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The FDA and Electronic Cigarettes, a Timeline… by Steve k.

The Food and Drug Administration and electronic cigarettes have a pretty long and storied history.  I’ve commented about the FDA and its attempts to ban and demonize ecigs pretty extensively.  I’ve realized perhaps not everyone is intimate with the rocky road we’ve been down. I thought perhaps a little perspective on how things have progressed so far might shed some light and provide a little context for many of the things discussed in the community.

To that end, I’ve put together a little timeline of how things have progressed with the FDA up to this point.

2007

Electronic cigarettes begin to make their way to the United States after experiencing some popularity in Europe.

2008

August 2008 GreenCig, a Chinese manufacturer registers their product with the FDA.  According to this post on the ECF, the company classified their device as a nasal inhaler. There was a great deal of debate on the forum as what that meant, and even what types of nicotine was FDA Approved.

September 2008 The World Health Organization issues a press release for e-cigarette companies to stop making health claims about e-cigarettes being an effective smoking cessation therapy.  The WHO states that “WHO has no scientific evidence to confirm the product’s safety and efficacy.”  The release also notes that some marketers claimed the devices had the approval of the organization.

November 2008 GreenCig’s application for approval of its electronic cigarette is rejected by the FDA. The FDA cited the application as a new drug submitted without study data.

2009

Early 2009 FDA begins seizing electronic cigarette shipments as they enter the country via China.  The agency cites the Food Drug and Cosmetics Act as grounds for seizing the devices as incorrectly labeled medication and delivery devices.

March 2009 A group of Senators headed by Senator Lautenberg of New Jersey urge the FDA to crack down on electronic cigarettes (despite the fact that the FDA was already seizing shipments by this point). Several bloggers pointed out that the senator received significant funding from the pharmaceutical industry.

April 2009 e-Cigarette Company Smoking Everywhere files a lawsuit in federal court to stop the FDA seizure of electronic cigarettes. The company’s primary argument is that electronic cigarettes are a cigarette product and not medical devices.

April 2009 The FDA releases its lab report on electronic cigarettes.  This report will be the basis for the future FDA press release attacking electronic cigarettes.

May 2009 nJoy joins Smoking Everywhere’s suit against the FDA.  nJoy made no health claims in its marketing material, which appeared to be the FDA’s basis for seizing shipments.

June 2009 President Obama signs the Family Smoking Prevention and Tobacco Control Act into law. The law gives the FDA jurisdiction over tobacco products. See the FDA’s Infographic for more detail on what the act entails.

July 2009 The FDA releases their infamous press release making a number of negative claims about electronic cigarettes based on limited testing of cartridges from Smoking Everywhere and nJoy (the two companies suing the agency). The claims included:

• e-Cigarettes were marketed directly to young people
• diethylene glycol (used in antifreeze) found in one cartridge
• Samples contained carcinogens
• Samples contained toxic chemicals
• The original press release didn’t mention varying nicotine levels, that appears to have come later

July 2009 NJoy publishes an analysis of the FDA’s lab report (edit: original link is dead, here is a copy of a cached version) citing a number of deficiencies in the report. Among the findings:

• Lack of standard protocols
• No comparison to nitrosamines in nicotine replacement products
• Many substances mentioned were below normally detectable quantities
• Many impurities were present but less than found in the Nicotrol inhaler
• Nicotine levels in the control device (inhaler) were not published
• No study of the vapor was conducted.

August 2009 Tobacco Control advocacy group Action on Smoking and Health (ASH) files an Amicus brief in the Smoking Everywhere lawsuit in support of the FDA.

September 2009 An ad-hoc group of e-cigarette proponents, the Alliance of Electronic Smokers filed an Amicus brief in favor of the e-cigarette companies and disputing the ASH brief.

2010

January 2010 The FDA is ordered to stop blocking imports of electronic cigarettes by Federal District Judge Richard Leon. Judge Leon noted that the FDA could use its newly granted tobacco regulation powers to deal with electronic cigarettes according to an article in the New York Times.

February 2010 The FDA wins a temporary stay of the injunction issued in January pending a review by the appeals board. The FDA is free to continue blocking shipments.

April 2010 A group of of public health organizations including he American Academy of Pediatrics, the American Cancer Society Cancer Action Network, the American Heart Association, the American Legacy Foundation, the American Lung Association, the American Medical Association, the Campaign for Tobacco-Free Kids, and Public Citizen file an Amicus brief in support of the FDA’s actions.

June 2010 Smoking Everywhere drops out of the court case. At the time, there were questions surrounding the company’s ability to survive amidst the legal fees and impact to its business caused by the seizures.

June 2010 nJoy files a brief appealing the stay on the basis of adverse impact on its ability to conduct business in addition to the FDA’s inability to demonstrate harm from electronic cigarettes.

July 2010 Another Amicus brief is filed in support of the FDA by health advocacy groups.

September 2010 The FDA sends a warning letter to five e-cigarette companies: E-CigaretteDirect (not the UK vendor), Ruyan, Gamucci, E-Cig Technology and Johnson Creek.  The letter states that the agency intended to regulate the products under the Federal Food, Drug and Cosmetic Act and their products were not in compliance.

