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Lorillard Receives FDA Market Authorization for New Products

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Lorillard, Inc. (NYSE: LO) today announced that is has received notification from the U.S. Food and Drug Administration (FDA) that its Newport Non-Menthol Gold Box and Box 100 products have been found to be substantially equivalent to tobacco products previously commercially marketed in interstate commerce in the U.S. The FDA's finding permits Lorillard to begin marketing of the new products, consistent with all existing requirements of regulated tobacco products.

Today's decision marks the first time the FDA has authorized the marketing of new tobacco products through its substantial equivalence (SE) pathway. Lorillard is the only tobacco manufacturer to have received such marketing authorization through the SE pathway and intends to introduce its new products to adult non-menthol smokers in the near future. The Family Smoking Prevention and Tobacco Control Act gave the FDA the authority to regulate tobacco products in 2009.

"We are very pleased that the FDA has found that Lorillard's Newport Non-Menthol Gold products are substantially equivalent to existing tobacco products currently marketed," stated Murray Kessler, Lorillard's Chairman, President and CEO. "As such, we are proud to be the first company in the industry to receive authorization to begin marketing these new products in the U.S. through the FDA's substantial equivalence pathway. We are encouraged by the Agency's fulfillment of its obligation prescribed in the Family Smoking Prevention and Tobacco Control Act of 2009 and believe that the FDA has carried out is evaluation process in a deliberate manner reflecting sound science. We look forward to continuing productive engagement with the Agency moving forward."

Newport, Lorillard's flagship premium cigarette, is the second-largest brand in the industry and is the top selling menthol brand. Lorillard believes it will further strengthen its competitive position and its overall Newport brand family with the addition of Newport Non-Menthol Gold, as it will become the Company's second Newport style in the non-menthol segment.

Posted-In: News FDA Press Releases


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