2. be labeled for the dietary management of a specific medical disorder, disease or condition for which there are distinctive nutritional requirements. 3. be intended to be used under medical supervision. Medical foods are foods that are specially formulated and processed, as opposed to naturally occurring foodstuffs used in their natural state. Medical foods are generally not available on the retail shelf. Medical foods are not foods that are simply recommended by a physician or health care professional as part of an overall diet designed to reduce the risk of disease or medical condition, such as weight loss products.
Health claims require prior regulatory approval.
Implied health claims include those statements, symbols, vignettes, or other forms of communication that suggest, within the context in which they are presented, that a relationship exists between the presence or level of a substance in food and a disease or health-related condition. The FDA considered both products to be unapproved drugs. 2. is intended for ingestion in pill, capsule, tablet, or liquid form. 3. is not represented as a conventional food or as the sole item of a meal or diet. Health claims concern the risk reduction of a health problem.