September 2010 The Federal Appeals Court hears arguments concerning the stay of the injunction in the nJoy V FDA case.

September 2010 (Side Note) The New York Times publishes a piece that the FDA caved to political pressure from Senator Lautenberg and others to approve a knee replacement device that the agency had previously denied approval.  Clearly not e-cigarette related, but I thought I would just leave that here.

December 2010 The Federal Appeals court rules in favor of nJoy and reinstates the injunction against electronic cigarette seizures. Judge Leon advises the agency to use the Tobacco Control act to regulate e-cigarettes. The FDA must decide if it wishes to take its case to the Supreme Court.

2011

Janurary – March 2011 Various vendors report in online forums and blogs that the FDA is continuing to stop electronic cigarette shipments into the country in defiance of the court order from December, 2010.

February 2011 Totally Wicked sues the FDA over shipment seizures in the wake of the previous court ruling.

April 2011 The FDA announces it will not appeal the decision in the nJoy case. The FDA finally stops intercepting e-cigarette shipments. The agency announces it will pursue e-cigarette regulation under the Tobacco Control Act. In its letter, the FDA announces that intends to leverage the following steps to regulate the devices under the Act:

• The Agency intends to propose a regulation that would extend the Agency’s “tobacco product” authorities in Chapter IX of the FD&C Act, which currently only apply to certain specifically enumerated “tobacco products,” to other categories of tobacco products that meet the statutory definition of “tobacco product” in Section 201(rr) of the Act.   The additional tobacco product categories would be subject to general controls, such as registration, product listing, ingredient listing, good manufacturing practice requirements, user fees for certain products, and the adulteration and misbranding provisions, as well as to the premarket review requirements for “new tobacco products” and “modified risk tobacco products.”
• The Sottera decision states that products made or derived from tobacco  can be regulated under the Tobacco Control Act unless they are “marketed for therapeutic purposes,” in which case they are regulated as drugs and/or devices.  The Agency is considering whether to issue a guidance and/or a regulation on “therapeutic” claims.
• Section 201(rr)(4) of the Tobacco Control Act prohibits the marketing of “tobacco products” in combination with other FDA-regulated products. As mentioned, FDA has already issued a draft guidance on this provision, which it intends to finalize.
• “Tobacco products” marketed as of February 15, 2007, which have not been modified since then are considered “grandfathered” and are not subject to premarket review as “new tobacco products.”  A “tobacco product” that is not “grandfathered” is considered a “new” tobacco product, and it is adulterated and misbranded under the FD&C Act, and therefore, subject to enforcement action, unless it has received premarket authorization or been found substantially equivalent.   FDA has already developed draft guidance explaining how manufacturers can request a determination from FDA that a “tobacco product” is “grandfathered.”

May 2011 Totally Wicked voluntarily drops its suit against the FDA in light of the announcement and the FDA’s stopping seizures.

July 2011 The FDA announces its intent to have draft regulations concerning other tobacco products (including e-cigarettes) by October.

October 2011 A group of Senators led again by Senator Lautenberg send a letter to the FDA urging the agency to “move swiftly” to begin regulation of electronic cigarettes.

December 2011 The FDA announces a comment period for regulation of non-face-to-face sales of electronic cigarettes, leading to speculation that the FDA may severely limit online and mailorder sales of electronic cigarettes.

2012

May 2012 After several quiet months from the FDA, lets slip via a sources sought request that it intended to have draft regulations of e-cigarettes in place by Summer 2012. The request was for technology to identify online and offline advertising for tobacco products.

August 2012 The FDA releases a report on “adverse events” reported from e-cigarette use. The report showed some 100 adverse effects were reported.  Analysis of the report on the ECF noted that there are millions of users of the system, and a number of individuals thinking they were being helpful submitted adverse impact reports for things like “being able to breathe easier” which likely artificially inflated the number of adverse impacts, which likely are just a handful of things.

Today

Summer has passed, and no draft regulations have been put forth by the FDA. Speculation among the cigar industry is that the agency likely won’t propose anything until the election is over. There is further speculation that the exact steps the FDA takes will depend on the political landscape after November.  This is perhaps true, but it seems to me that the train has already left the station and the FDA will roll something out in the future.

How oppressive it will be, nobody knows.  Speculation ranges from simple quality control over e-liquid on the low-end to very strict regulation allowing only pre-filled cartridges with either tobacco or menthol flavoring (along with online sales and advertising bans) on the extreme end of the spectrum.

Thank you for sticking with me through this massive undertaking.  I hope I gave you a little more perspective on how the FDA exists within our vaping culture. I’d love to hear what you think about the FDA and any potential regulations in the comments!

September 26, 2012 – Steve K. – http://stevevape.com/

How Vaping Saved my Life: A Firsthand Account

Of all people, I will be the first to testify to the destruction that tobacco cigarettes can cause. Some of my first memories were of my father sitting in our red recliner in the living room, chain-smoking his Pall Mall full flavor cigarettes. Up until I was a teenager, this is where I saw my father most times at home. He always seemed fine. It seemed as though cigarettes had no real impact on who he was or his health.

