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
and are subject to the general food and safety labeling requirements of the
Federal Food, Drug, and Cosmetic Act
The United States Federal Food, Drug, and Cosmetic Act (abbreviated as FFDCA, FDCA, or FD&C) is a set of laws passed by the United States Congress in 1938 giving authority to the U.S. Food and Drug Administration (FDA) to oversee the safety of f ...
. In Europe the
European Food Safety Authority established definitions for "foods for special medical purposes" (FSMPs) in 2015.
Definition
Medical foods, called "food for special medical purposes" in Europe, are distinct from the broader category of foods for special dietary use, from traditional foods that bear a
health claim
A health claim on a food label and in food marketing is a claim by a manufacturer of food products that their food will reduce the risk of developing a disease or condition. For example, it is claimed by the manufacturers of oat cereals that oat ...
, and from dietary supplements. In order to be considered a medical food the product must, at a minimum:
* 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:
* Nutritionally complete formulas
* Nutritionally incomplete formulas
* Formulas for
metabolic disorders
*
Oral rehydration products
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."
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.
See also
*
Clinical nutrition
*
Parenteral nutrition
*
Nutraceutical
A nutraceutical or bioceutical is a pharmaceutical alternative which claims physiological benefits. In the US, "nutraceuticals" are largely unregulated, as they exist in the same category as dietary supplements and food additives by the FDA, unde ...
*
Lipid emulsion
*
Fad diets
References
External links
* FDA Presentation dated March 2012 o
Regulation of Medical Foods
{{DEFAULTSORT:Medical Food
Enteral feeding