Rx Medical Food Market, by Product Type (Pills, Powder, Liquid, Others (Wafers, Chewable, and Bars)), by Therapeutic Application (Pain Management, Neurological Disorders, Gastrointestinal Disorders, Pulmonary Disorders, Metabolic Disorders, Others (Fibrosis, Dialysis, AIDS, etc.)), by Distribution Channel (Retail Pharmacies, Hospital Pharmacies), and by Region (North America, Latin America, Europe, Asia Pacific, Middle East, and Africa)- Size, Share, Outlook, and Opportunity Analysis, 2022 - 2030
Medical food is a category of food products for dietary management or preventive therapy for specific disease or medical conditions such as pulmonary, gastrointestinal, and metabolic disorders. Ingredients used in medical foods must have ‘generally recognized as safe’ (GRAS) status. Medical food is different from nutritional food, dietary supplements, and prescription drugs. Medical food is protein-based, nutrient-based (Omega 3 fatty acids, chelated zinc, and isoflavones), and may contain minerals and vitamins such as folic acid and thiamine. These products are prescribed by physicians or taken under their supervision. The U.S. Food & Drug Administration (FDA) has classified medical foods into four major categories; nutritionally complete products, nutritionally incomplete products, formulas for metabolic disorders, and oral rehydration solutions. The U.S. Food and Drug Administration separately regulates medical food under Orphan Drug Act (1988) to ensure safety of populace and curb presence of products falsely claiming to cure medical conditions. Medical food does not require premarket approval, specification as an investigational new drug (IND), and individual registration with the FDA. However, they are required to support all their health claims with proper laboratory and clinical studies.
Market Dynamics
Increasing number of organic strategies such as collaboration by the various regulatory authorities is expected to drive the global Rx medical food market over the forecast period. For instance, in October 2021, Food Safety and Standards Authority of India (FSSAI) had signed an agreement with Ministry of Food Processing Industries (MoFPI) to support Farmer Producer Organizations (FPOs), Micro Level Food Entrepreneurs, Self Help Groups (SHGs) and Producers Cooperatives to improve the standards of their food business. This agreement will include food safety training and Registration & License of the Micro Enterprises. FSSAI and MoFPI support micro enterprises for obtaining FSSAI license and registration.
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