FDA Proposes Long-Awaited E-cigarette Regulations
On April 24, the FDA proposed long-awaited rules that would extend the agency's authority over e-cigarettes, cigars, pipe tobacco, nicotine gels, hookah, and other dissolvable tobacco products that are currently unregulated. The proposed rules prohibit sales to children, require health warnings, and prohibit vending machine sales. The rules would also require makers of the newly regulated tobacco products to:
Legal News: Proposed Class Action Highlights Dangers of E-cigarettes and Need for FDA Regulation
A proposed class action in California federal court, McGovern v. NJOY, Inc. et al, claims NJOY used deceptive advertising to persuade consumers that its e-cigarettes are harmless, despite an FDA report showing e-cigarettes contain carcinogens and other potentially harmful chemicals. McGovern claims that NJOY's e-cigarettes contain the "same impurities and the same cancer-causing agents as traditional cigarettes" and alleges violations of the Consumer Legal Remedies Act, unfair competition or deceptive business practices, deceptive, false and misleading advertising, and consumer fraud.
E-cigarettes are battery operated devices that deliver a nicotine high similar to conventional cigarettes by heating nicotine in a disposable cartridge and producing a vapor that can be inhaled. E-cigarettes are marketed as a less-harmful alternative to cigarette smoking, but not enough is known about the health effects of "vaping". In samples taken by FDA's Division of Pharmaceutical Analysis, one leading brand of e-cigarettes was found to contain diethylene glycol, a toxic chemical found in antifreeze. Several other samples were found to contain carcinogens, including nitrosamines. In spite of FDA's concern, e-cigarettes currently exist in a legal no-man's land. The FDA does not regulate the manufacturing, marketing, or sales of these products. E-cigarettes are sold without any warning labels and without any legal age restriction.
Another major concern is that e-cigarettes are intentionally marketed to young people with kid-friendly flavors such as bubble gum, gummy bear, chocolate, cherry crush, and coca-cola. In a 2013 report, the Centers for Disease Control and Prevention (CDC) reported that e-cigarette use more than doubled among middle and high school students. Tobacco giants Altria Group, Inc., Lorillard, and Reynolds American have taken note of the market success of e-cigarettes and are introducing their e-cigarette versions nationwide. Consumer advocates worry that e-cigarettes are being used by the tobacco industry as an addictive gateway to other tobacco products.
Increasingly, cities (including Boston, Chicago, New York and Los Angeles) and states (including New Jersey, North Dakota, and Utah) are moving to fill the federal regulatory gap by taking steps to regulate the sale and public use of e-cigarettes. In the fall of 2013, attorney generals from 40 states called on the FDA to regulate e-cigarettes to address their marketing, ingredients, and sale to minors. FDA has responded with a proposed rule to include emerging tobacco products such as e-cigarettes, nicotine gels, and certain dissolvable tobacco products under the Tobacco Control Act. Until a final rule is passed, however, consumers are on their own. More information about the health risks posed by E-Cigarettes can be found in FDA's Consumer Health Information publication: "FDA Warns of Health Risks Posed by E-Cigarettes".
 McGovern v. NJOY, Inc. et al, 8:14-cv-00427 (U.S. District Court, California Central) (March 19, 2014).
 McIntyre, A., "NJOY Accused of Hiding E-Cigs' Health Dangers," Law360 (March 20, 2014).
 CDC, "Notes from the Field: Electronic Cigarette Use Among Middle and High School Students - United States, 2011-2012," Morbidity and Mortality Weekly Report, September 6, 2013.
 Waters, R., "E-Cigarette Makers Give Public the Finger," Forbes (January 27, 2014).
 Li, S., "FDA should regulate e-cigarettes, 40 state attorneys general say," Los Angeles Times (September 24, 2013).
 Cooper, T. "Why Altria Group Could Derail E-Cigarette Growth," The Motley Fool (March 17, 2014).
 HHS/FDA, "'Tobacco Products' Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act," RIN: 0910-AG38 (Proposed Rule, Fall 2013).
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