The U.S. Food and Drug Administration (FDA) has taken administrative action against a dietary supplement manufacturer following multiple breaches of the Federal Food, Drug, and Cosmetic Act, the agency said in a statement.
The Oregon-based company, James G. Cole, Inc., was found to have been distributing adulterated dietary supplements and drugs that were not approved by the regulator. In a bid to prevent unsafe products from reaching the market, the FDA is seeking a permanent injunction against the manufacturer, its president, James G. Cole, and its general manager, Julie D. Graves, the agency revealed. If the permanent injunction is granted by the U.S. Department of Justice, the company will be banned from distributing and promoting its products until it can prove that it is compliant with all requirements for good manufacturing practices.
Melinda K. Plaisier, the FDA's associate commissioner for regulatory affairs, stated that the company had repeatedly ignored FDA warnings. Despite these, James G. Cole, Inc. continued to manufacture and distribute products, promoting them as drugs, and kept on producing items in violation of good manufacturing practices for dietary supplements, she said.
The FDA stated that Cole had unlawfully claimed that the supplements treated medical conditions such as cancer, heart disease, autism, Alzheimer's disease and high cholesterol, among others. However, none of these products have been approved by the regulator.