Traditionally, medical foods were prescribed under the supervision of healthcare practitioners. Now, medical foods can be found in grocery stores and at pharmacy counters. Should they be? The definition of medical foods seems to be openly interpreted as the category grows.
The U.S. Food and Drug Administration (FDA) defines a medical food in three parts:
The first bullet point has become muddied now that medical foods are increasingly available direct to consumers. Take Abbott Laboratories' Pedialyte, for example, regarded as one of the first retail medical foods. Abbott also owns Ensure, a mix of prebiotics and antioxidants to help support adult digestive tract health. The company captured a large portion of the U.S. medical foods market in 2009: $1 billion of the total $1.6 billion market estimated in the published paper, "History of Tube Feeding."
Medical foods isn't just big business—they have been found to provide life-changing relief for serious medical conditions. A recently published study in the Journal of Clinical Lipidology found that Metagenics' UltraMeal PLUS 360 combined with a low-glycemic, Mediterranean-style diet resulted in a 44 percent reduction or net resolution of metabolic syndrome over a 12-week period.
"All our medical foods are sold to licensed healthcare practitioners who dispense them," said Robert Lerman, M.D., Ph.D., director of Medicine and Extramural Clinical Research for Metagenics. "Exactly why the FDA has allowed these other so-called medical foods to be sold in this way isn't clear to me."
Some of Metagenics' products can be found at online retailers, but this isn't sanctioned by the company and a full-time staffer works to shut down these online sales. "This is not the way Metagenics intends to sell its products," said Lerman. Currently, more than 75,000 healthcare providers worldwide using Metagenics' science-based medical foods, nutritional formulas and lifestyle therapy programs.
"How someone purchases the product I do not think matters," said Douglas Kalman, Ph.D., RD, FACN. Kalman is director of business development for Miami Research Associates. "Ensure is considered medical food and is easily purchased in the nutritional aisles of the supermarket and not in the pharmacy section."
Availability of medical foods in mass markets is causing some gray area for dietary supplements. "We're seeing products that look like dietary supplements now being marketed as medical foods for the purpose of disease-related claims," said Todd Harrison during a recent Nutrition Capital Network Webinar about medical foods. As a partner for Venable in Washington, D.C., Harrison said FDA clearly construes medical foods as a narrow category.
But take B vitamins that the elderly have a hard time processing. Because of this deficiency, could B vitamins be called a "distinctive nutritional requirement?" However, all indicators point to no because B vitamins can be found over the counter and taken independently of a healthcare practitioner's knowledge. And the FDA may not believe that a pill is an appropriate delivery vehicle, said Harrison.
FDA warning letters show that the following diseases or conditions do not have distinctive nutritional requirements:
Medical foods find their roots in the 1930s with the passage of the Federal Food, Drug and Cosmetic Act of 1938. The Dietary Supplement Health and Education Act of 1994, or DSHEA, amended this law, which remains to this day the primary law governing dietary supplements in the United States.
The 1938 act acknowledged a category now oft ignored by food and drug lawyers: "foods for special dietary use." This category shared some characteristics of modern medical foods (i.e., specially formulated), but they did not require a physician's supervision and largely included products such as meal replacements for weight loss and sugar-free products for diabetics, according to The Obesity Society.
It wasn't until the Orphan Drug Amendments of 1988 that medical foods received its definition. This definition and disclaimer states that although medical foods are "sometimes prescribed in addition to drugs, they represent an entirely different scientific and medical approach to managing diseases." Examples of medical foods that help to manage diseases include Axona by Accera for Alheimer's and UltraMeal PLUS 360 by Metagenics for metabolic syndrome.
Pursuing the medical food route has its pros and cons. The barrier to entry is moderate—not as high as a drug but not as low as a dietary supplement—and medical foods do not need FDA approval. However, all medical foods must comply with applicable requirements for the manufacture of foods, including GMP and GRAS regulations.
"If you can't convince the agency that the product has a unique dietary need," said Harrison of Venable, "you can fall back to dietary supplements and make a structure/function claim." But take omega-3s for example—could it potentially fit into and be marketed as a dietary supplement, a medical food and a drug? Harrison said if so, "they should be branded differently and not refer to each other's literature."
Harrison strongly advises that companies wishing to market medical foods give FDA a "very strong" scientific dossier to support its product's conclusions. This dossier should include a human clinical study of U.S. patients if the product is to be sold to that population.
Without one, the product stands little chance of being classified as a medical food. The dossier must demonstrate that "a specific disease or medical condition has unique nutritional needs that cannot be otherwise met through simple modification to the diet," said Harrison.
In other words, a product may be nutritional, but unless the nutrients are absolutely necessary to aid a condition—and they cannot be attained via simple means—the product won't be classified as a medical food.