Source: FDA, 4/17/19


The U.S. Food and Drug Administration announced during a public meeting that routine inspections to verify compliance with the Intentional Adulteration (IA) rule will begin in March 2020.

The FSMA final rule on intentional adulteration is designed to address hazards that may be intentionally introduced to foods, including by acts of terrorism, with the intent to cause wide-spread harm to public health. Unlike the other FSMA rules that address specific foods or hazards, the IA rule requires the food industry to implement risk-reducing strategies for processes in food facilities that are significantly vulnerable to intentional adulteration.

Food facilities covered by the rule will be required to develop and implement a food defense plan that identifies vulnerabilities and mitigation strategies for those vulnerabilities. These facilities will then be required to ensure that the mitigation strategies are working. The first compliance date arrives in July 2019.

FDA has heard from stakeholders that due to the novel nature of the IA rule and its requirements, they believe more time is needed to develop a fully compliant food defense plan. We are working hard to provide resources, including the final portion of draft guidance, which may be helpful to industry. To allow industry time with the forthcoming materials, tools, and trainings, and because the IA rule represents new regulatory territory for all of us, we will be starting routine IA rule inspections in March 2020. 

Keeping the compliance dates ensures industry will put in place measures that protect public health while FDA makes additional guidance and resources available. More information about the upcoming compliance date, the recently released draft guidance, and other resources is available in an updated conversation piece featuring FDA food defense experts Ryan Newkirk and Jon Woody.

For more information, click here.