Oral Nicotine Pouches: Rising Popularity and State of the Science

Abstract

Nicotine pouches are noncombustible products that contain nicotine but no tobacco plant material. With rising popularity and increased media attention surrounding ZYN and other nicotine pouch brands, questions remain about whether empirical evidence exists on the public health effects of these products. This review highlights how nicotine pouches, including ZYN, are rising in appeal and prevalence of use, particularly among adolescents and young adults. The use of nicotine pouches is also more prevalent among people who use other tobacco products (vs those who do not), including electronic cigarettes (e-cigarettes), and some people report using nicotine pouches to help reduce or quit the use of e-cigarettes or combustible tobacco products. Nicotine pouches deliver amounts of nicotine similar to other tobacco products and do so at a rate similar to other oral nicotine products, including some US Food and Drug Administration (FDA)–approved nicotine replacement therapies. In addition, nicotine pouches have the potential to be tobacco harm-reduction products if unintended harms can be minimized, although more research is needed to determine the health effect profile of nicotine pouches under naturalistic use conditions. Overall, additional research is needed to verify the results from industry-funded studies, further understand product characteristics that influence nicotine delivery and health effects, and translate findings to real-world use behaviors. This additional research could help determine whether nicotine pouches have a robust evidence base to meet the public health standard by which FDA evaluates new tobacco products.

Recent attention on nicotine pouches (NPs), such as ZYN, has raised questions about existing evidence regarding their public health impact. On April 4, 2024, the US Food and Drug Administration (FDA) issued 119 warning letters and 41 civil money penalty complaints against brick-and-mortar retailers engaging in the underage sale of ZYN NPs and selling unauthorized, flavored ZYN NPs. ¹ NPs are noncombustible (ie, smokeless) products that contain nicotine but no tobacco plant material. NPs are intended for oral consumption and do not require spitting. Although NPs do not contain tobacco leaf, they fall under the deeming rule to be regulated by the FDA Center for Tobacco Products (CTP) as tobacco products because they contain nicotine; no approvals have been made for NPs to be sold as a smoking cessation aid through FDA’s Center for Drug Evaluation and Research. NPs are sold with various nicotine concentrations and flavors, ² including mint/menthol, fruit, and other flavors (eg, cinnamon, coffee, smooth, chill). NPs have been manufactured by large tobacco companies (eg, ZYN [Swedish Match], on! [Altria], VELO [British American Tobacco], Rogue [Swisher]) and companies that do not sell traditional tobacco products (eg, FRĒ, 2ONE, Lucy, FR3SH). Some NP manufacturers have submitted premarket tobacco product applications to the FDA CTP to be considered for market authorization, which could result in a grant or deny order for these products to be sold, distributed, and marketed in the United States. ³

This review is a synthesis of the existing literature on NPs to assess what is known about their public health impacts and to identify existing research gaps. The University at Buffalo Institutional Review Board reviewed the project and determined the project did not meet the definition of human subjects research, as defined by the regulations at 45 CFR 46.102.

Chemical Characteristics of NPs

We reviewed websites for multiple NP brands (Box), which revealed that NPs may contain tobacco-derived or synthetic nicotine, although some websites did not specify the nicotine source despite claiming to be “tobacco-leaf free.” The website for NIC-S indicated the presence of only S-nicotine, 1 of the 2 configurational isomers or enantiomers: (S)-(-)-nicotine and (R)-(+)-nicotine. ⁴ Some websites (ZYN, on!, Juice Head) indicated the presence of nicotine salt (bitartrate dihydrate). Other ingredients included hydroxypropyl cellulose (ZYN), microcrystalline cellulose (ZYN, VELO, on!), maltitol (ZYN, VELO), gum arabic (ZYN), sodium carbonates (ZYN, VELO, on!, Juice Head), acesulfame potassium (ZYN, VELO, Juice Head), water (ZYN, VELO, FRĒ, FR3SH), salt (ZYN, VELO), sucralose or other sweeteners (ZYN, VELO, Juice Head, FRĒ, FR3SH, Sesh), citric acid (ZYN, VELO), and flavor additives (ZYN, VELO, on!, Juice Head, FRĒ, FR3SH). Among ingredients shown in NPs, some are Generally Recognized as Safe food substances (eg, hydroxypropyl cellulose, microcrystalline cellulose, gum arabic, sodium carbonates, citric acid). ⁵ Other websites did not provide ingredients (Lucy) or were vague (Rogue, Sesh), stating things such as “sugar-free food grade ingredients” or “sugar-free, vegan, and premium ingredients.” In addition, synthetic coolant agents, such as WS-3, have been identified in ZYN flavors Chill, Smooth, and the minty varieties. ⁶

