Medical Foods Policy and Regulatory Developments

Global Policy and Regulatory Medical Foods Developments

Codex Alimentarius

  • Codex Alimentarius was created by FAO and WHO in 1963 to develop food standards and guidelines, as well as related texts such as codes of practice under the Joint FAO/WHO Food Standards Programme.  The Codex Alimentarius Commission aims to protect consumer health, ensure fair trade practices, and promote coordination of all food standards work undertaken by international governmental and non-governmental organizations. 
     
  • The Codex Committee on Foods for Special Dietary Uses agreed to develop guidelines on labeling and claims for medical foods in 1980 and accepted the offer of the United States to prepare a set of proposed draft guidelines for consideration at the next session in 1982.  Report of the Twelfth Session of Codex Committee on Foods for Special Dietary Uses, ALINORM 81/26.
     
  • The draft guidelines on labeling and claims for medical foods prepared by the United States were discussed at the 1982 meeting.  Report of the Thirteenth Session of Codex Committee on Foods for Special Dietary Uses, ALINORM 83/26.
     
  • The draft guidelines on labeling and claims for medical foods prepared by the United States were also discussed at the 1985 meeting.  Report of the Fourteenth Session of the Codex Committee on Foods for Special Dietary Uses, ALINORM 85/26.
     
  • The Committee developed a standard instead of a guideline in 1987 and agreed to use “foods for special medical purposes” instead of “medical foods.”  The Proposed Draft Standard was submitted for step 3 comment.  Report of the Fifteenth Session of Codex Committee on Foods for Special Dietary Uses, ALINORM 87/26.
     
  • The Proposed Draft Standard was submitted to the 1989 session of the Codex Alimentarius Commission for adoption as a draft standard.  Report of the Sixteenth Session of the Codex Committee on Nutrition and Foods for Special Dietary Uses, ALINORM 89/26.
     
  • The Committee decided essential information for health professionals should be on the label but was not necessary for consumer labeling.  Report of the Meeting of Intergovenmental Working Groups (CX/FSDU 87) and Report of the Sixteenth Session of the Codex Committee on Nutrition and Foods for Special Dietary Uses, ALINORM 89/26.
     
  • Medical foods were to be labeled in accordance with the Codex’s “General Standard for the Labelling of and Claims for Foods for Special Dietary Uses.”  Codex Alimentarius Committee on Codex General Standard for Labeling of and Claims for Foods for Special Dietary Uses (1985). 
     
  • Certain additional provisions were required for labeling medical foods.  Specifically, medical foods must label the energy value and the content of protein, fat, carbohydrates, vitamins and minerals, and if applicable, amino acids or essential fatty acids.  Osmolality and acid-base balance, where appropriate, must also be on the label. Report of the Sixteenth Session of the Codex Committee on Nutrition and Foods for Special Dietary Uses, ALINORM 89/26. 

National Policy and Regulatory Medical Foods Developments

Canada

  • Defines a “food for special dietary use” as a food that has been specially processed or formulated to meet the particular requirements of a person: (a) in whom a physical or physiological condition exists as a result of a disease, disorder, or injury; or (b) for whom a particular effect, including but not limited to weight loss, is to be obtained by a controlled intake of food.  9.9 Foods for Special Dietary Use [Division 24, FDR]

European Union

  • Compiles European Union rulings and resources relating to foods for special medical purposes.

Germany

United States

Congress

  • Vitamin-Mineral Amendments, Pub. L. No. 94-278 (1976)
    • Prohibited the FDA from classifying vitamin and mineral supplements as drugs based solely on their combinations or potency, unless drug claims were made.  The legislation also incorporated FDA’s 1941 definition of special dietary use into the Food, Drug, and Cosmetic Act.
  •  Federal Food, Drug, and Cosmetic Act, Pub. L. No. 75-717, § 201 (f), (g), 52 Stat. 1040, 1041 (1938), as amended 21 U.S.C § 321 (f), (g) (1982)
    • Medical foods were regulated as drugs prior to 1972 according to Federal Food, Drug, and Cosmetic Act, 21 U.S.C.321(g)(1)(B).
  •  Orphan Drug Act, Pub. Law. 97-114 (1983)
    • Congress amended Orphan Drug Act to formally define a medical food in 1988; reaffirmed in 1992, and again in 1996.
  •  Nutrition Labeling and Education Act of 1990 and subsequent amendments give the FDA authority to require nutrition labeling of most packaged foods regulated by FDA and requires all nutrient claims and health claims meet FDA regulations.  The legislation incorporated the definition of medical foods from the Federal Food, Drug, and Cosmetic Act and exempted medical foods from nutrition labeling, health and nutrient claim requirements, and identified five criteria characteristics of medical food (21 CFR 101.9(J)(8)).  FDA incorporated the statutory medical food definition of this Act into 21 U.S.C.343.  FDA provided guidance on medical foods indicating that Section 101.9(j)(8) exempted medical foods from nutrition labeling, nutrient content claims, and health claim regulations if the product is:
    • 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, because of therapeutic or chronic medical needs, 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, the dietary management of which cannot be achieved by the modification of the normal diet alone;
    • 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;
    • Intended to be used under a medical physician’s supervision; and
    • 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.
  • Medical Foods Equity Act of 2011 (S.311 and H.1311) have been introduced and referred to Committee to provide coverage for medically necessary food under Federal health programs and private health insurance. 

United States Department of Health and Human Services

Food and Drug Administration

  • FDA provided guidance on medical foods in 1997.
  • FDA announced a new proposed regulations (ANPR) in 1996 but withdrew a couple years later.
  • Exempted foods for the use solely under medical supervision to meet nutritional requirements for specific medical conditions from certain labeling requirements. 21 C.F.R. §§ 101.9, 101.9 (h) (3),(4)
  • In 1991, FDA published in the Federal Register information on what a medical food is and the distinctive nutritional and medical supervision requirements of medical foods.
  • FDA contracted to develop enteral products with high nutritional efficacy to improve tissue repair and shorten convalescence during World War II and to address needs of the aerospace program for easily consumable, low residue, high calorie dietary products.  Fisher K, et al. A review of foods for medical purposes. FDA Contract No. 223-75-2090 June 1977; as noted in Hattan DG & Mackey DR. A review of medical foods: Enterally administered formulations used in the treatment of diseases and disorders. Food Drug Cosm. L. J. 44;479-501(1989).
  • FDA implemented a compliance program for medical foods in 1988, requiring all products to be manufactured according to Current Good Manufacturing Practice regulations.
  • FDA expressed during rulemaking in 1973 on vitamin and mineral dietary supplements that the Commissioner recognized medical foods as foods. 38 Fed. Reg. at 2152.
  • FDA reclassified medical foods as “foods for special dietary use” to encourage product development in 1972.  37 Fed Reg. at 18,230.
  • FDA defined foods for “special dietary uses” in 1941. 21 C.F.R. § 105.3

Non-Government Developments & Reports