On Thursday, the Federal Food and Drug Administration filed sweeping regulations regarding electronic cigarette products, and while public health officials lauded the rules as long overdue, small vape shop owners now fear their days in business are numbered.
Tad Jensen, president of the Utah Smoke Free Association, an organization that advocates on behalf of member vaping businesses across the state, said the 499 pages of legal jargon are not easily decipherable, but “ultimately what these regulations will do is put hundreds, if not thousands, of small shops out of business and force them into bankruptcy.”
Those fears could be well founded, since the FDA’s new rules require businesses to register each of their SKU (stock keeping unit) products separately in a lengthy process that could cost over $1 million per SKU.
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Doing the math, five flavors of e-liquid, each with three different nicotine levels,could run in excess of $15 million to clear the FDA process, Jensen said.
“It’s the same process the FDA puts pharmaceutical and tobacco products through, but they’re much bigger and can shoulder those costs,” Jensen said. “In the vaping industry, these are small businesses that we’re dealing with that don’t have that kind of money. If nothing changes, when this goes into effect, it will put about 99 percent of this industry out of business.”
Jensen owns three “Electronic Stix” shops in Layton, Ogden and Salt Lake City. He said the new rules take effect in 90 days, and then everyone will have two years to submit applications and come into compliance.
What scares him most is what happens to customers when an e-cigarette prohibition essentially takes effect. E-cigarettes are much safer than tobacco cigarettes, Jensen said, and if they’re eliminated, demand could drive the products on to the black market..The other ill effect Jensen fears is that many customers would return to traditional tobacco cigarette use.
Public health officials pleased
Brian Bennion, executive director of the Weber-Morgan Health Department, said public health officials are excited the FDA finally acted, in part because they’ve seen teen use of electronic cigarettes double in recent years. The nicotine in the e-liquid can also be deadly to a toddler who finds the flavor enticing and consumes the bottle’s contents.
In the absence of overarching regulation, local health departments took a patchwork approach and enacted ordinances that capped nicotine levels in the liquid, barred product sales to minors under the age of 19, required permits for liquid manufacturing or mixing facilities, and launched random compliance checks of underage sales at local shops. An education component was also included to warn parents and teachers of the risks of underage use.
In 2015, Rep. Paul Ray, R-Clinton, successfully sponsored legislation to requires sellers to be licensed, allows the state health department to oversee liquid product quality and nicotine content, and also imposes packaging and labeling standards.
“We’ve had to do a lot of work to cover the gaps that have been created over the years in tobacco world,” said Davis County Health Department Director Brian Hatch,“We’re excited and happy that they brought all those components under federal regulation so that we don’t have to keep piecemealing our local regulations.”
While the health-damaging effects of tobacco products is now undeniable, public health officials maintain there has not been enough research conducted on electronic cigarettes.
“We do know that nicotine is addictive, but there is anecdotal evidence that e-cigarettes help some get off the tobacco cigarette products,” Hatch said. “So we’re constantly rechecking and as information comes in, we realign what we need to do. That’s the nature of public health.”
Vape sellers: Don’t lump us with tobacco
Warren Braegger and Jason Bench, co-owners of the Vapor Vault in Ogden, say significant data has already been published.
“Studies coming out are showing how safe this is, how it’s far more effective than any smoking cessation products made by big pharma,” Braegger said. “”These are peer-reviewed, scientific, published papers.“
Braegger and Bench pointed to one recent study involving Mayo Clinic patients who used electronic cigarettes before and after surgery to avoid the ill-effects of their regular tobacco use.
”When you ban this, you’re forcing people back into tobacco, which we know kills people,“ Braegger said.
As far as SKUs, the Vapor Vault featured at least 50 unique items displayed on their shelves Friday, with many more of their signature Drag’n Juice flavors available for purchase..
”It would also apply to every battery, tip, lanyard, sticker, and anything we sell here,“ Braegger said, putting their FDA product registration costs completely out of reach.
”Every single product on the market now will come off and will be banned for sale until it goes through this process,“ Bench said. ”So the only people who will be able to afford to do that are people with billion dollar budgets . . . the people that caused the problem in the first place, big tobacco.“
In a nutshell, Braegger and Bench say that’s why they got into the vaping business in the first place.
”That’s what we’re trying to fight. We view ourselves as the opposite of big tobacco, and we can’t stand being lumped in with them,“ Bench said.
When asked if they expect to be gone in two years, Braegger said he wouldn’t go that far. ”There’s a big fight in us,“ he said.
Bench agreed: ”I’m not going anywhere.“