The Food and Drug Administration recently announced it will regulate electronic cigarettes as tobacco products, in other words, just like regular cigarettes. The agency had previously been pushing to regulate the smokeless cigarettes as drug delivery devices, but lost a court battle in early 2011. The FDA decided not to appeal the court’s decision, which puts to rest a legal battle that had been ongoing since 2009.
E-cigarette manufacturers and distributors and I imagine e-cigarette smokers consider the FDA’s decision not to appeal a major victory. If classified as drug delivery devices, e-cigarettes would be subject to much tighter regulations. Anti-smoking groups are expectedly disappointed the agency has accepted the court’s ruling.
E-cigarettes were first released overseas in 2002, but did not become readily available in the US market until 2006. E-cigarettes are plastic or metal battery-powered devices that use chemicals to turn liquid nicotine into vapor. They are designed to look and feel like regular cigarettes, but do not contain tobacco or produce smoke. As more places ban smoking indoors, e-cigarettes have become more popular. However, some states have begun banning electronic cigarettes indoors as well.
A lack of scientific evidence about health claims and the drawn-out court battles with the FDA have allowed electronic cigarette makers and sellers to operate in somewhat of a gray zone. Until now, e-cigarettes were not clearly classified as either drug delivery devices or tobacco products, so sales to minors and manufacturing flavored products had previously been legal. However, some e-cigarette manufacturers, such as Sottera, have come under fire for targeting minors. Many states have now passed legislation to prohibit e-cigarette sales to minors.
Some e-cigarette makers say their products are healthier alternatives to regular cigarettes, but the FDA warns that they often contain harmful toxins and may be addictive. Some people use the devices to try to quit smoking, but no studies have proven whether they actually curb smoking cravings. The FDA has cited companies, such as Dragonite International (formerly Ruyan America), for making unsubstantiated health claims. E-cigarettes are relatively new to the market and there is little research on the products’ safety compared to traditional cigarettes.
The days of legal loopholes and lacking laboratory testing may be short-lived, however. While e-cigarettes won’t be subject to the strict regulations and clinical trials of drugs, they will now have to comply with federal laws that apply to regular cigarettes and other tobacco products.