FDA Regulation of Tobacco Products July 9, 2021 Cigarette use remains the leading cause of preventable death in the United States, claiming an estimated 480,000 lives or more each year. Although cigarette use in the United States continues Hassan Z. Sheikh to decline, according to the Centers for Disease Control and Prevention (CDC), 34.2 an estimated 34.1 Analyst in Public Health million American adults smoked cigarettes every day or some days in 20182019, and nearly 1.2 million 910,000 Emergency Management American middle and high school students had smoked cigarettes in the past 30 days in 2019.

within a 30-day period in 2020. Victoria R. Green In recent years, electronic nicotine delivery systems (ENDS) have become increasingly popular. Analyst in Health Policy ENDS is an umbrella term for various types of electronic tobacco products, including electronic cigarettes (e-cigarettes). An e-cigarette is a battery-operated device typically containing nicotine, flavorings, and other chemicals that, when heated, creates inhalable vapor. According to CDC analyses, 8.1 analyses, 10.9 million American adults used e-cigarettes every day or some days in 20182019, and about 5.43.58 million American middle and high school students had used an e-cigarette within a 30-day period in 2020. FDA Regulation of Tobacco Products used an e-cigarette in the past 30 days in 2019. There has been debate in the public health community regarding the impact of ENDS on public health. Some view ENDS as a safer alternative for adult cigarette smokers, while others are alarmed by increased use among youth. Further, the emergence of e-cigarette, or vaping, product use-associated lung injury (EVALI) that has resulted in 60 deaths and the hospitalization of 2,711 individuals as of January 21, 2020 has raised further concern among public health stakeholders, Congress, and the general public.

The Food and Drug Administration (FDA), an agency within the Department of Health and Human Services (HHS), is responsible for regulating the manufacture, marketing, distribution, and sale of tobacco products. FDA'’s Center for Tobacco Products (CTP)—established in 2009 pursuant to the Family Smoking Prevention and Tobacco Control Act of 2009 (TCA; P.L. 111-31)—is primarily responsible for tobacco product regulation. The TCA amended the Federal Food, Drug, and Cosmetic Act (FFDCA) to establish a new chapter IX ("“tobacco products"”), which, as enacted, applied to cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco (e.g., snuff, chewing tobacco). However, FDA has the broad authority to regulate any other tobacco products deemed by the agency to meet the definition of a tobacco product and thus to be subject to chapter IX of the FFDCA. In 2016, pursuant to this authority, FDA promulgated regulations (known as "“the deeming rule"”) that extended the agency'’s authority over all tobacco products that were not already subject to the FFDCA, including ENDS. FDA’s regulation of tobaccoincluding ENDS.

Because tobacco products have no reported health benefits, FDA's regulation of these products differs in certain respects from FDA'’s regulation of medical products (e.g., prescription drugs, medical devices). Similar to medical product manufacturers, tobacco product manufacturers are subject to manufacturer requirements, including payment of user fees and premarket review, among other requirements. However, while medical product manufacturers are generally required to meet a standard of safety and effectiveness to receive premarket approval from FDA, tobacco product manufacturers are insteadin stead generally required to meet a standard "“appropriate for the protection of public health"” to receive marketing authorization. Tobacco product manufacturers, importers, distributors, and retailers are also required to comply with tobacco-specific requirements as a result of the harm that tobacco products pose to human health. Examples of such requirements include the development of tobacco product standards, submission of health information to the agency, and distribution and promotion restrictions, amon g others. This report provides a descriptive overview of FDA regulation of tobacco products. The report first discusses manufacturer requirements, followed by tobacco-specific requirements and compliance and enforcement. Congressional Research Service link to page 5 link to page 6 link to page 7 link to page 8 link to page 9 link to page 10 link to page 10 link to page 11 link to page 13 link to page 15 link to page 15 link to page 16 link to page 18 link to page 19 link to page 19 link to page 20 link to page 21 link to page 21 link to page 22 link to page 22 link to page 23 link to page 24 link to page 24 link to page 25 link to page 27 link to page 30 link to page 30 link to page 31 link to page 31 link to page 32 link to page 33 link to page 7 link to page 34 link to page 9 link to page 28 link to page 28 FDA Regulation of Tobacco Products Contents Introduction ................................................................................................................... 1 FDA’s Authority to Regulate Tobacco Products ................................................................... 2 Tobacco Product Regulation: Manufacturer Requirements ..................................................... 3 User Fees ................................................................................................................. 4 Establishment Registration and Product Listing .............................................................. 5 Tobacco Product Manufacturer Inspections .............................................................. 6 Good Manufacturing Practices (GMPs)......................................................................... 6 Premarket Review Pathways ....................................................................................... 7 Premarket Tobacco Product Applications (PMTA) Pathway ........................................ 9 Substantial Equivalence (SE) Pathway................................................................... 11 Exemption from Substantial Equivalence (EX REQ) Pathway ................................... 11 Modified Risk Tobacco Products (MRTP) Pathway ................................................. 12 Cessation Products ............................................................................................. 14 Tobacco Product Regulation: Tobacco-Specific Requirements.............................................. 15 Tobacco Product Standards ....................................................................................... 15 Flavors ............................................................................................................. 16 Nicotine ............................................................................................................ 17 Testing and Reporting of Ingredients .......................................................................... 17 Health Information .................................................................................................. 18 Harmful and Potentially Harmful Constituents ........................................................ 18 Health Documents .............................................................................................. 19 Records and Reports on Tobacco Products................................................................... 20 Distribution and Promotion Requirements ................................................................... 20 Restrictions on Sales and Distribution of Tobacco Products ...................................... 21 Tobacco Product Labeling and Advertisement Requirements..................................... 23 Compliance and Enforcement ......................................................................................... 26 Adulterated and Misbranded Tobacco Products ............................................................ 26 Adulterated Tobacco Products .............................................................................. 27 Misbranded Tobacco Products .............................................................................. 27 Tobacco Retailer Compliance Check Inspections .......................................................... 28 Notification and Recal ............................................................................................. 29 Figures Figure 1. Tobacco Products Currently Under FDA’s Authority, 2021....................................... 3 Figure A-1. The IQOS Tobacco Heating System ................................................................ 30 Tables Table 1. Tobacco User Fee Assessment Formulation, by Product Class, FY2021 ....................... 5 Table 2. Required Warning Statements on Tobacco Product Packaging and Advertising, by Tobacco Product .................................................................................................... 24 Congressional Research Service link to page 34 link to page 35 link to page 36 link to page 39 link to page 40 FDA Regulation of Tobacco Products Appendixes Appendix A. The IQOS Tobacco Heating System............................................................... 30 Appendix B. Tobacco Master Settlement Agreement of 1998 ............................................... 31 Appendix C. Definitions of Terms Used in This Report ....................................................... 32 Appendix D. Acronyms Used in This Report ..................................................................... 35 Contacts Author Information ....................................................................................................... 36 Congressional Research Service FDA Regulation of Tobacco Products Introduction submission of health information to the agency, and distribution and promotion restrictions, among others.

Cigarette use remains the leading cause of preventable death in the United States, claiming an estimated 480,000 lives or more each year.¹1 Further, between 2009 and 2012, cigarette smoking- attributable economic costs totaled over $289 billionbil ion in the United States.²2 Although cigarette use in the United States continues to decline,³3 according to Centers for Disease Control and Prevention (CDC) analyses, 34.2 million1 mil ion American adults smoked cigarettes every day or some days in 2019,4 and nearly 910,000days in 2018,⁴ and nearly 1.2 million American middle and high school students had smoked cigarettes within a 30-day period in 2020.5 smoked cigarettes in the past 30 days in 2019.⁵

Electronic nicotine delivery systems (ENDS) have become popular in recent years, particularly among youth. ENDS is an umbrellaumbrel a term for various types of electronic tobacco products, including electronic cigarettes (e-cigarettes). An e-cigarette is a battery-operated device typically typical y containing nicotine, flavorings, and other chemicals that, when heated, creates inhalable aerosol (i.e., vapor).⁶6 According to CDC analyses, 8.1 million10.9 mil ion American adults used e-cigarettes every day or some days in 2019.7 About 3.6 mil ion American middle and high school students had used an e-cigarette within a 30-day period day in 2020.8 The Food and Drug Administration (FDA), an agency within the Department of Health and Human Services (HHS), is responsible for regulating the manufacture, marketing, distribution, and sale of tobacco products. FDA’s Center for Tobacco Products (CTP)—established in 2009 pursuant to the Family Smoking Prevention and Tobacco Control Act of 2009 (TCA; P.L. 111- 31)—is primarily responsible for tobacco product regulation. The TCA established FFDCA chapter IX, under which FDA is authorized to regulate tobacco products. Within CTP, the Tobacco Products Scientific Advisory Committee (TPSAC) provides recommendations on 1 U.S. Department of Health and Human Services, The Health Consequences of Smoking: 50 Years of Progress. A Report of the Surgeon General, U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health, Atlanta, GA, January 2014, https://www.surgeongeneral.gov/library/reports/50-years-of-progress/50-years-of-progress-by-section.html. 2 U.S. Department of Health and Human Services, The Health Consequences of Smoking: 50 Years of Progress. A Report of the Surgeon General, Atlanta, GA, January 2014. 3 See Monica E. Cornelius, T eresa W. Wang, Ahmad Jamal, et al., “T obacco Product Use Among Adults—United States, 2019,” Morbidity and Mortality Weekly Report (MMWR), vol. 69, no. 46 (November 20, 2020), pp. 1736 -1742. See also Andrea S. Gentzke, MeLisa Creamer, Karen A. Cullen, et al., “Vital Signs: T obacco Product Use Among Middle and High School Students—United States, 2011–2018,” MMWR, vol. 68 (2019), pp. 157-164. 4 Current smoking is defined as using every day or some days of at least one tobacco product. See Monica E. Cornelius, T eresa W. Wang, Ahmad Jamal, et al., “T obacco Product Use Among Adults—United States, 2019,” Morbidity and Mortality Weekly Report (MMWR), vol. 69, no. 46 (November 20, 2020), pp. 1736 -1742. 5 Andrea S. Gentzke, T eresa W. Wang Ahmed Jamal, et al., “T obacco Product Use Among Middle and High School Students—United States, 2020,” Morbidity and Mortality Weekly Report (MMWR), vol. 69, no. 50 (December 18, 2020), pp. 1881-88. 6 National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH), Electronic Cigarettes (E-cigarettes), Retrieved from https://www.drugabuse.gov/publications/drugfacts/electronic-cigarettes-e-cigarettes on December 13, 2018. 7 See Monica E. Cornelius, T eresa W. Wang, Ahmad Jamal, et al., “T obacco Product Use Among Adults—United States, 2019,” Morbidity and Mortality Weekly Report (MMWR), vol. 69, no. 46 (November 20, 2020), pp. 1736 -1742. 8 Andrea S. Gentzke, T eresa W. Wang Ahmed Jamal, et al., “T obacco Product Use Among Middle and High School Students—United States, 2020,” Morbidity and Mortality Weekly Report (MMWR), vol. 69, no. 50 (December 18, 2020), pp. 1881-88. Congressional Research Service 1 link to page 34 link to page 35 link to page 36 link to page 39 link to page 39 FDA Regulation of Tobacco Products day or some days in 2018.⁷ About 5.4 million American middle and high school students used an e-cigarette in the past 30 days in 2019.⁸

The Food and Drug Administration (FDA), an agency within the Department of Health and Human Services (HHS), is responsible for regulating the manufacture, marketing, distribution, and sale of tobacco products. FDA's Center for Tobacco Products (CTP)—established in 2009 pursuant to the Family Smoking Prevention and Tobacco Control Act of 2009 (TCA; P.L. 111-31)—is primarily responsible for tobacco product regulation. The TCA established FFDCA chapter IX, under which FDA is authorized to regulate tobacco products. Within CTP, the Tobacco Products Scientific Advisory Committee (TPSAC) provides recommendations on tobacco regulatory decisions or any other matter listed in chapter IX of the FFDCA. The TPSAC tobacco regulatory decisions or any other matter listed in chapter IX of the FFDCA. The TPSAC includes 12 members with diversified experience and expertise.¹¹

Because tobacco products have no added health benefits, FDA'9 FDA’s regulation of these products differs in certain respects from FDA'’s regulation of medical products under its jurisdiction (e.g., prescription drugs, biologics, and medical devices). Similar to medical product manufacturers, tobacco product manufacturers are subject to manufacturer requirements, including payment of user fees, registration establishment, and premarket review, among others. However, while medical product manufacturers are generallygeneral y required to meet a standard of safety and effectiveness to receive premarket approval from FDA, tobacco product manufacturers are instead generallygeneral y required to meet a standard of "“appropriate for the protection of public health"” to receive marketing authorization. In addition, tobacco product manufacturers, importers, distributors, and retailers are required to comply with certain tobacco-specific requirements that have been authorized under the TCA as a result of the unique harms that tobacco products pose to human health. Examples of such requirements include the development of tobacco product standards, testing and reporting of ingredients, submission of health information to the agency, and distribution and promotion restrictions, among others.

This report describes (1) FDA'’s authority to regulate tobacco products; (2) general requirements for manufacturers of tobacco products, many of which are modeled after medical product requirements; (3) requirements that are unique to tobacco product manufacturers, distributors, importers, and retailers; and (4) compliance and enforcement. The report concludes with a discussion of policy issues and considerations for Congress. Appendix A describes the IQOS Tobacco Heating System, Appendix B briefly summarizes the Tobacco Master Settlement Agreement of 1998, Appendix C provides definitions of terms used in this report, andand Appendix D D provides acronyms used in this report.

