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 The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respo ...

's 1988 Orphan Drug Act Amendments and 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 food safety ...

. In Europe, the

European Food Safety Authority The European Food Safety Authority (EFSA) is the agency of the European Union (EU) that provides independent scientific advice and communicates on existing and emerging risks associated with the food chain. EFSA was established in February 2002 ...

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 oa ...

, 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 Nasogastric intubation is a medical process involving the insertion of a plastic tube (nasogastric tube or NG tube) through the nose, down the esophagus, and down into the stomach. Orogastric intubation is a similar process involving the insertion ...

) * 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 A metabolic disorder is a disorder that negatively alters the body's processing and distribution of macronutrients, such as proteins, fats, and carbohydrates. Metabolic disorders can happen when abnormal chemical reactions in the body alter the ...

* Oral rehydration products

Regulation

Medical foods are regulated by the

US Food and Drug Administration The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food ...

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 The Orphan Drug Act of 1983 is a law passed in the United States to facilitate development of orphan drugs—drugs for rare diseases such as Huntington's disease, myoclonus, ALS, Tourette syndrome or muscular dystrophy which affect small numbers ...

(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.

References

External links

* FDA Presentation dated March 2012 o
Regulation of Medical Foods
{{DEFAULTSORT:Medical Food

Definition

Regulation

See also

References

External links