Published Date Written by Staff ReportLast Thursday, Portland company Global Biotechnologies was raided by U.S. Marshals, after the U.S. Food and Drug Administration accused the firm of misbranding drugs in violation of federal law.
At FDA's request, U.S. Marshals seized drug products from Global Biotechnologies Inc. using a warrant issued by the U.S. District Court for the District of Maine, the FDA reported Wednesday.
The company's products, including Glucanol, Healthy Trac, Immunol, 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, the agency reported.
"The public relies on the FDA to keep companies from claiming that their products improve medical conditions or diseases," said Armando Zamora, acting director, office of enforcement, in the Office of Regulatory Affairs. "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."
Efforts to contact Robert Bogosian, president and owner of Global Biotechnologies, for comment were unsuccessful.
The FDA sent a warning letter to Global Biotechnologies advising the company that making treatment claims on its labels, promotional materials and websites caused the products to be unapproved new drugs and misbranded drugs in violation of federal law. During a recent inspection, the FDA found that the company had continued to make illegal claims that cause their products to be misbranded drugs, according to the FDA press release.
"New drugs may not be legally marketed in the United States without prior approval from FDA," explained Gail T. Costello, director of the FDA's New England District Office, in a letter to Bogosian.
Costello cited descriptions on labels of two products, HealthyTrac, which claims it "lowers cholesterol, blood glucose, and insulin levels" and "helps reduce cholesterol, serum glucose and serum insulin levels, important factors for diabetics," and on Immunol, which claimed, in part, that it "mediates activity of autoimmune diseases," the letter stated.
Immunol sells for $39.95 for 60 capsules; $300 for a 12-bottle case; HealthyTrac sells for $79.80 for a four-pack of 250-gram bottles, according to Global's website. The company, based on York Street, was established in 1993, according to the website.
No illnesses have been associated to date with Global Biotechnologies' products, according to the FDA.