The Medical Foods Market

What is a medical food? According to FDAs Web site and section 5(b) of the Orphan Drug Act, 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.

Sandy Bigelow, Ph.D., principal at Vanguard Global Associates, said, Medical foods are supposed to be developed for the dietary management of a disease; they need to provide nutritional sustenance, necessary macro and micronutrients, and vitamins and minerals.

Esra Ogru, Ph.D., chief operating officer, and Jeremy Cottrell, Ph.D., research scientist, Phosphagenics, said: Medical foods differ from normal foods in that they have substantiated health-promoting or disease-preventing benefits beyond the basic delivery of nutrients. And, they differ from nutritional supplements in that they are not designed for use by healthy people, but rather as a therapy for a particular medical condition under the guidance of a medical practitioner.

Marshall Fong, vice president of marketing at Ganeden Biotech, added, These products [medical foods] must be specially formulated and processed instead of being a naturally occurring food.

Original medical foods formulas were engineered for those with genetic diseases that could not handle certain nutrients. For example, patients with phenylketonuria (PKU) cannot metabolize the amino acid phenylalanine. In the 1950s, formulas were developed for those who couldnt metabolize more than 100 to 150 mg/d of phenylalanine, Bigelow said. PKU warnings on soda cans and other products are often necessary due to phenylalanines use in aspartame. Where history collides: one of the first formulas produced as a medical food was in the 1950s by Mead Johnson Nutrition so people with PKU could eat and sustain their lives. In the beginning, FDA regulated them as drugs because they were for diseases, but later switched them as regulated food products. However, Bigelow noted FDA found it untenable to regulate these products as drugs because, as such, they would have to assure the active ingredients were produced in the product at a particular level, which is difficult to do for nutrition formulas; so, in turn, FDA created a new category (in the regulatory sense) and regulated them as foods. And, in 1988 Congress defined what a medical food was in the Orphan Drug Act.

Sheila M. Campbell, Ph.D., R.D., in her paper, History of Tube Feeding, (Nutrition in Clinical Practice 2006;21:411-15), said, The first commercially available [enteral] formulas were elemental. They came on the market in the late 1960s. The formulas were tested by U.S. National Aeronautics and Space Administration (NASA) in an attempt to develop a residue-free formula for use by astronauts. An elemental formulas macronutrients are in simple forms, so little or no digestion is needed before absorption. NASA was looking for ways to eliminate the issue of disposing of human waste in outer space, but the formulas were not used due to their poor taste profile.

As medical foods are used the treat a specific medical condition, they are administered with oversight from a health care professional, Ogru and Cottrell said. This could be intensively as part of hospitalized treatment, even via a nasogastric tube, but typically, medical foods will be consumed orally.

Ensure was introduced in 1973 by a division of Abbott Nutrition, Ross Products. It was, the first intact-nutrient, lactose-free, ready-to-use adult medical nutrition product in the United States. It was an all-purpose product, designed for tube feeding and oral supplementation, Campbell noted in her 2006 paper. Glucerna® was the first enteral formula to be patented and was developed in 1989 by Ross Products for patients with diabetes, and Pedialyte® was one of the first retail medical foods for children.

There is no set protocol for a company to market a product as a medical food. Sebastian Cianci, FDA spokesman, said: There is no premarket review or approval process in order for manufacturers to market a product as a medical food; however, the product must meet the burden of the statutory definition of a medical food. The onus is on the manufacturer to be in compliance with all applicable regulations pertaining to the manufacturing and labeling of a medical food. The medical food must do what it's intended to do.

Medical foods only require a voluntary notification of safety to FDA to market the product to consumers. Bigelow said, Medical foods are primarily being sold to health-care professionals and used by informed individuals, which is the rational for not requiring FDA notification."

[Medical foods] are to be labeled as used under medical supervision," he continued. "No prescription is necessary, but people probably wouldnt go into the store and buy Glucerna unless they were told by a physician. Originally, FDA said it has be under physician supervision because Congress used the word physician, but that would exclude osteopath doctors, nutritionists and various other health care providers who have the proper training capable of administering medical foods." He said FDA opted for use under medical supervision instead of used under physicians direction.

Ogru and Cottrell noted while medical foods are not required to submit for pre-market approval or review by FDA, any health claims need to be substantiated by clinical trials and substantial scientific evidence, all ingredients must have GRAS (generally recognized as safe) status, and the product must also comply with general food safety and manufacturing standards. "It should be noted that nutritional supplements are also permitted to make health claims, but only when there is a well-established dietary link, such as calcium and osteoporosis," they added.

But, in 2002, Al Czap, publisher of Alternative Medicine Review, wrote an editorial, The FDA, Medical Foods and Patents (October 2002), in which he recommended caution when deciding to label a product as a medical food. This labeling exemption [FDAs definition of a medical food]one of a small handfulwas crafted to allow a physician to formulate a specialty food for a patient with limited or impaired capacity to ingest, digest, absorb or metabolize ordinary foodstuffs or nutrients. Every company who markets its proprietary medical food on the shelves of health-food storesby creating a truck-size loophole in a regulation where none rightfully existsputs in jeopardy the ability of legitimate food and supplement companies to manufacture and market needed products for a small portion of the patient populationthe orphan drug equivalent of a food if you will.

