New regulations expected this summer from the Food and Drug Administration (FDA) are expected to have a major impact on the e-cigarette industry.
What may be most damaging to the industry is a provision that would require e-cigarette makers to retroactively submit marketing applications for all their products, the Daily Caller reports. The cost could run to millions.
The new regulations could ban e-cigarette manufacturers from advertising that their products pose fewer health risks than traditional cigarettes unless they could provide scientific proof of the validity of such claims. E-cigarettes came under the authority of the FDA in 2009, and when the new regulations are made final, e-cigarettes may have many of the same restrictions as traditional tobacco products, including health warnings and a ban on sale to minors.
E-cigarettes are still relatively new—the first e-cigarette was developed in China in 2007—but the Daily Caller reports that nearly 20 million people in the U.S. regularly use e-cigarettes. According to Jan Verleur, co-founder and CEO of VMR Products, the new regulations could have devastating consequences for the industry. “This makes it so any product released after the grandfather date would require premarket approval,” Verleur told The Hill. He estimated that the process could cost up to half a million dollars per individual product. VMR’s costs could be more than fives times the company’s revenues.
The FDA has received more than 135,000 comments since issuing the proposed regulations over a year ago. 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. The products may be sold while they are under review, the Daily Caller reports. Both industry and advocacy groups are pushing the FDA to release the final rule this summer. “FDA is committed to moving forward expeditiously to finalize the rule,” FDA spokesman Michael Felberbaum told The Hill.
E-cigarettes do not burn tobacco. Instead, they deliver nicotine by heating nicotine liquid to produce a vapor. Advocates for e-cigarettes say they are an aid to quitting smoking and some researchers say they are less harmful than traditional cigarettes because they do not release the more than 60 carcinogens produced in burning tobacco. But some health officials are concerned that e-cigarettes could be a gateway to traditional cigarettes, according to the Wall Street Journal. In April, the Centers for Disease Control and Prevention (CDC) released a study indicating teen e-cigarette use tripled in 2014.
Because e-cigarettes are so new to the market, their long-term health effects are not known and this concerns health officials. The FDA said there has been a significant increase in calls to poison control centers and visits to emergency departments “related to liquid nicotine poisoning and other nicotine exposure risks.” Of particular concern is nicotine poisoning in young children, who swallow nicotine liquid or absorb it through their skin and eyes. As little as a teaspoon of liquid nicotine can be fatal for a small child, the New York Times reports. The liquids come in fruit and candy flavors that appeal to children and they are not packaged in childproof bottles. They do not carry warning labels, as they would under the proposed new rules. Poison control centers warn that many e-cigarette users—unaware of the serious risks—leave nicotine liquid where children have access to it.