Medical Foods Compliance

Medical foods have become a hot product category in recent years.  Have the confidence that your medical food is compliant with requirements before going to market. Get a Quote! The FDA defines medical foods as foods “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.”

Medical Foods can be classified into the following categories:

  1. Nutritionally complete formulas;
  2. Nutritionally incomplete formulas, including individual "modular" type products that may be mixed with other products before use (e.g., protein, carbohydrate, or fat modulars);
  3. Formulas for metabolic (genetic) disorders in patients over 12 months of age; or
  4. Oral rehydration products.

GRAS Ingredients for Medical Foods | GRAS Associates

Medical foods fall under the purview of food legislation but fits between foods, dietary supplements and drugs in the manner it can be distributed, manufactured, labelled and marketed.  Under the food category, ingredients contained in medical foods must be generally recognized as safe, be manufactured according to food GMPs (21 CFR part 110) and labels must be in compliance with food labelling requirements including food allergen labelling but are exempt from containing health or nutrient content claims. Under the definition of medical foods, not all foods, ingredients or dietary supplements can be a medical food.  It is important to remember and understand that medical foods are specially formulated and processed (not naturally occurring foodstuff), is intended for dietary management of patients who are unable to obtain nutrients through modifying the diet alone, are used under medical supervision and is intended only for patients requiring medical care on a recurring basis.