U.S. Marshals seize dietary supplements in Maine

U.S. Marshals recently seized misbranded Global Biotechnologies dietary supplements at the request of the FDA, and per a warrant issued by the U.S. District Court for the District of Maine, according to an FDA statement.

The complaint states that the company has made claims on its website and in promotional materials that its products (including Glucanol, Healthy Trac, Immunol, and Lactopril) can diagnose, cure, mitigate, treat, or prevent human diseases.

The products 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 products, causing them to be misbranded drugs in violation of the Federal Food, Drug, and Cosmetic Act.

“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.”

In 2006, FDA had sent the company a warning letter that their practices were in violation of the Federal Food, Drug, and Cosmetic Act. At that time, the company had committed to removing drug claims cited in the letter from its labeling. However, during a recent inspection, FDA found that the company had continued to make illegal claims that cause their products to be misbranded drugs.

To date, no illnesses have been associated with these products. Any illnesses or adverse events related to the use of the products, however, should be reported to FDA at caers@fda.hhs.gov or by calling 240-402-2405.