Meidcal Food - iNmed Food lifeScience

Why medical foods
Difference between medical food and dietary supplement
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.
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.
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 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.

Comparison between Medical Foods, Dietary Supplements & New Drugs

DIFFERENCE	Medical Foods	Dietary Supplements	New Drugs
Intended Use	Clinical dietary management of patients	Health Promotion of healthy individuals	Treatment of patients
Product Claims	"For the dietary management of a disease"	"Promote a health condition"	"For the treatment of a disease"
How to use	Under medical supervision	With self-responsibility	Under medical supervision
Ingredients & safety	Only GRAS (ingredients generally recognized as safe	Food ingredients & NDI (ingredients considered as safe) can be also used	New chemical compounds for which safety was demonstrated in newly conducted studies
Effectiveness	Required to be demonstrated by a clinical study	Not required	Required to be demonstrated by a clinical study