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Electronic cigarette merchants on guard as FDA regulations are proposed

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Some dismiss nicotine vapor produced by electronic cigarettes as harmless compared with inhaling smoke. But that claim, along with questions about how the popular devices should be made safely, is being debated by state and federal lawmakers.

Hanging in the balance is the fate of local e-cigarette merchants, who say they mostly agree with regulations announced last week by the federal Food and Drug Administration. But they remain wary that the proposal could be followed by more rules to threaten the emerging industry.

The FDA’s proposal would require makers of e-cigarettes and nicotine fluids to obtain approval of products before selling them, ban sales to minors nationwide, require health warnings and more.

Merchants say they’re more worried about bills recently introduced in the state Legislature, however. The state could be tougher than the FDA, they say, by approving legislation that would tax e-cigarettes as tobacco products and ban smoking the devices in certain indoor and outdoor public areas.

The recent wave of proposed federal rules comes as e-cigarette sales to minors under age 18 already are banned in 33 states including New York, according to USA Today. The FDA’s proposal can be viewed online http://wdt.me/BxFtgZ.

The battery-powered devices, often sold in bright colors, heat nicotine liquid into vapor that is inhaled, a process known as vaping. Business owners defend them, pointing out that they don’t expose users to as many harmful chemicals as regular cigarettes. Merchants also say they help wean traditional smokers off the habit.

Critics, meanwhile, are concerned that the gadgets pose a risk of nicotine addiction to children and allow users to evade smoke-free laws.

“A lot of the regulations the FDA is asking for we already do, and we welcome a lot of what they want,” said Michael M. Frennier, general manager of Unique Cigs, an e-cigarette store next to Universe Cellular and Dish at 21307 County Route 202 in the town of Watertown. The small business, launched in Syracuse four years ago, has nine locations across upstate New York.

“They want to make sure you don’t bottle nicotine fluid in a back room, but we bottle our fluid at an FDA-certified plant in Pennsylvania,” Mr. Frennier said. “We already use child-protective bottle caps and will soon have a full bottle seal that we hope will be out in the next 60 days. We’re very conscious about health and safety here, and we say that nicotine is for adults.”

The FDA’s e-cigarette rules aren’t as restrictive as those governing regular cigarettes, which are widely considered by researchers to be more harmful. The so-called “e-fluid” burned by e-cigarettes into vapor contains only a handful of ingredients. The combustion of normal cigarettes, by contrast, produces carbon monoxide and thousands of chemicals, including carcinogens.

Manufacturers would be required to disclose the chemicals used in devices and be banned from giving out free samples, according to the FDA proposal. Health warnings on products must note that nicotine may be addictive. What’s more, manufacturers must provide scientific evidence to back up claims that e-cigarettes are safer than regular ones.

The proposal would not ban TV ads or Internet sales to adults. It also would not ban flavors, such as cherry and bubble gum, from being used to make e-fluid.

The FDA has planned a 75-day comment period before regulations become law. Some rules will take effect after that time, while manufacturers will be given two years to comply with other regulations, such as documenting health risks with scientific studies.

Mr. Frennier said he does not object to most of the proposed FDA regulations, because he believes they will help legitimize an unregulated industry that has been an easy target for criticism.

“I think some of the regulations are written to help give time for big tobacco companies to get into the e-cigarette world and take over,” he said. “But a lot of the regulations we support. Making sure the fluid is made in a safe manner before it’s delivered is good, because then we won’t have people saying that it’s unsafe.”

Mr. Frennier said he is more concerned, though, about multiple bills proposed in early April by state lawmakers. He is particularly vexed by a bill that would redefine “tobacco products” under New York tax law to include any product containing nicotine. In effect, the amendment would impose a 95 percent tax on the wholesale price of all e-cigarette products that contain nicotine. More information about the bill is available online at http://wdt.me/nBJ3rv.

“New York has the highest cigarette tax in the nation, and so they don’t want to see that cash cow go away as more people stop using cigarettes,” Mr. Frennier said. “They don’t care about the cost savings that people are having by switching to e-cigarettes. And we have a very large customer base who have been successful in their own efforts to stop using traditional cigarettes. But if the cost of e-cigarettes goes up, they’ll go back to using them.”

Evolution E-cig, another growing e-cigarette company in upstate New York, opened a kiosk at the Salmon Run Mall in Watertown in November and soon may open a second location in the city and another in Potsdam, President Todd E. Harding said. The business also has locations in North Syracuse, DeWitt, Middletown and Poughkeepsie.

Mr. Harding read the FDA’s recent proposal and said he agrees with its intent: to make sure products bought by consumers are consistently manufactured safely. By requiring manufacturers to cite scientific studies to support claims about health benefits, the proposal will lend products credibility, he said, because research will prove they’re less harmful than traditional cigarettes. “The FDA wants to make sure you’re doing things the right way, that your liquid is as safe it can be and you’re putting the right label and cap on it,” Mr. Hardy said. “The bottom line is it’s going to make it where you’re going to have to be approved by the FDA over the next two years to sell products. It’s going to affect people that are doing this in their basements.”

Once the FDA plan is in place, “I think that’s when the states will act,” Mr. Hardy said. “If the FDA comes in and says, ‘This is a safe product’ and they back it, I think that will help stop the state from passing other proposals.”

But even if FDA-backed scientific studies show that vaping e-cigarettes is a safer alternative to smoking, Mr. Harding is skeptical that New York state will abandon its effort to impose a tax on products that is similar to what is imposed on regular cigarettes.

“I understand the state’s point of view,” Mr. Harding said. “The state is a business, and they look at it and see taxes dropping on a yearly basis because cigarette sales are dropping. That’s less and less taxes paid in New York state, and they have to continue to bring that revenue in. So they’re definitely going to do some type of tax on e-cigarettes — it’s expected. But I think it’s wrong, because we’re not selling tobacco, and they’re trying to lump us in” with that group.

A report published in April by a group of U.S. lawmakers titled “Gateway to Addiction?” issued the following recommendations to the Food and Drug Administration for governing the use of e-cigarettes:
• Establish authority over the e-cigarette industry with rules to prevent the sale of devices to teens under age 18, with limits on vending-machine purchases.
• Prohibit companies from marketing e-cigarettes in ways that are appealing to children and teens under age 18, such as advertising flavors that attract youth.
• Ban companies from distributing free samples of e-cigarettes and promoting products via social media, sponsorship of events and other activities geared toward young audiences.
• Make it illegal for manufacturers to promote e-cigarettes with the use of TV and radio advertisements.
• Require strong, uniform labels that inform consumers of health risks and prohibit misleading product claims.

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