Tobacco Asia

20 tobaccoasia Issue 5, 2026 September / October while others require additional information, these are being reviewed sepa- rately where appropriate." Rodriguez stressed that while enforcement discretion is a step forward, questions remain. The big one: what will US states do? "We know that cer- tain states and localities act in ways that are more prohibitionist and do not align with FDA's present view on promoting harm reduction via selective en- forcement," he said. "Will states choose to use the underlying non-authorized nature of these deprioritized products as a way to try to keep them off the market, even as cigarettes continue to be lawfully sold in their jurisdictions?" While the new enforcement policy outlines how FDA intends to priori- tize unauthorized products already on the market, the agency also moved to strengthen oversight of the companies that manufacture them—particularly those located outside the United States. FDA targets foreign tobacco product manufacturers FDA has also proposed a rule that, for the first time, would require foreign to- bacco product manufacturers to register their facilities and list their products with the agency. The move aims to strengthen oversight of imported tobacco products and help curb the flow of unauthorized vaping products and nico- tine pouches into the United States. If finalized, the rule would subject foreign manufacturers to many of the same FDA registration and product listing requirements that already ap- ply to domestic tobacco companies, closing what the agency describes as a longstanding regulatory gap. "All companies selling tobacco products in the United States should play by the same rules," said Bret Koplow, CTP acting director. "The FDA is working hard to close the gap between domestic and foreign companies, level the playing field for American businesses, and ensure that all manufacturers are held to the same standards." It's not the first time FDA has proposed rules for foreign manufacturers. In March 2023, FDA proposed the "Tobacco Product Manufacturing Practice (TPMP)" requirements. Those rules focus entirely on how tobacco products are made—dictating manufacturing quality control, contamination preven- tion, and design standards—and are still in the rulemaking process. The newly proposed rule, "Establishment Registration and Product Listing for Tobacco Products," would require domestic and foreign establish- ments that "manufacture, prepare, compound, or process" tobacco and nico- tine products intended for the US market to register with FDA and submit detailed product listings. For the first time, the proposal would establish several new compliance requirements for foreign manufacturers. Attorneys Bryan Haynes, Agustin Rodriguez, and Zie Alere of the law firm Troutman Pepper Locke noted in an analysis of the proposal that foreign manufacturers would be required not only to register their establishments before offering products for import into the United States, but also to designate a US-based agent and agree to permit FDA inspections of their overseas facilities as a condition of registration. Haynes and his colleagues stated that the proposed product listing re- quirements exceed FDA's current guidance for domestic manufacturers. In addition to identifying each product, manufacturers would be required to report the nicotine source and concentration, characterize flavors, and, for electronic nicotine delivery systems (ENDS), provide technical specifications such as e-liquid volume, propylene glycol/vegetable glycerin ratios, wattage, and battery capacity. "By linking each listed product to its submission tracking number (STN), FDA can cross-reference product listings against its database of pre- market submissions to identify products on the market without authoriza- tion," the attorneys stated. The proposal follows a series of high-profile en- forcement actions against unauthorized disposable e-cigarettes manufactured overseas, including record seizures at US ports and increased collaboration between FDA and Customs and Border Protec- tion. The agency has repeatedly identified foreign manufacturers—particularly those supplying un- authorized disposable products—as a major en- forcement priority. "The proactive establishment registration, systematic inspections, and product surveillance included in this proposed regulation would give the FDA significantly more tools to identify and act against illegal foreign tobacco products," the agency said. The proposed rule could enhance FDA's ability to monitor imports and enforce regulations governing the importation of tobacco and nicotine products, according to Keller & Heckman's Azim Chowdhury. "Today, FDA often sees the product at the border or in the marketplace and then has to work backward," he told Tobacco Asia. "A reg- istration and listing system would allow FDA to link products to establishments, product identifi- ers, submission numbers, labeling, advertising, im- port channels, and potentially foreign inspections. That would make FDA more proactive rather than purely reactive." The proposed rule would not apply only to vaping products and nicotine pouches. If finalized, it would apply to domestic and foreign establish- ments that manufacture, prepare, compound, or process tobacco products subject to Chapter IX of the Food, Drug, and Cosmetics Act, including cigars and other tobacco products imported or of- fered for import into the United States, according to Chowdhury. "The proposed rule would not, however, apply to 'premium cigars' that are currently out- side Chapter IX as a result of the premium-cigar litigation, provided they meet the applicable court-defined criteria," he explained. "That treat- ment could change through further litigation or future FDA rulemaking. Foreign manufacturers of non-premium cigars, including many flavored, machine-made, and filtered cigars, as well as for- eign pipe tobacco and pipe manufacturers, would generally be required to register and list products if those products are imported or offered for import into the United States." In 2023, the Premium Cigar Association (PCA) objected to the proposed TPMP rule. The newly proposed rule contains provisions that, like those in the 2023 proposed rule, would have bur- densome impacts on small businesses, and PCA has similar concerns, according to the group's c.e.o., Joshua Habursky. "Our stance on this proposed rule is con- sistent with all of our previous filings that pushed back against overregulation of the makers and sellers of premium tobacco products," Habursky stated in a release. "Registration and inspection are usually the opening salvo of more regulations to

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