Box.

Brands, websites, and product characteristics of reviewed nicotine pouches ^a

Brand	Website	Nicotine source
FRĒ	https://frepouch.com/	Not specified (tobacco-leaf free)
FR3SH	https://disposablevapez.com/fr3sh-tobacco-free-nicotine-pouches/	Synthetic
Juice Head	https://pouches.juicehead.co/	Synthetic (nicotine salt)
Lucy	https://lucy.co/	Tobacco-derived
NIC-S	https://nic-s.com/	Synthetic
on!	https://www.onnicotine.com/	Tobacco-derived (nicotine salt)
Rogue	https://www.roguenicotine.com/	Not specified (tobacco-leaf free)
Sesh	https://seshproducts.com/	Synthetic
VELO	https://www.velo.com/	Tobacco-derived
Zone	https://zonepouches.com/	Synthetic
ZYN	https://us.zyn.com/	Tobacco-derived (nicotine salt)

^aWebsites were accessed in April and November 2024.

Physicochemical Characteristics

The pH of NPs differs by brand, with 1 study finding wide variations in pH (6.86-10.1), mass, moisture content (1.1%-99.2%), and percentage of free nicotine (7.7%-99.2%). ⁷ Total nicotine content ranged from 1.29 to 6.11 mg/pouch, with free nicotine ranging from 0.17 to 6.07 mg/pouch. Of 44 NP brands, 43 had an alkaline pH, with a median pH of 8.8. ⁸ The range of pH in NPs allows for the presence of free base and/or protonated nicotine; thus, absorption is influenced across the oral mucosa dependent on the amount of free-base nicotine. ⁹ One study showed that moisture content in smokeless tobacco (SLT) products was in opposition to free-base nicotine; free-base nicotine was as high as 99.1%, but moisture ranged from 4.4% to 8.6%. ¹⁰ The study also showed a median nicotine level in NPs of 9.48 mg/pouch and that 2 NPs had nicotine content >40 mg/pouch. In an industry-conducted study of NPs, nicotine ranged from 1.8 to 47.5 mg/pouch and free-base nicotine ranged from 0.6% to 86%. ⁸

Toxicants

Industry-conducted studies showed low (or nonexistent) levels of tobacco-specific nitrosamines, polycyclic aromatic hydrocarbons, and other tobacco-related toxicants in NPs.^11,12 Low levels were shown of N′-nitrosonornicotine (NNN < 0.4-13.0 ng/pouch), 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone (NNK), N′-nitrosoanatabine (NAT), and N-nitrosoanabasine (NAB). ¹¹ Of 25 tobacco-related toxicants tested, 22 were not quantifiable in NPs or lozenge nicotine replacement therapy (NRT), 20 were not in gum NRT, and 11 were not in snus; tobacco-related toxicants were lower in most NPs than snus. ¹¹ An industry-conducted in vitro study on NPs (Nordic Spirit) indicated that NPs may be nonmutagenic, nongenotoxic, and noncytotoxic, in contrast with combustible cigarettes (hereinafter, cigarettes). ¹³ Research found quantifiable levels of formaldehyde and chromium as well as ammonia, chromium, and nickel in NPs. ¹¹ A laboratory analysis also showed low concentrations of nicotine-related impurities in NPs compared with tobacco products. ¹²

