Xcaliber International Receives SE Orders from The FDA
PRYOR, Okla., May 15, 2018 /PRNewswire/ — On May 10, 2018, Xcaliber International, Ltd., L.L.C. (“Xcaliber”), a Pryor, Oklahoma based cigarette manufacturer, received 15 orders from the U.S. Food and Drug Administration, Center for Tobacco Products (“FDA”) finding certain tobacco products that it manufactures to be “substantially equivalent” within the meaning of the 2009 Family Smoking Prevention and Tobacco Control Act.
“Xcaliber is among the first 4th Tier manufacturers to receive substantial equivalence orders,” said Chief Operating Officer Derrick Taylor. “With these orders, Xcaliber is poised to better serve its wholesale and retail partners in the 40-plus states in which we operate,” Taylor continued.
Under federal law, products that are provisionally marketed are subject to a finding by the FDA that they are either substantially equivalent to a product marketed in February 2007 or not substantially equivalent to that predicate tobacco product. “If the FDA issues an order determining products to be not substantially equivalent, the products must be removed from the domestic cigarette market. The orders issued by the FDA provide Xcaliber with certainty,” explained Eric Estes, General Counsel. “The issued SE orders are representative of many of our brands and Xcaliber looks forward to working with the FDA to achieve substantial equivalence on all of our products,” Estes continued.
Xcaliber, the premier partner for 4th Tier, is built on a foundation of unparalleled customer service, product consistency and margin generation. For more information, please visit www.xcaliberinternational.com.
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SOURCE Xcaliber International