FDA'’s Authority to Regulate Tobacco Products

As amended by the TCA, Section 901 of the FFDCA gives FDA the authority to regulate the manufacture, marketing, sale, and distribution of tobacco products. A tobacco product is defined as "“any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product (except for raw materials other than tobacco used in manufacturing a component, part, or accessory of a tobacco product)."¹²”10 Any article that is a drug, device, or combination product (a combination of a drug, device, or biological product) is excluded from the definition of tobacco product. Drugs, devices, and combination products are subject to chapter V authorities under the FFDCA.¹³11 However, it is not always clear whether a product that is derived from tobacco should be regulated as a drug, device, combination product, or a tobacco product (e.g., an ENDS product that makes certain health claims). As such, FDA has promulgated regulations to provide assistance to manufacturers intending to market products that are made or derived from tobacco based on the products' "intended uses."¹⁴

’ “intended uses.”12 9 FFDCA §917; 21 U.S.C. §387q. 10 FFDCA §201(rr); 21 U.S.C. §321(rr). 11 FFDCA §201(rr); 21 U.S.C. §321(rr). 12 FDA, “Clarification of When Products Made or Derived from T obacco Are Regulated as Drugs, Devices, or Combination Products: Amendments to Regulations Regarding ‘Intended Uses,’” 82 Federal Register 2193, January 9, 2017. Congressional Research Service 2 link to page 7 FDA Regulation of Tobacco Products Upon enactment, the TCA explicitly covered the following tobacco products: cigarettes and cigarette tobacco, roll-your-own tobacco, and smokeless tobacco.¹⁵13 However, the TCA gave FDA the broad authority to regulate any other tobacco products deemed by the agency to meet the definition of a tobacco product and thus subject to chapter IX of the FFDCA.¹⁶14 In 2016, FDA promulgated regulations (known as "“the deeming rule"”) that extended the agency'’s authority over all al tobacco products that were not already subject to the FFDCA, including ENDS, cigars, pipe tobacco, hookah tobacco, nicotine gels, dissolvable tobacco, and other tobacco products that may be developed in the future.¹⁷15 Figure 1 shows each of the tobacco products currently under FDA's authority.

’s authority. Figure 1. Tobacco Products Currently Under FDA'’s Authority, 2021 s Authority, 2020

Source: Prepared by CRS with images of smokeless tobacco products, ENDS, cigars, nicotine gels, dissolvable tobacco, and pipe tobacco from FDA's ’s website. Images of cigarettes, rol roll-your-own tobacco, and hookah tobacco are from Shutterstock. Notes: Some dissolvable tobacco products can be classified as smokeless tobacco products.

Tobacco Product Regulation: Manufacturer Requirements

Manufacturer Requirements Tobacco product manufacturers are subject to certain requirements, including payment of user fees, registration establishment, premarket review, and postmarket surveillancesurveil ance, among others. In the sections below, manufacturer requirements are discussed for tobacco products overalloveral , with exceptions for issues unique to certain classes of tobacco products.

13 FFDCA §901(b); 21 U.S.C. §387a(b). 14 FFDCA §901(b); 21 U.S.C. §387a(b). 15 21 C.F.R. §1100. Congressional Research Service 3 link to page 9 FDA Regulation of Tobacco Products User Fees User Fees

Pursuant to its authorities in the FFDCA, FDA is required to assess and collect user fees from domestic manufacturers and importers of tobacco products and use the funds to support CTP's ’s activities.¹⁸16 Similar to FDA'’s other user fee programs, the agency assesses and collects fees from industry sponsors of certain FDA-regulated products—in this case, tobacco manufacturers and importers—and uses those funds to support statutorily defined activities.¹⁹17 However, in contrast to other FDA centers that are generallygeneral y funded by a combination of discretionary appropriations from the General Fund and user fees, CTP is funded solely by user fees. The tobacco product fee authorities are also indefinite. Thus, unlike medical product fees that are authorized in legislation on a five-year cycle, tobacco product fees do not require reauthorization. As with other FDA user fees, the tobacco fees are only available pursuant to an annual appropriation from Congress, which provides FDA the authority to collect and spend fees.²⁰

18 Tobacco user fees are assessed and collected quarterly, and the total user fee amount that can be authorized and collected each year is specified in statute.²¹19 For fiscal year (FY) 2019 and subsequent fiscal years, this amount is $712 millionmil ion. The total user fee amount is assessed among six tobacco product classes specified in statute: (1) cigarettes, (2) cigars (including small smal cigars and cigars other than small smal cigars), (3) snuff, (4) chewing tobacco, (5) pipe tobacco, and (6) roll- your-own tobacco (seesee Table 1 for FY2021for FY2020 data).²²

data).20 The FFDCA requires that FDA use the Fair and Equitable Tobacco Reform Act of 2004 (FETRA)—enacted as Title VI of the American Jobs Creation Act of 2004 (P.L. 108-357)—)—framework to assess user fees on six classes of tobacco products,²³21 and these are the same six classes that are specified in the FETRA provisions.²⁴22 The FETRA provisions specify a two-step formula.²⁵23 The first step determines the allocationsal ocations for each of the six tobacco product classes, and the second step determines the individual domestic manufacturer and importer allocations al ocations within each respective tobacco product class. Because FETRA did not account for the differential taxing of cigars compared to the other tobacco product classes, the FFDCA specifies how user fees will fees wil be assessed for cigars.²⁶

24 FDA has determined that it currently does not have the authority to assess user fees on ENDS manufacturers and importers, or manufacturers or importers of certain other newly deemed tobacco products (e.g., hookah tobacco).²⁷25 This determination was made by FDA because 16 FFDCA §919; 21 U.S.C. §387s. 17 For more information, see CRS Report R44576, The Food and Drug Administration (FDA) Budget: Fact Sheet. 18 FFDCA §919(c); 21 U.S.C. §387s(c). 19 FFDCA §919(b)(1); 21 U.S.C. §387s(b)(1). 20 FFDCA §919(b)(2)(B(i); 21 U.S.C. §387s(b)(2)(B)(i). 21 FFDCA §919(b)(2)(B)(ii) & §919(b)(4); 21 U.S.C. §387s(b)(2)(B)(ii) & §387s(b)(4). 22 §625(c)(1) of P.L. 108-357; 7 U.S.C. §518d(c)(1). 23 USDA, “Determination of the Administrator of the Farm Service Agency and Executive Vice President of the Commodity Credit Corporation Regarding the Current “ Step A” and “ Step B” Assessment Methods in the T obacco T ransition Payment Program,” https://www.fsa.usda.gov/Internet/FSA_File/tobacco_determ_11162011.pdf. 24 FFDCA §919(b)(5); 21 U.S.C. §387s(b)(5). 25 FDA, “Requirements for the Submission of Data Needed T o Calculate User Fees for Domestic Manufacturers and Importers of Cigars and Pipe T obacco,” 81 Federal Register 28709, May 10, 2016. Congressional Research Service 4 link to page 9 FDA Regulation of Tobacco Products This determination was made by FDA because Congress did not specify enumerated classes for these products and did not provide a framework by which FDA could potentially potential y assess user fees for such products.²⁸

Establishment Registration and Product Listing

Owners and operators of domestic tobacco product manufacturers are required to immediately register with FDA upon beginning operations and to subsequently register their establishments by the end of each year.²⁹27 FDA is required to make this registration information public.³⁰28 As part of the registration requirements, domestic tobacco product manufacturers must also submit product listing information, which includes a list of all al tobacco products manufactured for commercial distribution.³¹29 The listing for each tobacco product must be clearly identified by the product category (e.g., smokeless tobacco) and unique name (i.e., brand/sub-brand). If the listed tobacco products differ in any way, such as a difference in a component or part, manufacturers are encouraged to list each tobacco product separately.³²30 In addition, the listing must include a 26 FDA, “Requirements for the Submission of Data Needed to Calculate User Fees for Domestic Manufacturers and Importers of Cigars and Pipe T obacco,” 81 Federal Register 28707, May 10, 2016. 27 FFDCA §905(b)-(c); 21 U.S.C. §387e(b)-(c). 28 FFDCA §905(f); 21 U.S.C. §387e(f). 29 Foreign manufacturers are not required to register until FDA issues regulations establishing requirements for such manufacturers, per FDA, Guidance for Industry: Registration and Product Listing for Owners and Operators of Dom estic Tobacco Product Establishm ents, December 2017, https://www.fda.gov/downloads/tobaccoproducts/labeling/rulesregulationsguidance/ucm191940.pdf. 30 FDA, Guidance for Industry: Registration and Product Listing for Owners an d Operators of Domestic Tobacco Product Establishm ents, December 2017, https://www.fda.gov/downloads/tobaccoproducts/labeling/ Congressional Research Service 5 FDA Regulation of Tobacco Products In addition, the listing must include a reference for the authority to market the tobacco product, and it must provide all al consumer information for each tobacco product, such as labeling and a "“representative sampling of advertisements."³³”31 However, given the potential administrative burden on the registrant, FDA specifies in a guidance document that labeling for each individually individual y listed tobacco product is not necessary if information that represents the labeling for a selected set of related products is provided.³⁴32 Registrants are encouraged to submit their materials online using FDA'’s Unified Registration and Listing System (FURLS) Tobacco Registration and Product Listing Module (TRLM).³⁵

33 Tobacco Product Manufacturer Inspections

Every tobacco product manufacturer that registers with FDA is subject to biennial inspections. This inspection requirement starts on the date the establishment registers, and FDA must conduct an inspection at least once in every successive two-year period thereafter.³⁶

34 The goal of such inspections is to review processes and procedures, observe and evaluate operations, document and collect information, identify any violations, communicate those violations to the manufacturer, and document any proposed corrective action plans.³⁷35 FDA personnel—upon presenting appropriate credentials and a written notice to the owner, operator, or agent in charge—are authorized to enter the tobacco product manufacturer to inspect the factory and all al pertinent equipment and materials "“at reasonable times and within reasonable limits and in a reasonable manner."³⁸”36 Upon completing the inspection and prior to leaving the premises, FDA is required to produce a written report describing any observed conditions or practices indicating that any tobacco product has been prepared in a way that is injurious to health.³⁹

37 Good Manufacturing Practices (GMPs)

FDA is required to promulgate regulations that outline good manufacturing practices (GMPs) to ensure that "“the public health is protected and that the tobacco product is in compliance"” with chapter IX of the FFDCA.⁴⁰ Specifically38 Specifical y, statute specifies that the regulations should include the methods, facilities, and controls involved in the manufacture, packing, and storage of a tobacco product.⁴¹ product.39 Prior to promulgating the regulations, TPSAC and the public (through an oral hearing) have an opportunity to recommend modifications to the proposed regulations. In addition, the regulations are required to take into account different types of tobacco products, the financial resources of different tobacco manufacturers, and reasonable time for manufacturers to comply with GMPs.⁴² rulesregulationsguidance/ucm191940.pdf. 31 FFDCA §905(i)(1)(B); 21 U.S.C. §387e(i)(1)(B). 32 FDA, Guidance for Industry: Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishm ents, December 2017, https://www.fda.gov/downloads/tobaccoproducts/labeling/rulesregulationsguidance/ucm191940.pdf. 33 FDA, Tobacco Registration and Product Listing Module (TRLM) User Guide, https://www.fda.gov/downloads/T obaccoProducts/Labeling/RulesRegulationsGuidance/UCM456130.pdf. 34 FFDCA §905(g); 21 U.S.C. §387e(g). 35 FDA, 2017, Compliance Training for Small Tobacco Product Manufacturers – Domestic Establishment Inspections, https://www.fda.gov/media/83422/download. 36 FFDCA §704(a)(1); 21 U.S.C. §374(a)(1). 37 FFDCA §704(b); 21 U.S.C. §374(b). 38 FFDCA §906(e)(1)(A); 21 U.S.C. §387f(e)(1)(A). 39 FFDCA §906(e)(1)(A); 21 U.S.C. §387f(e)(1)(A). Congressional Research Service 6 FDA Regulation of Tobacco Products with GMPs.40 A manufacturer may petition to be exempt from such requirements and receive approval from FDA if the agency determines that compliance with GMPs is not required to ensure that the tobacco product would be in compliance with chapter IX of the FFDCA.⁴³

41 To date, FDA has not promulgated GMP regulations. In 2012, 13 tobacco companies submitted recommendations to be included in the GMP regulations and subsequently met with FDA to review their recommendations and approach to developing them.⁴⁴42 FDA then established a public docket for additional comments on the tobacco companies'’ recommendations in 2013.⁴⁵43 However, FDA did not take further action specific to promulgating GMP regulations after these actions. FDA' FDA’s 2016 deeming rule stated that "FDA will “FDA wil have the authority to issue tobacco product manufacturing practice regulations under section 906(e)"” of the FFDCA for ENDS and other newly deemed products.⁴⁶44 Following the issuance of this rule, numerous ENDS industry stakeholders submitted recommendations to FDA highlighting differences between GMP regulations for ENDS products and other tobacco products (cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco).⁴⁷45 FDA then opened a public docket in November 2017 to allowal ow for comment on these proposed ENDS GMPs,⁴⁸46 but the agency has not taken further action since then.