NP Susceptibility and Use

Adolescents

Oral nicotine products, which include NPs, non-NRT nicotine lozenges and gum, and others (eg, gummies), but not SLT products, ¹⁴ are the second-highest endorsed product among US adolescents, behind e-cigarettes. ¹⁵ Adolescents are less susceptible to the use of oral nicotine products (8.7%) than the use of e-cigarettes (19.7%) or cigarettes (15%) ¹⁶ but more susceptible to oral nicotine product use than to SLT use. ¹⁷ Among nationally representative samples of US adolescents, although the prevalence of oral nicotine product use has remained low, use has increased over time (from 3.5% in 2019 to 4.1% in 2021), and the use of NPs may be higher among those who currently use other nicotine products (eg, e-cigarettes) than among those who do not. ¹⁵ Other factors positively associated with oral nicotine product use or susceptibility/willingness to use and use among adolescents have included age,^15,17 sex,^15,16 being non-Hispanic White, ¹⁵ being Hispanic, ¹⁶ sexual orientation,^16,17 and socioeconomic status. ¹⁶

Young Adults

Young adults have a lower prevalence of NP use than e-cigarette use (3.8% in a 2021 survey reported ever using NPs), ¹⁸ and NP use is higher among those who use other nicotine products (eg, SLT) than among those who do not. ¹⁹ Young adults who used e-cigarettes reported interest in oral nicotine products to reduce or quit vaping and indicated more interest in oral nicotine products (vs NRT gum or NRT lozenges) as an e-cigarette cessation aid. ²⁰ Cross-sectional data of US adolescents, young adults, and adults (aged 13-40 y) suggested greater proportions of oral nicotine product use among people aged 21 to 40 years than among people aged 13 to 20 years. ²¹ Other factors associated with NP use have included identifying as male and White (vs Asian). ¹⁹ Although the prevalence of NP use has remained relatively low compared with e-cigarette use among young adults, up to 29% may be susceptible to NP use. ¹⁸

Adults

In a 2017-2018 cross-sectional survey of US adults (conducted by Swedish Match with independent analysis), ²² ZYN NPs were rated as being appealing to only ~10% of adults who reported being never users of tobacco or former users of tobacco; however, 36%, 52%, and 75% of adults who reported current cigarette smoking, current SLT, or concurrent cigarette and SLT use, respectively, found ZYN NPs to be appealing. ²² Similarly, <5% of adults who never or formerly used tobacco reported that they would buy ZYN, whereas 27%, 44%, and 64% of adults who currently smoked, used SLT, or concurrently used cigarettes and SLT, respectively, were likely to buy ZYN. ²²

In a cross-sectional analysis of US adults surveyed in early 2021, 29% were aware of NPs, 6% had ever tried them, and 17% reported interest in using NPs in the next 6 months. ²³ Consistent with previous findings, the prevalence of awareness and use has been higher among those who use other nicotine products (vs those who do not) across surveys occurring since 2017.^22,24,25 Other factors associated with use of oral nicotine products among adults have included younger age, being male, and identifying as White (vs Black). ²⁴

Few studies have examined patterns of NP use among adults. In a 2017-2018 cross-sectional survey among adults who currently used ZYN NPs, most reported everyday use of ZYN and indicated wintergreen and cool mint as the most popular flavors; the most common reasons for use were to quit or reduce the use of other tobacco products, easy to use and conceal, and reduced health risks compared with cigarettes. ²² In a 2022 cross-sectional survey among adults who reported past-30-day use of NPs, respondents reported using NPs an average of 13 days during the past month. ²⁵ ZYN and Lucy were the most popular brands, with mint and tobacco being the most used flavors. The most commonly reported motivation for NP use was flavor availability. ²⁵

