On Thursday, the Food and Drug Administration (FDA) delivered a warning to five e-cigarette companies, indicating that the products that they carry will need FDA approval as drugs or drug delivery devices. The agency likewise called on other companies to coordinate with the FDA in order to discuss how to go about securing marketing approval, according to a report on the Los Angeles Times.
E-cigarettes are touted as a safer alternative to real cigarettes. The device delivers nicotine, and is being marketed by some distributors as a smoking cessation aid. Such a claim is classified as a medical claim and is not allowed under the Federal Food, Drug and Cosmetic Act. This marketing strategy, according to the FDA, necessitates securing pre-approval from the agency.
The five companies involved in the warning are as follows: E-Cig Technology Inc. of Las Vegas; E-CigaretteDirect of Parker, Colorado; Ruyan America Inc. of Minneapolis; Gamucci America, also known as Smokey Bayou Inc., of Jacksonville, Florida; and Johnson Creek Enterprises of Johnson Creek, Wisconsin.
The e-cigarette is a battery-operated device that contains a cartridge of nicotine, but does not have tobacco. The liquid contained in the device is vaporized and delivered to the lungs when a user inhales. Smoke is simulated through water vapor.
In addition to looking into the smoking cessation claims, the FDA also would like to look into whether the products are manufactured safely.
The companies, according to Michael Levy, the director of the division of new drugs and labeling compliance at the FDA, were given 15 days to respond.e-cigarette, electronic cigarette, stop smoking