Lorillard Receives FDA Market Authorization for New Products
GREENSBORO, N.C., June 25, 2013 /PRNewswire/ -- 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.
About Lorillard, Inc.
Lorillard, Inc. (NYSE: LO), through its Lorillard Tobacco Company subsidiary, is the third largest manufacturer of cigarettes in the United States. Founded in 1760, Lorillard is the oldest continuously operating tobacco company in the U.S. Newport, Lorillard's flagship premium cigarette brand, is the top selling menthol and second largest selling cigarette in the U.S. In addition to Newport, the Lorillard product line has four additional cigarette brand families marketed under the Kent, True, Maverick and Old Gold brand names. These five brands include 41 different product offerings which vary in price, taste, flavor, length and packaging. Lorillard, through its LOEC, Inc. subsidiary, is also the leading electronic cigarette company in the U.S, marketed under the blu eCigs brand. Newport, Kent, True, Maverick, Old Gold and blu eCigs are the registered trademarks of Lorillard and its subsidiaries. Lorillard maintains its headquarters and manufactures all of its traditional cigarette products in Greensboro, North Carolina.
Certain statements made in this press release are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, or the Reform Act. Forward-looking statements include, without limitation, any statement that may project, indicate or imply future results, events, performance or achievements, and may contain the words "expect," "intend," "plan," "anticipate," "estimate," "believe," "may," "will be," "will continue," "will likely result" and similar expressions. In addition, any statement that may be provided by management concerning future financial performance (including future revenues, earnings or growth rates), ongoing business strategies or prospects and possible actions by Lorillard, Inc. are also forward-looking statements as defined by the Reform Act.
Forward-looking statements are based on current expectations and projections about future events and are inherently subject to a variety of risks and uncertainties, many of which are beyond our control, that could cause actual results to differ materially from those anticipated or projected. Information describing factors that could cause actual results to differ materially from those in forward-looking statements is available in Lorillard, Inc.'s filings with the Securities and Exchange Commission (the "SEC"), including but not limited to, our Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. These filings are available from the SEC over the Internet or in hard copy, and are available on our website at www.lorillard.com. Forward-looking statements speak only as of the time they are made, and we expressly disclaim any obligation or undertaking to update these statements to reflect any change in expectations or beliefs or any change in events, conditions or circumstances on which any forward-looking statement is based.
SOURCE Lorillard, Inc.