Regulation

The U.S. FDA has consolidated two tobacco establishment registration and product listing forms into a redesigned Form FDA 3741 covering all regulated product categories, including e-cigarettes, heated tobacco products and nicotine pouches. The current requirements remain limited to domestic establishments. Separately, the FDA has proposed extending registration and product listing requirements to foreign manufacturers, signaling greater regulatory attention to manufacturing entities and product-level information across the tobacco and nicotine supply chain.

The Washington Examiner on December 9, 2025, reported: China's vape export volume to the U.S. rebounded sharply from 2.2 million kilograms to 14.8 million kilograms despite the crackdown. This volatility, confirming the annual multi-billion dollar trade gap, is the "Bullwhip Effect" in action. It transfers massive inventory to the U.S. market, putting the working capital of Chinese manufacturers and the supply chain at severe risk of lock-up and failure. Regulatory escalation is now imminent.

Proposed e-cigarette ban in Russia may boost sales of traditional cigarettes, with last year's market growth at 18.9%.

South Korea's food and drug safety agency unveils draft regulations on harmful substances in tobacco products.

US e-cigarette companies shift business overseas to evade FDA regulation, complicating efforts to prevent unapproved products from entering the country.

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

Michigan e-cigarette containing THC voluntarily recalled due to potential harmful ingredients; consumers urged to check specific brands for safety.

Synthetic nicotine is reshaping the industry, sparking debates on regulation, science, and market impact. In this 2Firsts interview, Dr. Pete Gibbons of Labstat International breaks down the key challenges and what lies ahead.