Appealing characteristics of E-cigarette marketing in the retail environment among adolescents.

Background: Nearly 3 million U.S. adolescents use e-cigarettes. E-cigarette marketing is associated with adolescent e-cigarette use; however, studies have not asked adolescents their perceptions about whether and which e-cigarette marketing in retail stores influences purchase and use. Methods: Eleven 90-minute focus groups with 12-19-year-olds (mean age 15.7, 46.6 % female) from 11 U.S. states (n = 58) recruited through Instagram and schools (May 2021-Aug 2022). Photographs of e-cigarette marketing in and around retail stores were used to aid discussion. Thematic analysis identified themes related to appealing marketing characteristics. Results: Adolescents indicated that e-cigarette marketing in and around retail stores arouses their curiosity, reminds them to buy, and normalizes using e-cigarettes. Adolescents identified specific e-cigarette marketing characteristics that they believed influence their decision to purchase and use e-cigarettes including the Tobacco Power Wall, free samples and flavor smelling samples, price incentives such as discounts and starter-kits, e-cigarette displays near checkout encouraging grab-and-go, displays near food, snacks or candy, and e-cigarette advertising through posters on store windows and stickers at checkout. Adolescents reported combining online and social media strategies to bypass age verification in retail stores (e.g., buying gift cards online and using them in stores). Adolescents suggested adding warning images on negative health effects of e-cigarettes, increasing prominence of minimum-age-of-tobacco-sale signs, and developing marketing education as counter-marketing strategies. Conclusions: Adolescents indicate that specific e-cigarette marketing characteristics in retail stores influence their purchase and use decisions. Addressing such e-cigarette marketing exposures in retail stores through counter-marketing messages may bolster adolescent e-cigarette prevention efforts.

Vuse Solo e-cigarettes do not provide net benefits to public health: a scientific analysis of FDA's marketing authorisation.

In October 2021, the US Food and Drug Administration (FDA) authorised marketing of RJ Reynolds Vapor Company's (RJR) Vuse Solo e-cigarette through FDA's Premarket Tobacco Product Application (PMTA) pathway. FDA concluded that RJR demonstrated Vuse products met the statutory standard of providing a net benefit to public health. A review of FDA's scientific justification reveals deficiencies: (1) not adequately considering Vuse's popularity with youth and evidence that e-cigarettes expanded the nicotine market and stimulate cigarette smoking; (2) trading youth addiction for unproven adult benefit without quantifying these risks and benefits; (3) not considering design factors that appeal to youth; (4) not addressing evidence that e-cigarettes used as consumer products do not help smokers quit and promote relapse in former smokers; (5) not discussing evidence that dual use is more dangerous than smoking; (6) narrowly focusing on the fact that e-cigarettes deliver lower levels of some toxicants without addressing direct evidence on adverse health effects; (7) downplaying significant evidence of other substantial harms; (8) not acting on FDA's own study showing no all-cause mortality benefit of reducing (but not stopping) cigarette use; and (9) improperly considering e-cigarettes' high abuse liability and potential for high youth addiction and undermining tobacco cessation. Because marketing these products is not appropriate for the protection of the public health, FDA should reconsider its Vuse marketing order as statutorily required and not use it as a template for other e-cigarette PMTAs. Policymakers outside the USA should anticipate that tobacco companies will use FDA's decision to try to weaken tobacco control regulation of e-cigarettes and promote their products.

Use, marketing, and appeal of oral nicotine products among adolescents, young adults, and adults.

