FDA Issues Warning to Retailers, Urging Them to Halt Sales of Elf Bar, the Leading Disposable E-Cigarette in the US

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The Food and Drug Administration (FDA) has taken action against several retailers selling fruit- and candy-flavored disposable e-cigarettes, including Elf Bar, the current top-selling brand. This move is part of the ongoing efforts by regulatory authorities to combat the influx of illicit disposable vapes flooding the US market in recent years.

Last month, the FDA issued orders allowing customs officials to seize shipments of Elf Bar, Esco Bar, and two other brands at US ports. These products have not received FDA authorization, and their appealing flavors, such as cotton candy, are seen as particularly enticing to teenagers.

In its most recent action, the FDA has issued warnings to 189 convenience stores, vape shops, and other retailers, emphasizing that the sale of illegal products that contribute to the addiction of young individuals will not be tolerated.

Brian King, the FDA’s tobacco center director, expressed the agency’s determination in an interview, stating, “We’re not going to stand by as bad actors are profiting off the sale of illegal products that are addicting our nation’s youth. Today’s action is just part of our long-standing efforts to address those products, particularly flavored disposable products.”

Despite the FDA’s persistent efforts to regulate the multibillion-dollar vaping industry, unauthorized e-cigarettes continue to enter the market, as revealed in data released by government researchers. An analysis by the Centers for Disease Control and Prevention (CDC) showed an increase in the number of e-cigarette brands in the US from 184 in early 2020 to 269 by late 2022.

This rise coincided with the surging popularity of disposable e-cigarettes. The analysis indicated that the market share of disposable e-cigarettes more than doubled from 24.7% in early 2020 to nearly 52% by late last year.

Researchers from the CDC and the nonprofit organization Truth Initiative analyzed sales data from IRI, which collects records from convenience stores, gas stations, and other retailers. They found that Elf Bar was the best-selling disposable e-cigarette in the US and the third-best selling e-cigarette overall by late last year, with only the reusable e-cigarettes Vuse and Juul surpassing its sales figures.

In a separate report concerning e-cigarette-related calls to US poison centers, both the FDA and CDC identified Elf Bar as a frequently mentioned product. Many of these calls involved children under the age of 5, who had accidentally ingested liquid nicotine. Such incidents can lead to seizures, convulsions, vomiting, and brain injuries. While the brand was reported in only a small portion of cases, the significant number of incidents associated with Elf Bar raised concerns among government scientists.

FDA’s King referred to this high number of reports involving Elf Bar as a “canary in the coal mine” and stressed the importance of taking proactive measures to prevent further expansion of such issues.

Elf Bar, manufactured by the Chinese company iMiracle Shenzhen, is part of a wave of imitative e-cigarettes that followed the success of Puff Bar, a popular brand of disposables that experienced a surge in sales after regulatory measures targeted older vaping products like Juul.

In early 2020, the FDA restricted flavors in cartridge-based reusable e-cigarettes, such as Juul, to menthol and tobacco flavors, which are more commonly preferred by adults. However, this restriction did not extend to disposable e-cigarettes, which are discarded after use.

Following the FDA’s attempt to remove Puff Bar from the market, the company relaunched its product, claiming to use laboratory-made nicotine that fell outside of the FDA’s original oversight of tobacco-derived nicotine. Most disposable e-cigarette manufacturers followed a similar strategy.

The legislative loophole was closed by Congress last year. According to the law, companies were required to withdraw their vaping products from the market and submit FDA applications. Nevertheless, new products continue to be launched despite these regulations.

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The Big Big News Health and Science Department is supported by the Howard Hughes Medical Institute’s Science and Educational Media Group. The AP bears sole responsibility for all content.

Frequently Asked Questions (FAQs) about disposable e-cigarettes

More about disposable e-cigarettes

• FDA’s Statement on Warning Letters
• CDC Analysis on E-cigarette Brands
• FDA’s Efforts to Regulate the Vaping Industry
• Truth Initiative’s Research on E-cigarettes