In 2011, the Food Safety Modernization Act (FSMA) was passed into law. According to data from the Centers for Disease Control and Prevention, about 48 million people in the US (1 in 6) get sick, 128,000 are hospitalized, and 3,000 die each year from foodborne diseases. The FSMA law allows the Food & Drug Administration (FDA) to better protect the nation’s food safety system. The FDA’s ruling seeks to focus on preventative measures as opposed to traditional reactionary measures like a food recall. With the addition of the FSMA law, the agency is given more enforcement authority to assure compliance by foreign and domestic food companies who are required to register under the Federal Food, Drug and Compliance Act (FD&C act).
In March of 2020, the FDA plans to begin the enforcement audits and inspections as required by the Intentional Adulteration Rule, otherwise known as the Food Defense Rule. The Food Defense Rule aims to further protect the nation’s food supply against intentional contamination which can cause widespread harm to the public, including terrorism. Threats can come from inside or outside the food facility and must be seriously monitored. This rule requires food companies to draft and implement a written food safety plan with four components - vulnerability assessment, mitigation strategies, mitigation strategies management components and training & recordkeeping. The FDA has added a number of compliance tools to its website in an effort to assist companies with developing a food safety plan, which can be found at www.fda.gov/fooddefense.