Introduction

Electronic cigarettes (“e-cigarettes”) have transformed from a niche smoking alternative in the late 2000s to a multi-billion dollar industry by the mid-2020s. Nowhere is this more evident than in the United States, one of the world’s largest vape markets, where evolving regulations have tried to keep pace with the rapid rise of vaping. Understanding the U.S. regulatory landscape is critical for stakeholders across the supply chain – especially for Chinese manufacturers and brands, who produce an estimated 95% of the world’s e-cigarettes (Elf Bar and other Chinese e-cigarette makers dodged US customs and taxes | AP News). In recent years, U.S. federal agencies and state governments have introduced a wave of new laws targeting e-cigarettes, spurred largely by concerns over youth usage and public health. These rules have particularly affected the disposable e-cigarette segment, which saw explosive growth by offering consumers convenient, flavored “vape pens” that require no refilling or recharging.

This report provides a comprehensive overview of how U.S. e-cigarette regulations have evolved and analyzes their impact on Chinese disposable vape exporters. We will cover the broad historical context of U.S. e-cigarette policy – from early federal oversight by the Food and Drug Administration (FDA) to aggressive state-level measures like flavor bans in California and New York. We then focus on disposable e-cigarettes, examining how this segment boomed via regulatory loopholes and subsequently drew intense scrutiny. Next, we analyze the implications of these regulatory shifts on Chinese manufacturers and brands that export to the U.S. market, highlighting challenges such as compliance costs, enforcement risks, and shifting market demand. Finally, we offer actionable strategies and recommendations for Chinese vape exporters to adapt to the new environment – from pursuing FDA authorization to diversifying product lines and markets – so they can remain competitive while aligning with regulations.

The goal is to equip international e-cigarette distributors, wholesalers, retailers, and other B2B stakeholders with an up-to-date, detailed understanding of U.S. vape regulations and practical guidance. The tone is informative and data-driven, incorporating real-world case studies, sales data, and expert insights to illustrate key points. In an industry defined by constant change, staying informed and adaptable is essential. With that in mind, let us first review the timeline of U.S. e-cigarette regulation and how we arrived at today’s rules.

Historical Evolution of U.S. E-Cigarette Regulations

Early Years (2007–2015): From Unregulated Products to FDA Oversight. The first e-cigarettes entered the U.S. around 2007 with little regulatory clarity. Initially, the FDA attempted to treat e-cigarettes as drug delivery devices (like nicotine inhalers) and even seized some imports around 2009, but a federal court decision in 2010 (Sottera, Inc. v. FDA) ruled that e-cigs could be regulated as tobacco products rather than as pharmaceutical products, so long as they were marketed for recreational use (Vaping and the FDA: An Updated Timeline). This paved the way for e-cigarettes to fall under the scope of tobacco control laws. In 2009, Congress had passed the Family Smoking Prevention and Tobacco Control Act, giving the FDA authority to regulate cigarettes and smokeless tobacco and also allowing the FDA to “deem” other nicotine products as tobacco products. However, it wasn’t until 2016 that the FDA formally extended its regulatory authority to e-cigarettes and related devices through what is known as the Deeming Rule (Vaping and the FDA: An Updated Timeline).

The 2016 FDA Deeming Rule and Premarket Requirements. On May 10, 2016, the FDA issued its final Deeming Rule, effective August 8, 2016, which brought all Electronic Nicotine Delivery Systems (ENDS) – including e-cigarettes, vape pens, e-liquids, and components – under FDA regulation (Vaping and the FDA: An Updated Timeline). Critically, this meant that any ENDS product not on the market as of February 15, 2007 (the “grandfather” date in the law) would be considered a “new tobacco product” requiring FDA approval to be sold in the U.S. (Vaping and the FDA: An Updated Timeline). Since modern e-cigarettes did not exist in 2007, virtually all e-cig products would require a premarket review. The FDA created the Premarket Tobacco Product Application (PMTA) pathway for manufacturers to seek authorization. Under this mandate, companies needed to submit extensive scientific data demonstrating that their product is “appropriate for the protection of public health” – weighing risks and benefits for the population as a whole (including both users and non-users, such as youth) (Vaping and the FDA: An Updated Timeline) (Vaping and the FDA: An Updated Timeline). Preparing a single PMTA is a lengthy and expensive process, commonly costing from several hundred thousand up to over a million dollars per product (Vaping and the FDA: An Updated Timeline), a burden that would prove challenging especially for small manufacturers. The original compliance policy allowed products already on the market as of 2016 to remain temporarily, with staggered deadlines for PMTA submissions. Initially, the deadline for submissions was set for 2018, but the FDA later postponed it to 2022 under a new administration in 2017 (Action needed on e-cigarettes – Truth Initiative).

Rise of Youth Vaping and Regulatory Backlash (2017–2019). During the late 2010s, e-cigarette use – especially among teenagers – surged dramatically, catching public health authorities by surprise. A new sleek device called Juul (a USB-drive-shaped vaporizer with high-nicotine pods) became a cultural phenomenon around 2017–2018, and youth vaping rates skyrocketed. Public health groups and lawmakers grew increasingly alarmed as surveys showed that current e-cigarette use among U.S. high school students jumped from about 11.7% in 2017 to 27.5% by 2019, an unprecedented rise (China e-cigarette titan behind ‘Elf Bar’ floods the US with illegal vapes | Reuters). The U.S. Surgeon General in late 2018 declared youth vaping an “epidemic.” This mounting concern led to a flurry of proposed regulatory actions. In 2019, several states and cities began implementing their own flavor bans and stricter age sales laws ahead of federal action. Notably, by the end of 2019, Massachusetts became the first state to ban sales of all flavored tobacco products (including menthol cigarettes and flavored vapes), and states like New York, New Jersey, and Rhode Island had moved to ban flavored e-cigarettes (discussed in detail in the state section) (New York’s Flavour Ban Goes Into Effect on July 1st – Vaping Post) (New York Takes Historic Action to… | Campaign for Tobacco-Free Kids). At the federal level, Congress passed, and President Trump signed, a landmark law in December 2019 raising the national minimum age for all tobacco sales from 18 to 21 years (“Tobacco 21”) (New York Takes Historic Action to… | Campaign for Tobacco-Free Kids). This federal age increase took effect immediately and applied to e-cigarettes as well, aligning the law with what many states had already adopted.

The Partial Flavor Ban on Cartridge-Based E-Cigarettes (2020). Alongside legislative changes, federal regulators targeted flavored e-cigarettes through administrative action. In early January 2020, the FDA – under pressure to address youth appeal – issued new enforcement guidance prohibiting many flavored e-cig products. Specifically, as of February 2020 the FDA prioritized enforcement against any flavored, cartridge-based e-cigarettes (the pod-based devices like Juul) except for tobacco or menthol flavors (As sales of flavored e-cigarettes continue to rise, state policies are critical to protecting young people). Fruit, candy, and dessert flavored pods were forced off the market. However, this policy exempted two major categories: (1) disposable e-cigarettes (the guidance explicitly applied to “cartridge-based” products, not single-use disposables) and (2) bottled e-liquids for refillable open-tank systems. The exemption was based on the market at that time – the youth issue was perceived to be mostly with Juul and similar pod systems sold in convenience stores. Unfortunately, this created a loophole that disposable vape brands would soon exploit (As sales of flavored e-cigarettes continue to rise, state policies are critical to protecting young people) (As sales of flavored e-cigarettes continue to rise, state policies are critical to protecting young people). As we will explore, after flavored pod sales were curtailed in 2020, many young consumers simply migrated to flavored disposables, which remained readily available.

