The number of different e-cigarette devices sold in the U.S. has nearly tripled to over 9,000, despite a three-year effort by the FDA to crack down on kid-friendly flavors.
FILE IMAGE - A person exhales vapor while using an electronic cigarette device at a smoke shop in New York, on Jan. 8, 2020. Photographer: Michael Nagle/Bloomberg via Getty Images
Most disposables mirror a few major brands, such as Elf Bar or Puff Bar, but hundreds of new varieties appear each month. Companies copy each other’s designs, blurring the line between the real and counterfeit. Entrepreneurs can launch a new product by simply sending their logo and flavor requests to Chinese manufacturers, who promise to deliver tens of thousands of devices within weeks.
"The FDA moves at a ponderous pace and the industry knows that and exploits it," said Dr. Robert Jackler of Stanford University, who has studied the rise of disposables. "Time and again, the vaping industry has innovated around efforts to remove its youth-appealing products from the market."The policy applies to cartridge-based e-cigarette flavors including fruit, candy, mint and dessert flavors.
"I don’t think there’s any panacea here," King said. "We follow a comprehensive approach and that involves addressing all entities across the supply chain, from manufacturers to importers to distributors to retailers." But in the meantime disposable vape makers have exploited two loopholes in the FDA's oversight, only one of which has been closed.
"It was preventable," said Mitch Zeller, who retired from the FDA last year. "But I was told there was no appeal." In September 2018, FDA officials declared teen vaping an "epidemic," pointing to rising use of Juul, Reynolds American’s Vuse and other brands. Reynolds and Juul have seen sales flatline amid the surge in disposables, according to the IRI data. Disposable e-cigarettes generated $2.74 billion last year.
"We’re a company that does very positive things for society and the community, and the government just attacked us," said Surriff, who added that he recently purchased new cars for several longtime employees. Made by iMiracle Shenzhen, Elf Bar alone has generated nearly $400 million in U.S. sales since late 2021, the IRI data shows. The company recently renamed its products in the U.S. to EB Design, due to a trademark dispute.
Fourteen years later, the FDA hasn't finalized manufacturing rules that would extend its authority to foreign vaping factories. In fact, regulators only released a draft regulation in March. The FDA itself recognizes the problem, stating in its proposed guidelines: "Covering foreign manufacturers is necessary to assure the protection of the public health," and noting "numerous reports of battery fires and explosions," with Chinese e-cigarettes.Vaping could be more harmful to lungs than smoking cigarettes
With limited resources, the FDA used "discretion" to delay decisions on many applications, allowing products — including major brands like Vuse — to stay on the market for years,
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