Vape Shops Brace for Impact of New Federal Liquid Nicotine RegulationsJul 8, 2015
Within the next two months, the Food and Drug Administration (FDA) is expected to unveil new rules that would require federal approval for nearly all flavored nicotine liquids and e-cigarette devices sold in vape shops.
The approval process could cost anywhere from $2 million to $10 million to collect data and put forward an application for each item, according to the regulatory consulting company SciLucent LLC, the Wall Street Journal reports.
In April 2014, the FDA proposed rules that would require e-cigarettes, including liquid nicotine and devices, to be approved by the agency. E-cigarette manufacturers say the FDA has never approved a new tobacco product. Companies would have six months after the FDA completes its rules to register products and ingredients with the agency, and two years to complete the process of seeking approval-which they may or may not get, according to the WSJ.
Nicotine liquid is used in electronic cigarettes. The device heats the liquid and delivers nicotine vapor to the user. 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. Children can swallow nicotine liquid and can also absorb it through the skin and the eyes. Dr. Thomas Frieden, director of the Centers for Disease Control and Prevention (CDC), said, "E-cigarette liquids as currently sold are a threat to small children." According to the New York Times, 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. Many e-cigarette users, unaware of the serious risks, leave nicotine liquid within reach of children.
Advocates of e-cigarettes say they help smokers kick their smoking habit. Researchers agree e-cigarettes are less harmful than traditional cigarettes, which release more than 60 carcinogens through combustion, and some studies have shown they can be effective in helping smokers quit, the WSJ reports. But e-cigarettes are so new-they arrived in the U.S. around 2008-their long-term health effects are not known. The 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.
More than 8,500 vape shops have sprung up in strip malls and stand-alone stores across the country, the WSJ reports, and shop owners worry about the effect of the new regulations on their businesses. Tige Mercer, who owns Vape Atlanta and co-owns a liquid-nicotine producer, says he could not afford the expense of seeking approval for the nicotine liquid and would have to give up that part of the business, which accounts for about 40 percent of his revenue. It would be more expensive for Mercer to buy nicotine from an outside supplier. Mercer had planned to expand his business but says that is now uncertain.
The Smoke-Free Alternatives Trade Association, a lobbying group representing vapor shops and manufacturers, estimates that 99 percent of the industry will go out of business after the FDA finalizes its rule, according to the WSJ.