The Spring 2021 White House Office of Management and Budget (OMB) Unified Agenda indicates that a proposed rule wil be issued in October 2021.47 Premarket Review Pathways

There are four different premarket review pathways for tobacco products: (1) premarket tobacco application (PMTA), (2) substantial equivalence (SE), (3) substantial equivalence (SE) exemptionexemption from substantial equivalence (EX REQ), and (4) modified risk tobacco product (MRTP). To legallylegal y market a new tobacco product,⁴⁹ product,48 a manufacturer must receive a PMTA marketing authorization order, unless. A PMTA is not necessary if FDA determines that the new tobacco product is substantiallysubstantial y equivalent to a predicate tobacco product —a product that was commercial y marketed as of February 15, 2007, 40 Small tobacco product manufacturers would not be required to comply with a regulation until four years after it is promulgated, per FFDCA §906(e)(1)(B)(v); 21 U.S.C. §387f(e)(1)(B)(v). 41 FFDCA §906(e)(2); 21 U.S.C. §387f(e)(2). 42 FDA, “T obacco Product Manufacturing Practice; Establishment of a Public Docket,” 78 Federal Register 16824, March 19, 2013. 43 FDA, “T obacco Product Manufacturing Practice; Establishment of a Public Docket,” 78 Federal Register 16824, March 19, 2013. 44 FDA, “Deeming T obacco Product s T o Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and T obacco Control Act; Restrictions on the Sale and Distribution of T obacco Products and Required Warning Statements for T obacco Products,” 81 Federal Register 28980, May 10, 2016. 45 RAI Services Company, “Proposed Good Manufacturing Practices Regulation T o Account for FDA’s Deeming Regulation” (Docket No. FDA-2013-N-022), June 7, 2017, https://www.fda.gov/files/tobacco%20products/published/Proposed-Good-Manufacturing-Practices-Regulation-to-Account-for-FDA%27s-Deeming-Regulation-%28Docket-No.-FDA-2013-N-022%29.pdf. 46 FDA, “T obacco Product Manufacturing Practice; Request for Comments,” 82 Federal Register 55613, November 22, 2017. 47 OMB, “Agency Rule List – Spring 2021: Department of Health and Human Services, Requirements for T obacco Product Manufacturing Practice,” https://www.reginfo.gov/public/do/eAgendaViewRule?p ubI d=202104&RIN=0910-AH91. 48 FFDCA §910(a)(1) [21 U.S.C. §387j(a)(1)] defines a new tobacco product as any tobacco product (including those products in test markets) that was not commercially marketed in the United States as of February 15, 2007, or any modification (including a change in design, any component, any part, or any constituent, including a smoke constituent, or in the content, delivery or form of nicotine, or any other additive or ingredient) of a tobacco product where the modified product was commercially marketed in the United States after February 15, 2007. Congressional Research Service 7 FDA Regulation of Tobacco Products or if it has previously been determined as substantial y equivalent to another predicate tobacco product—or is exempt from substantial equivalence.49 To legal yor is exempt from substantial equivalence.⁵⁰ To legally market a new tobacco product with reduced risk claims or modify a legallylegal y marked tobacco product to make reduced risk claims, a manufacturer must receive an MRTP order.

All Al tobacco products originallyoriginal y covered by the TCA are required to undergo premarket review, unless they are "“grandfathered products."⁵¹”50 Following the 2016 deeming rule, all al newly deemed tobacco products became subject to premarket review requirements as wellwel . In July 2017, FDA announced its Comprehensive Plan for Tobacco and Nicotine Regulation (Comprehensive Plan). As As part of its Comprehensive Plan, FDA issued guidance that pushed back premarket review application deadlines to August 2021 for newly deemed combustible tobacco products (e.g., cigars) and August 2022 for newly deemed noncombustible tobacco products (e.g., ENDS) on the market as of August 8, 2016.⁵²51 This administrative action was subject to legal challengechal enge, after several public health groups (e.g., AmericanAmerican Academy of Pediatrics, Campaign for Tobacco-Free Kids) filed a lawsuit against FDA.⁵³.52 In May 2019, the U.S. District Court for Maryland ruled in favor of the public health organizations,⁵⁴53 and in July 2019, imposed a 10-month deadline for application submissions for all al newly deemed tobacco products (i.e., May 2020) and a one-year deadline for reviewing the applications (i.e., May 2021).54 On April 22, 2020, the court extended the premarket application deadline by 120 days to September 9, 2020, due to the Coronavirus Disease 2019 (COVID-19) pandemic.55 FDA stated that it may continue to exercise enforcement discretion for manufacturers that submitted applications by the aforementioned date. In other words, barring a negative action on an application, FDA may effectively al ow such products to be marketed for up to a year from the deadline (i.e., September 9, 2021) while applications are being reviewed.56 As of mid-January 2021, FDA reported that it had processed SE requests for 6,800 products from 100 companies, EX REQ for 350 products from 15 companies, and PMTA applications for 4.8 mil ion products from over 230 companies.57 As of June 2021, Acting FDA Commissioner Janet Woodcock testified that the agency has completed initial processing of PMTA applications for 6.5 mil ion products submitted by over 550 companies. The vast majority of these submissions are for ENDS products.58 49 FFDCA §910(a)(2); 21 U.S.C. §387j(a)(2). 50 Products that do not meet the statutory definition of a new tobacco product are referred to as “grandfathered products” and do not require premarket review to be legally marketed. “Grandfathered products” have been commercially marketed in the United States as of February 15, 2007. 51 FDA, Guidance for Industry: Extension of Certain Tobacco Product Compliance Deadlines Related to the Final Deem ing Rule, Sixth Revision, November 2018, https://www.fda.gov/downloads/T obaccoProducts/Labeling/RulesRegulationsGuidance/UCM557716.pdf. 52Am. Acad. of Pediatrics v. FDA, 2019 U.S. Dist. LEXIS 81652 (D. Md., Mar. 26, 2019) (No. 8:18 -cv-00883-PWG). 53 Am. Acad. of Pediatrics v. FDA, 379 F. Supp. 3d 461 (D. Md. 2019). 54 Am. Acad. of Pediatrics v. FDA, 2019 U.S. Dist. LEXIS 00883 (D. MD. July 12, 2019). 55 Am. Acad. of Pediatrics v. FDA, (D. Md. April 22, 2020) (No. 8:18–cv– 883-PWG). 56 FDA, “Coronavirus (COVID-19) Update: Court Grants FDA’s Request for Extension of Premarket Review Submission Deadline for Certain T obacco Products Because of Impacts from COVID-19,” press release, April 23, 2020, https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-court-grants-fdas-request -extension-premarket-review-submission-deadline. 57 FDA, Perspective: FDA’s Progress on Review of Tobacco Product Applications Submitted by the Sept. 9, 2020 Deadline, February 16, 2021, https://www.fda.gov/tobacco-products/ctp-newsroom/perspective-fdas-progress-review-tobacco-product -applications-submitted-sept-9-2020-deadline. 58 FDA, T estimony of Dr. Janet Woodcock, Acting Commissioner, An Epidemic Continues: Youth Vaping in America, before the U.S. Congress, House Committee on Oversight and Reform, Subcommittee on Economic and Consumer Congressional Research Service 8 FDA Regulation of Tobacco Products Since 2014, most new tobacco products have been legal y marketed through the SE pathway.59 deadline for reviewing the applications (i.e., May 2021).⁵⁵

As shown in Table 2, since 2014, most new tobacco products have been legally marketed through the SE pathway. However, only requirements for the SE exemption pathway have been promulgated in regulations.⁵⁶60 This has posed some challengeschal enges for manufacturers when preparing application submissions for the PMTA, SE, and MRTP pathways. In April 2019, FDA issued a proposed rule on the content and format of SE reports,⁵⁷61 with public comment open until June 2019. Also in June 2019, FDA finalized its guidance on PMTA submissions specific to ENDS.⁵⁸62 In September 2019, FDA issued a proposed rule on the content and format of PMTA applications, with public comment open until NovemberDecember 2019.63 On March 2020, FDA reopened the comment period on only the aspect of the proposed rule dealing with agency collection activity.64 On January 19, 2021, the PMTA and SE final rules were displayed in the Federal Register but did not publish.65 A White House memorandum circulated the next day (i.e., January 20, 2021) ordered the withdrawal of any rules that did not publish from the previous administration, including the PMTA and SE rules.66 The Spring 2021 White House OMB Unified Agenda indicates that such rules would be reissued in May 2021,67 but as of the date of this publication, this has not yet occurred. 2019.⁵⁹ As of February 2020, FDA has not publicly indicated a timeline for issuance of a final rule.

Premarket Tobacco Product Applications (PMTA) Pathway

A manufacturer must submit a PMTA and receive a PMTA marketing authorization order to legally legal y market a new tobacco product that is not substantiallysubstantial y equivalent to a predicate tobacco product or exempt from substantial equivalence. To receive a PMTA order, the application must demonstrate that the product is "“appropriate for the protection of public health."⁶⁰”68 This determination is made based on the risks and benefits to the whole population of users and nonusers of the product, while taking into account

Policy, 117th Cong., 1st sess., June 23, 2021, https://oversight.house.gov/sites/democrats.oversight.house.gov/files/Woodcock%20T estimony.pdf, (hereinafter, FDA, T est imony of Dr. Janet Woodcock, “ An Epidemic Continues: Youth Vaping in America”). 59 FDA, “Modified Risk T obacco Products,” last updated May 05, 2021, https://www.fda.gov/tobacco-products/market-and-distribute-tobacco-product/substantial-equivalence#submit . 60 21 C.F.R. §1107.1. 61 FDA, “Content and Format of Substantial Equivalence Reports; Food and Drug Administration Actions on Substantial Equivalence Reports,” 84 Federal Register 12740, April 2, 2019. 62 FDA, Guidance for Industry: Premarket Tobacco Product Applications for Electronic Nicotine Delivery Systems, June 2019, https://www.fda.gov/media/127853/download. 63 FDA, “Premarket T obacco Product Applications and Recordkeeping Requirements,” 84 Federal Register 50566, September 25, 2019. 64 FDA, “Premarket T obacco Product Applications and Recordkeeping Requirements; Reop ening of the Comment Period,” 85 Federal Register 13840-13841, 2020. 65 FDA, “Premarket T obacco Product Applications,” updated June 3, 2021, https://www.fda.gov/tobacco-products/market -and-distribute-tobacco-product/premarket-tobacco-product-applications. 66 Ronald A. Klain, “Regulatory Freeze Pending Review: Memorandum for the Heads of Executive Departments and Agencies,” Presidential Actions, January 20, 2021, https://www.whitehouse.gov/briefing-room/presidential-actions/2021/01/20/regulatory-freeze-pending-review/. 67 OMB, “Agency Rule List – Spring 2021: Department of Health and Human Services, Premarket Tobacco Product Applications and Recordkeeping Requirements,” https://www.reginfo.gov/public/do/eAgendaVie wRule?p ubI d=202104&RIN=0910-AH44, and OMB, “ Agency Rule List – Spring 2021: Depart ment of Health and Human Services, Format and Content of Reports Intended to Demonstrate Substantial Equivalence,” https://www.reginfo.gov/public/do/eAgendaViewRule?pubI d=202104&RIN=0910-AH89. 68 FFDCA §910(c)(4); 21 U.S.C. §387j(c)(4). Congressional Research Service 9 FDA Regulation of Tobacco Products the increased or decreased likelihood that existing users of tobacco products will stop using such products; and

the increased or decreased likelihood that those who do not use tobacco products will start using such products.⁶¹

69 PMTA applications must include, among other things, full reports of health risk investigations; 70 a full statement of what is in the product (e.g., components, additives); a full description of manufacturing and processing methods; compliance with tobacco product standards; samples and components of the product; and proposed labeling of the product.⁶² FDA has 180 days after receipt of the complete application to determine whether the product will 71 FDA may “Refuse to Accept” (RTA) a premarket application if it contains certain procedural errors such as a failure of the application to pertain to a tobacco product, the application not being in English, not otherwise being in an electronic format FDA can read, or not containing an environmental assessment or valid claim of categorical exclusion. Once FDA has accepted a completed application, FDA has 180 days to determine whether the product wil receive a PMTA order.72receive a PMTA order.⁶³ If marketing is authorized, FDA can require that the sale and distribution of the tobacco product is restricted.⁶⁴

73 FDA can deny a PMTA application for various reasons. These include if the agency determines that marketing the new tobacco product would not be appropriate for the protection of public health; the methods used for manufacturing, processing, or packing the tobacco product do not align with good manufacturing practices; the proposed labeling of the tobacco product is false or misleading; or the tobacco product does not conform with regulations specifying tobacco product standards.⁶⁵74 FDA can withdraw or temporarily suspend a PMTA order if the agency finds that the continued marketing of the tobacco product is no longer appropriate for the protection of public health; the PMTA application contained false material; the applicant does not maintain records or create reports about its tobacco product; the labeling of the tobacco product becomes false or misleading; or the tobacco product does not conform to a tobacco product standard without appropriate justification.⁶⁶75 To determine if there are grounds to withdraw or temporarily suspend a PMTA order, FDA can require by regulation, or on an application-by-application basis, that applicants establish and maintain records, and provide postmarket surveillancesurveil ance reports to FDA following PMTA marketing authorization.⁶⁷

76 69 FFDCA §910(c)(4); 21 U.S.C. §387j(c)(4). 70 FDA published draft guidance for tobacco product manufacturers on how to design tobacco product perception and intention (TPPI) st udies that may be submitted as part of a PMT A, SE, or MRT P application. A T PPI study assesses an individual tobacco user’s perception of, intent to use, and understanding of tobacco products. Ultimately, a T PPI study can help a product manufacturer demonst rate that a new tobacco product meets the applicable premarket authorization standard. For more information, see “T obacco Products: Principles for Designing and Conducting T obacco Product Perception and Intention Studies; Draft Guidance for Industry; Availability,” 85 Federal Register 68341-68342, October 28, 2020 and FDA, Tobacco Products: Principles for Designing and Conducting Tobacco Product Perception and Intention Studies: Guidance for Industry, October 2020, https://www.fda.gov/media/143322/download. 71 FFDCA §910(b)(1); 21 U.S.C. §387j(b)(1). See also FDA, Draft Guidance: Applications for Premarket Review of New Tobacco Products, September 2011, https://www.fda.gov/downloads/T obaccoProducts/Labeling/RulesRegulationsGuidance/UCM273425.pdf. 72 T he 180 day clock does not start until FDA receives the complete application. 73 FFDCA §910(c)(1)(B); 21 U.S.C. §387j(c)(1)(B). T hese restrictions are permissible to the extent that sale and distribution is restricted under a regulation promulgated as part of FFDCA §906(d) [21 U.S.C. §387f(d)]. 74 FFDCA §910(c)(2); 21 U.S.C. §387j(c)(2). 75 FFDCA §910(d)(1); 21 U.S.C. §387j(d)(1). 76 FFDCA §910(f)(1); 21 U.S.C. §387j(f)(1). Congressional Research Service 10 FDA Regulation of Tobacco Products Substantial Equivalence (SE) Pathway Substantial Equivalence (SE) Pathway

A new tobacco product is considered to be substantially equivalent to a predicate tobacco product if it has the same characteristics as the predicate tobacco product or if it has different characteristics that do not raise different questions of public health.⁶⁸77 A product may serve as a predicate tobacco product if it was commerciallycommercial y marketed as of February 15, 2007, or if it has previously been determined as substantiallysubstantial y equivalent to another predicate tobacco product. A tobacco product may not serve as a predicate product if it has been removed from the market or has been determined to be adulterated or misbranded.

