Direct Line to FDA

Unless you have a direct line to FDAs Division of Compliance Policy it is often difficult to understand how the agency interprets the Federal Food Drug and Cosmetic Act. This is the law that defines what a food manufacturer must do and can not do with food that is sold in the United States and in many places is not clearly defined in black and white. A window to the agencys current thinking can be found in the Warning Letters that are issued to firms, in most cases as a follow-up to a facility inspection. FDA Warning Letters describe the situations that the agency officials found that were in violation with the FFDC Act. In my very first job out of college (more years ago than I want to remember) my boss introduced me to the publication Food Chemical News which each week describes the findings in the recent Warning Letters a good read for lessons learned from someone elses hard knocks. Now of course one doesnt need to subscribe to a separate publication for these lessons learned as Warning Letters are publicly available on the FDA website.

Since Seafood HACCP implementation in 1997, the vast majority of the Warning Letters issued to seafood firms are for violations of the Seafood HACCP regulation a prudent processor should read these letters to ensure that they can meet FDAs current expectations for compliance. Last year, FDA Commissioner, Dr. Hamburg, declared that the agency will be tougher on violations with swifter action action that the BSB supports. Along with this new approach for tough love is a focus on violations beyond food safety a consumer protection focus. Labeling that the agency felt was misleading for the consumer was the focus for several Warning Letters issued last month. And of course the Warning Letters issued to Registry Steaks and Seafood and Gourmet Express Marketing that addressed the issue that is of prime interest of the Better Seafood Board product that that agency determined was misbranded and adulterated due to glaze that was included in the net weight of the product.

Any firm that receives a Warning Letter has the right and responsibility to address the issues outlined in the letter. Commissioner Hamburg has instituteda novel program to encourage response from industry by making public the Warning Letter close-out process. Once corrections to violations have been successfully made, the agency will post a close-out letter like the one sent to Registry Steaks and Seafood earlier this month.

If you are interested in receiving weekly announcements of FDAs Warning Letters, click here a no-cost way to have a direct line to FDA.