In the fall of 2020, another significant regulatory deadline approached: after a court ruling, the FDA’s revised PMTA deadline for existing products was set to September 9, 2020 (moved up from 2022) (Action needed on e-cigarettes – Truth Initiative). By that date, any company wishing to keep its vaping products on the U.S. market had to submit PMTAs to the FDA; otherwise, those products would be considered illegal to sell. Over 6.5 million products (counting each flavor/strength variation separately) were submitted for FDA review by hundreds of companies (FDA Warns Nine Online Firms for Illegally Selling Flavored, Disposable E-Cigarettes | FDA) (FDA Warns Nine Online Firms for Illegally Selling Flavored, Disposable E-Cigarettes | FDA). This flood of applications included everything from major brands to small importers. The FDA was (and still is) tasked with evaluating each to determine if the product is beneficial for adult smokers and not excessively harmful to public health (particularly regarding youth uptake). Notably, many Chinese manufacturers or distributors participated indirectly by supporting U.S. importers’ applications, but few if any disposable vape brands succeeded in these submissions (most did not attempt full submissions for disposables in time).

COVID-19, EVALI, and Interim Trends. In late 2019 and early 2020, an outbreak of vaping-related lung injuries (called EVALI) further shaped perceptions. Though ultimately traced mainly to vitamin E acetate in illicit THC vape cartridges, the EVALI scare prompted some states (like Massachusetts and New York) to impose emergency bans on all vaping products in late 2019 (New York Takes Historic Action to… | Campaign for Tobacco-Free Kids). While these broad bans were temporary, they added momentum to the flavor ban movement. Then, in early 2020, the COVID-19 pandemic struck, and with schools closed and social life disrupted, youth vaping rates actually dipped somewhat in surveys for 2020 and 2021. For example, the National Youth Tobacco Survey showed current e-cig use among high schoolers fell to 19.6% in 2020 and about 11% in 2021 (likely due in part to reduced social opportunities and enforcement of the new flavor restrictions) (China e-cigarette titan behind ‘Elf Bar’ floods the US with illegal vapes | Reuters). However, as life normalized in 2022, youth vaping rebounded – largely driven by disposable flavored vapes that had filled store shelves. By 2022, 14.1% of high school students reported current e-cigarette use (up from 11% in 2021) and an astonishing 85%+ of those users preferred flavored products () (). The stage was set for another wave of regulatory responses.

Recent Federal Actions (2021–2023): Closing Loopholes and Enforcement. The period from 2021 to 2023 saw regulators addressing the loopholes that had allowed disposable vapes and other products to evade rules. One major gap was the rise of synthetic nicotine. After the 2020 flavor guidance and pending PMTA reviews, some companies (like the makers of Puff Bar disposables) switched from tobacco-derived nicotine to lab-made nicotine to claim their products were not “tobacco products” under FDA jurisdiction. This tactic worked for a time – synthetic nicotine vapes were sold widely in 2021 and early 2022 without FDA oversight. Lawmakers took note, and in March 2022 the U.S. Congress amended the law to expand FDA’s authority to all forms of nicotine, effective April 14, 2022 (). The new law gave synthetic nicotine manufacturers a short window (60 days) to submit PMTAs or cease sales, making any non-submitted product illegal by July 2022. Many disposable brands that had been using synthetic nicotine (often made by Chinese firms) theoretically had to stop selling after that date unless they filed applications (very few did). The FDA began issuing Marketing Denial Orders (MDOs) for flavored products – by late 2021 and 2022, the agency had outright denied millions of PMTA applications, especially for flavored e-liquids and vapes, citing lack of evidence that flavored products’ benefit to adult smokers outweighs the risk to youth (). To date, the FDA has authorized only tobacco-flavored (and a few menthol) e-cigarette products – 34 products in total as of the end of 2024 (FDA Warns Nine Online Firms for Illegally Selling Flavored, Disposable E-Cigarettes | FDA). All other products on the market are technically “unauthorized” and illegal to sell without enforcement discretion.

In parallel, the U.S. enacted the Prevent All Cigarette Trafficking (PACT) Act amendments (as part of a COVID relief bill signed in Dec 2020) that ban mailing of vaping products via U.S. Postal Service and impose strict requirements on online sales. By late March 2021, the USPS finalized rules prohibiting shipment of ENDS to consumers (PACT ACT acceptance procedures) (PACT ACT acceptance procedures). Private carriers like UPS, FedEx, and DHL also adopted policies against shipping vaping products to consumers. This effectively shut down or severely complicated direct-to-consumer online sales from domestic or overseas sellers, forcing most sales into physical retail channels or specialized delivery networks that comply with PACT’s age verification and state tax reporting rules (PACT ACT acceptance procedures). Chinese exporters who previously shipped products directly to U.S. customers faced new hurdles, as we’ll discuss later.

By 2023, enforcement began focusing squarely on the disposable vape problem. The FDA and U.S. Customs ramped up efforts to identify and seize unauthorized products at the border. In May 2023, the FDA took the notable step of placing the leading disposable brand Elf Bar (made by Shenzhen-based iMiracle and distributed by Heaven Gifts in China) on an import red alert, notifying customs to detain those shipments (China e-cigarette titan behind ‘Elf Bar’ floods the US with illegal vapes | Reuters). In December 2023, U.S. authorities announced the first large public seizure of Elf Bar products: 1.4 million flavored e-cigarettes from China worth approximately $18 million were confiscated (Elf Bar and other Chinese e-cigarette makers dodged US customs and taxes | AP News) (Elf Bar and other e-cigarette makers dodged US customs and taxes after China’s ban on vaping flavors – Hawaii Tribune-Herald). Moreover, the FDA has issued hundreds of warning letters and even started issuing fines to U.S. retailers selling illicit disposables (China e-cigarette titan behind ‘Elf Bar’ floods the US with illegal vapes | Reuters) (China e-cigarette titan behind ‘Elf Bar’ floods the US with illegal vapes | Reuters). Still, the sheer volume of new brands and shipments has made enforcement a game of whack-a-mole, as we will see in the case studies. As of December 2024, the FDA reported it had sent over 700 warning letters to manufacturers or distributors and over 800 warning letters to retailers for unauthorized vape product sales, and filed dozens of civil penalty cases (FDA Warns Nine Online Firms for Illegally Selling Flavored, Disposable E-Cigarettes | FDA). FDA officials openly acknowledge that their resources are stretched thin and that they currently lack authority to collect user fees from vape manufacturers to fund greater enforcement (China e-cigarette titan behind ‘Elf Bar’ floods the US with illegal vapes | Reuters).

In summary, U.S. federal regulation of e-cigarettes evolved from a hands-off approach in the early 2010s to a strict regime by the mid-2020s that: (a) requires pre-approval for any product (with very few approvals granted so far), (b) banned flavors in certain product formats and raised the tobacco age to 21, (c) closed the synthetic nicotine loophole, and (d) restricted mail shipping of vaping products. However, gaps in implementation and enforcement delays allowed an unregulated gray market – especially of flavored disposables largely produced in China – to flourish even as formal regulations tightened. Next, we will examine state-level regulations, which add another layer of complexity for vape exporters to navigate.

State-Level Regulations: A Patchwork of Policies

While the FDA sets baseline rules nationwide, individual states (and some cities) have enacted their own e-cigarette regulations that can be even more stringent. For Chinese exporters, this creates a patchwork of state laws to understand when their products enter different U.S. markets. We will focus on major state-level regulations, particularly flavor bans in key states like California and New York, and briefly note others.

