U.S. Marshals Seize Misbranded Drugs in Maine
On May 31, 2012, U.S. Marshals, in response to a warrant issued by the U.S. District Court for Maine, seized Glucanol, Healthy Trac, Immunol, and Lactopril products from Portland, Maine-based Global Biotechnologies, Inc.
“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,” Acting director in the Office of Regulatory Affairs
About the Drug Seizure
According to a U.S. Food and Drug Administration press release, Global Biotechnologies made claims on its website, in promotional materials, and on the products’ labels that its products could prevent human diseases. Despite these claims, the company did not provide adequate directions for use of its drug products. This caused these products, including Glucanol, Healthy Trac, Immunol, and Lactopril, to be misbranded drugs even though they met the FDA's definition of drugs. This misbranding is a violation of the FDA's Federal Food, Drug, and Cosmetic Act.
Company Had Received Prior Warnings
Before this seizure, the FDA sent a warning letter to Global Biotechnologies warning them 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 the Federal, Food, Drug and Cosmetic Act.”
Global Biotechnologies committed to making the proper changes; however, the FDA recently found that the company was still in violation.
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