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E-cigarette retailers welcome and worry about proposed Indiana regulations

New bills could impose strict rules on manufacture and sale of electronic nicotine delivery devices

Mike Cline, 64, started selling electronic cigarettes almost by accident. A lifelong smoker, he took the advice of his son and on Nov. 7, 2009, tried a popular alternative to smoking cigarettes. He inhaled from an e-cigarette.

"I haven't wanted a cigarette since then. This has been a miracle," Cline said.

Miracle or not, his discovery of e-cigarettes, battery-operated devices that turn nicotine-laced liquid into a vapor that is inhaled, led to a business. He began selling e-cigarette starter kits at a coin store he owned in Indianapolis, and they proved so popular, he eventually opened up the Indy Vapor Shop and sold his other business, which he had run for 32 years.

But lately he is worried about the health of his e-cigarette establishment. He fears that new regulations being proposed in Indiana to govern the fast-growing industry will stunt his company’s growth.

E-cigarettes are inspiring a lot of fear these days. People working in the industry worry that they're going to be hit with the same regulations that regular cigarette companies operate under. Meanwhile, public health officials and lawmakers feel that the e-cigarette industry has been allowed to flourish unchecked into what someday could become a public health crisis.

That worry was increased recently when the Centers for Disease Control and Prevention (CDC) released its annual youth tobacco survey, finding e-cigarette use among middle and high schoolers tripled from 2013 to 2014.

The report suggested that some of these students may be using e-cigarettes as a way to quit smoking, but lawmakers also fear that the reverse could happen, that if teenagers begin using e-cigarettes regularly, it could be a gateway to smoking cigarettes.

That's why Indiana is trying to pass legislation to regulate e-cigarettes, according to Bryan Corbin, a public information officer with the Indiana attorney general’s office.

"The focus of the Indiana attorney general’s office remains on the public health risks associated with rising e-cigarette use among Indiana’s teens, such as the threat of creating a whole new generation of nicotine addicts," he said.

‘The focus of the Indiana attorney general’s office remains on the public health risks associated with rising e-cigarette use among Indiana’s teens, such as the threat of creating a whole new generation of nicotine addicts.’

Bryan Corbin

spokesman, Indiana attorney general’s office

Exactly what will be in the final bills remains to be seen, but what seems the most likely to pass is that liquid or gel substances containing nicotine won't be allowed to be manufactured, sold or distributed unless the product is in child-resistant packaging, with fines as high as 500 percent of the retail value or $5,000. That's in Senate Bill 463, which the attorney general's office has been pushing.

Another bill, House Bill 1432, to which Indiana's e-cigarette industry has strenuously objected, has proposed that vapor shops selling e-cigarettes be licensed, which would give the Indiana Alcohol and Tobacco Commission more authority to police retailers that thwart the law. It would tax e-cigarettes, presumably as heavily as cigarettes, and include e-cigarettes in Indiana's statewide indoor smoking ban.

It also drills deep into the manufacturing of e-liquids, requiring manufacturers to install, in the area where e-liquids are produced and bottled, monitoring by a 24-hour video surveillance security system. It also mandates having a clean room for all manufacturing and bottling. Manufacturers would be obligated to have a security firm certify that it is meeting security requirements and to retain three 10-milliliter samples of e-liquid from each batch. Manufacturers would also need to pay $1,000 for a five-year permit; renewals would cost $500.

Regardless of whether House Bill 1432 goes too far, it's understandable that legislators want to establish some ground rules. There are many unanswered questions about e-cigarettes and the liquids, often called e-liquids or e-juice, that to in them, according to Thomas Marshall, a political science professor at the University of Texas at Arlington who is writing a book about policy, public opinion and smoking. Some of those questions, he said, include "whether the vapors do or don't contain harmful ingredients" and "what is actually in the materials used [in the liquids], which are mostly manufactured in China."