Flavor Bans in California: California is the most populous U.S. state and a trendsetter in tobacco control policy. In 2020, California’s legislature passed SB 793, a law banning the sale of virtually all flavored tobacco products (including flavored e-cigarette cartridges and e-liquids) in retail stores. This law was put on hold after the tobacco industry funded a referendum (Proposition 31) to overturn it, but in November 2022 California voters overwhelmingly approved Proposition 31, thereby upholding the flavor ban (Proposition 31 passes in California: flavored tobacco will be banned : NPR). As a result, as of December 2022, it became illegal in California to sell any flavored e-cigarette products – including menthol flavors – in brick-and-mortar stores (the law covers in-person sales; online sales into CA were already constrained by shipping rules). Public health advocates hailed this as a huge victory and hoped more states and even the federal government would follow (Proposition 31 passes in California: flavored tobacco will be banned : NPR) (Proposition 31 passes in California: flavored tobacco will be banned : NPR). The ban’s scope is broad: it prohibits flavors in e-liquids and devices (except tobacco flavor). California’s law also included menthol cigarettes in the flavor ban, demonstrating the state’s commitment to a comprehensive approach. Early data suggest the ban has significantly reduced sales of flavored vapes in California, as intended – one analysis found e-cigarette unit sales in California dropped over 40% in the year after the flavor ban’s implementation (). For Chinese exporters, this means that as of 2023, any flavored disposable (e.g. mango, mint, cola) cannot be sold through California retailers, removing or restricting access to one of their biggest state markets. Exporters who still ship flavored products to California risk them being unsellable (or only sold illicitly under-the-counter). Some companies have responded by producing California-compliant versions (tobacco-flavored only) or by avoiding distribution to California altogether in favor of states with no flavor restrictions.

Flavor Ban in New York: New York State took aggressive action even earlier. In April 2020, amid the height of the youth vaping furor and an EVALI lung injury scare, New York’s budget bill for FY2021 included a provision banning the sale of all flavored e-cigarettes statewide (New York’s Flavour Ban Goes Into Effect on July 1st – Vaping Post) (New York’s Flavour Ban Goes Into Effect on July 1st – Vaping Post). The law (effective May 18, 2020) prohibited flavors except tobacco flavor; it did allow that if a product ever obtained FDA premarket approval, flavored versions of that product could be sold, but at the time none existed (New York’s Flavour Ban Goes Into Effect on July 1st – Vaping Post). New York’s ban also uniquely banned all tobacco product sales in pharmacies and ended discount coupons for tobacco (New York’s Flavour Ban Goes Into Effect on July 1st – Vaping Post). By implementing this through the budget, New York became the fourth state to enact a flavor ban (after smaller states like Rhode Island and ahead of California) (New York’s Flavour Ban Goes Into Effect on July 1st – Vaping Post) (New York Takes Historic Action to… | Campaign for Tobacco-Free Kids). New York City had already banned flavored vapes (excluding menthol) in 2019, so the state law expanded restrictions statewide. As of mid-2020, retailers in New York cannot sell flavored disposable vapes or refill liquids; only tobacco (and menthol, if considered not a “flavor” under state law – New York’s law did exclude menthol cigarettes from the ban on flavored tobacco, but for e-cigs it banned all non-tobacco flavors including menthol vape liquids) (New York Takes Historic Action to… | Campaign for Tobacco-Free Kids). For Chinese brands, New York’s stance meant products like fruit-flavored disposables were barred, cutting off another huge market unless they stick to tobacco-flavored SKUs for New York. Some distributors still pushed product into New York illicitly, but they face state enforcement. New York also imposed a substantial excise tax on e-liquids (as do many states), which can drive up retail prices of imported products.

Other States with Flavor Restrictions: Following the pioneering moves of states like Massachusetts (which in November 2019 passed the nation’s first full flavor ban including all tobacco products) and the early 2020 bans in New Jersey, Rhode Island, and New York, at least seven U.S. states have some form of flavor ban as of 2023 (E-cigarettes: Facts, stats and regulations – Truth Initiative). New Jersey in January 2020 enacted a law banning flavors in vapes (except tobacco flavor), coinciding with a menthol cigarette ban proposal that ultimately did not pass at that time. Rhode Island’s Department of Health issued regulations in late 2019 banning flavored e-cigarette liquids, which were later made permanent. Massachusetts remains the strictest: its law (effective June 2020) not only banned all flavored e-cigs but also menthol cigarettes and flavored smokeless tobacco, and it imposed a 75% excise tax on e-cigarettes. For Chinese exporters, Massachusetts is essentially off-limits for any flavored product and even unflavored products carry heavy tax marks. Other locales like Washington, D.C. have also banned flavored e-cig sales (D.C.’s ban went into effect in 2022). Meanwhile, some states without flavor bans have pursued other regulatory measures: many have raised the age to 21 (now moot due to the federal T21 law), require retail licenses for vape sellers, restrict online sales (e.g., South Dakota bans direct internet sales of vaping products to consumers), or have clean indoor air laws that include vaping.

This patchwork means that a Chinese manufacturer’s product might be sellable in, say, Texas or Florida, but not in Massachusetts or California. Notably, Texas and Florida, large states with significant vape markets, have not implemented flavor bans at the state level (though some localities tried). Florida’s legislature actually passed a ban on flavored e-liquids in 2020, but it was famously vetoed by the governor over concerns it would drive adults back to smoking. Such divergence underscores why Chinese exporters must track state-level developments: a product line consisting of 10 flavors might effectively only be legal in perhaps half the country’s jurisdictions.

Taxation and Other Measures: In addition to outright bans, states have imposed taxes on vaping products that vary widely. For instance, California instituted a nicotine-based tax that, as of 2022, roughly doubled the price of nicotine e-liquids (California’s tax is proportionate to the tax on traditional cigarettes, leading to a high ad valorem rate). Minnesota and Maryland tax e-cigarettes as well, which can influence consumer behavior (higher prices might deter some users or push them to black-market purchasing). States also differ on whether they allow vaping in public indoor spaces, with some treating e-cigs like cigarettes under smoke-free laws. While these measures don’t directly prohibit sales, they can impact the attractiveness and ease of selling in those markets.

In summary, major states like California, New York, New Jersey, Massachusetts, and others have enacted laws that ban flavored e-cigarettes and otherwise tighten the sale of vaping products. For Chinese disposable vape exporters, these state policies mean that even if a product slips past federal enforcement, it might still face state-level legal barriers in a significant portion of the U.S. market. Exporters must tailor their distribution strategy (for example, focusing on flavor-allowed states or offering compliant versions) accordingly. The next section delves into the disposable e-cigarette segment – the very product type most often targeted by these flavor bans and the category that has seen explosive growth (largely supplied by Chinese manufacturers) in recent years.

The Rise of Disposable E-Cigarettes and Regulatory Loopholes

Disposable e-cigarettes are single-use vaping devices pre-filled with e-liquid and integrated with a battery, designed to be discarded once the liquid is exhausted. They require no charging or refilling by the user. This category existed in earlier forms (the first e-cigs were often disposables mimicking cigarettes, known as “cigalikes”), but modern disposables evolved to contain larger e-liquid volumes, higher nicotine strengths (often using nicotine salt formulations for smoother intake), and a vast array of sweet flavors. Around 2019–2020, disposables were a relatively small part of the market – the Juul-style pod systems dominated. But when regulators and Juul itself removed most pod flavors in late 2019, disposable vape sales soared as consumers and many underage users shifted to them. From 2020 to 2023, disposable e-cigarettes went from the margins to the most popular type of e-cigarette in the U.S. market, especially among youth.

