FDA proposes new rules to regulate e-cigs like cigarettes

The FDA yesterday proposed a new rule that would permit it to regulate e-cigarettes in the same way the agency regulates other tobacco products.

E-cig advocates were reportedly pretty happy with the proposed regulations, as they take a much lighter touch than was expected.  While they would ban the sale of e-cigarettes to children, they would not limit advertising.

The FDA regs also, interestingly, call for the regulation of cigars and hookahs, among other tobacco delivery devices.  From the FDA’s press release:

Products that would be “deemed” to be subject to FDA regulation are those that meet the statutory definition of a tobacco product, including currently unregulated marketed products, such as electronic cigarettes (e-cigarettes), cigars, pipe tobacco, nicotine gels, waterpipe (or hookah) tobacco, and dissolvables not already under the FDA’s authority. The FDA currently regulates cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco.

The basic structure of an e-cigarette, courtesy of the FDA.

The basic structure of an e-cigarette, courtesy of the FDA.

Our own Dr. Mark Thoma penned an E-Cig 101 post for us, explaining the basics of how e-cigarettes work, and summarizing some of the health and safety concerns surrounding them:

E-cigarettes have been around for about 10 years. First developed and marketed in China (not known as a bastion of consumer safety), they were designed to offer a convenient way to enjoy smoking. The e-cigarette is designed to vaporize a liquid (that contains nicotine, flavorants and other substances) and allow it to be inhaled. The liquid can have varying amounts of nicotine. It can also have other substances (flavorants) added (mint, fruit flavors and others.) These flavorants are seen by some as a marketing ploy to get children to start smoking. The liquid may contain other chemicals or impurities, as well.

As Mark reported earlier, because e-cigarettes are not currently regulated, companies can make them any way they want, with no standards whatsoever as to safety or quality.

What studies have found to date is that even nictotine-free e-cigarettes can contain nicotine, the amount of nicotine that e-cigs deliver can vary by as much as 60% from puff to puff, and that some e-cigs tested positive for nitrosamines, which may increase the risk of cancer in humans.

Mark noted that there are also concerns about refillable e-cigs, in which you buy pure nicotine that you use to refill the delivery system.  The NYT noted the potential problems with refillable e-cigs:

These “e-liquids,” the key ingredients in e-cigarettes, are powerful neurotoxins. Tiny amounts, whether ingested or absorbed through the skin, can cause vomiting and seizures and even be lethal. A teaspoon of even highly diluted e-liquid can kill a small child.

But, like e-cigarettes, e-liquids are not regulated by federal authorities. They are mixed on factory floors and in the back rooms of shops, and sold legally in stores and online in small bottles that are kept casually around the house for regular refilling of e-cigarettes.

E-cig advocates argue that e-cigs are still safer than cigarettes, since cigarettes contain such a long list of carcinogens.  From the American Lung Association:

There are approximately 600 ingredients in cigarettes. When burned, they create more than 7,000 chemicals. At least 69 of these chemicals are known to cause cancer, and many are poisonous.

The problem, experts say, is that we just don’t know enough about e-cigs, because they’re not regulated, and because there aren’t enough health and safety studies, so while we think they may be safer than cigarettes, we simply don’t know for sure.  From WebMD:

So far, evidence suggests that e-cigarettes may be safer than regular cigarettes. The biggest danger from tobacco is the smoke, and e-cigarettes don’t burn. Tests show the levels of dangerous chemicals they give off are a fraction of what you’d get from a real cigarette. But they aren’t regulated by the FDA, so what’s in them can vary.

“E-cigarettes may be less harmful than cigarettes,” Drummond says. “But we still don’t know enough about their long-term risks or the effects of secondhand exposure.”

I for one am glad to see the regulation.  This is something you ingest.  We ought to at the very least have standards for how it’s made, to ensure it’s safe.

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CyberDisobedience on Substack | @aravosis | Facebook | Instagram | LinkedIn. John Aravosis is the Executive Editor of AMERICAblog, which he founded in 2004. He has a joint law degree (JD) and masters in Foreign Service from Georgetown; and has worked in the US Senate, World Bank, Children's Defense Fund, the United Nations Development Programme, and as a stringer for the Economist. He is a frequent TV pundit, having appeared on the O'Reilly Factor, Hardball, World News Tonight, Nightline, AM Joy & Reliable Sources, among others. John lives in Washington, DC. .

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