FDA Focus: The FDA versus counterfeit drugs and counterfeit cures

Since the US Food and Drug Administration was created in 1938 by then President Franklin D Roosevelt, its primary task has been to test drugs and approve them for sale, if they are found to be safe and effective, for the treatment of diseases and conditions they were meant to treat. Thus, “FDA approved” is a mark of safety and quality that patients and consumers can trust. Since the 1980s, the FDA’s task has evolved to also include the investigation and prosecution of counterfeit drugs.

The problem of drug counterfeiting was first noticed by legitimate drug companies manufacturing authentic drugs. Their products were being copied and sold under similar labels and brand names but at a much cheaper price.

Counterfeit cures are a relatively new shift in drug counterfeiting. These ‘cures’ are usually sold as dietary supplements, and claim to improve or support an organ or structure in the body, or the function of an organ or structure. These mislead consumers as to their efficacy in curing disease. Food supplements that claim to cure cancer are examples of counterfeit cures. The FDA recently published a list of 131 counterfeit cures for cancer that are sold over the internet.