Unauthorized e-cigarettes pour into U.S.
WASHINGTON — The number of different electronic cigarette devices sold in the U.S. has nearly tripled to over 9,000 since 2020, driven almost entirely by a wave of unauthorized disposable vapes from China, according to tightly controlled sales data obtained by the Associated Press.
The numbers demonstrate the Food and Drug Administration’s inability to control the tumultuous vaping market more than three years after declaring a crackdown on kid-friendly flavors.
Most disposable e-cigarettes, which are thrown away when they’re used up, come in sweet, fruity flavors like pink lemonade, gummy bear and watermelon that have made them the favorite tobacco product among teenagers. All of them are technically illegal because they haven’t been authorized by the FDA.
Once a niche market, cheaper disposables made up 40 percent of the roughly $7 billion retail market for e-cigarettes last year, according to data from analytics firm IRI obtained by the AP. The company’s proprietary data collects barcode scanner sales from convenience stores, gas stations and other retailers.
More than 5,800 unique disposable products are now being sold in numerous flavors and formulations, according to IRI’s data, up 1,500 percent from 365 in early 2020. That’s when the FDA effectively banned all flavors except menthol and tobacco from cartridge-based e-cigarettes like Juul, the rechargeable device blamed for sparking a nationwide surge in underage vaping.
But the FDA’s policy — formulated under President Donald Trump — excluded disposables, prompting many teens to switch from Juul to the newer flavored products.
“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.”
Adding to the challenge, FDA has little visibility into a sprawling industry centered in China’s Shenzhen manufacturing hub. Agency records show that FDA inspectors have only conducted a tiny handful of inspections in China, despite the fact that it produces nearly all e-cigarettes used in the U.S. today.
“FDA theoretically has the authority to inspect foreign manufacturing facilities,” said Patricia Kovacevic, an attorney specializing in tobacco regulation. “But practically speaking, the inspection program that the FDA has in place only happens in the U.S.”
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.
Under pressure from politicians, parents and major vaping companies, the FDA recently sent warning letters to more than 200 stores selling popular disposables, including Elf Bar, Esco Bar and Breeze. The agency also issued orders blocking imports of those three brands. But IRI data shows those companies accounted for just 14 percent of disposable sales last year, leaving dozens of other brands untouched, including Air Bar, Mr. Fog, Fume and Kangvape.
FDA’s tobacco director, Brian King, said the agency is “unwavering” in its commitment against illegal e-cigarettes.
“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.”
IRI restricts access to its data, which it sells to companies, investment firms and researchers. A person not authorized to share the information gave access to the AP on condition of anonymity.
IRI declined to comment on or confirm the data, saying the company doesn’t offer such details to news organizations.
To be sure, the FDA has made progress in a mammoth task: processing nearly 26 million product applications submitted by manufacturers hoping to enter or stay on the market. And King said the agency hopes to get back to “true premarket review” once it finishes plowing through that mountain of applications.
5 TAKEAWAYS
How good a job is the Food and Drug Administration doing in its crackdown on kid-friendly electronic cigarette flavors? The Associated Press sought to answer that question by looking at tightly controlled sales data.
The AP obtained the data from the analytics firm IRI, which tracks barcode scanner sales from convenience stores, gas stations and other retailers. A person not authorized to share it gave access to the AP on condition of anonymity.
Here are five takeaways from the AP’s reporting:
E-CIGARETTES KEEP FLOODING INTO THE U.S. WITHOUT FDA PERMISSION
The number of unique e-cigarette products sold in the U.S. has mushroomed to over 9,000 since 2020, when the FDA began restricting vaping flavors and requiring manufacturers to request permission to stay on the market.
The FDA says it has reviewed millions of vaping applications, rejecting 99 percent of them because they have not been shown to benefit public health. That should mean fewer e-cigarettes being sold in U.S. stores, but hundreds of new varieties appear each month, flouting FDA rules.
ALMOST ALL OF THE NEW PRODUCTS ARE FLAVORED DISPOSABLE E-CIGARETTES MANUFACTURED IN CHINA
The increase in e-cigarettes has been almost entirely driven by Chinese-manufactured disposables, with more than 5,800 disposables currently being sold in U.S. stores, according to the IRI data. That number is up more than 1,500 percent from 356 disposables available in early 2020.
Most products mimic the designs and flavors of a few large brands, including Elf Bar, Puff Bar and Esco Bar. Counterfeiting is a big problem across the industry.
LOW-COST CHINESE MANUFACTURING HAS LOWERED THE BAR FOR NEW VAPING BRANDS
Manufacturers in the Chinese city of Shenzhen allow customers to order tens of thousands of e-cigarettes for as little as $2 each. Designs, artwork and flavors can be customized. Many companies promise to ship orders in two to three weeks.
FDA’S FORMER TOP TOBACCO OFFICIAL WARNED THE TRUMP ADMINISTRATION ABOUT DISPOSABLES
In late 2019, the FDA’s top tobacco official warned officials in President Donald Trump’s administration not to exempt disposables from a rule restricting fruit and candy flavors that can appeal to kids.
The FDA banned those flavors from reusable vaping systems like Juul in January 2020, amid a surge in youth vaping. But the regulation specifically exempted disposable e-cigarettes, leading to the explosion in new products on the market today.
The FDA’s former tobacco director, Mitch Zeller, told the Associated Press that White House officials made the decision without his input. When Zeller protested that teenagers would simply switch to using flavored disposables, he was told there was no appeal.
CHINESE MANUFACTURERS AREN’T SUBJECT TO REGULAR FDA INSPECTIONS DUE TO INCOMPLETE RULES
Congress gave the FDA the power to regulate tobacco companies in 2009, with the aim of scrutinizing industry ingredients and manufacturing. But currently, only U.S. manufacturing sites are required to register with the agency for routine inspections.
That means the FDA has little visibility into the conditions at Chinese facilities that produce many of the e-cigarettes sold in the U.S. today.