Every regulator eventually reaches for the registry. It is the oldest tool in the administrative kit: make everyone who sells into your market sign their name, list what they ship, and open their doors to inspection, and the honest operators fall into line. The weakness is just as old. A registry disciplines the companies that want to be legal and does close to nothing to the ones that decided long ago not to be. So when the FDA proposed on June 26 that foreign tobacco manufacturers finally register their factories and products, it answered a $10.6 billion flood of Chinese vapes with a sign-up sheet. The rule is reasonable. It is also aimed at an adversary that does not fill out forms.
The mechanics are straightforward and overdue. For the first time, foreign tobacco manufacturers selling into the United States would have to register their facilities, list every product, report each device’s specifications down to e-liquid volume, battery capacity, and wattage, keep records for four years, and let FDA inspectors onto their overseas plant floors. Domestic manufacturers have carried those obligations for years. Acting Center for Tobacco Products Director Bret Koplow framed the gap as fairness: “All companies selling tobacco products in the United States should play by the same rules,” he said. Comments run through September 14.
Now weigh what that sign-up sheet is meant to govern. China’s e-cigarette exports to the United States topped $10.6 billion in 2025, and only a sliver of that arrives with FDA permission. The agency has authorized 41 e-cigarette products for legal sale, all of them tobacco- or menthol-flavored. The GAO counted roughly 6,000 actually on shelves. The legal market is a rounding error inside the illegal one, and 1.6 million American kids are still vaping inside that gap.
The companies behind the flood are not waiting for a portal to open, and we know how they work because agents keep catching them mid-shipment. In the largest seizure of its kind, HHS and Customs and Border Protection pulled 4.7 million unauthorized e-cigarettes worth an estimated $86.5 million out of a single Chicago operation, almost all of it from China. Inspectors found the containers labeled with vague, falsified descriptions and understated values, a deliberate dodge of both import duties and safety review. These are not manufacturers who missed a compliance step. They run an evasion operation, and the customs paperwork they already file is fiction. Ask one of them to voluntarily register its factory and invite an inspector onto the floor, and the answer writes itself.
Set against that scale, the enforcement record is not encouraging. Over four fiscal years, 2022 through 2025, the Justice Department brought just 88 enforcement actions against illegal e-cigarettes, and 50 of those were nothing more than listings of unauthorized online sellers. A $76 million seizure in 2024, three million devices, looked enormous until you set it beside $10.6 billion in yearly imports, where it works out to less than one percent of a single year’s flow. And most illegal vapes never touch the internet. They move through gas stations, convenience stores, and vape shops, the corner of the market the enforcement effort largely skipped. “There is a mismatch between DOJ’s resources and the actual retail landscape,” University of Waterloo researcher Steven Xu told STAT. A registry sits at the manufacturer end of a supply chain whose soft spot is the cash register.
So the charitable read is that the rule formalizes a paper trail the compliant would have followed anyway, while the smugglers keep smuggling. The uncharitable read is sharper, and it comes from the agency’s own left hand. In May, weeks before this crackdown, the FDA quietly posted a memo extending enforcement discretion to nicotine products still under “scientific review”, meaning it would decline to pull them even without authorization, and it retargeted enforcement away from flavors and toward toy-shaped designs. Former FDA tobacco-center director Brian King read the shift as “a broader opening up and responsiveness to flavored products by the agency.” The memo skipped the federally required comment period and went out during Commissioner Marty Makary’s last full week before he resigned. Career staff said they learned of it the night before it published.
Hold the two letterheads side by side. One says foreign manufacturers must be held accountable to protect kids. The other, signed weeks earlier, eased the pressure on exactly the flavored products that hook them. You do not have to defend the captured premarket system that authorized 41 products in a decade to see the problem. A foreign adversary is dumping ten billion dollars of addictive, falsely labeled product onto American children through ports the government cannot police, and the federal response alternates between a registration form the smugglers will ignore and a memo that keeps flavored product on the shelf. The CBP officers intercepting containers in Chicago are doing the sovereignty work. The rule-writers are doing paperwork.
None of which makes the proposed rule wrong. You cannot inspect a factory you have no record of, so closing the registration gap is a precondition for any serious enforcement. But a precondition is not a cure, and the agency’s “protect public health” framing asks the public to grade it on its intentions rather than on a record that let an entire illicit market take root.
So watch the figures that measure seriousness, not the ones that measure paperwork. Watch whether the authorization count finally moves off 41. Watch whether enforcement shifts from online listings to the wholesalers and corner-store distributors the GAO flagged. Watch whether next year’s seizures represent a rising share of a falling flow or just a bigger bucket under the same open tap. The comment docket closes September 14, the tobacco center has no permanent chief, and the next real move belongs to whoever the administration installs to run it.
Sources
- FDA – Proposed rule to register and list foreign tobacco product manufacturers (June 26, 2026)
- STAT – GAO report on the gap between illegal-vape scale and FDA/DOJ enforcement
- PBS NewsHour – FDA enforcement-discretion memo on e-cigarettes and nicotine pouches blindsides officials
- HHS – Record 4.7 million / $86.5 million illegal e-cigarette seizure in Chicago, almost all from China
- GlobeNewswire – FDA proposed-rule release, with Bret Koplow quote