The proposed regulations that the Food and Drug Administration sent to the Office of Budget Management in October are expected to have a profound impact on the rapidly growing business of electronic cigarettes, both for nicotine and cannabis.

Federal guidance regarding e-cigarettes has been absent since 2010, when a federal judge agreed with e-cigarette manufacturers in Sottera Inc. v. Food and Drug Administration that the FDA did not have the authority to regulate the devices as “unapproved drug delivery products,” but could regulate them as tobacco products. Now the FDA is proposing that e-cigarettes should fall under the Family Smoking Prevention and Tobacco Control Act of 2009, which gives the FDA “the authority to regulate the manufacture, distribution and marketing of tobacco products to protect public health.” The White House is expected to decide on the FDA’s proposal soon.

Meanwhile, the two-year regulatory hiatus gave rise to a bustling business in electronic cigarettes. Sales tripled over last year and analysts say e-cigarettes are already a billion dollar-plus industry and growing fast. Particularly alarming to health organizations like the American Lung Association has been the rapid rise of e-cigarette use by kids. The Centers for Disease Control and Prevention reported in September that e-cigarette use more than doubled among middle and high school students from 2011-2012.

In the absence of federal regulations, states, cities, universities and even Major League Baseball parks have introduced their own rules governing the sale or use of electronic cigarettes. On December 19th, New York City included e-cigarettes in its ban on public smoking. Just a week before, the mayor of Los Angeles signed an ordinance that requires that e-cigarette retailers must be licensed like tobacco vendors and that they can’t sell e-cigarettes to minors (the state already bans e-cigarette sales to minors but encourages cities to craft their own regulations). The Los Angeles City Council is also considering a motion that would prohibit e-cigarette vaporizing wherever smoking is taboo.

Preferable Alternative or Insidious Menace?

E-cigarettes typically work by heating up a liquid solution typically consisting of propylene glycol, nicotine (not tobacco leaf) and some kind of flavoring (more than 90 flavors were featured at the Henley Vaporium, according to this Reuters story). Since the battery-operated pen-size devices heat the liquid just enough to vaporize it, the user inhales an almost odor-free misty vapor rather than burnt tobacco.

Anti-smoking organizations like the American Lung Association don’t trust e-cigarette manufacturers, including tobacco companies, to be entirely forthcoming about either the contents of their e-cigarette solutions or the intentions of their marketing tactics, pointing out that vulnerable youth appear to be an attractive target. The American Lung Association supported the FDA’s 2010 effort to regulate e-cigarettes as drug delivery devices, said Janice Nolan, assistant VP, National Policy and Advocacy for the American Lung Association. The organization now supports the FDA’s proposed policy of regulating electronic cigarettes like other tobacco products. If the FDA “deems” that e-cigarettes should be treated like tobacco, the agency could ban sales to kids, place restrictions on their use, and prohibit “false or misleading labeling and advertising and implement sanctions for violations of the law.”

E-cigarette advocates, on the other hand, argue that the devices should not be categorized as a tobacco product since they don’t actually contain tobacco. Some manufacturers, as well as some consumers, even say that electronic cigarettes have helped smokers kick their habit. Those claims have not been fully substantiated (a study published in The Lancet suggested that e-cigarettes are as successful as patches at helping smokers quit tobacco).

In addition to the tobacco industry and e-cigarette manufacturers, medical marijuana organizations like the Marijuana Policy Project and NORML also oppose regulating e cigarettes like tobacco products.

Bans on electronic cigarettes to eliminate the dangers of second-hand smoke are a “smoke screen,” said Dale Gieringer, California coordinator for the National Organization for the Reform of Marijuana Laws (NORML). Since respiratory hazards are a byproduct of combustion, there is no conceivable danger due to second-hand smoke using vaporizers, he said. “It’s a hysterical reaction by anti-smoking prohibitionists to the concept of people smoking and it’s based on junk science,” said Gieringer. “The anti-smoking lobby is hysterical about people consuming nicotine.”

Like cigarette smokers, a growing number of cannabis consumers have also eschewed combustion in favor of vaporizing. In 2004 Gieringer published a study in The Journal of Cannabis Therapeutics that showed that the use of a vaporizer (the Storz & Bickel Volcano) eliminated the harmful carcinogens associated with smoking while preserving the delivery of therapeutic THC. Another study at the University of California at San Francisco produced similar results. Further research has been stymied by the federal government’s classification of marijuana as a dangerous drug with no redeeming medical benefits.

Medical marijuana advocates are wary that in its zeal to reign in the runaway electronic cigarette market, the government might also impede patients from accessing their therapeutic medicine in a manner that is healthier than smoking.

Health advocates, local governments, the tobacco industry, electronic cigarette manufacturers, and medical marijuana organizations and patients all have a lot at stake in how the government decides to regulate e-cigarettes. Most people would agree that the e-cigarette industry is long overdue for federal regulations that would require product labeling, cite possible risks and limit sales to adults. But if the regulations end up being so onerous that they scuttle a technology that might prove to be a healthier alternative to smoking tobacco or cannabis, the FDA may have achieved a Pyrrhic victory.