FDA's Intentional Food Adulteration Guide Offers Flexibility, Expert Says Details Needed

Jessica O'Connell is quoted in an Inside Health Policy article regarding FDA's draft guidance aimed at helping the food industry reduce the risk of intentional adulteration. According to O'Connell, industry has had some concerns about how prescriptive the food defense plans would be and how burdensome recordkeeping would be. She adds that many companies already have food defense plans, but FDA requirements for them are a new concept.

While the guidance does provide plenty of detail on vulnerability assessment, mitigation strategies, and food defense monitoring, O'Connell says, there is still some ambiguity surrounding training and recordkeeping requirements. "It doesn't address the training or the records. It'll be interesting to see what the agency has to say about that, because those can be burdensome depending on how FDA implements that," she says. "The guidance is helpful to see how the agency is thinking about these things, but it's often hard to tell until we see how they're enforcing those things, which won't be until July 2019 for the bigger companies."