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FDA Rule Seeks Broad Regulation Over E-Cigarettes Because They Might Make People Want Real Cigarettes

They don't have research proving harm from the vapor substitutes, but say regulation "essential to protect the health of the public."

by
Bridget Johnson

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April 25, 2014 - 9:27 pm
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WASHINGTON — Citing the need to take greater measures against “gateways” as too many Americans are still using tobacco products, the Food and Drug Administration issued a proposed rule Thursday broadening its authority to include vapor-based e-cigarettes, cigars, pipes and other cigarette alternatives.

Health and Human Services Secretary Kathleen Sebelius told reporters on a conference call that it’s part of an initiative “to make this next generation tobacco-free.”

“CDC has found, for example, that the use of e-cigarettes among middle and high-school students doubled between 2011 and 2012. I think that bears repeating: the use of these products doubled,” she said of the devices that simulate smoking by producing vapor with or without nicotine.

“What we don’t know yet is the full impact and ramification that these products have on our nation’s health. We don’t yet have a full understanding as to whether these products serve as a gateway to the use of regular cigarettes. And we don’t know how they influence the behavior of current smokers,” Sebelius said. “This proposed deeming rule would allows us to gain a more robust understanding, and, if necessary, an ability to take action to mitigate potential harms.”

Currently, the FDA regulates cigarettes, cigarette tobacco, roll-your-own tobacco and smokeless tobacco. Proposed newly “deemed” products would include electronic cigarettes, cigars, pipe tobacco, certain dissolvables that are not “smokeless tobacco,” gels, and waterpipe tobacco.

“Once the proposed rule becomes final, FDA will be able to use powerful regulatory tools, such as age restrictions and rigorous scientific review of new tobacco products and claims to  reduce tobacco-related disease and death,” the agency said.

Sebelius lamented that “for all the progress we’ve made since the first surgeon general’s report 50 years ago, tobacco use remains the leading cause of preventable death and disease here in the United States and also around the world.”

“Every day, every day, more than 3,200 children try their first cigarette. And each day, 2,100 of those kids and young adults become daily smokers,” she said. “And if we fail to reverse those trends, 5.6 million American children who are alive today will die prematurely, due to smoking.”

The International Premium Cigar & Pipe Retailers Association said it is reviewing the rule before issuing a formal response, but the association did assure members that the trade group “is working hard to protect your rights and interests as a retail tobacconist.”

The public comment period on the rule is 75 days.

“To date, the agency has not been able to fully assess the public health impact of unregulated tobacco products including the alarming increase in youth use of certain unregulated tobacco products such as e-cigarettes and certain types of cigars. These facts highlight the need for regulation designed to prevent early tobacco use that may lead to a lifetime of nicotine addiction and a range of potential serious health problems,” said FDA Commissioner Dr. Margaret Hamburg.

Mitch Zeller, director of the FDA’s Center for Tobacco Products, said since they don’t know much about the effects of e-cigarettes one warning label is sought: “an addiction warning, reminding users that the product is addictive because it contains nicotine, which is an addictive chemical.”

Zeller acknowledged the therapeutic uses of nicotine, including “safe and effective” gum and lozenges that smokers use to quit.

“But when it comes to e-cigarettes, it’s the wild, wild west. We have e-cigarettes that are exploding in car chargers and wall sockets. We have people purchasing liquid e-nicotine cartridges. And it’s buyer beware. None of this is taking place in a regulated environment. And that’s why we’re proposing this rule,” he said. Zeller later added that the FDA had no proof of its own on exploding e-cigarettes, but read about instances in newspapers.

The FDA officials said they don’t have a timeline for finalization of the rule, but there is “a sense of urgency” to set it in stone.

“And we will take all of the input very seriously, but we are eager to see this process move forward towards the final deeming rule, so that those new requirements, restrictions and oversight mechanisms will fall into place, and also so that we can move to other regulatory activities that we think also are very, very essential to promote and protect the health of the public,” Hamburg said.