IMPORTANCE: Oral nicotine products such as pouches, lozenges, tablets, gums, and toothpicks are gaining popularity, especially among adolescents and young adults, with increased marketing. OBJECTIVE: To estimate use patterns of oral nicotine products and likelihood of buying and liking products based on marketing, using a large group of adolescents, young adults, and adults. DESIGN, SETTING, AND PARTICIPANTS: A cross-sectional, online survey among U.S. participants (n = 6,131; ages 13-40 years) was conducted in November-December 2021. MAIN OUTCOMES AND MEASURES: Ever, past-30-day, and past-7-day use, behaviors, and flavors of oral nicotine products. Liking marketing and likelihood of buying specific oral nicotine products (Zyn pouches and Lucy gum) from marketing. RESULTS: Our sample included 2,025 (33.0%) ever-users, 1,191 (19.4%) past-30-day users, and 998 (16.3%) past-7-day users of any oral nicotine product. Use patterns by age (in years): ever-users (<21: 816 (22.3%); 21-40: 1,209 (48.9%)); past-30-day users (<21: 458 (12.5%); 21-40: 733 (29.7%)); and past-7-day users (<21: 383 (10.5%); 21-40: 615 (24.9%)). Across products, 10-18% of participants reported using nicotine strength ranging from 6-10 mg. Fruit, sweet/dessert, alcohol, coffee, and mint were the most used flavors. When shown marketing, ever-users liked and were likely to buy Zyn pouches compared to never users, and participants under 21 years felt equally targeted by Lucy and Zyn marketing. Liking Zyn marketing even a little bit compared to not at all increased the likelihood of buying Zyn pouches across age groups. After observing marketing, participants < 21 years were more likely to buy Zyn if they perceived marketing to contain messages about good tasting flavors (AOR 1.43, 1.09-1.87; 0.009) and helping to feel comfortable in social situations (AOR 1.38, 1.02-1.87; 0.033), and were more likely to buy Lucy if they felt it could be used anywhere (AOR 1.57, 1.05-2.33; 0.026). CONCLUSIONS: This study provides a foundation for estimating use, behaviors, flavors, and marketing influence of oral nicotine products in the US and globally. Adolescent and young adult use of oral nicotine products and likelihood of buying products when exposed to marketing highlights the need for expanded tobacco use surveillance, marketing regulations, and counter marketing and educational efforts.

Adolescents, Young Adults, and Adults Continue to Use E-Cigarette Devices and Flavors Two Years after FDA Discretionary Enforcement.

This study assesses the use of e-cigarette devices and flavors using a large, cross-sectional survey of adolescents, young adults, and adults (N = 6131; ages 13−40 years old; Mage = 21.9) conducted from November to December 2021, 22 months after the FDA announced its prioritized enforcement policy against some flavored pod/cartridge-based e-cigarettes. We analyzed the patterns of use by age group: adolescents and young adults (AYAs) under 21 (minimum age of e-cigarette sales), young adults (21−24 years old), and adults (25−40 years old). The participants reported using e-cigarettes ever (44.2% < 21; 67.1% 21−24; 58.0% > 24), in the past 30 days (29.8% < 21; 52.6% 21−24; 43.3% > 24), and in the past 7 days (24.5% < 21; 43.9% 21−24; 36.5% > 24). Disposables were the most used e-cigarette device type across age groups (39.1% < 21; 36.9% 21−24; 34.5% > 24). Fruit, sweet, mint, and menthol flavors were popular across age groups; however, chi-squared tests for trends in proportions revealed age-related trends in past 30-day flavor use by device type. Findings suggest current AYA e-cigarette use may be higher than recorded by the NYTS 2021. The FDA, states, and localities should adopt more comprehensive restrictions on flavored e-cigarette products in order to reduce adolescent and young adult e-cigarette use.

Use Patterns, Flavors, Brands, and Ingredients of Nonnicotine e-Cigarettes Among Adolescents, Young Adults, and Adults in the United States.

