Future fuel: The use of 'medical food' in disease management
MDlinx Mar 06, 2024
The market for medical food is growing, due in large part to the increased prevalence of chronic disease. Many patients struggle with nutrient deficiencies secondary to genetic or chronic diseases (eg, phenylketonuria [PKU], UC, Crohn’s disease) and their associated drug treatments.
An early example of medical food is Lofenalac, which was used to treat patients with PKU. Before 1972, the FDA regulated medical foods as drugs.
In 1988, the Orphan Drug Act was amended, creating a statutory definition of medical food.
What is a medical food?
A medical food has a medical purpose. It is defined by the Orphan Drug Act as “a food which is 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.”
US FDA. Medical Foods Guidance Documents & Regulatory Information. January 25, 2022.
Technically, as explained in a review published in the Journal of Future Foods, medical foods are functional foods but differ in that they are formulated for a special dietary use intended to meet distinctive nutritional requirements of a disease or condition. They are also used under medical supervision during the specific dietary management of a disease or condition.
Li S, Ho C-T, Lange KW. Medical foods in USA at a glance. J Future Foods. 2021;1(2):141–145.
“They are not like those simply recommended by a physician as a diet to co-manage a disease or condition,” the review authors state, “neither a naturally occurring foodstuff used in a natural state for a patient, such as a plant without processing to treat a disease or to manage a patient condition with a specific diet.”
Medical foods are used in the dietary management of patients who have a limited or impaired capacity to ingest, absorb, digest, or metabolize regular foods and nutrients. In these patients, dietary management alone cannot achieve nutrient requirements. Medical foods are exempt from nutrition-labeling regulations.
Holmes JL, Biella A, Morck T, et al. Medical foods: science, regulation, and practical aspects. Summary of a workshop. Curr Dev Nutr. 2021;5(Suppl 1):nzaa172.
Medical foods are used as part of active and ongoing medical supervision. Patients requiring medical foods need medical care on a regular basis, as well as instruction on how to use medical foods.
Categorizing medical foods
There are three categories of medical foods, according to the Journal of Future Foods:
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Products that have the full range of nutrients, sans the offenders, such as phenylalanine or tyrosine; examples include Lofenalac, Ketonex-2, and Propimex
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Modular products such as capsules, pills, amino acid mixtures, and beverages; examples include GlutarAde and Foltx
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Low-protein foods found in a variety of baked goods, rice, meat, cheese, and pasta substitutes
More specific examples include:
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LIPISORB used in the treatment of patients with AIDS with fat malabsorption
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Carb Zero used in keto diets
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Souvenaid used to support memory function in early Alzheimer's disease
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KetoVie Peptide used in the dietary management of intractable epilepsy
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Cesinex used to treat diarrhea
Controversies regarding medical food
Medical foods are not subject to FDA regulation. As a review article in Clinical Therapeutics points out, medical foods undergo no premarket review or approval, and they can be dispensed without a prescription.
Markowitz JS, Gurley PC, Gurley BJ. Medical foods—a closer look at the menu: a brief review and commentary. Clin Ther. 2020;42(7):1416–1423.
In 2013, the FDA issued new guidance on when an Investigational New Drug application (IND) is required to conduct research with medical foods. This guidance continues to stoke controversy among physicians.
“The guidance essentially states that clinical investigations intended only to evaluate the nutritional effects or tolerability of a medical food do not require an IND. However, if investigators intended to evaluate other effects of a food on the structure or function of the body, then an IND would be required,” the review authors wrote.
Another concern over medical foods is third-party coverage, or lack thereof. Such coverage is not uniform across insurers or states, and Medicare and Medicaid don’t cover medical foods.
Looking forward
Most US medical foods were initially created to treat metabolic diseases. During the past decade, the number of products has increased, as more diseases are recognized as having a metabolic basis. The “foods” are available as pills, capsules, tablets, or drinks.
The Journal of Future Foods authors made projections about what’s to come for medical foods.
“With the emergence of functional food research and awareness,” they wrote, “medical food products are currently developed rapidly and will grow significantly in the near future, in particular, as future foods to prevent and manage chronic diseases and conditions. Large-scale studies are required to establish the effectiveness of medical foods, and the combination of medical foods with other non-pharmacological approaches should also be encouraged.”
What this means for you
Despite being available without a prescription, medical foods should only be used under close monitoring by a physician. Patients should be carefully instructed on their use. Coverage of medical foods remains an issue among payors.
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