What's the issue?

E-cigarettes, virtually nonexistent 10 years ago, have skyrocketed in popularity. Though often shaped like a traditional cigarette, they are fundamentally different in both design and ingredients and are widely believed by supporters and critics to be a safer alternative and a potentially valuable tool in weaning people off tobacco cigarettes. How much safer, however, and how well they function as a smoking cessation device are key questions subject to a fierce debate.

Instead of the traditional combustible cigarette lit with a match or lighter, e-cigarettes use a battery-operated heating element, called an atomizer, that vaporizes a liquid solution from a small cartridge of flavored liquid, frequently called "juice," into an aerosol mist that resembles smoke. The liquid, or e-liquid, usually, but not always, contains nicotine. Supporters say e-cigarettes are a perfect smoking cessation device because they provide a sufficient nicotine buzz without many of the more dangerous substances and harmful chemicals of a conventional cigarette.

Opponents, however, say there's no evidence that smokers won't simply continue to use both products. Mitch Zeller, director of the Food and Drug Administration's (FDA's) Center for Tobacco Products, recently told a congressional panel that because there is so little scientific evidence about e-cigarettes, all he could comfortably say was that "they have the potential to do good; they have the potential to do harm."

E-cigarettes are currently unregulated at the federal level. But in April 2014 the FDA moved to change that, issuing a proposed rule that would give the agency the authority to regulate e-cigarettes as a tobacco product, banning their sale to people under 18 and prohibiting free samples, among other constraints. The FDA will accept comments on the proposed rule until August 8, 2014, and could well extend that time. Then it is likely to spend many more months crafting its final rule.

Scores of studies are currently under way to assess three key questions: What is the efficacy of e-cigarettes as a smoking cessation device? Will they encourage more conventional tobacco smoking or less? And what is the safety of the vapor itself for users and people around them?

Meanwhile, large tobacco corporations have already moved into the roughly $2 billion market, the nation's largest tobacco companies each owning an e-cigarette company or creating their own product.

What's the background?

The first e-cigarette was patented in 1965 by Herbert Gilbert, an American, who said in a 2013 interview that he was simply trying to eliminate the burning process in tobacco.

Gilbert couldn't interest anyone in his patent in the mid-1960s, when few were questioning the safety of conventional cigarettes. But in the mid-2000s a pharmacist in China, Hon Lik, developed his own e-cigarette and patented it around the world, including the United States.

RECENT GROWTH: Since the mid-2000s e-cigarettes have seen exponential growth, and the term "vaping" has entered the general vocabulary, referring to the act of inhaling vaporized nicotine-laced liquid. The popularity of vaping rests in large part on its ability to allow people to smoke without the 60 or so carcinogenic substances created by burning cigarette tobacco. One Wall Street analyst who follows the tobacco industry noted that US consumption of e-cigarettes and a related product that also vaporizes nicotine might surpass consumption of combustible cigarettes within the next decade. The analyst predicts that profit margins of e-cigarettes might also surpass combustible cigarette margins within the next three years.

Statistics from the Centers for Disease Control and Prevention's (CDC's) Morbidity and Mortality Weekly Report show that between 2011 and 2012, the percentage of students in grades 6-12 who had tried e-cigarettes more than doubled to nearly 7 percent. A 2013 report in the journal PLoS ONE noted that by 2012 about 8 percent of all US adults and 32 percent of smokers had tried e-cigarettes.

Currently, the entire market is in a state of flux--there is no federal regulation, there is no critical mass of peer-reviewed literature, and the private sector is in the midst of a series of intellectual property lawsuits over various e-cigarette designs. Indeed, Fontem Ventures BV, a subsidiary of Britain's Imperial Tobacco, paid $75 million in late 2013 for a portfolio of e-cigarette patents from a Hong Kong-based firm cofounded by Lik. A few months later, in March 2014, Fontem Ventures BV sued 11 American e-cigarette makers including tobacco giant Lorillard in federal court alleging various patent infringements.

Overall, the e-cigarette market today comprises a mixture of small mom-and-pop retail outlets, which tend to sell a variety of e-liquids and more sophisticated e-cigarettes, as well as large companies. Two years ago Lorillard paid $135 million for blu eCigs.

In July 2014 tobacco company Reynolds American agreed to buy competitor Lorillard in a $27 billion deal that would make it the second largest tobacco company in the nation. Lorillard is currently the market leader in e-cigarettes, but in order to finance the deal and in an attempt to avoid antitrust scrutiny, Reynolds will sell the blu eCig brand to the Imperial Tobacco Group. The brand was introduced in Britain earlier this year, and Imperial plans to continue to expand the market for blu eCigs internationally.

In 2013 Reynolds American started marketing its Vuse brand in select markets, and in June 2014 it announced that the company would begin selling nationwide. Last year Altria, parent company of tobacco giant Philip Morris USA, began test-marketing its own e-cigarette, MarkTen, with a national rollout set for this year. And in February 2014 Altria also purchased e-cigarette maker Green Smoke for $110 million.

