TARGET HEALTH excels in Regulatory Affairs and works closely with many of its clients performing all FDA submissions. TARGET HEALTH receives daily updates of new developments at FDA. Each week, highlights of what is going on at FDA are shared to assure that new information is expeditiously made available.

Medical Food

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.” The FDA advises that it considers the statutory definition of medical foods to narrowly constrain the types of products that fit within this category of food (see Food Labeling; Reference Daily Intakes and Daily Reference Values; Mandatory Status of Nutrition Labeling and Nutrition Content Revision proposed rule (56 FR 60366 at 60377, November 27, 1991)).

Medical foods are distinguished from the broader category of foods for special dietary use and from foods that make health claims by the requirement that medical foods be intended to meet distinctive nutritional requirements of a disease or condition, used under medical supervision and intended for the specific dietary management of a disease or condition. The term “medical foods” does not pertain to all foods fed to sick patients. Medical foods are foods that are specially formulated and processed (as opposed to a naturally occurring foodstuff used in a natural state) for the patient who is seriously ill or who requires the product as a major treatment modality. In general, to be considered a medical food, a product must, at a minimum, meet the following criteria:

  1. the product must be a food for oral or tube feeding;
  2. the product must be labeled for the dietary management of a specific medical disorder, disease, or condition for which there are distinctive nutritional requirements;
  3. the product must be intended to be used under medical supervision 

The following criteria that clarify the statutory definition of a medical food can be found in the agency’s regulations at 21 CFR 101.9(j) (8). A food is a medical food exempt from nutrition labeling only if:

  1. It is a specially formulated and processed product (as opposed to a naturally occurring foodstuff used in its natural state) for the partial or exclusive feeding of a patient by means of oral intake or enteral feeding by tube;
  2. It is intended for the dietary management of a patient who, because of therapeutic or chronic medical needs, has limited or impaired capacity to ingest, digest, absorb, or metabolize ordinary foodstuffs or certain nutrients, or who has other special medically determined nutrient requirements, the dietary management of which cannot be achieved by the modification of the normal diet alone;
  3. It provides nutritional support specifically modified for the management of the unique nutrient needs that result from the specific disease or condition, as determined by medical evaluation;
  4. It is intended to be used under medical supervision; and
  5. It is intended only for a patient receiving active and ongoing medical supervision wherein the patient requires medical care on a recurring basis for, among other things, instructions on the use of the medical food.

 

Examples of Medical Foods include:

Folgard RX 2.2®: This medical food is indicated for the management of elevated homocysteine, or hyperhomocysteinemia, associated with cardiovascular disease, stroke, and other diseases. Folgard is a formula containing folic acid, vitamin B6 and vitamin B12, designed to lower plasma homocysteine levels.

LimbrelTM: This medical food is used in the nutritional management of metabolic processes associated with osteoarthritis. Damaged joints release excess phospholipids, which increase the production of prostaglandins and leukotrienes, leading to an inflammatory response. Limbrel is formulated with naturally occurring ingredients that inhibit the two enzymes lipoxygenase and cycloxygenase responsible for the production of inflammatory irritants.

 

For more information about our expertise in Regulatory Affairs, please contact Dr. Jules T. Mitchel or Dr. Glen Park.

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