PharmaRoth Labs, Inc. announced the FDA's response concerning the Company's New Dietary Ingredient (NDI) Application, filed last March. The Company's treatment is derived from natural ingredients, which generally allows it to be considered a nutraceutical product. However, upon careful review, the FDA determined that the active ingredient in Sucanon(R) will not be classified under a nutraceutical designation, but will henceforth be considered an Investigational New Drug (IND).

Due to the IND status of Sucanon(R), PharmaRoth would have to go through the FDA's IND process before the product would be available for US distribution.