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The first vaping products designed to prevent fires and explosions — and safety certified by UL — are scheduled to hit the market in a few weeks. While these redesigned electronic cigarettes will be available in Canada, they won’t be sold in the United States.
The vaping industry blames the U.S. Food and Drug Administration, which regulates tobacco products, for preventing Americans from buying these safety-enhanced devices.
“They have locked us into antiquated technologies,” said Tony Abboud, executive director of the Vapor Technology Association. “The U.S. government is suppressing innovation in a way that can only harm consumers going forward.”
UL, the global safety company that tests and certifies tens of thousands of consumer products each year, now has a safety standard for electronic cigarettes — and Joyetech, a big player in the e-cigarette market based in southern California, is the first manufacturer with a vaping product that meets this rigorous standard.
But here’s the rub: When the eGo A10, Joyetech’s UL-certified vaping device, hits the market this month it will be sold in Canada, but not the U.S.
Joshua Church, Joyetech’s chief regulatory and compliance officer, said safety is important to his company. “We did this (UL certification) to protect American consumers, but we can’t sell directly to them,” Church said in an exclusive interview from ShenZhen, China. “We’ve been frozen out of the U.S. market by the FDA whose last concern is product innovation. So, we’re sitting here stuck in the water.”
What’s the FDA doing and why?
“The FDA shares concerns about adverse effects associated with the use of e-cigarettes, such as overheating and exploding batteries, and the agency has taken several steps to address the issues,” Michael Felberbaum, FDA press officer, told NBC News.
These steps include a public workshop on potential safety hazards, educating consumers about how to avoid e-cigarette battery explosions and exploring product standards to address battery issues, Felberbaum said.
So then, what’s the holdup?
An FDA regulation prohibits the sale of any new e-cigarettes that were not sold in the U.S. prior to August 8, 2016 without pre-market approval. The industry calls that a “completely arbitrary” date from a technology perspective.
“The law Congress passed requires FDA premarket review for modifications to a tobacco product — including batteries,” Felberbaum said.
So if manufacturers modify a device that’s been on the market before that date — to add an automatic shutoff or energy management system for the battery, for example — it cannot be sold without premarket approval.
In May 2016, the FDA issued draft guidance for companies that wanted to file a Premarket Tobacco Application. The agency announced in July 2017 that it intended to develop standards to protect against battery problems as part of a comprehensive plan for tobacco and nicotine regulation.
Why would modifying a current electronic cigarette with safety features, such as a power management chip, make the device a new product? Because there’s no way to know if those changes would have any health impacts, the FDA told NBC News.
Manufacturers say they cannot begin the costly and time-consuming application process until the rules for this process are finalized, and no one knows when that will be.
“Technology innovates in cycles of months, not years, so the products being sold today were first designed almost three years ago,” VTA’s Abboud told NBC News. “Manufacturers have developed and are selling products in other parts of the world that have safety designs and safety protections in them, but we can’t make any changes to those products here in the U.S. without going through the FDA’s multimillion-dollar multi-year PMTA process.”
What’s causing the explosive battery failures?
We’ve all seen the videos of an e-cigarette bursting into flames in someone’s hand or in their pocket. When the powerful lithium ion battery fails, the explosion can cause serious injuries and start fires.
According to the U.S. Fire Administration, at least 195 electronic cigarettes exploded or caught fire between 2009 and 2016. These incidents resulted in 133 injuries, 38 of which were severe: facial injuries, third-degree burns, or loss of a body part.
In May, a smoker in Florida was killed when his electronic cigarette exploded, causing a “projectile wound to the head,” according to the autopsy report. Tallmadge D’Elia, 35, was found in a burning bedroom at his family’s home in St. Petersburg. This is believed to be the first death caused by an exploding e-cigarette.
The American Vaping Association said most of these mishaps are caused by improper use — when someone has loose batteries in their pocket that touch coins and short circuit or improperly rebuilds the heating coils and causes the battery to overheat.
“When stored, used and charged properly, vaping products pose no more of a fire risk than other products powered by lithium ion batteries, like cellphones and laptops,” said Greg Conley, president of the AVA.
Michael Pecht, director of the Center for Advance Life Cycle Engineering at the University of Maryland, says batteries used in vaping products are different than those used in other consumer products. They need to discharge a lot of power in short bursts to create the heat needed to vaporize the liquid being smoked.
“We’ve seen a huge number of problems with vaping products,” Pecht told NBC News. “I think there’s a lot of stuff that’s just not reported.”
UL tries to eliminate the major risk factors
The new voluntary safety standard for vaping products, known as UL 8139, covers the entire electrical system: battery, charger and built-in battery management systems.
A device with a removable battery cannot meet the UL 8139 standard. This eliminates the exploding battery in the pocket scenario. The device must also be designed in a way that makes it difficult for the user to change the heating coil or other major component.
UL requires an onboard battery management system, typically a chip, that regulates the power and automatically turns off the device if the battery starts to overheat. Manufacturers whose products pass the UL test must agree to quarterly factory inspections and annual follow-up testing to make sure they stay in compliance.
Michael Sakamoto, UL’s senior business development manager, said smokers who see the UL-listed logo on a vaping device can be assured “the risks are minimized and that they’re going to have a safer product in their hands.”
Where do we go from here?
The FDA says it encourages manufacturers interested in making modifications that address battery safety issues to contact the agency to discuss options on how they can do so in a timely fashion and the FDA will consider each situation on a case-by-case basis.
The vaping industry says it supports new regulations that make its products safer, and it urges the FDA to work with manufacturers to quickly finalize its premarket approval application process.
“We’re a technology industry and our hands are tied behind our back,” Abboud told NBC News. “We have solutions that will protect people to bring to market and we can’t.”