When it analyzed <"https://www.yourlawyer.com/topics/overview/Electronic-Cigarettes">electronic cigarettes (E-cigarettes)—a product that enables inhalation of nicotine without tar, tobacco, and carbon monoxide, the U.S. Food and Drug Administration (FDA) discovered a number of interesting ingredients. For instance, diethylene glycol, a toxin used in antifreeze was found, as were nitrosamines, a known carcinogen and other cancer-causing agents, according to the American Medical Association (AMA). Last month, those findings prompted the AMA House of Delegates to issue a recommendation that the cigarette alternatives be classified as so-called “drug-delivery devices, a move that would subject them to regulation by the FDA.
The AMA also urged state legislatures to ban e-cigarettes, and all nonapproved other nicotine devices, and to include e-cigarettes on the list of substances banned under current smoke-free laws, said the AMA.
The stance emerged after an AMA Council on Science and Public Health report that looked at the devices prevailing mandates and possible adverse effects; known information on the devices, including that they are nonflammable and deliver synthetic and tobacco-based tobacco; and were invented in China, said the AMA. There is limited independent research on the devices; inconsistent health implication, dosage, production, and ingredient information; and unclear labeling, said the AMA.
Some view e-cigarettes as a healthy alternative to traditional cigarettes; however, others are concerned about their safety data, said the BBC recently, citing warnings from two Greek researchers. According to the British Medical Journal, the dearth of information on the cigarette alternatives provokes questions as to whether or not the products actually offer a safe option or cause harm. Some studies point to harm, but industry argues e-cigarettes offer smokers a better choice. According to the Department of Health, consumers are warned to “exercise caution,†quoted the BBC.
Last July, the FDA talked about the potential for the devices’ health risks, specifically among younger people—a particularly sensitive demographic in the fight against nicotine addiction and smoking—who could start with e-cigarettes and move on to other nicotine products, said the AMA. Also, noted the AMA, the devices contain ingredients known to be dangerous to humans, according to its consumer health warning, and the product’s safety has not been established since clinical studies have not been submitted to the FDA. The FDA noted that the devices can be sold to anyone at any age and come in a variety of flavors, including chocolate and strawberry, a known draw for young people, wrote the AMA. The AMA agrees.
Of note, a law passed in 2009 provided power to the FDA over regulation of cigarettes and tobacco products, said Reuters in a prior report; however, e-cigarettes, although containing nicotine, are not considered to be subject to the 2009 regulation, added Reuters. The FDA disagrees, saying the product is both a drug and a device, which places it under agency regulation, wrote Reuters.
Last month, U.S. District Judge Richard J. Leon, taking the side of industry via electronic-cigarette makers’ Smoking Everywhere Inc. and NJoy, found the FDA to have no authority to regulate e-cigarettes and is not allowed to stop the devices entry into the United States, said the Journal. Judge Leon’s opinion was paired with a preliminary injunction permitting the two e-cigarette makers to continue their import of the controversial devices into the US, said the Journal.
