What is a medical food and why is Visbiome® classified as one?Updated 2 months ago

A medical food is a specially formulated product intended for the dietary management of a disease or condition with distinct nutritional requirements, as established by medical evaluation. It must be consumed under physician supervision and meet specific regulatory criteria set forth in the Orphan Drug Act [21 U.S.C. § 360ee(b)(3)] and 21 C.F.R. 101.9(j)(8).

Visbiome® qualifies as a medical food because it is designed to help manage the distinct nutritional requires of patients with dysbiosis-related conditions, such as Irritable Bowel Syndrome (IBS), Ulcerative Colitis (UC), and Antibiotic-Associated Diarrhea (AAD). Its proprietary probiotic formulation has been extensively studied in these patient populations, demonstrating its ability to meet their unique dietary needs. Independent medical evaluations have further confirmed its role in addressing these specific nutritional requirements.