Medical Foods: An Emerging Category

Medical foods sit between supplements and pharmaceuticals on the regulatory spectrum.

It is widely understood that nutrition plays an important role in maintaining health. Obtaining the right nutrients in the right amounts is generally accepted to be an appropriate component of managing patients who are at risk of or experiencing disease. With the baby boom generation reaching the age at which many age-related conditions manifest and metabolic processes begin to decline, the appropriate nutritional management of this rapidly expanding demographic is a growing area of focus for eye care practitioners. As this population ages, a little-known food category—medical foods—is poised to expand significantly to meet the needs of these patients.

Medical foods are products formulated to address nutritional deficiencies relating to specific diseases or conditions. In the context of eye care, the macular pigment (a layer of carotenoid molecules deposited in the retina) is a modifiable risk factor for several eye diseases, including age-related macular degeneration (AMD).1 Macular pigment has been shown to be lower in patients with AMD,2 glaucoma,3 diabetic retinopathy,4 and even in Alzheimer disease,5 as well as being a biomarker for cognitive function.6

Depleted macular pigment is a condition with a specific nutritional requirement. The average American obtains less than 2 mg of macular carotenoids per day, well below the level needed to restore and maintain the macular pigment.7 For patients with disease risk factors, including a low level of macular pigment, a medical food specifically formulated to address this condition may be considered.

Medical foods are regulated by the US Food and Drug Administration (FDA).8 Although medical foods do not need premarket approval (as is the case with pharmaceuticals), the category is regulated more closely than the nutritional supplement market, and manufacturers of medical foods must register their medical food status with the FDA.

Also unlike with nutritional supplements, a health care practitioner must administer the medical food—medical foods cannot be bought over the counter other than directly from a medical practice—and patients must be supervised in taking the medical food as part of their ongoing care.

A medical food is defined by the FDA 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.”8

If the regulatory control landscape is thought of as a spectrum, with dietary supplements at one end and pharmaceuticals at the other, medical foods sit squarely in between. They represent a more closely regulated category than supplements available over the counter, with tighter controls on both the ingredients included and the claims attached to the product.

From the perspective of patients, medical foods represent a category of products that are formulated to manage their specific conditions, provided by and supervised by their physicians. Medical foods are tax-deductible, they may be purchased with a health savings account or flexible spending account, and they may be covered by insurance, depending on provider and terms.

As eye care continues to develop and incorporate nutrition as a vital component of a complete approach to eye health, medical foods are poised to be a key contributor to patient care.

1. Nolan JM, Stack J, O’ Donovan O, et al. Risk factors for age-related maculopathy are associated with a relative lack of macular pigment. Exp Eye Res. 2007;84(1):61-74.

2. Bernstein PS, Zhao DY, Wintch SW, et al. Resonance Raman measurement of macular carotenoids in normal subjects and in age-related macular degeneration patients. Ophthalmology. 2002;109(10):1780-1787.

3. Igras E, Loughman J, Ratzlaff M, et al. Evidence of lower macular pigment optical density in chronic open angle glaucoma. Br J Ophthalmol. 2013;97(8):994-998.

4. Lima VC, Rosen RB, Maia M, et al. Macular pigment optical density measured by dual-wavelength autofluorescence imaging in diabetic and nondiabetic patients: a comparative study. Invest Ophthalmol Vis Sci. 2010;51(11):5840-5845.

5. Nolan JM, Loskutova E, Howard AN, et al. Macular pigment, visual function, and macular disease among subjects with Alzheimer’s disease: an exploratory study. J Alzheimers Dis. 2014;42(4):1191-1202.

6. Kelly D, Coen RF, Akuffo KO, et al. Cognitive function and its relationship with macular pigment optical density and serum concentrations of its constituent carotenoids. J Alzheimers Dis. 2015;48(1):261-277.

7. Bernstein PS, Delori FC, Richer S, et al. The value of measurement of macular carotenoid pigment optical densities and distributions in age-related macular degeneration and other retinal disorders. Vision Res. 2010;50(7): 716-728. doi:10.1016/j.visres.2009.10.014.

8. US Food and Drug Administration. Guidance for Industry: Frequently Asked Questions About Medical Foods; Second Edition. May 2016. http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/MedicalFoods/ucm054048.htm. Accessed August 25, 2016.