Baby boomers are living longer and are more active but they may still suffer from a chronic condition that needs medication or nutrient supplementation. The medical foods category is poised to play a role in health and quality of life beyond prescription drug therapies.
Medical foods (MFs) are FDA-regulated products, for which there exists a statutory definition, one regulation, and one guidance document for the industry. A subsection of the regulation (exempting MFs from the nutritional labelling requirements that apply to most foods) 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." See 21 C.F.R. sec. 101.9(j)(8).
Medical-food administration in hospitals is sometimes via feeding tubes (for seriously ill patients), but MFs most often are in powdered mix or pill form and do not require refrigeration. 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, but they must meet FDA compliance guidelines.
Here are my top 10 reasons why the medical-foods market should be on your list of product development goals.
- Recent research has shown that a number of diseases are associated with metabolic imbalances and that patients in treatment have specific nutritional requirements. Some examples are osteoporosis and osteopenia, insomnia, IBS, and heart disease.
- Many older Americans have or will develop chronic diseases that are amenable to the 'therapeutic,' dietary management benefits of medical foods. Medical foods help address these diseases and conditions in a drug-free way with food-based ingredients, yet are a medical product taken under supervision by a physician. "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," according to FDA regulations.
- Medical foods consist of 'natural' ingredients very similar to dietary ingredients used in supplements: vitamins, minerals, botanicals, and amino acids. They are the same constituents that occur naturally, but in a medical-foods formula are in concentrated, 'therapeutic' amounts — beyond simply modifying or augmenting the diet.
- Medical foods are intended for a vulnerable population suffering from a particular chronic disease and so have special, extra-rigourous guarantees of safety. All ingredients must be GRAS (Generally Recognized As Safe) or be FDA-approved food additives. Medical foods are taken under the supervision of a physician who monitors and adjusts the food 'dosage.' In addition, under FDA guidelines and the one regulation, even though pre-market FDA approval is not required for a medical food, the official requirements and responsibilities for the manufacturer — in terms of safety — are greater than for supplements, including solid scientific support for the formula as a whole.
- For the same reasons as above, medical foods have (indeed, must have) greater guarantees of efficacy than for dietary supplements.
- Dietary supplements are beneficial for maintaining good health, but cannot treat or even manage any disease or abnormal condition. Medical foods can help bridge the gap for older patients who may need more than supplements to stay healthy, but may not want to take prescription drugs, or add to the Rx or OTC drugs they are already taking.
- More and more information is available to MDs about medical foods and how to use them to help patients. Of note is a recent online piece written by Richard Isaacson, assistant professor of neurology and medicine at the University of Miami Miller School of Medicine. In 'Medical Foods: Overview of an Emerging Science,' Isaacson said, "Medical foods offer physicians an additional tool for approaching and managing various medical conditions. They can help improve the symptoms and/or slow the progression of a specific chronic condition, and they are complementary to approved pharmacologic therapies." Isaacson concluded by saying medical foods "represent an entirely different scientific and medical approach to managing diseases."
- On a monthly basis, medical foods are considerably cheaper than most drugs. One cost drawback is that medical foods for adults are typically not covered under health insurance plans.
- Under a doctor's evaluation and supervision, an older patient could be prescribed a specially-formulated medical food (say, for the dietary management of heart disease) that could potentially serve the same function as two or three prescription drugs. Also, adding a medical food instead of another drug to one's medical protocol means less risk of adverse drug interactions.
- A medical food is easier, cheaper and faster to bring to market than is a drug, yet can be a profitable, beneficial, high-profile product. However, we must point out that the FDA has repeatedly cautioned that medical foods constitute a 'narrow category;' not every disease or even every nutritional-deficiency disease is amenable to medical-food intervention. Given that no FDA pre-approval (or even premarket notification) is required, a company need not spend the millions of dollars for large clinical trials, lowering the barriers to entry for smaller companies.
Susan Brienza is an attorney in the Denver office of international law firm Patton Boggs LLP. This article is not meant, and should not be construed, as a legal opinion or as legal advice, but rather is intended to provide general information and some examples as to one aspect of FDA law.