Clinical data on the use of LOLA for Hepatic encephalopathy

Unlike supplements and pharamceuticals, a medical food, as defined in section 5(b)(3) of the Orphan Drug Act (21 U.S.C. 360ee(b)(3)), is “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.” Medical Foods, including HepLOLA can be purchased without a prescription. HepLOLA is made in the USA in an FDA inspected facility under cGMP guidelines.