FDA Issues Seven NSE Orders for Dissolvable Tobacco Products
Thursday, September 11, 2014
Posted by: Natalia Gromov
FDA issued orders that seven dissolvable tobacco products manufactured by Star Scientific, Inc. (now known as Rock Creek Pharmaceuticals) are not substantially equivalent (NSE) to the predicate products submitted by the manufacturer. These products are Ariva Cinnamon, Ariva Wintergreen, Ariva Mint, Ariva Java, Ariva Citrus, Stonewall Natural, and Stonewall Java. These orders stop the further sale and distribution of these products and were based on a complete scientific review which found that the products raised different questions of public health when compared to the predicate products.
While Star Scientific has stated these products are not being commercially sold at this time, an NSE order means these products cannot be sold, marketed, or distributed in interstate commerce in the future without submitting new applications to FDA.
FDA would also like to note that for products not on the market, there is no longer a queue to enter the SE review process and submitted applications will immediately enter review. Additionally, the agency is now actively reviewing, and will continue to issue decisions, on provisional tobacco products. FDA will also continue to prioritize those tobacco products based on their potential to raise different questions of public health.
To access FDA’s complete statement, please visit FDA’s website: http://www.fda.gov/TobaccoProducts/NewsEvents/ucm412025.htm
For more information on Misbranded and Adulterated NSE Tobacco Products, please visit FDA’s website: http://www.fda.gov/TobaccoProducts/Labeling/TobaccoProductReviewEvaluation/NewTobaccoProductReviewandEvaluation/ucm371765.htm
For additional information on Product Requirements, Marketing & Labeling, please go to: http://www.fda.gov/TobaccoProducts/Labeling/default.htm
You can report potential tobacco-related violations of the FD&C Act, including the sale, distribution, or importation of NSE products, through the Potential Tobacco Product violations Reporting Form found online at FDA’s website (https://www.accessdata.fda.gov/scripts/ptvr/index.cfm). This information will be reviewed by FDA’s Center for Tobacco Products, Office of Compliance and Enforcement
Source: U.S. Food and Drug Administration