By Brian Coon, MA with Becky Shipkosky

Illicit Electronic Nicotine Delivery Systems (ENDS)

According to recent estimates, up to 86 percent of all e-cigarettes on the U.S. market are illicit (Truth Initiative, 2024), meaning their ingredients and production are not subject to any health or safety oversight and do not have marketing authorization from the Food and Drug Administration (FDA). This may seem like a Wild West scenario, unprecedented in its lack of oversight, except it’s not. The FDA didn’t gain the authority to regulate cigarettes until 2009, and prior to that, nothing but a tobacco company’s reputation enforced quality control (Berman, 2018).

Anonymous Vape Manufacturers

Now think about the vape products in the stores. If you’ve ever purchased one, you most likely have no idea who manufactured it. (That’s intentional for reasons we’ll explore momentarily.) Reputational control is a non-factor for the anonymous-to-consumers companies behind most e-cigarettes sold in the U.S., which pack the finished products into unmarked or intentionally mislabeled boxes (Perrone, 2023). All manufacturers of illicit ENDS products do this, but some unknown portion of such factories are “shadow” entities, flying even under the Chinese government’s radar (Tencent Net, 2026).

While many consumers are aware that inhaling nicotine aerosol is hazardous to their health, products manufactured without oversight can contain (and have contained) immediately dangerous ingredients. And it’s worth noting that the e-cigarette products in question are not sold legally in any market. It’s not as if the manufacturers are following another country’s health and safety standards. There simply are none. We know this because most of the illicit products in the U.S. market would be illegal in other countries based on nicotine content alone, including China, incidentally (Akpata, 2026; Chowdhury, 2022).

An Illicit Product’s Journey to Consumers

An unauthorized ENDS product will most likely begin its life in Shenzhen, China, as about 90 percent of such products do (Mba & Mba, 2024). What happens next?

An exporter receives and palletizes the factory’s master cases and arranges their passage on cargo ships.
Products may pass through Indonesia or Vietnam to minimize customs scrutiny as they enter the U.S.
Once the products arrive, customs brokers file fraudulent documents stating the shipment contains something innocuous, like plastic toys or LED flashlights.
Wholesale buyers receive the products and sell them online or in bulk to retailers, with brick-and-mortar outlets comprising the majority.
Local retailers—some licensed to sell tobacco products, some not—sell them to consumers, typically only accepting cash to avoid detection.

It’s straightforwardly a smuggling operation. So, if we know this is happening, how is it allowed to continue? That is where the problem of U.S. regulation enters the picture.

Tech and Chemistry Outpace Regulation

The FDA has struggled to keep up with millions of e-cigarette applications. A fresh application is required for each new variation of a product, including flavor and device properties, and these applications can take two years or more to be approved. This is why just 39 of the over 6,000 distinct e-cigarette products on the U.S. market are actually FDA-approved (“Combating Illicit Substances: DOJ Enforcement of Unauthorized E-Cigarettes,” 2026).

Compliance and Enforcement

In 2026, U.S. Customs and Border Protection (CBP) has recently dedicated more resources to exactly the type of trade enforcement that catches shipments of illegal tobacco products. But despite five large, high-profile seizures in the first half of 2026, intercepting about 18 million devices (U.S. Customs and Border Protection, 2026), the market remains flooded for a few reasons:

ATF withdrawal: The Bureau of Alcohol, Tobacco, and Firearms (ATF) has shifted its focus away from domestic tobacco enforcement at the behest of the Attorney General (“Combating Illicit Substances: DOJ Enforcement of Unauthorized E-Cigarettes,” 2026).
Slow replacement: State and other federal agencies, as well as local police departments, are filling the gap left by the ATF withdrawal, but at a rate that varies widely across jurisdiction levels and locations.
Insufficient local enforcement: Enforcement has historically targeted online retailers, but brick-and-mortar shops sell the majority of illegal vape products (Todd, 2026).
More products: Manufacturers simply increase production when enforcement increases because seizures lead to a supply deficit.
Loss tolerance: The products are so cheap to make that manufacturers, exporters, brokers, and retailers would still profit if half or more of their products were lost to customs seizure (Team, 2026).
Trans-shipping: Exporters take advantage of the lower tariffs or relatively lower scrutiny of U.S. trade agreements with other countries by routing shipments through intermediary ports to mask their origin (“CTPAT Alert – Illegal Transshipping,” 2025).

In some ways, enforcement is a cat-and-mouse game. U.S. agencies devise new ways to catch illegal products, and then the exporters and brokers find new ways to bypass them.

Lack of Consensus

The federal and state agencies actively engaged in nicotine regulation enforcement represent a minimum of 154 distinct entities (four federal agencies plus three in each state). Courts and local governments have their hands in it as well, along with commercial payment processors. With hundreds of players, it’s not hard to imagine how fragmented regulation and enforcement are.

At the time of writing, 21 state attorneys general have signed a petition pressuring the FDA to reverse its guidance to deprioritize enforcement of products with pending applications (Attorney General Tong Leads Coalition Urging FDA to Reverse Guidance, n.d.). Several of those states have bans or directory mandates that render many of those pending products illegal at the state level (Reyes, 2026), products that are also illegal at the federal level, and still must be smuggled to enter the U.S.

Despite this, manufacturers and industry groups are suing states to allow these pending products, interpreting the FDA’s lack of action as implicit approval. Some courts are upholding the state bans and directory exclusions, while others are overturning them, creating a patchwork of increasingly complex laws across the states (Are State ENDS Directories Preempted? Federal Courts Are Split, 2025).

What Does This Mean for People in Recovery?

For those of us working in addiction treatment, all this regulatory chaos presents a clinical problem. When roughly 9 in 10 vape products available have no health or safety oversight, we can’t in good conscience condone their use by anyone in our care. For that reason, we don’t include vaping among cessation support options in our programs.

Many people in recovery do use tobacco or nicotine products, and there is even a popular misconception that continuing to use them provides a kind of support or helps to prevent relapse. In fact, when people quit nicotine alongside other substances, their rate of successful recovery improves by 25 percent (Prochaska et al., 2004). As SUD treatment providers, we should all be focused foremost on our patients’ success in recovery. It’s for this reason that we run a nicotine-free program and encourage other providers to consider doing the same.