Skip to main content
          Skip to FDA Search
          Skip to in this section menu
          Skip to footer links


U.S. flagAn official website of the United States government

					Here’s how you know
          			Dot gov**The .gov means it’s official.**Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
							      SSL**The site is secure.** The **https://** ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 
			U.S. Food and Drug Administration
				
        Search
            Menu
							
						Search FDA
									
									Submit search 
		Featured
							Contact FDA
	                FDA Guidance Documents
	                Recalls, Market Withdrawals and Safety Alerts
	                Press Announcements
	                Warning Letters
	                Advisory Committees
	                En Español

					Products
            Food
							Drugs
							Medical Devices
							Radiation-Emitting Products
							Vaccines, Blood, and Biologics
							Animal and Veterinary
							Cosmetics
							Tobacco ProductsTopics
            About FDA
							Combination Products
							Regulatory Information
							Safety
							Emergency Preparedness
							International Programs
							News and Events
							Training and Continuing Education
							Inspections and Compliance
							Science and ResearchInformation For
            Consumers
	            Patients
	            Industry
	            Health Professionals
	            Federal, State and Local Officials 
 In this section:

                Search for FDA Guidance Documents

Search for FDA Guidance Documents

                        Search General and Cross-Cutting Topics Guidance Documents
          Advisory Committee Guidance Documents
          Import and Export Guidance Documents
          Cross-cutting Guidance Documents Home
          Regulatory Information
          Search for FDA Guidance Documents
          Small Entity Compliance Guide: Mitigation Strategies to Protect Food Against Intentional AdulterationSearch for FDA Guidance Documents SMALL ENTITY COMPLIANCE GUIDE
	Small Entity Compliance Guide: Mitigation Strategies to Protect Food Against Intentional Adulteration
					
		
		August 2017


	Download the  Final Small Entity Compliance Guide
	    
      	      		Read the Federal Register Notice 

    Final

	  
	  
	Share
    Post
    Linkedin

    Email
    PrintDocket Number:
		    FDA-2013-N-1425
	    	    		    Issued by:
		    Guidance Issuing Office
          Center for Food Safety and Applied Nutrition


*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.

**Download the Guidance**

Related Information

FSMA Rule for Mitigation Strategies to Protect Food Against Intentional AdulterationSubmit Comments
	   		  			    		Submit Comments Online
					You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
						If unable to submit comments online, please mail written comments to:
						Dockets Management
							Food and Drug Administration
							5630 Fishers Lane, Rm 1061
							Rockville, MD 20852
						All written comments should be identified with this document's docket number: FDA-2013-N-1425.

                                                                                  Content current as of:
      08/25/2017
         
                  
Regulated Product(s)
		 Food & BeveragesTopic(s)
			  Defense & SecurityLaw(s) & Regulation(s)
			  Food Safety Modernization ActSearch for FDA Guidance Documents

        Search for FDA Guidance Documents

          
                        Search General and Cross-Cutting Topics Guidance Documents
          Advisory Committee Guidance Documents
          Import and Export Guidance Documents
          Cross-cutting Guidance Documents
 
 Footer Links
    FDA Archive
          About FDA
          Accessibility
      Visitor Information
          Website Policies / Privacy
          No FEAR Act
          Vulnerability Disclosure Policy
      FOIA
          HHS.gov
          USA.gov
    Contact FDA
      Follow FDA on Facebook
      Follow FDA on X
      Follow FDA on Instagram
      Follow FDA on LinkedIn
      View FDA videos on YouTube
      Subscribe to FDA RSS feeds
    FDA Homepage
    Contact Number
      1-888-INFO-FDA (1-888-463-6332) Back toTop