ENDS of an era: Opponents of FDA regulations say new rules choke e-cig, vape industry

ROCKINGHAM — Two weeks ago, the U.S. Food and Drug Administration quietly rolled out a set of regulations taking aim at the growing e-cig and vape industries after lumping numerous devices and e-liquid products together under a single definition: electronic nicotine delivery systems, or ENDS.

According to the FDA website, “Many ENDS are manufactured to look like conventional cigarettes, cigars, or pipes. Some resemble pens or other everyday items. Larger devices such as tank systems or mods bear little or no resemblance to cigarettes.”

The reason behind the strong new regulations, according to Alex Raines of One Stop Vape Shop in Rockingham, is a false belief that all e-liquids used by people who vape contain the dangerous chemical diacetyl.

“Diacetyl, that was linked to popcorn lung back during the ’90s with microwave popcorn in the factories,” Raines said. “But there are more cases of popcorn lung in people who are smoking than there are with vaping. There are no cases with vaping. You know how the media gets and how people get. They get scared of something they don’t understand.”

Diacetyl is found in some food flavorings but is harmless when ingested, but inhaling it has caused documented cases of an incurable lung disease called bronchiolitis obliterans, also known as “popcorn lung.”

Raines said that only two domestic manufacturers of vape juice have ever been found to contain the chemical, but once it was brought to their attention they quickly removed it from their products. The bottles containing juice with diacetyl, he explained, are likely to be the imported brands sold in gas stations and other non-speciality stores.

“Five Pawns was caught with it in their juice,” Raines said. “So they removed it, but that took away that rich, buttery flavor that diacetyl gave it and they started to lose money. So they decided, ‘We’ll sneak it back in and not say anything. People are stupid, they won’t know.’ But they got caught and now they’re facing a class action lawsuit.”

The FDA website states that going forward, those who manufacture ENDS must submit an application and obtain FDA authorization to market a new tobacco product, register establishment(s) and submit product listing to the FDA by Dec. 31, 2016, submit listings of ingredients, information on harmful and potentially harmful constituents and tobacco health documents.

They will also have to add a nicotine warning statement similar to those found on cigarette packages sold in the United States.

“A lot of people don’t even vape nicotine,” said Sherry Willhoyt, a visitor at the vape shop. “They only like the flavors. But the FDA keeps saying that there are all kinds of chemicals in the e-juice or that the people who mix the liquids have no way of regulating how much nicotine goes into it, and that’s a crock.”

Raines said the vape juices in the shop he works for contain four ingredients at most — and only three without the nicotine.

“People know what they’re getting,” he said. “Propylene glycol and vegetable glycerin are mixed with food flavorings that do not contain diacetyl. They can get them with or without any nicotine at all. And those are all the ingredients we ever use. They’re commonly found in the food you buy at the grocery stores and are not harmful.”

Propylene glycol is also used in asthma inhalers.

Amanda Mullins, who also works at the vape shop, said the danger is in purchasing products made in other countries and even by people in the U.S. whom you don’t know personally and trust.

“We tell people not to buy them online or from the gas station,” she said. “I don’t order food online, I’m definitely not ordering and inhaling something online when I don’t know what’s in it, when I don’t know where it’s been.”

Earlier in the year, Rep. Tom Cole, an Oklahoma Republican, sponsored HR 2058, a house resolution backing advocates of vaping and e-cigs in a bid to preserve their vaping rights. Rep. Richard Hudson, R-Concord, was among fifty-four co-sponsors of the resolution. He explained that to him, the regulations represented a clear case of federal government wielding a heavy hand against freedom of choice and the small business economy.

“This industry has operated within the law for years, but now the Obama Administration has stated they will have to stop selling their products until the FDA approves them,” Hudson said in a statement to the Daily Journal. “Like many of my constituents, I believe the federal government has overstepped its bounds. Not only will it increase uncertainty and cost jobs in this industry — which is led by small businesses — but it will also limit consumer choice.”

Jamie Shepard of the Tobacco Road Outlet store on U.S. 74 W. said the new restrictions could make a significant dent in sales — even for TRO, a shop that sells mostly traditional tobacco products like cigarettes, cigars and pipe tobacco.

“We adopted the electronic products probably six or seven years ago,” Shepard said. “And yeah, we sell a lot of it. I’d say it accounts for probably twenty percent of our sales.”

Raines said that the regulations imposed will roll out over a period of time, and that while it would not be technically impossible for a store like his to keep the doors open, it would prove far too costly.

“From what I understand from reading all the regulations, we have ninety days from they day they dropped the regulations which was Monday, May 6,” he said. “The way it starts off is in ninety days from May 6, nothing new is allowed to come out. No mods, no batteries, no juice, no nothing. So after ninety days, production stops. In order to get something new out you have to go through protocol with the FDA to get anything you make approved. You have to pay to have them tested and pay all these large sums of money in order to continue. Amounts nobody can reasonably afford. So vaping as we know it today with our hundred-watt boxes and our eLeaves and everything like that is going to be gone.”

He said that will leave everyone with only FDA approved choices, most likely the inventions of the moguls of big tobacco, who can afford to pay to play.