FDA has started a major campaign to explain product recalls to the public. In an extensive article and video called, “FDA 101: Product Recalls – From First Alert to Effectiveness Checks,” FDA explains the process in clear language for the general public. Go to http://www.fda.gov to view for yourself.
While FDA discusses that most recalls are voluntary, what isn’t discussed is the fact that FDA currently has limited enforcement authority regarding recalls of hazardous products that FDA regulates. Congress has pending legislation to give FDA increased recall authority, including mandatory recalls for dangerous food products. FDA Commissioner Margaret Hamburg discussed this during her speech to the Regulatory Affairs Professionals Society in Philadelphia (see previous post).
During the time that I worked as an FDA field investigator I would sometimes perform “recall audit checks.” I would go to a hospital, health product distributor, or pharmacy to find out if they had received a recall notice from the manufacturer of the recalled product. Sometimes they had taken prompt action to remove the product from their shelves. Sometimes they would just shrug their shoulders and say they didn’t remember or that they threw away such notifications. There is little FDA can do in that situation because the system is basically voluntary except for the most serious situations. For many, if not most recalls, a voluntary recall system is OK. They are not serious enough to utilize significant agency resources. However, when there are serious public health risks FDA needs the authority to take action.
Hopefully Congress will tmove forward soon with legislation to give FDA the authority it needs to enforce product recalls of significant public health concern.