Disposable Sales Skyrocket: Data from retail surveys illustrate this boom. According to a CDC Foundation analysis, from February 2020 to December 2023, disposable e-cigarette unit sales in the U.S. jumped by 212% – from about 4.1 million units to 12.7 million units sold in a typical four-week period (). By the end of 2023, disposables made up 57.2% of all e-cig sales nationally by unit share (). (For context, in January 2020 disposables were only ~24-26% of the market ( E-cigarette sales surge to more than 22 million units per month ), meaning their share more than doubled.) This aligns with reports from industry analysts: Truth Initiative noted a 541% increase in disposable sales between 2019 and 2023 (As sales of flavored e-cigarettes continue to rise, state policies are critical to protecting young people). The driver was clearly flavored disposables – as of Dec 2023, over 77% of disposable sales were in flavors other than tobacco or menthol (). Popular flavor profiles include fruits (mango, berry, apple, etc.), candies, mint/ice, and even creative mixes like “rainbow candy” or “blue razz lemonade.” These flavors are highly appealing to younger consumers, which explains why disposables became “the most commonly sold device on the market” but also the most problematic from a public health perspective (As sales of flavored e-cigarettes continue to rise, state policies are critical to protecting young people).

Youth Usage of Disposables: National youth surveys confirm that the disposable craze is heavily intertwined with underage vaping. In 2022, among middle and high school students who vaped, 54% reported usually using disposable e-cigarettes (far outpacing the 25% who used refillable pods, the next most common type) (Tobacco Trends Brief: Overall Tobacco Trends Brief | American Lung Association). In 2023, that figure grew – the CDC reported 60.7% of youth e-cigarette users in 2023 used disposables (). Moreover, the brand preferences of teens shifted to disposables. Whereas Juul was dominant circa 2018, by 2022 and 2023 new disposable brands took over. One FDA study of 2022 found that Elf Bar – a disposable brand – had become the number one brand among U.S. youth e-cig users, chosen by 56.7% of middle/high school vapers surveyed (China e-cigarette titan behind ‘Elf Bar’ floods the US with illegal vapes | Reuters). (Elf Bar essentially came out of nowhere; it was introduced around 2021 and within a year overtook the market due to its appealing flavors and ease of use.) Other disposable brands popular with youth included Puff Bar, Hyde, and Breeze. This youth appeal is exactly what triggered regulatory responses like the flavor bans and enforcement actions described earlier.

Why are disposables so attractive, beyond flavors? Several reasons: They’re easy to use (no maintenance), often cheap (as low as $10-$20 each, delivering as many puffs as a pack or more of cigarettes), highly potent (many contain 5% nicotine salt which can be equivalent to a couple packs of cigarettes worth of nicotine, and some devices boast 3,000–5,000 puffs (China e-cigarette titan behind ‘Elf Bar’ floods the US with illegal vapes | Reuters)), and were widely available in convenience stores, smoke shops, and gas stations. Disposables also benefited from a degree of anonymity – prior to mid-2022 they weren’t easily traceable via FDA registration because many importers didn’t submit their product info in the rushed PMTA process.

Loopholes and Gaps Exploited: The rise of disposables was facilitated by specific regulatory gaps in 2019–2021. The first was the aforementioned FDA flavor guidance in January 2020 that exempted disposables. Almost immediately after Juul and others pulled their sweet pod flavors off the market, new disposable brands like Puff Bar began flooding stores with flavors like O.M.G. (Orange Mango Guava) and Blue Razz. Indeed, a former FDA official noted: “The steps toward regulating disposables have been very weak and that has enabled this problem to get bigger and bigger.” (Elf Bar and other Chinese e-cigarette makers dodged US customs and taxes | AP News). Another gap was the synthetic nicotine loophole in 2021 – Puff Bar took advantage of this by re-launching in early 2021 claiming to use synthetic nicotine, thus avoiding FDA oversight until the law changed in 2022. Many other disposable brands followed suit, labeling their products as containing “tobacco-free nicotine.” The result was a Wild West market in 2021 and early 2022 where these disposables were sold openly despite technically violating the spirit of the law.

Even after the synthetic nicotine law, enforcement took time to ramp up. Many disposable importers simply ignored the requirement to submit PMTAs by May 14, 2022, gambling (correctly, to an extent) that FDA did not have the immediate capacity to police every convenience store. Some brands rebranded or slightly tweaked their products to stay ahead of any impending bans. For example, when FDA started targeting Puff Bar, new brands like Air Bar, Bidi Stick, Mr. Fog etc. appeared. And when Elf Bar gained notoriety in 2022, by 2023 we saw devices labeled “EB Create” or “Lost Mary” – which were essentially Elf Bar under a new name to evade detection (Elf Bar’s manufacturer changed the U.S. branding due to a trademark issue and regulatory attention) (Elf Bar and other Chinese e-cigarette makers dodged US customs and taxes | AP News).

Furthermore, disposable makers have been disguising products and shipments. Reports show that Chinese exporters mislabeled vape shipments as “battery chargers,” “flashlights,” “toys,” or other innocuous items to slip past customs (Elf Bar and other Chinese e-cigarette makers dodged US customs and taxes | AP News) (Elf Bar and other Chinese e-cigarette makers dodged US customs and taxes | AP News). Some devices themselves are made to look like everyday objects – there have been disposable vapes designed to resemble highlighters, pens, or USB sticks so that a student could hide them in plain sight (Disposables Accounted for 74% of China’s Total Vape Exports to the U.S. in 2023’s First Half – Vaping Post). This level of subterfuge underscores both the ingenuity and the regulatory challenge: standard enforcement methods were easily dodged.

Product Innovation and Trends: Modern disposables contain features unheard of a few years ago: large puff counts (3,000+ puffs) made possible by bigger batteries and e-liquid reservoirs, and even rechargeable disposables (devices that can be recharged via USB but not refilled with liquid – so they are still “disposable” once the liquid is done). The Elf Bar BC5000 is an example, containing 13 mL of e-liquid and a rechargeable battery to ensure all liquid can be used – offering about 5,000 puffs per unit (China e-cigarette titan behind ‘Elf Bar’ floods the US with illegal vapes | Reuters). These effectively blurred the line between disposables and traditional refillable devices, but they maintained the convenience of no-refill. Chinese manufacturers led this innovation wave, as they iterated designs at a rapid pace in their highly competitive domestic industry.

By delivering what consumers (including youth) wanted – ease of use, high nicotine, flashy flavors – disposables captured a huge market before regulators fully caught up. However, this success has a flip side: it put disposables squarely in the regulatory crosshairs. Health authorities blame disposables for undermining the gains of earlier regulations. Consequently, as noted, FDA and state actions since 2022 have increasingly focused on eliminating flavored disposables. Some other countries are following suit (the report mentioned governments from Australia to England moving to ban single-use vapes for youth and environmental reasons (Elf Bar and other Chinese e-cigarette makers dodged US customs and taxes | AP News)).

In the U.S., as of 2025 the situation is somewhat paradoxical: By law, virtually all disposable e-cigarettes on the U.S. market are illegal (none have FDA authorization, and most are flavored which is banned in several states), yet they remain widely available in many stores. This tension sets the stage for enforcement showdowns and significant market disruptions, which directly impact Chinese exporters supplying these products. In the next section, we examine exactly how these regulatory shifts – federal and state – have affected Chinese manufacturers and exporters of disposable vapes.

Impact on Chinese Disposable Vape Exporters

China is the undisputed manufacturing hub of the global vaping industry. The vast majority of vape devices – including disposables – are produced in China’s Shenzhen region, often by original design manufacturers who produce for multiple brands. As U.S. regulations tightened, Chinese companies have had to adapt their strategies and expectations for the American market. Here we analyze several key impacts on Chinese disposable vape exporters: market opportunity vs. legal risk, compliance and costs, competitive dynamics, and enforcement actions hitting exporters.