 

MY TEEN YEARS

Once I reached my teen years, drugs and alcohol began to enter the picture, as they do for almost any sociable teenager. I saw my friend smoking a cigarette at the age of 15, and I felt compelled to try it myself. Almost everyone I knew was doing it; so why not? I asked for a cigarette and was enthusiastically handed one by another young, naïve friend. I lit the cigarette, and by the time I had finished it, I felt sick to my stomach. Trying to remain cool, I attempted to cover my sickness up by telling everyone I had to use the restroom. I vomited in the lavatory and spent the rest of the day feeling terrible. This should have been a sign the moment where I decided that smoking just wasn’t for me.

I became a regular smoker by the age of 17 once I had passed the phase of smoking socially with my friends (and occasionally feeling sick from doing so). Smoking cigarettes still didn’t seem harmful to me; the only side effects I noticed were the occasional smoker’s cough and that I had to spend more time caring for my teeth.

THE EFFECTS OF SMOKING LATER IN LIFE

As the years wore on, I continued to smoke and developed a nasty, chronic smoker’s cough and an ease for getting winded. In my 40’s, I became worried for my health when I found it very difficult to catch my breath in various situations. Even at times when I was merely resting, I would find myself suddenly short of breath. I knew it was time to visit the doctor and find out what was going on with my body.

A series of doctor’s appointments, lab results, and blood work revealed that I was dealing with precancerous cells in my lungs. Distraught with this news, I knew it was time to make a change. I had attempted and failed to quit smoking many times before that, but when my own mortality had been sized up before me in a doctor’s office, it suddenly became very real.

MAKING THE SWITCH TO VAPING

Around the time of quitting cigarettes after discovering the precancerous cells in my body, electronic cigarettes had just made their way onto the scene. I’d heard of smoking e-cigarettes (or “vaping”), but never gave them any thought because I was too pre-occupied with tobacco cigarettes.

I quickly bought my first electronic cigarette kit, and never looked back. Because my electronic cigarette disperses nicotine without the harmful toxins and chemicals that tobacco cigarettes emit, I never thought twice about switching back from vaping to tobacco cigarettes. I get the nicotine fix that my body craves, without the negative side effects associated with traditional cigarettes.

Now that I am an official vaper, I think about what would have happened if I had kept going on my journey to destruction with tobacco cigarettes. Vaping is a very viable alternative to smoking real cigarettes, and in some cases, it can be the difference between life and death for you. I’d recommend that anyone begin vaping; it can be the best decision you ever made for your health and body.

 

– A Proud Vaper

E-Cigarettes: A $1.5 Billion Industry Braces for FDA Regulation

Photo illustration by Justin Metz;Cowboy: Mark Lisk/AlamyBehind this week’s cover

The first time J. Andries Verleur tried an e-cigarette in 2008, he burned his lip and accidentally inhaled the nicotine fluid. “It was one of the worst products I ever tried,” he recalls, “but the idea was amazing.”

Verleur, a heavy smoker, was living in Prague and happened to spot the strange new product in a Vietnamese grocery store. The crude early version obviously didn’t work very well, but Verleur, a serial entrepreneur, immediately realized that if it did work, it could upend the tobacco industry. That was worth looking into: Cigarettes are a global business that generates more than half a trillion dollars every year, according to data from Euromonitor International.

In its simplest form, an e-cigarette is a cartridge filled with a nicotine solution and a battery powering a coil that heats the solution into vapor, which one sucks in and exhales like smoke. Typically, it looks like a regular cigarette, except the tip, embedded with an LED, often glows blue instead of red. The active ingredient in e-cigarettes is the same nicotine found in cigarettes and nicotine patches.

The effects of inhaling nicotine vapor are not totally understood, but there is no evidence to date that it causes cancer. Experts and logic seem to agree that it’s a lot better than setting chopped-up tobacco leaves on fire and inhaling the nicotine along with thousands of combustion byproducts, some of which are definitely carcinogenic. Because cancer is the main drawback of smoking for a lot of people, the delivery of nicotine without lighting a cigarette is very attractive. And because it produces a wispy vapor instead of acrid smoke, an e-cigarette lets you bring your smoking back indoors, where lighting up in an enclosed space is no longer socially, or legally, acceptable.

Verleur saw right away that if e-cigarettes could be made as convenient and satisfying as a pack of smokes, he’d make a killing. He enlisted the help of his brother, an engineer working for an Agilent Technologies (A) spinoff; booked a trip to China; and began meeting with manufacturers. In 2009 he formed his company, V2Cigs, with four employees working out of an apartment.

Five years later, V2Cigs has six manufacturing facilities in Shenzhen, China, a Miami headquarters, 250 employees, and 5 million customers worldwide. Verleur says more than a million of those are in the U.S., where Bloomberg Industries projects total e-cigarette sales could reach $1.5 billion this year. Other competitors now include NJoy, Vapor (VPCO), and Victory Electronic Cigarettes (ECIG), as well as the major tobacco manufacturers and hundreds of others.

