E-cigarette makers fail to win exemption from FDA rules

E-cigarette makers failed to get a grandfather clause inserted in the $1.5 trillion omnibus spending bill that would have exempted certain products from being regulated by the U.S. Food and Drug Administration.

The exemption, one one of a number of policy riders considered for the House’s fiscal 2016 spending bill, would have given a pass to e-cigarettes that were on the market before the FDA finalizes its proposed rules.

The FDA released its proposed regulations on e-cigarettes in April 2014 but hasdelayed finalizing them amid significant push back from the products’ critics and proponents alike.

The draft regulations would require any e-cigarettes made after February 2007 to get agency approval before they can be sold.

The final FDA regulations are under review by the White House Office of Management and Budget and are expected to be released sometime next year.

The American Vaping Association, a trade group for the industry, said the decision equates to a modern-day “prohibition” of such devices and will harm public health by propping up traditional cigarettes.

“This deal protects cigarette markets,” said Gregory Conley, President of the American Vaping Association. “Congressional leaders have squandered a real opportunity to benefit both public health and small businesses across the country.”

Under the agency’s draft rules, e-cigarettes could not be sold to anyone under the age of 18 and their makers would be required to include health warnings stating that nicotine is addictive. Manufacturers would also be required to disclose their ingredients to the FDA and would not be allowed to make any claims that say their products are safer than tobacco products.

The debate over e-cigarettes centers on the claims by proponents who say the devices offer a less harmful alternative for users of tobacco products. But electronic cigarettes have come under increased scrutiny in recent years as their popularity has grown, with public health officials such as the Centers for Diseases Control and Prevention warning of their increased use among adolescents.

By Steven Ross Johnson

Source: Modern Healthcare – http://www.modernhealthcare.com/article/20151218/NEWS/151219862