NP Use Behavior Among Adults Who Use Tobacco

Few studies on NP use behavior among adults who use tobacco have been published. In an industry-funded work, adults who smoked cigarettes without immediate interest in quitting were recruited into a 6-week daily diary study and provided with 4-mg VELO NPs. ²⁶ All participants reported NP use in the first week, although 16% discontinued use by week 6. Among those who used VELO NPs through the full trial, the average number of NPs used per day increased during the 6-week period. Most participants (82%) reduced cigarette consumption to some extent, although only 16% reduced cigarette consumption by ≥50% and 3% quit smoking. ²⁶ Another industry trial of 6 weeks of ad libitum NP use (on!) by adults who smoked cigarettes or used SLT who were not interested in quitting found that 27% of those who smoked and 71% of those who used SLT had switched to NPs exclusively by the end of the study. ²⁷ An additional 39% of those who smoked and 14% of those who used SLT had reduced tobacco use by 50% to 99%. ²⁷

These industry-funded trials suggested that NPs may help adults who use tobacco to reduce their consumption, although more work is needed to determine whether such effects depend on NP characteristics (eg, brand, nicotine strength, flavor). Whether the reduction in tobacco use is comparable for NPs versus FDA-approved methods for smoking cessation remains unknown.

NP Abuse Liability

NP pharmacokinetics and abuse liability studies have shown both similar and diverging results (Table).^28-33 Some industry research showed lower maximum nicotine concentrations (C_max) for NPs than for cigarettes (eg, 9.0-11.5 vs 16.3 ng/mL), ²⁸ whereas other industry research showed similar or higher C_max for NPs than for cigarettes. ²⁹ Although dose-dependent increases in nicotine delivery were shown in NPs with higher versus lower nicotine content, ²⁹ differences in nicotine delivery were not shown by flavor. ²⁸ Industry-conducted research showed differences in nicotine delivery by brand, ³⁰ with higher C_max after use of Nordic Spirit 9 mg (18.4 ng/mL) and Lyft 10 mg (17.1 ng/mL) compared with ZYN 10 mg (11.0 ng/mL). Time to maximum nicotine concentration (T_max) was longer for NPs than for cigarettes (22-65 vs 7.0-8.5 min).^28-30 Study participants reported a reduced craving for nicotine or increased positive nicotine effects (eg, pleasant, satisfying, calm) with NPs, although not to the same level as with cigarettes.^28,29 One industry study included a 4-hour period of ad libitum use (ie, participants could use as few or as many NPs as they liked, with nicotine level in NPs ranging from 1.5 to 8 mg); the average number of NPs consumed ranged from 6 pouches (for the 8-mg strength) to 18 pouches (for the 1.5-mg strength), and the mean time of use ranged from 29 minutes (for the 1.5-mg strength) to 56 minutes (for the 2-mg strength). ²⁹ The duration of use was consistent with the manufacturer’s recommendations of NP use of up to 1 hour.

Table.

Example pharmacokinetic and pharmacodynamic studies of nicotine pouches, 2020-2023 ^a

