Medical Food Status
VSL#3® meets the requirements for a medical food, as defined in the Orphan Drug Act, 21 U.S.C. §360ee(b)(3), and FDA regulation 21 C.F.R. §101.9(j)(8), as follows:
(i) 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 (21C.F.R. § 101.9(j)(8)(i));
VSL#3® is specially formulated and processed to provide a precise mixture of certain bacterial species with potential synergistic relationships when consumed in high amounts. The product must be shipped and stored under refrigeration. VSL#3® is a powder that is to be mixed with yogurt, ice cream, apple sauce, or any other cold food or non-carbonated beverage for consumption. Each VSL#3® packet contains 450 billion viable bacteria. The daily intake of the product is between 1 and 4 packets/day (450 to 1,800 x 109CFU/day) for adults and 1/20 to 2 packets/day for children (20 to 900 x 109 CFU/day),
based on the bowel movements, body weight and age of the patient, as noted previously.
(ii) is intended for dietary management of the 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 has other special medically determined nutrient requirements, the dietary management of which cannot be achieved by modification of the normal diet alone (21 C.F.R. § 101.9(j)(8)(ii));
The importance of the gastrointestinal microflora in the normal functioning of the human gastrointestinal tract is well recognized.26,43,23,56 Several studies demonstrate that patients with ulcerative colitis (UC), irritable bowel syndrome, or an ileal pouch may have decreased luminal concentrations of lactobacilli and bifidobacteria compared with normal individuals. 14,52,4,70,72,73 UC, IBS and ileal pouch patients may benefit from consuming significantly higher levels of probiotic bacteria so as to maintain the appropriate quantity and balance of beneficial microflora in their gastrointestinal tract. This is particularly important for these patients in view of their frequent and often long-term antibiotic treatment and recent evidence implicating harmful intestinal bacteria in inflammatory bowel diseases and functional bowel disorders.21,40,70,71,72,73 Hence, UC, IBS and ileal pouch patients may have a distinct nutritional requirement that differs from normal individuals. Daily consumption of extremely high levels of protective probiotic bacteria is needed to maintain adequate and balanced colonization in the gastrointestinal tract, and this cannot be achieved simply by modification of the normal diet.
(iii) 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 (21 C.F.R. § 101.9(j)(8)(iii));
VSL#3® provides specifically modified nutritional support for the management of medically diagnosed ulcerative colitis (UC), Irritable Bowel Syndrome, or an ileal pouch by delivering a high concentration of several strains of live bacteria in a formulation that survives gastric fluid, bile, and pancreatic secretions, and colonizes the gastrointestinal tract. 19,20,44,66,3,2,74,33,69 The ratio of individual bacterium strains in VSL#3® is designed to produce an optimal effect on the composition of the gastrointestinal microecology.
(iv) is intended to be used under medical supervision (21 C.F.R. § 101.9(j)(8)(iv)); and
VSL#3® is intended for use under the supervision of a physician. VSL#3® will be clearly and conspicuously labeled “For use under the supervision of a physician.”
(v) 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 (21 C.F.R. § 101.9(j)(8)(v)).
VSL#3® is intended for use only by ulcerative colitis (UC), Irritable Bowel Syndrome and ileal pouch patients under the care of a physician. By necessity, patients with UC, IBS, or an ileal pouch must receive regular medical care. Such care would include monitoring of the patient’s diet, including consumption of VSL#3®.
