Xcaliber Receives Additional Substantial Equivalence Orders
PRYOR, Okla., June 12, 2018 /PRNewswire/ — On June 8, 2018, Xcaliber International, Ltd., L.L.C. («Xcaliber»), a Pryor, Oklahoma based cigarette manufacturer, received six 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 excited to receive these six substantial equivalence orders,» said Derrick Taylor, Chief Operating Officer. «This brings the total number of such orders that the company has received from the FDA to 21,» Taylor stated. Xcaliber announced the receipt of 15 substantial equivalence orders from the FDA on May 15, 2018.
«In April 2018, the FDA announced that approximately 1,500 products were to be removed from scientific review, pending the development and publication of regulations further outlining the substantial equivalence process,» stated General Counsel Eric Estes. «In addition to the 21 substantial equivalence orders received by Xcaliber, approximately 115 products manufactured by the company have been removed from scientific review as part of that regulatory action,» Estes continued.
«Xcaliber has a great team in place that is responsible for these successes,» continued Estes. «We look forward to working with the FDA and its staff on the remaining Xcaliber products under scientific review.»
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