Washington, DC: Further to health concerns regarding four currently marketed R.J. Reynolds Tobacco Company cigarette products, including its Camel Crush Bold brand, the US Food and Drug Administration (FDA) has issued orders that will stop their further sale and distribution.
Specifically, an investigation by the FDA found that Camel Crush Bold, Pall Mall Deep Set Recessed Filter, Pall Mall Deep Set Recessed Filter Menthol and Vantage Tech 13 cigarettes were not substantially equivalent (NSE) to their respective "predicate"products (i.e., products that were commercially marketed as of Feb. 15, 2007) as identified by the manufacturer.
More specifically, the agency concluded the products have different characteristics than the predicate products and that the manufacturer failed to show that the new products do not raise different questions of public health when compared to them. Consequently, at this time, these products can no longer be sold, distributed, imported or marketed in interstate commerce.
The scientific basis for these four decisions include a failure to demonstrate that increased yields of harmful or potentially harmful constituents, higher levels of menthol, and/or the addition of new ingredients in the currently marketed products, when compared to the predicate products, do not raise different questions of public health.
