What You Need to Know about the FDA Regulation

The FDA Food Safety Modernization Act (FSMA) directs the Food and Drug Administration (FDA) as the food regulatory agency of the U.S. Department of Health and Human Services to better protect public health by, among other things, adopting a modern, preventive, and risk-based approach to food safety regulation. On May 27, 2016, FDA published in the Federal Register a final rule, Mitigation Strategies to Protect Food Against Intentional Adulteration (IA rule) (81 FR 34165), that creates new requirements for the production of food by registered food facilities to protect the food supply against intentional adulteration. The final rule became effective on July 26, 2016.

We have prepared this Small Entity Compliance Guide in accordance with section 212 of the Small Business Regulatory Enforcement Fairness Act (Public Law 104-121, as amended by Public Law 110-28). This guidance document is intended to assist small entities in complying with the rule set forth in 21 CFR 121 concerning Mitigation Strategies to Protect Food Against Intentional Adulteration. The rule is binding and has the full force and effect of law.

FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe our current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in FDA guidances means that something is suggested or recommended, but not required.

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Related Information

• FSMA Rule for Mitigation Strategies to Protect Food Against Intentional Adulteration