Medical Foods in the United States are a special and growing food category that is designed to meet the nutritional needs of patients with specific diseases or medical conditions. The following is a detailed introduction to medical foods in the United States:

01 Definition and regulation

Medical food is a food that is distinct from dietary supplements and must have a medical purpose. The U.S. Food and Drug Administration (FDA) defines it as a food that is formulated for consumption or enteral administration under the supervision of a physician for the specific dietary management of a disease or condition whose unique nutritional requirements are determined through medical evaluation based on recognized scientific principles. Although medical foods are used by patients, they are regulated as foods (not medicine).

The FDA provides a more detailed statement of this concept in 21 CFR§101.9(j)(8).

• It is a specially formulated and processed product (as distinguished from whole food or food in its natural state) used for partial or complete nutritional supply of patients by oral or enteral feeding;

• It is designed to provide dietary management for patients whose ability to ingest, digest, absorb or metabolize ordinary foods or certain nutrients is limited or impaired due to treatment or chronic illness, or who have other medically determined special nutritional needs that cannot be met by normal dietary modifications alone;

• It provides nutritional support specifically tailored to the unique nutritional needs resulting from a specific disease or condition, as determined by a medical evaluation;

• It is intended for use under medical supervision;

• It is intended only for patients who are under active and ongoing medical supervision and who require regular medical care for a variety of reasons, including instructions for the use of medical foods.

02 Requirements for raw materials

According to Article 18 of the FAQs on Medical Foods (3rd Version) jointly issued by the U.S. Department of Health and Human Services, the Food and Drug Administration, and the Center for Food Safety and Applied Nutrition, ingredients added to medical foods should be safe and comply with all applicable provisions of the FD&C Act and FDA regulations.

(1) Use food additives in accordance with FDA’s food additive regulations (see 21 CFR part 172);

(2) Use colorants in accordance with colorant regulations (see 21 CFR parts 73 and 74);

(3) A substance generally recognized by qualified experts to be safe under the conditions of its intended use (generally recognized as safe (GRAS)) (see 21 CFR 170.30 and 21 U.S.C. 321(s));

(4) Substances approved in advance (see 21 CFR 170.3(1), 21 U.S.C. 321(s)(4)).

03 Product type

In the United States, medical foods are generally divided into three categories:

1) Products that contain all nutrients except pathogenic nutrients (such as phenylalanine or tyrosine);

2) Modular products, which can be used alone or combined with other products to meet specific nutritional needs, such as pills, capsules, amino acid mixes and drinks;

3) Low-protein foods, covering a variety of baked goods, pasta, rice, meat and cheese alternatives, and snacks.

04 Differences from dietary supplements

As shown in the above figure, medical foods are clearly different from dietary supplements. Like regular foods, they all fall into the category of food regulated by the FDA. The key difference between them and dietary supplements is that dietary supplements are provided to healthy people to meet their dietary needs to maintain or enhance their health and do not involve medical treatment; while medical foods are dietary management for specific diseases that require special nutritional needs.

Source: Antion

Note: This article is compiled by Antion. Please indicate the source for reprint.