FDA Releases Guidance on Protecting Against Food-Supply Attacks

The U.S. Food and Drug Administration (FDA) has released draft guidance on intentional adulteration of the food supply. The guidance aims to help manufacturers develop and implement plans to protect their products by providing details on the components of a food defense plan, including vulnerability assessments, mitigation strategies and training requirements. Large businesses must have a plan by July 26, 2019, with enforcement dates in 2020 and 2021 for small or very small businesses. FDA also indicated that it will issue two further installments of draft guidance on intentional adulteration focusing on vulnerability assessments and corrective actions.

“The likelihood of an incident at a particular facility is low, but the intentional adulteration of the U.S. food supply represents a very serious threat – one that could have devastating public health consequences,” FDA Commissioner Scott Gottlieb said in a statement. “The goal of this draft guidance, in its entirety, is to help provide greater clarity and predictability for manufacturers that need to take additional steps to come into compliance with the rule. We want to help ensure that the new requirements are cost-effective and not overly burdensome, while still being protective of the food system.”