Complaining To – Not About – The FDA

It's very easy to find fault with FDA. And with good reason – the agency seems to be dancing with two left feet much of the time. The new FDA weekly on-line column, Andy's Take, said to be written by FDA Commissioner Andrew von Eschenbach, has not been well-received by the media, and even most Internet-savvy consumers are probably unaware of its existence.

The communications disconnect between FDA and US consumers is disturbing. The agency relies heavily on patterns of consumer complaints and illness reports to decide where and how to spend its inadequate budget. Most of the major recalls and investigations that we learn about in the media – melamine in pet food, Salmonella in tomatoes – began as consumer complaints reported to FDA or outbreak clusters identified by state health agencies and the CDC.

But, before a consumer can lodge a complaint with FDA, he or she must know who to call. Earlier this month, the agency posted two new pages on its web site to guide consumers through the complaint process.

Your Guide To Reporting Problems To FDA tells consumers how to navigate the government's regulatory system. It offers tips on how to report problems, which agency to call (if the product is not under FDA regulation), and which office within FDA handles the various products and problems. Much of the information is displayed in an easy-to-use table.

FDA 101: How to Use the Consumer Complaint System and MedWatch, as its name implies, is a primer on how to make a consumer complaint to FDA. It lists the types of problems FDA wants to learn about from consumers, talks about what happens when a complaint is received, and provides the telephone numbers for all of the FDA regional Complaint Coordinators.

I strongly urge all my US readers to bookmark these web pages – or download the pdf versions – and to use this complaint process to make FDA aware of any health or safety issue you encounter with a product that this agency regulates.