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Top Rated Comments   
e-cigs bad.

Weed good, because it's counterculture, maaaaaaaaaaan.
33 weeks ago
33 weeks ago Link To Comment
This is just more nanny state control BS.

33 weeks ago
33 weeks ago Link To Comment
In the meantime pot is legal in two states.

And the FDA is worried about e-cigs being a "gateway"?

Words fail.
33 weeks ago
33 weeks ago Link To Comment
All Comments   (28)
All Comments   (28)
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As someone who lives with someone who has used one for the last two years, it has been a huge blessing in our lives. It is the only effective method my husband has used to quit smoking, and he tried them all over 35 years.

The article does not state the number of forest fires, wild fires, house fires started with e cigarettes. They do not create a yellow film, not do people litter with their butts, packages, etc.

People voluntarily have moved to them as a healthy alternative to smoking that has tertiary benefits. The anti smokers have argued that nicotine is the culprit in causing addiction, which is correct. But a few years back when they wanted to limit nicotine in cigarettes, doctors protested that it wasn't the nicotine, but the smoke that created the health hazards. E cigarettes most closely mimic the drug delivery system of traditional cigarettes. I cannot see people moving to more stinky, messy, dangerous materials to get the same buzz.

Big tobacco and big government was caught off guard by the extended order to create solutions to a problem that they created and did not solve.
33 weeks ago
33 weeks ago Link To Comment
"And it’s buyer beware. None of this is taking place in a regulated environment."

Oh, the horror!!! People are engaging in an activity without government oversight. Quick, someone call out the FDA SWAT team!
33 weeks ago
33 weeks ago Link To Comment
So... pot isn't a gateway but e-cigs are. Gotcha.
33 weeks ago
33 weeks ago Link To Comment
Government regulation used to be a means to effect an end. Now government regulation has become an end in itself that is wholly divorced from some goal that we might wish to achieve. The goal will be fabricated to justify the regulation.

There are way too many people who believe that there is no human activity at all, without exception, that can't be improved by giving the government the power to stick their nose into it and control it.
33 weeks ago
33 weeks ago Link To Comment
Who knows, maybe, stripping e-cigs from the nation's smokers will encourage them to take up the safer, more tax-producing habit of pot smoking. Gateway? Why not!

Moronic government regulations gives way to idiotic government regulations. Why, I assume this will require at least one new bureaucratic office that can be filled with left-wing sinecures.
33 weeks ago
33 weeks ago Link To Comment
If we're going to discuss "gateways" in a serious manner, let's discuss how one government regulation produces consequences that inevitably become a "gateway" to another.
33 weeks ago
33 weeks ago Link To Comment
Will they outlaw electronic pot cigarettes using the same illogic? Perhaps those brave Patriots who shoulder the endless tax burden and bureaucratic scorn to smoke conventional cigarettes can disguise their still legal substance as marijuana joints and avoid the hysterics.
33 weeks ago
33 weeks ago Link To Comment
e-cigs bad.

Weed good, because it's counterculture, maaaaaaaaaaan.
33 weeks ago
33 weeks ago Link To Comment
In any socialistic system, eventually all thought, speech and behavior must be characterized as either forbidden or mandatory.

Given inborn talent, ambition and sheer luck, equality of outcome is only achievable by total control and discrimination.

To keep from "running out of other people's money" socialism must incrementally seize all income, assets and property, which also requires total control. To keep people from revolting against that level of tyranny by the mob, behavior, speech and thought must be controlled.

It's all about control because a 'utopia' cannot exist without total control. And the left seeks utopia, having rejected the reality within which we exist, which bestows upon some more than upon others. Never understanding that progress, civilization and evolution itself are not possible when equality in all things is demanded.
33 weeks ago
33 weeks ago Link To Comment
This is just more nanny state control BS.

33 weeks ago
33 weeks ago Link To Comment
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