The labeling of medical foods may not bear the symbol “Rx only.” Section 503(b)(4)(A) of the FD&C Act (21 U.S.C. 353(b)(4)(A)) provides that a prescription drug is misbranded if the label of the drug fails to bear, at a minimum, the symbol “Rx only” to indicate that the product may not lawfully be dispensed without a prescription. Unlike prescription drugs, medical foods are not required by federal law to be dispensed by prescription. Therefore, the use of the symbol “Rx only” in the labeling of a medical food would misbrand a medical food under section 403(a)(1) of the FD&C Act because it would be a false and misleading statement about that product. However, because medical foods are required by statute to be formulated to be consumed or administered enterally under the supervision of a physician, FDA would not object to the use of language to communicate this requirement in the labeling of a medical food product that is not false or misleading (e.g., “must be used under the supervision of a physician”).
