E-Cigarette Companies Shift Operations Offshore to Bypass FDA Regulations, Including Lost Mary and Elfbar Brands

Feb.25.2025
E-Cigarette Companies Shift Operations Offshore to Bypass FDA Regulations, Including Lost Mary and Elfbar Brands
Reuters reports that some e-cigarette companies have shifted operations offshore to bypass U.S. regulations. Heaven Gifts moved its Lost Mary brand to a British Virgin Islands firm after the FDA banned Elfbar in 2023, while Ludicrous Distro began distributing unauthorized third-party products. The FDA has denied millions of licenses for new nicotine devices, particularly flavored vapes that appeal to teenagers. Despite bans, brands like Elfbar continue to be popular among youth vapers in the U.S

According to Reuters, several e-cigarette companies targeted by U.S. authorities have adapted their business strategies to bypass regulations, including shifting operations to offshore firms. This move has made it more difficult for the U.S. Food and Drug Administration (FDA) to prevent the importation of unauthorized vapes into the country. The FDA has been closely monitoring these changes, which include companies altering product labels or restructuring their businesses to avoid detection. However, the FDA did not specify which brands or companies were involved.

 

One notable example is the Chinese vape giant Heaven Gifts, which transferred its U.S. operations for its Lost Mary brand to a British Virgin Islands (BVI) company, Wonder Ladies Limited. This shift occurred after the FDA banned several companies, including those based in China, the U.S., and South Korea, from importing its flagship Elfbar brand in 2023. Despite the ban on Elfbar, Lost Mary remains available for sale in the U.S., signaling that the product is still being distributed despite not having FDA authorization.

 

Similarly, Ludicrous Distro, a Texas-based e-cigarette firm operating under the name American Vape Company, stopped selling its own unlicensed Esco Bars brand. Instead, the company began distributing a wider range of unauthorized vaping devices from third-party manufacturers. The company’s website reflects this change in focus.

 

Heaven Gifts’ spokesperson, Jacques Li, stated that the company had exited the U.S. market for its Lost Mary brand by transferring operations to Wonder Ladies, following the FDA’s ban on Elfbar. Li emphasized that the company was not attempting to circumvent FDA regulations, despite the move.

 

Ludicrous Distro, when asked about its decision to sell unauthorized products, did not provide a clear explanation. However, the company explained that it has always aimed to comply with the FDA’s evolving policies, which have created confusion in the industry.

 

The FDA has denied licenses for approximately 26 million new nicotine devices since October 2020, particularly targeting fruit and candy-flavored vapes, which the agency claims appeal to teenagers. The growing popularity of unauthorized products, such as Elfbar, has led to increasing concerns about youth vaping, with Elfbar becoming one of the most widely used brands among young vapers in the U.S. in 2024.

Trump Reportedly Signs Off on Plan to Fire FDA Commissioner Marty Makary
Trump Reportedly Signs Off on Plan to Fire FDA Commissioner Marty Makary
According to The Wall Street Journal, people familiar with the matter said President Trump has signed off on a plan to fire FDA Commissioner Marty Makary, though the plan is not yet final and could change. The report said Makary’s tenure has included clashes over vaping, abortion and drug policy, and that some senior administration officials view him as struggling to manage the agency.
May.09 by 2FIRSTS.ai
Special Report | China’s Tobacco Tax Debate Shifts Toward Tax Design as Policy Trade-offs Come Into Focus
Special Report | China’s Tobacco Tax Debate Shifts Toward Tax Design as Policy Trade-offs Come Into Focus
China’s tobacco tax debate is moving from whether to raise prices to how the tax system should be designed. At a Beijing forum on World No Tobacco Day, experts discussed higher specific excise taxes, minimum tax burdens and dynamic adjustments linked to income and inflation. The issue also connects to China’s broader consumption tax reform, health financing and chronic disease costs. Public reports did not mention e-cigarettes, heated tobacco, nicotine pouches or other new nicotine products.
Jun.11
France Bans Zyn and Other Nicotine Pouches, Violators Face Jail and Fines
France Bans Zyn and Other Nicotine Pouches, Violators Face Jail and Fines
France has officially banned nicotine pouches and other oral nicotine products, including Zyn. The new regulation classifies such products as “toxic substances” and imposes criminal penalties on their use, possession, purchase, and sale. Violators may face up to five years in prison and fines of up to €400,000 (approximately $436,600).
Regulations
May.25
NielsenIQ and Goldman Sachs Data Show Smokeless Was the Only Growing Major U.S. Nicotine Category
NielsenIQ and Goldman Sachs Data Show Smokeless Was the Only Growing Major U.S. Nicotine Category
NielsenIQ and Goldman Sachs data show U.S. smokeless nicotine product sales rose more than 8% year over year in the 52 weeks ended May 30, making it the only major nicotine category to record growth.
Market
Jun.23
FDA Warns Retailers Over Unauthorized Nicotine Pouches Resembling Candy and Everyday Products
FDA Warns Retailers Over Unauthorized Nicotine Pouches Resembling Candy and Everyday Products
The FDA issued warning letters to eight retailers selling unauthorized nicotine pouches and dissolvable tobacco products resembling candy, breath strips and cough drops. The action highlights rising scrutiny of packaging, youth appeal and accidental ingestion risks, as the agency clarifies enforcement priorities for unauthorized ENDS and nicotine pouch products while maintaining PMTA as the legal market pathway.
Special Report
May.21
Australian State Targets Illegal Tobacco Retailers With Tougher Closure Powers
Australian State Targets Illegal Tobacco Retailers With Tougher Closure Powers
According to Reuters, Australia’s state of Victoria introduced legislation to give police and the state tobacco licensing regulator stronger powers to shut businesses selling illegal tobacco, with non-compliant operators facing fines of more than A$2.4 million and up to 20 years in prison.
Jun.05