"Medical food" is an FDA-regulated medical product that is a confusing term and a bit of a misnomer. It is defined, by statute, at 21 U.S.C. § 360ee(b)(3) as "a food — which is formulated to be consumed or administered enterally \[by mouth\]— under the supervision of a physician — and which is intended for the specific management of a disease or condition — for which distinctive nutritional requirements — based on scientific principles — are established by medical evaluation." \[Dashes added.\] This definition is incorporated by 21 C.F.R. § 101.9(j)(8)(i)-(v), the FDA's nutrition labeling information regulation.
A medical food must be intended for and labeled for the dietary management of X disease or abnormal condition. One sub-section of this regulation states specifically: "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 (emphasis added)."
Medical foods are very different from dietary supplements, yet both types of products contain nutritional and food ingredients such as vitamins, minerals, amino acids, and herbs. Medical foods must be first be shown, by medical evaluation, to meet the distinctive nutritional needs of a particular patient population before they may be marketed, whereas supplements are intended for normal, healthy adults. Many chronic conditions that occur later in life are characterized by distinctive nutritional requirements and thus amenable to be addressed by medical foods: heart disease, kidney disease, liver disease, Parkinson's disease, Alzheimer's disease, osteoporosis or osteopenia, hypermetabolic states, metabolic syndrome, lung disease, and chronic obstructive pulmonary disease, abnormal glucose tolerance, diabetes, etc.1
Dietary supplements are beneficial for maintaining good health, but cannot treat or even manage any disease or abnormal condition. Beyond a certain age (60? 70?) and depending on genetic predispositions, environment, diet, etc. older consumers will need more than supplements to stay healthy, but may not want to take prescription drugs—or add to the Rx drugs they are already taking. Medical foods are specially formulated for a diseased patient population, and are part of the medical protocol for those patients, whereas dietary supplements are intended for a healthy consumer population. These medical products require physician supervision (and thus institutional administration, and/or a prescription, or close outpatient monitoring) whereas dietary supplements are self-administered by the consumer.
Given the statutory and regulatory requirements of medical foods and their intended use, benefits, and efficacy— for the daily dietary management of an existing chronic disease—there are several reasons that medical foods will become a growing trend in the natural products industry as the U.S. population ages:
- Many older Americans have or will develop chronic diseases or metabolic imbalances that are amenable to the therapeutic benefits of medical foods.
- Many Americans of the Boomer generation grew up with (well, matured with) organic foods and dietary supplements and prefer natural medical products over prescription drugs.
- There are many diseases and abnormal conditions where the diseases and their symptoms cannot be self-diagnosed and self-treated with over-the-counter (OTC) drugs that would be appropriate for, say, temporary constipation.
- Medical foods are very safe—when taken as directed—in that (by law) all ingredients must be either GRAS (generally recognized as safe) or be approved food additives.
- Medical foods contain food and nutrient ingredients, yet are administered and supervised by M.D.s, which thus provides more of a psychological comfort level for the management of chronic diseases.
- Finally, medical foods are unlikely to interact with OTC drugs and Rx drugs, as the ingredients are GRAS, and are typically not herbal (whereas some herbs can interact with drugs).
The billion dollar question is whether medical foods will be reimbursed by Medicare and by health insurance, even after the pending Healthcare reform legislation. But that is another story for another day . . .
Susan Brienza, Esq., Of Patton Boggs LLP, based in Washington, D.C.; [email protected].
1. Some examples from FDA's Advance Notice of Proposed Rulemaking, "Regulation of Medical Foods," Federal Register: November 29, 1996 (Volume 61, Number 231).