By the end of summer, the Food and Drug Administration (FDA) is expected to make final new rules that would require federal approval for most flavored nicotine liquids and e-cigarette devices sold in vape shops.
In April 2014, the FDA proposed rules that would require e-cigarettes, including liquid nicotine and devices, to be approved by the agency. When the new rules become final, companies would have six months to register products and ingredients with the agency, and two years to complete the approval process. E-cigarette manufacturers say the FDA has never approved a new tobacco product, according to the Wall Street Journal. SciLucent LLC, a regulatory consulting company, estimates that the approval process could cost anywhere from $2 million to $10 million to collect data and put forward an application.
E-cigarettes heat nicotine liquid to produce a vapor that delivers nicotine to the user without burning tobacco. In the rule-making notice, the FDA said the rise in popularity of e-cigarettes coincides with an increase in calls to poison control centers and visits to hospital emergency rooms “related to liquid nicotine poisoning and other nicotine exposure risks.” Of particular concern is nicotine poisoning in young children, who can swallow nicotine liquid or absorb it through the skin and the eyes. The New York Times reports that as little as a teaspoon of liquid nicotine can be fatal for a small child. Nicotine liquids come in candy and fruit flavors that appeal to children and the products do not come in childproof packaging or carry warning labels, as they would under the new rules. E-cigarette users unaware of the serious risks often leave nicotine liquid within reach of children.
Advocates for e-cigarettes say they are an aid to quitting smoking. Researchers say e-cigarettes are less harmful than traditional cigarettes, because they do not release the more than 60 carcinogens produced in the combustion of traditional cigarettes. Some studies have shown e-cigarettes can be effective in helping smokers quit, but because they are so new to the scene—arriving around 2008—their long-term health effects are not known. The Centers for Disease Control and Prevention (CDC) released a study in April indicating teen e-cigarette use tripled in 2014 and health officials are concerned e-cigarettes could be a gateway to traditional cigarettes, according to the WSJ.
Vape shops have sprung up across the country, now numbering about 8,500, the WSJ reports. Shop owners worry about the costs of complying with the new regulations. Tige Mercer, who owns Vape Atlanta and co-owns a liquid-nicotine producer, says he could not afford the expense of seeking approval for nicotine liquid and would have to give up that part of the business, which accounts for about 40 percent of his revenue. It would cost Mercer more to buy nicotine liquid from an outside supplier. He had planned to expand his business but says that is now uncertain.
According to estimates from the Smoke-Free Alternatives Trade Association, a lobbying group for vape shops and manufacturers, 99 percent of the industry will go out of business after the FDA finalizes its rule, the WSJ reports.