A Public Participation Forum for the FDA Center for Tobacco Products and its Federal Advisory Committee (TPSAC)

Tonawanda News — While many electronic cigarettes contain a fraction of the chemicals found in traditional tobacco products, some doctors — and at least one politician — are urging caution until more can be learned about the devices’ health effects and regulations have been implemented.

State Sen. Kemp Hannon, R-Garden City, in June introduced a bill to the Senate Health Committee seeking a ban of e-cigarettes, citing a 2009 Food and Drug Administration report that said some of the devices contained carcinogens and toxic chemicals. Since the FDA does not currently regulate e-cigarettes, the proposed legislation concluded they “pose a dangerous threat to the health and safety of New Yorkers.”

Hannon’s legislation didn’t make it to the state Senate floor this session, but Brad McNamara, owner of Juicy Vapor in the Town of Tonawanda — a store that sells a range of e-cigarettes and the flavored “juice” that goes into the devices — said he’d like get the message out to consumers that he doesn’t believe the devices are the danger the bill indicates. 

There are a multitude of products of all shapes and sizes on the market labeled as e-cigarettes, but most are battery-operated devices that contain cartridges filled with a combination of nicotine, flavor and chemicals that are turned into vapor when inhaled by the user. Some devices, like the ones Juicy Vapor sells, have a chamber that can be refilled with liquid chemicals, while others, like NJOY and Smoke-51 brand e-cigarettes, have disposable cartridges pre-filled with the liquid chemicals. 

The juices may be mixed up with or without nicotine, and could include anywhere from two to about 10 ingredients, including the possibility of hundreds of flavors. 

McNamara said the study of e-cigarettes done by the FDA in 2009 that found diethylene glycol — a toxic ingredient found used antifreeze — and carcinogens is old and out-of-date. 

“Things have changed drastically since then,” McNamara said, pointing out that while the study was done only three years ago, it’s a relatively long time ago considering the devices have only been on the market for about 10 years.

McNamara said he likes to keep Juicy Vapor juices simple, using propylene glycol and/or vegetable glycerin, alcohol, natural and artificial flavoring and coloring, and menthol crystals depending on the flavor, and nicotine upon request. When he first opened his business online in 2008, he ordered the juices from China, but after fears of quality control issues, he prefers to mix the chemicals at the 1-year-old Tonawanda site himself.

“Everything that we use is FDA-approved by itself, but when we put it together and use it the way we are, they won’t approve it, not yet,” McNamara said. 

Jennifer Haliski, public affairs officer for the center for tobacco products at the FDA, said that’s because under current agency rules, they can’t regulate e-cigarettes since they aren’t considered a tobacco product.  

“The agency regulates electronic cigarettes that are marketed for therapeutic purposes as drugs or devices,” by the FDA Center for Drug Evaluation and Research, she said.

“They regulate things like Nicorette (nicotine gum) and Chantix (a smoking cessation drug). So if (an e-cigarette company) is making a similar claim, they would have to go through that part of the FDA,” Haliski added. 

Haliski said the FDA is currently working on a new rule that could incorporate e-cigarettes under the umbrella of the Family Smoking Prevention and Tobacco Control Act, giving the agency the ability to regulate the devices. She cautioned that even if the devices had FDA-approval, like cigarettes, it doesn’t mean they are safe.

“People hear ‘FDA approved’ and automatically assume things are safe,” Haliski said. “There’s no known safe tobacco product.”

Regulation means the FDA would possibly seek to keep the products out of the hands of minors by banning certain types of

advertising and sponsorships. It would also monitor how the products are sold and just what ingredients go into them and at what concentrations.

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The FDA’s 2009 study said that of the two e-cigarette brands tested — NJOY and Smoking Everywhere — varying levels of nicotine were found within the same categories of nicotine strength and even in items labeled as having no nicotine. At places like Juicy Vapor, the chemicals are mixed together on site and customers can specify how much nicotine, propylene glycol and vegetable glycerin they want by percentage.

Dr. Richard J. O’Connor, associated professor of oncology in the department of health behavior at Roswell Park Cancer Institute, said he’s concerned by those variations in the devices.

“This is the major problem right now — (there are) no standards of manufacture, labeling or quality control to ensure that the devices work as intended and deliver what they claim they deliver,” he said. “No one can say with certainty that the devices are safe, since there is no formal regulation or oversight of manufacturing or quality control.” 

Dr. Michael Gough, a doctor of pulmonary and critical care medicine at Kenmore Mercy Hospital, said he’s concerned that research into the long-term health effects of the chemicals have so far been inconclusive.

“There is a wide range of literature out there that if you inhale the wrong thing it can be harmful … whenever you’re putting chemicals into your lungs, it can be dangerous,” he said. “There is a realistic, conceivable risk for doing something like this that is not minor.”

Gough said he doesn’t necessarily discourage his patients to stop using the devices if they find them helpful in the quitting process, but he doesn’t suggest using them.

“My opinion is that using an e-cigarette is very similar to using a regular cigarette, and if someone is going to be successful in cessation, breaking the physical routine of that is important,” he said.

O’Connor pointed out that despite the FDA study finding contaminants in some e-cigarettes, “regular cigarettes contain far more toxins.”

“Anecdotal evidence from surveys of users shows many say they used e-cigarettes to quit,” he said. “Some may find e-cigarettes helpful on the road to quitting, while others may not. But until there is tighter regulation and more data, I would advise caution with these new products.”

McNamara said for his part, he went from being a three-pack-a-day smoker to only “vaping” in 2008 and completely cut out nicotine in 2010.

“I don’t miss it at all,” he said, adding that his wife promptly quit smoking when she tried an e-cigarette, as well. 

Juicy Vapor customer Tom Nichter said he had smoked about a pack and a half of cigarettes each day for 18 years before he discovered e-cigarettes a year ago.

“I ordered an e-cigarette and the day that I got it was the last day I smoked a cigarette,” he said.

Nichter said that since he quit smoking traditional cigarettes, he’s less winded and doesn’t cough as much … and his wife appreciates the lack of a smoke smell following him around. He said he’s aware not much research has been done on the long-term health effects of the devices, but for now, he’s just happy not to be inhaling all the toxins he knows are in cigarettes.

“It says right on the package that cigarettes kill you. There are 1,000 different things in a cigarette (that can hurt you) … it’s pretty scary,” he said. “To know there’s a handful of food-grade ingredients (in Juicy Vapor juices) and they’re all OK to be ingested, I’d rather go that way.”

“I don’t know anybody that has been killed by an electronic cigarette,” he said.

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Danielle Haynes

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