Introduction

Cigarette use remains the leading cause of preventable death in the United States, claiming an estimated 480,000 lives or more each year.¹ Further, between 2009 and 2012, cigarette smoking-attributable economic costs totaled over $289 billion in the United States.² Although cigarette use in the United States continues to decline,³ according to Centers for Disease Control and Prevention (CDC) analyses, 34.1 million American adults smoked cigarettes every day or some days in 2019,⁴ and nearly 910,000 American middle and high school students had smoked cigarettes within a 30-day period in 2020.⁵

Electronic nicotine delivery systems (ENDS) have become popular in recent years, particularly among youth. 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 aerosol (i.e., vapor).⁶ According to CDC analyses, 10.9 million American adults used e-cigarettes every day or some days in 2019.⁷ About 3.6 million 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 tobacco regulatory decisions or any other matter listed in chapter IX of the FFDCA. The TPSAC includes 12 members with diversified experience and expertise.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 generally required to meet a standard of safety and effectiveness to receive premarket approval from FDA, tobacco product manufacturers are instead generally 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. 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, and Appendix 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)."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.¹¹ 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."¹²

Upon enactment, the TCA explicitly covered the following tobacco products: cigarettes and cigarette tobacco, roll-your-own tobacco, and smokeless tobacco.¹³ 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.¹⁴ In 2016, 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, cigars, pipe tobacco, hookah tobacco, nicotine gels, dissolvable tobacco, and other tobacco products that may be developed in the future.¹⁵ Figure 1 shows each of the tobacco products currently under FDA's authority.

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

Source: Prepared by CRS with images of smokeless tobacco products, ENDS, cigars, nicotine gels, dissolvable tobacco, and pipe tobacco from FDA's website. Images of cigarettes, 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

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

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 activities.¹⁶ 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.¹⁷ However, in contrast to other FDA centers that are generally 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.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.¹⁹ For fiscal year (FY) 2019 and subsequent fiscal years, this amount is $712 million. The total user fee amount is assessed among six tobacco product classes specified in statute: (1) cigarettes, (2) cigars (including small cigars and cigars other than small cigars), (3) snuff, (4) chewing tobacco, (5) pipe tobacco, and (6) roll-your-own tobacco (see Table 1 for FY2021 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,²¹ and these are the same six classes that are specified in the FETRA provisions.²² The FETRA provisions specify a two-step formula.²³ The first step determines the allocations for each of the six tobacco product classes, and the second step determines the individual domestic manufacturer and importer allocations 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 be assessed for cigars.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).²⁵ 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 assess user fees for such products.²⁶

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.²⁷ FDA is required to make this registration information public.²⁸ As part of the registration requirements, domestic tobacco product manufacturers must also submit product listing information, which includes a list of all tobacco products manufactured for commercial distribution.²⁹ 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.³⁰ In addition, the listing must include a reference for the authority to market the tobacco product, and it must provide all consumer information for each tobacco product, such as labeling and a "representative sampling of advertisements."³¹ However, given the potential administrative burden on the registrant, FDA specifies in a guidance document that labeling for each individually listed tobacco product is not necessary if information that represents the labeling for a selected set of related products is provided.³² Registrants are encouraged to submit their materials online using FDA's Unified Registration and Listing System (FURLS) Tobacco Registration and Product Listing Module (TRLM).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.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.³⁵ 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 pertinent equipment and materials "at reasonable times and within reasonable limits and in a reasonable manner."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.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.³⁸ Specifically, statute specifies that the regulations should include the methods, facilities, and controls involved in the manufacture, packing, and storage of a tobacco 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.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.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.⁴² FDA then established a public docket for additional comments on the tobacco companies' recommendations in 2013.⁴³ However, FDA did not take further action specific to promulgating GMP regulations after these actions. FDA's 2016 deeming rule stated that "FDA will have the authority to issue tobacco product manufacturing practice regulations under section 906(e)" of the FFDCA for ENDS and other newly deemed products.⁴⁴ 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).⁴⁵ FDA then opened a public docket in November 2017 to allow for comment on these proposed ENDS GMPs,⁴⁶ 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 will 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) exemption from substantial equivalence (EX REQ), and (4) modified risk tobacco product (MRTP). To legally market a new tobacco product,⁴⁸ a manufacturer must receive a PMTA marketing authorization order. A PMTA is not necessary if FDA determines that the new tobacco product is substantially equivalent to a predicate tobacco product—a product that was commercially marketed as of February 15, 2007, or if it has previously been determined as substantially equivalent to another predicate tobacco product—or is exempt from substantial equivalence.⁴⁹ To legally market a new tobacco product with reduced risk claims or modify a legally marked tobacco product to make reduced risk claims, a manufacturer must receive an MRTP order.

