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

Contains Nonbinding Recommendations

August 2017


How to Comment

Submit electronic comments on to docket number FDA-2013-N-1425.

Submit written comments to:
Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, rm. 1061
Rockville, MD 20852
All comments should be identified with the docket number FDA-2013-N-1425.

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.

This guidance represents the Food and Drug Administration’s (FDA or Agency) current thinking on this topic. It does not establish any rights for any person and does not bind FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff responsible for this guidance using the contact information on the title page.


Page Last Updated: 11/05/2017
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