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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

Bio

April 25, 2014 - 9:27 pm
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Zeller conceded that if a traditional pack-a-day smoker switched to e-cigarettes, “I think even with all the questions that we have, we would concede that that person is likely to be substantially reducing their risk.”

“The challenge for us as regulators is we’re responsible for enforcing a law that has a population-level health standard. And our job is to figure out, well, what are the net impacts at a population — population level of all the possible uses. Because there’s a much greater proportion of smokers who are concerned about their health and are interested in quitting,” he said.

“And what happens if instead of continuing down that pathway to quitting, especially using FDA-approved safe and effective medicinal products, they start engaging in what’s called dual-use. And they’re using e-cigarettes in situations where they can’t light up, and they wind up being less interested or motivated to quit.”

At that point, Zeller argued, “this putatively less harmful product actually increases harm because all it does is serve as a bridge for health-concerned smokers to get from their last cigarette to their next cigarette.”

“We don’t know what the patterns of use are. We’re funding massive studies to try to get a better handle on what the behaviors are, but it’s awfully complicated because it’s going to be an assessment of what is the impact on initiation; what is the impact on cessation. That’s mandated by law,” he added.

Zeller called the current rulemaking “sort of like walk before you run.”

“In order to be able to do a rulemaking on advertising, marketing and promotion, you have to have jurisdiction over the product. In order to have jurisdiction over the product, this rule has to go final and be in effect,” he said. “So that’s why we call this foundational. That’s why this is a historic day. There are these entire categories of products out there that many people think are safer than cigarettes, including unregulated combusting products that people think are safer than cigarettes.”

“And the whole point of being regulated under our statute is to bring a public-health based, evidence-based, regulatory approach to protecting consumers, protecting the public health.”

Sen. Richard Blumenthal (D-Conn.) criticized the FDA’s proposed rule as “too little, too late.”

“Instead of comprehensive, robust rules the FDA has offered a loophole-ridden skeleton– timid and tepid in restricting relentless marketing of smoking to children. For far too long the lack of effective regulation of tobacco products has been a gift to tobacco companies who continue to hook new generations of kids on tobacco products and create new addicts to make up for the hundreds of thousands who die each year from tobacco use,” the senator said in a statement.

“While FDA has finally taken preliminary action on the agency’s ability to regulate all tobacco products, the reality is that flavored cigars, nicotine candies, and e-cigarettes will all remain on the market as products that entice children and continue addiction until further action is taken,” Blumenthal added. “I will do all I can to help push for a final rule and additional regulatory action so that there will finally be meaningful regulation of all tobacco products.”

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Bridget Johnson is a career journalist whose news articles and opinion columns have run in dozens of news outlets across the globe. Bridget first came to Washington to be online editor at The Hill, where she wrote The World from The Hill column on foreign policy. Previously she was an opinion writer and editorial board member at the Rocky Mountain News and nation/world news columnist at the Los Angeles Daily News. She has contributed to USA Today, The Wall Street Journal, National Review Online, Politico and more, and has myriad television and radio credits as a commentator. Bridget is Washington Editor for PJ Media.

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Top Rated Comments   
e-cigs bad.

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

16 weeks ago
16 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.
16 weeks ago
16 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.
16 weeks ago
16 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!
16 weeks ago
16 weeks ago Link To Comment
So... pot isn't a gateway but e-cigs are. Gotcha.
16 weeks ago
16 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.
16 weeks ago
16 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.
16 weeks ago
16 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.
16 weeks ago
16 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.
16 weeks ago
16 weeks ago Link To Comment
e-cigs bad.

Weed good, because it's counterculture, maaaaaaaaaaan.
16 weeks ago
16 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.
16 weeks ago
16 weeks ago Link To Comment
This is just more nanny state control BS.

16 weeks ago
16 weeks ago Link To Comment
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