FDA Issues

At today’s Food and Drug Law Institute’s annual conference in Washington, D.C., FDA Commissioner Margaret Hamburg, M.D. said that one of her priorities is responding to the globalization of the food supply, and the increase in misbranded and adulterated food products imported into the United States.  Dr. Hamburg stated that the FDA “cannot wait until the food arrives at our borders,” that “extending the FDA’s global reach is key to our success,” and that the FDA’s new PREDICT system will focus FDA Inspectors to select, stop, and examine high-risk shipments being imported into the United States.

Ralph Tyler, FDA’s new Chief Counsel, stated that the laws enforced by the FDA affect 25% of the American economy.  The crowd in attendance applauded when Ralph stated that “FDA lawyers are not doing their jobs when they simply say ‘no'” to the food, drug, and cosmetic companies regulated by the FDA.

Michael Chappell, FDA’s Associate Commissioner for the Office of Regulatory Affairs (ORA), is the person responsible for managing the import, inspections and enforcement policy of the FDA.   He stated that companies are now operating in “an age of heightened enforcement by the FDA.”  He stated that “salmonella and listeria remain major problems in food manufacturing facilities.”  He advised that there were 19 million customs entries in 2009, and the number is ever increasing.   He stated that the FDA had in 2010 already issued a record number of Warning Letters to importers, producers, and distributors of FDA regulated products, especially dietary supplements and cosmetics.

In summary, my take away after hearing from the […]

The United States Congress is considering legislation to make the food we eat, especially imported food, “safe and secure”.  In my opinion, even if our food needs protecting, the proposed legislation only adds to the current Federal bureaucracy.  The U.S. Food and Drug Administration (FDA) already has a comprehensive regulatory procedure to stop, examine, and refuse imported food which it considers adulterated or misbranded, or otherwise not fit for human (or animal) consumption.  The current FDA system is working very well, and  the only achievement of the proposed legislation will be to increase the price of food.  We need enforcement of the current laws, not a bunch of new laws.

Granted, there are numerous instances of imported food making people sick, and even causing death.  15% of the food we eat is imported. Nevertheless, the overwhelming number of Americans who get sick or die from consuming food had nothing to do with imported food.  You may get sick at your local restaurant with food poisoning because of the poor handling of the food at the restaurant, not because the food came from overseas.

Currently, for any food to enter the United States, the importer must submit an electronic entry to both U.S. Customs and Border Protection and the FDA.  The entry information includes the name of the importer, a description of the imported food, the name of its manufacturer, the country of origin, the value, the buyer of the food, and where the food is to be delivered.  The requirements of the