It all still represents a tiny fraction of what Americans spend on tobacco, but it’s pretty solid for an industry that barely existed five years ago. A projection by Bloomberg Industries shows e-cigarette sales could surpass that of the traditional tobacco product by as early as 2023. Who will dominate the market is a different question, and one that may be answered not by the markets, but by the government.

A primitive, battery-operated “smokeless non-tobacco cigarette” was patented as early as 1963 and described in Popular Mechanics in 1965. Thomas Schelling, a Nobel prize-winning economist who helped start the Institute for the Study of Smoking Behavior and Policy at Harvard University’s Kennedy School in the 1980s, recalls that people in the 1960s were talking about a charcoal-based vaporizer that would heat some sort of nicotine solution. While those early versions might have been safer than a regular cigarette, they were too expensive and cumbersome to become a substitute for a pack of Camels in a country where, as Schelling notes, “you’re never more than 5 or 10 minutes away from a smoke.”

In a way, electronic cigarettes were made possible by cell phones. The drive to make phones smaller and lengthen their battery life led to the development of batteries and equipment small enough to fit in a container the size and shape of a cigarette. There’s some dispute over who invented the modern e-cigarette, but the first commercially marketed device was created by a Chinese pharmacist, Hon Lik, and introduced to the Chinese market as a smoking cessation device in 2004. From there, e-cigarettes made their way to small shops such as that of the Vietnamese grocer who sold Verleur his first one four years later.

E-cigarettes beat the traditional kind in one big way: You can legally have them shipped to you in the comfort and privacy of your home. (It’s not legal to send traditional cigarettes through the U.S. mail.) Blu, made by Greensboro (N.C.)-based Lorillard (LO), one of the biggest producers of tobacco cigarettes, makes a starter pack that comes with a charger that doubles as a storage container, and it looks just like a pack of cigarettes. It also comes with two batteries and five nicotine cartridges good for about 150 puffs apiece. The pack costs about $80 before shipping, which is roughly equal to the price of 8 to 16 packs of cigarettes. (Disposable e-cigarettes are cheaper to start, but in the long run they’re much less economical.) Because nicotine cartridges are exempt from tobacco taxes, which now make up much of the retail cost of a cigarette, a pack of cartridges is competitive with old-fashioned smokes, especially if you live in an expensive jurisdiction such as New York.

E-cigarette cartridges come in classic tobacco and menthol flavors—Verleur’s company even offers V2 Red, Sahara, and Congress, clearly aimed at loyal smokers of Marlboros, Camels, and Parliaments. But most companies also have less conventional flavors. Blu offers Peach Schnapps, Java Jolt, Vivid Vanilla, Cherry Crush, and Piña Colada, presumably for people who don’t just like a drink with a cigarette, but in one.

Click to enlarge

Jeff Ky is a salesman at My Vapez in Arlington, Va., where you can buy a variety of e-cigarettes and larger vaporizers that look like cigars. The array of flavors is astonishing, and he says the fruity flavors, not the traditional tobacco styles, are the most popular. Potential customers come into his store looking to quit and usually buy the classic tobacco flavor. Once they’ve kicked traditional cigarettes, they often start wanting something sweeter tasting, which Lorillard says is also its experience with Blu. Ky’s best-selling flavor is cantaloupe-kiwi, and he uses a mixture that’s supposed to taste like Strawberry Nesquik. Cartridges also come in varying strengths, ranging from high concentrations of nicotine to low concentrations to no nicotine at all for smokers trying to quit.

To find out how they tasted and if they were anything like a real cigarette, I ordered online a starter pack of Blu in menthol with a high concentration of nicotine. When the pack arrived, I had to read the directions carefully just to figure out how to charge the battery, which looked like the white part of a traditional cigarette, and then connect it to the nicotine cartridge, which looked like a filter.

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.

I couldn’t wait to try them in a bar, so I met a friend for a drink at a local Washington watering hole. I hadn’t had a cigarette in a bar since sometime in the late 1990s, and I felt self-conscious, maybe a little bit lonely: There’s no social aspect, or even the hint of an invitation, in an e-cigarette. You don’t pass the pack around, and no one is going to bum an e-cigarette off of you. “It becomes more like a hobby,” says Ky of his customers, with users showing off their newest gear. But yes, an e-cigarette still tastes good with a drink.

In fact, it tastes almost too good. Like most smokers, I quit cigarettes several times before succeeding, and each time I quit, I had reached a point where I was basically glad to put down the cigarettes because they made me feel terrible. E-cigarettes don’t hurt and don’t offer the same incentive to quit. You could use one on the treadmill if you were so inclined.

Nicotine helps regulate your mood, and it is an appetite suppressant, too, which is why smokers who quit generally gain weight. It’s a cognitive enhancer, and there’s some hotly contested evidence that it may slow the onset of Alzheimer’s disease. For a sedentary knowledge worker facing the declines of middle age, that’s an attractive combination. Indeed, one academic who does research in this area confided that he’s thinking of taking up e-cigarettes because of the advantages of nicotine, even though he’s never smoked. (He is not prepared to go on the record recommending that people add nicotine to their diets.)