If a new tobacco product is considered substantiallysubstantial y equivalent to the predicate tobacco product, the manufacturer is required to submit an SE report to FDA justifying a substantial equivalence claim at least 90 days prior to the introduction of the new tobacco product into the market.⁶⁹78 To accommodate manufacturers following enactment of the TCA, a new tobacco product that was introduced after February 15, 2007, but before March 22, 2011, could stay on the market while FDA reviewed the manufacturer'’s SE report, provided the report was submitted before March 23, 2011. However, if a manufacturer did not submit the SE report before March 23, 2011, or if the new tobacco product has been on the market since March 22, 2011, the product is not permitted to be marketed without an SE order from FDA, even if FDA takes longer than 90 days to approve and issue the order.⁷⁰

79 The contents of SE reports are not specified in statute or regulation,⁷¹80 but FDA has provided content recommendations for SE reports in guidance.⁷²81 Among other things, SE reports should include a summary, listing of design features, ingredients and materials, a description of the heating source and composition, and health information. Upon acceptance of the SE report application and FDA'’s evaluation that the predicate tobacco product selected is eligible, FDA evaluates the scientific data and information in the SE report. FDA will wil then issue a SE order letter or not substantiallysubstantial y equivalent order (NSE order) letter.⁷³

Substantial Equivalence (SE) Exemption Pathway

82 Exemption from Substantial Equivalence (EX REQ) Pathway A new tobacco product that has been modified from a legallylegal y marketed tobacco product by either adding or removing a tobacco additive, or by increasing or decreasing the quantity of an existing tobacco additive, may be exempt from demonstrating substantial equivalence.⁷⁴83 For such a product to be exempt, FDA must determine that (1) the modification would be considered minor, 77 Characteristics are defined as “materials, ingredients, design, composition, heating source, or other features of a tobacco product” in FFDCA §910(a)(3)(B) [21 U.S.C. §387j(a)(3)(B)]. 78 FFDCA §905(j); 21 U.S.C. §387e(j). 79 FDA, Guidance for Industry and FDA Staff: Section 905(j) Reports: Demonstrating Substantial Equivalence for Tobacco Products, January 2011, https://www.fda.gov/downloads/T obaccoProducts/Labeling/RulesRegulationsGuidance/UCM239021.pdf. 80 In April 2019, FDA issued a proposed rule on t he content and format of SE reports. FDA, “Content and Format of Substantial Equivalence Reports; Food and Drug Administration Actions on Substantial Equivalence Reports,” 84 Federal Register 12740, April 2, 2019. 81 FDA, Guidance for Industry and FDA Staff: Section 905(j) Reports: Demonstrating Substantial Equivalence for Tobacco Products, January 2011, https://www.fda.gov/downloads/T obaccoProduct s/Labeling/RulesRegulationsGuidance/UCM239021.pdf. 82 FDA, “Substantial Equivalence,” https://www.fda.gov/tobacco-products/market-and-distribute-tobacco-product/substantial-equivalence#submit . 83 FDA, “Exemption from Substantial Equivalence,” https://www.fda.gov/T obaccoProducts/Labeling/T obaccoProductReviewEvaluation/ExemptionfromSubstantialEquivalence/default.htm. Congressional Research Service 11 FDA Regulation of Tobacco Products product to be exempt, FDA must determine that (1) the modification would be considered minor, (2) an SE report that demonstrates substantial equivalence would not be necessary to ensure that marketing the tobacco product would be appropriate for protection of public health, and (3) an "“exemption is otherwise appropriate."⁷⁵”84 Before the product can be legallylegal y marketed, FDA must first grant the product an exemption from demonstrating substantial equivalence.⁷⁶85 Following this, a manufacturer must submit a SE exemption report detailing the minor modification and establishing that FDA has determined that the product is exempt from demonstrating substantial equivalence to a predicate product.⁷⁷

86 The content requirements for SE exemption reports are specified in regulation.⁷⁸87 Among other things, SE exemption reports must contain a detailed explanation of the purpose of the modification; a detailed description of the modification; a detailed explanation of why the modification is minor; a detailed explanation of why a SE report is not necessary; and a certification (i.e., signed statement by a responsible official of manufacturer) summarizing why the modification does not increase the tobacco product'’s appeal to or use by minors, toxicity, addictiveness, or abuse liability.

Modified Risk Tobacco Products (MRTP) Pathway

A modified risk tobacco product (MRTP) is defined as "“any tobacco product that is sold or distributed for use to reduce harm or the risk of tobacco-related disease associated with commerciallycommercial y marketed tobacco products."⁷⁹”88 For example, some ENDS manufacturers may decide to submit an ENDS product through the MRTP pathway if the application can justify that the product reduces the risk of tobacco-related disease compared with other tobacco products (e.g., cigarettes). However, an MRTP may not be introduced or delivered into interstate commerce until FDA has issued an MRTP order, regardless if it was already legally legal y on the market through another pathway (e.g., SE or SE exemption).⁸⁰89 Further, any manufacturer that has not received an MRTP order for its tobacco product may not market the product with a label, labeling, or advertising that implies the product has a reduced risk of harm or that uses the words "light," "mild," "low,"“light,” “mild,” “low,” or similar descriptions.⁸¹90 Smokeless tobacco products that use certain descriptors, such as "“does not produce smoke"” or "“smoke-free,"” are not automaticallyautomatical y considered MRTPs unless a manufacturer receives MRTP orders for those products.⁸²91 In addition, products that are intended to treat tobacco dependence are not considered MRTPs if they have been approved as a drug or device.⁸³

92 Manufacturers must include certain information in a MRTP application, including

a description of the proposed product and any proposed advertising and labeling;

84 FFDCA §905(j)(3); 21 U.S.C. §387e(j)(3). 85 21 C.F.R. §1107.1. 86 FFDCA §905(j)(1)(A)(ii); 21 U.S.C. §387e(j)(1)(A)(ii). See also FDA, “Exemption from Substantial Equivalence,” https://www.fda.gov/T obaccoProducts/Labeling/T obaccoProductReviewEvaluation/ExemptionfromSubstantialEquivalence/default.htm. 87 21 C.F.R. §1107.1. 88 FFDCA §911(b)(1); 21 U.S.C. §387k(b)(1). 89 FDA, Warning Letter, www.buyoneline-cigarettes.com, July 4, 2014, https://www.fda.gov/inspections-compliance-enforcement -and-criminal-investigations/warning-letters/wwwbuyonline-cigarettescom-04072014. 90 FFDCA §911(b)(2)(B); 21 U.S.C. §387k(b)(2)(B). 91 FFDCA §911(b)(2)(C); 21 U.S.C. §387k(b)(2)(C). 92 FFDCA §911(c); 21 U.S.C. §387k(c). Congressional Research Service 12 FDA Regulation of Tobacco Products the conditions for using the product; the conditions for using the product;

the formulation of the product;

sample product labels and labeling;

all all documents (including underlying scientific information) relating to research findings conducted, supported, or possessed by the tobacco product manufacturer relating to the effect of the product on tobacco-related diseases and health-related conditions, including information both favorable and unfavorable to the ability of the product to reduce risk or exposure and relating to human health;

data and information on how consumers actually use the tobacco product; and

such other information as the Secretary [FDA] may require.⁸⁴

93 FDA must refer all al complete MRTP applications to TPSAC given the health claims that need to be evaluated and verified in applications for these products. TPSAC then has 60 days to provide recommendations on the application to FDA. FDA can issue an MRTP order for a specified period of time (but not more than five years at one time⁸⁵time94) if, among other things, it determines that the tobacco product will wil significantly reduce harm and the risk of tobacco-related disease to individual individual tobacco users and benefit the health of the population as a whole by taking into account users and nonusers of tobacco products.⁸⁶95 To continue to market a MRTP after the order's ’s set term, a manufacturer would need to seek renewal of the MRTP order.

However, FDA may issue an order for certain tobacco products that may not meet the standard of significantly reducing harm to individual users and benefiting population health as a whole. This is possible if, among things, the manufacturer can demonstrate that the MRTP order for the tobacco product would be appropriate to promote public health; the label, labeling, and advertising for the tobacco product are limited to claims that the product presents less exposure to a substance; scientific evidence is not available and cannot be made available without conducting the long-term epidemiologic studies required to meet the MRTP standard; and the scientific evidence that is available demonstrates if future studies are conducted, they would likely demonstrate a measurable and substantial reduction in morbidity or mortality among users of the tobacco product.⁸⁷

96 MRTP Postmarket Requirements

To market a tobacco product that has received an MRTP order, the manufacturer must agree to certain postmarket surveillancesurveil ance and studies that examine consumer perception, behavior, and health pertaining to the product. Manufacturers required to conduct surveillancesurveil ance must submit the surveillancesurveil ance protocol to FDA within 30 days of receiving notice from FDA that such studies are required. Upon receipt of the protocol, FDA has 60 days to determine whether the protocol is sufficient to collect data that will allowwil al ow FDA to determine if the MRTP order is necessary to protect public health.

FDA can also require that labeling and advertising of the product enable the public to understand the significance of the presented information to the consumer'’s health. Further, FDA can impose conditions on the use of comparing claims between the tobacco product with an MRTP order and 93 FFDCA §911(d); 21 U.S.C. §387k(d). 94 FFDCA §911(g)(2)(C)(i); 21 U.S.C. §387k(g)(2)(C)(i). 95 FFDCA §911(g); 21 U.S.C. §387k(g). 96 FFDCA §911(g)(2); 21 U.S.C. §387k(g)(2). Congressional Research Service 13 FDA Regulation of Tobacco Products other tobacco products on the market, and require that the label of the product disclose substances in the tobacco product that could affect health.⁸⁸

97 FDA must withdraw the MRTP order, after the opportunity for an informal hearing, under specified circumstances. Examples of such circumstances include if new information becomes available available that no longer make an MRTP order permissible, if the product no longer reduces risk or exposure based on data from postmarket surveillancesurveil ance or studies, or if the applicant failed to conduct or submit postmarket surveillancesurveil ance or studies.98 or studies.⁸⁹

Cessation Products

FDA'”100 Cessation Products FDA’s Center for Drug Evaluation and Research (CDER) is generallygeneral y responsible for regulating over-the-counter and prescription drugs including tobacco-derived products that make health or cessation (i.e., quitting) claims, such as nicotine replacement therapies (NRTs).⁹²101 NRTs contain nicotine as an active ingredient. Two types of prescription NRT products (nasal spray and nicotine inhaler) and three types of over-the-counter (OTC) NRT products have been approved by FDA through CDER, and most of these products have been approved for over 20 years.⁹³102 The three types of OTC products include a nicotine gum, a transdermal nicotine patch, and a nicotine lozenge. Prescription medications that do not have nicotine as an active ingredient have also been approved by CDER for smoking cessation. These medications include Chantix (varenicline tartrate) and Zyban (buproprion hydrochloride).⁹⁴

In the future, ENDS manufacturers who make health or cessation claims for their products would likely 103 97 FFDCA §911(h); 21 U.S.C. §387k(h). 98 FFDCA §911(j); 21 U.S.C. §387k(j). 99 FDA, Draft Guidance for Industry and Investigators: Use of Investigational Tobacco Products, February 2019, https://www.fda.gov/media/94052/download. 100 FDA, Draft Guidance for Industry and Investigators: Use of Investigational Tobacco Products, February 2019. 101 Certain cessation products may be considered a combination product (composed of a drug and device). In such cases, the product is regulated based on the primary mode of action. For example, if a cessation product is a combination of a drug and a device, but its primary mode of action is dependent upon chemical action within the body or metabolizing within the body to achieve its intended effects, it would be considered a drug and regulated through CDER. For a general comparison of drug and device regulation, see CRS In Focus IF11083, Medical Product Regulation: Drugs, Biologics, and Devices, by Agata Dabrowska and Victoria R. Green. 102 FDA, “Advancing Medicinal Nicotine Replacement T herapies as New Drugs – A new step in FDA’s comprehensive approach to tobacco and nicotine,” https://www.fda.gov/news-events/fda-voices-perspectives-fda-leadership-and-experts/advancing-medicinal-nicotine-replacement-therapies-new-drugs-new-step-fdas-comprehensive-approach. 103 FDA, “Want to Quit Smoking? FDA-Approved Products Can Help,” https://www.fda.gov/consumers/consumer-updates/want -quit-smoking-fda-approved-products-can-help. Congressional Research Service 14 FDA Regulation of Tobacco Products In the future, ENDS manufacturers who make health or cessation claims for their products would likely need to receive approval for marketing from CDER (rather than marketing authorization need to receive approval for marketing from CDER (rather than marketing authorization from CTP).

from CTP). Tobacco Product Regulation: Tobacco-Specific Requirements

Requirements Tobacco product manufacturers, importers, distributors, and retailers are required to comply with certain tobacco-specific requirements as a result of the unique harms that tobacco products pose to human health. Each of these requirements is described below, and most requirements apply to all al tobacco products, with some specified exceptions.

