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White House Deletes FDA E-Cigarette Regulations， the online sale of e-cigarettes is not restricted

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The White House has significantly modified proposed Food and Drug Administration (FDA) tobacco regulations, so that the online sale of e-cigarettes is not restricted, Reuters reported Wednesday.

Charged with analyzing the economic implications of policy, the White House’s Office of Management and Budget (OMB) looked in detail at the FDA draft, which had included a prohibition of non-face-to-face sales, in effect banning online sales.

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OMB changed the language, so that the ban applies only to vending machines. Due to lobbying from the cigar industry, OMB also addressed cigars, modifying the existing two-part rule which separates regulated from unregulated into a two-option rule, which exempts premium cigars.

The cigar industry’s concerns were voiced by 24 Republican legislators in a letter to FDA Commissioner Margaret Hamburg.
“As you know, premium cigars are a niche product with an adult consumer base, much like fine wines. The majority of people who enjoy a cigar do so occasionally, often in social or celebratory settings,” they said.

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In response back in April, Erika Sward, assistance vice president for national advocacy at the American Lung Association was concerned.
“The part of the proposal we are deeply troubled by is the sweetheart deal for the cigar industry,” she said.

Despite recent Senate hearings regarding the safety of e-cigarettes, various health concerns were also removed by the OMB. Additionally, requirements that would mandate reviewing variable nicotine content, poor quality control, and a chemical used in e-cigarettes called diethylene glycol, have all been removed. According to the FDA, diethylene glycol is a chemical that has caused mass poisonings.

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Associated cost-benefit analyses have also been deleted. One deleted economic analysis in particular, regarding premium cigar exemptions, calculated that the exemption would save manufacturers anywhere from $1 million to $3 million. However, the resulting cost on public health would range from $32.6 million to $34.2 million.
 

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No.1 How e-cigarettes could save lives? Anti-smoking advocates should welcome electronic cigarettes.

   How e-cigarettes could save lives

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Sally Satel

Anti-smoking advocates should welcome electronic cigarettes, writes Sally Satel. (© Bobby Yip / Reuters/REUTERS)

 

By Sally Satel February 14 

Sally Satel is a resident scholar at the American Enterprise Institute and a psychiatrist specializing in addiction. She has served as an expert witness in tobacco litigation.
 

Should electronic cigarettes be regulated like tobacco products, emblazoned with warnings and subject to tight marketing restrictions? Those are among the questions before the Food and Drug Administration as it decides in the coming weeks how to handle the battery-powered cigarette mimics that have become a $1.5 billion business in the United States.

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Groups promoting intensive regulation include the American Lung Association and the Campaign for Tobacco-Free Kids. They worry that the health risks haven’t been fully established and that e-cigarettes will make smoking commonplace again, especially among teens. They are quick to push back in response to anything that might make e-cigarettes more attractive, such as the NJOY King ad that aired during the Super Bowl or when actors Leonardo DiCaprio and Julia Louis-Dreyfus were shown “vaping” at the Golden Globes.

A surgeon general’s report released last month, on the 50th anniversary of the office’s first warning about the dangers of smoking, had little to say about e-cigarettes. Its suggestions for further reducing tobacco use were familiar, including: increase taxes on cigarettes, prohibit indoor smoking, launch media campaigns and reduce the nicotine content of cigarettes.

E-cigarettes, however, could be what we need to knock the U.S. smoking rate from a stubborn 18 percent to the government’s goal of 12 percent by 2020. We should not only tolerate them but encourage their use.
Although critics stress the need for more research, we can say with high confidence that e-cigarettes are far safer than smoking. No tobacco leaves are combusted, so they don’t release the tars and gases that lead to cancer and other smoking-related diseases. Instead, a heating element converts a liquid solution into an aerosol that users exhale as a white plume.

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The solution comes in varying concentrations of nicotine — from high (36 mg per milliliter of liquid) to zero — to help people wean themselves off cigarettes, as well as e-cigarettes, and the addictive stimulant in them. But even if people continue using electronic cigarettes with some nicotine, regular exposure has generally benign effects in healthy people, and the FDA has approved the extended use of nicotine gums, patches and lozenges.

The other main ingredients in e-cigarettes are propylene glycol and glycerin. These are generally regarded as harmless — they’re found in toothpaste, hand sanitizer, asthma inhalers, and many other FDA-approved foods, cosmetics and pharmaceuticals. There are also traces of nitrosamines, known carcinogens, but they are present at levels comparable to the patch and at far lower concentrations than in regular cigarettes — 500- to 1,400-fold lower. Cadmium, lead and nickel may be there, too, but in amounts and forms considered nontoxic.

