FDA

Guidance for Industry: Frequently Asked Questions About Medical Foods


May 1997; Revised May 2007

Contains Nonbinding Recommendations

Additional copies are available from:
Office of Nutritional Products, Labeling and Dietary Supplements
Center for Food Safety and Applied Nutrition
Food and Drug Administration
5100 Paint Branch Parkway
College Park, MD 20740
(Tel) 301-436-2375
http://www.cfsan.fda.gov/guidance.html

U.S. Department of Health and Human Services
Food and Drug Administration
Center for Food Safety and Applied Nutrition
May 2007

Contains Nonbinding Recommendations

This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance.

Table of Contents


  1. INTRODUCTION
  2. Questions and Answers
    1. What is a medical food?
    2. Has FDA established by regulation any criteria that clarify the statutory definition of a medical food?
    3. Do the labeling requirements for nutrient content claims and health claims apply to medical foods?
    4. What labeling regulations apply to medical foods?
    5. What other regulations apply to medical foods?
    6. Does the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) apply to medical foods?
    7. Do medical foods have to be approved or registered with FDA?
    8. Does the FDA have a Compliance Program specifically for medical foods?
    9. What is the purpose of FDA's compliance program for medical foods?


  1. INTRODUCTION

  2. This list of frequently asked questions (FAQ's) is intended to be a convenient place for industry to find answers to common questions about medical foods. The responses to these FAQ's address common questions about the definition of and regulations for medical foods.

    FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.


  3. Questions and Answers

    1. What is a medical food?

    2. The term medical food, as defined in section 5(b) of the Orphan Drug Act (21 U.S.C. 360ee (b) (3)) is "a food which is formulated to be consumed or administered internally under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation." The agency advises that it considers the statutory definition of medical foods to narrowly constrain the types of products that fit within this category of food (see Food Labeling; Reference Daily Intakes and Daily Reference Values; Mandatory Status of Nutrition Labeling and Nutrition Content Revision proposed rule (56 FR 60366 at 60377, November 27, 1991)).

      Medical foods are distinguished from the broader category of foods for special dietary use and from foods that make health claims by the requirement that medical foods be intended to meet distinctive nutritional requirements of a disease or condition, used under medical supervision and intended for the specific dietary management of a disease or condition. The term "medical foods" does not pertain to all foods fed to sick patients. Medical foods are foods that are specially formulated and processed (as opposed to a naturally occurring foodstuff used in a natural state) for the patient who is seriously ill or who requires the product as a major treatment modality. In general, to be considered a medical food, a product must, at a minimum, meet the following criteria: the product must be a food for oral or tube feeding; the product must be labeled for the dietary management of a specific medical disorder, disease, or condition for which there are distinctive nutritional requirements; and the product must be intended to be used under medical supervision (see Food Labeling; Reference Daily Intakes and Daily Reference Values; Mandatory Status of Nutrition Labeling and Nutrition Content Revision proposed rule (56 FR 60366 at 60377, November 27, 1991). The criteria for being considered a medical food is more specifically addressed in question 2 below.


    3. Has FDA established by regulation any criteria that clarify the statutory definition of a medical food?

    4. Yes. The following criteria that clarify the statutory definition of a medical food can be found in the agency's regulations at 21 CFR 101.9(j) (8). A food is a medical food exempt from nutrition labeling only if:

      1. It is a specially formulated and processed product (as opposed to a naturally occurring foodstuff used in its natural state) for the partial or exclusive feeding of a patient by means of oral intake or internal feeding by tube;(2) capacity to ingest, digest, absorb, or metabolize ordinary foodstuffs or certain nutrients, or who has other special medically determined nutrient requirements, the dietary management of which cannot be achieved by the modification of the normal diet alone;
      2. It is intended for the dietary management of a patient who, because of therapeutic or chronic medical needs, has limited or impaired
      3. It provides nutritional support specifically modified for the management of the unique nutrient needs that result from the specific disease or condition, as determined by medical evaluation;
      4. It is intended to be used under medical supervision; and
      5. It is intended only for a patient receiving active and ongoing medical supervision wherein the patient requires medical care on a recurring basis for, among other things, instructions on the use of the medical food.



    5. Do the labeling requirements for nutrient content claims and health claims apply to medical foods?

    6. No. Medical foods are exempted from the labeling requirements for health claims and nutrient content claims under the Nutrition Labeling and Education Act of 1990 (see 21 U.S.C. 343 (q) (5) (A) (iv)).


    7. What labeling regulations apply to medical foods?

    8. Medical foods are foods and therefore their label must contain a statement of identity (the common or usual name of the product) (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 Federal Food, Drug, and Cosmetic Act (FFDCA) 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)). 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 foods also must be labeled in conformance with the principal display panel requirements (21 CFR 101.1), the information panel requirements (21 CFR.101.2), and the misbranding of food requirements (21 CFR 101.18).


    9. What other regulations apply to medical foods?

    10. Medical foods must comply with all applicable requirements for the manufacture of foods, including the Current Good Manufacturing Practices regulations (21 CFR part 110), Registration of Food Facilities requirements (21 CFR part 1 Subpart H) and, if applicable, the Low Acid Canned Food regulations (21 CFR part 113) and Emergency Permit Control regulations (21 CFR part 108). Ingredients used in medical foods must be approved food additives or a food additive that is the subject of an exemption for investigational use (21 U.S.C. 321 and 348), if the ingredients are not Generally Recognized as Safe (GRAS).


    11. Does the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) apply to medical foods?

    12. Yes. FALCPA requires that medical foods labeled after January 1, 2006, include on the label in plain language the food source name of the major allergens (i.e. milk, eggs, fish (e.g., bass, flounder, cod), crustacean shellfish (e.g., crab, lobster, or shrimp), , tree nuts (e.g., almonds, pecans, or walnuts), wheat, peanuts, and soybeans.


    13. Do medical foods have to be approved or registered with FDA?

    14. No. Medical foods do not have to undergo premarket review or approval by FDA and individual medical food products do not have to be registered with FDA.


    15. Does the FDA have a Compliance Program specifically for medical foods?

    16. Yes. You can find a copy of the agency's compliance program at "MEDICAL FOODS PROGRAM - IMPORT AND DOMESTIC (FY 06/07/08)"


    17. What is the purpose of FDA's compliance program for medical foods?

    18. The Compliance Program enables FDA inspectors to (1) obtain information regarding the manufacturing/control processes and quality assurance programs employed by domestic manufacturers of medical foods through establishment inspections, (2) collect domestic and import surveillance samples of medical foods for nutrient and microbiological analyzes, and (3) take action when significant violations of the Federal Food, Drug and Cosmetic Act (or related regulations) are found.


[1] This guidance has been prepared by the Office of Nutritional Products, Labeling and Dietary Supplements in the Center for Food Safety and Applied Nutrition at the U.S. Food and Drug Administration.

[2]Enteral feeding by tube refers to a tube or catheter that delivers nutrients beyond the oral cavity directly into the stomach or small intestine. It should not be confused with parenteral (or intravenous) nutrient formulations which are regulated under existing drug law.


This document supersedes Medical Foods, May 1997