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.
IEMs include inherited biochemical disorders in which a specific enzyme defect interferes with the normal metabolism of protein, fat, or carbohydrate.
As a result of diminished or absent enzyme activity in these disorders, certain compounds accumulate in the body to toxic levels, and lead to a host of medical and developmental consequences ranging from intellectual disability to severe cognitive impairment and even death.
Some examples of specific IEMs that medical foods could be used to manage involve amino acid/protein, organic acid, or fatty acid metabolism:
▪ Phenylketonuria (phenylalanine restriction).
▪ Ornithine transcarbamylase deficiency (nonessential amino acid restriction).
▪ Methylmalonic acidemia (isoleucine, methionine, threonine, and valine restriction).
▪ Very long-chain acyl-CoA dehydrogenase deficiency (long chain fatty acid restriction with an increase in medium chain fatty acid levels).
Medical foods are not drugs and, therefore, are not subject to any regulatory requirements that specifically apply to drugs.
Moreover, unlike prescription drugs, medical foods are not required by federal law to be dispensed by prescription. Therefore, the use of the symbol “Rx only” in the labeling of a medical food would misbrand a medical food under section 403(a)(1) of the FD&C Act because it would be a false and misleading statement about that product.
However, FDA would not object to the use of language to communicate this requirement in the labeling of a medical food product that is not false or misleading (“must be used under the supervision of a physician”).
Global medical foods market size value is expected to reach $23.6 billion in 2023, then $30.34 billion in 2028.
Product Type
- Pills
- Powder
- Liquid
Application
- Diabetes
- Cancer
- Neurological & Psychological Disorders
- Metabolic Disorders
- Pain Management
- Gastrointestinal Disorders
- Ophthalmology
Distribution Channel
- Pharmacies
- Drug Stores
- Supermarkets
- Hypermarkets
- 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.
Medical foods manufacturers must comply with all applicable FDA requirements for foods, including the following regulations:
• Current Good Manufacturing Practice (CGMP) (21 CFR part 110).
• Registration of food facilities (21 CFR part 1 subpart H).
• Thermally processed low-acid foods packaged in hermetically sealed containers (21 CFR part 113).
• Acidified foods (21 CFR part 114).
• Emergency permit control (21 CFR part 108).
• As with any food, a medical food that bears a false or misleading claim would be considered misbranded under section 403(a)(1) of the FD&C Act.
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