In June, 2016, the Inspector General, Daniel R. Levinson, notified Robert M. Califf, M.D., Commissioner of Food and Drugs, Food and Drug Administration, FDA, that, as a result of an ongoing audit his office was conducting, it was found that the method that the FDA used to initiate a food recall was inefficient and ineffective. Specifically, the FDAs policies and procedures did not have established time frames that firms would be required to meet when recalling some types of foods, and it does not follow its own procedures. Levinson and others are making it clear that the FDA food recall system is broken.Levinson’s audit consisted of 30 voluntary recalls of misbranded or contaminated food products. In every case, the FDA neglected to provide time frames that the companies must meet. One company waited over five months before initiating a recall. Fourteen illnesses were reported during that time. Another company did not initiate a recall of all products that were potentially contaminated for over two months. During that time, there were eight illnesses, one infant death, and two miscarriages reported.According to FDA’s Regulatory Procedures Manual, the FDA has the authority to issue a timeline to ensure that the firm institutes a voluntary recall in an expeditious, timely manner.  In addition, the FDA may issue a mandatory recall order if the firm does not initiate its own recall. Clearly, over five months is an unacceptable timeframe for a company to initiate a recall, and an unacceptable amount of time for FDA to ignore the need for more stringent actions against the company to ensure the safety of consumers.Levinson recommended that the FDA not only consider his office’s audit findings before the Food Safety Modernization Act is implemented, but to actually follow its own procedures when monitoring recalls. That Act was designed to ensure that food contamination is prevented, rather than simply responded to. It was signed into law by President Obama in 2011. The FDA is in the process of initiating final Rules and Regulations and amendments to interim Rules for the implementation of the Act.

Image Courtesy of Scott Bauer, U.S. Dept of Agriculture via https://commons.wikimedia.org/wiki/File:Breads_(1).jpg

On July 31, 2016, Senator Charles E. Schumer (D-N.Y.) issued a press release in response to an E-Coli outbreak caused by flour that began in December 2015, but was not recalled until May 2016. Schumer stated that “delays in getting bad food off store shelves is just a recipe for disaster. That’s why the FDA must come to the table with a healthy, new plan, detailing how they will revamp and execute a reformed food recall process. One that gets potentially contaminated food off the shelves before Americans risk getting sick, not after.”It is clear that the FDA food recall system is broken! When a federal agency does not follow its own policies and procedures, and takes a lackadaisical attitude toward ensuring that the nation’s food supply is safe, there is a major problem.Sources

Letter from Inspector General to Commissioner of Food and Drugs

FDA Regulatory Procedures Manual

Food Safety Modernization Act

Senator Schumer Press Release