June 7, 2012
PORTLAND, MaineU.S. Marshals seized products from Global Biotechnologies Inc. because they were promoted as diagnosing, curing, mitigating, treating or preventing diseases on the company website, in promotional materials and on the products labels. At FDA's request, the U.S. District Court for the District of Maine issued a warrant for the seizure of the products, which were labeled dietary supplements, but made drug claims.
Products seized on May 31, 2012, from Portland, Maine-based Global Biotechnologies included Glucanol, Healthy Trac, Immunol and Lactopril. FDA said these products meet the definition of drugs because they were promoted to treat diseases. Because the company failed to provide adequate directions for use for its drug products, those products were misbranded drugs in violation of the Federal Food, Drug and Cosmetic Act, according to the agency.
The public relies on 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 diseaseespecially when they cannot do sorepresents a danger to the publics health."
FDA sent a warning letter to Global Biotechnologies in 2006 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. The warning letter came after a Nov. 2, 2005, visit from FDA to the company's facility and after a review of the company websites globalbio.com and neistitute.com. At that time, FDA noted drug claims for Healthy Trac included, "Lowers Cholesterol, Blood Glucose, and Insulin Levels" and "Helps reduce Cholesterol, Serum Glucose and Serum Insulin Levels, important factors for diabetics." Immunol's drug claims included, "Mediates Activity of Autoimmune Diseases" and " With the addition of ImmunoI to your diet, the numbers and activity level of the immune system cells responsible for optimal health will increase.."
FDA also warned Global Biotechnologies that using the statement "FDA approved as a food additive" on Healthy Trac 's label may mislead consumers because while arabinogalactan, the sole ingredient identified the label, is an approved food additive, it's only approved when it's used in microcapsules for flavoring substances, or as an emulsifier, stabilizer, binder or bodying agent in essential oils, nonnutritive sweeteners, flavor bases, non-standardized dressings and pudding mixes. FDA said it had not approved, or even reviewed, the safety of arabinogalactan for consumption as a single-ingredient product.
At that time, FDA said the company committed to removing drug claims cited in the warning letter from its labeling. However, during a recent inspection, FDA found the company had continued to make illegal claims that cause their products to be misbranded drugs.
In the 2006 warning letter, Gail T. Costello, Director of FDA's New England District Office , said, "You should review the labeling for all of your products to ensure that they comply with the applicable requirements of the Act and implementing regulations. Failure to do so may result in regulatory action without further notice, such as seizure and/or injunction."
This recent seizure showed FDA will back up on its threats, even if it is six years later.
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