Importance: Nonnicotine e-cigarettes contain chemicals, flavorants, and solvents that have known health harms and/or have not been proven safe for inhalation. Objective: To evaluate nonnicotine e-cigarette use patterns, including common flavors, brands, and ingredients. Design, Setting, and Participants: This cross-sectional study included a convenience sample of US residents aged 13 to 40 years who completed an online survey in November and December 2021. Quota sampling was used for an equal proportion of participants aged 13 to 17 years, 18 to 20 years, and 21 to 40 years, balanced for sex, race, and ethnicity per the latest US Census. Main Outcomes and Measures: Nonnicotine e-cigarette use (ever, past 30- and past 7-day, number of times used, time taken to finish); co-use with nicotine e-cigarettes; age at first try; and flavors, brands, and ingredients used. Results: Overall, 6131 participants (mean [SD] age, 21.9 [6.8] years; range, 13-40 years; 3454 [56.3%] identifying as female) completed the survey (55.1% completion rate). Among all participants, 1590 (25.9%) had ever used a nonnicotine e-cigarette, 1021 (16.7%) used one in the past 30 days, and 760 (12.4%) used one in the past 7 days. By age group, 227 of 1630 participants aged 13 to 17 years (13.9%), 497 of 2033 participants aged 18 to 20 years (24.4%), 399 of 1041 participants aged 21 to 24 years (38.3%), and 467 of 1427 participants aged 25 to 40 years (32.7%) had ever used nonnicotine e-cigarettes. Among 1590 participants who had ever used a nonnicotine e-cigarette, 549 (34.5%) had used one more than 10 times; 1017 (63.9%) finished 1 nonnicotine e-cigarette in less than 1 week. Co-use of nonnicotine with nicotine e-cigarettes was reported by 1155 participants (18.8%), 1363 (22.2%) exclusively used nicotine e-cigarettes, and 431 (7.0%) exclusively used nonnicotine e-cigarettes. Most-used flavors were sweet, dessert, or candy (578 [36.3%]); fruit (532 [33.4%]); and mint or menthol (321 [20.2%]); similar flavor patterns were observed for the top 2 flavors among those who used nonnicotine e-cigarettes in the past 30 days, followed by combinations of coffee, alcohol, flower, plant, and mint or menthol flavors by age group. Participants most reported using tetrahydrocannabinol (587 [36.9%]), cannabidiol (537 [33.7%]), melatonin (438 [27.5%]), caffeine (428 [26.9%]), and essential oils (364 [22.9%]) in their nonnicotine e-cigarettes. Conclusions and Relevance: In this study of adolescents, young adults, and adults, a sizeable proportion reported having used nonnicotine e-cigarettes and co-using them with nicotine e-cigarettes. Surveillance studies should further assess nonnicotine e-cigarette use patterns and regulations, and prevention should be developed to address youth appeal, unsubstantiated health claims, and possible health harms.

Flavored Tobacco Sales Restrictions Reduce Tobacco Product Availability and Retailer Advertising.

OBJECTIVE: This study examined differences in the availability and advertising of flavored tobacco products before and after flavored tobacco sales restrictions were enacted in Alameda and San Francisco Counties in California. MAIN OUTCOME MEASURES: Data were collected from a sample of tobacco retailers in Alameda and San Francisco Counties at two time points: 2015, before flavored tobacco policies were enacted, and in 2019-2020, after some cities had enacted policies. Retailers were separated by city into Category 1 (n = 442)-retailers in cities that enacted a flavored tobacco policy between the two data collection periods, and Category 2 (n = 89), those that had not. Means comparison tests were conducted to evaluate significant differences over time and by category. RESULTS: There was significantly reduced availability of menthol cigarettes, flavored little cigars, smokeless tobacco, vape pens, and Blu brand menthol e-cigarettes between 2015 and 2020 in Category 1 retailers. Category 2 retailers had reduced availability only for Blu menthol e-cigarettes and demonstrated an increase in smokeless tobacco availability. Exterior store advertising for cigarettes, little cigars, cigars, and e-cigarettes also decreased significantly in Category 1 cities relative to Category 2 cities; 8.1% of Category 1 stores were advertising flavored tobacco products in 2019-2020 compared to 36.2% of Category 2 stores. There was also a 78% reduction in flavored ads between 2015-2019 in Category 1 cities compared to a 38% decrease in Category 2 cities. Tobacco advertising inside Category 2 stores increased. Finally, Category 2 cities had significantly greater availability of cigalikes, mod or tank vapes, flavored e-cigarettes, and e-liquids compared to Category 1 cities. CONCLUSIONS: Comprehensive flavored sales restriction policies reduce flavored tobacco availability and tobacco advertising, which may help prevent youth tobacco initiation and exposure.

E-cigarette devices, brands, and flavors attract youth: Informing FDA's policies and priorities to close critical gaps.

