Vaping's Dirty Little Secret
Because the industry is federally unregulated, e-liquids can be manufactured just about anywhere: in a controlled, sterile lab, on a tool bench in a garage, or anything in between.
Image: Shaye Anderson/Motherboard
A stained concrete floor is littered with cardboard boxes, large plastic jugs half filled with liquid flavorings, and milk crates full of empty containers. A stainless steel cart holds a precarious arrangement of pump-topped bottles, measuring cups, and a pad of folded paper towel stained with candy-colored rings. A bug clings to a mound of plastic lids.
Last fall, images of these scenes surfaced online, depicting the manufacturing facilities of Dr. Crimmy's, a fast-growing e-liquid company based in Gainesville, Georgia. Many in the vaping community were disgusted, and vowed to drop the brand from their rotation. The company's owner defended the photos—reportedly taken by a former employee and leaked to Convicted Vapes, an e-liquid review YouTube channel—saying they were not only months old, but also taken out of context, and mostly depicted areas where production was not taking place. The company currently works out of a lab that, at least on the surface, appears to be much more sanitary and controlled.
But the incident was illustrative of a pervasive problem in vaping. Because the industry is federally unregulated, e-liquids can be manufactured just about anywhere: in a controlled, sterile lab, on a tool bench in a garage, or anything in between. With no oversight or governing agency, consumers often have no idea where on this spectrum the lab making their favorite juice falls. It's only when companies get publicly outed, or post carefully-choreographed lab tour videos, that customers get a glimpse at how the sausage (-flavored e-liquid) is made.
And so the idea of a garage lab has become a part of vaping mythology that's difficult to shake. As far as I can tell, no company has been publicly exposed for mixing juice in an actual garage, but many in the industry tell me there are some set-ups that are little better.
Though federal regulations are coming, the industry has been attempting to self-regulate for years, both to root out any bad actors and to prepare for the new laws. With hundreds of vaping companies in the US, it hasn't been an easy task, especially because there's still no consensus on exactly what a "good lab" should look like.
It's left the vape industry facing some difficult questions. Will the self-imposed regulations be enough to help the industry quickly meet standards when the axe finally falls? And can vaping ever escape the stigma of the proverbial garage lab?
"We lost customers and we gained customers. As far as overall how it hurt the business? It could have been a lot worse," Jerry Kramer, general manager and head of operations at Dr. Crimmy's, said about the photo leak last fall. "It was a hard situation. I think everybody learned from it, though."
Some of the images, the owners said at the time, depicted the commercial facility where they had been making juice, but were snapped during a renovation when no production was taking place. The rest of the images, which show what looks like active production, were of the owner's basement, where a makeshift lab had been created while the company waited for the renovations to be complete:
Since May of last year, Dr. Crimmy's has been operating out of its newly-renovated commercial facilities which, in a video posted online, appear to be clean and tidy and the company has implemented high cleanliness standards, according to Kramer. The workers don gowns, gloves, and hair nets before entering the mixing room. The work stations are made of stainless steel, and the mixing room walls and floors are coated in an easily-cleaned epoxy. The entire lab is scrubbed and sanitized at least once a day, Kramer said, and none of the liquids are ever unsealed outside the mixing room. They're also hoping to move to a larger facility with an ISO-certified clean room later this year.
"I can honestly say that if there were regulations and [regulators] wanted to step in this building today, they would have no problem with the way we're doing things," Kramer told me.
Regulations are coming. In 2014, the Food and Drug Administration released proposed regulations for e-cigarettes: a preview of the finalized laws that will be released later this year. The proposals include requiring vaping product manufacturing facilities to register with the FDA and be subject to random inspections. All products would also have to provide the FDA with complete and accurate ingredient lists.
"FDA would be able to take enforcement action against any tobacco products that did not meet these basic standards," the proposal reads. "If a product was produced in insanitary conditions or was contaminated, or if its labeling contained a misleading claim it would be subject to FDA enforcement action, including seizure or injunction."
The trouble in the meantime is that the definition of "insanitary" changes depending on who you ask. Do e-liquids—which are vaporized, then inhaled into the lungs, and often used as a way to quit smoking—need to be produced to the standards of medical grade products like inhalers? Or, as an alternative to cigarettes, are the kind of standards that the tobacco industry is held to good enough?
"We wanted to show them that we do have control. We do have standards."
There are industry groups trying to figure this out. The American E-Liquid Manufacturing Standards Association (AEMSA) formed in 2012 to sort out these issues and create a framework of best practices for manufacturers to follow. The group updates its list of standards each year. The lengthy, detailed standards include requirements such as having childproof caps on all e-liquids, food-grade working surfaces in labs, and measuring nicotine for mixing using equipment that is calibrated to be either NIST or ASTM compliant.
Companies that pay for membership can become AEMSA certified once they prove that they follow the practices, but since the guidelines are posted online, any company can follow them, and many non-members advertise this choice, although there's no one verifying it.
