390 North Orange Avenue, Suite 2300 | Orlando, FL 32801 | United States
FDA Medical Foods

Medical foods are not regulated as drugs.

E: info@itbholdingsllc.com

Days
Hours
Minutes
Seconds
MeDICAL FOODS

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 and DRUGS

Medical foods are not drugs and, therefore, are not subject to any regulatory requirements that specifically apply to drugs.

CONTACT ITB HOLDINGS LLC