The definition of Medical Foods is contained in the 1988 Orphan Drug Amendments to the FDCA. Medical Foods are different from dietary supplements.
Medical Foods are used to meet the distinct nutritional requirements of patients due to a disease or condition. The ingredient(s) must be found in a food source – but the dose amount is administered at a level that addresses the distinct nutritional requirements that are not possible through a normal diet. All Medical Foods ingredients must have GRAS status (Generally Recognized as Safe or be approved food additives). Moreover, Medical Foods may only be used under medical supervision.
The regulatory body overseeing Medical Foods is the Center for Food Safety and Applied Nutrition (CFSAN). At Red River Pharma, we manufacture several state-of-the-art Medical Food products that are prescribed and dispensed nationwide and internationally. Our delivery formats include tablets, caplets and capsules in bottles, blisters and stick packs. Our manufacturing processes follow the strictest cGMP guidelines.
Red River Pharma has become one of the nation’s preeminent Medical Foods manufacturing sites. Our expertise in this category is a clear advantage for any company considering Medical Food production.
Click on any of the logos below to learn more about the products we produce.