FEDERAL EFFORTS: The Family Smoking Prevention and Tobacco Control Act of 2009 gave the FDA authority to regulate cigarettes--and the tobacco in cigarettes--as well as roll-your-own and smokeless tobacco. The Tobacco Control Act allows the FDA to oversee the manufacture, marketing, distribution, and sale of regulated tobacco products and to protect the public from the harmful effects of tobacco products using science-based regulations. But it left unregulated such prominent tobacco products as cigars, pipe and hookah tobacco, nicotine gels, and e-cigarettes.

The law does give the FDA authority to "deem" other products that meet the statutory definition of tobacco--a product "made or derived from tobacco" and "intended for human consumption"--as subject to its regulatory oversight. The nicotine found in the liquid used in most e-cigarettes provides that nexus with the Tobacco Control Act, because the nicotine is derived from tobacco.

On April 25, 2014, the FDA began its formal "deeming" process by publishing its proposed rule on how it plans to regulate e-cigarettes. The comment period will extend to August 8, 2014, and already has attracted thousands of formal comments from all sides of the debate.

What's the policy?

The FDA didn't originally set out to regulate e-cigarettes using the Tobacco Control Act. Beginning in 2008 the agency tried to regulate e-cigarettes as unapproved drug and device combination products, because they were often marketed as tobacco cessation aids to help people quit smoking. Under that standard, e-cigarette makers must prove that their product is safe and effective as advertised, which can cost hundreds of millions of dollars in clinical trials to prove. The e-cigarette makers sued the FDA in federal court, and in December 2010 the US Court of Appeals for the D.C. Circuit ruled in Sottera, Inc., v. Food and Drug Administration that as long as Sottera's products are not marketed for therapeutic use--in this case, as smoking cessation devices--then the FDA could only regulate e-cigarettes as tobacco products.

The FDA did not appeal the decision, but on April 25, 2011, it announced that it would propose regulations to extend its "tobacco product" authority to cover e-cigarettes. Three years later to the day, that process began with the publication of the proposed 67-page rule in the Federal Register. It calls for, among other things, a ban on free samples and sale to minors; a warning label, a required submission of ingredient listings; and a prohibition against "modified risk descriptors" such as "light," "low," and "mild."

Not every requirement will take effect at the same time. For example, e-cigarette makers will not be required to disclose ingredients until two years after the final rule is announced. The proposed rule also covers cigars, pipe tobacco, nicotine gels, hookah tobacco, and certain dissolvable tobacco products not already under the FDA's regulatory authority.

The proposed rule also explicitly acknowledges the lack of scientific data and specifically requests "health and behavioral data about the effects of using e-cigarettes" as well as data on the co-use of e-cigarettes with the "initiation and continuation" of other tobacco products. This is particularly important because e-cigarettes, notes the FDA, may have the potential to curb smoking-related illnesses and deaths. But that depends on the extent to which e-cigarettes actually can help a large number of adult smokers to quit. "If...there is significant initiation by young people, minimal quitting, or significant dual use of combustible and non-combustible products, then the public health impact could be negative," the FDA wrote in its proposed rule.

Initial industry reaction to the proposed rule, according to press reports, was relatively positive, with e-cigarette makers praising the FDA's "scientific-based approach."

Advocates who oppose e-cigarettes generally welcomed the proposals as well, although they were quick to point out the absence of any effort to restrict advertising or flavors, which range from bubble gum to cherry to mint to Turkish tobacco and beyond. An FDA spokesperson said the agency must first gain legal jurisdiction over e-cigarettes under the Tobacco Control Act before applying any possible future restrictions on advertising or flavorings.

Meanwhile, many states and local municipalities have already determined that e-cigarettes are either a nuisance, a health threat, or a potential revenue source. Minnesota taxes e-cigarettes at the same rate as tobacco (the only state to do so thus far), 38 states have passed laws banning the sale of e-cigarettes to minors, and many city and state laws already prohibit the public use of e-cigarettes.

What's The Debate?

Most people believe that e-cigarettes are a safer alternative to combustible tobacco cigarettes for consumers who already smoke. But under the Tobacco Control Act, the FDA must consider the risks and benefits of e-cigarettes to the whole population, not simply whether the product is "safe and effective," the traditional standard the FDA uses when it evaluates a medical product.

The crux of the debate over e-cigarettes is whether their potential value as a smoking cessation tool outweighs any negative impact. Those potential negative impacts may range from possibly dangerous secondhand smoke or vapor to the so-called gateway effect, in which people start with e-cigarettes, only to move on to combustible cigarettes.

This gateway argument is important for public health authorities to consider, if only because cigarette smoking remains the leading cause of avoidable death in the United States. Fifty years after the first Surgeon General's report on smoking and health, there are still nearly half a million tobacco related deaths annually. Each day 3,200 youth under the age of 18 try their first tobacco cigarette, and more than 700 of them go on to become daily smokers.

For now, however, it is not a debate that can be resolved, simply because, as the FDA states in its proposed rule, "We do not currently have sufficient data about e-cigarettes to determine what effects they have on the public health."

To help fill that void, the agency is currently funding more than three dozen studies about e-cigarettes looking at everything from user behavior to marketing to toxicology to the precise makeup of the "juice" that the atomizers turn into vapor that users blow out of their nose or mouth.

