The labeling for medical foods must comply with all applicable food labeling requirements except for those specific requirements from which medical foods are exempt. Specifically, the labeling of medical foods must contain:
• A statement of identity (21 CFR 101.3);
• An accurate statement of the net quantity of contents (21 CFR 101.105);
• The name and place of business of the manufacturer, packer, or distributor (21 CFR 101.5); and
• A complete list of ingredients, listed by their common or usual name and in descending order of predominance (21 CFR 101.4).
In addition, all words, statements, and other information required by or under authority of the FD&C Act to appear on a label or labeling of a medical food must appear with prominence and conspicuousness (21 CFR 101.15) and be in English except that, for medical foods distributed solely in the Commonwealth of Puerto Rico or in a Territory where the predominant language is one other than English, the predominant language may be substituted for English (21 CFR 101.15(c)(1)). Further, if a label bears any representation in a foreign language, then all mandatory label information must be repeated in each foreign language used on the label (21 CFR 101.15(c)(2)). Medical food labels must also conform with the principal display panel requirements under 21 CFR 101.1 and the applicable information panel requirements under 21 CFR 101.2. Further, the requirements concerning the misbranding of food (21 CFR 101.18) apply to medical foods.