All tobacco products originally covered by the TCA are required to undergo premarket review, unless they are "grandfathered products."⁵⁰ Following the 2016 deeming rule, all newly deemed tobacco products became subject to premarket review requirements as well. In July 2017, FDA announced its Comprehensive Plan for Tobacco and Nicotine Regulation (Comprehensive Plan). 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, 2016.⁵¹ This administrative action was subject to legal challenge, after several public health groups (e.g., American Academy of Pediatrics, Campaign for Tobacco-Free Kids) filed a lawsuit against FDA.⁵² In May 2019, the U.S. District Court for Maryland ruled in favor of the public health organizations,⁵³ and in July 2019, imposed a 10-month deadline for application submissions for all 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 allow 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 million 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 million products submitted by over 550 companies. The vast majority of these submissions are for ENDS products.⁵⁸

Since 2014, most new tobacco products have been legally marketed through the SE pathway.⁵⁹ However, only requirements for the SE exemption pathway have been promulgated in regulations.⁶⁰ This has posed some challenges 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,⁶¹ with public comment open until June 2019. Also in June 2019, FDA finalized its guidance on PMTA submissions specific to ENDS.⁶² In September 2019, FDA issued a proposed rule on the content and format of PMTA applications, with public comment open until December 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.

Premarket Tobacco Product Applications (PMTA) Pathway

A manufacturer must submit a PMTA and receive a PMTA marketing authorization order to legally market a new tobacco product that is not substantially 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."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

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.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.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 will receive a PMTA order.⁷² If marketing is authorized, FDA can require that the sale and distribution of the tobacco product is restricted.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.⁷⁴ 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.⁷⁵ 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 surveillance reports to FDA following PMTA marketing authorization.⁷⁶

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.⁷⁷ A product may serve as a predicate tobacco product if it was commercially marketed as of February 15, 2007, or if it has previously been determined as substantially 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 substantially 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.⁷⁸ 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.⁷⁹

The contents of SE reports are not specified in statute or regulation,⁸⁰ but FDA has provided content recommendations for SE reports in guidance.⁸¹ 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 then issue a SE order letter or not substantially equivalent order (NSE order) letter.⁸²

Exemption from Substantial Equivalence (EX REQ) Pathway

A new tobacco product that has been modified from a legally 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.⁸³ For such a 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."⁸⁴ Before the product can be legally marketed, FDA must first grant the product an exemption from demonstrating substantial equivalence.⁸⁵ 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.⁸⁶

The content requirements for SE exemption reports are specified in regulation.⁸⁷ 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 commercially marketed tobacco products."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 on the market through another pathway (e.g., SE or SE exemption).⁸⁹ 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," or similar descriptions.⁹⁰ Smokeless tobacco products that use certain descriptors, such as "does not produce smoke" or "smoke-free," are not automatically considered MRTPs unless a manufacturer receives MRTP orders for those products.⁹¹ In addition, products that are intended to treat tobacco dependence are not considered MRTPs if they have been approved as a drug or device.⁹²

Manufacturers must include certain information in a MRTP application, including

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

the conditions for using the product;

the formulation of the product;

sample product labels and labeling;

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.⁹³

FDA must refer all 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 time⁹⁴) if, among other things, it determines that the tobacco product will significantly reduce harm and the risk of tobacco-related disease to individual tobacco users and benefit the health of the population as a whole by taking into account users and nonusers of tobacco products.⁹⁵ To continue to market a MRTP after the order'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.⁹⁶

MRTP Postmarket Requirements

To market a tobacco product that has received an MRTP order, the manufacturer must agree to certain postmarket surveillance and studies that examine consumer perception, behavior, and health pertaining to the product. Manufacturers required to conduct surveillance must submit the surveillance 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 allow 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 other tobacco products on the market, and require that the label of the product disclose substances in the tobacco product that could affect health.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 that no longer make an MRTP order permissible, if the product no longer reduces risk or exposure based on data from postmarket surveillance or studies, or if the applicant failed to conduct or submit postmarket surveillance or studies.⁹⁸

Cessation Products

FDA's Center for Drug Evaluation and Research (CDER) is generally 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).¹⁰¹ 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.¹⁰² 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).¹⁰³

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 from CTP).

