House Republicans are seeking to prevent the U.S. Food and Drug Administration (FDA) from requiring pre-market reviews of e-cigarettes that are already on the market. Democrats say the move would leave unsafe products on store shelves.
The Republicans’ protest can in the form of a spending bill approved by a House subcommittee Thursday. As part of a broader rule regulating electronic cigarettes for the first time, the FDA wants e-cigarette brands marketed since February 2007 undergo pre-market reviews retroactively once the final rule is approved, but the spending bill would circumvent that requirement. If the rule is approved, companies would have to submit the applications within two years of the regulation’s approval. The FDA would then definitively determine whether the product is “appropriate for the protection of the public health.” If not, the agency could take the product off the market, according to AP.
In addition to e-cigarettes, the FDA rules and the House legislation would apply to cigars, hookahs, nicotine gels, waterpipe tobacco, dissolvable tobacco products, as well as other unregulated tobacco products. Cigarettes, smokeless tobacco and roll-your-own tobacco products are already regulated by the agency, AP reported.
Republicans argue that the pre-market approval process would be too time-consuming and costly and could potentially drive companies out of business. Alabama Republican Representative Robert Anderholt, who sponsored the bill, called the provision a mere “technical change” that would keep the newer products under FDA oversight but allow them to be regulated like older tobacco products. Anderholt said the legislation would not impact the FDA’s proposed ban on sales of the products to minors and would still certain product standards, according to AP.
Public health groups are concerned the legislation could make it difficult for the FDA to prevent tobacco companies from marketing the new products to kids, and Democrats said before the panel’s vote that regulation of the industry would be reduced by the bill at the same time the popularity of e-cigarettes is exploding. New York Democratic Representative Nita Lowey told AP the bill “is nothing short of a giveaway to the tobacco industry. Lowey is the top Democrat on the Appropriations Committee.
Matthew Myers, president of the Campaign for Tobacco-Free Kids, told AP the House language could keep kid-friendly flavored tobacco products on the market.
The FDA would not comment on the legislation, but FDA spokesman Michael Felberbaum told AP: “When finalized, the rule will represent a significant first step in the agency’s ability to 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.”