Medical food

Specialized food products for dietary management of diseases

Medical food on an IV pole

Medical food is a category of products intended for the dietary management of a disease or condition that has distinctive nutritional needs that cannot be met by normal diet alone. These products are specially formulated and processed for the patient who is seriously ill or requires the product as a major component of a disease or condition's specific dietary management.

Definition and Regulation

Medical foods are defined in the United States under the Orphan Drug Act and are subject to the Food and Drug Administration's (FDA) regulations. Unlike dietary supplements, medical foods are intended for use under medical supervision and are not available for purchase by the general public without a prescription.

The FDA defines medical foods as "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."

Characteristics

Medical foods are distinct from conventional foods and dietary supplements in several ways:

• Formulation: They are specially formulated to meet specific nutritional requirements.
• Supervision: They require medical supervision for use.
• Labeling: They must be labeled for the dietary management of a specific disease or condition.

Examples of Medical Foods

Medical foods can come in various forms, including powders, liquids, and bars. Some common examples include:

• Enteral nutrition products: These are often used for patients who cannot consume food orally and require feeding through a tube.
• Metabolic disorder products: These are designed for individuals with specific metabolic disorders, such as phenylketonuria (PKU).
• Nutritional support for chronic diseases: Products that provide nutritional support for conditions like Alzheimer's disease, diabetes, and chronic kidney disease.

Usage and Administration

Medical foods are typically used in hospitals, clinics, and home care settings. They are administered under the guidance of healthcare professionals, such as physicians, dietitians, and nurses. The administration can be oral or enteral, depending on the patient's condition and ability to consume food.

Market and Industry

The medical food industry is a specialized sector within the broader healthcare and nutrition industries. Companies involved in the production of medical foods must adhere to strict regulatory standards and often engage in extensive research and development to create products that meet the specific needs of patients with various medical conditions.

Related Pages

• Dietary supplement
• Enteral nutrition
• Parenteral nutrition
• Orphan Drug Act
• Food and Drug Administration