Tobacco Product Standards

Prior to enactment of the TCA, Congress was concerned that the tobacco industry had the ability to design new tobacco products or modify existing ones that might appeal to children or increase exposure to harmful tobacco product constituents.⁹⁵104 The TCA gave FDA the authority to adopt tobacco product standards that it deems necessary to protect the public'’s health,⁹⁶105 but it explicitly prohibited FDA from creating a standard that bans cigarettes, smokeless tobacco products, cigars, pipe tobacco, or roll-your-own tobacco products.⁹⁷106 Congress could choose to amend this language at any time.

A new tobacco product standard can set certain manufacturing, packaging, and distribution and sale requirements for tobacco products. For example, FDA can set requirements for ingredients, additives, components, or parts allowedal owed in a tobacco product; testing of the tobacco product and test results demonstrating compliance with the standard; measurement of characteristics of the tobacco product; appropriate labeling of the tobacco product; and limited sale and distribution of the tobacco product.⁹⁸107 To adopt a tobacco product standard, FDA is required to consider scientific evidence on

the risks and benefits to the population as a whole, including users and nonusers of tobacco products, of the proposed standard; the increased or decreased likelihood that existing users of of tobacco products will stop using such products; and the the increased or decreased likelihood that those who do not use tobacco products will start using such products.⁹⁹

108 To propose a new tobacco product standard, FDA is required to publish a proposed rule in the Federal Register and allowal ow for a public comment period of no less than 60 days. If FDA determines that the tobacco product standard is appropriate for the protection of public health based on an evaluation of public comments, a report from TPSAC (if the standard was referred to them), and other evidence, the agency must promulgate a final regulation to establish the standard. This regulation cannot take effect until at least one year after its publication, unless FDA determines that "“an earlier effective date is necessary for the protection of public health."¹⁰⁰

FDA is required to periodically”109 104 U.S. Congress, House Committee on Energy and Commerce, Family Smoking Prevention and Tobacco Control Act, Part 1, Report to accompany H.R. 1256, 111th Cong., 1st sess., March 26, 2009, H.Rept. 111-58, p. 4. 105 FFDCA §907(a)(3); 21 U.S.C. §387g(a)(3). 106 FFDCA §907(d)(3); 21 U.S.C. §387g(d)(3). 107 FFDCA §907(a)(4); 21 U.S.C. §387g(a)(4). 108 FFDCA §907(a)(3)(B)(i); 21 U.S.C. §387g(a)(3)(B)(i). 109 FFDCA §907(d)(2); 21 U.S.C. §387g(d)(2). Congressional Research Service 15 FDA Regulation of Tobacco Products FDA is required to periodical y reevaluate tobacco product standards to determine if new data need to be reflected. In addition, a tobacco product standard may be amended or revoked either on the initiative of FDA or an interested party via petition (i.e., citizen petition). If FDA or a citizen petition callscal s for an amendment to or revocation of an existing tobacco product standard, a proposed rule would be issued in the Federal Register for public comment. As with a new tobacco product standard, FDA would make a determination regarding the existing standard based on review of the public comments, a TPSAC report (if relevant), and other evidence. For FDA to revoke a standard, the agency must find that the standard is "“no longer appropriate for the protection of public health."¹⁰¹

”110 Flavors

When enacting the TCA, Congress recognized that flavors, specificallyspecifical y, can make tobacco products more appealing to youth and expose tobacco users to additional carcinogens or other toxic constituents.¹⁰²111 Although FDA has the authority to establish new tobacco product standards (as previously described), Section 907 of the FFDCA establishes a tobacco product standard explicitly banning characterizing artificial or natural flavors (other than tobacco or menthol), herbs, or spices in any constituent, additive, and component or part of a cigarette.¹⁰³112 While tobacco and menthol flavors are not included in the prohibition on characterizing flavors in cigarettes, FDA may be able to establish a tobacco product standard addressing menthol in cigarettes.¹⁰⁴

cigarettes.113 Within one year of its establishment, TPSAC was required to submit a report and recommendations to the Secretary of HHS regarding the impact of menthol cigarette use on public health, specificallyspecifical y addressing use among youth and racial and ethnic minorities.¹⁰⁵114 In its final report released in July 2011, TPSAC concluded that "“removal of menthol cigarettes from the marketplace would benefit public health in the United States."¹⁰⁶”115 In July 2013, FDA released an advance notice of public rulemaking (ANPRM) on a tobacco product standard for menthol in cigarettes, seeking comments, data, research, and any other relevant information.¹⁰⁷116 A final regulation has not yet been promulgated; however, Former Commissioner Gottlieb expressed interest in accelerating the promulgation of this tobacco product standard.¹⁰⁸

117 FDA released an ANPRM in March 2018, "“Regulation of Flavors in Tobacco Products,"” that requested public comments, data, research results, and other information related to the role of flavors generallygeneral y in tobacco products, among other things.¹⁰⁹118 After one extension, the comment period closed in July 2018 and the agency had received over 500,000 comments. In January 2020, 110 FFDCA §907(c)(3); 21 U.S.C. §387g(c)(3). 111 U.S. Congress, House Committee on Energy and Commerce, Family Smoking Prevention and Tobacco Control Act, Part 1, Report to accompany H.R. 1256, 111th Cong., 1st sess., March 26, 2009, H.Rept. 111-58, p. 4. 112 FFDCA §907(a); 21 U.S.C. §387g(a). 113 FFDCA §907(a)(1)(A); 21 U.S.C. §387g(a)(1)(A). 114 FFDCA §907(e); 21 U.S.C. §387g(e). 115 T obacco Products Scientific Advisory Committee (T PSAC) and Center for T obacco Products (CT P), Public Health Im pact of Menthol Cigarettes, FDA, Silver Spring, MD, July 2011, p. 208. 116 FDA, “Menthol in Cigarettes, T obacco Products; Request for Comments,” 78 Federal Register 44485, July 24, 2013. 117 FDA Statement, “Statement from FDA Commissioner Scott Gottlieb, M.D., on proposed new steps to protect youth by preventing access to flavored tobacco products and banning menthol in cigarettes,” November 15, 2018, https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm625884.htm. 118 FDA, “Regulation of Flavors in T obacco Products,” 83 Federal Register 12299, March 21, 2018. Congressional Research Service 16 FDA Regulation of Tobacco Products period closed in July 2018 and the agency had received over 500,000 comments. In January 2020, FDA stated its intention to issue a proposed rule that would "“ban the use of characterizing flavors in cigars,"” but did not speak to characterizing flavors in other tobacco products.¹¹⁰

119 In April 2021, the agency released a statement outlining its intent to issue proposed product standards to ban menthol in cigarettes, and al characterizing flavors in cigars.120 The Spring 2021 White House OMB Unified Agenda indicates that FDA aims to release a proposed rule regarding cigars in August 2021, and a proposed rule regarding cigarettes in April 2022.121 Nicotine Nicotine

Nicotine is the naturallynatural y occurring drug in tobacco that can cause addiction to the product.¹¹¹122 The FFDCA allowsal ows FDA to address nicotine yields of a tobacco product through development of a tobacco product standard,¹¹²123 but it prohibits the agency from establishing a tobacco product standard that would require the reduction of nicotine yields to zero.¹¹³

124 A key feature of FDA'’s Comprehensive Plan is to implement regulatory policies on addiction, appeal, and cessation based on scientific evidence and public input. One stated goal was to lower nicotine in cigarettes to a minimally minimal y or non-addictive level to benefit the public'’s health. In March 2018, FDA released an ANPRM for development of a tobacco product standard that would set a maximum nicotine level for cigarettes.¹¹⁴125 The ANPRM seeks public comment on whether a tobacco product standard should apply to other combusted tobacco products (e.g., cigars, pipe tobacco); what a non-addictive level of nicotine would be; and other feasibility issues if such a tobacco product standard is implemented. The comment period closed in July 2018, after an extension, with nearly 8,000 comments received. As of February 2020, FDA has not taken further regulatory action.

Testing and Reporting of Ingredients

FDA has the authority to conduct or to require testing, reporting, or disclosure of tobacco product constituents, including smoke constituents.¹¹⁵126 Pursuant to FFDCA Section 915, FDA is required to promulgate regulations that require the testing and reporting of components or parts of a 119 FDA, Guidance for Industry: Enforcement Priorities for Electronic Nicotine Delivery Systems (ENDS) and Other Deem ed Products on the Market Without Prem arket Authorization , January 2020, p. 31, https://www.fda.gov/media/133880/download. 120 FDA, “FDA Commits to Evidence-Based Actions Aimed at Saving Lives and Preventing Future Generations of Smokers,” press release, April 29, 2021, https://www.fda.gov/news-events/press-announcements/fda-commits-evidence-based-actions-aimed-saving-lives-and-preventing-future-generations-smokers. 121 OMB, “Agency Rule List – Spring 2021: Department of Health and Human Services, T obacco Product Standar d for Characterizing Flavors in Cigars,” https://www.reginfo.gov/public/do/eAgendaViewRule?pubId=202104&RIN=0910-AI28 and OMB, “ Agency Rule List – Spring 2021: Department of Health and Human Services, T obacco Product Standard for Menthol in Cigarettes,” https://www.reginfo.gov/public/do/eAgendaViewRule?p ubI d=202104&RIN=0910-AI60. 122 National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health, Centers for Disease Control and Prevention, The Health Consequences of Sm oking – 50 Years of Progress, U.S. Department of Health and Human Services, Atlanta, GA, 2014, https://www.surgeongeneral.gov/library/reports/50-years-of-progress/full-report.pdf. 123 FFDCA §907(a)(4); 21 U.S.C. §387g(a)(4). 124 FFDCA §907(d)(3)(B); 21 U.S.C. §387g(d)(3)(B). 125 FDA, “T obacco Product Standard for Nicotine Level of Combusted Cigarettes,” 83 Federal Register 11818, March 16, 2018. 126 FFDCA §915(c); 21 U.S.C. §387o(c). Congressional Research Service 17 FDA Regulation of Tobacco Products to promulgate regulations that require the testing and reporting of components or parts of a tobacco product to protect the public health. Because FDA has not yet promulgated these testing and reporting regulations, tobacco product manufacturers are not currently subject to these requirements.¹¹⁶

requirements.127 As part of these regulations, once they are promulgated, FDA may require tobacco product manufacturers to disclose the results of the testing of tar (a chemical substance produced when tobacco is burned) and nicotine through labels, advertising, or other means to protect public health and not mislead consumers about harms associated with use of the tobacco product. Small Smal tobacco product manufacturers would be given additional time to comply, and FDA could additionally additional y delay compliance on a case-by-case basis for small smal tobacco product manufacturers.¹¹⁷

manufacturers.128 Health Information

Tobacco product manufacturers are required to submit specified health information to FDA. This health information includes a list of all al ingredients, such as substances, compounds, and additives that are added to the tobacco product by the manufacturer. Health information also includes "a “a listing of all al constituents, including smoke constituents as applicable, identified by the Secretary as harmful or potentiallypotential y harmful to health in each tobacco product."¹¹⁸”129 Manufacturers must provide this information within each brand of the tobacco product, and the quantity included in each brand (e.g., Marlboro) and sub-brand (e.g., Marlboro Gold).¹¹⁹130 FDA'’s compliance policy for ingredient listings, as specified in guidance, focuses on finished tobacco products (i.e., tobacco products packaged and ready for consumption), including cigarettes, cigarette tobacco, roll-your-own tobacco, smokeless tobacco, and newly deemed tobacco products (e.g., ENDS).¹²⁰131 Further, FDA is focusing on components or parts of finished tobacco products that are made or derived from tobacco or contain ingredients that are burned, aerosolized, or ingested while the tobacco product is being used. As an example, e-liquids of ENDS are currently subject to this ingredient listing requirement, while batteries of ENDS are not.

Harmful and Potentially Harmful Constituents

As interpreted by FDA in guidance, the phrase harmful and potentially harmful constituents (HPHCs) refers to any chemical or chemical compound in a tobacco product or in tobacco smoke that

that is, or potentially is, inhaled, ingested, or absorbed into the body, including as an aerosol (vapor) or any other emission; and

causes or has the potential to cause direct or indirect harm to users or non-users of tobacco products.¹²¹

132 127 FDA, “Deeming T obacco Products T o Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and T obacco Control Act; Restrictions on the Sale and Distribution of T obacco Products and Required Warning Statements for T obacco Products,” 81 Federal Register 28980, May 10, 2016. 128 FFDCA §915(d); 21 U.S.C. §387o(d). 129 FFDCA §904(a)(3); 21 U.S.C. §387d(a)(3). 130 FFDCA §904(a)(1); 21 U.S.C. §387d(a)(1). 131 FDA, Guidance for Industry: Listing of Ingredients in Tobacco Products, Revised November 2018, https://www.fda.gov/downloads/T obaccoProducts/Labeling/RulesRe gulationsGuidance/UCM527044.pdf. 132 FDA, Guidance for Industry and FDA Staff: Harmful and Potentially Harmful Constituents in Tobacco Products as Used in Section 904(e) of the Federal Food, Drug, and Cosm etic Act, Revised August 2016, https://www.fda.gov/ Congressional Research Service 18 FDA Regulation of Tobacco Products Examples of HPHCs include toxicants, carcinogens, and addictive chemicals and compounds. By 2012 (three years after enactment of the TCA), FDA was required to establish a list of HPHCs in each tobacco product and, as applicable, to identify HPHCs by brand and sub-brand of tobacco products.¹²²133 Based on TPSAC'’s recommendations and after receiving multiple rounds of public comment on these recommendations, FDA established a list of 93 HPHCs in tobacco products. This list specifies whether the HPHC is a carcinogen, respiratory toxicant, cardiovascular toxicant, reproductive or developmental toxicant, and/or addictive.¹²³

