MEDICAL FOOD SERVICES

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 notes:

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

There are five criteria for a medical food:

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.

Medical foods are labeled as foods, but are exempted from the labeling requirements that apply to nutrient content claims and health claims under the Nutrition Labeling and Education Act of 1990. Current good manufacturing practices (CGMPs) apply.

We recognize the regulatory differences between:

• Beverages
• Color Additives
• Dietary Supplements
• Food Additives
• Foods
• GRAS (Generally Recognized as Safe) Ingredients
• Homeopathic Drugs
• Medical Devices
• Medical Foods
• New Dietary Ingredients (NDIs)
• Over-the-Counter Drugs
• Weight-Loss and Diet Products

We also understand the subtle distinctions between various claims and how to craft claims, including:

• Health Claims
• Nutrient Content Claims
• Qualified Health Claims
• Structure/Function Claims

If you think your product might be a medical food, contact our experienced FDA legal team for a consultation.