Medical Foods

Fosteum: Medical Food Product Medical foods are an official FDA category of products that must have therapeutic value based on recognized science. All medical foods must meet the distinctive dietary requirements of a particular disease. According to the FDA and by law, medical foods must be given orally, manage a particular dietary need for the given disease, and be taken under a medical physician’s supervision. Fosteum is developed, manufactured, and labeled in accordance with both the statutory and FDA regulatory definitions of a medical food.

Medical food ingredients are food ingredients and therefore must be Generally Recognized As Safe (GRAS), a strict FDA standard indicating a product is safe for its intended use. The standard for an ingredient to achieve GRAS status requires not only technical demonstration of non-toxicity and safety, but also general recognition and agreement on that safety by experts in the field.

Fosteum has been developed, manufactured and labeled in accordance with all applicable federal and state laws and regulations. Fosteum is an FDA-regulated, prescription-only product which is to be used under the supervision of a physician.

Medical Foods and Supplements are not Interchangeable

A common mistake is to confuse medical foods with supplements because both types of products contain nutritional ingredients. MEDICAL FOODS AND SUPPLEMENTS ARE NOT INTERCHANGEABLE. Medical foods are a separate regulatory classification from supplements. Some of the differences between medical foods and supplements are:

  • Medical foods must be shown to meet the distinctive nutritional needs of a particular patient population in clinical trials before they may be marketed, while supplements require no efficacy tests or clinical trials.
  • Medical foods require medical physician supervision whereas supplements are intended for use by the consumer without medical supervision.
  • Medical foods are specially formulated for a diseased patient population whereas supplements are intended to maintain health in a consumer population.
  • Medical foods make medical claims (i.e., to manage the disease) whereas supplements are forbidden to make disease claims.
  • Medical foods are intended for dietary management of an existing disease. Supplements are intended to maintain structure and/or function in a healthy population.
  • Medical food ingredients require a higher standard of safety (GRAS – Generally Recognized As Safe per FDA standards). Supplements need only have a “presumption of safety”.

Medical foods and supplements are defined as separate categories of products by Federal statutes. Each category’s regulations are enforced separately by the FDA, FTC and state laws. A medical food is a medical product, prescribed and supervised by a physician, whereas a supplement is a consumer product which can be purchased by anyone for their own unsupervised use.

Medical foods have historically been found in hospitals whereas supplements are found in retail stores. Medical foods generally provide higher standards of product quality, safety and claims support.


Talk to your doctor about Fosteum

Last modified on 07-25-2007