Intended for healthcare professionals

Observations Yankee Doodling

Finally the US regulates e-cigarettes as tobacco

BMJ 2016; 353 doi: (Published 06 May 2016) Cite this as: BMJ 2016;353:i2596
  1. Douglas Kamerow, senior scholar, Robert Graham Center for policy studies in primary care, professor of family medicine at Georgetown University, and associate editor, The BMJ
  1. dkamerow{at}

Treating them as tobacco will outlaw sales to children

It seems a long time coming. We watched electronic cigarettes grow without regulation from an oddity to a pastime of nine million Americans, from boutique businesses to a $3.5bn (£2.4bn; €3bn) industry dominated by major tobacco companies. Now e-cigarettes are more popular among our high school students than tobacco cigarettes.1

The Food and Drug Administration tried to regulate e-cigarettes as drug delivery devices in 2010 but was beaten back in the courts by the fledgling industry. In 2014 the FDA announced new draft rules after it gained authority in 2009 to regulate tobacco products. We waited for the final rules. And we waited. Apparently it took a lot of time to respond to the public comments and iron out numerous compromises in the policy.

More than two years later the FDA has finally issued 500 pages of regulations for e-cigarettes, cigars, pipe tobacco, and hookahs.2 3 They include most of the national regulation that the public health community wants, to the anguish of manufacturers and some harm reduction advocates.

No free samples

From 8 August sales to under 18s will be banned, as will vending machine sales (except in adult only locations) and free samples. By May 2018 all packets of e-cigarettes that contain nicotine must include a warning that it is addictive.

By August 2018 e-cigarette and e-juice manufacturers must submit their products to the FDA for premarketing review, registering them, listing their ingredients, and specifying any harmful substances that they include. The FDA then has a year to decide whether to give marketing clearance.

What does all this mean? Lots of good news. Youngsters will have a much more difficult time getting e-cigarettes, starting very soon. Within three years we will at last know what is in the e-cigarettes and e-juice sold in every US convenience store. And many shady backroom brews and questionable imported vats of e-juice will be outlawed, because their makers will not have the resources needed for registration and approval.

To my mind, the regulations have two major gaps, however. Firstly, they do not restrict flavorings, very popular among young people. The FDA could have banned flavors, as it does (except for menthol) in tobacco cigarettes, but it chose not to in deference to the possibility that some flavors attract adults away from combustible tobacco cigarettes.3

Secondly, although the regulations prohibit false or misleading advertising and require proof of claims that e-cigarettes are safer than combustible conventional cigarettes, they still allow advertising of the increasingly ubiquitous e-cigarette on cable television, in magazines, and on the internet. Many of them are attractive to young “vapers” and could have been banned with good effect.

Another possible criticism, but which is not appropriate, is that the regulations do not increase taxes on e-cigarettes to levels that approach those of tobacco cigarettes. This is because the FDA has no power to levy taxes, the authority for which is under the Department of the Treasury.

Favoring big tobacco

Some harm reduction advocates will say that the difficult and expensive applications and testing that the FDA now requires will put small vape shops out of business and play into the hands of the major cigarette companies, which alone can muster the resources to continue to produce and market e-cigarettes. I’m not thrilled about this either, but I’ve been in a few vape shops and watched them mix their e-juices. Not a reassuring sight. I’d rather have big, regulated companies producing something I’m going to put in my lungs, even if it means sustaining their sales and growth.

We may discover that e-cigarettes can provide a safe and effective way for smokers to reduce or stop smoking combustible cigarettes. If so, and as long as kids can’t get them, I’m happy for those e-cigarettes to be produced by big tobacco.



View Abstract