“Few, if any, chemicals at levels detected in electronic cigarettes raise serious health concerns,” a 2011study in the Journal of Health Policy determined. “A preponderance of the available evidence shows [e-cigarettes] to be much safer than tobacco cigarettes and comparable in toxicity to conventional nicotine replacement products.”

The potential for e-cigarettes to help people quit smoking is encouraging. Yet so far there has been little research on their effectiveness.
A study published in the Lancet in November concluded that e-cigarettes, with or without nicotine, were as effective as nicotine patches for helping smokers quit. Granted, patches have had a disappointing record in helping people stay off cigarettes for more than a few months. But there are reasons to think that e-cigarettes would be even more effective outside the laboratory.
 

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Participants in the Lancet study were randomly assigned to nicotine e-cigarettes, patches or placebo e-cigarettes. In the real world, of course, people get to choose. And e-cigarettes have several advantages over patches and gums. For one, they provide a quicker fix, because the pulmonary route is the fastest practical way to deliver nicotine to the brain. They also offer visual, tactile and gestural similiarities to traditional cigarettes.

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No.2 How e-cigarettes could save lives? Anti-smoking advocates should welcome electronic cigarettes.

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Reporter Megan McArdle tested the comparison for a Bloomberg Businessweek article this month: “After I’d put it together, I had something surprisingly close to one of the cigarettes I used to smoke. The mentholated tobacco flavor rolled sinuously over my tongue, hit the back of my throat in an unctuously familiar cloud, and rushed through my capillaries, buzzing along my dormant nicotine receptors. The only thing missing was the unpleasant clawing feeling in my chest as my lungs begged me not to pollute them with tar and soot.”

This is where anti-smoking advocates get worried about e-cigarettes being too attractive and encouraging people — especially young people — to become addicted to nicotine and, in some cases, to progress to smoking. The Centers for Disease Control and Prevention stoked concerns with data released in September showing that 1.78 million middle and high school students had tried e-cigarettes and that one in fivemiddle school students who reported trying them said they hadn’t tried traditional cigarettes. “This raises concern that there may be young people for whom e-cigarettes could be an entry point to use of conventional tobacco products, including cigarettes,” the CDC concluded.

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According to that same CDC study, however, an extremely small percentage of teenagers use e-cigarettes regularly — only 2.8 percent of high school students reported using one in the previous 30 days in 2012. And while that number is rising — it was 1.5 percent in 2011 — teenage cigarette smoking rates are at record lows. That might suggest that increased exposure to e-cigarettes isn’t encouraging more people to smoke. But the numbers are so small that it’s too early to make definitive claims about the relationship between teen vaping and smoking.
Yes, we still need research on the long-term health and behavioral impacts of e-cigarettes. Brad Rodu, a pathologist at the University of Louisville, offers an apt analogy between electronic cigarettes and cellphones.


When cellphones became popular in the late ’90s, there were no data on their long-term safety. As it turns out, the risk of a brain tumor with prolonged cellphone use is not zero, but it is very small and of uncertain health significance.
 

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In the case of e-cigarettes, Rodu says that “at least a decade of continued use by thousands of users would need to transpire before confident assessments could be conducted.” Were the FDA to ban e-cigarette marketing until then, the promise of vaping would be put on hold. Meanwhile, millions of smokers who might otherwise switch would keep buying tobacco products. “We can’t say that decades of e-cigarette use will be perfectly safe,” Rodu told me, “but for cigarette users, we are sure that smoke is thousands of times worse.”
The FDA should call for reliable, informative labeling and safe manufacturing standards for e-cigarettes. It should also allay concerns about potential gateway use and youth addiction to nicotine by banning the marketing and sale of e-cigarettes to minors. It should not be heavyhanded in restricting marketing and sales to adults.
Instead, promoting electronic cigarettes to smokers should be a public health priority. Given that the direct medical costs of smoking are estimated to be more than $130 billion per year, along with $150 billion annually in productivity losses from premature deaths, getting more smokers to switch would result in significant cost savings — as well as almost half a million lives saved each year.
We should make e-cigarettes accessible to smokers by eschewing hefty taxes, if we tax them at all, and offering free samples and starter kits. Those kits, which contain a battery, a charger and nicotine-liquid cartridges, typically run between $30 and $90. To reduce the hurdle to initiation, any payer of smoking-related costs — health insurers, Veterans Affairs medical centers, companies that offer smoking-cessation programs for their employees, Medicare, Medicaid — should make the starter kits available gratis. Users should have to pay for their own replacement cartridges, but those are much cheaper than cigarette packs.

