What You Should Know About Medical Foods

Clinical Dietary Management

Many foods claim to be healthy or have health benefits, but medical foods are in another category altogether. They’re regulated by the FDA under the Orphan Drug Act and are specially formulated to be consumed or administered orally or enterally. Because they should be used under physician supervision, one way to provide medical foods is by prescription to ensure proper, safe use. Doctors use medical foods to provide for the management of the distinctive nutritional requirements of people who have a variety of chronic medical conditions like IBS-D or IBD. They’re specially formulated and processed to help patients get results that are not achievable through normal dietary intake or dietary modification.

Is a Medical Food Right for Your IBS-D or IBD?

You and your doctor can discuss if adding a prescription medical food product to your diet can help you with one or more of the following therapeutic or chronic symptoms:

  • Limited or impaired capacity to ingest, digest, absorb, or metabolize ordinary foodstuffs or certain nutrients.
  • Chronic loose or frequent stools (diarrhea).

The FDA Orphan Drug Act

As defined by the Orphan Drug Act (1988 Amendment), a medical food is: 1

  • A food which is formulated to be consumed or administered enterally (orally) under the supervision of a physician
  • Intended for specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation

According to the FDA, a product must meet criteria in order to be considered a medical food (21 CFR 101.9 (j) (8))

FDA Criteria:

“It is a specially formulated and processed product (as opposed to a naturally occurring foodstuff used in its natural state) for the partial or exclusive feeding of a patient by means of oral intake or enteral feeding by tube;

It is intended for the dietary management of a patient who, because of therapeutic or chronic medical needs, has limited or impaired capacity to ingest, digest, absorb, or metabolize ordinary foodstuffs or certain nutrients, or who has other special medically determined nutrient requirements, the dietary management of which cannot be achieved by the modification of the normal diet alone;

It provides nutritional support specifically modified for the management of the unique nutrient needs that result from the specific disease or condition, as determined by medical evaluation;

It is intended to be used under medical supervision; and

It is intended only for a patient receiving active and ongoing medical supervision wherein the patient requires medical care on a recurring basis for, among other things, instructions on the use of the medical food.”

A Prescription Medical Food Product for People with IBS-D or IBD

A prescription medical food product is available specifically to help people who have IBS-D or IBD. There is no other prescription medical food product like it on the market; there is no generic substitute, and it is not available OTC.

Learn more >>

Sources:

Medical Food For Managing IBS-D EnteraGam®

1. Isaacson R. Medical foods: overview of an emerging science. Targeted Medical Pharma Web site. http://www.tmedpharma.com/docs/Medical-Foods-by-issacson.pdf. Accessed February 1, 2016.


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