US Electronic Cigarette Industry Faces Uncertainty as FDA Makes Rulings

Electronic cigarette manufacturers are pushing back against an unfavorable ruling from the US Food and Drug Administration, while retailers await the final outcome and stock up on e-cigarette products.

Although the Food and Drug Administration (FDA) continues to issue responses to various pre-market tobacco applications (PMTAs) submitted, electronic cigarettes appear to be a challenging category within the tobacco industry. However, customers are still flocking to stores in search of their favorite electronic cigarette devices.

According to market research company IRI based in Chicago, electronic smoking devices saw a 13.2% increase in dollar sales in the US convenience channel over the 52 weeks ending October 2, 2022, reaching $6.87 billion (approximately RMB 47.9 billion). However, unit sales remained relatively stable, only decreasing by 1%. The surge in dollar sales may be due to a nearly $2 (approximately RMB 14) increase in unit prices.

However, convenience store retailers are still waiting for the FDA's final decision on premarket tobacco product applications (PMTAs), which were submitted for tobacco products before September 9, 2020, and for non-tobacco nicotine products before May 14, 2022. Out of over one million applications for non-tobacco derived or synthetic nicotine products as of October 7, 2022, more than 1,600 have been accepted, with the majority being electronic cigarettes or e-liquids. Over 889,000 applications have received Refuse to Accept (RTA) letters.

On October 26, 2022, the FDA issued a marketing denial order (MDO) for several electronic cigarette products under the Logic brand owned by Japan Tobacco. These include the Logic Pro Menthol E-liquid Kit and the Logic Power Menthol E-liquid Kit.

However, according to Thomas Briant, the Executive Director of the National Association of Tobacco Outlets (NATO) in the United States, "Japan Tobacco's Logic brand has sued the FDA and has been granted a court stay of the MDO, pending judicial review.

After making these rulings, the FDA issued 32 marketing denial orders (MDOs) to Magellan Technologies for their Hyde electronic cigarettes, and issued warning letters to EVO Brands LLC and PVG2 LLC dba Puff Bar for marketing electronic cigarettes that have not been authorized for receipt and delivery in the United States.