Enteral diets that are formulated simply as adult meal replacements are considered to be foods by the U.S. FDA and are not regulated any differently than standard foods. Webster's Dictionary defines food as "material consisting essentially of protein, carbohydrate, and fat used in the body of an organism to sustain growth, repair, and vital processes, and to furnish energy; also such food together with supplementary substances (as minerals, vitamins, and condiments)." Like regular foods, enteral diets are formulated with items that are generally recognized as safe (GRAS) or items approved as food additives by the FDA.
The FDA has a role in approving or advising food manufacturers regarding the health messages for conventional foods. There are two opposing views about the potential effects of regulating such messages: if health claims are not allowed, then the public may not be informed of the potential benefit of consuming certain foods. On the other hand, allowing health messages on foods opens the door for false or exaggerated claims to be made. Recently, the policy of the FDA has been changing toward the allowance of certain health messages. Regulations or food labeling are detailed in two sections of the Code of Federal Regulations (111).
The development of more specialized enteral formulas for specific diseases has placed these formulas under increasingly intense secrutiny by the FDA. In 1988, the orphan drug amendment created a new category of food called medical food, which was defined as follows: "The term medical food means 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" (112). Implicit in this definition is the notion that disease conditions can change an individual's nutritional requirements or food intake leading to a deficiency or overabundance of a nutrient. Although the amendment did issue the definition of a medical food under the current federal regulations that implement the Food, Drug, and Cosmetic Act, there is no procedural framework for the evaluation of medical food products. This contrasts with the detailed regulations for the development and approval of new drugs and food additives as well as the regulations for the formulation and manufacture of infant formulas specified in the Infant Formula Act of 1980 (113).
Was this article helpful?