Somewhere in America, a store owner opens an envelope from the Food and Drug Administration. Inside is a laminated card listing every vape product he is legally permitted to sell. He reads it in forty seconds flat, because there are only 39 items on it.
That’s not 39 brands or 39 categories, you understand, but 39 individual vape products made by four companies, approved by the FDA after a review process that eliminated virtually everyone else. That is the entire legal market.
The store owner looks up at his shelves – which consist of a few hundred vape products – and realizes that the majority of his inventory is, technically, contraband. He did not know this.
According to the FDA, as much as 54% of the vapes sold in America are unauthorized. Some estimates place the figure closer to 70%. The agency’s solution to this compliance crisis was nothing more than a laminated card mailed to 300,000 retailers, in the hope that the nation’s shopkeepers would dutifully comply.
Of course, most of them didn’t, and who would blame them?
The short answer is China. When the FDA’s approval process priced small American manufacturers out of the market, Chinese factories stepped in to fill the gap, and, as usual, they have done so with remarkable enthusiasm.
Export data shows Chinese e-cigarette shipments to the US rising from 2.2 million kilograms in June 2025 to nearly 15 million by October. The products arrive disguised as shoes, toys, and household goods, slipping through ports of entry with vague descriptions and falsified paperwork.
The FDA, having created the conditions for this flood, has spent the past year scrambling to mop it up. The agency refused over 9,000 import shipments in fiscal 2025, up from roughly 100 in fiscal 2023. A joint operation at the Port of Chicago seized 4.7 million units worth $86.5 million in a single sweep.
A DEA-led initiative called Operation Vape Trail raided smoke shops nationwide and turned up 2.3 million illicit vape units, 115 illegal firearms, and a drug tunnel, which gives you some idea of the kind of economy that flourishes when legitimate businesses are regulated out of existence.
The UK also regulates vape products. There are strict rules about nicotine strength, bottle size, labeling, and child-resistant packaging. Manufacturers must notify the Medicines and Healthcare products Regulatory Agency before a single unit reaches a shelf. It is not, by any stretch of the imagination, a free-for-all.
The difference is in the numbers. The MHRA database currently lists over 45,000 legally notified products. Visit any reputable specialist retailer such as Vape Superstore, and every product on display has been registered, reviewed, and cleared for sale. The customer does not need to wonder whether the product they are interested in is legal, because the system was designed to make compliance straightforward rather than functionally impossible.
Britain built a regulatory framework that lets a market operate within clear boundaries, while America built one so restrictive that only 39 products made it through, and most of the market simply went around it.
The engine of the problem is the Premarket Tobacco Product Application, a process that costs anywhere from $28,000 to $2.5 million per product, per flavor, per nicotine strength. A small company with 20 flavors across three strengths would need 60 separate applications, potentially costing upward of $100 million, with no guarantee of approval.
Small manufacturers either closed, went underground, or never existed. The FDA now spends upward of $120 million a year seizing unauthorized products at the border, which is a great deal of money to spend fighting a problem your own regulatory system created.
The human absurdity is worth considering. 18 states now maintain their own PMTA registry laws, each with a different list of permitted products. A vape that is perfectly legal in Mississippi may be an actual criminal offense in California. The US Postal Service largely prohibits vape shipments, and yet a study in JAMA found that 80% of online vape deliveries arrived via USPS anyway, with only 1% involving any form of ID verification.
Meanwhile, Reynolds American and Altria, two of the largest tobacco companies in the country, have announced plans to launch new flavored vape products without FDA authorization, openly flouting the very system they helped shape. If the corporations are not following the rules, one does wonder what, precisely, the laminated card was supposed to achieve.
In Britain, a retailer who wants to know whether a product is legal can search the MHRA’s public database in seconds. Over 45,000 products are on it, representing hundreds of manufacturers. The framework was designed to work, and so it does.
In America, a retailer receives a laminated card listing 39 products and is left to determine which of the hundreds on their shelves now constitute a federal violation. The card does not explain the process, does not offer a path to compliance, and does not account for the fact that the majority of the American vape market exists outside the law.
The MHRA database is updated daily. The laminated card, presumably, is not.
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