Food and Dietary Supplement Package Labeling-Guidance from FDA's Warning Letters and Title 21 of the Code of Federal Regulations.

Package labels for foods and dietary supplements must conform with Title 21 of the Code of Federal Regulations. This review provides guidance for the content and format of labels, including for the Nutrient Facts panel and Supplement Facts panel, and for drafting structure/function claims, health claims, and nutrient content claims. Also provided is guidance on how to refrain from drafting disease claims. Inappropriate disease claims on a food or dietary supplement compels FDA to review the product as a drug. Disease claims is the most common source of complaint in FDA's warning letters. This review makes use of all of FDA's warning letters that were published over a 14-y span (2002to 2015). This is the first comprehensive review on package labels to make use of FDA's warning letters as a source document.