Author (year)	Sample	Nicotine pouch product	Administration time	Cmax, ng/mL	Tmax, min c
		Comparison product b
Rensch et al (2021) 28	Adults who smoke cigarettes (N = 41)	On! (6 flavors d ) 4 mg	30 min	Berry: 12.1 (4.8)	Berry: 33.2 (7.9)
		Participants’ usual brand of cigarette	10 puffs, 30-s IPI (5 min total)	17.7 (7.7)	7.9 (3.0)
Liu et al (2022) 29	Adults who dual use smokeless tobacco and cigarettes (N = 29)	On! (mint) 1.5, 2, 3.5, 4, and 8 mgParticipants’ usual brand of cigarettes and smokeless tobacco 2 g	30 minCigarette: 10 puffs, 30-s IPI (5 min total); smokeless tobacco: 30 min	8 mg: 15.4 (5.5)Cigarette: 12.2 (5.5); smokeless tobacco: 9.8 (3.4)	8 mg: 33.9 (5.5)Cigarette: 8.5 (3.6); smokeless tobacco: 34.4 (6.6)
McEwan et al (2022) 30	Adults who dual use smokeless tobacco and cigarettes (N = 35)	Lyft (mint) 10 mg, ZYN (spearmint) 10 mg, Nordic Spirit (mint) 9 mg, Skruf (mint) 8 mg, on! (mint) 6 mg	60 min	Nordic Spirit: 18.4 (30.1) e	Nordic Spirit: 62 (10-120) f
		Pall Mall Red	Ad libitum, 5 min	13.9 (82.7) e	7 (3-20) f
Lunell et al (2020) 31	Adults who used smokeless tobacco (N = 17 in part 1; N = 29 in part 2)	ZYN (Smooth) 3 and 6 mg for part 1 and 8 mg for part 2	60 min	3 mg: 7.7 (6.3-9.0) g ; 6 mg: 14.7 (12.3-17.1) g ; 8 mg: 18.5 (16.1-20.8) g	3 mg: 61 (56-66) g ; 6 mg: 66 (59-72) g ; 8 mg: 59 (55-62) g
		General snus 8 mg for part 1; Longhorn Moist snuff 18 mg and General snus (flavor) 2×8  mg for part 2	60 min	General snus: 10.6 (8.9-12.3) g ; Longhorn: 16.9 (14.4-19.5) g ; General snus (×2): 21.1 (19.0-23.4) g	General snus: 69 (60-78) g ; Longhorn: 65 (58-72) g ; General snus(×2): 63 (58-68) g
Azzopardi et al (2022) 32	Adults who smoke cigarettes (N = 32)	“Test product” nicotine pouch 4 mg	60 min	8.5 (2.1)	1.0 h (0.1-1.5 h) f
		NRT (gum and lozenge), both 4 mg	Gum: 30 min; lozenge: until dissolved (~10 min)	Gum: 4.4 (1.5); lozenge: 8.3 (3.0)	Gum: 0.8 h (0.5-1.3 h) f ; lozenge: 1.0 h (0.2-3.0 h) f
McEwan et al (2023) 33	Adults who smoke cigarettes (N = 41)	VELO (wintergreen) 4 mg, VELO (8 flavors) 7 mg	45  min (move nicotine pouch from one side of mouth to the other about every 10 min)	4 mg: 11.22 (28.7%) h ; wintergreen 7 mg: 17.89 (26.2%) h ; cinnamon: 17.89 (26.2%) h	4 mg: 46.0 (30.0-73.0) f ; wintergreen: 7 mg: 46.0 (30.0-90.0) f cinnamon 46.0 (30.0-90.0) f
		None	NA	NA	NA

Abbreviations: cigarette, combustible cigarette; C_max, maximum concentration; IPI, interpuff interval; NA, not applicable; NRT, nicotine replacement therapy; T_max, time to maximum concentration.

^aListed studies were funded by the tobacco industry. Unless indicated, C_max and T_max values are reported as mean (SD).

^bMeasurements for study product and test product show the strength of the product.

^cShown in minutes unless otherwise indicated.

^dFlavors not listed; however, the greatest value and flavor are indicated for C_max and T_max.

^eGeometric mean (geometric coefficient of variation).

^fMedian (minimum–maximum).

^gMean (95% CI).

^hMean (coefficient of variation).

NPs have also been compared with other oral or SLT products. In a study funded by Swedish Match, the effects of an NP (ZYN, 8 mg) were compared with snus (General snus, 2 × 8 mg pouches; 16 mg total) and moist snuff (American Longhorn, 18 mg) among adults who used conventional SLT products. ³¹ C_max of General snus (21.2 ng/mL) was greater than C_max of NPs (18.5 ng/mL), but C_max levels in NPs were not different from C_max in moist snuff (16.9 ng/mL). However, another study observed higher C_max in a high-dose NP (15.4 ng/mL) than in SLT (9.8 ng/mL). ²⁹ T_max did not differ between products and ranged from 59 to 65 minutes. ³¹ In a study that compared NPs with NRT products among adults who were current smokers, NP C_max (8.5 ng/mL) was comparable with nicotine lozenge C_max (8.3 ng/mL) but higher than nicotine gum C_max (4.4 ng/mL); however, T_max did not differ among products. ³² In addition, participants reported that they “liked” the NP more than oral NRT, although participants also found the nicotine gum more satisfying, better tasting, and more pleasurable in the mouth (eg, enjoyed sensations) than NPs.