The professor and I are exactly why some public-health experts want e-cigarettes treated like regular cigarettes: plastered with warnings, laden with taxes, and definitely not sold in flavors such as piña colada. “If e-cigarettes were regulated so that they became a way to get people off cigarettes, we would lead the cheer. But the issues are complicated,” says Matt Myers, president of Campaign for Tobacco-Free Kids. “E-cigarettes are not harmless. You want to discourage people who do not currently use e-cigarettes from taking up the habit. Our concern is that it will re-glamorize smoking and lead people to switch to cigarettes, or experiment with cigarettes.”

In October the European Parliament rejected a proposal to regulate e-cigarettes as medical devices. The U.S. Food and Drug Administration, which is in the process of drafting rules, is expected by observers to follow suit. The decision is important to pharmaceutical companies such as GlaxoSmithKline (GSK) and Pfizer (PFE), which sell nicotine patches and gums that are regulated as medical tools and may not want unregulated competition.

The proposed regulations could be anything from basic rules ensuring that the nicotine cartridges contain what they’re supposed to and that the devices are safe to a scheme of the kind that Myers wants, with restrictions on flavored products and sexy marketing campaigns. Tight regulation would make the market much more complicated for upstarts such as V2Cigs, which don’t have the marketing or lobbying muscle of Big Tobacco.

Some local government officials and regulators in other countries have already made a decision. Under former Mayor Michael Bloomberg (who owns Bloomberg LP, parent of Bloomberg Businessweek), New York in December expanded the ban on smoking in public places to include electronic cigarettes. In Chicago, Mayor Rahm Emanuel pushed for the same restrictions, and they have been adopted. Brazil has banned e-cigarettes outright.

As nothing but a replacement product for existing smokers, e-cigarettes seem like a public-health win. Widespread adoption by current smokers “could potentially reduce smoking deaths by more than 90 percent,” says Joel Nitzkin, a public-health physician who is a senior fellow at free-market think tank R Street in Washington.

But what if current smokers aren’t the only people who use them? What if e-cigarettes lure back people who used to smoke or attract new smokers? What if people who otherwise would have quit keep using nicotine? And perhaps the No. 1 argument: What if e-cigarettes make smoking normal again in public places, with the attendant annoyance of a neighbor or officemate blowing nicotine-laced steam everywhere?

Since the Office of the Surgeon General warned of its dangers in the 1960s, smoking has declined dramatically and is quite rare among the U.S. middle class. That’s because of its health risks, but also because of the social stigma and inconvenience associated with smoking. With the exception of some hipsters, smoking is largely a lower-income phenomenon. “You may be establishing something you want to establish in your group, but it’s a pretty downscale group,” says Mark Kleiman, a professor of public policy at the University of California at Los Angeles.

But if the stigma is undone, “we could go back to 50 percent of the population routinely using nicotine,” Kleiman says. That doesn’t mean he thinks we should ban e-cigarettes. “Given the certain gain from switching current smokers to e-cigs and the uncertain signs of the effects of adding new users, it seems to me that we should get public policy out of the way for now while watching to see how many of today’s happy e-cig users become unhappy users three years from now.”

A 2011 study published in the Journal of Public Health Policy concluded that “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.” It also said there’s “reason to believe that they offer an advantage over traditional nicotine delivery devices.” The other main ingredients in e-cigarettes are what the FDA calls “generally recognized as safe”: glycerine, found in many foods, and propylene glycol, the main ingredient in theatrical fog.

E-cigarettes don’t only assuage the desire for nicotine but also the desire to have a cigarette, which isn’t exactly the same thing: One study found that even an e-cigarette rigged to deliver “minimal” nicotine could reduce cravings in a substantial minority of smokers. V2Cigs’ Verleur estimates that while half of his customers use his product to replace cigarettes, either completely or in places where they aren’t allowed to smoke, about one-quarter start at the highest concentration and work their way down toward the no-nicotine version, at which point some stop entirely, while others keep buying the nicotine-free ones.

Even without the combustion, nicotine is a vasoconstrictor that narrows blood vessels and drives up blood pressure. Doing that a dozen times a day is less bad than getting lung cancer, but it’s still not great. Besides, there is no study on what inhaling those “generally recognized as safe” compounds might do to your lungs if you inhale them daily for a few decades. It’s hard to imagine that the health effects could be worse than setting something on fire and deliberately breathing the smoke. But they’re probably not as good as quitting. “The antismokers think we’re going to win—that we can get to zero tobacco,” says Kleiman. If that’s what you believe, then you’re likely to endorse stiff restrictions on e-cigarettes. On the other hand, if you think U.S. tobacco consumption will stay stubbornly stuck between 10 percent and 20 percent of the population for the foreseeable future—which means tobacco deaths will remain in the hundreds of thousands annually—you’re more likely to be agitating for the federal government to take a light hand, even if it means opening the door to the possibility of a renewed national mania for nicotine.

