FDA is dequiring Pre-market Reviews of E-cigarettes. Republicans in the House of Representatives have introduced a bill to ease proposed government regulations for companies that sell e-cigarettes and other new tobacco products.
A spending bill approved by a House subcommittee Thursday would prevent the Food and Drug Administration (FDA) from requiring pre-market reviews of e-cigarettes already on the market. House Democrats charge the legislation could lead to unsafe products on the market, The Associated Press (AP) reports.
The FDA rule would require e-cigarettes marketed since February 2007 to undergo pre-market reviews retroactively once the final rule is approved. Manufacturers would have to submit applications within two years of the final rule, and then the FDA would ensure that the product is “appropriate for the protection of the public health.” If not, the agency could take an e-cigarette brand off the market. In addition to e-cigarettes, the FDA’s proposed rules and the House legislation would apply to tobacco products such as cigars, hookahs, nicotine gels, waterpipe tobacco and dissolvable tobacco products. The FDA already regulates cigarettes, smokeless tobacco, and roll-your-own tobacco products, the AP reports.
Newer Products Under Fda Oversight.
Rep. Robert Aderholt, who sponsored the bill, said the provision is just a technical change that would keep the newer products under FDA oversight but allow them to be regulated in the same way as older tobacco products. The legislation would not affect the provision to ban the sales of the products to minors and would still allow certain product standards. But public health groups say the legislation would hamper the FDA’s ability to prevent tobacco companies from marketing new products to children. Democrats expressed concern that the change would reduce regulation on the industry at the same time that e-cigarette use is rapidly increasing.
The proposed FDA rules, which are expected to be finalized in the coming months, are aimed at reining in the fast-growing e-cigarette industry. E-cigarettes heat liquid nicotine instead of burning tobacco, creating a vapor the user inhales. The vapor looks like smoke, but does not contain many of the chemicals or tar of conventional cigarettes and does not have the odor of burning tobacco. While some smokers use e-cigarettes as an aid to quitting smoking, there is not much scientific evidence that e-cigarettes help smokers quit or smoke less, and it is unclear how safe they are, according to the AP. Some health experts see e-cigarettes as a way to introduce young people to nicotine, which is highly addictive. The nicotine liquid comes in a variety of fruit and candy flavors, with catchy names. Doctors have warned of the dangers of liquid nicotine to small children. As little as a teaspoon can be fatal to a small child, and, currently, the liquid does not have to be sold in childproof bottles or carry a warning.
Though the FDA would not comment on the legislation, spokesman Michael Felberbaum said the “the rule will represent a significant first step in the agency’s ability to effectively regulate tobacco products and, as we learn more about these products, the agency will have additional opportunities over the long term to make a positive difference in the public health burden of tobacco use in this country,” according to the AP.
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