Reliance on the U.S. Market and Growth vs. Risk: The United States has been one of the largest export destinations for Chinese e-cigarette makers. In the first half of 2023, China’s e-cigarette and related product exports were valued at $5.48 billion – a 29.9% jump from the year prior, largely attributed to overseas demand for disposables after China’s own domestic flavor ban (China e-cigarette titan behind ‘Elf Bar’ floods the US with illegal vapes | Reuters). Notably, about 74% of China’s vape product exports to the U.S. in H1 2023 were disposable vapes, amounting to roughly $1.1 billion in value (Disposables Accounted for 74% of China’s Total Vape Exports to the U.S. in 2023’s First Half – Vaping Post). This indicates how central the U.S. disposable boom has been to Chinese suppliers. Companies like Shenzhen iMiracle (maker of Elf Bar) and Heaven Gifts saw huge revenue from the U.S. – one dataset shared with Reuters showed that Heaven Gifts’ fruity disposables (Elf Bar and its sister brands) amassed over $650 million in U.S. sales in the 12 months ending October 2023, capturing an estimated 9% of the entire U.S. e-cig market (China e-cigarette titan behind ‘Elf Bar’ floods the US with illegal vapes | Reuters). Chinese exporters essentially rode a wave of high demand and relatively weak enforcement to rapidly grow their shipments to America.

However, this also means Chinese firms are deeply exposed to U.S. regulatory risk. If U.S. policies are enforced to the letter, much of that business could vanish overnight. A dramatic example: RLX Technology (RELX) – a leading Chinese vape brand – took a compliance-focused approach, investing millions since 2020 on FDA-required studies for its products, only to find itself stuck in regulatory limbo with no U.S. product approvals and a collapsed Chinese domestic market; RLX’s valuation plummeted from $35 billion at IPO to around $3 billion by late 2023 (China e-cigarette titan behind ‘Elf Bar’ floods the US with illegal vapes | Reuters) (China e-cigarette titan behind ‘Elf Bar’ floods the US with illegal vapes | Reuters). Meanwhile, competitors like Heaven Gifts/Elf Bar ignored U.S. rules and made hefty profits in the short term (China e-cigarette titan behind ‘Elf Bar’ floods the US with illegal vapes | Reuters) (China e-cigarette titan behind ‘Elf Bar’ floods the US with illegal vapes | Reuters). But that strategy is catching up: once FDA put Elf Bar on import alert in mid-2023, Heaven Gifts had to halt using the Elf Bar name and even announced it would “go offline” (though it appears they continue operations quietly) (Elf Bar and other Chinese e-cigarette makers dodged US customs and taxes | AP News) (Elf Bar and other Chinese e-cigarette makers dodged US customs and taxes | AP News).

Compliance Burdens and PMTA Costs: For Chinese manufacturers to legally continue selling in the U.S. long-term, they would need to obtain FDA authorization for their products. This is a daunting task. As noted, the PMTA process is costly and complex. A Chinese company would need either a U.S. subsidiary or a partner to file applications, conduct lab tests (for ingredients, aerosol emissions, etc.), toxicological risk assessments, behavioral studies on use patterns, and perhaps clinical studies – all to persuade FDA that their product helps adult smokers enough to outweigh youth risks. So far, FDA has been extremely reluctant to authorize any flavored products. In fact, the FDA has not authorized a single fruit- or sweet-flavored e-cigarette as of early 2025; only tobacco flavors (and a couple menthol) by big companies have passed. This suggests that a Chinese disposable brand’s chances of getting, say, a “Mango Ice 5%” disposable approved are effectively near-zero under current standards. Even a tobacco-flavored disposable might be a hard sell unless the company can demonstrate strict youth access controls or other special mitigations.

Thus, many Chinese firms faced a choice: invest millions with no guarantee of approval, or continue selling without approval and risk enforcement. Most opted for the latter (at least until enforcement hit). For instance, Geek Bar, Lost Mary, HQD, and others continued distribution without FDA authorization. By late 2024, the FDA began sending warning letters to some manufacturers (one warning in December 2024 targeted a manufacturer of Geek Bar and others) (FDA Warns Nine Online Firms for Illegally Selling Flavored, Disposable E-Cigarettes | FDA) (FDA Warns Nine Online Firms for Illegally Selling Flavored, Disposable E-Cigarettes | FDA), but many Chinese producers are beyond FDA’s direct reach – the FDA cannot easily fine or arrest foreign company executives. As FDA’s Center for Tobacco director Dr. Brian King admitted, “We can’t levy penalties or file lawsuits against foreign companies” and the agency’s resources are limited in stopping the flow at the border (China e-cigarette titan behind ‘Elf Bar’ floods the US with illegal vapes | Reuters) (China e-cigarette titan behind ‘Elf Bar’ floods the US with illegal vapes | Reuters). This has emboldened some Chinese exporters to keep shipping despite the rules, essentially treating occasional seizures as a cost of doing business. They also frequently rebrand products to stay ahead. For example, when “Elf Bar” became flagged, iMiracle renamed U.S. versions to “EBCreate” and also pushed its sub-brand “Lost Mary” more – attempting to claim that any Elf Bar-branded products in the U.S. were “counterfeits” after they announced stopping Elf Bar shipments (Elf Bar and other Chinese e-cigarette makers dodged US customs and taxes | AP News) (Elf Bar and other Chinese e-cigarette makers dodged US customs and taxes | AP News). Similarly, other companies introduce new brand names if one gets too hot (e.g., if Geek Bar were targeted, you might see “Geek Bear” or other knockoff names pop up). This cat-and-mouse game is a hallmark of the current impact: it forces Chinese exporters to be agile and sometimes covert, rather than building stable brand equity in the U.S.

Import Bans, Seizures, and Distribution Challenges: A tangible impact on Chinese exporters is the increased seizure of shipments by U.S. Customs. Once an import alert is issued (as happened for Elf Bar in May 2023), customs agents actively look for and detain those products. Reuters reported that on Nov 6, 2023, officials stopped a shipment from a company linked to Elf Bar’s manufacturer (China e-cigarette titan behind ‘Elf Bar’ floods the US with illegal vapes | Reuters). In December 2023 came the publicized seizure of 1.4 million units (which included Elf Bar and other brands) (Elf Bar and other Chinese e-cigarette makers dodged US customs and taxes | AP News). Chinese companies have responded by trying to ship under different descriptions or using third-party reshippers. According to AP investigative reports, Chinese vape exporters routinely falsified customs paperwork – declaring vape cargo as other electronics to avoid detection (Elf Bar and other Chinese e-cigarette makers dodged US customs and taxes | AP News). Heaven Gifts even openly advertised “discreet shipping” on its website, not labeling packages with its company name or mentioning e-cigarettes, and undervaluing the invoices to reduce customs scrutiny or taxes (Elf Bar and other Chinese e-cigarette makers dodged US customs and taxes | AP News). These practices, once secret, are now coming to light and may prompt U.S. authorities to crack down harder. As U.S. Customs gets more data (the FDA in 2023 started sharing lists of unauthorized products), it becomes riskier for Chinese exporters to ship large consignments. One immediate effect is Chinese firms might split shipments into smaller lots, use air freight under personal allowance limits, or route through intermediaries – all of which increase shipping costs and complexity.

