Medical foods are foods that are 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 they were defined in the Food and Drug Administration's 1988 Orphan Drug Act Amendments[1] and are 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.[2]
- ^ FDA. CFR 21 Part 101 Subpart A. Archived from the original on 2008-12-03. Retrieved 2007-09-21.
- ^ "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". EFSA Supporting Publications. 12 (11). 2015. doi:10.2903/sp.efsa.2015.EN-904.