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          Supplemental Draft Guidance for Industry: Mitigation Strategies to Protect Food Against Intentional AdulterationSearch for FDA Guidance Documents GUIDANCE DOCUMENT
	Supplemental Draft Guidance for Industry: Mitigation Strategies to Protect Food Against Intentional Adulteration
					
		
		February 2020


	Download the  Draft  Guidance Document
	    
      	      		Read the Federal Register Notice 

    Draft

	  	    Not for implementation. Contains non-binding recommendations.
	  
	  
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    PrintDocket Number:
		    FDA-2018-D-1398
	    	    		    Issued by:
		    Guidance Issuing Office
          Center for Food Safety and Applied Nutrition


The FDA Food Safety Modernization Act (FSMA) added to the Federal Food, Drug, and Cosmetic Act (FD&C Act) several new sections that reference intentional adulteration.  For example, section 418 of the FD&C Act (21 U.S.C. 350g) addresses intentional adulteration in the context of facilities that manufacture, process, pack, or hold food, and that are required to register under section 415 (21 U.S.C. 350d).  Section 420 of the FD&C Act (21 U.S.C. 350i) addresses intentional adulteration in the context of high-risk foods and exempts farms except for farms that produce milk [1].

We implemented these intentional adulteration provisions through a rule entitled “Mitigation Strategies to Protect Food Against Intentional Adulteration” (IA rule).We published the final rule in the Federal Register of May 27, 2016.  (81 FR 34166).

This supplemental draft guidance adds to the draft guidance previously published in March 2019 with chapters covering topics focusing on food defense corrective actions, food defense verification, reanalysis, and recordkeeping. It also includes appendices on FDA’s mitigation strategies database and how businesses can determine Small and Very Small Businesses status under the IA rule.

[1] The IA rule did not include any requirements for farms that produce milk. As such, farms that produce milk are not covered under this draft guidance.

Related Information

Food Defense Guidance Documents & Regulatory Information
	Food Defense Main PageSubmit Comments
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						All written comments should be identified with this document's docket number: FDA-2018-D-1398.

                                                                                  Content current as of:
      02/13/2020
         
                  
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