FDA Releases Sweeping New Regulations for E-Cigarettes

On May 4, 2016, the Food and Drug Administration (FDA) extended its regulatory authority to electronic cigarettes, with a sweeping set of regulations, including a ban on their sale to anyone under 18.

E-cigarettes are battery-powered devices that turn liquid nicotine into an inhalable vapor. Nicotine itself is addictive–which is why smokers find it so hard to quit—but the vapor lacks the chemicals and tars of burning tobacco. For this reason, e-cigarettes are considered safer than traditional cigarettes, the New York Times reports. The document runs to 499 pages.

The e-cigarette industry and public health experts have debated the health risks of e-cigarettes since they came to market. At the heart of the debate are differing views about the safety of the devices and differing views about the purpose of e-cigarettes. The industry says e-cigarettes help smokers quit, but many health experts fear that e-cigarettes, which are increasingly popular with teenagers, are a pathway to eventual use of traditional cigarettes, according to the Times. Evidence from a teen health survey indicated that teens who use e-cigarettes are more likely to try traditional cigarettes. But, at the same time, smoking rates for youth have declined since e-cigarettes were introduced and so some experts say this is proof enough that the fears have not come to pass, the Times reports.

Smoking is the leading cause of preventable death in the United States, with more than 480,000 tobacco-related deaths each year in the United States. Forty million American adults smoke.

E-cigarettes were introduced about a decade ago as a means to deliver nicotine without the harmful tar and cancer-causing chemicals in cigarette smoke. The devices quickly spawned a multibillion-dollar business, including vape shops, which sell the devices and often mix the nicotine liquid the devices use. Authorities estimate that about nine million American adults currently use e-cigarettes.

Health experts generally agree that e-cigarettes are less harmful than traditional cigarettes, but e-cigarettes have not been extensively studied and so little is actually known about their long-term health effects. Experts are concerned that the devices themselves pose safety concerns. The batteries can explode or catch fire, causing injuries and property damage. The liquid nicotine can be dangerous if swallowed. As little as a teaspoon of nicotine liquid can be deadly for a young child and the liquid comes in fruit and candy flavors appealing to children.

Under the new regulations, the devices must be registered with the FDA. Manufacturers must provide a detailed account of their products’ ingredients and their manufacturing processes. Manufacturers must apply to the FDA for approval to sell the products and this requirement applies to vape shops that mix their own e-cigarette liquid, the Times reports.

Manufacturers will be subject to FDA inspections and they are prohibited from marketing their products as “light” or “mild” without FDA approval. Companies are forbidden to give out free samples.

The American Vaping Association, an industry trade group, says this is “prohibition” not regulation. The association says the approval process would cost more than $1 million, and would take hundreds of hours to complete, according to the Times.

Under the regulations, companies with products on the market now, including vape shops that mix their own liquids, will have two years to submit an application to the FDA for approval of a product. The product can stay on the market for another year while the agency reviews the application, the Times reports.