The FDA Is Blocking a New E-Cigarette That Won’t Explode in Your Face

When it comes to the US government’s role in the industry, they have done more harm than good to consumers.

E-cigarettes have been an undeniable force for good. They have helped countless smokers curb their tobacco use and saved many lives from cancer and other diseases. Yet, they still come with their fair share of problems—explosions being a top concern.

“Vaping” has been adopted by an estimated 10.8 million Americans. But as its use has become more widespread, there have been several instances of device batteries exploding, causing harm to both users and their physical property. And in rare instances, these explosions have even been fatal.

The FDA has made it impossible to bring its new product to market.

Regulators, all too eager to meddle in as many markets as possible, have used these explosions as an excuse to regulate the industry. Innovators, on the other hand, have already recognized the need for safer products in the e-cig market.

Joytech, a leading e-cigarette manufacturer, has stepped up to fill this void by creating safer devices that meet new industry standards. But rather than celebrating Joytech for providing a solution, the FDA has made it impossible to bring its new product to market. And anyone looking to buy these safer devices will have to look outside the US.

A Problem in Need of a Solution

Earlier this year, Florida resident Tallmadge D'Elia was killed when his e-cigarette exploded, sending particles of the device into his skull and leaving more than 80 percent of his body severely burned. In addition to the loss of precious life, his family’s home, where the explosion occurred, also caught fire. Not all e-cig battery explosions end this tragically, but other users have been severely injured.

Alexander Shonkwiler recalls the horror he experienced when his e-cig exploded in his pocket, setting his pants on fire and burning his upper legs:

I heard what sounded almost like a sparkler going off, and then bang, a huge explosion, a huge flash of light and these flames were coming at my face. As I looked down, my leg was on fire. I ripped my pants off, and even with my pants off, my leg was still on fire because the battery acid sprayed all over my leg and dripped down my leg.

Dr. Elisha Brownson, a trauma and burn critical-care fellow at Harborview Medical Center in Seattle, commented on this phenomenon a couple of years ago, saying:

We’re seeing significant tissue injury as well as damage to the mouth or the hands and the tendons. It basically combines a flame burn and a tissue blast injury.

According to the US Fire Administration, there have been 195 reported e-cigarette explosions since vaping began rising in popularity. Instances of explosions have become enough of a problem to cause serious concern in the industry. E-cigarettes use lithium-ion batteries, which are powerful batteries that have rather disastrous consequences when they short or fail.

Venkat Viswanathan, an assistant professor of mechanical engineering at Carnegie Mellon University, explained what happens when these devices short out, saying:

The electrolyte inside the battery is basically the equivalent of gasoline. So when these batteries short out, there’s a surge of heat that causes this flammable electrolyte to combust and explode.

Many have exploited the explosions to try to usher in more government interference and regulate the vaping industry. But when it comes to the US government’s role in the industry, they have done more harm than good to consumers.

Family Smoking Prevention and Tobacco Control Act

In 2009, Congress passed the Family Smoking Prevention and Tobacco Control Act, which placed extra regulatory hurdles on the tobacco industry, all in the name of protecting the children. While e-cigs do not contain tobacco—hence their appeal to those looking to kick the habit—in 2016 the FDA sought to extend this law to include all e-cigarettes that were brought to market after February 15, 2007.

The premarket approval process takes upwards of 1,700 hours and millions of dollars per product, making it exceedingly difficult for smaller companies to gain FDA approval.

For any product not on the market prior to this date, its creators were forced to seek premarket approval from the FDA. But this is not as simple as filling out a form online. The premarket approval process takes upwards of 1,700 hours and millions of dollars per product, making it exceedingly difficult for smaller companies to gain FDA approval. And with the exception of “big tobacco,” many e-cigarette producers are smaller companies.

The 2007 date was of particular interest since it was before e-cigs began to rise in popularity. In fact, the only entity that had patents to e-cig devices prior to that date was big tobacco, which has undoubtedly taken a financial hit as more people have switched to vaping, making this law even more obviously an exercise in crony capitalism. Fortunately, this created enough of an upset in the vape industry that the government was forced to change the predicate date, often called the “grandfather” date, to August 8th, 2016. However, this date is seen as arbitrary.

