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Medical Food Labeling and Ingredient Requirements
Even though the commercialization of medical foods does not require FDA approval, the agency has published a guidance document for the industry (last updated in May 2016). Barring specific exemptions, medical foods are required to comply with all applicable food labeling requirements. The ingredients added to these products should be “safe and in compliance with all applicable provisions of the FD&C Act and FDA regulations.”

Overview of FDA’s Regulations for the Medical Foods Industry
  • Medical food manufacturers are not required to seek the approval of FDA to commercialize their products.
  • As medical foods are not drugs, they are “not subject to any regulatory requirements that specifically apply to drugs.” 
  • FDA’s Office of Nutrition and Food Labeling has published a guidance document for the medical foods industry. 
  • FDA’s guidance documents “do not establish legally enforceable responsibilities” as they only provide the agency’s “current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.” 
  • FDA’s Guidance for Labeling Requirements of Medical Foods 
  • Except for specific exemptions, medical foods are required to comply with every applicable food labeling requirement.
  • The labeling must contain information such as a “statement of identity,” an accurate statement of the “net quantity of contents,” the name and place of business of the “manufacturer, packer, or distributor,” and a “complete list of ingredients, listed by their common or usual name and in descending order of predominance.” 
  • The information published must appear with “prominence and conspicuousness 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.” 
  • The labels must also follow the “principal display panel requirements under 21 CFR 101.1 and the applicable information panel requirements under 21 CFR 101.2.” 
  • The labeling of medical foods must not bear the symbol “Rx only” (prescription only) and National Drug Code (NDC) numbers as they are not drugs. 
  • A medical food is exempted from the above labeling requirements if it is “a specially formulated and processed product for the partial or exclusive feeding of a patient by means of oral intake or enteral feeding by tube,” intended for the dietary management of a patient who “has limited or impaired capacity to ingest, digest, absorb, or metabolize ordinary foodstuffs or certain nutrients, or who has other special medically determined nutrient requirements,” provides “nutritional support specifically modified for the management of the unique nutrient needs that result from the specific disease or condition,” intended to be “used under medical supervision,” and intended only for “a patient receiving active and ongoing medical supervision wherein the patient requires medical care on a recurring basis.” 
  • Medical foods are also exempted from the labeling requirements for nutrient content and health claims. 


FDA’s Guidance for Ingredient Added to Medical Foods
  • The ingredients added to medical foods should be “safe and in compliance with all applicable provisions of the FD&C Act and FDA regulations.”
  • Any ingredient added should be a “food additive used in accordance with FDA’s food additive regulations,” a “color additive used in accordance with the color additive regulations,” a “substance that is generally recognized, by qualified experts, to be safe under the conditions of its intended use,” and a “substance that is authorized by a prior sanction.” 
  • As mentioned above, the list of ingredients added to the medical foods must be published on the labels of the products.

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