FDA to Require Registration for Foreign Tobacco Manufacturers, Including Smoore, to Combat Illegal E-Cigarettes
Addressing Regulatory Gaps in Foreign Manufacturers
The FDA has proposed a rule, 'Establishment Registration and Product Listing for Tobacco Products,' to regulate foreign tobacco and e-cigarette manufacturers. Previously, only domestic manufacturers were required to register their facilities and submit product listings. This measure extends the same obligation to foreign manufacturers, aiming to curb the illegal distribution of products in the U.S. e-cigarette market, which is estimated at $13.7 billion to $15.9 billion annually.
Mandatory Product Specification Registration and On-Site Inspections
The proposed rule requires foreign manufacturers to register their facilities annually and update product listings twice a year. Specifically, for disposable e-cigarettes, which are popular among young people, manufacturers must submit detailed specifications, including nicotine concentration, flavors, battery capacity, wattage, and e-liquid volume. Furthermore, the FDA will have the authority to conduct on-site inspections of foreign manufacturing facilities, eliminating regulatory loopholes.
Strengthening Market Dominance of Major U.S. Tobacco Companies
Once finalized, this regulation will create a favorable environment for major U.S. tobacco companies, such as Altria Group (MO) and British American Tobacco (BTI), which have already received Premarket Tobacco Product Application (PMTA) approval and are operating legally. In contrast, foreign disposable e-cigarette manufacturers, including iMiracle (Elfbar manufacturer) based in Shenzhen, China, and overseas OEM/ODM companies like Smoore International Holdings (6969.HK) and RLX Technology (RLX), will face significant compliance costs and inspection risks. The elimination of illegal disposable products from the market is likely to lead to increased market share for legal brands.
Regulatory Timeline and Investor Strategy
The FDA will finalize the proposed rule after a public comment period ending on September 14, 2026. This proposal reflects the U.S. government's strong commitment to protecting public health by preventing indiscriminate exposure of young people to e-cigarettes. Investors should closely monitor the pace of regulatory approval and the effectiveness of enforcement measures, including collaboration with Customs and Border Protection (CBP) at the border, to predict long-term market trends.
The FDA's proposal to require registration for foreign tobacco manufacturers represents a critical turning point in standardizing regulatory compliance and eliminating the inflow of illegal disposable products in the U.S. e-cigarette market, valued at $13.7 billion to $15.9 billion annually. In the short term, the implementation of this regulation, along with the public comment period ending on September 14, 2026, is expected to highlight increased customs costs and practical regulatory risks for foreign OEM and brand companies, such as Smoore International Holdings (6969.HK) and RLX Technology (RLX), exporting to the U.S. In the medium to long term, the elimination of illegal products is expected to restore the dominant market position and expand sales for legal U.S. tobacco companies with PMTA approval, such as Altria Group (MO)'s NJOY and British American Tobacco (BTI)'s Vuse. Therefore, market participants should pay attention to the shifts in market dynamics resulting from the regulatory compliance gap and strategically adjust their portfolios by increasing their holdings in legal manufacturers and reducing their exposure to companies with supply chain risks.