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        Guidance Documents & Regulatory Information by Topic (Food and Dietary Supplements)

Medical Foods Guidance Documents & Regulatory Information Home
          Food
          Guidance & Regulation (Food and Dietary Supplements)
          Guidance Documents & Regulatory Information by Topic (Food and Dietary Supplements)
          Medical Foods Guidance Documents & Regulatory InformationGuidance Documents & Regulatory Information by Topic (Food and Dietary Supplements) Medical Foods Guidance Documents & Regulatory Information
  	
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    PrintThe term medical food, as defined in section 5(b) of the Orphan Drug Act (21 U.S.C. 360ee (b) (3)) is "a food which is formulated to be consumed or administered enterally under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation."

Guidance for Industry: Frequently Asked Questions About Medical Foods
	Medical Food Compliance Program - Import and Domestic (PDF 172KB)

                                                                                  Content current as of:
      01/25/2022
                  
                   
Regulated Product(s)
		 Food & BeveragesMedical Foods Guidance Documents & Regulatory Information
 
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