Visbiome’s Medical Food Status
Visbiome is thought of as a medical food that is used for the dietary management of pouchitis, ulcerative colitis (UC) and irritable bowel syndrome (IBS).
Visbiome™ is regarded a medical food as it is defined by the Orphan Drug Act and additional FDA regulations. Visbiome™ is specially formulated and processed to give a particular mixture of certain bacterial strains to the gastrointestinal tract.
We know that the gastrointestinal “microbiome” or microflora, is very important to help in the day-to-day normal functioning of the human gastrointestinal tract. Those suffering with UC, IBS, and pouchitis have documented deficiencies in luminal concentrations of lactobacilli and bifidobacteria compared with healthy individuals.
Also, frequent and/or long-term use of antibiotic treatment in these patient populations can result in extended exacerbation and deficiencies in the microbiome.
That’s why UC, IBS and ileal pouch sufferers have a greater nutritional requirements that are not the same as the general population. They need to be consuming high levels of probiotic bacteria to maintain an adequate and balanced microflora. In these people. It has been found that sufficient adjustment of the microflora can’t be achieved through modification of the normal diet.
Visbiome™ is intended for those with UC, IBS or an ileal pouch who are receiving active and ongoing medical supervision with regular instruction on the use of medical foods.
The Orphan Drug Act defined a “medical food” as “a food which is formulated to be consumed or administered enterally under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation” [21 U.S.C. § 360ee(b)(3)]. The regulation in 21 C.F.R. 101.9(j)(8) sets forth criteria that a medical food must meet.
Based on this information, the regulation outlines that a food is a medical food only if:
- It is a specially formulated and processed product (different to a naturally occurring food substance used in its natural state) for the partial or exclusive feeding of a patient either through being taken in orally or via an enteral feeding tube;
- It is intended for the dietary management of a person who, because of their chronic or therapeutic needs, has a limited or impaired capacity to take in, digest, absorb or metabolize ordinary foods or particular nutrients, or on the other hand who has any other particular medically needed nutrient requirements, the dietary management of which is unable to be achieved by changing the normal diet only;
- It gives nutritional support particularly changed for the management of the unique nutritional needs that are as a result of the specific disease or condition when made through medical exam;
- It is intended to be used under medical supervision; and
- It is intended only for a person who is receiving active and ongoing medical supervision because the patient needs medical care on a regular basis that includes being given instructions on how to use of the medical food.
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