definiens: means, subject to the limitations set forth below, any food or other preparationfor human consumption, including enteral or parenteral consumption, which ( i ) when taken into the body, serves tonourish or build up tissues, supply energy or maintain, restore or support adequate nutritional status or metabolicfunction, and ( ii ) is formulated to be useful in nutritional or dietary management or supplementation, or is formulatedspecifically for patients with a specific disease or condition or special dietary needs, and ( iii ) are marketed tophysicians, health care professionals and health - related institutions ( i.e., hospitals, physician ’s offices, skilled nursingfacilities and clinics ) where such marketing activities account for greater than thirty percent ( 30 % ) of the aggregateannual promotional spending allocable to such medical nutritional product line, and ( iv ) may optionally also bepromoted directly to the end consumers or marketed at retail for general use