PURPOSE: Identify e-cigarette devices, brands, and flavor types used by adolescents and young adults soon after the enactment of flavor restrictions, youth access laws, FDA's enforcement prioritization against some flavored pod/cartridge-based e-cigarettes, and during COVID-19 pandemic-related school closures. METHODS: National cross-sectional online survey (N = 4,351) in May 2020 assessed popularity, ever- and past-30-day use of e-cigarette device types (pod/cartridge-based, disposables, others), brands, flavor types and flavor-enhancers, by age group (under age 21 and 21 and over). RESULTS: While pod/cartridge-based e-cigarettes had the highest ever-use (82.7% <21; 69.8% ≥21) and were most often-used (41.9% <21; 41.4% ≥21), most past 30-day-users (50.8% <21; 61.9% ≥21) and 7-day-users (36.0% <21; 56.7% ≥21) used disposables. Mint/menthol was the most-used flavor type (pod/cartridge-based: 48.2% <21, 48.1% ≥21; disposables: 51.6% <21, 56.4% ≥21), followed by fruit (pod/cartridge-based: 37.4% <21, 35.5%≥ 21; disposables: 51.6% >21, 46.2% ≥ 21), and sweet/dessert/candy flavor types (pod/cartridge-based: 24.4% <21, 24.7% ≥21; disposables: 29.7% <21, 33.8% ≥21). Participants reported using add-on e-cigarette flavor-enhancers (pod/cartridge-based: 24.6%; disposables: 31.3%). CONCLUSION: Soon after FDA's January 2020 announcement of prioritized enforcement against flavored pod/cartridge-based e-cigarettes and during the pandemic lockdown, adolescents' and young adults' past 30-day use included mostly flavored disposables rather than pod/cartridge-based e-cigarettes, mint/menthol flavors, and some used add-on flavor enhancers. To reduce youth use, comprehensive regulation of e-cigarette devices and flavors should be enacted and enforced at federal, state, and local levels.

FDA's reduced exposure marketing order for IQOS: why it is not a reliable global model.

The US Food and Drug Administration (FDA) issued orders in July 2020 authorising Philip Morris Products S.A. to market its heated tobacco product (HTP) IQOS inside the USA with claims that it reduces exposure to some dangerous substances. FDA's 'reduced-exposure' orders explicitly prohibit the marketing of IQOS with claims that IQOS will reduce harm or the risk of tobacco-related diseases. Under US law, FDA's IQOS orders are problematic because FDA disregarded valid scientific evidence that IQOS increases exposure to other dangerous toxins and that Philip Morris Products S.A. failed to demonstrate that consumers understand the difference between reduced-exposure and reduced-harm claims. Unfortunately, both 'reduced-exposure' and 'reduced-harm' are classified as 'modified risk tobacco products' under US law. Exploiting this confusion, Philip Morris International used the FDA decision as the basis for marketing and public relations campaigns outside the USA to press governments to reverse policies that ban or regulate the sales and marketing of HTPs, including IQOS. Parties to the WHO Framework Convention on Tobacco Control should reject tobacco companies' unsubstantiated explicit or implied claims of reduced harm associated with HTPs and resist Philip Morris International's and other companies' calls to relax HTP regulations based on the FDA's actions. Instead, parties should adopt policies aligned with the Framework Convention on Tobacco Control when dealing with HTPs and other novel tobacco products.

Underage Youth and Young Adult e-Cigarette Use and Access Before and During the Coronavirus Disease 2019 Pandemic.

