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Expected FDA Regulations on E-Cigarette Industry Could Have Major Financial Impact

Aug 17, 2015

The Food and Drug Administration (FDA) is expected to make final new regulations on e-cigarettes that could have a major financial impact on the e-cigarette industry.

The provision that could be most damaging is a requirement that e-cigarette makers submit marketing applications for all their products, even those already on the market, the Daily Caller reports. The process could cost millions.

Under the new regulations, e-cigarette manufacturers could not advertise that their products are less harmful to health than traditional cigarettes unless they could provide scientific proof for such claims, the Daily Caller says. E-cigarettes came under the authority of the FDA in 2009, but the agency did not propose regulations for the devices until about a year ago. When the proposed regulations are made final, e-cigarettes may be under many of the same restrictions as traditional tobacco products, including health warning labels and a ban on sale to minors.

The first e-cigarette was developed in China in 2007, but the Daily Caller reports that nearly 20 million people in the U.S. now regularly use e-cigarettes. Jan Verleur, who is co-founder and CEO of VMR Products, manufacturer of the V2 e-cigarette brand, said the new FDA rules could be devastating to the industry. "This makes it so any product released after the grandfather date would require premarket approval," Verleur told The Hill. The process could cost up to half a million dollars per individual product, Verleur says.

Since issuing the proposed regulations, the FDA has received more than 135,000 comments. The date when the rules will take effect has not been announced but the FDA has said companies will have two years to submit their applications and while an application is under review, the product may continue to be sold, the Daily Caller reports. FDA spokesman Michael Felberbaum told The Hill, "FDA is committed to moving forward expeditiously to finalize the rule."

Advocates for e-cigarettes say they are an aid to quitting smoking and some researchers say they are less harmful than traditional cigarettes because the user does not inhale tar and other carcinogens in tobacco smoke. But doctors and public health experts have expressed a variety of concerns about e-cigarettes. Some say e-cigarettes could be a gateway to smoking, according to the Wall Street Journal, and they point to marketing that targets teenagers. The Centers for Disease Control and Prevention (CDC) said teen e-cigarette use tripled in 2014.

Because e-cigarettes are so new to the market, their long-term health effects have not been established. But the FDA reports a significant increase in calls to poison control centers and visits to emergency rooms "related to liquid nicotine poisoning and other nicotine exposure risks." Nicotine poisoning in young children is a particular concern. Young children can drink the liquid or absorb it through their skin and eyes. According to the New York Times, as little as a teaspoon of liquid nicotine can be fatal for a small child. Many of the liquids come in fruit and candy flavors that appeal to children and they are not packaged in childproof bottles. E-cigarette users who are not aware of the poisoning risk may leave nicotine liquid where young children have access to it.

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