FDA reins in e-cigarettes: public protection or industry suffocation?

After years of wrangling between electronic cigarette manufacturers and those calling for stricter controls, the US Food and Drug Administration (FDA) released Thursday a long-awaited series of rules that will haul the industry under federal oversight.

The fresh regulations will restrict sales to minors and implement new health warnings, but the aspect stoking most controversy is a requirement for all electronic cigarettes, or e-cigarettes, launched since 2007 – the vast majority of the market – to undergo federal review.

The multi-billion-dollar e-cigarette industry has at times been the subject of both praise, for helping people quit traditional cigarettes, and condemnation, for potentially sucking youngsters into the world of nicotine, and many have called for a more thorough examination of the potential health benefits and costs.

“We have more to do to help protect Americans from the dangers of tobacco and nicotine, especially our youth,” said Sylvia Burwell, secretary of the US Department of Health & Human Services, in a statement released by the FDA. “As cigarette smoking among those under 18 has fallen, the use of other nicotine products, including e-cigarettes, has taken a drastic leap. All of this is creating a new generation of Americans who are at risk of addiction.”

E-cigarettes were originally touted as stepping stones for smokers on the road away from addiction, and they afford the undisputed benefit of providing the nicotine of traditional cigarettes without the attendant chemicals and tar of burning tobacco.

Indeed, in a 2015 report commissioned by Public Health England, an agency that advises the British government, experts found that “best estimates show e-cigarettes are 95% less harmful to your health than normal cigarettes.”

In response, the British government’s chief medical officer, Dame Sally Davies, said she wanted to see e-cigarettes arriving on the market only as “licensed medicines.”

“This would provide assurance on the safety, quality and efficacy to consumers who want to use these products as quitting aids, especially in relation to the flavorings used, which is where we know least about any inhalation risks,” Dame Sally told the Guardian, cautioning that “there continues to be a lack of evidence on the long-term use of e-cigarettes,” and they should only be used by smokers seeking to quit.

Yet this last point is perhaps the facet of the debate causing most friction, as critics of e-cigarettes blame them for introducing nicotine to a generation of youngsters who might otherwise have steered clear.

A recent study by the US Centers for Disease Control and Prevention (CDC) found that e-cigarette advertising was luring huge proportions of the nation’s children into the world of tobacco.

Middle school students who said they saw advertisements for e-cigarettes "most of the time" or "always" were 87 percent more likely to use e-cigarettes than teens who said they never saw advertisements. For high school students, 71 percent were more likely to use e-cigarettes.

While the health risks of e-cigarettes themselves remain undetermined, some public health advocates have welcomed the latest development, whereby the FDA will have far more control.

“Too many children and teens are using e-cigarettes, cigars and other tobacco products,” said Harold P. Wimmer, National President and CEO of the American Lung Association, in a statement. “The American Lung Association welcomes this long-awaited step to protect public health.”

The tobacco industry will be less impressed, and it is already driving action against the FDA’s new oversight, using its considerable sway on Capitol Hill, having already given more than $1.8 million to members of Congress this election cycle, according to Reuters.

Indeed, some House Republicans are already pushing industry-backed legislation that seeks to strip away the retroactive requirements of the new rules, retaining safety reviews only for new products.