134 Using FDA'’s list, manufacturers are required to report HPHCs by brand and quantity of HPHCs in each brand and sub-brand.¹²⁴135 Given potential monetary and feasibility challengeschal enges that were associated with reporting all al 93 HPHCs on FDA'’s list, FDA released an accompanying 2012 draft guidance that provided an abbreviated list of HPHCs that manufacturers of cigarettes, smokeless tobacco, and roll-your-own tobacco would be required to report to FDA.¹²⁵136 FDA has not issued an update to the 2012 draft guidance. As a result, FDA does not intend to enforce this requirement for newly deemed tobacco products (e.g., ENDS) until after the publication date of the final guidance.¹²⁶ guidance.137 However, in August 2019, FDA announced that, for the first time, it is seeking public comment on 19 additional HPHCs that can be found in ENDS products.¹²⁷138 The public comment period closed in October 2019.¹²⁸

139 Health Documents

Tobacco product manufacturers are required to submit to FDA all al documents developed by the manufacturer or any other party on health, toxicological, behavioral, or physiologic effects of current or future tobacco products, including constituents, ingredients, components, and additives.¹²⁹140 FDA interprets these documents to include "cell“cel -based, tissue-based, animal, or human studies, computational toxicology models, information on addiction, intentions to use, cognition, emotion, motivation, and other behavioral effects at both the population-level (epidemiology) as well wel as the individual level (such as abuse liability)."¹³⁰

”141 downloads/T obaccoProducts/Labeling/RulesRegulationsGuidance/UCM241352.pdf. 133 FFDCA §904(a)(3); 21 U.S.C. §387d(a)(3). 134 FDA, “Harmful and Potentially Harmful Constituents in T obacco Products and T obacco Smoke; Established List,” 77 Federal Register 20034, April 3, 2012. 135 FFDCA §904(a)(3) [21 U.S.C. §387d(a)(3)]; FFDCA §915 [21 U.S.C. §387o]. 136 FDA, Draft Guidance: Reporting Harmful and Potentially Harmful Constituents in Tobacco Products and Tobacco Sm oke Under Section 904(a)(3) of the Federal Food, Drug, and Cosm etic Act, March 2012, https://www.fda.gov/downloads/T obaccoProducts/Labeling/RulesRegulationsGuidance/UCM297828.pdf. 137 FDA, Guidance for Industry: Extension of Certain Tobacco Product Compliance Deadlines Related to the Final Deem ing Rule, Revised March 2019, https://www.fda.gov/media/105346/download. 138 FDA In Brief, “FDA seeks comment on proposed additions to list of harmful and potentially harmful constituents found in tobacco products, including electronic nicotine delivery systems such as e-cigarettes and e-liquids,” August 2, 2019, https://www.fda.gov/news-events/fda-brief/fda-brief-fda-seeks-comment -proposed-additions-list-harmful-and-potentially-harmful-constituents?utm_campaign=080219_FIB_FDA%20seeks%20comment%20on%20proposed%20additions%20to%20tobacco%20constituents%20list&utm_medium=email&utm_source=Eloqua. 139 FDA, “Harmful and Potentially Harmful Constituents in T obacco Products; Established List; Proposed Additions; Request for Comments,” 84 Federal Register 38032, August 5, 2019. 140 FFDCA §904(a)(4); 21 U.S.C. §387d(a)(4). 141 FDA, Guidance for Industry: Health Document Submission Requirements for Tobacco Products, Revised October 2017, https://www.fda.gov/downloads/T obaccoProducts/Labeling/RulesRegulationsGuidance/UCM208916.pdf. Congressional Research Service 19 FDA Regulation of Tobacco Products Records and Reports on Tobacco Products Records and Reports on Tobacco Products

FDA has the authority to require, by regulation, tobacco product manufacturers and importers to establish and maintain records to ensure that tobacco products are not adulterated or misbranded and to otherwise protect public health.¹³¹142 Through such regulations, FDA can also require manufacturers and importers to report if a tobacco product may have caused or contributed to a "“serious unexpected adverse experience or any significant increase in the frequency of a serious, expected adverse product experience."¹³²”143 Required reports cannot be overly burdensome and cannot disclose the identity of a patient, except under certain circumstances.¹³³

144 FDA has not yet promulgated regulations specifying these requirements. However, FDA issued a proposed rule in April 2019 on the content of a SE report. The proposed rule would require applicants submitting an SE report and receiving an SE order to maintain all al records supporting the SE report for at least 4four years.¹³⁴145 FDA also issued a proposed rule in September 2019 for PMTAs that, among other things, would require manufacturers to "“keep records regarding the legal marketing of certain tobacco products without a PMTA."¹³⁵

”146 As mentioned, the Spring 2021 White House OMB Unified Agenda indicates that these final rules would be issued in May 2021,147 but as of the date of this publication, this has not yet occurred. Distribution and Promotion Requirements

Prior to 2009, restrictions on the distribution of tobacco products were largely enforced at the state level, and promotion of cigarettes and smokeless tobacco was largely overseen by the Federal Trade Commission (FTC).¹³⁶148 However, in 2009, the TCA explicitly gave FDA the authority to require, by regulation, restrictions on the sale and distribution of a tobacco product if such a regulation would be appropriate for the protection of public health.¹³⁷149 In addition, the FFDCA specifies that FDA can impose restrictions, by regulation, on the advertising and promotion of a tobacco product consistent with the First Amendment.¹³⁸

150 142 FFDCA §909(a); 21 U.S.C. §387i(a). 143 FFDCA §909(a)(1); 21 U.S.C. §387i(a)(1). 144 FFDCA §909(a)(3)&(6); 21 U.S.C. §387i(a)(3)&(6). 145 FDA, “Content and Format of Substantial Equivalence Reports; Food and Drug Administration Actions on Substantial Equivalence Reports,” 84 Federal Register 12740, April 2, 2019. 146 FDA, “Premarket T obacco Product Applications and Recordkeeping Requirements,” 84 Federal Register 50566, September 25, 2019. 147 OMB, “Agency Rule List – Spring 2021: Department of Health and Human Services, Premarket Tobacco Product Applications and Recordkeeping Requirements,” https://www.reginfo.gov/public/do/eAgendaViewRule?p ubI d=202104&RIN=0910-AH44, and OMB, “ Agency Rule List – Spring 2021: Department of Health and Human Services, Format and Content of Reports Intended to Demonstrate Substantial Equivalence,” https://www.reginfo.gov/public/do/eAgendaViewRule?pubI d=202104&RIN=0910-AH89. 148 T he Federal Cigarette Labeling and Advertising Act of 1965 (FCLAA; 15 U.S.C. §1331-1340) and the Comprehensive Smokeless T obacco Health Education Act of 1986 (CST HEA; 15 U.S.C. §4401 -4408) are overseen by the Federal T rade Commission (FT C). For more information on the FCLAA, see FT C, “Federal Cigarette Labeling and Advertising Act,” https://www.ftc.gov/enforcement/statutes/federal-cigarette-labeling-advertising-act. For more information on the CHST HEA, see https://www.ftc.gov/enforcement/statutes/comprehensive-smokeless-tobacco-health-education-act-1986. 149 FFDCA §906(d)(1); 21 U.S.C. §387f(d)(1). 150 FFDCA §906(d)(1); 21 U.S.C. §387f(d)(1). Congressional Research Service 20 FDA Regulation of Tobacco Products In addition to authorizing FDA to regulate the sale and distribution of tobacco products, the TCA also directed FDA to reissue its 1996 Tobacco Rule.¹³⁹151 Among other things, the 1996 Tobacco Rule imposed requirements on the sale, labeling, and advertising of cigarettes and smokeless tobacco.¹⁴⁰152 The TCA provided that the final rule must be identical to the 1996 rule, with specified exceptions. FDA reissued the 1996 rule in March 2010,¹⁴¹153 and the 2016 deeming rule extended the applicability of sale and distribution restrictions, as well wel as certain labeling and advertising requirements to newly deemed tobacco products (e.g., ENDS). In FY2020 appropriations, Congress amended the federal minimum age of tobacco product purchasing from 18 to 21.¹⁴²

154 Current law and regulations restricting the sale and distribution of tobacco products will wil be discussed first, followed by current law and regulations on the labeling and advertising of tobacco products.

products. Restrictions on Sales and Distribution of Tobacco Products

The FFDCA—pursuant to changes made by the Further Consolidated Appropriations Act, 2020 ( (P.L. 116-94)—prohibits retailers from sellingsel ing tobacco products to any person younger than 21 years of age¹⁴³age155 and limits FDA'’s ability to promulgate regulations that restrict the sale of tobacco products to those over 21 years of age.¹⁴⁴156 FDA has stated that this new age sales restriction is currently in effect.¹⁴⁵

157 Prior to this statutory change, the minimum age of sale of tobacco products under federal regulations was 18 years of age, and the FFDCA precluded FDA from promulgating regulations restricting the sale of tobacco products to those over 18. As such, current federal regulations, which were promulgated in 2016 prior to the enactment of P.L. 116-94, prohibit retailers from selling sel ing cigarettes, smokeless tobacco products, and newly deemed tobacco products to anyone younger than 18, and require retailers to verify the age of persons purchasing these products who are younger than 27.¹⁴⁶158 To conform these regulations to changes made by P.L. 116-94, FDA is required to update the regulations by June 20, 2020 to specify that retailers may not sell sel tobacco products to those under 21 years of age and that retailers are required to verify the age of individuals individuals attempting to purchase tobacco products who are younger than 30. The final rule is to take effect not later than September 20, 2020.¹⁴⁷

159 Although the Spring 2021 White House OMB 151 T CA §102(a). In 2000, the Supreme Court invalidated FDA’s 1996 tobacco rule. See FDA v. Brown & Williamson T obacco Corp., 529 U.S. 120 (2000). In this case, the Court concluded that under existing law, FDA lacked the authority to regulate tobacco products. Id. at 160. 152 FDA, “Cigarettes and Smokeless T obacco,” 61 Federal Register 44615, August 28, 1996. 153 FDA, “Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless T obacco T o Protect Children and Adolescents,” 75 Federal Register 13225, March 19, 2010. 154§603 of Division N of the Further Consolidated Appropriations Act, 2020 ( P.L. 116-94). 155 FFDCA §906(d)(5); 21 U.S.C. §387f(d)(5). 156 FFDCA §906(d)(3)(A)(ii); 21 U.S.C. §387f(d)(3)(A)(ii). 157 FDA, “Newly Signed Legislation Raises Federal Minimum Age of Sale of T obacco Products to 21,” January 15, 2020, https://www.fda.gov/tobacco-products/ctp-newsroom/newly-signed-legislation-raises-federal-minimum-age-sale-tobacco-products-21. 158 21 C.F.R. §1140.14. 159 Pursuant to §603(c) of Division N of the Further Consolidated Appropriations Act, 2020 ( P.L. 116-94), FDA is required to provide written notification to congressional committees of jurisdiction regarding the progress of promulgating the final rule not later than 90 days after enactment of P.L. 116-94. If the final rule has not been promulgated 180 days after enactment, FDA is required to provide a written notification and justification for the delay in rulemaking to the committees of jurisdiction. Congressional Research Service 21 FDA Regulation of Tobacco Products Unified Agenda indicated that this rule would be published in May 2021,160 as of the date of this publication, these rules have not been published. Regulations also specify that manufacturers, distributors, or retailers may not distribute free Regulations also specify that manufacturers, distributors, or retailers may not distribute free samples of cigarettes, smokeless tobacco products, and newly deemed tobacco products, with the exception of smokeless tobacco in qualified adult-only facilities.¹⁴⁸161 Vending machine sales of cigarettes, smokeless tobacco, and newly deemed tobacco products are prohibited, unless the vending machine is located in a qualified adult-only facility.¹⁴⁹162 Consistent with the limitations specified in statute, these regulations do not prohibit the sale of tobacco products in specific categories of retail outlets (e.g., pharmacies, specialty stores).¹⁵⁰

163 Synar Regulations

As mentioned, prior to the enactment of the TCA, restrictions on the sale and distribution of tobacco products were primarily enforced at the state level, and compliance with state laws prohibiting tobacco sales to minors varied.¹⁵¹164 Evidence emerged about health problems associated with tobacco use by youth and about the ease with which youth could purchase tobacco products through retail sources.¹⁵²165 In 1992, the Alcohol, Drug Abuse, and Mental Health Administration (ADAHMA) Reorganization Act (P.L. 102-321) was signed into law, and it included an amendment aimed at decreasing youth access to tobacco. More specificallyspecifical y, Section 1926 (known as the Synar amendment) of the ADAHMA Reorganization Act required that the Substance Abuse and Mental Health Services Administration (SAMHSA) make available the full Substance Abuse Prevention and Treatment Block Grant (SABG) award funding to states and U.S. territories only if they had laws in effect that prohibit the sale or distribution of tobacco products to individuals younger than 18 years old.¹⁵³166 The SABG is a block grant program that distributes funds to 60 eligible eligible states, U.S. territories, and freely associated states to plan, execute, and evaluate substance use prevention, treatment, and recovery support services for affected individuals, families, and communities.¹⁵⁴167 The SABG provides a consistent federal funding stream to states through formula grants, and it is one of SAMHSA'’s largest programs.¹⁵⁵