Among the FDA’s most difficult decisions will be determining whether e-cigarettes will be a gateway product, encouraging young smokers to develop a nicotine habit that might lead to tobacco use. After all, many of the things that make e-cigarettes attractive to smokers make them even more attractive to minors. It’s actually pretty unpleasant to start smoking—it causes dizziness, it causes coughing, and it usually takes kids a while to learn to inhale—but anyone can inhale e-cigarette vapor on the first puff. And since e-cigarettes don’t have much odor, they’re harder for parents to detect. During the debate over New York’s policy, a September report from the Centers for Disease Control and Prevention showing e-cigarette use on the rise among teenagers was prominently discussed. Spokesmen for Altria Group (MO), Reynolds American (RAI), and Lorillard—the Big Three of tobacco—are in agreement that children should be prevented from buying e-cigarettes, just as they are prevented from buying the regular kind.

Small e-cigarette manufacturers who exploited the power of the Internet have had the nascent market largely to themselves, but that’s changing. “A year and a half ago, there were over 450 e-cigarette companies in the U.S. market, many of them mom-and-pop operations,” Verleur says. There are still a few hundred companies out there, most of them tiny. According to Verleur, “over 70 percent of U.S. market share is held by about 10 companies.”

Lorillard, which makes Kent and Newport cigarettes, has joined the e-cigarette market aggressively. It almost has to, according to Kenneth Shea of Bloomberg Industries, not only because cigarette sales have plateaued, but because 90 percent of the company’s sales come from menthol cigarettes, which the FDA is under pressure to ban, as it banned other flavored tobacco products that public-health advocates argued were especially appealing to children. In 2012, Lorillard bought Blu for $135 million in cash and has boosted its distribution to more than 125,000 stores. The brand is the market leader.

Big Tobacco’s advantages will probably strengthen once the FDA releases its proposed rules. Analysts expect some restrictions on Internet sales because it’s too easy for minors to get the devices online. But while it’s relatively easy for a small company to become established on the Internet, it’s much harder to secure scarce shelf space behind a drugstore counter. The tighter the FDA regulation, the more valuable distribution networks and marketing power become. And of course, the more lobbyists a company can afford, the more likely it is to get regulations it likes.

Altria and Reynolds, which are the market leaders in sales of regular cigarettes, are entering the market as well. On Feb. 3, Altria announced it was buying e-cigarette company Green Smoke for $110 million. They have also created their own products, MarkTen (Altria) and Vuse (Reynolds). Their e-cigarettes look sleek, but like traditional cigarettes come in only two flavors: regular and menthol. They’re rolled out exclusively through retailers. Altria has launched its MarkTen in only two test markets, as Reynolds has with its Vuse. In November the Wall Street Journal reported that in Colorado, where Vuse was introduced in July, the product gained 55 percent of the e-cigarette market in a few months.

For all the taxes and regulations that have been slapped on the companies, their profit margins are healthy: Demand for their product is inelastic, consumers are loyal, and most of the market is controlled by Altria, Reynolds, and Lorillard. Tobacco is a business they would clearly rather not endanger with a misstep in the e-cigarette market—either by enraging the government or by cannibalizing their own sales.

The tobacco companies are also entering the market without any of their iconic brands, which tend to lose customers only when smokers quit or die. There’s no Camel or Marlboro e-cigarette. The Tobacco Master Settlement Agreement reached with state attorneys general in 1998 makes it tricky to use cigarette brands on other merchandise. Although some company will probably test that in the future, clearly no one’s feeling so bold yet. Doing without a major brand is a big handicap, particularly because the small companies have already spent years establishing a brand. Verleur points out that he and his competitors have experience working out technical issues with the electronics and the nicotine solution, neither of which are likely to be core strengths at a company that specializes in burning leaves. He waits for the government’s decision on which the fate of his business rests. The more lightly the area is regulated, the better chance the upstarts will have of taking on Big Tobacco and winning. “It’s our sincere hope,” he says, “that regulators and legislators take a responsible approach towards our category.”

By Megan McArdle February 06, 2014 | McArdle is a Bloomberg View columnist.

As seen on; http://www.businessweek.com/printer/articles/182779-e-cigarettes-a-1-dot-5-billion-industry-braces-for-fda-regulation

E-Liquid: Which liquid nicotine strength is right for you?

When it comes to deciding on your e-cigarette liquid, you want to get it right. Every decision in this process is an important one, yet choosing the right e-liquids nicotine strength is right at the top among the most important. It can make all the difference between success and failure in using your e-cigarette as an alternative to traditional tobacco.

Before you happened upon this ingenious little device called the electronic cigarette, you probably had no idea there was such a thing as liquid nicotine. We all equate nicotine with tobacco cigarettes, or maybe nicotine gum or the patch at most. You know now that e cigarette liquid forms a key component in what makes an e-cig so effective for so many people, but it can also scare consumers because of the negative association that nicotine has picked up over the years.

