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November 18, 2017

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New FDA regulations could damage Nevada’s vapor industry

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L.E. Baskow

John Woods of Jus Tha Tip blows some vapor past some of their hand-made products during the Vape Exhibit at the Sands Expo and Convention Center promoting a variety of new and interesting E-cigarette products on Saturday, May 21, 2016.

Health district official: Vape industry blowing smoke

As coordinator of the tobacco program at the Southern Nevada Health District, Maria Azzarelli mapped stores selling vapor products in Clark County.

Of particular interest to the study, done in conjunction with the Nevada attorney general’s office, was just how close vape shops were to “youth venues,” such as schools. “I found out how hard it was to track it. You don’t need a tobacco license to sell electronic cigarettes,” Azzarelli says. “7-Eleven sells e-cigarettes. You have to search ‘e-cigs’ and ‘vapes’ (online) to find them.”

What she found was about 1,200 tobacco shops in Clark County, constantly opening and closing, and no way to tell how many sold e-cigarettes. Azzarelli points to a Centers for Disease Control and Prevention study released in January finding “about 2.4 million middle and high school students were current (past 30-day) users of electronic cigarettes, or e-cigarettes, in 2014.”

“There’s unregulated juice, unrestricted flavoring and unrestricted coloring,” Azzarelli says. “At the end of the day, what comes off an electronic cigarette is an aerosol that we know causes cancer … We are dealing with a (vapor industry) marketing machine that spits out misinformation.”

As 5 o’clock rolls around, people are trickling into Charles Ploski’s Henderson business. A father and his grown son, a new dad and a married couple all shop and stay awhile, maybe grabbing a soda while they chat with Ploski. This warm interaction could be at a coffeehouse or neighborhood pub, but it’s Friday night at a vape shop.

They enter Ploski’s Vapor Cave with devices in hand, seeking “vape juice” (or liquids, as Ploski prefers) — nicotine liquid in flavors such as vanilla, cotton candy and tobacco. The average age of his customers is 40-45, but they come as young as 18 and as old as 78. Ploski says his shop at 2960 St. Rose Parkway defies the stereotype of a smoky lounge for young hipsters.

“We aren’t all millennials trying to blow clouds around,” he says. “We just don’t want to smoke (tobacco) anymore.”

A recent study by the Roswell Park Cancer Institute in Buffalo, N.Y., shows that smokers who switch to electronic cigarettes get the same levels of nicotine with fewer toxins and cancer-causing chemicals. Yet Ploski, who serves on the board of the Nevada Vaping Association, says the industry is “dealing with a lot of bad publicity.”

E-cigarette and vaping regulations announced by the U.S. Food and Drug Administration in May took effect Aug. 8, forbidding any new products from entering the market. Shop owners can continue offering e-liquid flavors and devices that already are for sale, but they can’t introduce anything new. Even mixing existing flavors is prohibited after the first of several deadlines over the next three years.

By Aug. 8, 2018, all e-cigarette and vapor products must be filed through the FDA’s Premarket Tobacco Application, buying the applicant another 12 months to secure approval. “If it has not been approved by Aug. 8, 2019, it comes off the shelf,” Ploski said.

Gregory Conley, president of the New Jersey-based American Vaping Association, called the earlier deadline “the Prohibition date for 98.9 percent of our industry,” after which selling unapproved merchandise “will be a felony.”

Nevada Vaping Association Co-chairman Alex Mazzola owns Las Vegas-based Flavor Vapor. The 3-year-old business has seven employees and operates as Mob Liquid at 3650 N. Rancho Drive, where Mazzola makes e-liquid combinations that will soon have to be approved by the FDA.

“The FDA is portraying this as unsafe for kids, but we don’t want to sell to kids,” Mazzola says. “Two years ago, Gov. (Brian) Sandoval signed a law making it illegal to sell to anyone under 18. So, the FDA can act like they are doing the healthy thing, but they are just putting us out of the game.” Mazzola adds that the Nevada Vaping Association has a couple hundred members, but many other vapor-product sellers are not members, so it’s difficult to do a statewide tally of all who will be affected.

‘The millionaire’s lottery’

Several pieces of proposed legislation could potentially save the vapor and e-cigarette industry. Among them is HR 2058, which would grandfather in existing vapor products as of this August, and the Cole-Bishop amendment, a rider to an agriculture appropriations bill that would cut funding of the FDA’s efforts to regulate new tobacco products. Or, as Republican Rep. Mark Amodei (who sponsored both bills) would say, to impose “a regulatory death sentence.”

“It’s do-or-die for the vapor industry at this point,” Conley says. “Only the large tobacco companies will be able to afford this application process. But even they are worried.”

Conley says that process could cost hundreds of thousands of dollars, though Vapor Cave’s Ploski puts it closer to $1 million dollars. “We’re calling it ‘the millionaire’s lottery,’ because it’s a gamble. There’s no guarantee you will get the approval once you spend all that money,” Ploski says.

The American Vaping Association advocates for an estimated 10,000 to 15,000 vapor businesses and other tobacco shops that sell vapor products. And it’s a plaintiff in one of several lawsuits seeking to stop the new regulations.

Instead, Conley favors the Cole-Bishop amendment’s requirement that vapor shops register with the FDA, as it’s almost impossible now to map all the sellers of e-cigarettes and vapor products. Many cities and counties don’t have separate classification for vapor shops, whose products are complicated because they’ve intermingled. Shops may sell their own vape juices or outside brands, and different companies might make the heating coil, modifier and device that combine to deliver a nicotine dose.

Thus, the enormous burden of the regulations, Conley explains. “You have to test various different liquids with various different devices with various different coils in various different settings, and that is where the money comes in.”

Vapor vs. Big Tobacco

Vast opportunities in the vapor industry have led to home-based businesses such as Danny Blessing’s 3SixtyCoils. He sells his handmade coils online and at shops, including Vapor Cave, and says he’ll defy any repressive FDA rules. “They will have to take my equipment. Somebody has to stand up to them. I will go underground if I have to.”

Juan Gonzalez’s VapeSling is another home-based business. The mod-holder inventor has launched a letter-writing campaign to his representatives in Washington, D.C., and says he has received positive responses from Rep. Joe Heck, R-Nev., and Sen. Dean Heller, R-Nev.

“I feel it is unfair and ridiculous to ask for millions of dollars (to approve) new flavors,” Gonzalez says.

Steam Spirit Vapor owner Judy Buttram, a former corporate caterer who has been in the business for four years, fears for the future of her shop at 600 W. Sunset Road : “Everybody will go out of business. Nobody has a million dollars to spend on an application to the FDA. Big Tobacco is behind this.”

The theory that cigarette conglomerates are trying to shove out mom-and-pop vapor shops is shared by many, including Ploski and Cloud Wars owner Reshad Mahan. Mahan believes his 2-year-old shop at 4130 S. Sandhill Road can survive the regulations by diversifying more into pipes, glassware and other merchandise, but he is not happy.

“It’s just out of the question. I can’t afford to go through (the application) process, and zero percent of vape shops in the Las Vegas Valley can afford this.”

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