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E-cigarette Makers Fail to Secure Exemption from FDA Regulation of Their Products

Dec 22, 2015

In the recently passed government funding bill, E-cigarette makers were not granted the grandfather clause that would have exempted certain products from being regulated by the U.S. Food and Drug Administration (FDA).

The House considered a number of policy riders when it was negotiating the 2016 spending bill, but did not grant this one to e-cigarette makers. The exemption would have given an exemption to e-cigarettes already on the market before the FDA finalizes proposed rules, Modern Healthcare reports.

The FDA released proposed e-cigarette regulations in April 2014 but has not yet delayed made the regulations final because of objections from both critics and proponents of e-cigarettes. In the draft regulations, any e-cigarettes made after February 2007 would be required to get FDA approval before they could be sold. The final regulations are under review by the White House Office of Management and Budget and the FDA expects to release the final rules sometime next year, according to Modern Healthcare.

The American Vaping Association-an industry trade group-says the decision to deny the exemption is the equivalent of modern-day "prohibition" of the devices and will harm public health, Modern Healthcare reports. Gregory Conley, president of the American Vaping Association, said, "This deal protects cigarette markets." He criticized Congressional leaders for "squander[ing] a real opportunity to benefit both public health and small businesses across the country."

Among its provisions, the FDA draft rules prohibit sales of e-cigarettes to anyone under the age of 18 and require manufacturers to include health warnings advising users that nicotine is addictive. Manufacturers would have to disclose e-cigarette ingredients to the FDA and would not be allowed to claim that their products are safer than traditional tobacco products.

The e-cigarette debate rests in part on claims that e-cigarettes are a safer alternative to traditional tobacco products. But electronic cigarettes have come under increasing scrutiny as the product's popularity has grown, especially among teenagers. The Centers for Disease Control and Prevention (CDC) and other public health officials are alarmed by the increased use of e-cigarettes by young people and some health officials are concerned that e-cigarette use will be a gateway to use of traditional tobacco products, with their many health risks.

Evidence is emerging that e-cigarettes pose greater risks than the industry has acknowledged. Some of the fruit- and candy-flavored liquids used in e-cigarettes contain chemicals that cause bronchiolitis obliterans-also known as Popcorn Lung-a serious, irreversible lung condition. The New York Times reported that young children can suffer serious, even fatal, nicotine poisoning if they swallow as little as a teaspoon of e-cigarette liquid. The fruit and candy flavors of the liquids can be very appealing to young children. A tablespoon of the highly concentrated liquid can kill an adult. Currently, e-liquids do not have to be packaged with childproof caps or warnings to keep them out the reach of children.

Safety officials warn of the possibility of injuries from e-cigarette explosions or battery fires. A young Florida man was critically injured when an e-cigarette exploded in his face. He suffered internal and external burns and damage to his lungs. He was put in a medically induced coma to ease his pain. Other e-cigarette users have suffered burns and injuries to hands, fingers, lips, and faces from exploding e-cigarettes. E-cigarettes have ignited fires that have caused property damage and injuries.

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