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Also, we should allow and welcome public vaping in adult environments such as bars, restaurants and workplaces. Vapers would serve as visual prompts for smokers to ask about vaping and, ideally, ditch traditional cigarettes and take up electronic ones instead.
It may be hard for anti-smoking activists to feel at ease with e-cigarettes in light of their view that traditional cigarette makers have long downplayed the health dangers of their product. This perception has generated distrust of anything remotely resembling the act of smoking. It doesn’t help that major tobacco companies are now investing in e-cigarettes.
But if we embrace electronic cigarettes as a way for smokers to either kick their nicotine addictions or, at least, obtain nicotine in a safer way, they could help instigate the wave of smoking cessation that anti-smoking activists — and all of us — are hoping for.

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Is the E-Cigarette Bubble About to Burst? However，the vapers are becoming more common

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On a sunny Friday this spring, a thick haze lingered in the lobby of the Hyatt Dulles in Herndon. It was sweet, like apples and chocolate, and was coming from people huddled around tables near an indoor koi pond, sucking on metal contraptions with skinny mouthpieces that made them look like miniature oboes.


More people sat at the bar, challenging one another to see who could blow the biggest clouds. When I asked the bartender how he liked serving this crowd, he shrugged and said it was okay. Not that long ago, he noted, “you could smoke in here—it was horrible.”
The Virginia Indoor Clean Air Act bans smoking in elevators, public schools, polling places, and restaurants. But the law doesn’t extend to electronic cigarettes or personal vaporizers, which is what people at the Hyatt Dulles were puffing. The battery-powered devices work by heating a liquid nicotine solution and turning it into an inhalable mist. (They are, in effect, wee versions of the fog machine Lady Gaga uses to becloud herself onstage.) The vapor the devices emit looks like cigarette smoke, but they’re noncombustible: no tobacco, smoke, or ash. To use such a device is to “vape.” A person who vapes is a vaper.

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About 2,000 vapers were at the Hyatt Dulles for Vapefest, a semiannual gathering for e-cigarette vendors and enthusiasts. First held in 2010, the convention is now billed as the “longest-running vape event in the nation.” It has spawned at least 15 copycats, including VapeBash, Vapestock, Vape-a-Palooza, Vapetoberfest, and, yes, Vapor Gras.
At Vapefest, vapers roamed the Hyatt hallways and rode the elevators dragging on their devices full of flavored e-juice, leaving trails redolent of cinnamon and crème brûlée. Meanwhile, in my room, a placard on the bedspread warned that I’d be hit with a $250 cleaning fee if I stank the place up with cigarettes.

• • •

Throughout Washington and across the country, close encounters with vapers are becoming more common, and it doesn’t take an extreme environment like Vapefest to guarantee a sighting. But you might not know a vaper when you see one. That’s because e-cigs are typically designed to mimic the look of traditional cigarettes—hardcore vapers call them “cig-alikes,” disparagingly—and they glow at the tip when dragged on. Likewise, some personal vaporizers resemble paraphernalia available in a head shop, except they’re sold in vape shops.
Six or seven years ago, there was no such thing as a vape shop. Today there are about 5,000 nationwide, and new stores are opening all the time. The District’s first, called DC Vape Joint, opened in Adams Morgan in March. Many thousands more convenience stores and kiosks, such as those at Union Station and Tysons Corner Center, sell cig-alikes.

There’s also Vape News Magazine, a glossy bimonthly out of St. Louis with 25,000 readers; podcasts (Click, Bang!; The TVA Show); online communities (Vaping Forum, Planet of the Vapes); YouTube channels (Vaped Crusader, Vaping Monkey); and the National Vapers Club, organizer of Vapefest.
For such a young market—e-cigs didn’t appear until around 2006—vaping is already doing big business. Last year, e-cig sales topped $2 billion, according to industry analyst Bonnie Herzog of Wells Fargo Securities. By 2017, Herzog expects sales to surpass $10 billion. At this rate, and barring any red tape that could stifle innovation, she adds, the market could outpace that of traditional cigarettes by 2024—a prospect that hasn’t gone overlooked by Big Tobacco.