"We decided that setting standards for ourselves was absolutely something that we could do and should do," Scott Eley, AEMSA's president and one of its founding members, told me over the phone. "The vaping community at the time was billed as a bunch of crazy guys in a basement or bathroom or a garage making this e-liquid in buckets and not having any control. We wanted to show them that we do have control. We do have standards that we're producing to."
To create the standards, AEMSA looked to other industries like food production for inspiration, but also consulted with experts like Kurt Kistler, a chemistry professor at Penn State who studies e-cigarettes. Eley told me that the standards were primarily consumer-focused, but are also intended to protect workers who are having to interact with potentially harmful chemicals, such as liquid nicotine, and to prepare for the coming federal regulation.
Some producers go beyond even these standards, opting to invest in ISO-certified clean rooms to mix their juices. ISO—the International Organization for Standardization—will issue certifications for labs that meet the physical requirements for health and safety. This includes things from the type of surfaces in the room, to the type of equipment workers have to wear, but largely focuses on airflow and filtration. The lower the ISO number (for clean rooms, it ranges from 1 to 9), the more strictly the air in the room needs to be controlled. A lab that produces medical implants, for example, would need to have very high ISO certification to ensure nothing is contaminated.
Mitten Vapors, a Michigan-based e-liquid manufacturer, recently invested in upgraded facilities including an ISO-6 certified clean room.
"I believe it's the highest that anybody in the industry has. There could be a company with a higher [ISO level], but not that I know of," said Jamie Zichterman, the owner of Mitten Vapors. "I think we need to have certain standards in the industry. Right now there are new companies popping up every day and you don't know if they're making juice in a really clean lab or with their buddies out in a garage somewhere."
It's not just clean manufacturing: Unlike the tobacco and alcohol industries, the vape industry currently has no federal regulations on packaging and marketing (though some states have passed laws on this front). Because of this, one of the biggest criticisms lobbed at vaping is that it's attracting youth. In the US, more high schoolers use e-cigarettes than any other kind of nicotine product, and the use is increasing. This has legislators concerned, because while vaping has been shown to be much less harmful than smoking, it's still not harm-free, and it's not a habit anyone—including the vaping industry—wants teens picking up. There have also been a handful of reports of young children accidentally ingesting e-liquid and getting nicotine poisoning.
This is something the industry is independently working to address, too. Vape Free Youth is a collective of vaping companies committed to finding ways to reduce youth vaping, including child-proof lids, changing logos to be less cartoonish, and being more subtle about candy-flavored liquids.
Still, the specter of the garage lab juice factory still haunts the industry. Texas Rebel Juice, another e-liquid company, faced similar criticism to Dr. Crimmy's when images of its lab, showing workers drinking and playing cards in the mixing room, were posted online in 2014. A company spokesperson said at the time that the photos were taken after hours, and some images were from before the room was finished and operational, but it still turned some vapers off the brand.
"People can't help but look at that and have some kind of reaction, most of which will be disappointment, confusion, concern," one forum user wrote. "I saw it and started to wonder if my own vendors were doing the right thing and that had never crossed my mind before."
Texas Rebel Juice did not immediately respond to Motherboard's request for comment.
The truth is that lots of juice companies began as grassroots startups by vaping enthusiasts who went from making their own juice, to sharing with friends, to selling in a short period of time. That means that lots of juice companies in the US started off mixing in the owner's home kitchen. How clean the setup was in that kitchen and how quickly the company moved to a more controlled, commercial space depends on the company. It's also not unheard of for vape shop owners to slap on a pair of rubber gloves and mix a bottle of juice for a customer right on the store counter. So we're left with an industry where pretty much anything goes.
"I truly believe, when people are just getting into the business, a lot more of that goes on than people think it does. I know it does," Kramer told me. Even Dr. Crimmy's started off in the owner's kitchen in the beginning, he said.
After the Dr. Crimmy's images were posted online, the owner and management took part in a live broadcast of Mod Envy, a vaping podcast and YouTube show. In what amounted to the vaping world equivalent of a tribunal, the Dr. Crimmy's team fielded questions and criticisms from well-known vaping reviewers, who puffed on custom mods and squirmed uneasily at their explanations.
"I feel like I'm being lied to," said Catelin Powers, an e-liquid reviewer, during the show.
As more information about the impacts of vaping becomes available, concerns over how juice is made and what it's made of are swirling in the community. Though there will always be those vapers who don't care what's in their juice as long as it tastes good, more and more consumers are getting informed and demanding higher standards. The industry has come a long way, but until the formal requirements from the FDA are enacted, there are still plenty of pockets for kitchen-mixed juice companies to hide. As much as the industry has tried to self-regulate, it's unlikely the spectre of the garage lab will truly be vanquished until federal regulations come into play.
Correction: An earlier version of this story misrepresented the federal cleanroom standards assigned by the International Standards Organization (ISO). The numbers range from 1 to 9, with lower numbers representing stricter cleanliness standards.