Rock Creek Pharmaceuticals, Inc. announced it has received a written response from the U.S. Food and Drug Administration (FDA) in response to the New Dietary Ingredient Notification (NDIN) for the formulations of Anatabloc(R) and CigRx(R) submitted by the company in June 2014. The letter indicated that the FDA considers anatabine citrate, a principal ingredient in these products, to be a drug, because anatabine citrate is intended to provide anti-inflammatory support, and is the subject of a previously filed Investigational New Drug Application (INDA). The NDIN submission came in response to a previously issued FDA letter to the company, which indicated that an NDIN was required before the Company's supplements could be marketed.

In August 2014, the company voluntarily suspended CigRx and Anatabloc sales, as the company conducts an internal review and analysis of its supplement business, which is expected to be complete by year end 2014.