The makers of Camels, Marlboros, and Newports have all fired up their own e-cig products. R.J. Reynolds introduced Vuse Digital Vapor Cigarettes in July of last year. Altria has MarkTen, and this past April the company acquired a small e-cig manufacturer called Green Smoke. Blu, the country’s top-selling brand, is made by Lorillard.
The company got free publicity at the Golden Globe Awards this year when Julia Louis-Dreyfus vaped a Blu as a gag. The audience roared as the Veep star, in black cat-eye sunglasses, an updo, and a strappy red evening gown, puffed importantly on the long black wand, its tip lighting up like an electrified topaz gemstone. (Watch the GIF.)

Lorillard has left the official flacking to former Playboy centerfold Jenny McCarthy, now of The View, who has gushed about Blus in ads for the brand. The message: E-cigs won’t yellow your teeth or make your hair smell, and they can be enjoyed anywhere—no one will give you the stink-eye, she says. The tagline: Take Back Your Freedom.

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Industry Is Winning the E-Cig Regulation Battle from Time--a critical time for e-cig business

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It’s a critical time for the e-cigarette industry. In April, the FDA announced proposed rules to regulate e-cigarettes as tobacco products. The announcement kicked off a period of public comment so that e-cig makers and public health experts can raise concerns and give the FDA the necessary facts to write an appropriate set of final rules. Regulation is just like writing the rules of a new game—on one side there are businesses vying for industry-friendly regs, and on the other are public health advocates.
 

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So far, it looks like the businesses are winning. When the FDA first announced the start of the rule-making process, Time wrote about the positive reaction to them by e-cigarette executives, who saw them as a reasonable first step that would not greatly interfere with their businesses. Now, a few weeks into the rule-making process, business continues to be optimistic while public health advocates are getting worried.


“The deeming rule that the FDA has proposed is very, very, very limited in its scope,” says Stanton Glantz, a cardiology professor at the University of San Fransisco and one of the most vociferous proponents of strict rules for e-cigs. “It requires a useless warning label and says they can’t be sold to kids under 18, but it doesn’t put any restrictions on internet sales, which means kids under 18 can easily get them. It has no restrictions on marketing at all.” This puzzles Glantz. “You would think that the Obama administration would be supporting tobacco control because it would reduce health care costs.” As far as Glantz is concerned, the administration has erred on the side of the tobacco interests.

Naturally, one of the biggest concerns among health advocates is children’s access to e-cigarettes—and marketing of e-cigs to teens is up 321%, as TIME recently reported. The Centers for Disease Control and Prevention estimates that almost 2 million students in the U.S. have tried e-cigarettes. Policies to address the issue run the gambit from the least controversial—like establishing an age restriction on purchasing e-cigs and child proof packaging—to the more divisive, like prohibiting marketing to teens, prohibiting internet sales, and restricting the use of kid-friendly candy-like flavors.
But even the most basic restrictions—like better product labeling, and child proofing—were absent from the FDA’s initial deeming rules, making other restrictions on advocates’ wish lists seem that much further away. “Any meaningful rules on marketing of e-cigarettes are years, and years, and years away,” says Glanz, pointing out that if restrictions were imposed, e-cog companies would likely sue over marketing restrictions on first amendment grounds.
Craig Weiss, the CEO of NJOY in Scottsdale, Arizona, one of the leading electronic cigarette brands, also thinks the FDA rules will stay fairly restrained. 

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“The FDA are smart people,” he says. “They have to read everything and they will, but I think what you saw in the proposed regulations, that’s what you are going to see in the ultimate regulations as well.”
As for whether any child-marketing restrictions would make sense down the line, Weiss says there are appropriate curbs, but there is no reason e-cigarette marketing should be as strict as tobacco. “You are confusing the arsonist with the firefighter,” he says. “Why would you treat products that are part of the solution as products that are part of the problem?” he says. Though NJOY is careful not to make direct claims that their products can help smokers quit, Weiss is a big believer in the potential for electronic cigarettes to replace cigarettes. Weiss supports limits on the age of actors in ads and rules against e-cigs appearing in cartoons, but he rejects the idea that there is anything wrong with his ads, which do feature young adults.
   

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That’s not good enough for public health advocates. “The best way to market to kids is to market to young adults,” says Glantz, “If you designed marketing to stop smoking in a 50 year old, it could be done. That’s not what they are doing. It wouldn’t be on MTV, it would be on evening news.”

