An ingredient that is added to a medical food should be safe and in compliance with all applicable provisions of the FD&C Act and FDA regulations. Any ingredient added to a medical food should be: (1) a food additive used in accordance with FDA’s food additive regulations (see 21 CFR part 172); (2) a color additive used in accordance with the color additive regulations (see 21 CFR parts 73 and 74); (3) a substance that is generally recognized, by qualified experts, to be safe under the conditions of its intended use (generally recognized as safe (GRAS)) (see 21 CFR 170.30 and 21 U.S.C. 321(s)); or (4) a substance that is authorized by a prior sanction (see 21 CFR 170.3(l), 21 U.S.C. 321(s)(4)).