NP Health Effects

The health effect profile of NPs has been so far poorly characterized. The lack of combustion, inhalation, and tobacco leaf suggests that NPs may produce less harm than combustible tobacco products; however, NPs may have risks. Concerns about NPs include negative developmental effects of nicotine in adolescence, acute nicotine poisoning, possible health effects of long-term use, and nicotine dependence. ³⁴ Still, NPs may be a potential tobacco harm-reduction tool if unintended harms can be minimized. ³⁵

In an industry study, biomarkers of potential harm linked to smoking-related diseases were lower among a sample of people who used NPs (VELO) than among those who smoked cigarettes, despite higher exposure to total nicotine equivalents for NPs than cigarettes. ³⁶ Levels of total 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL), white blood cell count, carboxyhemoglobin, intracellular adhesion molecule 1 (sICAM1; an inflammatory marker), and 6 biomarkers of exposure (3-HPMA, 3-OH-B[a]P, HMPMA, MHBMA, S-PMA, and NNN) were 22.7% to 97.2% lower for people who used NPs versus cigarettes. Some biomarker levels were similar between people who used NPs and those who never smoked or did not use NPs. Other biomarkers related to oxidative stress (8-Epi-PGF2a) were similar between people who used NPs or smoked cigarettes. A similar industry study assessed biomarkers among adults who smoked cigarettes and switched to NPs (on!), continued smoking, or completely quit all tobacco. ³⁷ After 7 days, biomarkers of exposure (except nicotine) were reduced by 42% to 96% among adults who switched to NPs compared with adults who continued smoking cigarettes, and levels were comparable with adults who quit completely.

With regard to oral health, people who switched from snus to NPs for 6 weeks had reductions in preexisting oral mucosal lesions, and snus increased proinflammatory cytokine production in peripheral blood mononuclear cells compared with untreated or cells exposed to NPs. ³⁸ However, a survey of people who use NPs indicated potential adverse oral events, including mouth lesions, sore mouth, and sore throat. ²⁵ Together, results have suggested lower toxicant profiles for NPs than for other tobacco products.

NP Marketing and Perceptions

Marketing

NPs are marketed by various media, including online, print, radio, television,^39-41 and direct mail, ⁴² with type of media outlet tending to be brand specific. ⁴⁰ From 2018 through April 2020, oral nicotine products accounted for 25% ($18 million) of all SLT advertisement expenditures, behind expenditures for conventional SLT (63%) and ahead of snus (12%), ³⁹ but surpassing conventional SLT by late 2019. From January 2016 through June 2023, advertisement expenditures were primarily among VELO, ZYN, Black Buffalo, and on!, with VELO accounting for nearly 90% of all advertisement expenditures among oral nicotine products. After the FDA CTP was granted regulatory authority over nontobacco nicotine products in April 2022, advertisement expenditures for VELO dropped to $0 and the manufacturer of ZYN became the biggest spender, although advertisement expenditures for ZYN were lower than expenditures for VELO in previous years. ⁴⁰

NPs have been cross-promoted with leading cigarette brands, in which NPs were positioned as a smoke-free and tobacco-free alternative, convenient for use where other product use was not possible, and having various product features (eg, flavors, modernity, use of pharmaceutical terms).^42,43 In the context of sale restrictions for flavored tobacco, ZYN has advertised its products as “flavor-ban approved.” ⁴⁴ Lucy oral nicotine product brands have not been granted remarket tobacco product application (PMTA) orders but are promoted as “PMTA accepted,” implying market authorization when there is none yet. ⁴⁵

