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Dairy Facts 2016

FDA Releases Food Defense Rule Compliance Guide for Small Businesses

Aug 25, 2017

The Food and Drug Administration yesterday released a guide to help small businesses comply with the Mitigation Strategies to Protect Food Against Intentional Adulteration Rule of the Food Safety Modernization Act. The rule requires many U.S. food companies to develop action plans to counteract the possibility, however unlikely, that an act of intentional adulteration could affect the U.S. food supply and cause widespread public harm.

The guidance includes recommendations for companies building a food defense plan, analyzing vulnerabilities, implementing mitigation strategies and managing records that adequately monitor these actions.

FDA’s guidance documents don’t establish legally enforceable responsibilities, but they describe FDA’s current thinking on a topic and should be viewed as recommendations unless specific regulatory or statutory requirements are cited.

Intentional Adulteration Rule

Under the rule, facilities use strategies to address vulnerabilities, establish and maintain food defense monitoring procedures and corrective actions, maintain records of the strategies and ensure that employees are properly trained. Companies will also be required to update and reevaluate these plans every three years.

Businesses with 500 or more employees must comply with the rule by July 26, 2019, and businesses with fewer than 500 employees will have to comply by July 27, 2020. Very small businesses are exempt from the rule, but will be required to have documents that prove they are exempt by July 26, 2021.

IDFA anticipates that FDA will release more guidance in the coming months and year.

Read, “Guidance for Industry: Mitigation Strategies to Protect Food Against Intentional Adulteration - What You Need to Know About the FDA Regulation: Small Entity Compliance Guide.”

For more information, contact Emily Lyons, IDFA director of regulatory affairs, at

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