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FDA Refuses to Act to Stop Sales of Ariva Tobacco Mints Ruling Points Out Gaping Hole in Consumer Protection

Statement by Matthew L. Myers, President Campaign for Tobacco-Free Kids

Washington, DC - The U.S. Food and Drug Administration (FDA) decided today to deny the request of 18 public health organizations, including the Campaign for Tobacco-Free Kids, that it regulate Ariva, a new mint flavored lozenge the size of a tic-tac that contains tobacco and nicotine. The FDA’s ruling opens a gaping hole in the protections provided to the American public from a whole new generation of potentially life threatening products. Ariva contains 60 percent compressed tobacco powder, but comes in the shape of a candy-like product and is packaged and marketed like a smoking cessation product. Unlike every other candy, mint or smoking cessation product, Ariva will now go unregulated by the FDA.

While the FDA claims that it does not have the authority to regulate Ariva because of the 2000 United States Supreme Court decision that concluded that the FDA does not have authority over traditional tobacco products as customarily marketed, the Court also made clear that it was not interfering with FDA’s authority over tobacco products that are properly categorized as food or drugs just because they contain tobacco. While Ariva contains tobacco, it is clearly neither a traditional tobacco product nor is it marketed like one. It is used and consumed like a food and has been marketed as a drug. We believe the FDA’s decision is wrong and places consumers in unnecessary jeopardy.

FDA’s failure to act in this case demonstrates that it is more important than ever that Congress enact effective FDA regulation of all tobacco products immediately.