Concerns Over Illegally Sold Vapes in the U.S.

Anyone who’s stepped into a convenience store at a gas station has probably noticed a shelf filled with vapes. Most of these are actually not legal. Out of around 6,000 e-cigarette products sold in the U.S., only 48 have received approval for sale.

Back in May, when the Food and Drug Administration (FDA) relaxed its enforcement policy regarding vapes, it seemed to invite manufacturers of the many unapproved products to start ignoring the law. As a result, we are witnessing a rise in unauthorized products being sold openly. The law didn’t change; it’s still illegal to sell those items, but the FDA has essentially decided not to enforce it.

The agency mentioned its intention to compile and share a public list of unapproved products it wouldn’t prioritize for enforcement. However, three months later, this list hasn’t materialized. This list was meant to provide some accountability, giving the public insight into the various products the FDA chose to overlook.

One possible reason for the absence of this list could be that the FDA doesn’t want to disclose how many unauthorized products it has decided not to act against, and the number could be significant. If the agency were confident in its policy, it would publish the list. But an agency that has doubts about how extensive its non-enforcement really is typically avoids sharing that information.

On May 8, the FDA put this guidance into immediate effect, bypassing public comments based on the reasoning that “prior public participation is not feasible or appropriate.” Under this guidance, manufacturers can continue selling their products even if their application for review is simply accepted, and the process drags on.

However, it’s important to note that acceptance doesn’t imply the product is deemed safe or effective. According to the FDA’s own guidelines, acceptance means that the application has enough information for review. Essentially, it’s a judgment on the documentation, not on the actual product’s safety.

The absence of a list is significant. Without it, no one outside the FDA can differentiate between authorized, tolerated, or outright illegal products. Retailers, distributors, state enforcement officers, customs agents, and customers are now in the dark. Even companies that have followed legal procedures are left guessing. The FDA has essentially signaled to many manufacturers that merely filing paperwork might suffice. Meanwhile, companies that have invested years and considerable resources into meeting federal approval are left in the lurch.

There’s still no clarity on who might appear on this non-enforcement list. For instance, could it include brands like Charlie’s Chalk Dust, which the FDA previously addressed at a trade show for unauthorized products? And what about Elf Bar and Lost Mary, the disposable vapes linked to numerous FDA warning letters and a large portion of youth e-cigarette usage?

Here’s a point that should raise eyebrows even among those who avoid vaping.

China isn’t just a source of smuggled vapes. The Justice Department has indicted Chinese chemical companies for shipping precursor materials for fentanyl while disguising these shipments to evade detection. Senator Tom Cotton from Arkansas has urged the U.S. Attorney General to investigate counterfeit drug ingredients coming from unregistered foreign entities, chiefly in China. This includes numerous shipments and cases of Americans harmed or killed by counterfeit substances. Representative Richard Hudson from North Carolina has also called for the FDA to act using its existing authority regarding this matter.

The FDA has effectively stated that, when its backlog becomes too long, it will ignore products that require prior authorization. This sets a troubling precedent. Other agencies that experience similar backlogs may now feel encouraged to follow suit.

Resolving this issue doesn’t have to be complicated. The FDA should ideally process applications within the 180-day timeframe established by Congress rather than allowing a void when it fails to do so.

Lawmakers need to press FDA officials about the situation: will the agency publish the promised list, or will it revoke this guidance altogether? A regulatory body that does not disclose the products it is neglecting to monitor owes the public a clear explanation.