Tobacco Product Regulation: Tobacco-Specific 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 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.¹⁰⁴ The TCA gave FDA the authority to adopt tobacco product standards that it deems necessary to protect the public's health,¹⁰⁵ but it explicitly prohibited FDA from creating a standard that bans cigarettes, smokeless tobacco products, cigars, pipe tobacco, or roll-your-own tobacco products.¹⁰⁶ 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 allowed 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.¹⁰⁷ 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 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.¹⁰⁸

To propose a new tobacco product standard, FDA is required to publish a proposed rule in the Federal Register and allow 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."¹⁰⁹

FDA is required to periodically 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 calls 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."¹¹⁰

Flavors

When enacting the TCA, Congress recognized that flavors, specifically, can make tobacco products more appealing to youth and expose tobacco users to additional carcinogens or other toxic constituents.¹¹¹ 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.¹¹² 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.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, specifically addressing use among youth and racial and ethnic minorities.¹¹⁴ 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."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.¹¹⁶ A final regulation has not yet been promulgated; however, Former Commissioner Gottlieb expressed interest in accelerating the promulgation of this tobacco product standard.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 generally in tobacco products, among other things.¹¹⁸ After one extension, the comment 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.¹¹⁹ In April 2021, the agency released a statement outlining its intent to issue proposed product standards to ban menthol in cigarettes, and all 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 is the naturally occurring drug in tobacco that can cause addiction to the product.¹²² The FFDCA allows FDA to address nicotine yields of a tobacco product through development of a tobacco product standard,¹²³ but it prohibits the agency from establishing a tobacco product standard that would require the reduction of nicotine yields to zero.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 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.¹²⁵ 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.¹²⁶ Pursuant to FFDCA Section 915, FDA is required 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.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 tobacco product manufacturers would be given additional time to comply, and FDA could additionally delay compliance on a case-by-case basis for small tobacco product manufacturers.¹²⁸

Health Information

Tobacco product manufacturers are required to submit specified health information to FDA. This health information includes a list of all ingredients, such as substances, compounds, and additives that are added to the tobacco product by the manufacturer. Health information also includes "a listing of all constituents, including smoke constituents as applicable, identified by the Secretary as harmful or potentially harmful to health in each tobacco product."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).¹³⁰ 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).¹³¹ 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

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.¹³²

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.¹³³ 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.¹³⁴

Using FDA's list, manufacturers are required to report HPHCs by brand and quantity of HPHCs in each brand and sub-brand.¹³⁵ Given potential monetary and feasibility challenges that were associated with reporting all 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.¹³⁶ 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.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.¹³⁸ The public comment period closed in October 2019.¹³⁹

Health Documents

Tobacco product manufacturers are required to submit to FDA all 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.¹⁴⁰ FDA interprets these documents to include "cell-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 as the individual level (such as abuse liability)."¹⁴¹

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.¹⁴² 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."¹⁴³ Required reports cannot be overly burdensome and cannot disclose the identity of a patient, except under certain circumstances.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 records supporting the SE report for at least four years.¹⁴⁵ 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."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).¹⁴⁸ 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.¹⁴⁹ 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.¹⁵⁰

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.¹⁵¹ Among other things, the 1996 Tobacco Rule imposed requirements on the sale, labeling, and advertising of cigarettes and smokeless tobacco.¹⁵² The TCA provided that the final rule must be identical to the 1996 rule, with specified exceptions. FDA reissued the 1996 rule in March 2010,¹⁵³ and the 2016 deeming rule extended the applicability of sale and distribution restrictions, as well 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 21.¹⁵⁴

Current law and regulations restricting the sale and distribution of tobacco products will be discussed first, followed by current law and regulations on the labeling and advertising of tobacco 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 selling tobacco products to any person younger than 21 years of age¹⁵⁵ and limits FDA's ability to promulgate regulations that restrict the sale of tobacco products to those over 21 years of age.¹⁵⁶ FDA has stated that this new age sales restriction is currently in effect.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 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 27.¹⁵⁸ 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 tobacco products to those under 21 years of age and that retailers are required to verify the age of individuals attempting to purchase tobacco products who are younger than 30. The final rule is to take effect not later than September 20, 2020.¹⁵⁹ Although the Spring 2021 White House OMB 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 samples of cigarettes, smokeless tobacco products, and newly deemed tobacco products, with the exception of smokeless tobacco in qualified adult-only facilities.¹⁶¹ 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.¹⁶² 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).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.¹⁶⁴ 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.¹⁶⁵ 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 specifically, 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.¹⁶⁶ The SABG is a block grant program that distributes funds to 60 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.¹⁶⁷ The SABG provides a consistent federal funding stream to states through formula grants, and it is one of SAMHSA's largest programs.¹⁶⁸

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.¹⁷⁰ 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.¹⁷¹ 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 tobacco products to those under age 21 and comply with annual reporting requirements to SAMHSA on enforcement and compliance actions. SAMSHA was required to update the Synar regulations by June 20, 2020 to account for these changes.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)¹⁷³ and the Comprehensive Smokeless Tobacco Health Education Act of 1986 (CSTHEA) include certain labeling requirements and advertising restrictions on cigarettes and smokeless tobacco, respectively.¹⁷⁴ FTC generally oversees these two acts.¹⁷⁵ 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).¹⁷⁶