You’ll be surprised to know that nicotine on its own, and in moderation, really isn’t bad for you. In fact, there are studies that point to the positive effects of nicotine usage. Studies have shown that nicotine can help you focus, increase your cognitive process, and even help treat symptoms of depression and Alzheimer’s disease.

Choosing the right nicotine strength has a lot to do with how much you smoke and which type of cigarettes you smoke. Let’s take a look at the basic parameters in accordance with the most popular e cigarette liquid standards on the market right now:

No Nicotine: This level will work for you if you just want the feel of smoking a cigarette. If you are anything more than an extremely light (a few cigarettes a week) smoker, this won’t be enough. At least not in the beginning, but we’ll get to that later.

6mg or 0.6%: Considered the ultra-light level, 6mg can be effective if you are used to smoking ultra-light cigarettes such as Capris or Pall Mall ultra-lights.

12mg or 1.2%: Here we start to get into the area where more smokers fall into. This would be considered a light level nicotine strength for most e-cigarette brands. If you smoke a light cigarette, especially if you smoke less than a pack a day, this could fit your needs well.

18mg or 1.8%: The majority of smokers will want to start with this level of liquid nicotine or higher. If you smoke a full flavored or regular cigarette and have up to a pack a day, you will want your e cigarette liquid to contain at least 18mg of liquid nicotine.

E-cigarettes: Healthy tool or gateway device?

(CNN) — If the tiny sample of smokers in a new study in the British journal Lancet are any indication, electronic cigarettes might be slightly more effective than nicotine patches in helping people quit smoking.

Great, right? Except another new study from the Centers for Disease Control and Prevention suggests more children and teens are trying them.

The implications of both these studies means electronic cigarettes have been getting a lot of attention lately. Just what e-cigarettes are and what role they should play in helping people quit smoking depends very much on who you speak with about this topic.

Smoking is still the leading cause of avoidable death in the United States. The devices are not one of the FDA-approved methods to help people quit, but many people are using them this way. A growing number of scientists are studying them to see whether they may be a way to end an epidemic.

The topic, though, remains as polarizing a health issue as sex education or diet sodas.

An e-what?

The e-cigarette was actually developed by a pharmacist in China.

The pharmacist, Hon Lik, was a three-pack-a-day smoker. That was nothing unusual — more than 300 million people in China are regular smokers. But when Lik’s father, who was also a heavy smoker, died of lung cancer, Lik decided he had to come up with an alternative that wouldn’t kill him.

Most scientists believe nicotine itself, while highly addictive, is not what causes cancer for smokers or for the people around them who breathe their second-hand smoke. Instead, it’s the toxic chemicals that are created when tobacco and filler products burn that are dangerous.

If there was a way to get nicotine addicts their fix without the burn, you just might avoid the health problems. Nicotine then becomes as harmless as any other addictive substance, such as caffeine, some experts say.

So Lik developed an e-cigarette — a device that uses a small battery to atomize a pure liquid solution of nicotine. Nothing is burned. There is no ash. There is no smoke. There is nicotine, and then there is flavoring added for taste.

Essentially the person using these inhales a kind of vapor that looks like fog from a fog machine. A recent review of all the scientific research done on e-cigarettes by Drexel University professor Igor Burstyn concludes “current data do not indicate that exposures to vapors from contaminants in electronic cigarettes warrant a concern.”

In plain language, Burstyn concludes: “It’s about as harmless as you can get.”

“I wouldn’t worry at all if someone was smoking one of these by my kids,” Burstyn said. “From a pure health perspective, these are not as bad as a cigarette.”

E-cigarettes came to the U.S. market around 2009. The CDC now estimates about one in five Americans have tried smoking an e-cigarette — that’s about 6% of adults who smoke.

There are e-cigarette stores, but now you can also buy them online or in convenience stores. Some look like regular cigarettes; some look like pens or thumb drives.

First you buy a starter kit, which costs between $40 and $130. In the kit is the e-cigarette, a charger and a few cartridges. The cartridges typically last as long as a 20-pack of cigarettes and sell for around $10. You can also buy a bottle of e-liquid to refile the cartridge yourself.

The anti-e-cigarette camp

Critics point out e-cigarettes come in kid-friendly flavors such as gummy bear, atomic fireball candy and cookies and cream. It makes them worry that e-cigarettes will become a gateway to encourage kids to develop a lifelong nicotine addiction — or worse, try the real thing.

Only about 20 states specifically forbid the sale of e-cigarettes to children.

Tobacco use has been on the decline with kids; it’s about half what it was in the mid-1990s. But the latest CDC study shows a growing number of middle and high school students have tried e-cigarettes.

One in 10 high school students surveyed said they had tried e-cigarettes last year. That’s double the number from 2011. One high school in Connecticut banned them after the principal said administrators dealt with at least one incident involving e-cigarettes every day.

CDC director Tom Frieden characterized this trend as “deeply troubling.”

But as far as risky behavior goes, it’s still a tiny fraction of students. The survey showed about 3% of these kids said they had used one in the last 30 days. By contrast, 39% of students said they drank some amount of alcohol in the past 30 days, 22% binge drank and 24% rode with a driver who had been drinking.

