Medical Foods - Not Dietary Supplements

A common mistake made by those not completely familiar with medical foods (MF) is to confuse them with dietary supplements, because both types of products have nutritional ingredients. Medical Foods and Dietary Supplements are not interchangeable.

• Medical Foods & Dietary Supplements are discrete FDA regulatory classifications, as defined by the Orphan Drug Act for MFs and Dietary Supplement Health and Education Act (DSHEA) for supplements.
• MFs require physician supervision (and thus institutional administration or a prescription or close outpatient monitoring), whereas dietary supplements are sold OTC and are self-administered by the consumer.
• MFs are specially formulated for a diseased patient population, whereas dietary supplements are intended for a healthy consumer population.
• MFs make medical claims (i.e., to nutritionally manage the disease) whereas dietary supplements make structure/function claims (i.e., to support the healthy function of the particular body part or system) and are forbidden to make disease claims and drug claims.
• MF ingredients have a higher standard of safety (GRAS - Generally Recognized As Safe per FDA standards) whereas Congress exempted dietary ingredients from the GRAS standard, requiring only that their ingredients either have a mere presumption of safety (i.e., were on the market as foods or supplements prior to the passage of DSHEA in 1994), or a reasonable expectation of safety (shown through scientific evidence submitted 75 days pre-market).
• MFs must be first be shown, by medical evaluation, to meet the distinctive nutritional needs of a particular patient population before they may be marketed, whereas supplements a) may not be intended, promoted or sold for a disease, and b) require no efficacy tests or trials pre-market.
• MFs may be the sole nutrient or food of a patient group, e.g., terminal AIDS patients, whereas supplements may not be a meal replacement.
• Supplements as well as selected conventional foods are eligible to make certain categorized health claims (FDA pre-approved claims that a substance prevents or lowers the risk of a disease), whereas medical foods are not, given that they are intended for dietary management of an existing disease.
• While dietary supplements are governed by meticulous labeling regulations, including a detailed Supplement Facts box, there are virtually no labeling regulations for MFs, and they are exempt from the nutrition labeling regulations required for conventional foods.

While both supplements and MFs are both regulated by the FDA and the FTC, MFs must be administered under physician supervision whereas dietary supplements have no such requirement.