The distributor of a coffee product found to contain an analogue of the erectile dysfunction drug sildenafil receives an official FDA warning letter Aug. 23, following a consumer advisory and voluntary recall in June (1"The Tan Sheet" July 5, 2010, In Brief). INZ Distributors of Brooklyn, N.Y., sells an unapproved, misbranded new drug, the agency's New York District office says. Magic Power Coffee is an adulterated food, due to the presence of an ingredient not generally recognized as safe, and improperly labeled as a dietary supplement given its representation as a conventional food/beverage, FDA says. INZ faces product seizures and possible injunction if it fails to correct the violations within 15 days, according to the letter

FDA's consumer advisory against a coffee product that contains an active drug ingredient for erectile dysfunction reflects the agency's growing capability to keep up with noncompliant firms that add drug substances to so-called dietary supplements

With a late-stage compound on its hands, MGB is currently in discussions with several biotech and pharma companies and also with venture capitalists to continue late-stage development of a novel antibiotic which could transform treatment of Clostridium difficile.