The US is the world’s largest vape market, but only 34 vape products have been authorized by FDA. Photo credit: Alexandra Paula Chiscareanu, Pexels.
According to a recent Reuters report quoting representatives from US regulatory agencies and two companies, several vape product manufacturers targeted by US authorities have adjusted their business strategies in response to the US Food and Drug Administration’s (FDA) crackdown on unauthorized vape products.
Chinese e-cigarette maker Heaven Gifts, the news agency says, has moved the operations of its brand Lost Mary—which in 2023 controlled 9% of the US vape market—to a British Virgin Islands (BVI) firm, Wonder Ladies Limited. The move occurred after FDA banned several companies spanning China, the US, and South Korea from importing Elfbar, another flagship brand of the Heaven Gifts group, in 2023.
Reuters investigations have shown that Heaven Gifts retains Lost Mary’s US trademark through its Hong Kong subsidiary, Imiracle Limited, while Wonder Ladies’ name now appears on US packaging. The news agency claims it has found links between Heaven Gifts executives and multiple BVI firms tied to unauthorized vape sales.
Another company from Texas, Ludicrous Distro—a trading name for American Vape Company—ceased selling its unauthorized Esco Bars brand, Reuters reports, but now distributes vapes without PMTA approval from third-party manufacturers via its website.
In a statement to Reuters, FDA said it was aware of and closely monitoring instances in which companies attempted to change the labeling of illegally marketed products or the structure of their business to avoid detection.
Tactics like these further complicate the agency’s efforts to control the proliferation of illicit vapes. To date, FDA has approved only 34 tobacco- and menthol-flavored vape products, all from major tobacco companies. Since 2020, the authority has issued marketing denial orders (MDO) for over 26 million e-cigarette products.
The US has the world’s largest market for vape products. Statista estimates that in 2025, its revenue will reach a staggering US$9.4 billion, with an anticipated annual growth rate of 5.69% from 2025 to 2029. However, in the top ten ranking of US vape product sales, none of the 34 authorized products appear—the overwhelming majority of vape sales are illegal. In 2024, Geek Bar Pulse, the leading US vape brand, was estimated by Reuters, in collaboration with market research firm Circana, to have generated US$582.8 million in sales. According to this data, Lost Mary ranked seventh with estimated sales of US$58.3 million.
The exact scope of the illicit vape market in the US remains unclear. Tobacco companies such as British American Tobacco claim the market is growing. During a conference in February, Altria’s c.e.o. Billy Clifford said the US vape market had expanded by 30% in 2024, a development driven entirely by illicit products.
Private preliminary retail sales data collected by Circana and released through Reuters in late February suggest the illicit market is contracting. Their research found that sales of unauthorized, flavored disposable vapes in 2024 amounted to US$2.4 billion, or 35% of vape products sold via outlets such as convenience stores and supermarkets. According to the research firm, this compares to a sales value of US$3.2 billion in 2023 and US$2.8 billion in 2022. However, Circana does not track vape sales made online, in independent stores, or in specialty vape outlets.
Over the past year, FDA has intensified its efforts to combat the illicit vape market through several key actions, including enhanced enforcement efforts, warning letters to online retailers and manufacturers, and civil penalties against retailers. In June 2024, the agency partnered with the Department of Justice to establish a collaborative task force. In October last year, FDA began implementing a reorganization of multiple parts of the agency, including the Center for Tobacco Products (CTP).
Whether the agency will have sufficient means and manpower to tackle the illicit vape market in the future remains to be seen. In mid-February 2025, the Trump administration initiated significant job cuts within FDA, targeting probationary employees across various divisions, including those focused on tobacco products. These cuts are part of a broader effort to reduce the federal workforce, with potential implications for the agency's capacity to regulate tobacco products effectively.