Medical food

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Novartis Fibersource HN medical food deployed on an IV pole

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[1] 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

Examples

Allergic conditions

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.

Diabetes mellitus

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.

Metabolic stress

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.

Chronic pain

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]

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).[1]

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."[2]

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.[3]

Specific examples of marketed medical foods and their claimed uses

  • Axona (caprylic triglyceride) – Alzheimer’s disease [4]
  • Banatrol Plus (banana flakes/bimuno) – Diarrhea [5]
  • Deplin (l-methylfolate) – Depression [6]
  • Fosteum (genistein aglycone/citrated zinc bisglycinate/cholecalciferol) – osteopenia and osteoporosis [7]
  • Limbrel (flavocoxid) – Osteoarthritis [8]
  • Metanx (L-methylfolate calcium/pyridoxal 5′-phosphate/methylcobalamin) – Diabetic neuropathy [9]
  • Theramine (l-arginine, 5-htp, histidine, l-glutamine) - Myalgia [10]

See also

References

  1. ↑ 1.0 1.1 FDA. CFR 21 Part 101 Subpart A. 
  2. ↑
  3. ↑
  4. ↑ "Axona homepage — Axona®: Fuel the Brain". About-axona.com. 2013-05-02. Retrieved 2013-08-30. 
  5. ↑ "Banatrol Plus". Medtrition.com. Retrieved 2013-08-30. 
  6. ↑ "Deplin® (L-methylfolate) | Official Site". Deplin.com. 2011-06-03. Retrieved 2013-08-30. 
  7. ↑ "Fosteum PLUS - The Purity of Genistein with the Strength of Calcium". Fosteum.com. 2013-05-31. Retrieved 2013-08-30. 
  8. ↑ "Osteoarthritis Information - Knee Osteoarthritis Symptoms". Limbrel. Retrieved 2013-08-30. 
  9. ↑ "Home". Metanx.com. 2013-01-24. Retrieved 2013-08-30. 
  10. ↑ http://journals.lww.com/americantherapeutics/pages/results.aspx?txtKeywords=theramine

External links

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