Importance: Understanding patterns of e-cigarette use and access during the coronavirus disease 2019 (COVID-19) pandemic is important because e-cigarettes may put users at risk for more severe respiratory effects and other health problems. Objective: To examine whether underage youth and young adults who ever used e-cigarettes self-reported changes in access and use of e-cigarettes since the COVID-19 pandemic began. Design, Setting, and Participants: A national, cross-sectional online survey study was conducted from May 6 to May 14, 2020. This sample of 4351 participants aged 13 to 24 years across the US included 2167 e-cigarette ever-users. Quota sampling was used to balance for age, sex, race/ethnicity, and 50% having ever used e-cigarettes. Main Outcomes and Measures: Change in e-cigarette use (increase, decrease, quit, no change, and switch to another product) and access to e-cigarettes (easier or harder, and change in point-of-purchase) before and after the COVID-19 pandemic began, reasons for change, number of times e-cigarettes were used, nicotine dependence, and sociodemographic data. Results: This study focused on 2167 e-cigarette ever-users among 4351 participants who completed the survey. Among 2167 e-cigarette users, a total of 1442 were younger than 21 years and 725 were aged 21 years or older; 1397 were female (64.5%) and 438 identified as lesbian, gay, bisexual, transgender, queer (20.2%). The survey completion rate was 40%. Since the COVID-19 pandemic began, 1198 of 2125 e-cigarette users (56.4%) changed their use: 388 individuals (32.4%) quit, 422 individuals (35.3%) reduced the amount of nicotine, 211 individuals (17.6%) increased nicotine use, 94 individuals (7.8%) increased cannabis use, and 82 individuals (6.9%) switched to other products. Participants reported that not being able to go to vape shops and product unavailability were the reasons accessing e-cigarettes was difficult after the pandemic began. Since the COVID-19 pandemic began, individuals reported purchasing from alternative retail stores (disposables, 150 of 632 [23.7%]; pod-based, 144 of 797 [18.1%]; and other e-cigarette, 125 of 560 [22.3%], ie, between 18.1% and 23.7%), purchasing online instead of retail (disposables, 115 of 632 [18.2%]; pod-based, 156 of 797 [19.6%]; and other e-cigarette, 111 of 560 [19.8%], ie, between 18.2% to 19.8%), and shifted to retail instead of online (disposables, 11 of 632 [1.7%]; pod-based, 17 of 797 [2.0%]; and other e-cigarette, 13 of 560 [2.3%], ie, between 1.7%-2.3%). Other individuals reported no change: from retail stores (disposables 262 of 632 [41.5%]; pod-based 344 of 797 [43.2%]; and other e-cigarette, 223 of 560 [39.8%], ie, between 39.8% and 43.2%) and online (disposables 94 of 632 [14.9%]; pod-based 136 of 797 [17.1%]; and other e-cigarette, 88 of 560 [15.8%], ie, between 14.9% and 17.1%). Underage youth reported e-cigarette deliveries from vape shops and/or dealers or friends who received such deliveries, and 63 of 229 (27.5%) self-reported accessing e-cigarettes without age verification. e-Cigarette users were 52% less likely to quit or reduce their use if they previously used e-cigarettes between 11 and 99 times (adjusted odds ratio, 0.48; 95% CI, 0.30-0.78), 68% less likely to quit if they previously used e-cigarettes more than 100 times (adjusted odds ratio, 0.32; 95% CI, 0.20-0.51), and 51% were less likely to quit if they were nicotine dependent (adjusted odds ratio, 0.49; 95% CI, 0.35-0.70). Conclusions and Relevance: During the COVID-19 pandemic, youth e-cigarette users reported changes in e-cigarette use, point-of-purchase, and ability to purchase e-cigarettes without age verification. The US Food and Drug Administration and local policy makers may find these data useful to inform policies to prevent e-cigarette sales to underage youth.

Analysis of FDA's IQOS marketing authorisation and its policy impacts.

BACKGROUND: Philip Morris Products SA (PMPSA) submitted a premarket tobacco application (PMTA) to US Food and Drug Administration (FDA) seeking an order permitting it to market IQOS in the USA. US law requires FDA to deny marketing authorisation if applicants fail to demonstrate that their product is 'appropriate for the protection of the public health'. FDA issued a marketing order for IQOS in April 2019, which Philip Morris is using to promote IQOS outside the USA. METHODS: We analysed FDA's Technical Project Lead Review and marketing order for IQOS, relevant law and guidance on PMTAs and independent research on the health impacts of IQOS. RESULTS: FDA found that the evidence PMPSA submitted did not demonstrate reduction in long-term disease risks and that IQOS aerosol emits toxins with carcinogenic and genotoxic potential, some at higher levels than conventional cigarettes. PMPSA did not appropriately consider the health impacts of dual use, the product's attractiveness to youth or data showing that consumers do not accurately perceive the addiction risks of IQOS. Despite FDA's own scientists' recommendations and independent research showing that IQOS presents serious risks to users including cytotoxic, genotoxic, hepatotoxic, cardiovascular and pulmonary risks, FDA concluded that IQOS is 'appropriate for the protection of the public health'. CONCLUSION: FDA's decision allowing IQOS to be marketed in the USA disregarded valid scientific evidence and misapplied the public health standard mandated by law. This decision may have important health impacts, influence marketing IQOS outside the USA and erode public confidence in FDA's future PMTA decisions.

Heated tobacco product regulation under US law and the FCTC.

Tobacco companies are marketing new 'heated tobacco products' (HTPs) composed of battery-powered holders, chargers and tobacco plugs or sticks. The non-tobacco HTP components have escaped effective regulation under many countries' tobacco control laws because they are packaged and sold separately from the tobacco-containing components. In the USA, HTPs cannot be marketed unless the Food and Drug Administration determines that allowing their sale would be 'appropriate for the protection of the public health'. Philip Morris International (PMI) is seeking permission to market its IQOS HTP in the USA with 'modified risk tobacco product' (MRTP) claims that it reduces exposure to harmful substances and is less harmful than other tobacco products. However, PMI has not submitted adequate scientific evidence required by US law to demonstrate that the product is significantly less harmful to users than other tobacco products, that its labelling would not mislead consumers, or that its marketing-with or without MRTP claims-would benefit the health of the population as a whole. Parties to the WHO Framework Convention on Tobacco Control (FCTC) must take measures to reduce tobacco use and nicotine addiction, and prevent false or misleading tobacco product labelling, advertising and promotions; the introduction of new HTPs must be assessed according to these goals. All components of HTPs should be regulated at least as stringently as existing tobacco products, including restrictions on labelling, advertising, promotion and sponsorship, sales to minors, price and taxation policies and smokefree measures. There is nothing in US law or the FCTC that prevents authorities from prohibiting HTPs.

