THE FDA IS FLEXING ITS ENFORCEMENT MUSCLES
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 top 3 people at FDA is that it is a much more aggressive agency under the leadership of Dr. Hamburg than previously. Importers should be more careful than ever to understand and comply with the FDA regulations, or not be surprised to receive a Notice of Refusal, a Warning Letter, or even a civil penalty or subpoena.