Saying “the jury is still out” on the ramifications of electronic cigarettes would be a massive understatement. E-cigarettes* are designed to mimic tobacco cigarettes in both look and feel. Most of them have three basic parts: a battery-operated heating element; a replaceable or refillable cartridge containing nicotine; and an atomizer that converts the cartridge contents into a nicotine-containing vapor that the user inhales. They’re the world’s most common type of electronic nicotine delivery system (ENDS).
China originally developed the product about 10 years ago. Its availability through internet and retail sales and its ubiquitous use have surged in a very short period of time. In just two years (from 2009 to 2011), e-cigarette use increased from 1% to more than 6%. Most users were current or former tobacco smokers. Industry analysts expect e-cig consumption to surpass use of traditional cigarettes within the next 10 years.
In the USA, the Food and Drug Administration does not regulate e-cigarettes “customarily marketed [as] tobacco products,” only those for therapeutic use. About half of state regulatory authorities do, in some way or other, and some local governments and businesses. The cigarette substitutes are also untaxed, rendering them much, much cheaper than cigarettes or other straight-tobacco products.
Unfortunately, the product is so new that its health impact or cluster of effects is unknown. Most public health officials worldwide have been calling for more data (large, randomized, controlled trials) to help them weigh the potential risks and benefits of e-cigarettes and inform regulators about what actions to take, if any.
The questions fall into many categories:
Reasons for use (e.g., recreational, psychological, smoking cessation),
Human health effects,
Human-based risk factors,
Pediatric issues, including ethics of both use and sale,
Current product designs and knowledge of them,
Clinical pharmacology (nicotine is both a drug and a poison),
Addictive potential, both individually and comparatively,
Toxicology of e-liquid constituents, including flavors and contaminants,
Toxicology of aerosol constituents,
Environmental issues of manufacture and use,
Effectiveness vs other nicotine-containing smoking cessation methods (gum, patch, etc.),
Effectiveness vs non-nicotine-containing smoking cessation methods,
Industry’s relation to existing tobacco companies and small-scale entrepreneurship,
Benefits/costs of regulation,
Liability for use/abuse, and
Research gaps in all areas.
You can see why even among the most informed advocates, clinicians, scientists, and policymakers have problems evaluating the new products. CNN quotes Margaret Hamburg, FDA commissioner:
“It’s really the wild, wild West out there because e-cigarettes are increasingly in the marketplace. They’re coming in different sizes, shapes, and flavors in terms of the nicotine in them, and there’s very worrisome data that show that young people in particular are starting to take up e-cigarettes, especially the flavored ones—and that might be a gateway to other harmful tobacco products.”
A February 25 article in the American Heart Association’s journal Circulation addressed some of the evidence that does exist:
“Studies have concluded that e-cigarettes can help reduce the number of cigarettes smoked and may be as effective for smoking cessation as the nicotine patch. Although there is a lack of data concerning the safety and efficacy of e-cigarettes as a smoking cessation therapy, available evidence showed no significant difference in adverse event rates between e-cigarettes and the nicotine patch.“
In the widely read British medical journal The Lancet late last year, the issue also came up. Basic question: how to balance the need for less harmful nicotine delivery to current tobacco smokers, versus an increase in nicotine addiction, especially among youth and young adults.
The Lancet debate begs the more immediate and possibly more important question of impact on smokers’ first-hand and other ongoing and fatal lung disease, its medical burden, and the considerable socioeconomic costs. From the smoking prevention and cessation standpoint, as noted in Thomas J. Glynn’s March 14, 2014, article in CA: A Cancer Journal for Clinicians, the evidence seems not to involve much debate.
The importance of most other factors remains to be determined.
On April 24 of this year, the US Food and Drug Administration proposed rules that call for strict regulation of electronic cigarettes, cigars, pipe tobacco, nicotine gels, water pipe tobacco, and hookahs. They involve an age limit of 18, a vending machine ban, health warnings about nicotine, manufacturer registration and product contents listing, and FDA product review.
Here’s where to find out more from the FDA and register any adverse events you may have suffered from an e-cigarette product. You can register a comment on the proposals with FDA until late July at this link.
Once FDA has discarded the issue or finalized its rules, manufacturers will have two years to comply.
*Disclosure: This article was sponsored by Vapour Lites. That said, it had no control over the editorial content of the article.