The Food and Drug Administration (FDA) has recently taken measures to address the issue of illegal disposable e-cigarettes with fruit and candy flavors being sold by numerous retailers. One of the most popular brands, Elf Bar, has received a warning letter from the FDA.
This move is part of a broader regulatory effort to combat the influx of illicit disposable vapes that have flooded the market in the United States in recent years.
In the previous month, the FDA granted orders that empower customs officials to confiscate shipments of Elf Bar, Esco Bar, and two other brands at American ports. These products have not obtained FDA authorization and are available in flavors such as cotton candy, which regulators believe can attract teenagers.
As part of their ongoing efforts to tackle flavored disposable products, the FDA has issued warnings to a total of 189 convenience stores, vape shops, and other retailers.
“We will not stand idly by while unscrupulous individuals profit from the sale of illegal products that are addicting our nation’s youth,” stated Brian King, the director of the FDA’s tobacco center. “Today’s action is just one step in our longstanding campaign to address these products, especially flavored disposable ones.”
In spite of the Food and Drug Administration’s longstanding efforts to regulate the vaping industry, recent data released by government researchers indicates that unauthorized e-cigarettes are still being introduced into the market.
According to an analysis conducted by the Centers for Disease Control and Prevention (CDC), the number of e-cigarette brands in the United States increased from 184 in early 2020 to 269 by late 2022.
This rise in e-cigarette brands aligns with the growing popularity of disposable e-cigarettes. The analysis revealed that the market share of disposable e-cigarettes more than doubled from 24.7% in early 2020 to nearly 52% by the end of last year.
The data was collected by researchers from the CDC and the nonprofit organization Truth Initiative, who analyzed sales records from convenience stores, gas stations, and other retailers using data from IRI.
Among the various e-cigarette brands, Elf Bar emerged as the top-selling disposable e-cigarette in the United States and the third-best selling e-cigarette overall by the end of last year. The only e-cigarettes with higher sales were the reusable options Vuse, produced by Reynolds American, and Juul.
In addition, both the FDA and CDC have highlighted Elf Bar in a distinct report that focuses on the thousands of calls made to U.S. poison centers regarding e-cigarettes, with a particular emphasis on cases involving children under the age of 5.
The accidental ingestion of liquid nicotine can lead to serious health consequences such as seizures, convulsions, vomiting, and brain injury. While reports of nicotine poisoning have fluctuated over the past decade, government scientists have noted that calls related to these incidents increased by over 30% between the previous spring and March of this year.
Although brand information was not available in 95% of the cases, when it was reported, Elf Bar was consistently identified as the most frequently mentioned product. This underscores the significance of addressing the potential risks associated with certain e-cigarette brands, particularly those that may pose a higher risk to children.
Despite the absence of complete data, FDA’s Brian King expressed concern over the significant number of reports involving Elf Bar, considering it as a potential warning sign or indicator of a broader issue.
The manufacturer of Elf Bar, iMiracle Shenzhen, is a Chinese company, and this brand is part of a trend of imitative e-cigarettes that have emerged following the success of Puff Bar. Puff Bar gained immense sales momentum after regulatory actions targeted older vaping products like Juul.
In early 2020, the FDA imposed restrictions on flavors for cartridge-based reusable e-cigarettes such as Juul, limiting them to menthol and tobacco, which are more commonly used by adults. However, these flavor restrictions did not extend to disposable e-cigarettes, which are discarded after use.
When the FDA attempted to remove Puff Bar from the market, the company relaunched by stating that it was now using lab-made nicotine, which fell outside the FDA’s initial oversight of tobacco-derived nicotine. Many other disposable e-cigarette manufacturers followed a similar strategy.
Last year, Congress closed this regulatory loophole. According to the law, companies were required to withdraw their vaping products from the market and submit FDA applications. However, new products continue to be introduced, indicating a failure to comply with these regulations.
