FDA Sends Warning Letters to Electronic Cigarette Makers

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The U.S. Food and Drug Administration issued warning letters to five electronic cigarette distributors, saying the products are being marketed illegally as safer alternatives to smoking and even as smoking-cessation aids. In addition to making unsubstantiated claims, other violations include poor manufacturing practices.

Letters were sent to E-CigaretteDirect, Ruyan America, Gamucci America, E-Cig Technology and Johnson's Creek Enterprises. The FDA also sent a letter to the Electronic Cigarette Association, alerting the group that it intends to regulate electronic cigarette products to protect the public health. The FDA is already involved in a separate lawsuit with other e-cigarette companies that involves the agency's jurisdiction over the products, according to The Wall Street Journal.

Electronic cigarettes often look like cigarettes. They're designed to deliver nicotine or other substances in the form of a vapor, by heating a cartridge containing the substance. This vapor can then be inhaled. Cleverly, some e-cigarettes are made to look like everyday items such as pens and USB memory sticks, to avoid being noticed.

Just Smoke and Mirrors?

The FDA is concerned about the products' safety and effectiveness, especially in light of claims that e-cigarettes can safely help people quit smoking.

E-Cig Technology, for example, writes on its website: "Why choose E-Cig? . . . E-Cig can help you reduce or quit smoking habits." In the instruction manual it claims: "It can refresh the smokers and satisfy their smoking addiction, making them happy and relaxed, so as to relief [sic] the suffering of quitting smoking." All the companies that the FDA sent letters to make similar claims. But so far, none of the claims have been supported by any scientific evidence.

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There is much that scientists and the public don't know about e-cigarettes, the FDA explains. "They are being promoted as a safe alternative to smoking, and we don't know that," says Dr. Janet Woodcock, director of the FDA Center of Drug Evaluation and Research in a video.

Other than impurities that could be dangerous, as well as cancer-causing chemicals already found in limited testing the FDA has conducted, another issue is delivering highly addictive nicotine to the body. Plus, e-smokes are readily available to teenagers because there are no age restrictions on their sale.

Experts from such organizations as the World Health Organization and the American Academy of Pediatrics Tobacco Consortium have previously raised similar concerns.

E-Cigs Must Seek FDA Approval

For a drug product to gain FDA approval, a company must demonstrate to the agency that the product is safe and effective for its intended use. The company must also demonstrate that manufacturing methods are adequate to preserve the strength, quality and purity of the product. At this point, the FDA says it doesn't believe that adequate quality controls have been put in place. For now, the companies have 15 days to respond. Depending on their response, the agency could act to remove the products from the market, but it would likely involve a court fight.

In 2006, U.S. consumers spent approximately $83.6 billion on cigarettes. Between 2000 and 2004, cigarette smoking was estimated to be responsible for $193 billion in annual health-related economic losses in the U.S. Cigarette smoking results in 5.1 million years of potential life lost in the U.S. annually. For those who want to quit smoking, the FDA suggests a number of FDA-approved smoking cessation aids.
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