The Strength of Calcium
with the Purity of Genistein
Pay no more than $45 on every Fosteum prescription

About

Medical Foods

What Are Medical Foods?

Medical foods are an official Food and Drug Administration (FDA) category of products that must have therapeutic value based on recognized science. The name “medical foods” was chosen by the FDA. 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 (by mouth), must manage a particular dietary need for the given disease, and must be taken under a medical physician's supervision. Fosteum PLUS 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 that 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 PLUS has been developed, manufactured and labeled in accordance with all applicable federal and state laws and regulations. Fosteum PLUS 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 THE SAME. 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, but supplements need no clinical trials or tests for effectiveness. Medical foods require medical physician supervision whereas supplements are intended for use by the general public without medical supervision. Medical foods are specially formulated for patients with a specific disease whereas supplements are intended to maintain health in a the general population.
  • Medical foods make medical claims (i.e., to manage the disease) but 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, the Federal Trade Commission (FTC) and state laws. A medical food is a medical product, prescribed and supervised by a physician, whereas a supplement is a consumer product that 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.

  • Why Fosteum Plus?
  • Why Medical Foods?
Why Fosteum Plus?
Fosteum PLUS is the only product available clinically proven to manage bone loss that offers calcium, phosphate and MK-7 in a single capsule along with genistein, citrated zinc bisglycinate and vitamin. Each ingredient is chosen for its specific action in helping to build quality bone.
Why Medical Foods?
Medical foods are an official Food and Drug Administration (FDA) category of products that must have therapeutic value based on recognized science. The name “medical foods” was chosen by the U.S. Congress. All medical foods must meet the distinctive dietary requirements of a particular disease.