The U.S. Food and Drug Administration (FDA) has issued a Guidance document intended to help small companies meet its regulations regarding the protection of food against intentional adulteration.
The FDA rule, which was published in July 2016, requires registered food facilities to take specific steps to protect the food supply from intentional adulteration. These include the development of a written food defence plan, training for certain personnel, and maintaining records of training, food defence monitoring, food defence corrective actions and food defence verification. Compliance with the FDA’s intentional adulteration requirements is effective as early as July 2019, although the transition period for small and very small businesses extends to 2020 and 2021 respectively.
Issued in August, the FDA’s Guidance for Small Entities provides detailed explanation of the requirements of its intentional adulteration rule, especially as they apply to smaller companies, and can be useful in helping companies meet those requirements in advance of the compliance deadline. However, it is important to note that Guidance documents issued by the FDA and other U.S. federal agencies do not have the force of law, and are intended only to provide insight into an agency’s current thinking on a given subject.
The complete text of the FDA’s Guidance document on protecting food from intentional adulteration can be accessed here.