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Dark Clouds on E-Cigs' Horizon Have Arrived

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John David Smith opened Rock 'n' Roll Vapes in the heyday of what many considered the Wild West in the vaping industry. Thousands of electronic cigarette shops like Smith’s in Arlington had been appearing across the country since vaping appeared on the scene in 2007. Mostly mom-and-pop vape shops in the beginning, their owners mixed their products in backrooms, using food additives and nicotine to create e-juice that turned into a smoke-like cloud of vapor when heated by a battery-powered element in a vaping pen.

Many people heralded “vaping” as a safer alternative to cigarettes, challenging the pharmaceutical industry’s control over smoking cessation products. Like other vape business owners, Smith quit smoking because of vaping and opened his shop to help other people to quit — and then the Food and Drug Administration moved to regulate vaping beginning Aug. 8.

The FDA's regulation of the vaping industry is being challenged in federal court in Washington, D.C., while Smith and other vape business owners are rushing to comply with new rules by the Dec. 31 deadline.

“They are not getting in a rush to come busting into shops and shutting people down,” Smith says. “But there is a lot of panic in the industry and a lot of hearsay, and a lot is coming from people who I’m not sure had even sifted through the FDA’s 500-page document.”

The FDA now requires vape shop owners and manufacturers to stop saying vaping is a safe alternative to cigarettes or a way to quit smoking, despite many former smokers claiming the contrary.

Jah Flynn, the co-owner of Alice in Vapeland and former smoker, says he and his co-owner, Nicole Li, spent the last four and a half years helping people to quit smoking. Now they can’t even recommend how to use the devices to quit smoking.

“As a business owner, I would like to tell my customers my opinion,” Flynn says. “But I can’t even go to my Facebook page and say that vaping is safer than smoking.”

He says part of the problem is public perception.

“They’ll say, 'I have heard vaping is just as bad [as smoking] so I’m not going to do it,'” Flynn says. “So I think it has prevented people from using vaping to quit smoking.”

It isn’t clear what will happen to Flynn or other vape business owners if they are caught making the claim that vaping is safer than cigarettes. Enforcement began Aug. 8. Flynn says it was a dreaded day for the vaping industry.

“That’s part of the craziness,” he says. “We don’t know what the penalties are, and we don’t know what the exact limits are. That is the thing. It’s the uncertainty that the FDA can turn around and say, ‘You didn’t file this or do this.’ My rule is to expect the worst.”

The FDA’s regulations also require vaping businesses to prove their e-juice was substantially equivalent to tobacco products on the market in early February 2007. If they can’t, which many of them can’t, they must go through a costly premarket tobacco application process for each product.

The federal agency claims the cost will depend on a number of factors, including the pathway to market being applied for, the type and the availability of data on the specific product and similar products. It estimates the cost to apply will range between $117,000 and $400,000 per product.

The FDA indicates on its website that high costs may come from vape business owners like Smith needing to conduct original research and testing and the staff time spent compiling it.

Flynn says the new regulations and the uncertainty has forced many vape business owners out of business. "What people are worrying about is they are going to be very vague on what is required and if it is not done right you are done," he says.

It has also led the Right to be Smoke-Free Coalition and nine other groups to take their battle with the FDA to a federal district court in D.C.

Some of the groups argue the FDA’s regulations violate the First Amendment because it prevents them from passing out samples. They also claim the vape pens (or electronic nicotine delivery systems) cannot be considered a tobacco product under the Tobacco Control Act’s definition because they do not contain tobacco, only nicotine.

“The agency offers no rationale based on the definition of ‘tobacco product’ or the legislative history indicating such definition can be stretched so far [to include vaping products],” the groups claimed in court documents.

Groups such as the American Vaping Association and the Electronic Vaping Coalition aren’t the only ones taking action against the FDA. A Republican from the West Virginia House of Delegates is also suing the agency over its regulations because he’s an e-cigarette user and claims they’ll only cause former smokers who use vape and e-liquid products to pick up their smoking habits.

Smith is following the cases in D.C. and spending hundreds of hours with his wife filling out applications for their 700 e-juice flavors. But he says he feels the FDA’s estimates are overblown.

Smith says he plans only to register his “main flavors” and apply for a substantial equivalency for his “off flavors” because they contain similar ingredients found in his main flavors.

And he’s also found a friend in a chemistry student to help him analyze the chemical makeup of his homemade e-juice. It’s a move he claims is potentially saving him thousands of dollars.

“I’m ahead of the curve,” he says. “Thank God for college students.”

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