Moreover, the PACT Act’s implementation means even after clearing customs, distributing to retailers involves more hurdles: products must go through distributors who ensure state taxes are paid and that deliveries comply with the no-mailing rules (usually requiring expensive private hazmat-certified carriers for nicotine). Many traditional wholesalers have avoided dealing in blatantly illegal products, leaving distribution to a shadow network of smaller, sometimes fly-by-night wholesalers. For Chinese manufacturers, this means less stable distribution channels, potential payment risks, and reliance on partners who may disappear if enforcement hits. Some U.S. convenience store chains have begun to voluntarily stop selling the most egregious illicit disposables after FDA fines – which can shrink the retail footprint available for Chinese brands. For example, by late 2023, over 300 U.S. retailers were warned by FDA about selling Elf Bar, and at least 60 were issued fines, many being gas station stores (China e-cigarette titan behind ‘Elf Bar’ floods the US with illegal vapes | Reuters) (China e-cigarette titan behind ‘Elf Bar’ floods the US with illegal vapes | Reuters). Large chains do not want that liability, so they drop those products, which then pushes them into more marginal outlets.

Competitive Impact and Industry Shake-Out: The regulatory environment is also reshaping competition. Large multinational tobacco companies (like BAT/Reynolds, Altria, NJOY) that have complied with FDA requirements are now lobbying hard to eliminate the “rogue” Chinese imports that undercut them (China e-cigarette titan behind ‘Elf Bar’ floods the US with illegal vapes | Reuters) (2FIRSTS | Reuters Reveals BAT’s Letter to Trump Urging Vape Ban: What It Means for China’s Supply Chain). In fact, in early 2025, it was reported that Reynolds American (BAT’s U.S. arm) petitioned the U.S. Trade Representative to ban disposable vape imports from China entirely, citing unfair competition and illegal trade practices (2FIRSTS | Reuters Reveals BAT’s Letter to Trump Urging Vape Ban: What It Means for China’s Supply Chain). They estimated ~70% of the $12.9 billion U.S. vapor market was unauthorized disposables (mostly from China) (2FIRSTS | Reuters Reveals BAT’s Letter to Trump Urging Vape Ban: What It Means for China’s Supply Chain). If such trade actions gain traction, Chinese exporters could face blanket import bans or high tariffs. (Tariffs are another factor: since 2018, U.S. tariffs of 25% have applied to many Chinese e-cig devices (Chinese Vape Tariff Hits 35% as U.S.-China Trade War Escalates – Ecigator), raising costs. Rumors of additional tariffs specifically on vapes have circulated as trade tensions persist, which would make Chinese products pricier and less competitive unless they relocate production.)

We are already seeing winners and losers: Companies that tried to play by the rules (like RLX) have not been able to monetize the U.S. at all and lost market share to the rule-breakers (China e-cigarette titan behind ‘Elf Bar’ floods the US with illegal vapes | Reuters) (China e-cigarette titan behind ‘Elf Bar’ floods the US with illegal vapes | Reuters). But those rule-breakers now face a reckoning as enforcement ramps up, possibly leveling the playing field or even favoring domestic players with authorized products. The Chinese firms that disregarded regulations thrived in the short term – e.g., Heaven Gifts’ market share put it just behind Vuse and Juul in the U.S. (China e-cigarette titan behind ‘Elf Bar’ floods the US with illegal vapes | Reuters) – yet this came at the cost of now being a prime target of authorities and competitors. Meanwhile, some Chinese OEM manufacturers that supply components to authorized brands (for instance, SMOORE, a major Shenzhen manufacturer, reportedly supplies ceramic coil technology to Reynolds’ Vuse devices) might see more stable business if crackdowns push consumers to the legal products that they quietly help manufacture. Thus, regulatory changes are shifting revenue streams: directly exporting branded disposables to the U.S. is high risk/high reward and possibly unsustainable, whereas aligning with compliant supply chains or focusing on less-regulated markets might be safer.

Environmental and Other Concerns: A side note – the proliferation of disposables has raised environmental concerns due to littered lithium batteries and plastic waste. While not yet a primary driver of U.S. law, this concern is growing (some countries like the UK are weighing environmental bans on disposables (Elf Bar and other Chinese e-cigarette makers dodged US customs and taxes | AP News)). Chinese makers might eventually need to address this (e.g., recycling programs or designing devices for disassembly) if they want to avoid further negative press that could lead to local sales restrictions (some U.S. municipalities are exploring environmental rules on single-use vapes). Forward-thinking exporters may pre-emptively adapt, but many have not yet due to focus on immediate sales.

In essence, Chinese disposable vape exporters have been both beneficiaries and victims of U.S. regulatory swings. Beneficiaries, in that gaps allowed them rapid growth and dominance in 2020–2022; victims, in that the tightening noose now threatens that business model. They face issues of legal uncertainty, potential loss of key markets (with flavor bans carving out big states), costs of compliance they mostly haven’t budgeted for, and increased friction (tariffs, shipping hassles, seizures) in getting products to U.S. customers. The next and final section of this report will offer strategies and recommendations for these exporters to navigate the new landscape – essentially, how to adapt to survive and thrive under stricter U.S. regulations.

(Elf Bar and other e-cigarette makers dodged US customs and taxes after China’s ban on vaping flavors – Hawaii Tribune-Herald) Figure: A display of Elf Bar disposable vapes, one of the top-selling Chinese brands, in a Washington D.C. shop in 2023. Elf Bar’s 5,000-puff devices with flavors like “Rainbow Candy” became hugely popular in the U.S., but also drew the ire of regulators. In late 2023, U.S. authorities seized 1.4 million Elf Bar units as illegal products (Elf Bar and other Chinese e-cigarette makers dodged US customs and taxes | AP News), exemplifying the growing enforcement against Chinese disposables.

Strategies and Recommendations for Chinese Exporters

Facing the strong headwinds of U.S. regulations, Chinese disposable vape exporters must adapt or risk irreparable loss of the market. Below are actionable strategies and recommendations for these companies to navigate the new regulatory environment:

1. Pursue Regulatory Compliance (Where Feasible): It may be tempting to continue operating under the radar, but the window for that is closing. Chinese manufacturers should seriously evaluate investing in the FDA Premarket Tobacco Application (PMTA) process for at least their flagship products. While costly, obtaining FDA authorization would provide a legitimate, long-term foothold in the U.S. market. One practical approach is to focus on a tobacco-flavored or menthol product – since FDA has signaled openness to those – and seek approval for that first. A successfully authorized device (even if unflavored) could later open the door to line extensions if science and policy ever allow flavors. Exporters should partner with U.S.-based regulatory consultants and laboratories to navigate PMTA requirements. Pooling resources through an industry consortium is another idea – several companies could jointly fund research on common device components (for example, toxicity of certain coils or plastics) to support multiple applications. Yes, the upfront cost is high, but consider it an R&D investment akin to what pharmaceutical or consumer product companies undertake to ensure access to major markets. In contrast, continuing purely illegal sales runs the risk of sudden elimination (as seen with recent FDA import bans). In the Reuters profile, RELX’s strategy of complying did not pay off quickly (China e-cigarette titan behind ‘Elf Bar’ floods the US with illegal vapes | Reuters), but in the long run, being among the few with approved products (if they achieve that) could be immensely valuable – especially if competitors get forced out (China e-cigarette titan behind ‘Elf Bar’ floods the US with illegal vapes | Reuters). Chinese firms should also proactively implement youth prevention measures (like serial numbering for tracking, mystery shopper programs for retailers, and robust age-verification tech for any online marketing) and include those in their FDA submissions to demonstrate responsibility.

