
years, at the address listed on the certification: 
 A complete and accurate record of the sales of each nicotine product sold or the amount of 
nicotine products delivered to a wholesaler in Florida; and 
 To whom each nicotine product was sold on a wholesale basis, including the business name, 
license number, shipping and business addresses, e-mail address, and telephone number for 
                                                
33
 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: SB 1006   	Page 11 
 
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 products dealers, wholesale nicotine 
products dealers, wholesale dealers of cigarettes, and distributing agents of cigarettes must keep 
a record of the amount of each nicotine product received, delivered, or sold in Florida and to 
whom each nicotine product was sold or delivered or from whom they received each nicotine 
product, 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 products dealers, wholesale nicotine 
products 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 nicotine products.  
 
Section 569.312(4), F.S., requires nicotine product manufacturers, 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 upon 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. 
 
Under the bill, it is not clear if the record keeping requirement in s. 569.312(2) and (4), F.S, 
applies to distributors of tobacco products other than cigarettes, because the record maintenance 
requirements in s. 569.312, F.S., 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. 
 
Shipment of unregistered nicotine products into Florida  
Section 4 of the bill creates s. 569.313, F.S., to prohibit the unregistered shipment of nicotine 
products into Florida. 
 
Section 569.313(1), F.S., prohibits nicotine products 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; 
 Not submitted a premarket tobacco product application; or  
 Not submitted the certification required for the nicotine product.  BILL: SB 1006   	Page 12 
 
 
Section 569.313(2), F.S., provides that any person who knowingly ships and receives an 
unregistered nicotine product in violation of s. 569.313, F.S., commits a first degree 
misdemeanor.
34
  
 
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 of the bill 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 within this state, or to sell nicotine products or nicotine 
dispensing devices to any retail nicotine products dealer, 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; or, 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; to any 
corporation an officer of which has had such permit revoked; or to any person who is or has been 
an officer of a corporation whose permit has been revoked. 
 
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, 
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 
                                                
34
 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: SB 1006   	Page 13 
 
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 of the bill creates s. 569.317, F.S., to provide that a wholesale nicotine products dealer 
permitholder may only purchase and sell nicotine products contained on the division’s nicotine 
products 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 of the bill 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 8 of 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. 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 to deal, at retail, in nicotine products that are not 
listed on the division’s nicotine products directory. Any person who knowingly ships or receives 
such nicotine products in violation of this prohibition commits a misdemeanor of the second 
degree.
35
  
 
Section 569.34(5), F.S., provides that on or after January 1, 2025, it is unlawful for a retail 
nicotine products dealer to purchase nicotine products 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 
                                                
35
 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: SB 1006   	Page 14 
 
exempts from this prohibition nicotine products 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 nicotine products 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. 
 
Seizure and Destruction of Contraband Nicotine Products 
Section 10 of the bill creates s, 569.345, F.S., to provide that all nicotine products 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.
36
 The 
bill requires the court having jurisdiction to order the destruction and forfeiture of contraband 
nicotine products.  
 
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 nicotine products must be borne by the person from whom the contraband nicotine 
products are seized. 
 
Effective Date 
The bill takes effect October 1, 2024.  
IV. Constitutional Issues: 
A. Municipality/County Mandates Restrictions: 
None. 
B. Public Records/Open Meetings Issues: 
None. 
                                                
36
 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: SB 1006   	Page 15 
 
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. 
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. The division has not provided a fiscal analysis 
for this bill. 
VI. Technical Deficiencies: 
None. 
VII. Related Issues: 
The bill revises the meaning of the term “nicotine product” in s. 569.31, F.S., to provide that 
“each individual stock keeping unit is considered a separate nicotine product.” The meaning of  BILL: SB 1006   	Page 16 
 
this provision is unclear in regards to what types of product or “stock keeping unit” this 
provision is meant to encompass.  
 
Section 569.311(6)(c), F.S., provides that, if a nicotine products manufacturer seeks review of 
the decision under ch. 120, F.S., to remove it from the directory, the division must keep the 
nicotine product 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.
37
 The bill sponsor 
may wish to consider amending the bill to provide for removal of a nicotine product from the 
directory upon the issuance by the division of a final order determining that the nicotine product 
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 nicotine product must be renewed after a prescribed period. There are parts of the bill that 
have unclear language or misuse legal terms. The bill also uses the term “certification” and 
“registration” interchangeably. 
 
Under the bill, it is not clear if the record keeping requirement in s. 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 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. 
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. 
 
                                                
37
 See s. 120.569, F.S.  BILL: SB 1006   	Page 17 
 
This bill creates the following sections of the Florida Statutes: 569.311, 569.312, 569.313, 
569.316, 569.317, and569.345. 
IX. Additional Information: 
A. Committee Substitute – Statement of Changes: 
(Summarizing differences between the Committee Substitute and the prior version of the bill.) 
None. 
B. Amendments: 
None. 
This Senate Bill Analysis does not reflect the intent or official position of the bill’s introducer or the Florida Senate.