Most NP advertisements that featured people included people classified as male^41,43 and White. ⁴³ Atlanta, Houston, and Las Vegas (VELO test markets) were prominent local markets for NP advertising, and spending on NP advertising was greater in the Northwest and Southeast than in other US regions.^39,41 In 4 US states, retail availability of NPs was higher in chain convenience stores (vs other store types) and neighborhoods with a greater percentage of non-Hispanic White residents (vs neighborhoods with a low percentage of non-Hispanic White residents). ⁴⁶ Adults who smoked cigarettes or used conventional SLT thought that the oral nicotine product advertisements may appeal to “youth, new users, tobacco users seeking to cut down/quit” or “high class,” “white-collar” people. ⁴⁷

Perceptions

Among the few studies that directly assessed perceptions of NPs, a 2017 survey of people who used ZYN showed that most people cited relative harm as a reason for initiation; among those who smoked cigarettes, many used ZYN to reduce or quit cigarettes. ²² In 2022, focus groups of adults who used tobacco viewed NPs as having less or similar risk to cigarettes or conventional SLT, ⁴⁷ whereas young adults were unsure about the relative harm. ¹⁸ The use of a “tobacco-free” descriptor has been associated with NPs perceived as less harmful than SLT. ⁴⁸

In a study of Reddit posts on oral nicotine products, most posts (54.2%) had a positive sentiment, 30.3% were neutral, and 15.5% were negative. ⁴⁹ Young adults and adults perceived oral nicotine products as being convenient, concealable, and usable in places where smoking or vaping is not allowed; those who used e-cigarettes (vs those who did not) had a higher prevalence of these beliefs.^20,47 Among young adults who used e-cigarettes, 44.4% expressed interest in using oral nicotine products to reduce or quit vaping.^20,25

Discussion and Public Health Implications

NPs are increasing in prevalence and may appeal to some sociodemographic groups. People who use other nicotine products may be interested in NPs to help reduce or quit their use of other tobacco, although whether NPs can be an effective cessation aid remains unclear. Research in NPs is needed to monitor trends in the prevalence of use, characteristics and patterns of use, transitions between products, factors promoting use, and short- and long-term health effects of use, particularly among adolescents and young adults. The FDA CTP authorizes new tobacco products based on a public health standard that considers the risks and benefits to the US population, including people who use and do not use tobacco. If rigorous data demonstrate that NPs aid in transitioning from more harmful combustible tobacco products, that data must be weighed against the potential that flavored NPs may attract adolescents and young adults or other people who do not use nicotine products. Accurate and consistent measurement of the effects of NPs in an evolving market is an immediate priority. ¹⁴

NPs may deliver amounts of nicotine similar to other tobacco products but deliver nicotine more slowly than cigarettes do but similar to other oral products (ie, SLT, NRT). Between-study differences may have resulted from the various NPs (brands, nicotine strengths) used or study design aspects (eg, length of administration, subjective measures). Additional research is needed to verify the results of industry-funded studies, further understand product characteristics (eg, nicotine strength, pH, flavor) that may influence nicotine delivery and health effects, and translate findings to understand abuse liability and real-world use behaviors. With the consideration that some snus products have received a modified risk marketing order from the FDA CTP, NP manufacturers may also consider applying for similar modified risk claim authorization. However, more robust longitudinal evidence is needed to establish whether these products can meet the public health standard, let alone modified risk standards.

Industry strategies to promote NPs resemble promotion strategies for other noncigarette nicotine products, in which NPs are highlighted as an alternative to existing products and promoted for improved health, innovation, and convenience. Not surprisingly, NPs are perceived by consumers as less harmful than other tobacco products. Although some evidence suggests that NPs may reduce harms compared with cigarettes, additional data are needed to support harm-reduction potential, particularly under real-world use conditions. Continued research is needed to understand the potential toxicity, health effects, abuse liability, and, ultimately, the public health impacts of NPs.