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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. 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.
Medical foods are distinct from the broader category of foods for special dietary use and from traditional foods that bear a health claim. 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
Medical foods for management of allergic conditions may contain both gamma-linolenic acid (GLA), a short chain omega-6 fatty acid primarily sourced from the seeds of the borage plant, and eicosapentaenoic acid (EPA), an omega-3 polyunsaturated fatty acid sourced from fish. These fatty acids help to inhibit the production of leukotrienes in the system. Sufficient quantities of GLA and EPA necessary for reduction of leukotrienes cannot be obtained from a normal diet. Leukotrienes are inflammatory molecules produced by immune cells (neutrophils, basophils, mast cells, macrophages and eosinophils) in the body. They are involved in the inflammatory response and cause the narrowing of the airways, increased mucus production and tissue swelling associated with both allergies and asthma. In order to control allergic symptoms, research shows that it helps to inhibit the production of leukotrienes in the body.
Medical foods for management of diabetes mellitus generally contain slowly digested carbohydrates, which helps minimize peaks in blood sugar. Consistent maintenance of optimal blood sugar levels (avoiding highs and lows) over time can help reduce the complications of diabetes.
Gastrointestinal tract impairment
Medical foods for management of gastrointestinal tract (GI tract) impairment provide an amino acid-based diet in its most easily digestible (elemental) form to aid in poor nutrient absorption due to digestive disease, malabsorption, severe food allergies, or other conditions in which the GI tract is severely compromised.
Medical foods for management of metabolically stressed patients provide supplemental glutamine to nourish the GI tract and restore glutamine while a patient is in a stressed, catabolic state.
Amino acid based medical foods which address the increased nutritional deficiencies associated with chronic idiopathic pain. Deficiencies in tryptophan, histidine, serine and arginine have been documented.[medical citation needed]
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.
Specific examples of marketed medical foods and their claimed uses
- Axona (caprylic triglyceride) – Alzheimer's disease
- Banatrol Plus (banana flakes/Bimuno, galacto-oligosaccharide – diarrhea
- Deplin (l-methylfolate) – depression
- Fosteum (genistein aglycone/citrated zinc bisglycinate/cholecalciferol) – osteopenia and osteoporosis
- Limbrel (flavocoxid) – osteoarthritis
- Metanx (L-methylfolate calcium/pyridoxal 5′-phosphate/methylcobalamin) – diabetic neuropathy
- Theramine (l-arginine, 5-htp, histidine, l-glutamine) – myalgia
- FDA. CFR 21 Part 101 Subpart A.
- Ablow, Keith (18 June 2013). "Deplin: A 'medical Food' That Treats Depression".
- Affairs, Office of Regulatory. "Medical Foods Guidance Documents & Regulatory Information".
- Nutrition, Center for Food Safety and Applied. "Medical Foods - Guidance for Industry: Frequently Asked Questions About Medical Foods; Second Edition".
- "Axona homepage — Axona®: Fuel the Brain". About-axona.com. 2013-05-02. Retrieved 2013-08-30.
- "Banatrol Plus". Medtrition.com. Retrieved 2013-08-30.
- "Deplin® (L-methylfolate) | Official Site". Deplin.com. 2011-06-03. Retrieved 2013-08-30.
- "Fosteum PLUS - The Purity of Genistein with the Strength of Calcium". Fosteum.com. 2013-05-31. Retrieved 2013-08-30.
- "Osteoarthritis Information - Knee Osteoarthritis Symptoms". Limbrel. Retrieved 2013-08-30.
- "Home". Metanx.com. 2013-01-24. Retrieved 2013-08-30.
- Barham, J. B.; Edens, M. B.; Fonteh, A. N.; Johnson, M. M.; Easter, L.; Chilton, F. H. (August 2000). "Addition of eicosapentaenoic acid to gamma-linolenic acid-supplemented diets prevents serum arachidonic acid accumulation in humans". The Journal of Nutrition. 130 (8): 1925–1931. PMID 10917903.
- Johnson, M. M.; Swan, D. D.; Surette, M. E.; Stegner, J.; Chilton, T.; Fonteh, A. N.; Chilton, F. H. (August 1997). "Dietary supplementation with gamma-linolenic acid alters fatty acid content and eicosanoid production in healthy humans". The Journal of Nutrition. 127 (8): 1435–1444. PMID 9237935.
- Medical Foods Compliance Program Guidance Manual
- US Food and Drug Administration's Guidance for Industry: Frequently Asked Questions about Medical Foods May 2007
- FDA Presentation dated March 2012 on Regulation of Medical Foods