Tuesday, June 23, 2015

House Subcommittee Spending Bill Challenge’s the FDA’s Efforts to Regulate E-Cigarettes and Other Unregulated Tobacco Products

A House subcommittee approved a spending bill Thursday that would prevent the U.S. Food and Drug Administration (FDA) from requiring pre-market reviews of e-cigarettes and other unregulated tobacco products that are already on the market.

The FDA wants e-cigarette brands marketed since February 2007 to undergo pre-market reviews retroactively once the final rule is approved. If approved, manufacturers of tobacco products would be required to submit the applications within two years of the regulation’s approval and the FDA would then ensure that the product is “appropriate for the protection of the public health.” If House Republicans have their way, however, the spending bill could stop the requirement from going into effect, according to The Associated Press (AP).

The FDA rules and the House legislation would apply to e-cigarettes and other unregulated tobacco products including cigars, hookahs, nicotine gels, waterpipe tobacco and dissolvable tobacco products. Cigarettes, smokeless tobacco and roll-your-own tobacco products are already regulated by the agency, AP reported.

Republicans say the pre-market approval process would take too long and be too expensive, and could put companies out of business. Alabama Republican Representative Robert Anderholt, who sponsored the bill, said the provision was a “technical change” that would keep the newer products under FDA oversight but allow them to be regulated like older tobacco products. Anderholt added that the legislation would not affect the FDA’s proposed ban on sales of the products to minors and would still certain product standards, according to AP.

Before the panel’s vote, Democrats said the bill would reduce regulation of the tobacco industry, as the popularity of e-cigarettes continues to soar. New York Democratic Representative Nita Lowey, who is the top Democrat on the Appropriations Committee, called the bill “nothing short of a giveaway to the tobacco industry.” Public health groups say the legislation could make it challenging for the FDA to prevent companies from marketing new products to kids, AP reported.

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.”

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from Parker Waichman http://www.yourlawyer.com/blog/house-subcommittee-spending-bill-challenges-the-fdas-efforts-to-regulate-e-cigarettes-and-other-unregulated-tobacco-products/

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