People using e-cigs are ingesting a mist including nicotine, water, glycerin (a sugar alcohol) and propylene glycol, a synthetic liquid that absorbs water and is used to create artificial smoke in theatrical productions. But because there isn't a federal agency monitoring the e-cigarette industry, there are no standards for what else it may contain. For instance, in 2009 the U.S. Food and Drug Administration released a laboratory analysis of e-cigarette samples that found carcinogens and toxic chemicals in them, such as diethylene glycol, an ingredient used in antifreeze.

That doesn't mean all e-liquids have toxins in them. But the lack of oversight means that some could, especially if they come from a fly-by-night operations.

Much of the discussion about regulating e-cigarettes has frustrated vapor store owners like Tony Reed. He owns Indigo Vapor, a vapor store that sells flavored liquids that he makes on the premises of his business in South Bend, Indiana. Among the flavors his store sells are Gramma's GiddyUp (apple pie and vanilla) and Battered Drop (lemon-frosted cupcake).

"If the laws pass as they were being written, the cost of doing business would be draconian. We'd have to move to Michigan," said Reed, who added that he is pro-regulation on certain issues, like selling e-cigarettes to minors.

"Childproof packaging and warning labels — those we've always considered the cost of doing business. That makes sense, and they should be implemented," he said.

But he said he has heard about some regulations that would pretty much put him out of business, such as manufacturers needing to have doors with a retinal-scan entry. Since he makes vapor flavors in his lab, he would have to incur that expense.

"It's obscene. It would cost upward of a hundred thousand dollars," Reed said.

Indiana and other states have been working on legislation in part because the FDA thus far hasn't acted on e-cigarettes.

On June 22, 2009, the Family Smoking Prevention and Tobacco Control Act was signed into law, but e-cigarettes are not part of that. When the FDA attempted to prevent Sottera, an importer and distributor of electronic cigarettes, from bringing its products into the United States, the company sued the FDA in court and won.

"So they have been supercautious to not get ahead of their research on e-cigarettes — and until recently, there hasn't been much research," said Marshall.

However, the FDA is expected to propose regulations for e-cigarettes soon. Shortly after the CDC released its youth tobacco survey, Dr. Stephen Ostroff, the acting head of the FDA, said that the agency was moving "full speed ahead" with its plan to strengthen federal regulations on e-cigarettes. If that happens, the FDA would prohibit e-cigarettes from being sold to those under the age of 18. While 41 states already ban e-cigarette sales to minors, it's easy for children to order them online.

Miguel Martin, the president of Logic Technology Development, an electronic cigarette company headquartered in Pompano Beach, Florida, said that he is looking forward to the FDA’s coming out with national regulations on e-cigarettes, provided that they're "science-based recommendations," in part because it would make it easier for the industry than having to work with different laws in 50 states.

"We would be hopeful that federal and state laws will treat electronic cigarettes differently than traditional cigarettes," he said. "Other than the names, they're different products."

‘If the laws pass as they were being written, the cost of doing business would be draconian. We’d have to move to Michigan.’

Tony Reed

owner, Indigo Vapor

Regardless of how e-cigarettes are ultimately regulated, Dr. Derek Yach, the director of the Vitality Institute, a health research organization in New York City, hopes that states don't overregulate e-cigarette stores out of business. He wants to keep children away from e-cigarettes but not keep e-cigarettes away from smokers.

"E-cigarettes are far safer than cigarettes. It's almost beyond debate now," said Yach, who for five years was the director of the World Health Organization, the United Nations' agency for health.

Cline, a heart attack survivor, said that before switching to e-cigarettes, he had a persistent smoker's cough and couldn't walk far without getting out of breath. Now he can walk up and down stairs easily, and he said his taste buds have even regenerated.

Given that he sells the product, he probably won't ever give up e-cigarettes, but for those who want to give up both smoking and vaping, Yach said studies have shown that e-cigarettes can help smokers quit the nicotine habit for good.

But Yach stressed that he favors "smart regulation" for the industry, especially when it comes to children, something that Martin also said he is for.

"I don't know how someone can responsibly say it's a good idea to have cotton candy or bubble gum flavoring," Martin said.

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