In addition, manufacturers, distributors, and retailers may not sell or distribute tobacco products with labels, labeling, or advertising that are not in compliance with the FFDCA and accompanying FDA regulations.¹⁷⁷ Certain labeling and advertising requirements specific to cigarettes and smokeless tobacco include the following:

• 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.¹⁷⁸
• Manufacturers and distributors of imported cigarettes and smokeless tobacco may not market, license, distribute, or sell any product that bears the brand name, logo, or any other identifying patterns associated with the brand name.¹⁷⁹
• Labeling and advertising in audio and video formats are limited. For example, audio formats cannot include music or sound effects.¹⁸⁰

Tobacco product package labeling and advertisements must also include warning statements. Table 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 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.¹⁸¹ 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.¹⁸² The final rule was challenged 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.¹⁸³

FDA planned to develop and propose a new graphic warning rule and has continued to conduct research for this rule since 2013.¹⁸⁴ In 2016, multiple health organizations filed a suit against FDA to compel the agency to promulgate a final rule more quickly.¹⁸⁵ In March 2019, FDA was ordered to issue a proposed rule by mid-August 2019 and a final rule by mid-March 2020.¹⁸⁶ The proposed rule, issued in August 2019, specifies requirements for new cigarette health warnings.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 well 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 challenged 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

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 as seizures, injunctions, and criminal prosecution (with the Department of Justice).¹⁹¹

Adulterated and Misbranded Tobacco Products

The FFDCA prohibits the adulteration and misbranding of tobacco products, as well as the introduction, receipt, and delivery of adulterated or misbranded tobacco products into interstate commerce.¹⁹²

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; and/or
• if a manufacturer does not comply with user fee, tobacco product standard, premarket review, and/or GMP requirements (when promulgated).¹⁹³

Misbranded Tobacco Products

A tobacco product is deemed misbranded if

• the labeling is false or misleading in any way;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;¹⁹⁵
• the labeling, packaging, and shipping containers of tobacco products do not contain the label "sale only allowed in the United States";¹⁹⁶
• it was manufactured, prepared, propagated, compounded, or processed in a facility that was not registered with FDA;¹⁹⁷
• its advertising is false or misleading in any way;¹⁹⁸ and/or
• it is sold by a retailer to an individual under 21 years of age¹⁹⁹ or is sold in violation of regulations promulgated on the sale and distribution of tobacco products.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.²⁰¹ To date, FDA has not issued such regulations.

Tobacco Retailer Compliance Check Inspections

FDA is required to contract with states and territories to carry out compliance check inspections of tobacco retailers.²⁰² 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.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.²⁰⁴ If a first-time violation is reported (e.g., sale to a minor, illegal 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.²⁰⁵ 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.²⁰⁶ According to FDA, as of February 28, 2021, the agency has "conducted more than a million compliance check inspections and issued over 98,000 Warning Letters, 25,000 [CMPs], and 200 [NTSOs]."²⁰⁷

As mentioned, in FY2020 appropriations, Congress amended the federal minimum age of tobacco product purchasing from 18 to 21.²⁰⁸ FDA has stated that this new age sales restriction is currently in effect, but also recognizes that the agency and retailers will need to update current practices to account for these changes.²⁰⁹ As such, FDA had stated that "during this ramp-up period, FDA will 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

Notification and Recall

FDA has the authority to issue notifications and recalls 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) recall 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 recall 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 recall of the tobacco product, FDA must amend the order to require such recall, specifying a timetable for and requiring periodic progress reports on the recall.

Appendix A. 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 electrically 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 electrically 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 Morris Products S.A. IQOS System Holder and Charger," April 2019, https://www.fda.gov/media/124247/download. Notes: From left to right, pictured is the IQOS Tobacco Heating System Charger, Holder, and Heatstick, respectively.

Given the novel technology of the IQOS, some industry stakeholders saw this product as a potential precedent for the premarket review process that ENDS products will eventually undergo. On May 15, 2017, FDA received PMTAs from Phillip 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, some stakeholders raised concerns that small ENDS manufacturers may not have the resources to engage in the PMTA process. In addition, there are concerns FDA may need additional resources to accommodate the influx of lengthy ENDS PMTA applications.

Appendix B. Tobacco Master Settlement Agreement of 1998²¹⁶

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.²¹⁷ The remaining four states—Mississippi, Florida, Texas, and Minnesota—had settled individually 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. Specifically, 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 billboard advertising, excluding billboard 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 nationally recognized non-tobacco brand names for cigarettes; and
• limited free samples of cigarettes to adult-only facilities.

Appendix C. Definitions of Terms Used in This Report

Appendix D. Acronyms Used in This Report

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.²¹⁷ The remaining four states—Mississippi, Florida, Texas, and Minnesota—had settled individually 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. Specifically, 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 billboard advertising, excluding billboard 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 nationally recognized non-tobacco brand names for cigarettes; and
• limited free samples of cigarettes to adult-only facilities.