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Medical food

{{Short description|Specially fomulated food in medical setting}}

Image:Novartis Fibersource HN medical food on IV pole.JPG Fibersource HN medical food]]

Medical food is food that is specially formulated and intended for the dietary management of a disease that has distinctive nutritional needs that cannot be met by normal diet alone. In the United States, it was defined in the Food and Drug Administration's 1988 Orphan Drug Act Amendments{{cite book|url=http://www.cfsan.fda.gov/~lrd/CFR101-9.HTML|title=CFR 21 Part 101 Subpart A|author=FDA|access-date=2007-09-21|archive-url=https://web.archive.org/web/20081203115251/http://www.cfsan.fda.gov/~lrd/cfr101-9.html|archive-date=2008-12-03|url-status=dead}} and subject to the general food and safety labeling requirements of the Federal Food, Drug, and Cosmetic Act. In Europe, the European Food Safety Authority established definitions for "foods for special medical purposes" (FSMPs) in 2015.{{cite journal|title=Outcome of a public consultation on the Draft Scientific and Technical Guidance of the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) on foods for special medical purposes in the context of Article 3 of Regulation (EU) No 609/2013|journal=EFSA Supporting Publications|volume=12|issue=11|doi=10.2903/sp.efsa.2015.EN-904|year=2015|doi-access=free}}

Definition

Medical foods, called "food for special medical purposes" in Europe,{{cite web|title=Food for special medical purposes|url=https://ec.europa.eu/food/safety/labelling_nutrition/special_groups_food/medical_en|publisher=European Commission|language=en|date=13 October 2017}} are distinct from the broader category of foods for special dietary use, from traditional foods that bear a health claim, and from dietary supplements. In order to be considered a medical food the product must, at a minimum:{{cite web|title=Food And Drug Administration Compliance Program Guidance Manual: Chapter 21 – Food Composition, Standards, Labeling And Economics|url=https://www.fda.gov/downloads/food/complianceenforcement/ucm073339.pdf|website=U.S. FDA|access-date=May 16, 2017}}{{cite web|title=State Statutes & Regulations on Dietary Treatment of Disorders Identified Through Newborn Screening November 2016|url=http://www.nccrcg.org/docs/NCC/ACA/Products/Dietary_Treament_Supplements_2016.pdf|website=U.S. FDA|access-date=May 16, 2017|archive-url=https://web.archive.org/web/20170628112519/http://www.nccrcg.org/docs/NCC/ACA/Products/Dietary_Treament_Supplements_2016.pdf|archive-date=June 28, 2017|url-status=dead}}

  • be a food for oral ingestion or tube feeding (nasogastric tube)
  • be labeled for the dietary management of a specific medical disorder, disease or condition for which there are distinctive nutritional requirements, and
  • be intended to be used under medical supervision.

Medical foods can be classified into the following categories:

Regulation

Medical foods are regulated by the US Food and Drug Administration under the Food Drug and Cosmetic Act regulations. 21 CFR 101.9(j) (8).

The 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."{{cite web|url=https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/MedicalFoods/default.htm|title=Medical Foods Guidance Documents & Regulatory Information|first=Office of Regulatory|last=Affairs}}

Medical foods are not required to undergo premarket review or approval by FDA. Additionally, they are exempted from the labeling requirements for health claims and nutrient content claims under the Nutrition Labeling and Education Act of 1990. In 2016 the FDA published an update: Guidance for Industry: Frequently Asked Questions About Medical Foods; Second Edition. Definitions and labeling requirements are included.{{cite web|url=https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/MedicalFoods/ucm054048.htm|title=Medical Foods - Guidance for Industry: Frequently Asked Questions About Medical Foods; Second Edition|first=Center for Food Safety and Applied|last=Nutrition}}

See also

References

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External links

  • FDA Presentation dated March 2012 on [https://www.fda.gov/downloads/ForIndustry/DevelopingProductsforRareDiseasesConditions/OOPDNewsArchive/UCM292733.pdf Regulation of Medical Foods]

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