Medical foods are not regulated as drugs.
A medical food is formulated to be consumed or administered enterally and 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.
An example of a disease or condition that a medical food could be used to manage is phenylketonuria, a genetic disorder. Someone with this disorder may need medical foods that are formulated to be free of the amino acid phenylalanine.
A medical food is intended for use under the supervision of a physician. It doesn’t include products such as meal replacements or diet shakes, or products for the management of diseases, such as diabetes, that can be managed through modification of the normal diet alone.
Medical foods do not undergo premarket approval by the FDA. Still, medical food companies must comply with other requirements, such as current good manufacturing practices and registration of food facilities. Medical foods do not have to include a Nutrition Facts label on their labels.
However, any statements on their label or in other labeling must be truthful and not misleading.
A medical food must, at a minimum, meet the following criteria:
a) food for oral or tube feeding
b) labeled for the dietary management of a medical disorder, disease, or condition, and
c) to be used under medical supervision, and is primarily obtained through hospitals, clinics, and other medical and long term care facilities.
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 are to be used under medical supervision.
The term “medical foods” does not pertain to all foods fed to sick patients. Medical foods are specially formulated and processed (as opposed to a naturally occurring foodstuff used in its natural state) for the patient who is seriously ill or who requires the product as a major treatment modality.
Typical medical foods are enteral nutrition products provided through the gastrointestinal tract, taken by mouth, or provided through a tube or catheter that delivers nutrients beyond the oral cavity or directly to the stomach.
Medical Foods can be classified into the following categories:
- Nutritionally complete formulas
- Nutritionally incomplete formulas, including individual “modular” type products that may be mixed with other products before use (protein, carbohydrate, or fat modulars)
- Formulas for metabolic (genetic) disorders in patients over 12 months of age
- Oral rehydration products.
Medical foods are not drugs and, therefore, are not subject to any regulatory requirements that specifically apply to drugs.
Market size value in 2021 was $21.24 billion. However, revenue forecast in 2028 is $30.34 billion.
- Neurological & Psychological Disorders
- Metabolic Disorders
- Pain Management
- Gastrointestinal Disorders
- Drug Stores
- Online Channels
Manufacturers, exporters and importers are required to register their facilities with the U.S. FDA, and provide adequate assurances that these products meet applicable U.S. food safety standards.
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