The labeling of medical foods should not include NDC numbers. Drug products are identified and reported using a unique, three-segment number, called the NDC, which is a universal product identifier for human drugs.4
NDC numbers are intended for uniquely identifying drugs and should not be used in the labeling of medical foods since they are not drugs. The presence of an NDC number on a food product that is not a drug misbranded the product under section 403(a)(1) of the FD&C Act. In addition, any representation that creates an impression of official FDA approval through the use of an NDC number in labeling constitutes misbranding.
