FDA & e Cigarettes from FDA Site
Q: What are electronic cigarettes?
A: Electronic cigarettes are products designed to deliver nicotine or other substances to a user in the form of a vapor. Typically, they are composed of a rechargeable, battery-operated heating element, a replaceable cartridge that may contain nicotine or other chemicals, and an atomizer that, when heated, converts the contents of the cartridge into a vapor. This vapor can then be inhaled by the user. These products are often made to look like such products as cigarettes, cigars, and pipes. They are also sometimes made to look like everyday items such as pens and USB memory sticks, for people who wish to use the product without others noticing.
Q: What concerns does FDA have regarding electronic cigarettes?
A: FDA has not evaluated any e-cigarettes for safety or effectiveness. When FDA conducted limited laboratory studies of certain samples, FDA found significant quality issues that indicate that quality control processes used to manufacture these products are substandard or non-existent. FDA found that cartridges labeled as containing no nicotine contained nicotine and that three different electronic cigarette cartridges with the same label emitted a markedly different amount of nicotine with each puff. Experts have also raised concerns that the marketing of products such as e-cigarettes can increase nicotine addiction among young people and may lead kids to try other tobacco products. Visit FDA’s Electronic Cigarettes webpage for additional information.
Q: What action did FDA take today on electronic cigarettes?
A: FDA issued warning letters to five distributors of electronic cigarettes for violations of the Federal Food, Drug, and Cosmetic Act (FDCA). These violations included unsubstantiated claims and poor manufacturing practices.
Q: Would it be possible for an electronic cigarette to receive FDA approval?
A: Yes. FDA issued a letter to the Electronic Cigarette Association inviting 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 intends to regulate electronic cigarettes and related products in a manner consistent with its mission of protecting the public health.