Had the manufacturers of e-cigarettes been forced to comply with the original predicate date, it is estimated that 99 percent of the industry would have been completely destroyed, as they would have been unable to afford the grueling approval process.

Had the manufacturers of e-cigarettes been forced to comply with the original predicate date, it is estimated that 99 percent of the industry would have been completely destroyed, as they would have been unable to afford the grueling approval process.

But the Tobacco Control Act does not just mandate that products prior to the predicate date seek approval; it also requires that any modified products go through the same procedure, which brings us back to the issue of exploding batteries.

A Solution Hampered by the Government

The entire vape industry has been very proactive in practicing self-regulation lest the government have an excuse to intervene. In fact, many e-cigarette manufacturers have sought independent safety certifications from UL—a global company that tests the safety of consumer products. But try as they may, it still hasn’t been enough to convince regulators to apply common sense.

Joytech, an e-cigarette maker, improved on its older eGo AiO e-cigarette model in order to fix the exploding battery problem. UL, concerned with the safety of these batteries, set a new standard that covers the electrical system of each device, including the battery, charger, and built-in battery system, referred to as “UL 8139.”

Unfortunately, this modification has, in the eyes of the federal government, constituted the creation of a new device.

The new standards forbid the use of removable batteries, which caused Shonkwiler’s pants to catch on fire. UL also specified that it should be more difficult for users to take apart and access the heating coil and other mechanical components. And most importantly, new devices are to include a chip that will automatically turn off the device should it begin to overheat. But the new safety standards don’t end there.

In order to keep your UL safety certification, the device must go through quarterly inspections and annual follow-ups to ensure that the standards are still being met. As UL senior business development manager Michael Sakamoto said, “the risks are minimized and that they’re going to have a safer product in their hands.”

Unfortunately, this modification has, in the eyes of the federal government, constituted the creation of a new device.

Michael Felberbaum, FDA press officer, said, “The law Congress passed requires FDA premarket review for modifications to a tobacco product — including batteries.”

Joyetech’s chief regulatory and compliance officer, Joshua Church, stressed how seriously they are taking this issue:

We did this (UL certification) to protect American consumers, but we can’t sell directly to them. We’ve been frozen out of the US market by the FDA whose last concern is product innovation. So, we're sitting here stuck in the water.

The FDA’s response was vague and ultimately unhelpful. Felberbaum commented:

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.

To be clear, when the FDA says it has “taken several steps,” what it really means is that the agency has used tax dollars to host workshops instructing users how to properly use e-cigarette devices. Meanwhile, a substantial solution to the problem exists, but consumers have no legal access to it all because of a law that was meant to apply to tobacco products, not vape products.

Tony Abboud, the executive director of the Vapor Technology Association, commented on this absurdity, saying:

They have locked us into antiquated technologies. The US government is suppressing innovation in a way that can only harm consumers going forward.

He continued:

Technology innovates in cycles of months, not years, so the products being sold today were first designed almost three years ago. 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.

The FDA has given no further assistance to the industry aside from insisting that they begin the premarket approval process. So instead of being available to consumers in the US, Joytech will have to bring its product to the Canadian market. Not only are the FDA’s actions hampering the potential monetary gains from the sale of the improved eGo AiO e-cigarette, but they are also putting consumers in harm's way.

The FDA claims to exist to protect Americans, but it is stifling innovation that protects consumers from exploding e-cigarettes. This is completely contrary to their mission.

Abboud hit the nail on the head when he said, “We’re a technology industry and our hands are tied behind our back. We have solutions that will protect people to bring to market and we can’t.”

While Samsung did have to spend over $5 billion to correct the problem, they were not inhibited from finding a solution and bringing a new phone to the market.

E-cigarettes are not the only electronic devices to encounter issues with combustible lithium-ion batteries. Just a couple of years ago, there were major problems with Samsung Galaxy Note 7 batteries that resulted in two major product recalls. However, while Samsung did have to spend over $5 billion to correct the problem, they were not inhibited from finding a solution and bringing a new phone to the market.

Unlike e-cigarettes, smartphones are not regulated by the FDA, which allowed Samsung to nip the problem in the bud before it escalated any further. It would be nice if the same courtesy were afforded to Joytech and other brands in the vape industry.

If the government really wants to protect people, it should stand aside and let the vape industry innovate and serve its consumers.

More by Brittany Hunter

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