168 160 OMB, “Agency Rule List – Spring 2021: Department of Health and Human Services, Prohibition of Sale of T obacco Products to Persons Younger T han 21 Years of Age,” https://www.reginfo.gov/public/do/eAgendaViewRule?pubId=202104&RIN=0910-AI51. 161 21 C.F.R. §1140.16(d). Regarding free samples, unlike other restrictions in the deeming rule that were applied to newly deemed products made or derived from tobacco (“covered to bacco products”), the free sample ban applies to all tobacco products subject to FDA’s authority, including components or parts not made or derived from tobacco (e.g., atomizers in ENDS products). See FDA, Guidance for Industry: The Prohibition of Distribu ting Free Sam ples of Tobacco Products, October 2017, https://www.fda.gov/media/108259/download. 162 21 C.F.R. §1140.16(c). 163 FFDCA §906(d)(3)(A)(i); 21 U.S.C. §387f(d)(3)(A)(i). 164 T homas E Radecki and C Dianne Zdunich, “T obacco sales to minors in 97 US and Canadian communities,” Tobacco Control, vol. 2 (1993), pp. 300-305. 165 SAMHSA, “About the Synar Amendment and Program,” https://www.samhsa.gov/synar/about. 166 Public Health Service Act (PHSA) §1926 (42 U.S.C. §300x -26), as established by the Alcohol, Drug Abuse, and Mental Health Administration (ADAHMA) Reorganization Act ( P.L. 102-321). 167 SAMHSA, Justification of Estimates for Appropriations Committees for FY2020, p. 259, https://www.samhsa.gov/sites/default/files/about_us/budget/samhsa_fy_2020_cj_submission_031919_508_final.pdf . T he ADAMHA Reorganization Act (P.L. 102-321) split the original 1981 Alcohol, Drug, and Mental Health Services (ADMHS) block grant into the Mental Health Block Grant and the Substance Abuse Prevention and T reatment Block Grant (SABG). 168 SAMHSA, Justification of Estimates for Appropriations Committees for FY2020, p. 259, https://www.samhsa.gov/sites/default/files/about_us/budget/samhsa_fy_2020_cj_submission_031919_508_final.pdf ; SAMHSA, Operating Plan Congressional Research Service 22 FDA Regulation of Tobacco Products The Synar regulations were promulgated by SAMHSA in 1996 to provide further guidance to states on implementation of the Synar amendment.169 The regulation requires, among other things, that states enact and enforce laws that prohibit the sale or distribution of tobacco products to individuals younger than 18; conduct annual inspections of retailers that are representative of retail outlets accessible to minors; and submit an annual report to SAMHSA on enforcement and compliance actions in order to receive their full SABG funding.¹⁵⁶170 As the term tobacco product, is not defined in the regulation, SAMHSA has indicated that each state may decide which tobacco products should be included in tobacco retailer inspections, but encourages states to include tobacco products being used most often by youth.¹⁵⁷171 In FY2020 appropriations, Congress further amended the Synar amendment to require states, as a condition of receiving SABG funding, to conduct annual, random inspections of retail outlets to ensure that such outlets are not selling sel ing tobacco products to those under age 21 and comply with annual reporting requirements to SAMHSA SAMHSA on enforcement and compliance actions. SAMSHA will bewas required to update the Synar regulations by June 20, 2020 to account for these changes.¹⁵⁸

172 However, as of the date of this publication, the Synar regulations have not been updated to reflect the increased age stipulation. Tobacco Product Labeling and Advertisement Requirements

The Federal Cigarette Labeling and Advertising Act of 1965 (FCLAA)¹⁵⁹173 and the Comprehensive Smokeless Tobacco Health Education Act of 1986 (CSTHEA) include certain labeling requirements and advertising restrictions on cigarettes and smokeless tobacco, respectively.¹⁶⁰ FTC generally174 FTC general y oversees these two acts.¹⁶¹175 For example, one advertising restriction within these acts includes a ban on advertising cigarettes, little cigars, and smokeless tobacco products on radio, television, or other media subject to the jurisdiction of the Federal Communications Commission (FCC).¹⁶²

176 In addition, manufacturers, distributors, and retailers may not sell sel or distribute tobacco products with labels, labeling, or advertising that are not in compliance with the FFDCA and accompanying FDA regulations.¹⁶³177 Certain labeling and advertising requirements specific to cigarettes and smokeless tobacco include:

• the following: for FY2019, https://www.samhsa.gov/sites/default/files/samhsa_fy2019_operating_plan_508.pdf. 169 45 C.F.R §96.130. 170 SAMHSA, “T obacco Regulation for Substance Abuse Prevention and T reatment Block Grants,” 61 Federal Register 1492, January 19, 1996. 171 SAMHSA, “FFY 2014 Annual Synar Reports: T obacco Sales to Youth,” https://store.samhsa.gov/system/files/synar-15.pdf. 172 PHSA §1926(c)(2); 42 U.S.C. §300x-26(c)(2). 173 T he FCLAA was amended by the Public Health Cigarette Smoking Act of 1969. 174 T he FCLAA and the CHST HEA are overseen by the Federal T rade Commission (FT C). For more information on the FCLAA, see FT C, “Federal Cigarette Labeling and Advertising Act,” https://www.ftc.gov/enforcement/statutes/federal-cigarette-labeling-advertising-act. For more information on the CHST HEA, see https://www.ftc.gov/enforcement/statutes/comprehensive-smokeless-tobacco-health-education-act-1986. 175 T he FT C enforces unfair or deceptive marketing practices for tobacco products that may be in violation of Section 5 of the Federal T rade Commission Act (FT CA; 15 U.S.C. §41 -58). For more information on the FT CA, see FT C, “Federal T rade Commission Act,” https://www.ftc.gov/enforcement/statutes/federal-trade-commission-act. 176 15 U.S.C. §1335; 15 U.S.C. §4402(c). 177 FDA’s tobacco product regulations are included in 21 C.F.R. Part 1140. Congressional Research Service 23 link to page 28 link to page 29 link to page 29 FDA Regulation of Tobacco Products  Manufacturers, distributors, and retailers may not sponsor any athletic, musical, Manufacturers, distributors, and retailers may not sponsor any athletic, musical, or other social or cultural event with the brand name of a cigarette or smokeless tobacco product.¹⁶⁴
• 178  Manufacturers and distributors of imported cigarettes and smokeless tobacco may not market, license, distribute, or sell sel any product that bears the brand name, logo, or any other identifying patterns associated with the brand name.¹⁶⁵
• 179  Labeling and advertising in audio and video formats are limited. For example, audio formats cannot include music or sound effects.¹⁶⁶

180 Tobacco product package labeling and advertisements must also include warning statements. Table 3 2 lists the different health warning statements required to be displayed on tobacco product package labeling and in tobacco product advertisements, by product. For example, all ENDS al ENDS package labeling and advertising is required to include "“WARNING: This product contains nicotine. Nicotine is an addictive chemical."

Cigarette Graphic Warning Labels

The TCA required FDA to promulgate regulations requiring color graphics depicting the negative health consequences of cigarette smoking.¹⁶⁷181 In 2011, FDA published a final rule requiring graphic warning labels on cigarette packaging—in addition to nine new warning statements proposed in text—that would take effect 15 months after it was promulgated.¹⁶⁸182 The final rule was challenged chal enged in court, and in 2012, an appeals court vacated the rule on First Amendment grounds and remanded the issue to the agency. Ultimately, FDA did not seek further judicial review.¹⁶⁹

183 181 15 U.S.C. §1333(d), as amended by T CA §201(a). 182 FDA, “Required Warnings for Cigarette Packages and Advertisements,” 76 Federal Register 36628, June 22, 2011. 183 FDA, “Cigarette Graphic Health Warnings,” updated January 30, 2020, https://www.fda.gov/tobacco-products/ Congressional Research Service 25 FDA Regulation of Tobacco Products FDA planned to develop and propose a new graphic warning rule and has continued to conduct research for this rule since 2013.¹⁷⁰184 In 2016, multiple health organizations filed a suit against FDA to compel the agency to promulgate a final rule more quickly.¹⁷¹185 In March 2019, FDA was ordered to issue a proposed rule by mid-August 2019 and a final rule by mid-March 2020.¹⁷²186 The proposed rule, issued onin August 16, 2019, specifies requirements for new cigarette health warnings.¹⁷³ Among other things, the warnings would occupy the top 50% of the front and rear panels of cigarette packages, and at least 20% of the top area of cigarette advertisements. However, it is to be determined whether this proposed rule will be subject to further litigation.

187 In March 2020, FDA published the final rule establishing new cigarette health warnings for cigarette packages and advertisements.188 Among other things, the rule specifies that 11 new textual warning statements and accompanying color graphics are to be placed on cigarette packages and advertisements. The rule further requires tobacco product manufacturers, distributors, or retailers to submit for FDA approval a plan for the random and equal display and distribution of the required warnings on packages, as wel as a quarterly rotation of those warnings in advertisements. FDA issued guidance regarding the submission of these plans in May 2020.189 This final rule was chal enged by manufacturers, distributers, and retailers. While litigation is currently pending, the effective date of the final rule has been postponed from June 18, 2021 to July 13, 2022.190 Compliance and Enforcement Compliance and Enforcement

If FDA finds that a retailer, manufacturer, importer, or distributor is not complying with FFDCA chapter IX requirements or FDA regulations, the agency can take corrective action. Such corrective actions include warning letters, civil money penalty (CMP) complaints, and no- tobacco-sale order (NTSO) complaints, as well wel as seizures, injunctions, and criminal prosecution (with the Department of Justice).¹⁷⁴

191 Adulterated and Misbranded Tobacco Products

The FFDCA prohibits the adulteration and misbranding of tobacco products, as well wel as the introduction, receipt, and delivery of adulterated or misbranded tobacco products into interstate commerce.¹⁷⁵

Adulterated Tobacco Products

In general, a tobacco product is deemed adulterated if

• it is contaminated by any substance that may render the product injurious to health;
• it has been prepared in unsanitary conditions that may have contaminated the product;
• commerce.192 labeling-and-warning-statements-tobacco-products/cigarette-graphic-health-warnings. 184 FDA, “Cigarette Graphic Health Warnings,” updated January 30, 2020, https://www.fda.gov/tobacco-products/labeling-and-warning-statements-tobacco-products/cigarette-graphic-health-warnings. 185 American Academy of Pediatrics v. U.S. Food & Drug Admin , 330 F. Supp. 3d 657 (D. Mass. 2018); https://www.tobaccofreekids.org/assets/content/press_office/2016/2016_10_04_fda_complaint.pdf. 186 American Academy of Pediatrics v. U.S. Food & Drug Admin , 2019 U.S. Dist. LEXIS 34946 (D. Mass. 2019); https://www.tobaccocontrollaws.org/litigation/decisions/us-20190305-american-academy-of-pediatrics. 187 FDA, “T obacco Products; Required Warnings for Cigarette Packages and Advertisements,” 84 Federal Register 42754, August 16, 2019. 188 FDA, “T obacco Products; Required Warnings for Cigarette Packages and Advertisements,” 85 Federal Register 15638-15710, March 18, 2020. 189 FDA, Guidance for Industry: Submission of Plans for Cigarette Packages and Cigarette Advertisements (Revised), updated February 2021, https://www.fda.gov/media/133839/download. 190 For more information about the litigation and new requirements, see FDA, “Cigarette Labeling and Health Warning Requirements,” updated June 4, 2021, https://www.fda.gov/tobacco-products/labeling-and-warning-statements-tobacco-products/cigarette-labeling-and-health-warning-requirements. 191 For more general information about enforcement of the FFDCA, see CRS Report R43609, Enforcement of the Food, Drug, and Cosm etic Act: Select Legal Issues. 192 FFDCA §301(a)-(c); 21 U.S.C. §331(a)-(c). Congressional Research Service 26 FDA Regulation of Tobacco Products Adulterated Tobacco Products In general, a tobacco product is deemed adulterated if  it is contaminated by any substance that may render the product injurious to health;  it has been prepared in unsanitary conditions that may have contaminated the product;  its packaging is composed of any substance that could be harmful to health; its packaging is composed of any substance that could be harmful to health; and/or
• and/or  if a manufacturer does not comply with user fee, tobacco product standard, premarket review, and/or GMP requirements (when promulgated).¹⁷⁶

193 Misbranded Tobacco Products

A tobacco product is deemed misbranded if

•  the labeling is false or misleading in any way;¹⁷⁷
• 194  its package labeling does not include specified manufacturing information, statements, or warnings required by regulation, or does not comply with an established tobacco product standard;¹⁷⁸
• 195  the labeling, packaging, and shipping containers of tobacco products do not contain the label " “sale only allowedal owed in the United States";¹⁷⁹
• ”;196  it was manufactured, prepared, propagated, compounded, or processed in a facility that was not registered with FDA;¹⁸⁰
• 197  its advertising is false or misleading in any way;¹⁸¹198 and/or
•  it is sold by a retailer to an individual under 21 years of ageage199 or is sold in violation of regulations promulgated on the sale and distribution of tobacco products.¹⁸²

200 FDA may, by regulation, require prior approval of statements made on labels of tobacco products to ensure that the tobacco product is not misbranded. However, such a regulation cannot require prior approval of an advertisement, except for MRTPs.¹⁸³201 To date, FDA has not issued such regulations.

regulations. 193 FFDCA §902; 21 U.S.C. §387b. 194 FFDCA §903(a)(1); 21 U.S.C. §387c(a)(1). 195 FFDCA §903(a)(2),(5), & (9); 21 U.S.C. §387c(a)(2),(5), & (9). 196 FFDCA §903(a)(2)(D); 21 U.S.C. §387c(a)(2)(D). 197 FFDCA §903(a)(6); 21 U.S.C. §387c(a)(6). 198 FFDCA §903(a)(7)(A) [21 U.S.C. §387c(a)(7)(A)]; 21 C.F.R. §1141.14. 199 As noted earlier in this report, FDA regulations do not currently reflect the new minimum age limit for tobacco retailers. FDA nonetheless is requiring tobacco retailers to continue ensuring that consumers meet the new age threshold. For more information, see FDA, “ T obacco 21,” updated February 2, 2021, https://www.fda.gov/tobacco-products/retail-sales-tobacco-products/tobacco-21. 200 FFDCA §903(a)(7)(B); 21 U.S.C. §387c(a)(7)(B). 201 FFDCA §903(b); 21 U.S.C. §387c(b). Congressional Research Service 27 FDA Regulation of Tobacco Products Tobacco Retailer Compliance Check Inspections Tobacco Retailer Compliance Check Inspections

