What to Know About Medical Foods

The FDA defines a medical food as a food that is made to be consumed enterally (orally or by tube feeding), administered by a healthcare provider, and used to manage a medical condition for which there are distinct dietary requirements.

This is different from your healthcare provider telling you to eat less fried food and more veggies. You won't find medical foods at the grocery store. Much like a prescription drug, medical foods are given to patients for specific dietary needs related to their specific disease or condition.

This article takes a closer look at what medical foods are, why they are ordered, and how they are regulated by the FDA. It also includes examples of medical foods and the respective medical conditions they are used for.

What Are Medical Foods?

At minimum, to be a medical food, a product must be specially formulated and processed for the purpose of oral or tube feeding by a healthcare provider.

Medical foods are intended for people who, due to specific medical needs, are unable to ingest, digest, absorb, or metabolize ordinary foods or certain nutrients.

For those who require medical foods, simply modifying their normal diet is not enough to meet their medical needs. Medical foods are therefore necessary to manage the nutritional needs that result from their condition.

Examples of Medical Food Use

Many medical conditions cause nutritional deficiencies that cannot be managed through dietary modifications alone.

Malabsorption, in which a person's body cannot digest or absorb nutrients in food, is one such condition that commonly calls for a medical food. Crohn's disease and ulcerative colitis both cause malabsorption, potentially necessitating the use of medical food to meet nutritional needs.

Cancer treatments, particularly chemotherapy, can also result in severe nutritional deficiencies, such as folate deficiency. In this case, a medical food may be formulated with folate to address the deficiency.

Other examples of medical foods and their uses include:

• LIPISORB: A medical food containing vitamins A, B1, C, D3, E, K, folic acid, and other nutrients; administered to people with AIDS to manage fat malabsorption
• Souvenaid: A medical food containing vitamins B6, B12, C, E, selenium, folic acid, omega-3 fatty acids, and other nutrients; administered to people with early-stage Alzheimer's disease to support memory function
• OXEPA: A medical food containing taurine, calcium, magnesium, and various vitamins and minerals; administered to people with severe lung injuries or who require ventilation
• Cesinex: A medical food containing tannic acid and dried egg whites; administered to people experiencing severe diarrheal diseases, like dysentery

While a prescription is not required to use a medical food, the FDA expectation is that medical foods would be used only under medical supervision. In order to use a medical food, you will need to be consistently monitored by a healthcare provider for your condition.

FDA Regulations for Medical Foods

Medical foods are not regulated in the same way that pharmaceutical drugs are. They fall under the FDA's food category, and like other food products, they are required to meet certain labeling requirements, such as listing all ingredients on the packaging.

Medical foods are often referred to as GRAS, which stands for ​"generally recognized as safe." In order for the FDA to give this recognition, the FDA requires that the producer prove their product is safe for its intended use.

This most often requires companies to go through similar procedures you might see when drugs are evaluated for approval by the FDA. A company may need to demonstrate animal studies, case studies in patients, or other unpublished studies and data to prove their medical food product's safety.

Any company processing, packing, or holding medical foods must register with the FDA. This allows the FDA to conduct site visits to facilities where medical foods are produced to ensure the producer is fully compliant with FDA standards for safety and efficacy.

Additionally, nutrient and microbiological analyses of medical foods are performed for all medical foods.

Summary

Medical foods are foods formulated to address nutritional deficiencies that cannot be managed through typical dietary modifications. They are administered by healthcare providers to people who are unable to ingest, digest, absorb, or metabolize ordinary foods or nutrients due to a medical condition.

While the FDA does not regulate medical foods in the same way they regulate pharmaceutical drugs, medical food producers must still prove that their product is safe for its intended medical use.

A Word From Verywell

Although a prescription is not required to use a medical food, keep in mind that medical foods are only considered safe when administered by a healthcare provider for the product's intended use. Even if you recognize all the vitamins and other ingredients listed on a medical food's packaging, you should not use the product unless your healthcare provider is monitoring you.