The FDA has sent warning letters to five manufacturers of e-cigarettes telling them that they cannot market the devices as a way to quit smoking without FDA approval.
If manufacturers claim that e-cigarettes treat a disease — in this case, nicotine addiction — they have to prove to the FDA that the product is both safe and effective for its intended use. All five manufactures say that the products help users to stop smoking, but none have sought FDA approval.
In addition, FDA intends to regulate e-cigarettes under its new powers from the Family Smoking Prevention and Tobacco Control Act. In a letter to the Electronic Cigarette Association, the FDA said,
FDA intends to regulate electronic cigarettes and related products in a manner consistent with its mission of protecting the public health.
Currently e-cigarettes contain no health warnings, and marketing is often targeted at young people.
E-cigarettes are battery-operated devices that contain liquid nicotine, flavoring, and other chemicals. The liquid is vaporized and inhaled, providing a dose of nicotine. Although the electronic vaporizers often resemble cigarettes, cigars, or pipes, some are manufactured to look like ballpoint pens.
Warning letters went to E-CigaretteDirect, Ruyan America Inc., Gamucci America (Smokey Bayou Inc.), E-Cig Technology Inc. and Johnson’s Creek Enterprises.
Certain companies received additional warnings. E-Cig Technology markets drugs in unapproved liquid forms, such as tadalafil, an erectile dysfunction drug, and rimonabant, a weight loss drug that has not been approved for use in the United States. Johnson’s Creek, which markets Smoke Juice designed to refill empty e-cigarette cartridges, was cited for poor manufacturing processes, including quality control and testing.
Last year FDA lab tests found that e-cigarettes contained cancer-causing substances and toxic chemicals, including diethylene glycol, a poisonous ingredient of antifreeze.
Many studies have linked smoking to increased risk of colon and rectal cancer, but an American Cancer Society study, published in 2009, that tracked 185,000 men and women for more than 13 years found that smoking raised the chance of getting colorectal cancer independent of other risk factors. Just being a lifelong smoker increased risk of colorectal cancer by 30 to 50 percent. Good news was that there was no link to cancer for people who quit before they were 41.