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Vapers worry about FDA e-cigarette regulations

Five years ago, Amanda Love smoked a pack and a half a day. Today, she's off cigarettes entirely.

"I have five kids. I did it for my health and because they are teaching that stuff now in school. When your fifth-grader comes home and says, 'I just learned in school that that's bad.' Right, I'll stop," Love said. "My health has improved — I can walk up hills now."

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Love's smoking cessation solution? Vaping. Beginning with e-cigarettes purchased at the mall, Love eventually discovered the wide variety of custom flavors available through Westminster's Vape Dojo, which not only sells the vaping devices but also mixes a custom line of flavored e-liquid — the nicotine containing fluid heated into a stream of vapor in a vaping device — right in the shop. Love now works the counter there.

"I started vaping at 36 [milligrams of nicotine], and 36 mg now is unheard of," she said. "It wasn't until I came to Vape Dojo that they said, 'Sweetheart, you do not need all that nicotine.' They put me at 12 mg. I figured out with the tank that I was using, that that was a little too harsh too, and I was able to go to a 6 mg. That was in a five-week span. That was four years ago."

Love is worried that her favorite flavors might disappear — that Vape Dojo might even be forced to close — now that the U.S. Food and Drug Administration has issued new regulations on the manufacture and sale of e-cigarette products. Asserting its authority under the 2009 Family Smoking Prevention and Tobacco Control Act, the FDA on May 5 began defining e-cigarettes as tobacco products and shops that mix their own e-liquid as tobacco manufacturers, a move that might force shops like Vape Dojo to go through an expensive approval process to continue selling their products.

"The classic line you see up there, we have to do away with completely," Love said, gesturing at the large menu on the wall of Vape Dojo that features flavors such as caramel banana, blueberry vanilla and "Zen Juice." "People are upset about that."

Betty Jenkins, of Gwynn Oak, is one Vape Dojo customer who is worried about the regulations. A smoker for 35 years, she said vaping has helped her go from smoking a pack a day to six cigarettes a day or less, and she said her choice of flavors, cotton candy and Jolly Rancher, carry an aromatic value added.

"It's given us a better environment, tasting things better and given us our tastebuds back. Our clothes stink from the cigarettes and all that," Jenkins said. "They want us to quit smoking, but when we come up with a solution to help quit, they want to take it away."

The FDA's take

Officially, no vape or e-cigarette manufacturer or retailer can claim that their products help people to quit smoking — that would require filing an application with the Center for Drug Evaluation and Research within the FDA — but in a May 5 conference call with reporters, Mitch Zeller, director of the FDA Center for Tobacco Products, said the agency is aware of the "anecdotal evidence."

"There's no question that a hypothetical pack-a-day smoker who is otherwise unable or unwilling to quit cigarettes — if that person completely switched to e-cigarettes, there's no question that that person would be significantly reducing his or her risk," Zeller said. "But we can't make policy at a national or population level on the basis of hypothetical individuals or anecdotal reports of benefit."

Citing an absence of good evidence that e-cigarettes are leading to smoking cessation — and in the face of evidence suggesting that some teens might be picking up vaping who have never smoked, as well as questions about the safety and purity of some e-liquids on the market — Zeller said during the call that the FDA needed to move to establish regulatory authority over the marketplace. It was a move that he said would allow the FDA to answer open questions about the appeal of e-cigarettes to teens, the health risks of vaping and its possible efficacy in reducing smoking.

Under the new FDA regulations, any manufacturer of e-liquid and some e-cigarette devices first brought to market after 2007 would be treated as new tobacco products and would have to go through a premarket application process to establish their safety. That's a potentially expensive undertaking that will require both large manufacturers and small shops, like Vape Dojo, that mix their own flavors into e-liquid, to produce laboratory analysis detailing all of the ingredients in their products.

It might even be necessary for shops to make separate applications for each flavor they would like to sell, a proposition that is a nonstarter for many retailers, according to Chris Herche, co-owner of EVape Cafe in Westminster.

"We know that with other [tobacco products] that have gone through that application process, it's been about 1,500 man hours and the cost has been anywhere from $200 to $1 million per product," Herche said. "It would pretty much eradicate the market and hand over the sale of vape products to the bigger companies, such as tobacco companies, that have the money to put out the close to a million dollars for each product to get it approved."

Tobacco companies have lobbied the FDA to restrict vaping products other than their own. In 2014, the Winston-Salem Journal reported that tobacco giant RJ Reynolds, maker of the Vuse brand e-cigarette — often called a "ciggalike" by self-identified vapers because of the often-disposable devices' physical similarity to a real cigarette — submitted a 119-page document to the FDA arguing that vapor products that allowed users to mix in flavors of their own choice should be banned. E-cigarettes like Vuse, or the Imperial Tobacco-owned Blu brand, offer fewer flavors than the wide array of options available in local vape shops.

