Medical Food Status
What is a medical food and why are Visbiome™ and Visbiome™ Extra Strength Medical Foods?
The Orphan Drug Act of 1988 defines “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). FDA regulations 21 C.F.R. 101.9(j)(8) set forth additional criteria for makers of medical food products.
VISBIOME is a medical food as defined by the Orphan Drug Act and additional FDA regulations. VISBIOME is specially formulated and processed to provide a precise mixture of certain bacterial species to the gastrointestinal tract. The gastrointestinal microflora, or “microbiome”, is important for the normal functioning of the human gastrointestinal tract.1,2,3 Patients with irritable bowel syndrome (IBS), ulcerative colitis (UC), and pouchitis have documented deficiencies in luminal concentrations of lactobacilli and bifidobacteria compared with healthy individuals. 4,5,6,7,8,9 In addition, frequent and/or long-term use of antibiotic treatment in these patient populations can further exacerbate deficiencies in the microbiome. Likewise, the gut microbiome of patients with hepatic encephalopathy (HE), and associated liver conditions such as cirrhosis, have been shown to be significantly altered compared to controls. 10,11,12,13,14,15 For example, in patients with liver cirrhosis, differences in colonic mucosal microbiota are found in patients with the cirrhosis plus HE versus those with cirrhosis without HE.
IBS, UC, pouchitis, and HE patients, thus, have distinct nutritional requirements that differ from the general population and thus require the consumption of high levels of probiotic bacteria to maintain an adequate and balanced microflora. In these patients, sufficient adjustment of the microflora cannot be achieved through modification of the normal diet.
VISBIOME is intended for those with irritable bowel syndrome (IBS), ulcerative colitis (UC), pouchitis, or hepatic encephalopathy (HE) who are receiving active and ongoing medical supervision with regular instruction on the use of medical foods.