The Rhode Island Department of Health (HEALTH) applauds the recent enforcement action taken by the U.S. Food and Drug Administration (FDA) against distributors of electronic cigarettes. Last week, the FDA issued warning letters to five leading distributors for violations of the Federal Food, Drug and Cosmetic Act, including unsubstantiated health claims, deceptive marketing tactics and poor manufacturing practices. FDA also announced its intention to regulate electronic cigarettes and related products. Electronic cigarettes are sold locally by Providence-based Cigotine LLC.
“There is no reliable science to support the claims that local electronic cigarette vendors are making,” said Director of Health David R. Gifford, MD, MPH. “Recent research suggests that electronic cigarettes contain carcinogens and other toxic chemicals. In February 2009, Rhode Island and many other states asked FDA to review this product and require premarket approval of it. We are pleased that the FDA has taken these steps to combat a public health threat.”
FDA asserts that electronic cigarettes should be subject to FDA regulation as drugs because they deliver potentially harmful doses of nicotine to users – a drug found to cause addiction as powerful and self-enforcing as addiction to cocaine or heroin. For a drug to gain FDA approval and make statements about its ability to prevent or treat illness or disease, it must meet strict safety, efficacy, and manufacturing standards. Because electronic cigarettes are not regulated by the FDA, companies are not required to report a list of ingredients, the quantity of each ingredient or the potency of each ingredient.
HEALTH recommends tobacco users consult with a healthcare provider or a pharmacist to identify an approved cessation therapy or contact the Rhode Island Tobacco Control Quitline at 1-800-Try-to-Stop (1-800-879-8678). Quitline services are offered at no-cost to Rhode Islanders.
For more information on the FDA’s action against electronic cigarette distributors, visit: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm225224.htm
Warning letters and a Q&A on electronic cigarettes available at: http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm172906.htm