They question the FDA's reaction to thousands of "vapers" illegal

The numbers demonstrate the inability of the US Food and Drug Administration (FDA) to rein in the crowded vaping market, more than three years after declaring a crackdown, especially on palatable flavors. more to minors.

Thrown away when the contents are empty, most disposable e-cigarettes come in sweet, fruity flavors with names like pink lemonade, gummy bear, and watermelon, which have made them a favorite tobacco product among consumers. teenagers. All of them are technically illegal because they have not been authorized by the FDA.

Disposable devices, which are cheaper and once only a niche market, accounted for 40% of the roughly $7 billion retail e-cigarette market last year, according to data from research firm IRI obtained by the PA. Company-proprietary data is based on sales recorded via barcode scanners at convenience stores, gas stations and other retailers.

According to IRI data, more than 5,800 unique disposable products are now sold in numerous flavors and formulations, up 1,500% from the 365 registered at the beginning of 2020. That’s when the FDA effectively banned all flavors—except menthol and tobacco—from cartridge-powered refillable e-cigarettes like those of the Juul brand, a device blamed for sparking a nationwide surge in underage vaping.

But FDA policy, formulated under President Donald Trump, excluded disposable products, prompting many teens to switch from Juul to newer brands with more flavors.

“The FDA is moving at a slow pace and the industry knows this and takes advantage of it,” explains Dr. Robert Jackler of Stanford University, who has studied the rise of these disposable devices. “Time and time again, the vaping industry has caught up to efforts to remove its youth-appealing products from the market.”

Adding to that challenge, the FDA has little presence in a sprawling industry centered in Shenzhen, China. FDA inspectors have conducted only a few inspections in China, according to agency records, despite the fact that the Asian nation produces nearly all of the e-cigarettes currently consumed in the United States.

“In theory, the FDA has the authority to inspect foreign factories,” stresses Patricia Kovacevic, an attorney specializing in tobacco regulation. “But practically speaking, the inspection program that the FDA has only applies in the United States,” she adds.

Most disposables are Elf Bar or Puff Bar brands, but hundreds of new varieties appear every month. Companies copy each other’s designs, blurring the line between the real thing and the copy. Entrepreneurs can launch a new product simply by submitting their logo and flavor requests to Chinese manufacturers, who promise to deliver tens of thousands of devices weeks later.

Under pressure from politicians, parents, and major vaping companies, the FDA recently sent warning letters to more than 200 stores that sell popular disposable products, including Elf Bar, Esco Bar, and Breeze. The agency also issued orders to block imports of those three brands, but IRI data shows those companies accounted for just 14% of disposable e-cigarette sales last year, leaving dozens of other brands untouched, including Air Bar, Mr. Fog, Smoke and Kangvape.

FDA director for the tobacco industry Brian King said the agency is “unwavering” in its commitment against illegal e-cigarettes.

“I don’t think there is any panacea here,” King said. “We follow a holistic approach and that means addressing all entities along the supply chain, from manufacturers to importers, distributors and retailers.”

Research firm IRI restricts access to its data, which it sells to companies, investment firms and researchers. A person not authorized to share that information gave the AP access to it, on condition of anonymity.

IRI declined to comment or confirm the data, saying the company does not provide those details to news organizations.

Indeed, the FDA has made strong strides in a daunting task: processing nearly 26 million product applications submitted by manufacturers seeking to enter or remain on the market. And King said the agency hopes to go back to “true pre-market review” once it finishes going through that mountain of applications.

Meanwhile, parents, health advocacy groups, and major vaping companies agree on one thing essentially: The FDA should remove flavored disposables from the market.

But lobbying by tobacco giant Reynolds American, maker of Vuse e-cigarettes, has made some advocates wary of pressing the issue. The company itself petitioned the FDA earlier this year to restrict flavors in all disposable vape products.

The FDA’s King says the agency already has great authority to regulate disposable products.

“There is no legal loophole to close,” King stated, pointing to recent FDA actions against manufacturers of disposable products.

But King’s predecessor at the FDA says the current situation could have been avoided had it not been for the Trump administration’s decision to exclude disposables from the 2020 flavor ban.

“It was preventable,” lamented Mitch Zeller, who retired from the FDA last year. “But they told me there was no appeal.”

In September 2019, Trump announced at a press conference a plan to ban non-tobacco flavors from all e-cigarettes, both refillable and disposable. But his political advisers worried that it might upset voters.

Zeller said he was later told, in December 2019, that the flavor restrictions would not apply to disposable vapes.

“I told them, ‘You don’t need a crystal ball to predict that minors will migrate to disposables, that you’re not affected by this, and ultimately you’re not going to solve the problem,’” Zeller recalled.

FUENTE: AP

California18

Welcome to California18, your number one source for Breaking News from the World. We’re dedicated to giving you the very best of News.

Leave a Reply