June 6, 2012

FDA alleges Portland company misbranded drugs

The probe by the U.S. Food and Drug Administration targets Global Biotechnologies, a company based on York Street.

From staff reports

PORTLAND — U.S. Marshals say they seized drug products from a Portland company that the U.S. Food and Drug Administration says have been misbranded.

The FDA alleges that Global Biotechnologies, Inc. has made claims on its website, in promotional materials and on labels that its products can diagnose, cure, mitigate, treat or prevent human diseases.

The FDA says the products including Glucanol, Healthy Trac, Immunol and Lactopril meet the definition of drugs because they are promoted to treat diseases but that the company failed to provide adequate directions for their use, misbranding them.

But Dr. Robert Bogosian, who owns the company, said none of the products in questions were actually seized. The products remain at his business tagged and marked as being under quarantine.

"It has nothing to do with product quality," Bogosian said. "It's a simple labeling issue that will be resolved."

“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," said Armando Zamora, acting director of the FDA's office of enforcement.

"We don't knowingly go out and say that we can cure cancer because we don't, Bogosian said. "We have made no claims that are dangerous."

Global Biotechnologies is located at 54 York St.

No illnesses have been associated with the products, but the FDA sent the company a warning letter in February 2006.

To see a copy of the warning letter, click here.

To see a copy of the FDA's press release, click here

The Associated Press contributed to this report.

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