FDA puts e-cigarette companies on notice over teen access

16 September, 2018, 13:15 | Author: Eric Barnett
  • FDA takes ‘historic action’ on youth e-cigarette ‘epidemic’	 	 	 			File an e-cigarette

"Because of numerous rule-making delays and a seeming reluctance to fully assert its authority, FDA for years has repeatedly missed opportunities to keep tobacco products out of the hands of our children and we have seen e-cigarette use among youth hit epidemic levels", Hansen said.

The agency also issued around 1,100 warning letters and 131 fines. "We won't allow the current trends in youth access and use to continue, even if it means putting limits in place that reduce adult uptake of these products", he said. The agency issued 12 warning letters to companies they declared have deceptive marketing labels on e-liquids.

Gottlieb called the action "historic" and said it was the largest coordinated enforcement effort in the agency's history. He promised, too, that the FDA would be keeping close tabs on manufacturers' own internet storefronts and distribution practices to detect sales to minors.

He said "everything is on the table", including criminal charges.

And while Kirshenbaum says there's still more studying to be done, experts know enough to send out a warning. The agency had for decades had no power to regulate cigarettes or other tobacco products, but Congress passed a law in 2009 giving FDA limited power to do so.

These successes on behalf of kids - and a near-universal presumption of their innocence - can help provide momentum to this new FDA crackdown.

A loss for public health and win for big tobacco?

Gottlieb said he plans in the coming weeks to debut additional enforcement actions targeting companies that may be marketing products to children in ways that are misleading.

"There's a general perception out there that e-cigarettes are safe And they're certainly not safe." says Leslie Phillips. But he stopped short of requiring any such changes.

The appeal of e-cigarettes is that users are said to inhale far fewer toxins than cigarette smokers.

But that hasn't stopped more than 2 million middle and high schoolers from vaping in 2017, according to the FDA. Nearly 12% of high school students and 3% of middle school students reported using e-cigarettes in the prior 30 days.


The U.S. market for vaping products has exploded as well. JUUL alone has more than 70% of e-cigarette sales in the US according to recent Nielsen data.

Now, the FDA wants to crack down on flavored products.

Dr Gottlieb acknowledged that the toughened approach would force "hard trade-offs" when it comes to promoting e-cigarettes to adults.

While e-cigarettes were first marketed to help adults quit smoking combustible cigarettes, they have now become a gateway to nicotine for teenagers. Those products include e-cigarettes. This epidemic is particularly troubling given the high addiction potential that products like JUUL present to youth.

"The way that e-cigarettes are marketed, they are really are marketed to naive users of tobacco products and they're also marketed to younger people", Kirshenbaum said. We don't want kids to be vaping.

FDA Commissioner Scott Gottlieb said the agency plans to take new steps to address the matter.

The FDA on Wednesday ordered five brands - Juul, British American Tobacco's Vuse, Altria's MarkTen, Imperial Brands' Blu E-cigs and Japan Tobacco's Logic - to submit plans, within 60 days, to discourage teen use of their products.

If we had an affordable, easy-to-use device that eliminated 90 percent of the health problems associated with HIV or cervical cancer in exchange for relatively minor risks and side effects, we would consider it monstrous to withhold that product from the market.

"Let me be obvious: All the pieces is on the table", said Gottlieb.

Manufacturers offer and market e-cigarette flavours that clearly appeal to minors, including candy and bubble gum flavours.

"Don't get hacked", one PSA said.

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