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GLEN ALLEN, Va. -- The Food and Drug Administration (FDA) has issued not substantially equivalent (NSE) orders to Star Scientific Inc. to stop the sale and distribution of seven dissolvable tobacco products: Ariva Cinnamon, Ariva Wintergreen, Ariva Mint, Ariva Java, Ariva Citrus, Stonewall Natural and Stonewall Java.
The NSE orders were based on a complete scientific review that found the seven products had different characteristics compared to the predicate products identified by the manufacturer, and that the company failed to show the new products did not raise different questions of public health, according to the FDA.
These products entered the market during a provisional period established by the Tobacco Control Act in June 2009. As part of that provisional period, the company had to submit a substantial equivalence (SE) report to the FDA by March 22, 2011 in order for the products to remain on the market. Although Star Scientific previously announced it discontinued the manufacturing of these products, the company did not withdraw its pending SE reports for these items.
The FDA's action now prohibits these products from being unilaterally reintroduced to the marketplace by the company. In order to sell or distribute these products in the future, the company would have to submit new applications to the FDA and receive the proper marketing authorization, the agency stated.
Star Scientific, which is based in Glen Allen, formally changed its corporate name to Rock Creek Pharmaceuticals Inc. in June. Star Scientific shareholders approved a corporate transition at the end of last year to include a change in the composition of the company's board of directors, the appointment of a new team of executive officers, and a corporate name change as the company embarks upon a new strategic direction of pharmaceutical development.