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The FDA is concerned that pleasant flavors such as cotton candy or bubble gum are a sign that vape products are being marketed to children, but many former smokers who vape retort that it is the variety of flavors that help make their product of choice a good replacement for traditional cigarettes.

Brad Posner, of Reisterstown, began smoking cigarettes at 18 years old, and now, at 19, has rejected them entirely for vaping an e-liquid flavor that is a mixture of vanilla and peppermint, blowing the mildly scented vapor in the lounge area of EVape Cafe.

"If you think about it, you are going away from tobacco for a reason," he said, explaining that he did not like the imitation tobacco flavors offered in some of the tobacco company branded e-cigarettes. "You are going away from cigarettes."

Posner also enjoys coming to the EVape Cafe because it provides him with a personal connection to the people providing him with his e-liquid.

"You know the guys — unlike cigarettes, where you don't have a face behind it," Posner said. "There are faces behind vaping in Westminster. They are people that you trust, it's Chris [Herche]."

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Keeping it local

While Posner reclined and exhaled another billowing cloud of exhaled vapor, Herche was busy at the cafe counter working on a "build," using a pare of needle-nose pliers to manually wrap high-resistance wire into a coil for a customer's vape device. He said he would welcome "common sense" regulations, such as requiring manufacturing standards for e-liquid and preventing vape sales or marketing to minors, but he believes the FDA should have answers to questions about harm before moving to regulate the marketplace in the way it has.

"In our view, they didn't really go based on any science to make these regulations. It was a knee-jerk reaction, and they are really overplaying certain parts of it," Herche said. "A lot of these shops are going to close — the smaller manufacturers are going to close."

Manufacturers, large or small, have two years to continue selling their vaping products while putting together a premarket application for the FDA, and can continue selling for a third year while the FDA reviews the application.

But EVape Cafe, which has its own line of e-liquid, Equilibrium Vapors, that is marketed nationally, does not expect to be able to afford to submit an application, Herche said. It is also unclear, at this point, how likely it is to receive the go-ahead from the FDA.

"They could turn it down, and then you are out that money. If somebody is trying to go get financing for it and it's just a maybe, they're not going to be able to finance that," Herche said. "They are going to have to pull it out of their pockets and actually pay these huge fees on hopes."

Herche, Love and others in the vaping community now hold out hope that some sort of legal action could halt or reverse the nature of the FDA regulations.

"What I am hearing is that these big consumer advocacy groups are coming together," Herche said. "There is going to be a lot of lobbying, there's going to be litigation and hopefully we get injunctive relief."

The litigation backlash has in fact begun, with major e-liquid manufacturer Nicopure Labs LLC, maker of Halo brand e-liquids, filing suit in federal court on Tuesday, May 10.

In the House of Representatives, an amendment to the federal fiscal year 2017 agriculture appropriations bill proposed by Rep. Tom Cole, R-Oklahoma, would change the FDA rule so that vaping devices marketed as recently as 2015 could be grandfathered in, obviating the need for stores and manufacturers to go through the expensive premarket application process.

It is unclear at this time if any legal actions will change the nature of the FDA regulations. In the media conference call, Zeller said the regulations will ensure the safety of vaping products and the cost of the application process might well decrease substantially once manufacturers get started.

"There's going to be incredible efficiencies," Zeller said. "The actual manufacturer of, say, the liquid nicotine or the flavor can open a master file with the Food and Drug Administration that contains all of the proprietary, commercially confidential information that we need … companies that want to use those ingredients can simply reference the master file rather than having to duplicate the costs of all of those extra scientific analyses."

It might also be a little early to assume that vape shops will be closing their doors after two years; even if shops such as Vape Dojo can no longer mix their own e-liquid flavorings, they will still be able to retail the e-liquid produced by larger manufacturers who have gone through the application process. Still, e-liquid makers such as Herche believe there will be some inevitable consolidation of the market.

"It's going to have to come down to some companies coming together and doing it as a bigger organization," he said.

If former smokers are suddenly faced with only a few choices when it comes to e-cigarettes, perhaps only those made by the larger tobacco companies, Herche believes many will simply return to smoking cigarettes again.

For longtime smokers such as Betty Jenkins, who has tried all of the products, the answer is clear: She wants to keep buying the product that has worked for her and hopes that one way or another, her cotton candy e-liquid will stay on the shelves at Vape Dojo.

"I've tried the gum; I've tried the patch; I've tried the pills; I've tried them all. None of them worked," she said. "I've tried the Blu's, I have tried the other ones — the only ones that have worked for me are the ones they make right here."

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