William Eric Brown, a 24-year old man of Tarrant County, TX, entered a vape shop seeking help from the clerks. According to an unnamed store manager of the Smoke and Vape DZ vape shop, Brown was having issues with a product that the store’s staff didn’t sell. After the interaction, according to local authorities, Brown further fumbled with his device until the battery exploded forcing debris into his body. Records obtained from the Tarrant County Medical Examiner concluded that he died of “cerebral infarction and herniation due to … dissection of the left internal carotid artery.”
Blood splattered all over his grandmother’s car. Brown was pronounced dead at a local hospital sometime later, according to the Medical Examiner records. Local news media soon identified that Brown died of a battery explosion from a mechanical mod device. The brand of the device supposedly had several issues, according to accounts from shop staff. The staff and witnesses are bound to silence as the investigation continues. I reached out to Tarrant County asking about the brand of mod that was used in Brown’s final moments; however, no response was provided.
I begin this column by referencing this sobering news because Brown’s death is now being peddled by anti-vaping activists as further justification to overregulate the industry. I speak on behalf of all of us at Vaping Post by offering Brown’s family our condolences and respect. However, I do have to say this: Government regulations have prevented the sale of safer vaping products. Effectually, this prohibition threatens the lives of millions of consenting legal consumers who use e-cigarettes and vaporizers daily. “There are mechanical mods out there,” says Mark Anton, executive director of the Smoke Free Alternatives Trade Association (SFATA), in a phone call. He elaborated further that mechanical mods if misused could force a battery to “run away” and cause a chemical chain reaction that results in an explosion. According to reports, the battery within Brown’s mod was a lithium-ion battery. While these batteries have crept into the lives of Americans relatively unnoticed, they are widespread and serve as the power sources for thousands of consumer electronic products. For mods, lithium ions can emit much power. However, if these batteries are pushed too far, an explosion could be the result. During our conversation, Anton pointed to the case of Samsung’s release of their Note 7 device a few years ago as an example of faulty batteries. Hundreds of defective cells caused phones to combust causing a general recall. The company was able to recover the products, nonetheless.
Because much of Brown’s case remains sealed, we can only speculate to what happened. Many of these speculations could focus on whether Brown was using the device correctly all the way to a fatal but infrequent case of catastrophic equipment failure. No one in the media knows as far as I can tell. However, unlike this case to that of Samsung’s, the mobile phone industry has global safety standards that are accepted by both the government and the industry. This isn’t the case for the vaping industry in the United States. “What we really need is standards for this industry, Anton added. “Standards will bring higher quality to the devices and the consumable portion of the product.” I couldn’t agree more with Anton. Due to the Food and Drug Administration’s (FDA) regulations, the American vaping industry is unable to bring newer and safer products to market. Last year, the Northbrook, IL-based safety certification firm UL, formerly Underwriters Laboratories, established a new safety protocol for the electrical systems built into e-cigarettes. Dubbed standard ANSI/CAN/UL 8139, this new industrial protocol is the first substantive manufacturing framework that promotes safer and higher quality e-cigarette products.
“The testing requirements for UL 8139 specifically evaluate the safety of the electrical, heating, battery and charging systems,” according to UL. These testing requirements include seven standards that include battery testing and safety window monitoring for lithium-ion cells. These standards are also novel to industry and have been accepted with open arms in international markets. For example, the manufacturer Joyetech Group was the first company to have a product that met the standards of UL 8139. This brings up the problem, in any case. According to a NBC News report from last October, Joyetech is barred from selling its UL-compliant eGo AiO product in the United States due to FDA regulatory controls.
“We did this (UL certification) to protect American consumers, but we can’t sell directly to them,” Joshua Church, Joyetech’s chief regulatory and compliance officer, said in this report. “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.” Instead of a launch in the United States, Joyetech has since begun distribution to Canada. Keep in mind; this case isn’t unique. Since FDA’s rulemaking in 2016, the sale of new products is virtually banned in the United States. That’s the case unless manufacturers submit to a pre-market approval process for all future products. The Family Smoking Prevention and Tobacco Control Act of 2009, as amended, compels the FDA to force manufacturers to submit new products made after August 8, 2016, to a Premarket Tobacco Product Applications (PMTAs) process for review by regulators. According to the industry, this process is arbitrary and quite costly. Agency estimates put each PMTA application and the accompanied approval process at $300,000 per product submitted. Other calculations by commentators put the cost estimates into the millions. Timeframes for application reviews also average from 500 hours to 1700 hours. At a minimum, that is about 63 days of review per product application.
“While new and improved vapor products are widely available in Canada and Europe, U.S. regulators have frozen technology in time – August 8, 2016, to be exact,” reads a statement from the Vapor Technology Association (VTA) provided to me by the group’s board treasurer, lawyer Chris Howard (general counsel for E-Alternative Solutions). “Today, the United States already is years behind the curve as a result of the FDA’s regulations.”
You never know, if regulations were made more flexible, the several instances of vaporizer explosions and Brown’s case could’ve been prevented.
As a result of the PMTA regulation, e-cigarettes and vaporizers are viewed as traditional tobacco products. Because the vaping industry is a technology industry, the FDA is ultimately empowered to regulate batteries, software, circuit boards, and microchips under the agency’s tobacco regulatory framework. Moreover, to make matters worse, this is virtually the same regulatory framework that’s outlined under the antiquated Federal Food, Drug, and Cosmetic Act of 1938. This aspect of the FDA’s current regulatory framework on e-cigarettes also doesn’t accomplish anything actionable while it curtails product innovations.
Adding new reforms and regulation that is accepted by the industry can do good for consumer safety. As outlined here, there’s no recourse to suggest any market-friendly adoption of rules that do respect consumer and business rights under the current system. Organizations like SFATA, VTA, and others are working independently or in tandem to create industry standards and promote a narrative of self-regulation. You never know, if regulations were made more flexible, the several instances of vaporizer explosions and Brown’s case could’ve been prevented.