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FDA releases proposed regulations for e-cigarettes, other products

The proposed regulations would impose an age limit, require product registration with the FDA

E-cigarette users have operated mostly outside of the Food and Drug Administration’s (FDA) reach, but now, the government agency is making an attempt to bring e-cigs and other unregulated tobacco products under its umbrella.

On April 24, the FDA proposed strict rules that would monitor a host of smoking-related substances, including electronic cigarettes, cigars, pipe tobacco, nicotine gels, water pipe tobacco and hookahs. Among the proposed regulations are an age limit of 18 to buy the products, warning labels on the products, and the requirement to register all products and ingredients with the FDA. Retailers would also be barred from giving the products away as samples.

Currently the FDA only holds dominion over cigarettes, smokeless tobacco and roll-your-own tobacco. However, e-cigarettes in particular have become much more popular in recent years. According to a report from the Centers for Disease Control and Prevention (CDC), the percentage of high school students who had used e-cigarettes doubled between 2011 and 2012, from 4.7 percent to 10.0 percent.

This rise, said FDA commissioner Margaret Hamburg, meant that the FDA needed to step in and introduce regulations right away. “It's really the wild, wild west out there,” Hamburg said, “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.”

Currently, the FDA does not even know how many different types of e-cigarettes are available, and it has not been able to fully investigate the effects of e-cigarette use on the human body.  Dr. Michael Eriksen, dean of the School of Public Health at Georgia State University, told CNN that his department’s studies on e-cigarettes have opened up a number of questions.

“How concentrated is liquid nicotine? Are there impurities in it? Is it properly handled like a pesticide?” he says. “Nicotine is a pesticide fundamentally and we take so many precautions about pesticides for our lawns and how to wear gloves. But what precautions do consumers take when they put the nicotine vials in? People treat it [liquid nicotine] as sugar when it's a toxin.”

Perhaps because of this unregulated nature, poison control centers have seen a rise in calls related to e-cigarettes. According to the CDC, poison control centers received 215 calls related to e-cigarettes in February 2014, over half of which involved children.


For more on the FDA in legal news, check out these recent articles:

POM heads to court, will field labeling suits as both plaintiff and defendant

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Pharma companies still fail to embrace social media

The aftermath of Caronia in pursuing off-label cases

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Zach Warren

Zach Warren is Assistant Editor of InsideCounsel magazine, where he oversees online content submissions and administers InsideCounsel's enewsletters. Zach specializes in new media and multimedia...

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