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.