The Food and Drug Administration is accepting comments through Sept. 14 on a proposed rule that would extend to foreign establishments that manufacture, prepare, compound, or process tobacco products the requirement to register their establishments and list their tobacco products with the FDA. Currently only domestic establishments are subject to these requirements.
The FDA states that the “proactive establishment registration, systematic inspections, and product surveillance included in this proposed regulation” would “significantly expand” the agency’s knowledge of tobacco products manufactured abroad for import into the U.S. and give it “significantly more tools to identify and act against illegal foreign tobacco products.”
According to an FDA press release, the proposed rule would also require manufacturers to:
- maintain product labeling, advertising, and consumer information records for at least four years after their use;
- provide information to uniquely identify each tobacco product, including FDA-assigned submission tracking number, nicotine concentration and source, characterizing flavors, package sizes and types, and product dimensions;
- also provide specifications such as e-liquid volume, battery capacity, and wattage for e-cigarettes;
- submit information through the FDA’s online system (in most cases); and
- review and update their establishment registrations annually and their product listings twice a year.
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