So long e-cigarette entrepreneurs? FDA regulation could be a real drag

April 24, 2014 6:47 PM

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So who wins and who loses under the Food and Drug Administration's plan to regulate additional tobacco products, such as e-cigarettes and cigars?

The big winner is public health since tobacco use is the leading cause of preventable death in this country.

"This proposed rule is the latest step in our efforts to make the next generation tobacco-free," said Kathleen Sebelius, secretary of Health and Human Services.

The American Association for Cancer Research welcomed the FDA's proposed regulation, particularly since the use of e-cigarettes is on the rise.

“We do not know the nature of the long-term health consequences of these devices or what effect they will have on smoking continuation or uptake by adults and youth," said Dr. Roy Herbst, chief of medical oncology at Yale Cancer Center and chair of the association's tobacco and cancer subcommittee. "Therefore, FDA regulation of these products is appropriate."

The new rule would add electronic cigarettes, cigars, pipe tobacco, nicotine gels, waterpipe tobacco and dissolvables to the list of tobacco products subject to FDA regulation. Makers of these products would have to register with the FDA and list their products and ingredients, so the FDA could review them. They also couldn't claim any health benefit from using their products unless the FDA confirms that claim is backed up by scientific evidence.

Sales to children would be prohibited, and labels would have to include health warnings. For e-cigarettes, that means a warning that nicotine is addictive.

That sounds like a hassle if you're an e-cigarette entrepreneur, but it will take a while for the FDA rule to go into effect, and products being sold now can stay on the market pending FDA review, according to the Washington Post.


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