E-cigarettes and “vapes” are growing more common in the U.S. And the FDA isn’t sure what that means.
Truthfully, no one really knows. Vaping, in this case referring to the small battery-powered devices that heat up flavored nicotine so users can inhale the vapors, is the relatively new kid on the block; too early in its life in the public mind to be heavily regulated or produce science on the long-term effects. For now, all we know is that it’s an improvement on the classic cigarette.
As one would guess, that’s not enough for the FDA, who has been struggling to put the e-cigarette in a regulatory box since it hit the scene. But although e-cigarette use is often linked to increased smoking habits, it may be a bit premature for the FDA to purport they know what they’re doing.
Light Up
E-cigarettes first popped up in China in 2007, and since then they have become a major disruptor to the tobacco industry. Global cigarette sales started plateauing, and ultimately dropping over the next few years, while e-cigarettes and other vapes plumed into an industry worth billions. Last year there were more than 19,000 vape stores worldwide, with 466 brands providing vape systems. And according to WHO that number is expected to grow by 17 percent by 2030.
It helped that the habit existed in a bit of a legal wild west. Only last year the FDA released a proposed rule to expand their authority to regulate e-cigarettes and its ilk, which would reign in the previously virtually unfettered market. And as the market awaits their final regulations, now months overdue, many e-cig vendors worry the FDA has gone too far.
Burnt Out?
Under the new guidelines, any product that hit the shelves after February 2007 would have to apply retroactively for approval from the FDA—which could cost retailers (often small businesses) up to millions in processing fees. And though the FDA has said they’d give businesses up to two years to comply, many worry that no amount of time would be enough.
“The process could cost us half a million to million dollars per [flavor,]” said Jan Verleur, co-founder and CEO of VMR Products, which claims to be the world’s largest online retailer for cigarettes, in The Hill. With over 500 flavors, the compliance costs would add up to more than five times the company’s revenue size, according to Verleur.
For many small-scale or vape only manufacturers, the only ones who will be left standing at the end of the FDA’s regulation will be big tobacco companies. One trade association even estimates that the rules will put 99 percent of the industry out of business.
Which wouldn’t be a problem if the FDA’s moves were entirely sensical: The vaporizing industry has been hazy on the law for a while, and not too many people are on the other side of this issue. But the harsh restrictions only make sense if there’s science to back them up—which there largely isn’t.
Loosey Standards
The FDA, meanwhile, has maintained that the regulations are for the good of the nation’s health, as The Los Angeles Times reports:
The FDA said increases in nicotine poisonings reported by poison control centers and emergency rooms show that rules are needed. According to the American Assn. of Poison Control Centers, toxic exposures from e-cigarette devices and liquid nicotine increased from 271 in 2011 to more than 3,500 in 2014. In California, toxic exposures rose from 12 reported in 2011 to 243 in 2014. Most of the victims were children under 6.
The thing is, so far there is little to no consensus on what the long-term effects of e-cigarettes are. It’s pretty widely believed that e-cigarettes are more healthy than classic cigarettes. But that’s about all scientists know, or rather, are willing to cautiously agree on. Not even the degree to which it’s better, whether secondhand vapors are damaging, or whether the long-term effects will prove just as costly. And while some studies link underage e-cigarette use with increased likelihood to smoke, others say the opposite, even supporting the belief that e-cigarettes help long-term smokers quit smoking altogether.
To complicate all that, vaporizer stores and users alike have been mixing together different flavors and liquids for years to engineer a tailor-made high—meaning that research might be out of touch with the habits of habitual users, and the FDA’s regulations scope may not be able to keep up.
To their credit, the FDA is conducting their own scientific review of the effects of e-cigarettes. But as Vox writes, it’s hard to really cut through all the confusion around e-cigarettes, especially this early in their lifetime:
The state of the science, in short, is crap. Many of the studies don’t pass basic tests of methodological rigor. There are only two published randomized control trials — considered the gold standard of scientific evidence — on e-cigarettes (this one and this one). Worse, many of them may be hopelessly corrupted by industry money or bias.
…One of the great complexities of research in this area is the fact that e-cigarettes types vary so widely. “What is an e-cigarette?” asks Judith Prochaska, a professor at Stanford’s prevention research center, rhetorically. The devices can hold a wide range of flavors and chemicals, they burn and deliver nicotine differently, and their technology is advancing fast. It’s hard to know whether findings of studies are generalizable at all.
But perhaps the biggest complication is that e-cigarettes are extremely new — and so the most important research hasn’t had time to be conducted. The first peer-reviewed studies only started emerging in 2010, meaning we are still far from the kind of scientific certainty that can give clues about the effects of e-cigarettes over decades.
But that probably won’t change the FDA’s plans (or the states that have already regulated them in some way). Though the regulations were expected in June, the government agency has been pushing to release their final regulations by the end of summer—which could be any day now. Which means by the end of the year, vape and e-cig stores will finally know what kind of cloud is hanging over their head. But for whether it’s based on firm science or smoke and mirrors, we’ll just have to wait and see.