Congress Denies E-cigarette Makers Exemption from FDA Regulation


E-cigarette makers were not granted the grandfather clause in the omnibus spending bill that would have exempted certain products from being regulated by the U.S. Food and Drug Administration (FDA).

This exemption was one of a number of policy riders considered for the House’s 2016 spending bill. It would have given an exemption to e-cigarettes already on the market before the FDA finalizes its proposed rules, Modern Healthcare reports.
The FDA released proposed e-cigarette regulations in April 2014 but has delayed making the regulations final because of objections from both critics and proponents of e-cigarettes. The draft regulations would require any e-cigarettes made after February 2007 to get FDA approval before they can be sold. The final regulations are under review by the White House Office of Management and Budget. The FDA expects to release the final rules sometime next year, according to Modern Healthcare.

The American Vaping Association, an industry trade group, said the decision to deny the exemption is equivalent to a 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.” Conley said Congress “squandered a real opportunity to benefit both public health and small businesses across the country.”

The FDA draft rules contain a prohibition on sales of e-cigarettes to anyone under the age of 18 and, further, manufacturers would be required 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 centers on claims that e-cigarettes are a safer alternative to traditional tobacco products. But electronic cigarettes have come under increasing scrutiny as their 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. Some health officials are concerned that e-cigarette use will prove to be a gateway to use of traditional tobacco products, with their known health risks.

Research has shown that e-cigarettes pose greater risks than the industry has acknowledged. Candy-flavored liquids used in e-cigarettes, for example, contain chemicals that cause bronchiolitis obliterans—known as Popcorn Lung—a serious, irreversible lung condition. Young children can suffer serious, even fatal, nicotine poisoning if they swallow e-cigarette liquid. The fruit and candy flavors of the liquids can be very appealing to young children and, at present, the liquids do not have to be packaged with childproof caps or warnings to keep them out the reach of children.

There have also been a number of reports 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. Doctors put him in a 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 also been responsible for igniting fires that have caused property damage.