The real problem is that 88% of adult smokers who smoke daily said they started when they were kids, according to the CDC. Kids who start down the path to using e-cigarettes may stick with them for life.

“So much is unknown about them and what the long-term complications could be with their use,” said the American Lung Association’s Erika Sward. “Bottom line, we don’t know what the consequences of using them are, and we are very troubled that kids would find them attractive.”

E-cigarettes are unregulated in the United States; no laws make manufacturers tell you what you are actually inhaling. The unknown is one of the many qualities of e-cigarettes that the American Lung Association doesn’t like.

It’s “a complete unregulated Wild West,” Sward said. She wants the FDA to move quickly with regulatory oversight, which she says would make manufacturers disclose what the actual ingredients are in each of the 250 or so brands available.

In 2009, a FDA test on a small number of e-cigarette samples found “detectable levels of known carcinogens and toxic chemicals to which users could potentially be exposed.” They found diethylene glycol in one cartridge at a 1% level; this is an ingredient used in antifreeze and can be toxic to humans in large quantities. Diethylene glycol is also found in some dental products and in some pharmaceuticals.

After that study, the FDA banned the sale of e-cigarettes. They warned e-cigarette smokers that they were inhaling “toxic” and “harmful” chemicals. However, in 2010, a court ruled that “the FDA had cited no evidence to show that electronic cigarettes harmed anyone,” and stores could go on selling them.

The early e-adopters

On the other side of the debate are the passionate supporters of e-cigarettes. Many who use them say it is the first thing that has helped them stop using cigarettes — something more than 90% of smokers fail to do with any of the existing FDA-approved methods. There are blogs and message boards dedicated to them. And there are countless impassioned testimonials from the people who use them.

Florida resident Craig Lashley says they’ve changed his life.

“I got tired of being like that little kid in ‘Peanuts’ who had the cloud of smoke following him all the time,” Lashley said. “I didn’t like the way I smelled when I smoked, and I didn’t like what smoking said about me, especially to kids.”

He discovered the e-cigarette about a year ago and hasn’t smoked a regular cigarette since.

He says he smells better, feels better and spends a lot less — about $10 a week on e-cigarettes. He used to spend about $45 a week on regular cigarettes.

“I like the feel of blowing smoke,” Lashley said. “It seems to me like (e-cigarettes are) a healthier alternative.”

A growing number of respected physicians and scientists agree, and they say these products could end a major health problem.

“Electronic cigarettes and other nicotine-containing devices offer massive potential to improve public health, by providing smokers with a much safer alternative to tobacco,” the Royal College of Physicians says. “They need to be widely available and affordable to smokers.”

The latest study, published in the British journal the Lancet, examined whether people who used them as an alternative to smoking would abstain from using regular cigarettes.

The New Zealand authors studied the behavior of 657 people who were trying to quit. One group got nicotine patches, another got nicotine e-cigarettes and others got placebo e-cigarettes without the nicotine.

Over a period of six months, only a tiny fraction of the people in the study actually quit smoking.

People using the nicotine e-cigarettes quit at a slightly better rate compared with those using the patch, though. Some 7.3% using the e-cigarettes abstained from smoking traditional cigarettes compared with the 5.8% who stopped with the patch. About 4.1% stopped with just the placebo e-cigarettes.

It was such a small number of people who quit that the authors concluded “more research is urgently needed to clearly establish their overall benefits and harms at both individual and population levels.”

Dr. Michael Siegel, a physician who has spent the past couple decades working on tobacco control initiatives, has been surprised by the negative reaction to e-cigarettes from so many people in the public health sector. Siegel says the studies he’s done have shown e-cigarettes are a help.

“True we don’t know the long-term health effect of e-cigarettes, but there’s a very good likelihood that smokers are going to get lung cancer if they don’t quit smoking,” he said. “If they can switch to these and quit smoking traditional cigarettes, why condemn them?”

Siegel theorizes the e-cigarettes might look too much like smoking.

“It’s ironic the very thing that makes them so effective … drives the anti-smoking groups crazy. But what makes them so effective is it mimics the physical behaviors smokers have, which is something the patch can’t do.”

Siegel does believe there is an urgent need for more regulations.

Ray Story, founder of the Tobacco Vapor Electronic Cigarette Association, agrees. He says his association has also pushed for age verification legislation.

“When you have these companies trying to promote these as something they are not, and you have stores that sell them in the candy aisle, you are going to have a problem,” Story said. “If they are officially categorized as a tobacco product, you get an automatic age verification put in place.

“Nicotine is addictive, and we want the federal government to create guidelines and a structure that will confine these to being sold as adult products.”

Lashley says no matter what the debate, he will continue to spread the e-cigarette gospel to his fellow adults.

So far, his co-workers have been receptive to the idea. He used to be the only one with an e-cigarette on smoke breaks. Now he says he’s got more than a dozen colleagues doing the same.

One colleague, though, complained about it.

“He said ‘I’m sick of all these people smoking electronic cigarettes,” Lashley said. “When I asked him why he said. ‘Simple, now I can’t bum any off of them.’ “