Misbranded Drug Products Seized from Maine Manufacturer

June 13, 2012 1:15 pm Topics: Federal regulations

US Marshals seized drug products from Global Biotechnologies, Inc, Portland, ME, on May 31, 2012, at the request of Food and Drug Administration (FDA) and pursuant to a warrant issued by the United States District Court for the District of Maine. As explained in an FDA news release, the complaint submitted indicates that “the company has made claims on its website, in promotional materials, and on the products’ labels that its products can diagnose, cure, mitigate, treat or prevent human diseases. The company’s products, including Glucanol^TM, Healthy Trac^TM, Immunol^TM, and Lactopril^®, meet the FDA definition of drugs because Global Biotechnologies promoted them to treat diseases. However, the company failed to provide adequate directions for use for its drug products, causing those products to be misbranded drugs in violation of the Federal Food, Drug and Cosmetic Act.” Armando Zamora, acting director, office of enforcement, in the Office of Regulatory Affairs stated that “Using these products in the mistaken belief that they will cure a disease – especially when they cannot do so – represents a danger to the public’s health.” FDA indicates that no illnesses have been associated to date with Global Biotechnologies’ products. Illnesses or adverse events related to use of these products should be reported to the FDA at caers@fda.hhs.gov or by calling 240/402-2405.