Article: Source Matters

Source Matters!

Photomicrograph of Melamine Crystal
(courtesy of FDA)

Rockville, Maryland (CSG) -- Here at the headquarters of the United States Food and Drug Administration, staff physicians, veterinarians and scientists make decisions daily impacting the lives of millions of people -- and animals -- throughout the United States. In particular, the Center for Veterinary Medicine (CVM), headed by Stephen F. Sundlof, D.V.M., is charged with the important task of ensuring the safety of certain products intended for use with or consumption by animals.

The FDA is not staffed to perform tests on all drugs or foods or dietary supplements. However, the Agency has been proactive in recent months in warning consumers concerning dangers of certain raw materials and other ingredients coming from the People's Republic of China. See http://www.fda.gov/oc/opacom/hottopics/petfood.html for details. This very critical consumer protection and food security mission is one that everyone responsible for making purchases on behalf of their families and animals can appreciate.

According to CVM's Dr. Sundlof, "FDA's inspection and investigation staff has increased surveillance of products coming in from China." Michael Rogers, Director of the Division of Field Investigations in FDA’s Office of Regulatory Affairs, confirms that there are "challenges" associated with trying to make inspections in China, and that the process "goes through the Chinese government." Dr. Sundlof of CVM said that certain evidence available to the Agency "would lend credibility to the theory" that the contamination detected in 2007 "may be intentional."

Dr. Rogers related that part of the Agency's frustration has been that the Chinese government has indicated that the content of the tainted shipments "was not their regulatory responsibility." He continued, "We need to follow up with the Chinese Government and get into China and actually do the inspection to determine what the real facts are. But regardless of how it got in here, it should not have been a component of any food for either animals or humans."

In the future, the FDA expects to be receiving further information from consumers themselves, who are the best source of primary data concerning product safety. See http://www.fda.gov/opacom/backgrounders/complain.html for details. In particular, the Agency is committed to improving postmarket surveillance for adverse events so that crises, such as the one that precipitated the withdrawal from the market of the nonsteroidal anti-inflammatory drug (NSAID) Vioxx in 2004 (see http://www.fda.gov/bbs/topics/news/2004/NEW01122.html), and have more recently caused the FDA to require new and stricter warnings on NSAID labels, so that they disclose significant cardiovascular and gastrointestinal risks (see http://www.fda.gov/bbs/topics/news/2005/NEW01171.html), will become a thing of the past.