Ingredients used in medical foods must have generally recognized as safe (GRAS) status, which is assigned to naturally found food materials. 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 namely, nutritional complete products, nutritionally incomplete products, formulas for metabolic disorders, and oral rehydration solutions. The U.S. FDA separately regulates medical food category 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.

The global Rx medical food market was valued at US$ 14,504.6 million in 2016 and is expected to witness a robust CAGR of 7.0% over the forecast period (2017-2025).

Some major players operating in the Rx medical food market are Abbott Laboratories, Danone, Mead Johnson & Company, LLC, Fresenius Kabi AG, Nestle, Primus Pharmaceuticals, Inc., Targeted Medical Pharma, Enzymotec ltd., AlfaSigma, and Pivotal Therapeutics.

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Increasing regulatory support and awareness about medical food among healthcare professionals is expected to fuel market growth

The U.S. FDA amended regulations related to formulation and marketing of medical food in 2013, the category, which was previously ill-defined. The new additions clarified some issues associated with marketing and branding of medical food products. Furthermore, the U.S. FDA also states that medical food does not require prescription, rather requires to be consumed under the supervision of a medical practitioner. Furthermore, the medical food market is expected to gain traction, owing to major investments by players such as Nestlé and Danone in research and development of medical foods along with widening scope of applications such as chronic pain, and personalized medicine. Medical food currently available in the market include Axona (Accera), Limbrel, Deplin, Lofenalac, Ensure, Vasculera, and Vascazen.

North America is expected to hold a dominant position in the Rx medical food market over the forecast period, followed by Europe and Asia-Pacific

North America accounts for the largest share in the Rx medical food market, followed by Europe and Asia-pacific. The regulatory authorities in North America and Europe have clearly defined and distinguished the medical food category. The CRN will provide a common platform for major players in the industry to work together towards the advancement of medical food and to increase awareness about medical food among healthcare practitioners and consumers. Nestlé has set out a US$ 500 Mn budget to support medical food research by 2021, which is expected to boost growth of the Rx medical food market over the forecast period.

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