Officials laud FDA action on electronic cigarettes

PROVIDENCE – Rhode Island health officials are applauding the U.S. Food and Drug Administration for taking action against distributors of electronic cigarettes, which are being marketed across the country as a safer alternative to smoking.
On Sept. 9, the FDA issued letters to five electronic cigarette distributors warning that they were violating federal law by making unsubstantiated claims and engaging in poor manufacturing practices.
The FDA also advised the Electronic Cigarette Association that plans to regulate electronic cigarettes and related products as drugs under the Federal Food, Drug, and Cosmetic Act (FDCA), with the goal of protecting public health.
“FDA invites electronic cigarette firms to work in cooperation with the agency toward the goal of assuring that electronic cigarettes sold in the United States are lawfully marketed,” the agency wrote to the group.
Under the FDCA, to gain FDA approval, a drug maker must prove its product is safe and effective for its intended use, and that manufacturing methods are adequate to preserve the strength, quality and purity of the product.
The law also bars drug makers from making claims about their product – such as that it can treat or cure a disease such as nicotine addiction – unless those claims and the drug’s safety have been proven. All five cigarette-makers, however, claim their products help smokers quit.
In Rhode Island, electronic cigarettes are sold by Providence-based Cigotine LLC. The state health director, Dr. David R. Gifford, was among several officials who in February 2009 asked the FDA to review electronic cigarettes and begin regulating them.
“There is no reliable science to support the claims that local electronic cigarette vendors are making,” Gifford said in a news release. “Recent research suggests that electronic cigarettes contain carcinogens and other toxic chemicals. … We are pleased that the FDA has taken these steps to combat a public health threat.”
Rather than use these products, local health officials recommend that smokers consult with their doctor or pharmacist to identify an appropriate cessation therapy, or call the R.I. Tobacco Control Quitline at (800) Try-to-Stop (1-800-879-8678). Quitline services are free for state residents.
The warning letters and a Q&A electronic cigarettes are posted here.