2. Develop U.S.-Specific Product Lines (Tobacco/Unflavored Options): Given the flavor bans in many states and FDA’s stance, Chinese brands should formulate versions of their disposables in tobacco flavor (and possibly menthol) to sell legally in flavor-ban jurisdictions. While tobacco flavor vapes are a small share of current sales (because consumers prefer sweet flavors), there is still a market among adult ex-smokers. Having a “50-state legal” product could be a selling point when pitching to large distributors or convenience store chains who are now wary of illegal inventory. Some companies have already started this – for instance, after Massachusetts banned flavors, certain wholesalers stocked tobacco-only disposable SKUs for that state. Additionally, consider launching devices with zero nicotine for markets where nicotine is the regulated component. A 0% nicotine disposable with a flavor might avoid FDA tobacco product regulation (though states like California still ban all flavored “tobacco products” broadly, which might include zero-nicotine e-cigs as well). At the federal level, nicotine-free vapes currently aren’t under FDA tobacco authority; however, they might then fall under other regulations (consumer product safety, etc.). This is a gray area some companies are testing. It’s not a huge market yet, but could be a niche to explore (e.g., “shisha-like” flavored vapor with no nicotine, if legally sellable, could be marketed for adults who want the sensory experience without the drug).

3. Enhance Product Compliance and Transparency: Chinese manufacturers should ensure their products at least meet all the quality, labeling, and safety standards that regulators expect. This includes: using FDA-compliant warning labels on packaging (“WARNING: This product contains nicotine…”), child-resistant packaging where applicable, and limiting marketing imagery that could be seen as targeting youth (no cartoons, etc.). While these alone don’t make a product legal without PMTA, they demonstrate good faith and may reduce the chances of enforcement compared to a product blatantly violating basic rules. In fact, some importers got warning letters for using unauthorized celebrity images or cartoons on their vape products (FDA Warns Nine Online Firms for Illegally Selling Flavored, Disposable E-Cigarettes | FDA) (FDA Warns Nine Online Firms for Illegally Selling Flavored, Disposable E-Cigarettes | FDA) – an unnecessary risk factor. Exporters should audit their product lines for such issues. Also, publish verified test results for ingredients and emissions to show consumers and regulators that the company is monitoring quality (for instance, ensuring no diacetyl, no heavy metals above trace levels, etc.). If enforcement officials see a company making an effort at compliance versus one flouting all rules, it could influence priorities (FDA has limited resources and may focus on the worst actors first (China e-cigarette titan behind ‘Elf Bar’ floods the US with illegal vapes | Reuters)).

4. Work with U.S. Importers and Retailers on Compliance: Exporters must strengthen partnerships with their U.S. distributors and help them comply with domestic laws. This might mean assisting them in registering with the ATF under the PACT Act, properly labeling shipments with HAZMAT nicotine markings, and calculating state-wise nicotine taxes. By helping distributors navigate these, Chinese companies show they are willing to play by the rules, which can encourage distributors to keep their products in stock rather than switching to a competitor. It’s also important to educate retail partners on the importance of not selling to minors (perhaps providing training or point-of-sale age verification systems). Retailer compliance protects the brand from unwanted scrutiny. As an example, after FDA started issuing fines to stores selling Elf Bar, some stores dropped the brand (China e-cigarette titan behind ‘Elf Bar’ floods the US with illegal vapes | Reuters). Proactive outreach by an exporter to emphasize compliant retailing could reassure store owners that keeping the product won’t land them in legal trouble – or at least that the brand is backing them up with guidance.

5. Diversify Markets and Reduce Over-Reliance on the U.S.: Given the volatility of U.S. regulations, Chinese companies should hedge by expanding in other regions. The EU, UK, Canada, Southeast Asia, Latin America, and the Middle East all have growing vape markets, each with their own regulations but none quite as strict (for now) as the U.S. For instance, the UK, while considering environmental disposable bans, currently allows flavors (with a nicotine cap of 20 mg/mL) and has a large demand for disposables – Chinese brands like Elf Bar actually became top sellers in the UK as well. The EU’s Tobacco Products Directive requires a notification (not a full authorization like FDA), which is easier to comply with; focusing on compliant 2% nicotine versions for Europe can sustain volume if U.S. volume dips. Similarly, some Asian markets (e.g., Indonesia, Philippines) are opening up. By broadening their export destinations, Chinese manufacturers won’t be ruined if the U.S. completely shuts the door. In fact, AP noted that the global backlash in some countries might “lead vaping entrepreneurs to focus even more on the U.S.” due to loopholes (Elf Bar and other Chinese e-cigarette makers dodged US customs and taxes | AP News), but that is a high-risk approach. A smarter approach is balanced growth – enjoy U.S. profits but invest them into market access elsewhere as a buffer. Also, consider emerging opportunities like medicinal or wellness vaping products (for vitamins, caffeine, etc.) in markets that allow them, since those might not be regulated as tobacco – though caution, they could fall under other regulations (and the FDA would consider anything inhaled as potentially a drug or device).

6. Adapt Product Design to Regulatory Trends: If flavor and nicotine content are the main regulatory targets, innovators might explore harm reduction design features that appeal to regulators. For example, developing disposables with user-locking or age-verification tech (perhaps linking to a smartphone app to unlock, verifying age). Or implementing dose-limiters where the device controls how frequently it can be puffed (to reduce abuse by youth). These sorts of features could be pitched to FDA as mitigating measures in a PMTA. Additionally, with environmental concerns growing, companies could design disposables that are more recyclable – perhaps a deposit-return system where users can return used devices for recycling (some UK retailers started doing this voluntarily). While not mandated yet, being ahead on environmental responsibility could score goodwill points and preempt future bans.

7. Monitor and Engage in Policy Discussions: Chinese companies often have a hands-off approach to U.S. policy, but they could benefit from engagement. Joining or forming trade associations that include importers and possibly sympathetic U.S. small businesses could give them a voice. For instance, a coalition of convenience store owners and importers could lobby that a measured approach (like licensing rather than banning products) would be better than outright prohibition that just drives a black market. It’s notable that domestic U.S. vape shops and some public health experts have argued for allowing some flavors for adults under strict conditions. Chinese manufacturers might indirectly support research or campaigns that highlight the role of e-cigarettes in smoking cessation for adults – shifting the narrative from “youth epidemic” to “adult harm reduction.” If regulations eventually moderate (for example, if FDA in a few years entertains the idea of approving a flavor under certain conditions), those who contributed constructively to the conversation will have an advantage. Also, keep close watch on U.S. regulatory announcements, FDA guidances, state legislature bills, etc. – having an early warning can help pivot strategy quickly. For this, hiring regulatory analysts or law firms in the U.S. is wise.

8. Explore Alternative Business Models: If direct export of branded disposables becomes untenable, Chinese firms can consider other models. One option is contract manufacturing for U.S. brands that do manage to get FDA approval. For example, if a U.S. pharmaceutical or tobacco company develops a new vape device and gets it approved, they might outsource production to a Chinese OEM. Many Chinese factories (like SMOORE, which is behind brands like Vaporesso and also supplies NJOY and others) already operate in this capacity. Ensuring your manufacturing facilities meet international standards (ISO, cGMP for tobacco, etc.) could land such contracts. Another model: shift from selling nicotine devices to supplying components or technology – such as vape chips, heating coils, or pods that can be filled in the U.S. under license. By being the tech provider rather than the marketer, Chinese companies might stay involved in the value chain with less regulatory exposure.

