Regulatory Compliance

MEDICAL FOODS ARE FDA REGULATED


Medical Foods and Convenience Packs (generic pharmaceuticals and Medical Foods in one package) are issued a separate NDC code by the FDA.

Prior to 1972, Medical Foods were regulated as drugs. In an attempt to promote product innovation, and because they were generally used under strict physician supervision, the classification was changed.

Medical Foods were recategorized under the Orphan Drug Act and are held to stringent standards.

All efficacy claims for Medical Foods must be based on recognized scientific principles and sound laboratory and clinical data (100th Congress Orphan Drug Act Amendment, 1988).

Medical Foods must be comprised of components designated as GRAS (Generally Recognized as Safe). This demands that all ingredients are deemed as non-toxic and safe by experts in the field.

Physicians are sometimes unaware that some of the products they regularly prescribe are actually classified as Medical Foods.

They have steadily gained clinical prominence and acceptance as a safer way to manage the metabolic processes underlying many chronic disease states.

By definition, a Medical Food must meet a specific nutritional need of a particular disease or condition.

"Although Medical Foods have been used for decades, they are poorly understood as a product category. Confusion about their classification and regulation derives in part from the fact that these products were regulated as drugs prior to 1988. The word 'food' in "Medical Foods" may contribute further to the confusion".

Published Abstract authored by Dr. Sarah Morgan, MD

FDA GUIDANCE FOR THE INDUSTRY

FIRST DATABANK registration

MEDISPAN registration

FDA REGISTRATIONS



Medical Foods are Not Vitamins or Supplements


Medical Foods are often confused with dietary supplements, however the terms are not interchangeable and Medical Foods have distinct regulatory guidelines.

While supplements may make claims to support a health function of the body, Medical Foods are intended only for the diseased population.

In 1990, the FDA stated that Medical Foods:

  • Ameliorate clinical manifestations of the disease
  • Favorably influence the disease process
  • Positively influence morbidity and mortality
    (patient outcomes)

All Medical Foods produced by Physician Therapeutics and distributed by HMA are in capsule form.