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July 2010

FDA Issues

Pills That Will Make You Smarter, Lose Weight, and Cure Cancer

posted by Customs & International Trade Law Blog July 18, 2010 1 Comment

All those dietary supplements advertised on television and readily available on the Internet claim to do one thing or another.  Taking certain pills allegedly will make you smarter, give you a burst of energy, end problems with erectile dysfunction, or even cure cancer. The United States Food and Drug Administration (FDA) is the primary Federal agency responsible for protecting the American consumer from such false claims.  The FDA does this through its Office of Regulatory Affairs (ORA), and pursues criminal investigations through its Office of Criminal Investigations (OCI). 

The mission of the Office of Criminal Investigations (OCI) is to conduct and coordinate investigations of suspected criminal violations of the Federal Food, Drug, and Cosmetic Act (FDCA). OCI has an office at FDA Headquarters in Rockville, Maryland, and field offices around the United States.  For example, the Miami Field Office is located in Ft. Lauderdale, Florida, and covers 8 Southeastern States, plus Puerto Rico and the U.S. Virgin Islands.  Special Agents of the OCI investigate street level distribution of counterfeit, unapproved, and designer drugs, major organized illicit diversion of prescription drugs, fraudulent schemes involving ineffective AIDS, cancer, and Alzheimer cures, large scale product substitution conspiracies, application and clinical investigator fraud, and health frauds involving harmful FDA-regulated drugs and medical devices.

In Miami, Florida, two importers were recently arrested for importing cheese contaminated with Staphylococcus aureus, making the food adulterated.  A conviction for introducing contaminated food into the United States may result in 3 years in prison and a fine of $250,000.

Whenever contacted by a Special Agent of the FDA’s OCI, be sure to contact an attorney knowledgeable in FDA laws, regulations, policies, and procedures.