How Do Medical Foods Work?
Medical Foods function differently for various disease states and conditions. There are medical foods that address specific disease related neurotransmitter deficiencies ( Theramine® , Sentra PM®, Sentra AM®), disease induced folate deficiencies (Deplin®), and glucose deficiencies associated with alzheimers disease (Axona®). There are also medical foods that are commonly used in hospital settings to provide enteral nutrition and are commonly classified as Nutritionally complete formulas, Nutritionally incomplete formulas, Formulas for metabolic disorders or Oral rehydration products (Peptamen®). All medical foods are intended for the dietary management of disease for which there are established distinctive nutritional requirements that are based on recognized scientific principles and medical evaluation.
Medical Foods provide the human body with basic nutrients that affect the function of the autonomic nervous system, operating through its neurotransmitters, controls important body functions, such as heart rate, respiratory rate, gastrointestinal function, appetite, sleep, sexual performance, blood pressure, and mood. Additionally, neurotransmitters and neuromodulators play a crucial role in regulating the function of the cardiovascular, reproductive, musculoskeletal, immune, respiratory, and memory systems.
Generally Recognized as Safe (GRAS) Ingredients and Medical Foods
Generally Recognized as Safe (GRAS)
"GRAS" is an acronym for the phrase Generally Recognized As Safe. Under sections 201(s) and 409 of the Federal Food, Drug, and Cosmetic Act (the Act), any substance that is intentionally added to food is a food additive, that is subject to premarket review and approval by FDA, unless the substance is generally recognized, among qualified experts, as having been adequately shown to be safe under the conditions of its intended use, or unless the use of the substance is otherwise excluded from the definition of a food additive. Under sections 201(s) and 409 of the Act, and FDA's implementing regulations in 21 CFR 170.3 and 21 CFR 170.30, the use of a food substance may be GRAS either through scientific procedures or, for a substance used in food before 1958, through experience based on common use in food. Under 21 CFR 170.30(b), general recognition of safety through scientific procedures requires the same quantity and quality of scientific evidence as is required to obtain approval of the substance as a food additive and ordinarily is based upon published studies, which may be corroborated by unpublished studies and other data and information.
Under 21 CFR 170.30(c) and 170.3(f), general recognition of safety through experience based on common use in foods requires a substantial history of consumption for food use by a significant number of consumers.
Medical foods must comply with all applicable requirements for the manufacture of foods, including the Current Good Manufacturing Practices regulations (21 CFR part 110), Registration of Food Facilities requirements (21 CFR part 1 Subpart H) and, if applicable, the Low Acid Canned Food regulations (21 CFR part 113) and Emergency Permit Control regulations (21 CFR part 108). Ingredients used in medical foods must be approved food additives or a food additive that is the subject of an exemption for investigational use (21 U.S.C. 321 and 348), if the ingredients are not Generally Recognized as Safe (GRAS).
Medical Foods are Regulated by the FDA Compliance Program
The Compliance Program enables FDA inspectors to obtain information regarding the manufacturing/control processes and quality assurance programs employed by domestic manufacturers of medical foods through establishment inspections, collect domestic and import surveillance samples of medical foods for nutrient and microbiological analyses, and take action when significant violations of the Federal Food, Drug and Cosmetic Act (or related regulations) are found.