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Medical Daily
Medical Daily
Joseph James

About 69% of Tracked E-Cigarette Sales Last December Involved Products the FDA Never Authorized, New Analysis Finds

Roughly seven of every ten dollars spent on e-cigarettes at American convenience stores, gas stations, and grocery chains last December went to products the Food and Drug Administration has never authorized for sale, according to a new analysis by scientists at the CDC Foundation.

The figure is 69.4 percent of tracked dollar sales and covers 4,421 distinct products. The report, published in NEJM Evidence as part of the Public Health Alerts series, drew on retail scanner data from the market research firm Circana for the period ending in late December 2025. Disposable devices in flavors the authors describe as potentially appealing to young people made up the majority of unauthorized sales.

For a shopper, the practical meaning is narrow but real. The product on the counter has not been through the federal review that determines whether it meets the statutory public health standard.


The Authorization Standard and What It Certifies

Under the Family Smoking Prevention and Tobacco Control Act of 2009, a manufacturer must obtain a marketing authorization from the FDA before legally marketing a new tobacco product in the United States. Obtaining one requires a determination that the product is appropriate for protecting public health, a population-level judgment that weighs risks and benefits, including the likelihood that young people will start using it.

As of December 2025, 39 e-cigarette products held such orders. Every other e-cigarette on the American market is being sold without one.

Authorization is not a safety endorsement. It does not mean a product is safe, and the FDA has not authorized any e-cigarette as a smoking cessation device. What it certifies is that the agency reviewed the product and concluded the population-level tradeoff was acceptable. An unauthorized product has not cleared that bar.


The Pattern Runs Along Flavor and Device Lines

The authorization gap is not evenly distributed, and the breakdown is more informative than the headline percentage.

Among tobacco-flavored e-cigarette sales in December 2025, 93.1 percent were authorized. Among menthol-flavored sales, 26.1 percent were. None of the sales in any other flavor category, including fruit, sweet, candy, and mint, involved an authorized product.

By device type, half of closed refill sales were unauthorized. Among disposables, 97.6 percent were. That matters because disposables have become the dominant format: CDC Foundation sales tracking has documented disposable devices climbing from roughly a quarter of unit share in early 2020 to a clear majority by 2025, while prefilled cartridge sales fell over the same period.

The measurement has inherent limitations, and the authors acknowledge them. As CIDRAP noted in its coverage, the Circana data covers 48 states, excluding Alaska and Hawaii, and captures convenience, grocery, drug, and retail chains, clubs, dollar stores, gas stations, mass merchandisers, and military bases. Vape shops and online sellers are not tracked at all.

That omission matters. Vape shops are a major distribution point, and the true market share of unauthorized products across all channels is unknown. The authors argue that better data on untracked channels would improve monitoring and enforcement.


Federal Enforcement Has Been Running Behind the Market

A Government Accountability Office report published in March found that the Department of Justice took 88 civil and criminal e-cigarette-related enforcement actions from fiscal year 2022 through fiscal year 2025, with the largest share, 60, coming in fiscal 2025. Much of that increase came from adding entities to DOJ's list of noncompliant e-cigarette delivery sellers rather than from prosecutions.

GAO also documented the scale of joint seizures. A DOJ and FDA task force established in June 2024 coordinated an action in October seizing 3 million e-cigarette products originating in China, with an estimated retail value of $76 million, and a September 2025 action that took more than 2 million illicit vaping products from distributors and retailers across seven states.

One frequently misreported detail deserves correction. The Attorney General did direct the Bureau of Alcohol, Tobacco, Firearms and Explosives in February 2025 to shift resources from its alcohol and tobacco enforcement programs to other departmental priorities. GAO found that as of January 2026, ATF was nonetheless still maintaining the delivery seller list. DOJ officials told GAO that e-cigarette enforcement is a small part of their responsibilities and that the caseload is too small to support a meaningful assessment of resources.


The Age Pattern in the Use Data

The report places current e-cigarette use at 7.0 percent among U.S. adults, 24.8 percent among young adults aged 18 to 24, 7.8 percent among high school students, and 3.5 percent among middle school students.

The young adult figure is more than three times the overall adult rate. That concentration, combined with the finding that unauthorized sales skew toward flavored disposables, is the core public health concern the authors raise.

Parents should understand that shelf availability says nothing about federal status. A product sold at a convenience store near a high school may well be unauthorized, and packaging offers no reliable signal either way.

Nicotine dependence in adolescence is a specific risk. The developing brain is more susceptible to addiction, and frequent use patterns established young tend to persist. Disposable devices compound the problem because many carry high nicotine concentrations in a form that requires no maintenance, no refilling, and no visible smoke, which makes sustained daily use easy to conceal.


Reasonable Steps for Households and Adults Who Vape

No one should treat this finding as a reason to switch from an unauthorized product to an authorized one on the assumption that the authorized version is safe. The authorized list covers tobacco and menthol flavors, and authorization reflects a population-level judgment rather than an individual safety guarantee.

Adults who smoke and are using e-cigarettes to quit should know that no vaping product is FDA-authorized for cessation. Approved cessation aids include nicotine replacement therapies such as patches, gum, and lozenges, along with prescription options, and a clinician can help sort through them.

For parents, a conversation about frequency and dependence is more useful than identifying a specific brand. Anyone experiencing chest pain, shortness of breath or persistent cough after vaping should seek medical evaluation and tell the clinician what they have been using, including whether the product contained THC.

Given the untracked channels, the 69.4 percent figure is better read as a floor than a ceiling. Broader coverage in the morning health briefing from KFF Health News placed the finding alongside other consumer product safety reporting the same week.


Key Questions Answered

What did the analysis find? Scientists at the CDC Foundation estimated that 69.4 percent of e-cigarette dollar sales in tracked retail channels in December 2025 involved products without FDA marketing authorization, covering 4,421 distinct products.

What does FDA authorization actually mean? It means the agency reviewed the product and determined that it was appropriate for protecting public health at the population level. It does not mean the product is safe, and no e-cigarette is authorized as a quit-smoking aid.

How many e-cigarettes are authorized? As of December 2025, 39 products held marketing-granted orders.

Which products were most likely to be unauthorized? Disposables and non-tobacco flavors. Nearly all disposable sales were unauthorized, and no sales of fruit, sweet, candy, or mint-flavored products involved an authorized product.

Does this cover all sales? No. The data comes from convenience stores, grocery stores, drug stores, retail chains, clubs, dollar stores, gas stations, mass merchandisers, and military bases in 48 states. Vape shops and online sales were not tracked.

Who uses e-cigarettes most? The report cites 24.8 percent of adults aged 18 to 24, compared with 7.0 percent of adults overall, 7.8 percent of high school students, and 3.5 percent of middle schoolers.

What should someone trying to quit smoking use instead? Approved cessation options include nicotine replacement therapies and prescription medications. A clinician can help choose among them based on smoking history and other conditions.

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