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About Medical Foods

Federal Medical Foods Statute

The term ''medical food'' means 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.

21 U.S.C. sec. 360ee(b)(3). -- [from the Orphan Drug Act]

Regulatory Definition of Medical Foods

Specially formulated - not in diet
GRAS (Generally Recognized as Safe) ingredients
Enteral/Oral administration
Medically determined dietary need
Dietary management claims of the disease
Food GMP required
Exempt from nutritional product labeling
Based on recognized science (ie., preclinical, toxicology and clinical trials)
Given to a diseased population or for chronic conditions
Given under a physician's supervision
Not approved, but meets FDA regulations

Generally Recognized As Safe

Any substance that is intentionally added to food is a food additive, that is subject to premarket review and approval by FDA, unless the substance is generally recognized, among qualified experts, as having been adequately shown to be safe under the conditions of its intended use, or unless the use of the substance is otherwise excluded from the definition of a food additive.

GRAS – FDA mandated safety standard

Sections 201(s) and 409 of the Federal Food, Drug, and Cosmetic Act (the Act):

Understanding the difference : Dietary Supplements, Medical Foods and Drugs

  Dietary Supplements Medical Foods Drugs
Physician Supervision Not Required Required Requied (for Prescription Drugs)
Pre-market Scientific Testing Not Required Required Required
Pre-market FDA approval Not Required Not Required Required
Target Population Intended for normal, healthy adults Specially formulated for meeting nutritional requirements of a specific diseased population Specially formulated for patients with a specific indication or symptoms
Claims Make structure/function claims to support healthy functions of body parts, systems, organs or processes Make medical claims for dietary management of a specific disease characterized by distinctive nutritional requirements Make therapeutic claims for treating, preventing or mitigating specific indications
Safety Profile New supplements with new dietary ingredients (NDIs) need only be demonstrated as "reasonably expected to be safe" All ingredients be GRAS Generally Recognized as Safe or approved food additives Need to establish safety through clinical trials
Scientific Requirements Not required if no claims. Claims may be based on existing scientific literature or traditional use. Based on recognized scientific principles, established by medical evaluation Preclinical and Clinical phases I, II and III