Light and mild redux: heated tobacco products' reduced exposure claims are likely to be misunderstood as reduced risk claims.

INTRODUCTION: Heated tobacco products (HTPs) are being marketed in several countries around the world with claims that they are less harmful than combusted cigarettes, based on assertions that they expose users to lower levels of toxicants. In the USA, Philip Morris International (PMI) has submitted an application to the Food and Drug Administration (FDA) in 2016 seeking authorisation to market its HTPs, IQOS, with reduced risk and reduced exposure claims. METHODS: We examined the PMI's Perception and Behavior Assessment Studies evaluating perceptions of reduced risk claims that were submitted to the FDA and made publicly available. RESULTS: Qualitative and quantitative studies conducted by PMI demonstrate that adult consumers in the USA perceive reduced exposure claims as reduced risk claims. CONCLUSION: The data in the PMI modified risk tobacco product IQOS application do not support reduced risk claims and the reduced exposure claims are perceived as reduced risk claims, which is explicitly prohibited by the FDA. Allowing PMI to promote IQOS as reduced exposure would amount to a legally sanctioned repeat of the 'light' and 'mild' fraud which, for conventional cigarettes, is prohibited by the US law and the WHO Framework Convention on Tobacco Control.

IQOS labelling will mislead consumers.

BACKGROUND: Philip Morris International (PMI) continually expands and diversifies their nicotine product portfolio, which includes IQOS, a heated tobacco product. In December 2016, PMI filed a modified risk tobacco product (MRTP) application with the US Food and Drug Administration (FDA), seeking authorisation to market IQOS in USA with three claims of reduced harm: 'switching completely from conventional cigarettes to the IQOS system…' (1) 'can reduce the risks of tobacco-related diseases;' (2) 'significantly reduce[s] your body's exposure to harmful or potentially harmful chemicals;' and (3) 'presents less risk of harm than continuing to smoke cigarettes.' Consumers may misunderstand what is meant by 'switching completely'. METHODS: We critically reviewed study reports submitted to FDA by PMI in support of proposed marketing claims in its MRTP application for IQOS and focused on the statement that switching completely to IQOS reduces risk. RESULTS: We found deficiencies with evidence provided by PMI supporting their assertions that: current smokers will understand what is meant by the phrase 'switching completely'; the proposed claims will not decrease smokers' intentions to quit; and IQOS users will in fact 'switch completely' from smoking cigarettes to using IQOS. The studies and measurement instruments employed by PMI suffer from design flaws and their reporting of associated findings is misleading. CONCLUSION: Consumers will not understand the condition of the claims-that they must quit using cigarettes completely to achieve the inferred health benefits of IQOS. Rather, they are likely to misunderstand the unsupported claims of reduced risks to mean IQOS are harm-free.

Substantial Equivalence Standards in Tobacco Governance: Statutory Clarity and Regulatory Precedent for the FSPTCA.

The Family Smoking Prevention and Tobacco Control Act (FSPTCA) of 2009 creates the first national system of premarket regulation of tobacco products in American history. The FDA must now review and give marketing authorization to all new tobacco products, based on a public health standard, before they can be legally marketed. Yet the law also contains an alternative pathway for market entry-the substantial equivalence (SE) clause-by which novel and altered tobacco products can be marketed by demonstrating their substantial equivalence to existing products. Over 99 percent of tobacco product applications sent to the FDA under the new law have used this mechanism, and loose application of the SE mechanism carries the risk of undoing the FDA's gatekeeping power under the law. We review the statutory and regulatory precedent for SE, examining the FSPTCA itself as well as regulatory precedent from drug and device regulation (from which the term substantial equivalence and much of the associated statutory language was derived). Our review of standards and scientific precedent demonstrates that exacting scrutiny under the public health standard should govern all SE reviews and that clinical data incorporating social scientific evidence should be routinely required for SE claims by tobacco product sponsors.