E-cigarette Regulatory Gaps and Substance Use Recovery
An overwhelming majority of e-cigarette products in the U.S. have no safety or health oversight.
Regulatory and enforcement agencies are far from having a handle on the illicit vape market.
SUD treatment providers can't be sure of the safety of these so-called harm-reduction tools.
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........