Weiss responds: “I’m interested in converting every adult smoker in the country to these products. I think it would be a tragedy for smokers to be smokers for decades before we advertise in a way that is appealing to them.”
The battle over e-cig regulation isn’t settled, but if what’s going on now is any indication, that battle may have actually been over—and won by industry—before it even started.

Correction appended: The original version of this story incorrectly described which restrictions are absent from the FDA’s initial deeming rules.


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An E-Cig That Tells You How Much You’ve Increased Your Life Expectency With Every Puff

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Forget for just a moment that e-cigarettes contain several of the same toxic substances in regular cigarettes but in higher quantities such as carbon monoxide, heavy metals and several substances used in antifreeze known to cause cancer. Hekvapor claims to be the first connected e-cig to actually add years to your life each time you puff.

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It works by hooking the device up to an app on your smartphone which captures your vitals every time you vape, even when your phone is out of sight. The app tracks how often you smoke and how much nicotine is currently in your body. It then shows you how much you’ve been smoking and how much that’s cost you and then gives encouragement to cut down and eventually kick the habit altogether.
The app also shows you just how much you’ve increased your life expectancy by number of days by switching to an e-cigarette instead of smoking real cigarettes. Not sure how much you can trust the “science” on that claim, though.
The jury’s still out at the FDA on just how harmful (or not) e-cigarettes are. It doesn’t currently consider them a part of tobacco products but has issued a proposal to consider e-cigarettes as such. However, the FDA does consider any e-cigarettes claiming therapeutic effects, such as helping people to quit, under their jurisdiction.

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A study published in the May issue of the journal Addiction found that 20 percent of those using e-cigarettes were able to quit easier than those using regular cigarettes, making them more effective than nicotine patches or gum. Cancer stick or not, that gives some cred to Hekvapor’s claims.

While not an e-cig, bootstrapped pocket mobile device Intelliquit strives to do something similar. A quick gander at their website doesn’t reveal much but it does claim to provide biofeedback for those hoping to quit each time they take a puff.
Hekvapor’s app will also tell you how much you’ve saved by switching to its “smart” cigarette every time you use it.
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it is reprinted from techcrunch. Thanks for your attention.
 

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Reports of children consuming poisonous liquid from e-cigarettes rose sharply in Minnesota last year, prompting health officials to warn that the state may be facing a new public health hazard.

Only one child was hospitalized as a result of consuming the nicotine-laced liquid, but the total number of cases — 50 — was a tenfold increase over 2012, the Minnesota Department of Health said Tuesday.

“We really want parents to know that this liquid nicotine can pose a fatal risk and that they should store it out of the reach of children,” said Dr. Ed Ehlinger, state health commissioner.

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The increase tracks the growing popularity of e-cigarettes, battery-powered cartridges that heat up flavored liquid and produce an inhaled nicotine vapor. Many e-cigarette users, or “vapers,’’ use them as a lower-nicotine alternative to cigarettes, or as a bridge to quitting cigarettes altogether. One in five smokers had tried e-cigarettes in 2011, twice as many as a year earlier, according to the U.S. Centers for Disease Control and Prevention.
Of the 50 cases reported by Minnesota Poison Control, 14 resulted in trips to hospital emergency rooms and one required treatment in intensive care. The cases involved children and teens up to age 19, but the majority — 36 — involved children age 3 or younger.
“We think of concentrated nicotine as a very serious poison, equivalent to dangerous prescription drugs,” said Stacey Bangh, clinical supervisor of the poison center, which is located at Hennepin County Medical Center.
 

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The report on poisoning cases also comes amid a legislative debate over whether to expand the Minnesota Clean Indoor Air Act to apply to e-cigarettes, meaning they couldn’t be used in workplaces, bars and other public indoor spaces.
Such a change, however, would not do anything to protect children from the small vials that contain e-cigarette liquid. Matt Black, president of the Minnesota Vapers advocacy group, said that risk would be better addressed by a requirement that all such vials be sold with childproof caps.

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“I take the same precautions with my liquids as I did with my cigarettes,” said Black, whose daughter is 13. “[Keep] them up on high shelves if you have small kids, or hidden if you have older kids.”
Most e-cigarette vials already have safety caps, but they are not required by state or federal law. Ehlinger said he would support efforts to increase child-resistant packaging.
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