Some risks have already been identified. A study published in May 2014 in Nicotine and Tobacco Research found that e-cigarettes that use tank systems, which allow larger quantities of juice to be vaporized, and often have larger batteries that heat with higher temperatures, can also produce formaldehyde, a known carcinogen, at the same levels as combustible cigarettes. A practice known as "dripping," in which e-cigarette users drip liquid nicotine on the heating coil, can increase the amount of formaldehyde.

The liquid nicotine added to the juice is also highly toxic, even when diluted in the juice, potentially causing vomiting and seizures and even death for a small child. Some manufacturers already package their juice in child-proof containers, but there is no standard, since e-liquids are not yet regulated by the FDA. The number of calls to poison centers linked to e-liquids jumped threefold in 2013 to 1,352, according to figures from the National Poison Data System cited by the New York Times. And in April the CDC released a report that said calls to poison centers involving e-cigarette liquids with nicotine rose from one per month in September 2010 to 215 per month in February 2014.

E-cigarette proponents are hoping that the product's benefits as a smoking cessation tool will soon be definitively proven. The authors of a study that appeared May 20, 2014, in the monthly journal Addiction interviewed nearly 6,000 smokers trying to quit on their own and found that about one in five using e-cigarettes had stopped smoking at the time of the survey, while only half that number--about one in 10--had been able to stop using conventional nicotine patches and gum. E-cigarette advocates argue that unlike the patch or nicotine gum, e-cigarettes mirror the entire smoking experience, which makes it a far more enjoyable and potentially effective cessation device.

So far, however, the research is contradictory. A randomized control study published in 2013 in The Lancet and funded by the Health Research Council of New Zealand found that e-cigarettes helped smokers quit at "similar" levels to nicotine patches. And a study published in JAMA Internal Medicine in March 2014 found that using e-cigarettes was not associated with greater rates of quitting cigarettes or reducing cigarette consumption after one year.

It's likely that one or more e-cigarette makers might soon try to market their product as an approved smoking cessation device. Although that would require approval through the FDA's drug and device authority, it would also give the product an enormous opportunity in the roughly $2 billion smoking cessation market. Currently, no e-cigarettes are approved as such.

What's next?

Until the FDA issues its final rule, possibly not until next year, and then decides whether or not it will regulate e-cigarette advertising, expect to see a market that harkens back to advertising techniques once common with tobacco cigarettes, using cartoons and celebrities and loaded language.

The advertising campaign of Lorillard's blu e-Cigs (soon to be acquired by the Imperial Tobacco Group), for example, includes a one-minute video ad with television personality Jenny McCarthy that simultaneously plays on people's health concerns and their desire to protect their personal autonomy. "Now that I've switched to blu, I feel better about myself," says McCarthy, hunched over an e-cigarette in a nightclub, adding: "Finally, with blu, I took back my freedom."

The market is also continuing to grow, spurred by the big tobacco companies--Altria, and Reynolds and Lorillard (pending the merger)--that are cash-rich and have extensive retail distribution networks and brand building capabilities.

Thousands of comments from parties on all sides of the e-cigarette debate continue to pour into the FDA's website. By law, the FDA is required to review them all.

Resources

Daniela Saitta, Giancarlo Antonio Ferro, and Riccardo Polosa. "Achieving Appropriate Regulations for Electronic Cigarettes." Therapeutic Advances in Chronic Disease 5, no. 2 (March 2014).

Dominic L. Palazzolo. "Electronic Cigarettes and Vaping: A New Challenge in Clinical Medicine and Public Health. A Literature Review." Frontiers in Public Health 1 (November 18, 2013).

Food and Drug Administration. "Deeming Tobacco Products to be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Regulations on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products; Proposed Rule." Federal Register 79 no. 80 (April 25, 2014).

Jessica K. Pepper and Noel T. Brewer. "Electronic Nicotine Delivery System (Electronic Cigarette) Awareness, Use, Reactions, and Beliefs: A Systematic Review." Tobacco Control (November 20, 2013).

Jordan Paradise. "No Sisyphean Task: How the FDA Can Regulate Electronic Cigarettes." Yale Journal of Health Policy, Law, and Ethics 13, no. 2 (Summer 2013).

Konstantinos E. Farsalinos and Riccardo Polosa. "Safety Evaluation and Risk Assessment of Electronic Cigarettes as Tobacco Cigarette Substitutes: A Systematic Review." Therapeutic Advances in Drug Safety 5, no. 2 (February 13, 2014).

About Health Policy Briefs

Written by

T.R. Goldman

Health Journalist

Editorial review by

Jordan Paradise

Associate Professor of Law

Seton Hall University School of Law

Jessica K. Pepper

Postdoctoral Fellow

UNC Center for Regulatory Research on Tobacco Communication

Rob Lott

Deputy Editor

Health Affairs

Tracy Gnadinger

Assitant Editor

Health Affairs

Health Policy Briefs are produced under a partnership of Health Affairs and the Robert Wood Johnson Foundation.

Cite as: "Health Policy Brief: E-Cigarettes and Federal Regulation," Health Affairs, Updated July 18, 2014.

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