Medical Foods: Science, Regulation, and Practical Aspects. Summary of a Workshop

Abstract

On August 13–14, 2019, the Healthcare Nutrition Council and the ASN held the Medical Foods Workshop: Science, Regulation, and Practical Aspects. Medical food products help patients manage their disease and improve their quality of life. Yet many hurdles exist to getting patients new products. In this workshop, participants addressed some of these hurdles, with specific emphasis on topics like the statutory term distinctive nutritional requirements, the regulatory term modification of the diet alone, the role of clinical guidelines, the requirement that medical foods be used under medical supervision, and differentiation of foods for special dietary use from medical foods, as well as product innovation and future research. Real-world examples were discussed for intractable epilepsy, diabetes, end-stage renal disease, and inflammatory bowel disease.

The emerging role of medical foods and therapeutic potential of medical food-derived exosomes

“…Recently, the range of medical food has been expanded to include medical foods to manage various diseases, such as inflammation, osteoporosis, and venous insufficiency, and it is subdivided into different categories, such as functional foods, nutraceuticals, and dietary supplements. 7 Functional foods are naturally occurring and modified foods with bio-functionalities. Alternatively, nutraceuticals are ingredients or food bio-actives with bio-functionality.…”

“…5 Medical food is consumed or administered under the supervision of a physician. 6,7 Specically, it is food with unique nutritional requirements determined by medical evaluation for the purpose of managing a specic diet for a disease or condition. 8,9 The rst medical food to be released was Lofenalac (Lofenala®) in 1958, which was initially classied as a drug by the FDA and then reclassied as medical food in 1972.…”

Enhancing cognitive function in older adults: dietary approaches and implications

“…Of importance, in the US, “medical food” can legally refer only to food that treats a condition with a distinctive nutritional requirement ( 49 ). However, major neurocognitive disorder does not have such a requirement.…”

Use of Medical Foods to Fight Chronic Diseases: A Narrative Review

“…One of the first examples of medical foods was "Lofenalac", which was used for the dietary management of patients in the treatment of phenylketonuria (PKU), an inborn disease of metabolism. In 1988, the Orphan Drug Act was rearranged to create a legal definition for the term medical food (Holmes et al 2021). In 1990, the Nutritional Labeling and Education Act (NLEA) exempted medical foods from the health claims and nutrition labeling requirements.…”