FDA is required to contract with states and territories to carry out compliance check inspections of tobacco retailers.¹⁸⁴202 In some instances, FDA has awarded contracts to third-party entities that hire commissionable inspectors to conduct compliance check inspections of tobacco retailers in states and territories where FDA has not been able to contract with a state or territory agency. FDA personnel may also conduct their own investigations.¹⁸⁵

203 FDA ensures that tobacco retailers are in compliance with federal law and regulations through undercover buy inspections. During these inspections, the retailer is unaware an inspection is taking place. A trained minor, in consultation with a commissioned FDA inspector, attempts to purchase a tobacco product.¹⁸⁶204 If a first-time violation is reported (e.g., sale to a minor, illegal il egal advertising), a warning letter is sent to the tobacco retailer, and the addressee has 15 working days to respond to the letter, with no associated fines involved. When subsequent violations of tobacco regulations or requirements are detected during these undercover buy inspections, FDA files a CMP complaint. The associated fines vary based on the number of regulation violations and the time period in which the violations occurred.¹⁸⁷205 If retailers have repeated violations of the restrictions on the sale and distribution of tobacco products, FDA may seek a NTSO, which would prohibit sale of tobacco products at that retail outlet. A NTSO could be separate or combined with CMPs.¹⁸⁸206 According to FDA, as of June 2019February 28, 2021, the agency has "“conducted more than a million mil ion compliance check inspections and issued nearly 88over 98,000 Warning Letters, 22 25,000 [CMPs], and 160200 [NTSOs]."¹⁸⁹

”207 As mentioned, in FY2020 appropriations, Congress amended the federal minimum age of tobacco product purchasing from 18 to 21.¹⁹⁰208 FDA has stated that this new age sales restriction is currently in effect, but also recognizes that the agency and retailers will wil need to update current practices to account for these changes.¹⁹¹209 As such, FDA hashad stated that "“during this ramp-up period, FDA will wil continue to only use minors under the age of 18 in its compliance check program.”210 As of February 2021, FDA has started using individuals under the age of 21 to test nationwide retailer compliance.211 202 FFDCA §702(a)(1)(B)(i); 21 U.S.C. §372(a)(1)(B)(i). 203 FDA, “FDA T obacco Retail Inspection Contracts,” https://www.fda.gov/tobacco-products/retail-sales-tobacco-products/fda-tobacco-retail-inspection-contracts. 204 FDA, “Undercover Buy Inspections,” https://www.fda.gov/media/123583/download. 205 T CA §103(q)(2)(a). 206 FDA, Guidance for Tobacco Retailers: Determination of the Period Covered by a No -Tobacco-Sale-Order and Com pliance With an Order, August 2015, https://www.fda.gov/downloads/tobaccoproducts/labeling/rulesregulationsguidance/ucm460155.pdf. 207 FDA, “ FY 2022 Justification of Estimates for Appropriations Committees,” May 28, 2021, https://www.fda.gov/media/149616/download#page=284. 208 §603 of Division N of the Further Consolidated Appropriations Act, 2020 ( P.L. 116-94). 209 FDA, “Newly Signed Legislation Raises Federal Minimum Age of Sale of T obacco Products to 21,” January 15, 2020, https://www.fda.gov/tobacco-products/ctp-newsroom/newly-signed-legislation-raises-federal-minimum-age-sale-tobacco-products-21. 210 FDA, “Newly Signed Legislation Raises Federal Minimum Age of Sale of T obacco Pro ducts to 21,” January 15, 2020. 211 FDA, “T obacco 21,” updated February 2, 2021 at https://www.fda.gov/tobacco-products/retail-sales-tobacco-products/tobacco-21. Congressional Research Service 28 FDA Regulation of Tobacco Products Notification and Recall FDA has the authority to issue notifications and recal s of tobacco products once they are on the market.212 FDA can issue a notification through a public service announcement if the tobacco product “presents an unreasonable risk of substantial harm to the public health,”213 provided that FDA determines there are no other practical means to eliminate such risk. A tobacco product manufacturer can initiate or FDA can request a (voluntary) recal if the tobacco product is thought to be in violation of the FFDCA.214 In addition, FDA has the authority to mandate a tobacco product recal under specified circumstances. If FDA determines that a tobacco product contains a manufacturing or other defect that would “cause serious, adverse health consequences or death,” the agency can issue an order requiring the appropriate person (e.g., the manufacturer, retailer, importer, or distributor) to immediately stop distribution of the tobacco product.215 FDA is required to provide the person subject to the order an opportunity for an informal hearing not later than 10 days after the order is issued. Following the hearing, FDA is required to vacate the order if the agency determines that there is insufficient evidence to maintain the order. If after the informal hearing FDA determines that the order should be amended to include a recal of the tobacco product, FDA must amend the order to require such recal , specifying a timetable for and requiring periodic progress reports on the recal . 212 FFDCA §908(a); 21 U.S.C. §387h(a). 213 FFDCA §908(a)(1); 21 U.S.C. §387h(a)(1). 214 For more information on FDA’s general recall authority, see CRS Report R43609, Enforcement of the Food, Drug, and Cosm etic Act: Select Legal Issues. 215 FFDCA §908(c)(1); 21 U.S.C. §387h(c)(1). Congressional Research Service 29 FDA Regulation of Tobacco Products Appendix A. continue to only use minors under the age of 18 in its compliance check program."¹⁹²

Notification and Recall

FDA has the authority to issue notifications and recalls of tobacco products once they are on the market.¹⁹³ FDA can issue a notification through a public service announcement if the tobacco product "presents an unreasonable risk of substantial harm to the public health,"¹⁹⁴ provided that FDA determines there are no other practical means to eliminate such risk.

Issues for Congress and Policy Considerations

Although the TCA expanded FDA's authority to regulate tobacco products in 2009, stakeholders have recently identified several issues related to the regulation of these products that may be of interest to Congress:

ENDS: Harm Reduction Potential among Adults vs. Use among Youth, Including Flavored ENDS Use

Since the emergence of ENDS in the tobacco marketplace, there has been ongoing debate regarding their public health impact. The public health community generally views them as a harm reduction tool for adults who specifically smoke cigarettes. Harm reduction refers to the replacement of a more harmful activity with a less harmful one when elimination of the activity is difficult or infeasible. ENDS have the potential to reduce harm among adult cigarette smokers who have experienced difficulty quitting, as the aerosol from ENDS "contains fewer numbers and lower levels of most toxicants than does smoke from combustible tobacco cigarettes."¹⁹⁸

E-cigarette, or Vaping, Product Use-Associated Lung Injury (EVALI)

Tobacco to 21

Many public health stakeholders have been concerned about youth access to tobacco products more broadly and expressed support for raising the minimum age of purchasing tobacco products from 18 to 21. Numerous scientific studies and Surgeon General Reports have documented that tobacco product use often begins before the age of 18.²²⁵ Nearly 90% of cigarette smokers have tried their first cigarette by age 18, and 98% have tried their first cigarette by age 26.²²⁶

Remote Sales

Related to the issue of youth access to tobacco products—including ENDS—some have identified remote sales (i.e., non-face-to-face sales) as an opportunity for minors to illegally purchase tobacco products, due to difficulties in enforcing purchasing restrictions through this medium. While the Prevent All Cigarette Trafficking (PACT) Act of 2009 (P.L. 111-154) placed certain restrictions on remote sales of cigarettes and smokeless tobacco, it did not outright prohibit them. Further, the PACT Act limits the ability of states and local governments to regulate the delivery carriers involved in remote sales—complicating enforcement efforts—and did not place such restrictions on other tobacco products, such as ENDS.²³²

ENDS: User Fees

As mentioned, FDA does not collect user fees from ENDS manufacturers and importers. Given recent concerns around ENDS products, CTP has dedicated a portion of its user fees paid by other tobacco product manufacturers and importers to address ENDS-specific issues. Therefore, some stakeholders have suggested that manufacturers and importers of ENDS products be subject to tobacco user fees to offset costs associated with FDA's current and future ENDS-specific activities. However, FDA has determined that it currently does not have the authority to assess user fees from ENDS manufacturers and importers because Congress did not specify an enumerated class for ENDS products and did not provide a framework by which FDA could potentially assess user fees for ENDS products.²³⁶

Appendix A. The IQOS Tobacco Heating System

The IQOS Tobacco Heating System The IQOS Tobacco Heating System (IQOS) is commonly referred to as a "“heat-not-burn"” tobacco product. This new technology differs from ENDS technology because it aerosolizes the tobacco plant itself, rather than a tobacco-derived e-liquid. FDA has determined that the IQOS meets the definition of a cigarette and, as such, is subject to additional FFDCA requirements and regulations specific to cigarettes, such as advertising restrictions.

The IQOS is composed of three main components:

•  The IQOS Heatstick is a filtered, noncombusted cigarette. A Heatstick is designed to be electricallyelectrical y heated to release nicotine-containing aerosol. The nicotine is derived from a reconstituted tobacco sheet made from ground tobacco powder.
•  The IQOS Holder is an electricallyelectrical y powered and rechargeable unit that holds and warms the Heatstick. The Holder is used for a single Heatstick for about six to seven minutes, after which the Holder needs to be charged and the used Heatstick is discarded.
•  The IQOS Charger recharges and cleans the Holder after each use.

Figure A-1. The IQOS Tobacco Heating System

Source: FDA, "Decision Summary: Phillip Source: FDA, “Decision Summary: Phil ip Morris Products S.A. IQOS System Holder and Charger,"” April 2019, https://www.fda.gov/media/124247/download. 124247/download. Notes: From left to right, pictured is the IQOS Tobacco Heating System Charger, Holder, and Heatstick, respectively. respectively.

Given the novel technology of the IQOS, some industry stakeholders seesaw this product as a potential precedent for the premarket review process that ENDS products will eventually wil eventual y undergo. On May 15, 2017, FDA received PMTAs from PhillipPhil ip Morris International (PMI) for the IQOS Tobacco Heating System (IQOS). PMI filed four PMTA applications for the IQOS. Three PMTA applications were for the Heatstick—two of which were for menthol flavored heatsticks— and one PMTA application was for the Holder and Charger.

Nearly two years later, on April 30, 2019, FDA authorized the IQOS Tobacco Heating System for marketing through these PMTAs. Based on the substantial back and forth between PMI and FDA to elicit the information needed for the complete PMTA applications, there is concern that small some stakeholders raised concerns that smal ENDS manufacturers may not have the resources to engage in the PMTA process in the future. There is also concern thatprocess. In addition, there are concerns FDA may need additional resources to accommodate the inevitable influx of lengthy ENDS PMTA applications.

Appendix B. Congressional Research Service 30 FDA Regulation of Tobacco Products Appendix B. Tobacco Master Settlement Agreement of 1998216 of 1998²⁴³

On November 23, 1998, attorneys general from 46 states, the District of Columbia, and the U.S. territories signed a contractual agreement (the Master Settlement Agreement, or MSA) with the major cigarette companies to settle state lawsuits to recover the costs, borne by Medicaid and other public programs, of treating smoking-related illnesses.²⁴⁴il nesses.217 The remaining four states — —Mississippi, Florida, Texas, and Minnesota — —had settled individually individual y with the companies prior to the MSA. Under the terms of the MSA, the companies agreed to make annual payments in perpetuity and accept certain restrictions on tobacco product advertising, marketing, and promotion. SpecificallySpecifical y, the MSA:

•  prohibited cigarette companies from targeting youth in the advertising, promotion, or marketing of their products;
•  banned the use of cartoons in advertising;
•  limited each company to brand-name sponsorship of one sporting or cultural event a year, excluding concerts, team sports, events with a significant youth audience, or events with underage contestants;
•  banned public transit advertising;
•  banned outdoor billboardbil board advertising, excluding billboardbil board advertising for brand- name sponsored events;
•  limited advertising outside retail stores to signs no bigger than 14 sq. ft;
•  banned company payments to promote cigarettes in various media, including movies and TV;
•  banned non-cigarette apparel with brand-name logos except at brand-name sponsored events;
•  banned gifts of non-cigarette items to youth in exchange for cigarettes;
•  restricted the use of nationallynational y recognized non-tobacco brand names for cigarettes; and
•  limited free samples of cigarettes to adult-only facilities. 216 T his appendix summary was adapted from archived CRS Report R40475, FDA Tobacco Regulation: The Family Sm oking Prevention and Tobacco Control Act of 2009. 217 T he full text of the MSA is available on the website of the National Association of Attorneys General, which is responsible for enforcement, at http://www.naag.org/backpages/naag/tobacco/msa. Congressional Research Service 31 FDA Regulation of Tobacco Products Appendix C. limited free samples of cigarettes to adult-only facilities.

Appendix C. Definitions of Terms Used in This Report

Appendix D. Congressional Research Service 34 FDA Regulation of Tobacco Products Appendix D. Acronyms Used in This Report ANPRM Advance Notice of Public Rulemaking CDC Centers for Disease Acronyms Used in This Report

C. Stephen Redhead, Deputy Assistant Director, and Vanessa K. Burrows, a former CRS Legislative Attorney, wrote Appendix B of this report. The author also wishesauthors also wish to acknowledge Amber Wilhelm for her assistance in formatting Figure 1 of the report. Disclaimer This document was prepared by the Congressional Research Service (CRS). CRS serves as nonpartisan shared staff to congressional committees and Members of Congress. It operates solely at the behest of and under the direction of Congress. Information in a CRS Report should n ot be relied upon for purposes other than public understanding of information that has been provided by CRS to Members of Congress in connection with CRS’s institutional role. CRS Reports, as a work of the United States Government, are not subject to copyright protection in the United States. Any CRS Report may be reproduced and distributed in its entirety without permission from CRS. However, as a CRS Report may include copyrighted images or material from a third party, you may need to obtain the permission of the copyright holder if you wish to copy or otherwise use copyrighted material. Congressional Research Service R45867 · VERSION 11 · UPDATED 36 assistance in formatting Figure 1 of the report.