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Head of FDA’s Tobacco Center to Soon Start Ruling on Products


The new head of the Food and Drug Administration’s (FDA) Center for Tobacco Products said he will soon start ruling on whether the agency will approve 4,000 new and existing products.

Mitch Zeller told Bloomberg News he will work to reduce the backlog of 500 requests to approve new products, and 3,500 products already in stores. Zeller said the FDA is very close to ruling on whether tobacco companies can sell new products they claim have the same characteristics as existing products.

The FDA must determine whether the new products have variations that raise new concerns about public health. If the agency determines they do not raise new health issues, it can rule the products are substantially equivalent, Zeller said.

According to the article, new tobacco products marketed after February 15, 2007, must be approved for sale by the FDA. Products marketed before March 22, 2011 can continue to be sold, if the FDA determines they are substantially equivalent to an older product, or one that has been deemed substantially equivalent.

Zeller has also been reviewing the risks of menthol in cigarettes, and is considering whether to increase the FDA’s authority over e-cigarettes, cigars and other tobacco products.

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