Wednesday, December 5, 2007

The FDA..Through Rose-colored Glasses

The latest on-line FDA Consumer update contained a Q&A session with the Director of FDA's Office of Regional Operations, Deborah Ralston. In response to a question about FDA's import surveillance program, Ms. Ralston said,
"For example, we work cooperatively with U.S. Customs and Border Protection to help identify shipments containing potentially dangerous foods and prevent them from entering the country. By law, certain information must be submitted to FDA about food products before they are allowed to enter the U.S. We keep our Prior Notice Center open to receive this information 24 hours a day, 365 days a year. This means that FDA knows in advance when and where specific food shipments will enter the United States, what those shipments will contain, the countries and entities where they originate, and the facility where the food was manufactured.

So although we don't physically inspect every product, we electronically examine 100% of imported food products before they reach our borders. Based on criteria we have set up, an automated system alerts us to any concerns. Then we investigate further and, if warranted, do a physical examination of the product."

But compare this statement to the following excerpt from the recently released internal FDA report:

"Many of the FDA systems reside on technology that has been in service beyond the usual life cycle. Systems fail frequently, and even email systems are unstable — most recently during an E. coli food contamination investigation. More importantly, reports of product dangers are not rapidly compared and analyzed, inspectors’ reports are still hand written and slow to work their way through the compliance system, and the system for managing imported products cannot communicate with Customs and other government systems (and often miss significant product arrivals because the system cannot even distinguish, for example, between road salt and table salt)."
FDA is overwhelmed and underfunded, and has been for many years. The problem gets worse day by day. Yet, instead of giving us an honest appraisal of the agency's problems, its spokespeople continue to paint a rosy picture of FDA's ability to carry out its diverse mandates. Is it any wonder that the agency is struggling to deal effectively with the deluge of imported products arriving at our ports of entry?

No comments:

Post a Comment

Note: Only a member of this blog may post a comment.

Post a Comment