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FDA Cites Electronic Cigarette Distributors

Electronic cigarettes, or battery-operated devices that contain cartridges of nicotine and other chemicals (also called e-cigarettes), are marketed to people who are trying to quit smoking. However, the U.S. Food and Drug Administration cited five distributers of e-cigarettes for violations including unsubstantiated claims and poor manufacturing practices.

The FDA said that e-cigarettes falsely claim that the product can help people quit smoking, as they turn a highly addictive substance into an inhalable vapor. Michael Levy, division of new drugs and labeling compliance in the FDA's Center for Drug Evaluation and Research, said that the products haven’t been proven to be safe and effective.

Tests in July showed that some e-cigarettes contain toxins and cancer-causing chemicals, including an ingredient found in antifreeze. At least one of the companies was selling unapproved weight loss and erectile dysfunction drugs to be used in the e-cigarette cartridges. The drugs are liquid and can be vaporized and inhaled through the e-cigarette.

Another company that markets SmokeJuice, a liquid used to refill e-cigarette cartridges, was fined for failing to establish required quality control and testing.

The FDA said that regulating e-cigarettes and related products would be part of its mission to protect public health, and that the agency invites e-cigarette manufacturers to work with the agency to make sure that they are legally marketed.

The law states that companies can’t say a drug treats or mitigates a disease without being approved by the FDA.

Source: HealthDay, Steven Reinberg, FDA Sends Warning to E-Cigarette Distributors, September 9, 2010