FDA Sends Warning Letters to Electronic Cigarette Companies
On September 9, the FDA issued warning letters to five electronic cigarette distributors for what the agency said were violations of the Federal Food, Drug, and Cosmetic Act (FDCA), including unsubstantiated claims and poor manufacturing practices. The companies have 15 days to respond to the letters, FDA officials said.
Electronic cigarettes, or e-cigarettes, are battery-operated devices that hold liquid-filled cartridges containing nicotine and often different flavorings. The devices heat the liquid in the cartridge, transforming it into a vapor that is inhaled by the user. These products are often made to look like small, cigarette-shaped devices, but may also be made to resembles cigars and pipes or to look like everyday items such as pens and USB memory sticks for people who wish to use the product without others noticing.
In a separate letter to the Electronic Cigarette Association, the FDA said the agency intends to “regulate electronic cigarette and related products in a manner consistent with its mission of protecting the public health.” The letter outlines the regulatory pathway for marketing drug products in compliance with the FDCA.
Read more about the FDA’s actions in an online press release.