9. Long-Term Pivot to Innovation and Reduced Risk Products: The writing on the wall is that products highly attractive to youth (small, fruity, high-nicotine disposables) face a rough road in the U.S. Chinese companies could think ahead and invest in the next generation of nicotine products that regulators might view more favorably. This could be devices with lower nicotine levels or novel nicotine formulations that satisfy cravings with less intake (for example, some companies are looking at synthetic nicotine analogues that might have lower addiction potential). Or potentially, devices that can be prescription-based for smoking cessation (recently, the FDA authorized some nicotine gums and lozenges as over-the-counter quit aids; a vape designed strictly as a therapy with doctor oversight could be another pathway). While these are speculative and beyond the traditional retail space, they illustrate that agility and innovation could create new niches. Chinese vape makers have strong R&D – they can iterate quickly. If they apply that R&D to compliance-friendly innovation (rather than just new flavors), they could stay ahead of regulators in a positive way.

10. Strengthen Traceability and Clamp Down on Counterfeits: A somewhat underappreciated issue is counterfeiting. Successful Chinese brands like Elf Bar often get copied by illicit factories. Those counterfeits, if harmful or if they flood the market, can further alarm regulators and tarnish the brand’s efforts to comply. Exporters should implement anti-counterfeit measures (unique codes, holograms) and work with U.S. customs to actually stop fake versions of their products. This might sound counter-intuitive (why invite customs scrutiny?), but distinguishing authentic products could allow enforcement to target counterfeits while perhaps sparing legitimate shipments that are following rules. iMiracle’s spokesman claimed many Elf Bars in the U.S. were counterfeit (China e-cigarette titan behind ‘Elf Bar’ floods the US with illegal vapes | Reuters) – if true, that’s another problem to solve. A reputable brand aligning with regulators to combat truly unregulated fakes could demonstrate goodwill.

By adopting some or all of these strategies, Chinese disposable vape exporters can transition from an era of easy profits via regulatory arbitrage to a more stable, compliant, and diversified business model. The road will not be easy – it effectively requires evolving from a gray-market player to a legitimate market competitor meeting high standards. Yet the alternative may be to lose access to the U.S. entirely, especially as enforcement and legislation continue to tighten. Companies that adapt fastest – balancing compliance with consumer demand – will be best positioned to survive the current crackdown and perhaps even prosper if the market eventually stabilizes under clearer regulations.

Conclusion

The evolution of U.S. e-cigarette regulations over the past decade has been rapid and at times unpredictable, driven largely by public health concerns over youth vaping. Federal authorities like the FDA have moved from a permissive stance to requiring pre-approval for all products, banning flavors in certain formats, raising the purchase age, and cracking down on synthetic nicotine and illicit sales. Major states have layered on their own strict rules, with several banning the flavors that made disposable vapes so popular. These changes have re-shaped the market landscape: the once-booming disposable segment – dominated by Chinese-made products – now operates under significant legal risk in the U.S.

For Chinese disposable vape exporters, the impact of these regulatory shifts has been profound. In the short term, many enjoyed massive sales growth by exploiting loopholes (such as the 2020 disposable exemption and synthetic nicotine gap) and filling consumer demand for convenient, flavored vapes. Chinese brands like Elf Bar, Geek Bar, and others rapidly gained U.S. market share, in some cases outcompeting domestic brands. However, the very success of these products triggered stronger responses from regulators and competitors. Now, Chinese companies find themselves at a crossroads: continue business as usual and face escalating enforcement – including seizures, import bans, and loss of retail channels – or adapt to the new reality through compliance and innovation.

This report has detailed how U.S. regulatory evolution is forcing a pivot in strategy. The era of easy entry for any new flavored vape is ending; moving forward, products will need to clear high regulatory hurdles or risk being pushed into the black market. Chinese exporters, therefore, should treat U.S. regulations not as a distant nuisance but as a core business factor to manage. By investing in regulatory compliance (PMTAs for key products), tailoring product lines to fit within flavor restrictions, and collaborating with distribution partners on lawful practices, exporters can mitigate risk. Diversifying into other global markets and product categories will reduce over-reliance on a volatile U.S. environment. Engaging constructively with regulators – rather than perpetually evading them – might unlock sustainable market presence, even if that means shifting from selling candy-flavored disposables to perhaps selling tobacco-flavored or medically-oriented devices for smokers. The Chinese vaping industry’s strength has always been its agility and manufacturing prowess; now it must add regulatory savvy to its repertoire.

For international distributors, wholesalers, and retailers, understanding these dynamics is equally important. They must recognize which products are legally sound to carry and which ones might disappear overnight due to a ban or seizure. Many may choose to align with manufacturers who have a longer-term compliance strategy, to avoid disruptions to their supply. B2B customers should communicate their needs upstream – for example, requesting manufacturers to provide documentation or create compliant product versions for certain states. In doing so, they encourage responsible practices that ultimately make the supply chain more secure.

In closing, while U.S. regulations have undoubtedly increased challenges for Chinese disposable vape exporters, they do not spell the end of opportunity. The U.S. adult nicotine user base (including tens of millions of smokers and vapers) still demands alternatives to cigarettes. E-cigarette technology, largely pioneered by Chinese firms, remains a promising harm reduction tool if it can be delivered in a way that satisfies regulators’ public health concerns. Companies that adapt by focusing on compliance, quality, and adult-centered products will be well-positioned to regain the narrative. The market is likely to mature – with fewer, more law-abiding players in the field. Chinese exporters who want to be among those players must evolve from the tumult of the “wild west” era into disciplined, innovative and regulation-conscious businesses.

By learning from the history and trends outlined in this report, stakeholders can better prepare for what lies ahead. The U.S. e-cigarette regulatory landscape will continue to evolve, and staying informed is key. In 2024 and beyond, we may see further refinement of FDA’s review processes, possibly new federal flavor or nicotine concentration standards, and continued state initiatives (or even federal legislation) addressing disposables and flavors. International manufacturers and traders should keep a close watch on these developments. Those who proactively adjust their strategies – prioritizing legal compliance, engaging with regulators, and upholding product stewardship – will not only reduce risks but could also build trust and brand longevity among partners and consumers. The evolution of regulations need not be seen solely as a threat; with the right approach, it can be an impetus for the industry to mature, innovate in responsible ways, and ensure that e-cigarette products are indeed part of the solution for adult smokers and not part of a problem for youth.

In summary, the U.S. e-cigarette market is entering a new phase – one governed by stricter rules and higher standards. Chinese disposable vape exporters who recognize this shift and adapt accordingly will find that they can still succeed and even lead in this transformed landscape. By following the recommendations discussed – from compliance efforts to product diversification – exporters can navigate the challenging regulatory waters and continue to serve the sizable demand for vaping products in a manner that is sustainable and acceptable to regulators. The road ahead requires diligence and change, but it also holds the promise of a more stable and reputable industry for all players involved.

Sources: This report has referenced data and statements from the U.S. FDA, CDC, Associated Press, Reuters, industry analyses, and other reputable sources to ensure accuracy and credibility. Key sources include FDA regulatory announcements and enforcement updates (FDA Warns Nine Online Firms for Illegally Selling Flavored, Disposable E-Cigarettes | FDA) (FDA Warns Nine Online Firms for Illegally Selling Flavored, Disposable E-Cigarettes | FDA), CDC and CDC Foundation sales and survey data () (), news investigations by AP and Reuters on Chinese vape operations (China e-cigarette titan behind ‘Elf Bar’ floods the US with illegal vapes | Reuters) (Elf Bar and other Chinese e-cigarette makers dodged US customs and taxes | AP News), and state government releases on legislation (e.g., California and New York flavor bans) (Proposition 31 passes in California: flavored tobacco will be banned : NPR) (New York’s Flavour Ban Goes Into Effect on July 1st – Vaping Post). These provide a solid evidence base for the trends and recommendations discussed.