Charles Mueller noted in Nutrition in Clinical Practice (1995 Feb;10(1):8-15), Before effective regulations can be developed, medical foods need to be defined further in order to distinguish them from each other and from other classes of nutritional products such as parenteral nutrients or infant formulas. Because we believe that the role of medical foods is in supportive care rather than pharmacologic therapy, we argue that these products should be subject to regulations similar to those that apply to conventional foods.

The cost of administering medical foods is another area of confusion for health care providers. Bigelow noted under Medicare part B, the U.S. government pays for and reimburses hospitals for liquid nutrition formulas that are given to patients in the hospital. And a report provided by American Agricultural Economics Association in its series 2005 Annual meeting, July 24 to 27, Providence, RI, said, Medical foods fall in-between food and drugs. Because they are more expensive than normal foods, some states have mandated insurance companies (or their own state agencies) to provide coverage for the afflicted community, leaving a checkered pattern of coverage across the U.S., where insurance laws fall within state domain. The reports results indicated the choice of reimbursement mechanism is affected largely by the same variables as legislative adoption.

Gauging the Market for Medical Foods

In her paper, Campbell estimated the U.S. market for medical nutrition products to have surpassed $1 billion in 2006. And, to the best of Bigelows understanding, the medical foods market is currently worth approximately $1.6 billion; of this figure, Ensure and Boost® sales (from Abbott Nutrition) account for approximately $1 billion of the $1.6 billion.

With such a dominant market share, the entire medical foods category can be reflected in the sales trend of Ensure and Boost, which are part of Abbott's nutritional products division. According to Abbotts fiscal 2008 annual report its nutritional products net sales to external customers grew significantly from 2006 to 2008, with double-digit growth between 2007 and 2008. There is no data available on the exact sales growth of Ensure and Boost, but this division growth suggests a positive trend which could further suggest opportunity in the medical foods market.

Several medical foods have come to the market in the past decade. In 2006, Limbrel® (flavocoxid), the first medical food for the management of osteoarthritis launched; in 2009, Axona was deemed by FDA as a medical food, targeting metabolic deficiencies associated with Alzheimer's disease; the well-researched VSL #3, a probiotic for ulcerative colitis and ileal pouch, hit the market in 2002; and NiteBite, a snack bar for the nutritional management of hyperglycemia, has been marketed since 1996.

We offer medical foods for irritable bowel syndrome (IBS), lactose intolerance and Crohns disease, Fong said. We have completed two clinical trials on IBS and one in Crohns. There are other published trials on the Bacillus coagulans strain in IBS, antibiotic-associated diarrhea and immune boosting.

Phosphagenics does not currently have any medical foods on the market, but have clinical trials underway testing our proprietary vitamin E phosphate formulation (Phospha E) in collaboration with our commercial partners, Ogru and Cottrell said.

To help clarify the market, Bigelow broke down medical foods into two channels: the ethical channel, used in hospitals and skilled nursing facilities; and the retail channel, used in retail stores such as Wal-Mart, Walgreens and CVS. Ogru and Cottrell added Currently medical foods fall into a couple of categories, from those used as a hospital-based treatment for intensively ill or recovering patients to those used everyday to treat or prevent chronic disease.

In 1997, a published research report (J Nutraceut. 1997;1(3):45-57) speculated federal officials were revisiting the availability of medical foods, stating: In the Fall of 1996, reacting to industry's increasingly expansive interpretation of the medical food classification, FDA proposed a more restrictive definition of the category. Whether the category's estimated growth rate of 25 percent per year will continue, and the medical foods market share (estimated at $50 to $60 million, today) will represent a substantially larger slice of the $17.2 billion nutrition industry market, depends on the complex interactions between regulatory, marketing and technical factors over the next two years, by which time the FDA is expected to have implemented its new regulatory policies.

However, Cianci said, There are no current plans to revisit the regulation as it pertains to medical foods; the Advanced Notice of Proposed Rulemaking, dated November 29, 1996, continues to reflect the current thinking of FDA.

So how does the medical foods forecast look? Ogru and Cottrell believe there are three broad factors indicating that medical foods will continue to grow in importance over the coming years. From a medical standpoint, we are seeing an increasing prevalence of diseases that are candidates for treatment with medical foods such as metabolic syndrome, IBS and food intolerances. Additionally, our aging population will see an increase incidence of age-related digestive tract diseases as well as reduced general digestive and absorptive function. There is a high level of acceptance of metabolic foods as a therapy by patients, however work remains to reduce skepticism in elements of the medical community that medical foods are viable alternatives to prescription drugs and different from nutritional supplements. From a regulatory standpoint, FDA made steps in 1988 to encourage the development of additional medical foods by awarding them orphan drug status and introducing a special product category. These regulatory changes reduce the costs and time associated with bringing medical foods to market, as beforehand medical foods were treated as pharmaceutical drugs. And lastly, the field of candidates for development into medical foods is always expanding due to constant advances in the understanding of nutrition and disease, coupled with advances in food technology increasing the number of products that can be formulated and commercialized.

Campbell sees reason for medial foods formulas to grow in importance, at least in certain areas of health. In her report, she said the completion of the Human Genome Project will have major effects on tube feeding. Nutrigenomics can be expected to influence acute nutrition intervention, including tube feeding, by allowing the identification of bioactive food components that will ameliorate the onset, incidence or progression of acute disease and complicating conditions. We can expect to see a blossoming of disease-, condition- and genetic-specific formulas.

The medical foods market does have room for growth and many companies are stepping up to take advantage of the opportunities this market has to offer.