In May of 2007, FDA released a guidance entitled “Frequently Asked Questions About Medical Foods.” Historically, medical foods were regulated as drugs in order to ensure their use under physician supervision. In 1972, FDA re-classified these products from drugs to foods for special dietary use. In the years since, questions have continued to surface concerning what constitutes a medical food.
The recent FDA guidance helps: a) Distinguish between medical foods and products that are regulated as conventional foods, drugs and dietary supplements; and b) Clarify what regulatory requirements apply to medical foods.
What is a medical food?
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 enterally 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.” This definition was incorporated by reference into the Nutrition Labeling and Education Act (P.L. 101-535) of 1990.
FDA has stated that it considers the medical food category to be very narrow. Foods for special dietary use (such as for sick people) and foods that make health claims are not medical foods by such characterizations alone. 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.” To be considered a medical food for regulatory purposes, a product must meet a number of specific requirements (discussed in the response to question 3 below).
What is the significance of “medical food” classification?
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)). 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.
What specifications must medical foods meet to qualify for such exemptions?
Under 21 CFR 101.9(j) (8), a product is a medical food for nutrition labeling exemption purposes only if:
- 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 enteral feeding by tube;
- It is 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;
- 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;
- It is intended to be used under medical supervision; and
- 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.
What labeling regulations apply to medical foods?
As part of the broader category of foods, medical foods must comply with the general food labeling requirements under 21 CFR 101 (e.g., a statement of identity; a statement of the net quantity of contents; the name and place of business of the manufacturer, packer, or distributor; a complete list of ingredients; prominence and packaging display requirements; anti-misbranding requirements and requirements regarding foreign language use). In addition, the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) requirements concerning major allergens also apply to medical foods.
What other regulations apply to medical foods?
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).
This is simply a summary of the FDA guidance provided solely for your information. It does not constitute legal advice nor does your use of this information create a client relationship with Thompson Hine. The text of the full guidance is available at: http://www.cfsan.fda.gov/~dms/medfguid.html. For advice or questions, you can contact Elizabeth directly at Elizabeth.Gobeil (at) ThompsonHine.com or (404) 541-2912.
Thanks to Elizabeth for the contribution and excellent information.